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Grants.gov is the official U.S. government platform for finding and applying for federal grants. Operated by the U.S. Department of Health and Human Services, it serves as the central hub for grant opportunities across all federal agencies. Simpler.Grants.gov is the next generation platform being built with public collaboration to set a new standard for transparency and usability in government grant services.
Funding Opportunities
NIAID Investigator Initiated Program Project Applications (P01 Clinical Trial Not Allowed)
This Funding Opportunity Announcement (FOA) invites submission of investigator-initiated Program Project (P01) applications. The proposed programs should address scientific areas relevant to the NIAID mission including: biology and pathogenesis of infectious microbes, including HIV; host-microbe interactions; mechanisms regulating immune system development and function across the lifespan, and in response to infectious pathogens; immune dysfunction resulting in allergy, asthma, autoimmunity, immunodeficiency, or transplant rejection; and translational research to develop vaccines, therapeutics, and diagnostics to prevent and treat infectious and immune-mediated diseases. Each P01 application submitted to this FOA must include at least two related, synergistic research projects that share a common central theme, focus, and/or overall objective; and an administrative core. A P01 may include scientific cores, if needed for the proposed research.
National Cancer Institute Program Project Applications for the Years 2023, 2024, and 2025 (P01 Clinical Trial Optional)
Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) invites applications for investigator-initiated Program Project (P01) applications. The proposed Program may address any of the broad areas of cancer research, including (but not limited to) cancer biology, cancer prevention, cancer diagnosis, cancer treatment, and cancer control. Basic, translational, clinical, and/or population-based studies in all of these research areas are appropriate. Each application submitted in response to this FOA must consist of at least three research projects and an Administrative Core. The projects must share a common central theme, focus, and/or overall objective. This is a multi-year funding opportunity covering years 2023, 2024, and 2025.
Collaborative Program Grant for Multidisciplinary Teams (RM1 - Clinical Trial Optional)
This funding opportunity announcement (FOA) is designed to support highly integrated research teams of three to six PD/PIs to address ambitious and challenging research questions that are important for the mission of NIGMS and are beyond the scope of one or two investigators. Collaborative program teams are expected to accomplish goals that require considerable synergy and managed team interactions. Project goals should not be achievable with a collection of individual efforts or projects. Teams are encouraged to consider far-reaching objectives that will produce major advances in their fields. Applications that are mainly focused on the creation, expansion, and/or maintenance of community resources, creation of new technologies or infrastructure development are not appropriate for this FOA. This FOA is being reissued to allow submission of applications that include NIH defined clinical trials. NIGMS will not accept clinical trials that are designed to test safety and efficacy of interventions (Phase I, Phase II, Phase III) for the purpose of future clinical treatment and/or regulatory approval in response to this FOA.
NEI Collaborative Clinical Vision Research: Chair's Grant (UG1-Clinical Trial Required)
The NEI uses UG1 cooperative agreement awards to support investigator-initiated large-scale clinical trials, human gene-transfer, stem cell therapy trials, and other complex or high resource- or safety-risk clinical trials. These projects are multifaceted and of high public health significance requiring clear delineation of study organization including roles and responsibilities and require careful performance oversight and monitoring. For purposes of this Notice of Funding Opportunity (NOFO), the proposed study must be intended to evaluate interventions aimed at screening, diagnosing, preventing, or treating vision disorders, or to compare the effectiveness of two or more established interventions. The NEI UG1-supported studies are typically funded as a group of single-component companion grant awards including the Chairs Grant, the Coordinating Center, and Resource Centers, when appropriate. Specifically, this NOFO encourages applications for the Chair's grant, which includes the scientific rationale, study aims and significance of the research project.
NEI Collaborative Clinical Vision Research Project: Resource Center Grant (UG1 Clinical Trial Required)
The NEI uses UG1 cooperative agreement awards to support investigator-initiated large-scale clinical trials, human gene-transfer, stem cell therapy trials, and other complex or high resource- or safety-risk clinical trials. These projects are multifaceted and of high public health significance requiring clear delineation of study organization including roles and responsibilities and require careful performance oversight and monitoring. For purposes of this Notice of Funding Opportunity, the proposed study must be intended to evaluate interventions aimed at screening, diagnosing, preventing, or treating vision disorders, or to compare the effectiveness of two or more established interventions. The NEI UG1-supported studies are typically funded as a group of single-component companion grant awards including the Chairs Grant, the Coordinating Center, and Resource Centers, when appropriate. Specifically, this NOFO encourages applications for the Resource Center grant which provides imaging, laboratory, or other requisite services for a multi-center clinical trial or other complex or high-risk clinical trial.
NEI Collaborative Clinical Vision Research Project: Coordinating Center Grant (UG1 Clinical Trial Required)
The NEI uses UG1 cooperative agreement awards to support investigator-initiated large-scale clinical trials, human gene-transfer, stem cell therapy trials, and other complex or high resource- or safety-risk clinical trials. These projects are multifaceted and of high public health significance requiring clear delineation of study organization including roles and responsibilities and require careful performance oversight and monitoring. For purposes of this Notice of Funding Opportunity (NOFO), the proposed study must be intended to evaluate interventions aimed at screening, diagnosing, preventing, or treating vision disorders, or to compare the effectiveness of two or more established interventions. The NEI UG1-supported studies are typically funded as a group of single-component companion grant awards including the Chairs Grant, the Coordinating Center, and Resource Centers, when appropriate. This NOFO specifically encourages applications for the Coordinating Center grant, which provides details of the Coordinating Center's responsibilities and operations.
Limited Competition: National Primate Research Centers (P51) (Clinical Trials Not Allowed)
This funding opportunity announcement encourages grant applications that support the activities of the National Primate Research Centers (NPRCs). Nonhuman primates (NHPs) are most closely related to humans, both physiologically and genetically. Therefore, NHPs are critical animal models for basic and translational research aimed at understanding human biology, both in normal and diseased states. Proper husbandry and management of NHPs require specialized physical and intellectual resources, which are most effectively and economically provided in centralized primate centers, the resources of which are made available to investigators on a national basis. The NPRCs provide these resources to investigators/grantees who utilize NHPs in biomedical research and thereby complement and help enable the missions of the NIH Institutes and Centers. This is a limited competition opportunity specifically designed to support existing National Primate Research Centers infrastructure.
Center for Inherited Disease Research (CIDR) High Throughput Sequencing and Genotyping Resource Access (X01 Clinical Trial Not Allowed)
The Center for Inherited Disease Research (CIDR) high-throughput genotyping, sequencing and supporting statistical genetics services are designed to aid the identification of genes or genetic modifications that contribute to human health and disease or to enhance existing collections of well-phenotyped specimens in biorepositories by the addition of genotype or next-generation sequence data. The laboratory specializes in genomic services that cannot be efficiently carried out in individual investigator laboratories. CIDR provides the most up-to-date platforms, services and statistical genetic support. This is an NIH-wide initiative that is managed by NHGRI (National Human Genome Research Institute). The program offers access to specialized high-throughput sequencing and genotyping resources to support research that cannot be efficiently conducted in individual laboratories.
Native American Research Centers for Health (NARCH) (S06 Clinical Trial Optional)
The Native American Research Centers for Health (NARCH) program is a grant opportunity offered by the National Institutes of Health to support federally-recognized American Indian/Alaska Native (AI/AN) tribes and tribal organizations. The program funds health-related research, research career enhancement, and research infrastructure enhancement activities within Native American communities. This program is designed to build research capacity and support health disparities research specifically focused on AI/AN populations. The grant enables tribal entities to establish and maintain research centers that can conduct meaningful health research while enhancing the research skills of tribal members and improving research infrastructure. The NARCH program falls under multiple NIH assistance listings including Environmental Health, Human Genome Research, Aging Research, Alcohol Research Programs, Minority Health and Health Disparities Research, and various other biomedical research categories. Applications are accepted through a rolling deadline structure with a final closing date of August 7, 2026. Eligible applicants include federally-recognized Native American tribal governments and other Native American tribal organizations. The program allows for clinical trial optional proposals, providing flexibility in the types of research projects that can be proposed.
NEI Institutional Mentored Physician Scientist Award (K12 Clinical Trial Optional)
The purpose of this Notice of Funding Opportunity (NOFO) is to encourage institutions to propose creative and innovative institutional research career development programs which will prepare clinically trained vision scientists for independent research careers. This NOFO is intended to expand and strengthen the community of clinician investigators engaged in vision research. This Notice of Funding Opportunity (NOFO) allows the appointment of Scholars proposing to serve as the lead investigator of an independent clinical trial; or proposing a separate ancillary clinical trial; or proposing to gain research experience in a clinical trial led by another investigator as part of their research and career development program. For this career development program scholars are limited to clinical trials that are minimal risk. The existing clinical trial must be a NIH-defined clinical trial that fulfills the NIH requirement for minimal risk trial. A minimal risk trial is one in which the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Advanced Laboratories for Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness (ALACRITY) Research Centers (P50 Clinical Trial Optional)
This Funding Opportunity Announcement (FOA) invites applications for centers to support transdisciplinary teams of clinical and mental health services researchers, behavioral scientists, social scientists, health information and communications technologists, health systems engineers, decision scientists, and mental health stakeholders (e.g., service users, family members, clinicians, payers) to engage in high-impact studies that will significantly advance clinical practice and generate knowledge that will fuel transformation of mental health care in the United States. Advanced Laboratories for Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness (ALACRITY) Research Centers will support the rapid development, testing, and refinement of novel and integrative approaches for (1) optimizing the effectiveness of therapeutic or preventive interventions for mental disorders within well-defined target populations; (2) organizing and delivering optimized mental health services within real world treatment settings; and (3) continuously improving the quality, impact, and durability of optimized interventions and service delivery within diverse care systems. The ALACRITY Centers program is intended to support research that maximizes synergies across various components of the mental health research ecosystem, including new discoveries in clinical research, transformative health care technologies, advances in information science, and new federal and state mechanisms for organizing mental health care.
National Centers for Biomedical Imaging and Bioengineering (NCBIB) (P41 Clinical Trials Optional)
This Funding Opportunity Announcement (FOA) encourages grant applications for Biomedical Technology Resource Centers (BTRCs). BTRCs are national resource centers for conducting research and development on new technologies that are driven by the needs of basic, translational, and/or clinical researchers. BTRCs also make their technologies available to other investigators, train members of the research community in the use of the technologies, and disseminate the technologies broadly. The program supports the development and maintenance of cutting-edge biomedical imaging and bioengineering technologies that serve as national resources for the scientific community.
Alcohol and Other Substance Use Research Education Programs for Health Professionals (R25 Clinical Trial Not Allowed)
The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this NIAAA/NIDA R25 program is to support educational activities that foster a better understanding of biomedical, behavioral, and clinical research on alcohol and other substance use disorders and their implications. This FOA supports creative educational activities with a primary focus on Outreach, specifically designed to engage practicing health care professionals in education about current and emerging knowledge derived from scientific research on the neurobiology, epidemiology, prevention, and/or treatment of alcohol and other substance use disorders and related health conditions, with the ultimate goal of improving care for individuals who use alcohol and other substances.
Understanding Expectancies in Cancer Symptom Management (R01 Clinical Trial Required)
This Notice of Funding Opportunity (NOFO) is intended to support mechanistic research that aims to understand how and why expectancy effects occur in a cancer context, elucidate their role in cancer symptom management, and identify patients, symptoms, cancer sites, and contexts in which expectancy effects can be leveraged to improve cancer outcomes. Expectancies are defined in this context as beliefs about future outcomes, including ones response to cancer or cancer treatment. Expectancies can be evoked by social, psychological, environmental, and systemic factors. Expectancy effects are the cognitive, behavioral, and biological outcomes caused by expectancies. Expectancy effects can be generated by expectancies held by patients, clinicians, family members, caregivers, and/or dyadic/social networks. This R01 grant supports clinical trial research and is available to a wide range of eligible organizations including academic institutions, government entities, nonprofits, and for-profit organizations.
NIH Brain Development Cohorts (NBDC) Biospecimen Access (X01 Clinical Trial Not Allowed)
The Adolescent Brain Cognitive Development (ABCD) Study is the largest longitudinal study of brain development and child health collecting data from more than 11,000 children across the U.S. beginning when they are 9-10 years old and continuing for a decade. In addition to behavioral assessments, youth undergo neuroimaging and provide biospecimens, including saliva for hormone analysis, urine and hair for substance use and exposure, deciduous teeth for environmental exposure, and blood for genetic analysis and metabolic and hematologic assays. This initiative allows investigators to apply for access to biological samples from the ABCD Study. The program provides researchers with biospecimens to conduct investigations into brain development, substance use, mental health, environmental exposures, and related health outcomes in adolescents. This is an X01 mechanism that does not allow clinical trials and is specifically designed to facilitate secondary data analysis using existing ABCD Study biospecimens.
Population Assessment of Tobacco and Health (PATH) Study Biospecimen Access (X01)
The Population Assessment of Tobacco and Health (PATH) Study provides the scientific community with biospecimens (urine, plasma, serum, and genomic DNA) and related research data on behaviors, attitudes, biomarkers and health outcomes associated with tobacco use in the U.S. This opportunity allows investigators to apply for access to the biospecimens from the PATH Study. Information about the PATH Study and this resource may be found on the PATH Study series page at the University of Michigan's National Addiction and HIV Data Archive Program (NAHDAP) website, part of the Inter-University Consortium for Political and Social Research's (ICPSR) website. This is a resource access grant (X01) mechanism through the National Institutes of Health to enable researchers to conduct studies using existing biospecimen data from the PATH Study.
Specialized Programs of Research Excellence (SPOREs) in Human Cancers for Years 2024, 2025, and 2026 (P50 Clinical Trial Required)
Through this funding opportunity announcement (FOA), the National Cancer Institute (NCI) invites applications for P50 Research Center Grants for Specialized Programs of Research Excellence (SPORE). The program will fund P50 SPORE grants to support state-of-the-art investigator-initiated translational research that will contribute to improved prevention, early detection, diagnosis, and treatment of an organ-specific cancer or a highly related group of cancers. The research supported through this program must be translational and must stem from research on human biology using cellular, molecular, structural, biochemical, and/or genetic experimental approaches. SPORE projects must have the goal of reaching a translational human endpoint within the project period of the grant. A group of highly related cancers are those that are derived from the same organ system, such as gastrointestinal, neuroendocrine, head and neck, and other cancers. Other programmatically appropriate groups of cancers may include those centered around a common biological mechanism critical for promoting tumorigenesis and/or cancer progression in organ sites that belong to different organ systems. In addition, a SPORE may focus on cross-cutting themes such as pediatric cancers or cancer health disparities.
Cancer Research Education Grants Program - Curriculum or Methods Development (R25 Clinical Trial Not Allowed)
The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this NCI R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nations biomedical, behavioral and clinical research needs. To accomplish the stated over-arching goal, this Notice of Funding Opportunity (NOFO) will support creative educational activities with a primary focus on Curriculum or Methods Development. Applications are encouraged that propose innovative, state-of-the-art programs that address the cause, diagnosis, prevention, or treatment of cancer, rehabilitation from cancer, or the continuing care of cancer patients and the families of cancer patients.
Cancer Research Education Grants Program - Courses for Skills Development (R25 Clinical Trial Not Allowed)
The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this NCI R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation's biomedical, behavioral and clinical research needs. This Notice of Funding Opportunity (NOFO) supports creative educational activities with a primary focus on Courses for Skills Development. Applications are encouraged that propose innovative, state-of-the-art programs that address the cause, diagnosis, prevention, or treatment of cancer, rehabilitation from cancer, or the continuing care of cancer patients and the families of cancer patients.
Cancer Research Education Grants Program - Research Experiences (R25 Clinical Trial Not Allowed)
The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this NCI R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation's biomedical, behavioral and clinical research needs. This Notice of Funding Opportunity (NOFO) supports creative educational activities with a primary focus on Research Experiences. Applications are encouraged that propose innovative, state-of-the-art programs that address the cause, diagnosis, prevention, or treatment of cancer, rehabilitation from cancer, or the continuing care of cancer patients and the families of cancer patients.
National Institute of General Medical Sciences Predoctoral Basic Biomedical Sciences Research Training Program (T32)
The goal of the NIGMS Predoctoral Basic Biomedical Sciences Research Training Program is to develop a pool of well-trained scientists available to address the Nations biomedical research agenda. This funding opportunity announcement provides support to eligible, domestic institutions to develop and implement effective, evidence-informed approaches to biomedical graduate training and mentoring that will keep pace with the rapid evolution of the biomedical research enterprise. NIGMS expects that the proposed research training programs will incorporate didactic, research, and career development elements to prepare trainees for careers that will have a significant impact on the health-related research needs of the Nation. The program supports institutional training grants that enable eligible domestic institutions to provide comprehensive training opportunities for predoctoral students pursuing research-based degrees in basic biomedical sciences.
NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00 - Independent Basic Experimental Studies with Humans Required)
The purpose of the NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00) program is to increase and maintain a strong cohort of new and talented, NCI-supported, independent investigators. This program is designed for postdoctoral fellows with research and/or clinical doctoral degrees who do not require an extended period of mentored research training beyond their doctoral degrees. The objective of this award is to facilitate a timely transition of these fellows from their mentored, postdoctoral research positions to independent tenure-track (or equivalent) faculty positions. The program will provide independent NCI research support during this transition to help awardees to launch competitive, independent research careers. Researchers in the scientific areas of cancer control, cancer prevention and cancer data sciences are especially encouraged to work with their institutions to apply. This notice of funding opportunity (NOFO) is for basic science experimental studies involving humans, referred to in NOT-OD-18-212 as prospective basic science studies involving human participants. These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research.
NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00 - Independent Clinical Trial Not Allowed)
The purpose of the NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00) program is to increase and maintain a strong cohort of new and talented, NCI-supported, independent investigators. This program is designed for postdoctoral fellows with research and/or clinical doctoral degrees who do not require an extended period of mentored research training beyond their doctoral degrees. The objective of this award is to facilitate a timely transition of these fellows from their mentored, postdoctoral research positions to independent tenure-track (or equivalent) faculty positions. The program will provide independent NCI research support during this transition to help awardees to launch competitive, independent research careers. Researchers in the scientific areas of cancer control, cancer prevention and cancer data sciences are especially encouraged to work with their institutions to apply. This Notice of Funding Opportunity (NOFO) is designed specifically for candidates proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Under this NOFO candidates are permitted to propose a research experience in a clinical trial led by a mentor or co-mentor.
NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00 - Independent Clinical Trial Required)
The NCI Pathway to Independence Award (K99/R00) program is designed to increase and maintain a strong cohort of new and talented, NCI-supported, independent investigators. This program is specifically designed for postdoctoral fellows with research and/or clinical doctoral degrees who do not require an extended period of mentored research training beyond their doctoral degrees. The objective of this award is to facilitate a timely transition of these fellows from their mentored, postdoctoral research positions to independent tenure-track (or equivalent) faculty positions. The program provides independent NCI research support during this transition to help awardees launch competitive, independent research careers. This specific notice of funding opportunity is designed for candidates proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial as part of their research and career development. Researchers in the scientific areas of cancer control, cancer prevention and cancer data sciences are especially encouraged to work with their institutions to apply.
NHLBI Program Project Applications (P01 Clinical Trials Optional)
The National Heart, Lung, and Blood Institute (NHLBI) Program Project Grant (P01) supports research related to fundamental processes and diseases of the heart, blood and lymphatic vessels, lungs, and blood, including transfusion medicine, blood resources, and sleep disorders other programs including implementation science, health disparities, and translation research that address the mission of the Institute. This FOA requires a minimum of three interrelated research projects that investigate a complex biomedical theme or research question. The projects may be supported by core units, if justified, to facilitate economy of effort, space, and equipment. The NHLBI provides support for Program Project Grants (PPGs) in the belief that collaborative research efforts can accelerate the acquisition of knowledge more effectively than a simple aggregate of research projects that have no interaction or thematic integration. NHLBI is particularly interested in encouraging new scientific directions in PPGs. Use of the P01 activity code is viewed as an opportunity to attract scientists who have not traditionally been supported by the NHLBI. Further, the PPG environment presents an opportunity for emerging scientific leaders to gain insight into how to lead a successful scientific Program, and applicants will have the opportunity to include a project led by an Early Stage Investigator (ESI). All projects in the Program must be interrelated and have objectives that address a central theme within the scientific mandate of the NHLBI.
Competing Revisions to Existing NIH Single Project Research Grants and Cooperative Agreements (Clinical Trial Optional)
The National Institutes of Health (NIH) notifies NIH award recipients that funds may be available for revision applications to support the expansion of existing projects and/or programs within the awarding IC identified in the competitive revision Notice of Special Interest (NOSI). This program allows current NIH grant holders to apply for additional funding to expand the scope of their existing research projects. Applications for Revisions will be evaluated for scientific and technical merit by appropriate Scientific Review Groups, in accordance with NIH peer review policy and procedures, using stated review criteria. Only applications submitted in response to a NOSI published by an NIH Institute or Center will be allowed to apply to this Notice of Funding Opportunity (NOFO). The program covers multiple research areas including vision research, aging research, mental health research, cancer detection and diagnosis, child health and human development, drug use and addiction research, alcohol research, minority health and health disparities, human genome research, and other NIH-supported research areas.
Alcohol Research-Related Resource Award (R24 Clinical Trial Not Allowed)
The purpose of the Resource-Related Research Projects (R24) grant is to support investigator-initiated resources designed to provide materials and services to support and advance biomedical research on a national basis. An R24 resource grant mechanism is a non-hypothesis-driven activity to provide data, materials, tools, or services that are essential to making timely, high quality, and cost-efficient progress in a field. The resource should be available to any qualified investigator, and should be highly quality controlled, and not duplicate resources available commercially or through other sources. Resources should be designed to provide services to the broad alcohol research community and should not be limited by any specific regional focus. This grant program supports the development and maintenance of research resources that facilitate alcohol-related biomedical research across the scientific community.
NIDA Mentored Clinical Scientist Development Program Award in Substance Use and Substance Use Disorder Research (K12 Clinical Trial Optional)
This funding opportunity announcement (FOA) from the National Institutes of Health encourages applications for institutional research career development (K12) programs that propose to support intensive supervised research training and career development experiences for clinician scientists (Scholars) leading to research independence in the area of substance use and substance use disorder research. The program is designed to develop the next generation of clinical researchers in addiction science through structured mentorship and career development support. The K12 mechanism provides funding to institutions to develop and implement comprehensive career development programs for early-stage clinical researchers. This award aims to enhance the pool of well-trained, independent clinical investigators focused on advancing substance use and substance use disorder research.
High Priority HIV and Substance Use Research (RM1 Clinical Trial Optional)
This funding opportunity announcement supports high priority research at the intersection of HIV and substance use. The program invites innovative research projects with the potential to open new areas of HIV/AIDS research and/or lead to new avenues for prevention, treatment and cure of HIV among people who use drugs (PWUD). Applications are required to have a detailed research plan, preliminary data, and a clear description of the nexus with substance use. The FOA is open to both individual researchers and research teams and includes all areas of research from basic science to clinical and implementation research. All studies must focus on NIH HIV/AIDS Research Priorities as outlined in NOT-OD-20-018: UPDATE: NIH HIV/AIDS Research Priorities and Guidelines for Determining HIV/AIDS Funding.
Limited Competition: Specific Pathogen Free Macaque Colonies to Support HIV/AIDS Research (U42 Clinical Trial Not Allowed)
The purpose of this Notice of Funding Opportunity (NOFO) is to provide continuing support for specific pathogen-free (SPF) macaque colonies previously funded under the auspices of PAR-21-089 and PAR-18-669 that support Human Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS) research. Breeding colonies are essential to sustain appropriate SPF macaques for research related to HIV/AIDS. Pedigree SPF macaques are free of certain viruses, which may confound the results of HIV/AIDS-related investigations or present a risk to the personnel who care for the animals. The SPF macaques are genetically characterized for major histocompatibility complex (MHC) class I types, because MHC class I genotypes have large effects on macaque immune responses to Simian Immunodeficiency Virus (SIV) that can induce AIDS in nonhuman primates (NHPs) and on human immune responses to HIV. This is a limited competition funding opportunity specifically for institutions previously funded under this program to continue supporting their SPF macaque breeding colonies.
NIDCD Research Career Enhancement Award for Established Investigators (K18 Clinical Trial Required)
The purpose of the NIDCD Research Career Enhancement Award for Established Investigators (K18) program is to enable established, proven investigators to augment or redirect their research programs through the acquisition of new research skills to answer questions relevant to the hearing, balance, smell, taste, voice, speech and language sciences. This career enhancement award provides support for investigators who have demonstrated research capability and productivity to acquire new research expertise that will expand their investigative opportunities in deafness and communication disorders research. The program is designed for researchers who need to develop new skills or approaches to answer important research questions in their field.
NIDCD Research Career Enhancement Award for Established Investigators (K18 Independent Basic Experimental Studies with Humans Required)
The purpose of the NIDCD Research Career Enhancement Award for Established Investigators (K18) program is to enable established, proven investigators to augment or redirect their research programs through the acquisition of new research skills to answer questions relevant to the hearing, balance, smell, taste, voice, speech and language sciences. This K18 award supports career enhancement for established investigators who have demonstrated expertise in their field and are seeking to expand their research capabilities through skill acquisition. The program is offered by the National Institute on Deafness and Other Communication Disorders (NIDCD) and falls under NIH Assistance Listings 93.173 - Research Related to Deafness and Communication Disorders.
NIDCD Research Career Enhancement Award for Established Investigators (K18 Clinical Trial Not Allowed)
The NIDCD Research Career Enhancement Award for Established Investigators (K18) program is designed to enable established, proven investigators to augment or redirect their research programs through the acquisition of new research skills. This career development award supports researchers seeking to answer questions relevant to the hearing, balance, smell, taste, voice, speech and language sciences. The award allows experienced investigators to gain new expertise and methodological capabilities to enhance their ongoing research careers in communication disorders and related fields. This K18 mechanism does not allow clinical trials and is specifically focused on career enhancement through skills acquisition and research redirection.
NIDCD's Mentored Research Education Pathway for Otolaryngology Residents and Medical Students (R25 - Clinical Trial Not Allowed)
The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The overarching goal of this NIDCD R25 program is to support educational activities that help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences. This program is specifically designed for otolaryngology residents and medical students to develop research skills and pursue careers in research related to deafness and communication disorders. The program provides mentored research education experiences aligned with the National Institute on Deafness and Other Communication Disorders (NIDCD) mission areas.
NIA Career Transition Award (K22 Independent Clinical Trial Not Allowed)
The purpose of the NIA Career Transition Award (CTA) is to facilitate the transition of mentored researchers to tenure-track faculty conducting research that advances the mission of NIA. This three-year award provides protected time through salary and research support and is targeted at applicants who plan to start a tenure-track faculty position within a year of the award. The award is designed to support early career researchers making the critical transition from postdoctoral training to independent faculty positions. The program specifically supports individuals who are positioned to establish independent research programs aligned with the National Institute on Aging's mission to understand the nature of aging and to extend the healthy, active years of life.
BRAIN Initiative: Production and distribution facilities for brain cell type-specific access reagents (U24 Clinical Trial Not Allowed)
This BRAIN Initiative Notice of Funding Opportunity (NOFO) supports scaled reagent production and distribution facilities involving technologies to access brain cell types. The program encourages facilities for production and distribution of these reagents by a broad set of neuroscientists. This NOFO is part of the BRAIN Initiative Armamentarium for Brain Cell Access transformative project. Efforts will be supported to produce and distribute gene transfer, gene regulation, and genome engineering reagents for use in both genetically tractable and less tractable systems, including primates and human tissue, which are relevant for future translational efforts. Reagents to be produced and distributed are those designed and validated under other NOFOs from the Armamentarium transformative project. This funding opportunity uses the U24 cooperative agreement mechanism, which involves substantial NIH scientific and/or programmatic involvement with the awardee during performance of the funded project.
INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) Predoctoral to Postdoctoral Fellow Transition Award (F99/K00 Clinical Trial Not Allowed)
The purpose of the INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Predoctoral to postdoctoral Fellow Transition award (F99/K00) is to recruit exceptional graduate students from a variety of research fields to pursue postdoctoral training focused on Down syndrome related research. Talented graduate students from disciplines including, but not limited to, genetics, biochemistry, data science, imaging, engineering and neurobiology are invited to apply to this opportunity. This fellowship provides a transition from predoctoral to postdoctoral training, supporting early-career researchers working on Down syndrome research across multiple disciplines.
NIDCD Mentored Career Development Award for Postdoctorate Au.D./Ph.D. Audiologists (K01 Independent Clinical Trial Not Allowed)
The purpose of the NIDCD Mentored Career Development Award for Postdoctorate Au.D./Ph.D. Audiologists (K01) is to support comprehensive and rigorous postdoctoral research and career development experiences in the biomedical, behavioral, or clinical sciences of promising Au.D./Ph.D. audiologists who have the potential to become productive, independent investigators in scientific health-related research fields relevant to NIDCD's mission. This is a mentored career development award specifically designed for postdoctoral audiologists with Au.D./Ph.D. credentials who seek to develop research careers. The program provides support for comprehensive research training and career development in areas related to deafness and communication disorders. This opportunity does not allow independent clinical trials.
NIDCD Mentored Career Development Award for Postdoctorate Au.D./Ph.D. Audiologists (K01 Clinical Trial Required)
The purpose of the NIDCD Mentored Career Development Award for Postdoctorate Au.D./Ph.D. Audiologists (K01) is to support comprehensive and rigorous postdoctoral research and career development experiences in the biomedical, behavioral, or clinical sciences of promising Au.D./Ph.D. audiologists who have the potential to become productive, independent investigators in scientific health-related research fields relevant to NIDCD's mission. This mentored career development award provides structured support for audiologists with dual Au.D./Ph.D. degrees during their postdoctoral training period. The program aims to develop the next generation of independent investigators in hearing and communication disorders research through comprehensive mentorship and research training. Recipients will engage in supervised research while developing the skills necessary to transition to independent scientific careers in areas aligned with the National Institute on Deafness and Other Communication Disorders' research priorities.
NIDCD Mentored Career Development Award for Postdoctorate Au.D./Ph.D. Audiologists (K01 Independent Basic Experimental Studies with Humans Required)
The purpose of the NIDCD Mentored Career Development Award for Postdoctorate Au.D./Ph.D. Audiologists (K01) is to support comprehensive and rigorous postdoctoral research and career development experiences in the biomedical, behavioral, or clinical sciences of promising Au.D./Ph.D. audiologists who have the potential to become productive, independent investigators in scientific health-related research fields relevant to NIDCD's mission. This grant provides mentored career development support for postdoctoral audiologists with both clinical and research training. The program is designed to facilitate the transition of Au.D./Ph.D. audiologists into independent research careers focused on deafness and communication disorders. The award supports mentored research experiences that will prepare recipients to conduct independent research in areas aligned with the National Institute on Deafness and Other Communication Disorders mission.
Building Interdisciplinary Research Careers in Women's Health (BIRCWH) (K12 Clinical Trial Optional)
The NIH Office of Research on Women's Health (ORWH) and participating NIH Institutes and Centers invite institutional career development award applications for Building Interdisciplinary Research Careers in Women's Health (BIRCWH) Career Development Programs. Programs will support mentored research career development of junior faculty members, known as BIRCWH Scholars, who have recently completed clinical training or postdoctoral fellowships, and who will be engaged in interdisciplinary basic, translational, behavioral, clinical, and/or health services research relevant to the health of women and, where appropriate, the use of both sexes to better understand the influence of sex as a biological variable on health and disease. This Funding Opportunity Announcement (FOA) allows appointment of Scholars (K12) proposing to serve as the lead investigator of an independent clinical trial; or proposing a separate ancillary clinical trial; or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development.
Medical Scientist Training Program (MSTP) (T32)
The Medical Scientist Training Program (MSTP) provides support to eligible domestic institutions to develop and implement effective, evidence-based approaches to integrated dual-degree training leading to the award of both professional medical doctorate degrees and research doctorate degrees (Ph.D. or equivalent). The goal is to develop a broad pool of highly trained physician-scientist leaders available to meet the needs of the Nation's biomedical research agenda. With dual qualification in rigorous scientific research and clinical practice, graduates will be equipped with the skills to develop research programs that accelerate the translation of research advances to the understanding, detection, treatment and prevention of human disease, and to lead the advancement of biomedical research. The proposed research training programs are expected to incorporate didactic, research, mentoring and career development elements to prepare trainees for careers that will have a significant impact on the health-related research needs of the Nation. Areas of particular importance include the iterative optimization of MSTP training efficacy and efficiency, and fostering the persistence of MSTP alumni in research careers.
Utilizing Equipment to Study Environmental Extrinsic Factors and Enhance Rigor and Reproducibility of Animal Research (R24, Clinical Trials Not-Allowed)
The Office of Research Infrastructure Programs (ORIP) invites grant applications from core facilities, resource centers, animal vivaria, or individual investigators of other shared resources to systematically study the roles of critical environmental extrinsic factors in biological, behavioral, and treatment studies using animal model species, with the objective of enhancing the rigor and reproducibility of animal research. The research area must be broadly applicable to the scientific interests of two or more NIH Institutes or Centers (ICs) and must evaluate the biological processes that impact multiple organ systems in order to align with the ORIPs NIH-wide mission and programs. The program supports the acquisition or update of modern equipment for measuring, monitoring, recording, and reporting environmental, biological or biobehavioral variables. The equipment requested must be capable of recording and reporting multiple parameters simultaneously.
BRAIN Initiative: Preclinical Proof of Concept for Novel Recording and Modulation Technologies in the Human CNS (R18 - Clinical Trial Not Allowed)
This funding opportunity facilitates the translation of novel recording and modulation technologies that can be used to treat and/or diagnose central nervous system (CNS) diseases and disorders and to better understand the human CNS, from proof of concept up to the stage of readiness for first in human (FIH) studies. Technologies may incorporate any signal modality (e.g., electrical, optical, magnetic, acoustic) or a combination thereof. Diverse team-based applications that integrate appropriate domains of expertise are encouraged. The program supports R18 research project grants focused on preclinical proof of concept development for innovative neurotechnologies. This initiative is part of the broader BRAIN Initiative aimed at advancing tools and technologies for understanding brain function.
BRAIN Initiative: Data Archives for the BRAIN Initiative (R24 Clinical Trial Optional)
This Notice of Funding Opportunity (NOFO) solicits applications to develop web-accessible data archives to capture, store, and curate data related to BRAIN Initiative activities. The data archives will work with the research community to incorporate tools that allow users to analyze and visualize the data, but the creation of such tools is not part of this NOFO. The data archives will use appropriate standards to describe the data, but the creation of such standards is not part of this NOFO. A goal of this program is to advance research by creating a community resource data archive with appropriate standards and summary information that is broadly available and accessible to the research community for furthering research. This program is offered by the National Institutes of Health to support the development of comprehensive data infrastructure that will serve the neuroscience research community and advance BRAIN Initiative objectives.
Developmental AIDS Research Center on Mental Health and HIV/AIDS (P30 Clinical Trial Optional)
The National Institute of Mental Health (NIMH) Division of AIDS Research (DAR) encourages applications for Center Core grants (P30) to support HIV/AIDS Research Centers (ARC). The ARC is intended to provide infrastructure support that facilitates the development of high impact science in HIV/AIDS and mental health that is relevant to the NIMH mission. This Notice of Funding Opportunity (NOFO) intends to support innovative, interdisciplinary research in several areas, including basic, NeuroHIV, behavioral and social, integrated biobehavioral, applied, clinical, translational, and implementation science. The program provides infrastructure support for research centers focused on mental health aspects of HIV/AIDS, encouraging collaborative and innovative approaches across multiple research disciplines.
AIDS Research Center on Mental Health and HIV/AIDS (P30 Clinical Trial Optional)
The National Institute of Mental Health (NIMH) Division of AIDS Research (DAR) encourages applications for Center Core grants (P30) to support HIV/AIDS Research Centers (ARC). The ARC is intended to provide infrastructure support that facilitates the development of high impact science in HIV/AIDS and mental health that is relevant to the NIMH mission. This Notice of Funding Opportunity (NOFO) intends to support innovative, interdisciplinary research in several areas, including basic, NeuroHIV, behavioral and social, integrated biobehavioral, applied, clinical, translational, and implementation science. The program aims to build research infrastructure and capacity for conducting high-quality research at the intersection of mental health and HIV/AIDS. Eligible applicants include higher education institutions, nonprofits, businesses, tribal organizations, and various government entities.
Mentored Patient-Oriented Research Career Development Award (Parent K23 Independent Clinical Trial Required)
The purpose of the NIH Mentored Patient-Oriented Research Career Development Award (K23) is to support the career development of individuals with a clinical doctoral degree who have made a commitment to focus their research endeavors on patient-oriented research. This program provides mentored career development support for individuals conducting patient-oriented research, which includes mechanisms to study disease processes, interventions, or clinical outcomes directly involving human subjects. The K23 award is designed to help early-career investigators establish their research programs and develop the skills necessary to become independent researchers. This opportunity requires an independent clinical trial as part of the research plan.
Mentored Patient-Oriented Research Career Development Award (Parent K23 Independent Clinical Trial Not Allowed)
The NIH Mentored Patient-Oriented Research Career Development Award (K23) is designed to support the career development of individuals with a clinical doctoral degree who have made a commitment to focus their research endeavors on patient-oriented research. This award provides mentored research support for clinician-scientists at an early stage of their career, helping them develop into independent investigators. The K23 award is specifically for patient-oriented research that does not involve independent clinical trials. Recipients receive funding to dedicate substantial time to research career development under the guidance of experienced mentors. The program aims to foster the next generation of clinical researchers who will advance patient-oriented biomedical research across various health areas supported by the National Institutes of Health.
Mentored Patient-Oriented Research Career Development Award (Parent K23 Independent Basic Experimental Studies with Humans Required)
The NIH Mentored Patient-Oriented Research Career Development Award (K23) is designed to support the career development of individuals with a clinical doctoral degree who have made a commitment to focus their research endeavors on patient-oriented research. This program provides mentored research career development support for clinician-investigators who are committed to conducting patient-oriented research and who require additional supervised research experience to transition to independent research careers. The K23 award is intended for individuals who are in the early stages of their independent research careers and have the potential to develop into productive, independent investigators in clinical research. The program emphasizes the importance of mentored training and career development activities to enable recipients to achieve research independence in patient-oriented research.
Global Infectious Disease Research Training Program (D43 Clinical Trial Optional)
This Funding Opportunity Announcement (FOA) encourages joint applications for the Global Infectious Disease (GID) Research Training programs from U.S. and low- and middle-income country (LMIC) institutions. The application should propose a collaborative training program that will strengthen the capacity of a LMIC institution to conduct infectious disease research. FIC will support research-training programs that focus on major endemic or life-threatening emerging infectious diseases, neglected tropical diseases, infections that frequently occur as co-infections in HIV infected individuals or infections associated with non-communicable disease conditions of public health importance in LMICs. Training related to prevention, treatment or public health approaches to any technical area of basic, epidemiology, clinical, behavioral or social science health research may be supported. Research Training programs should incorporate didactic, mentored research and career development skills components to prepare individuals for careers that will have significant impact on the priority health research needs of LMICs. This FOA allows support of trainees as the lead investigator of an independent clinical trial or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development.
The NCI Worta McCaskill-Stevens Career Development Award for Community Oncology and Prevention Research (K12 Clinical Trial Optional)
The purpose of the Worta McCaskill-Stevens K12 funding opportunity is to support institutional career development awards designed to prepare newly trained clinicians who have made a commitment to independent research careers in community oncology or cancer prevention, and to facilitate their transition to more advanced support mechanisms or independent research funding (e.g., K08, R03, R21, R01). The NOFO will allow the appointment of Scholars proposing to serve as the lead investigator of an independent community-based clinical trial; or proposing a separate ancillary study to an existing prevention, screening or control clinical trial; or proposing to gain research experience in a community-based clinical trial led by another investigator; or proposing to serve as leader of innovative clinical trial approaches that expand engagement of a wide variety of communities in cancer clinical research, as part of their research and career development. This career development award is specifically aimed at clinicians transitioning to independent research careers, with a focus on community-based oncology and cancer prevention research.
Mentored Quantitative Research Development Award (Parent K25 Independent Clinical Trial Required)
The purpose of the Mentored Quantitative Research Career Development Award (K25) is to attract to NIH-relevant research those investigators whose quantitative science and engineering research has thus far not been focused primarily on questions of health and disease. The K25 award will provide support and 'protected time' for a period of supervised study and research for productive professionals with quantitative (e.g., mathematics, statistics, economics, computer science, imaging science, informatics, physics, chemistry) and engineering backgrounds to integrate their expertise with NIH-relevant research. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial, as part of their research and career development. Applicants not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion FOA.
Mentored Quantitative Research Development Award (Parent K25 Independent Basic Experimental Studies with Humans Required)
The purpose of the Mentored Quantitative Research Career Development Award (K25) is to attract to NIH-relevant research those investigators whose quantitative science and engineering research has thus far not been focused primarily on questions of health and disease. The K25 award will provide support and 'protected time' for a period of supervised study and research for productive professionals with quantitative (e.g., mathematics, statistics, economics, computer science, imaging science, informatics, physics, chemistry) and engineering backgrounds to integrate their expertise with NIH-relevant research. This program aims to develop careers of quantitative scientists and engineers by providing mentored research experience in health-related fields. The award supports investigators transitioning their expertise into biomedical, behavioral, and clinical research relevant to NIH's mission.
Mentored Quantitative Research Development Award (Parent K25 Independent Clinical Trial Not Allowed)
The purpose of the Mentored Quantitative Research Career Development Award (K25) is to attract to NIH-relevant research those investigators whose quantitative science and engineering research has thus far not been focused primarily on questions of health and disease. The K25 award will provide support and protected time for a period of supervised study and research for productive professionals with quantitative backgrounds including mathematics, statistics, economics, computer science, imaging science, informatics, physics, chemistry, and engineering to integrate their expertise with NIH-relevant research. This Funding Opportunity Announcement is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.
Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Clinical Trial Required)
The primary purpose of the NIH Mentored Clinical Scientist Research Career Development Awards (K08) program is to prepare qualified individuals for careers that have a significant impact on the health-related research needs of the Nation. This program represents the continuation of a long-standing NIH program that provides support and 'protected time' to individuals with a clinical doctoral degree for an intensive, supervised research career development experience in the fields of biomedical and behavioral research, including translational research. The K08 award is designed to support early-career clinical scientists during a mentored research experience that will enhance their research capabilities and prepare them for independent research careers.
Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Clinical Trial Not Allowed)
The primary purpose of the NIH Mentored Clinical Scientist Research Career Development Awards (K08) program is to prepare qualified individuals for careers that have a significant impact on the health-related research needs of the Nation. This program represents the continuation of a long-standing NIH program that provides support and 'protected time' to individuals with a clinical doctoral degree for an intensive, supervised research career development experience in the fields of biomedical and behavioral research, including translational research. The K08 award is designed to support individuals with clinical doctoral degrees who are committed to a career in research and who need additional supervised research experience. The program aims to develop the next generation of clinical scientists by providing mentored research training and career development support.
Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Basic Experimental Studies with Humans Required)
The NIH Mentored Clinical Scientist Research Career Development Awards (K08) program is designed to prepare qualified individuals for careers that have a significant impact on the health-related research needs of the Nation. This program represents the continuation of a long-standing NIH program that provides support and "protected time" to individuals with a clinical doctoral degree for an intensive, supervised research career development experience in the fields of biomedical and behavioral research, including translational research. The K08 award provides structured mentorship and funding to enable clinical scientists to develop the skills and expertise necessary to become independent researchers.
Independent Scientist Award (Parent K02 - Independent Clinical Trial Not Allowed)
The NIH Independent Scientist Award (K02) fosters the development of outstanding scientists and enables them to expand their potential to make significant contributions to their field of research. The K02 award provides three to five years of salary support and protected time for newly independent scientists who can demonstrate the need for a period of intensive research focus as a means of enhancing their research careers. Each independent scientist career award program is tailored to meet the individual needs of the candidate. This funding opportunity is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial. Applicants are permitted to propose research experience in a clinical trial led by another investigator.
Mentored Research Scientist Development Award (Parent K01 - Independent Clinical Trial Required)
The NIH Mentored Research Scientist Development Award (K01) provides support and protected time for three to five years for an intensive, supervised career development experience in the biomedical, behavioral, or clinical sciences leading to research independence. This program is designed to help researchers develop the skills and expertise necessary to become independent investigators. Some NIH Institutes and Centers use the K01 award specifically for individuals who propose to train in a new field or for individuals who have had a hiatus in their research career because of illness or pressing family circumstances. The award offers comprehensive support during the critical early stages of a research career, helping mentored scientists transition to independent research positions. Participating NIH Institutes and Centers utilize this mechanism to foster the development of the next generation of research scientists across diverse biomedical and behavioral research areas.
Mentored Research Scientist Development Award (Parent K01 - Independent Clinical Trial Not Allowed)
The NIH Mentored Research Scientist Development Award (K01) provides support and protected time for three to five years for an intensive, supervised career development experience in the biomedical, behavioral, or clinical sciences leading to research independence. This program is designed for individuals seeking career development experiences that lead to research independence. Some NIH Institutes and Centers use the K01 award for individuals who propose to train in a new field or for individuals who have had a hiatus in their research career because of illness or pressing family circumstances. This Funding Opportunity Announcement is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial. Applicants are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.
Mentored Research Scientist Development Award (Parent K01 Independent Basic Experimental Studies with Humans Required)
The NIH Mentored Research Scientist Development Award (K01) provides support and protected time (three to five years) for an intensive, supervised career development experience in the biomedical, behavioral, or clinical sciences leading to research independence. Although all of the participating NIH Institutes and Centers (ICs) use this support mechanism to support career development experiences that lead to research independence, some ICs use the K01 award for individuals who propose to train in a new field or for individuals who have had a hiatus in their research career because of illness or pressing family circumstances. Other ICs use the K01 to support career development in specific fields. This career development award is designed to help researchers transition to independent research positions through mentored training and research experience.
NIH Pathway to Independence Award (Parent K99/R00 Independent Clinical Trial Not Allowed)
The NIH Pathway to Independence Award (K99/R00) program is designed to increase and maintain a strong cohort of new and talented, NIH-supported, independent investigators. This program facilitates a timely transition of outstanding postdoctoral researchers with a research and/or clinical doctorate degree from mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. The program provides independent NIH research support during this transition period to help awardees launch competitive, independent research careers. The award is structured in two phases: the initial mentored phase (K99) followed by an independent research phase (R00) once the recipient secures a faculty position.
NIH Pathway to Independence Award (Parent K99/R00 Independent Clinical Trial Required)
The purpose of the NIH Pathway to Independence Award (K99/R00) program is to increase and maintain a strong cohort of new and talented, NIH-supported, independent investigators. This program is designed to facilitate a timely transition of outstanding postdoctoral researchers with a research and/or clinical doctorate degree from mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. The program will provide independent NIH research support during this transition in order to help awardees to launch competitive, independent research careers. The K99/R00 mechanism provides up to five years of support consisting of two phases: an initial mentored phase (K99) and a subsequent independent phase (R00).
NIH Pathway to Independence Award (Parent K99/R00 Independent Basic Experimental Studies with Humans Required)
The NIH Pathway to Independence Award (K99/R00) program is designed to increase and maintain a strong cohort of new and talented, NIH-supported, independent investigators. This program facilitates a timely transition of outstanding postdoctoral researchers with a research and/or clinical doctorate degree from mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. The program provides independent NIH research support during this transition in order to help awardees launch competitive, independent research careers. The K99/R00 mechanism specifically supports basic experimental studies with humans required, providing funding across multiple NIH institutes and centers. This funding opportunity is designed to bridge the critical gap between postdoctoral training and independent faculty positions, helping talented early-career investigators establish themselves as independent researchers.
Midcareer Investigator Award in Patient-Oriented Research (Parent K24 - Independent Basic Experimental Studies with Humans Required)
The NIH Midcareer Investigator Award in Patient-Oriented Research (K24) provides support to mid-career health-professional doctorates for protected time to devote to patient-oriented research (POR) and to act as research mentors primarily for clinical residents, clinical fellows and/or junior clinical faculty. This program supports health professionals who are actively engaged in patient-oriented research and wish to dedicate a portion of their time to mentoring the next generation of clinical researchers. The award provides salary support and research development resources to enable recipients to maintain their research programs while serving as mentors. The program aims to strengthen the research capabilities of clinical investigators and build capacity in patient-oriented research through effective mentorship and research training.
Midcareer Investigator Award in Patient-Oriented Research (Parent K24 Independent Clinical Trial Required)
The NIH Midcareer Investigator Award in Patient-Oriented Research (K24) provides support to mid-career health-professional doctorates for protected time to devote to patient-oriented research and to act as research mentors primarily for clinical residents, clinical fellows and/or junior clinical faculty. This award is designed to support established investigators who have demonstrated success in patient-oriented research and who wish to continue their research careers while mentoring the next generation of clinical researchers. The K24 award provides salary support and protected time for the recipient to conduct patient-oriented research and mentor early-career investigators in clinical research settings. This funding opportunity requires an independent clinical trial as part of the research plan.
Midcareer Investigator Award in Patient-Oriented Research (Parent K24 Independent Clinical Trial Not Allowed)
The NIH Midcareer Investigator Award in Patient-Oriented Research (K24) provides support to mid-career health-professional doctorates for protected time to devote to patient-oriented research (POR) and to act as research mentors primarily for clinical residents, clinical fellows and/or junior clinical faculty. This funding opportunity is designed to enable experienced clinical investigators to continue their patient-oriented research while providing mentorship to the next generation of clinical researchers. The program aims to support investigators who have demonstrated excellence in patient-oriented research and have the commitment and capacity to mentor junior clinical investigators. The award provides protected time for both research activities and mentoring responsibilities. Eligible applicants include a wide range of organizations including public and private institutions of higher education, nonprofits, small businesses, tribal governments, and other eligible entities. Foreign organizations are not eligible to apply, though foreign components of U.S. organizations are allowed. The program supports research across multiple health domains including cardiovascular diseases, mental health, infectious diseases, drug abuse, aging, and other health-related areas.
NHLBI Emerging Investigator Award (EIA) (R35 Clinical Trial Optional)
The purpose of the NHLBI Emerging Investigator Award (EIA) is to promote scientific productivity and innovation by providing long-term support and increased flexibility to experienced Program Directors/Principal Investigators (PDs/PIs) who are currently PDs/PIs on at least two NHLBI R01-equivalent awards and whose outstanding record of research demonstrates their ability to make major contributions to heart, lung, blood and sleep (HLBS) research. The EIA is intended to support a research program, rather than a research project, by providing the primary and most likely sole source of NHLBI funding on individual grant awards. The EIA will support the research program of NHLBI-funded investigators for up to seven years. The EIA will provide investigators increased freedom to conduct research that breaks new ground or extends previous discoveries in new directions. It will also allow PDs/PIs to take greater risks and to pursue research that requires a longer timeframe. Research supported by the EIA must be within the scope of the NHLBI mission.
NHLBI Outstanding Investigator Award (OIA) (R35 Clinical Trial Optional)
The NHLBI Outstanding Investigator Award (OIA) promotes scientific productivity and innovation by providing long-term support and increased flexibility to experienced Program Directors/Principal Investigators who are currently on at least two NHLBI R01-equivalent awards and whose outstanding record demonstrates their ability to make major contributions to heart, lung, blood and sleep research. The OIA supports a research program for up to seven years, providing investigators increased freedom to conduct research that breaks new ground or extends previous discoveries in new directions. The award provides a stable funding environment to improve productivity and facilitate nimble, ambitious, creative research. It accelerates scientific innovation by enabling flexibility in pursuing new research directions as they arise, since investigators will not be bound to specific aims proposed in advance. The OIA reduces time spent writing grant applications and managing multiple awards, allowing more time for conducting research, mentoring students and junior scientists, and providing scientific service. Research supported by the OIA must be within the scope of the NHLBI mission related to heart, lung, blood and sleep disorders research. The program is intended to provide the primary and most likely sole source of NHLBI funding on individual grant awards, allowing PDs/PIs to take greater risks and pursue research that requires a longer timeframe.
Independent Scientist Award (Parent K02 - Independent Clinical Trial Required)
The purpose of the NIH Independent Scientist Award (K02) is to foster the development of outstanding scientists and enable them to expand their potential to make significant contributions to their field of research. The K02 award provides three to five years of salary support and 'protected time' for newly independent scientists who can demonstrate the need for a period of intensive research focus as a means of enhancing their research careers. Each independent scientist career award program must be tailored to meet the individual needs of the candidate. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial, as part of their research and career development.
Independent Scientist Award (Parent K02 Independent Basic Experimental Studies with Humans Required)
The purpose of the NIH Independent Scientist Award (K02) is to foster the development of outstanding scientists and enable them to expand their potential to make significant contributions to their field of research. The K02 award provides three to five years of salary support and protected time for newly independent scientists who can demonstrate the need for a period of intensive research focus as a means of enhancing their research careers. This Parent Funding Opportunity Announcement is for basic science experimental studies involving humans, specifically prospective basic science studies involving human participants. These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that should be submitted include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions.
NINDS Research Education Opportunities (R25 Clinical Trial Not Allowed)
The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this NINDS R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation's biomedical, behavioral and clinical research needs. This program is offered by the National Institute of Neurological Disorders and Stroke (NINDS) as part of the National Institutes of Health and focuses on research education in neurosciences and neurological disorders. The funding opportunity does not allow clinical trials and is designed to build capacity in the research workforce through educational programming and training initiatives.
Summer Research Education Experience Program (R25 Clinical Trial Not Allowed)
The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this R25 program is to support educational activities that foster a better understanding of biomedical, behavioral and clinical research and its implications. This funding opportunity announcement (FOA) will support creative educational activities with a primary focus on research experiences for high school or undergraduate students or science teachers during the summer academic break. The proposed program needs to fit within the mission of the participating NIH Institute or Center (IC) that the application is being submitted to and should not have a general STEM focus. This program aims to enhance research education and training in biomedical, behavioral, and clinical research areas aligned with NIH's mission.
NIMH Research Education Mentoring Program for HIV Researchers (R25 Clinical Trial Not Allowed)
The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this National Institute of Mental Health (NIMH) R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nations biomedical, behavioral and clinical research needs and advance the priorities outlined in the Office of AIDS Research (OAR) Annual Strategic Plan and the research program priorities of the NIMH Division of AIDS Research (DAR). This NOFO supports creative educational activities with a primary focus on Research Experiences and Mentoring Activities that either capitalize on existing networks of collaborating investigators or develop institute-based research education programs. Both research experiences and mentoring activities are required; research experiences are expected to be primary. Research Education Programs are expected to enhance the professional development of the participants and foster a career trajectory towards independent research in the mental health of HIV/AIDS.
Standardizing Data and Metadata from Wearable Devices (R01 Clinical Trial Not Allowed)
The purpose of this NOFO is to support the creation of standards and related efforts that will allow researchers to easily access data from personal tracking devices. The awardees will be expected to partner with device manufacturers as well as the researcher community if the effort is going to be successful. It is expected that the awardees will create standards for personal tracking device data that serve the same purpose as the DICOM or Neuroimaging Informatics Technology Initiative (NIfTI) formats and standards do for medical image files. This R01 grant supports research projects that develop standardization frameworks to enable consistent data collection, storage, and sharing across different wearable device platforms.
National Cancer Institute Youth Enjoy Science Research Education Program (R25 Clinical Trial Not Allowed)
The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The overarching goal of this R25 program is to encourage individuals who have not had substantial biomedical research experience, or who have the potential to significantly benefit from additional biomedical research experience to pursue further studies or careers in research. The NCI Youth Enjoy Science (YES) Program will support efforts to create and maintain an institutional program to engage grades 6-12 and/or undergraduate students in cutting edge cancer research experiences. The proposed institutional programs may also provide research experiences for the grade 6-12 teachers and undergraduate faculty members. The goals are to inspire interest in biomedical sciences, help envision research as a career path, and strengthen practical research and career skills. In alignment with these goals, institutions may develop unique programs that capitalize on their research strengths and are responsive to their target populations. This funding opportunity seeks to facilitate educational activities that encourage students to become knowledgeable about cancer and available to focus on cancer later in their careers through research experiences, curriculum or methods development, and outreach activities.
Limited Competition: Building Partnerships and Broadening Perspectives to Advance Ethical, Legal, and Social Implications (ELSI) Research (BBAER) Program (UM1), Clinical Trial Optional
The National Human Genome Research Institute (NHGRI) seeks to broaden the types of knowledge, skills, expertise, experience, and perspectives brought to bear in research addressing the ethical, legal and social implications (ELSI) of advances in human genetics or genomics. This Notice of Funding Opportunity (NOFO) solicits UM1 applications from domestic organizations located in the United States and its territories that received less than $30 million per year in total NIH funding for the past three fiscal years. These organizations are underrepresented among those receiving NHGRI funding for ELSI research. The Building Partnerships and Broadening Perspectives to Advance Ethical, Legal, and Social Implications (ELSI) Research (BPAER) Program will support: 1) transdisciplinary ELSI research addressing timely, complex, and understudied topics, 2) the establishment of research teams that include representatives from relevant communities who are affected by and have an interest in the proposed research, 3) research capacity building to develop, conduct and sustain ELSI research, and 4) workforce development opportunities for early career scholars, research team members, and other research project staff. Transdisciplinary ELSI research projects require involvement from two or more fields of knowledge and use of multiple research approaches. Relevant communities must be actively and meaningfully involved on ELSI research teams across all phases of proposed research projects. Research capacity building plans must be informed by a needs assessment. Given the complex structure, a strategic management plan, evaluation plan, and sustainability plan are required to ensure successful completion of the program.
Successor-in-Interest (Type 6 Parent Clinical Trial Optional)
The National Institutes of Health (NIH) hereby notify recipient organizations holding specific types of NIH grants that applications for change of recipient organization status, often referred to as Successor-In-Interest, may be submitted to this NOFO. Applications for change of recipient organization status are considered prior approval requests and will be routed for consideration directly to the Grants Management Specialist named in the current award. This funding opportunity allows organizations that are undergoing changes in organizational status to request transfer of existing NIH grants to the new organizational entity. Although successor-in-interest requests may be submitted through this NOFO, there is no guarantee that an award will be transferred to the new organization. All applicants are encouraged to discuss potential requests with the awarding IC before submission. This mechanism supports continuity of NIH-funded research during organizational transitions.
Change of Recipient Organization (Type 7 Parent Clinical Trial Optional)
The National Institutes of Health (NIH) notifies recipient organizations holding specific types of NIH grants that applications for change of recipient organization may be submitted to this NOFO. This assumes such a change is programmatically permitted for the particular grant. Applications for change of recipient organization are considered prior approval requests and will be routed for consideration directly to the Grants Management Specialist named in the current award. Although requests for change of recipient organization may be submitted through this NOFO, there is no guarantee that an award will be transferred to the new organization. All applicants are encouraged to discuss potential requests with the awarding IC before submission. This opportunity covers multiple NIH assistance listings including cancer research, infectious diseases, mental health, cardiovascular diseases, drug abuse research, and many other health-related research programs.
NHLBI Career Transition Award for Intramural Postdoctoral Fellows and Research Trainees (K22 Clinical Trial Required)
The purpose of the NHLBI Career Transition Award (K22) program is to provide highly qualified postdoctoral fellows in the NHLBI Division of Intramural Research the opportunity to transition their research programs as new investigators to extramural institutions. To achieve these objectives, the NHLBI Career Transition Award will support two phases of research: a mentored intramural phase (up to two years) and an extramural phase (three years), for a total of five years of combined support. Transition from the intramural phase of support to the extramural phase is not automatic. Approval of the transition will be based on the success of the awardee's research program during the mentored phase as determined by an NHLBI progress review, which will include an evaluation of a research plan to be carried out at the extramural institution. The program focuses on research areas including blood diseases and resources, cardiovascular diseases, lung diseases, sleep disorders, and translation and implementation science for heart, lung, blood diseases, and sleep disorders.
NHLBI Career Transition Award for Intramural Postdoctoral Fellows and Research Trainees (K22 Independent Clinical Trial Not Allowed)
This funding opportunity provides highly qualified postdoctoral fellows and other doctoral-level researchers currently in training in the NHLBI Division of Intramural Research with the opportunity to transition their research programs to extramural institutions as junior investigators. The K22 Career Transition Award is designed to support the career development of promising researchers who are transitioning from NIH intramural training positions to independent faculty positions at extramural institutions. This award facilitates the establishment of independent research programs focused on heart, lung, blood diseases, and sleep disorders research. The program aims to retain talented researchers within the biomedical research community by providing critical support during this important career transition period.
NIH Research Software Engineer (RSE) Award (R50 Clinical Trials Not Allowed)
The purpose of this notice of funding opportunity (NOFO) is to provide salary support for exceptional Research Software Engineers (RSEs) that contribute their skills to the development and dissemination of biomedical, behavioral or health related software, tools, and algorithms as well as to the training of prospective users of these tools. This award supports RSEs working in various health-related domains including sleep disorders, minority health, diabetes, neurosciences, oral diseases, musculoskeletal research, genomics, child health, cardiovascular diseases, cancer biology, drug abuse research, vision research, mental health, aging research, complementary health, alcohol research, environmental health, blood diseases, and medical library assistance.
Innovative Programs to Enhance Research Training (IPERT) (R25 Independent Clinical Trial Not Allowed)
NIGMS will support innovative educational activities designed to equip participants with technical, operational, or professional skills required for careers in the biomedical research workforce. Activities must be open to the broader biomedical research community and may focus on participants at one or more career stages from undergraduates to professionals (for example faculty, staff scientists). Funded programs will have a robust program leadership structure, participant recruitment plan, and evaluation and dissemination plans. This R25 program announcement does not allow independent clinical trials.
High Priority HIV and Substance Use Research (R01 Clinical Trial Optional)
The purpose of this Funding Opportunity Announcement (FOA) is to support high priority research at the intersection of HIV and substance use. This FOA invites innovative research projects with the potential to open new areas of HIV/AIDS research and/or lead to new avenues for prevention, treatment and cure of HIV among people who use drugs (PWUD). Applications submitted under this FOA are required to have a detailed research plan, preliminary data, and a clear description of the nexus with substance use. This FOA is open to both individual researchers and research teams and includes all areas of research from basic science to clinical and implementation research. All studies must focus on NIH HIV/AIDS Research Priorities as outlined in the NIH guidelines for determining HIV/AIDS funding.
Modern Equipment for Shared-use Biomedical Research Facilities: Advancing Research-Related Operations (S15 Clinical Trial Not Allowed)
This Notice of Funding Opportunity (NOFO) invites eligible academic or research institutions to apply for funding support to purchase latest scientific equipment that will enhance and modernize research-supporting operations of existing shared biomedical research facilities. Targeted are laboratory research core facilities, animal research facilities, and other similar shared-use research spaces. The goal of this NOFO is to strengthen research-auxiliary activities of biomedical research facilities and to enhance the efficiency of their operations. The NOFO does not support the purchase of scientific research instruments or their components, nor components of building-level infrastructure equipment that indirectly support research activities. This program aims to improve the operational capacity and efficiency of shared research facilities through strategic equipment modernization.
Tribal Institutional Review Board Establishment and Enhancement (TIRBEE) (R24 - Clinical Trial Not Allowed)
The purpose of the Tribal Institutional Review Board Establishment and Enhancement (TIRBEE) award is to support federally recognized American Indian/Alaska Native (AI/AN) Tribes, Tribal colleges and universities, Tribal health programs, or Tribal organizations to establish Institutional Review Boards (IRBs) or enhance the capacity of existing Tribal IRBs. This R24 grant mechanism provides funding to eligible Tribal entities to build infrastructure and capacity for ethical review of research conducted in Tribal communities. The program aims to strengthen Tribal sovereignty in research oversight and ensure culturally appropriate ethical review processes for research involving AI/AN populations. This funding opportunity does not allow clinical trials and is specifically focused on establishing or enhancing IRB capabilities within Tribal organizations.
NIDA Animal Genomics Program (U01 Clinical Trial Not Allowed)
The purpose of the NIDA Animal Genetics Program is to identify genetic, genomic, and molecular (epi)genetic variants that underlie phenotypes associated with addictive behaviors and/or vulnerability to distinct stages along the substance use disorders (SUD) trajectory. This includes examining initial/acute use, escalation of use, acquisition of tolerance, dependence, uncontrolled use, abstinence and relapse or recovery. Applications may examine behaviors associated with SUD such as impulsivity, novelty seeking, and delayed discounting, as well as comorbidities demonstrating genetic correlations with phenotypes and behaviors linked with SUD including anxiety, stress, poor maternal care, and social defeat. NIDA encourages applications that take genomics, multi-omics, and/or data-based approaches that integrate multi-level omics data, delineate gene networks, and/or uncover the function of known or newly discovered genetic or epigenetic variants. Other areas of interest include genomics analysis at the circuit level and the application of neuroscience to genomics studies. NIDA expects these studies to uncover novel mechanisms that contribute to various stages across the SUD trajectory and inform future studies about potential targets and therapeutic strategies for addiction.
Advancing Healthcare for Older Adults from Populations that Experience Health Disparities (R01 - Clinical Trial Optional)
The purpose of this initiative is to advance the science and implementation of innovative multi-level health care research for older adults from populations that experience health disparities. The initiative will support research designed to (1) gain a better understanding of appropriate screening, diagnostic, and clinical care guidelines in a primary care setting, (2) explore shared decision-making that is needed to enhance care planning and patient agency between clinicians and care teams with the older adult and their caregiver(s), and (3) identify effective strategies for care coordination. This is an R01 grant opportunity that supports both basic and clinical research projects.
NLM Information Resource Grants to Reduce Health Disparities and Promote Health for All (G08 Clinical Trial Not Allowed)
This Notice of Funding Opportunity Announcement (NOFO) solicits resource grant applications for projects that will provide accurate, useful, usable, and understandable health information to populations that experience health disparities and their health care providers. This NOFO supports the development of resources that can be used to improve health and well-being and that lead to reductions in health disparities. Access to accurate, useful, usable, and understandable health information is an important factor when managing health and health care. Proposed projects should harness the capabilities of information technology and medical or health libraries to disseminate clear, evidence-based health-related information in formats used by individuals and their health care providers. Proposed projects should emphasize the development and deployment of new information resources or services, or expand and improve an existing resource or service, to meet the needs of populations experiencing health disparities and to promote health access for all.
Clinical and Translational Science Award (UM1 Clinical Trial Optional)
This Notice of Funding Opportunity announcement (NOFO) invites applications for the Clinical and Translational Science Award (CTSA) Program hubs that will be part of a national, collaborative consortium focused on bringing more treatments for all people more quickly through advancing clinical and translational science (CTS). The program focuses on developing, demonstrating, and disseminating scientific and operational innovations that improve the efficiency and effectiveness of clinical translation from identification to first-in-human studies to medical practice implementation to community health dissemination. It promotes partnerships and collaborations to facilitate and accelerate translational research projects locally, regionally, and nationally, while creating innovative research programs and partnerships across institutions and communities to address health disparities and deliver the benefits of translational science to all. The award also creates and implements scientific and operational innovations that increase the quality, safety, efficiency, effectiveness, and informativeness of clinical research, provides a national resource for the rapid response to urgent public health needs, and creates and disseminates CTS training for clinical research professionals of all disciplines on the research team.
Tribal Undergraduate to Graduate Research Training and Leadership Experiences (TURTLE) Program (UE5/T32)
The purpose of the Tribal Undergraduate to Graduate Research Training and Leadership Experiences (TURTLE) program is to fund federally recognized American Indian/Alaska Native (AI/AN) Tribes, tribal colleges or universities, Tribal health programs, or Tribal organizations to identify and develop a pool of scientists to conduct research on AI/AN health and health disparities. Through this Notice of Funding Opportunity (NOFO), NIGMS will provide support for a phased award to eligible AI/AN Tribal Entities to develop (UE5) and implement (T32) effective training and mentoring activities for research-oriented individuals earning a doctoral degree in a biomedical research field at a variety of institutions across the United States and territories. The overall purpose is to support the development of individuals who have the technical, operational, and professional skills required to conduct AI/AN health research in a culturally appropriate, ethically responsible and rigorous manner, to complete Ph.D.s in a biomedical field, and to transition into careers in the biomedical research workforce.
Tribal Undergraduate to Graduate Research Training and Leadership Experiences (TURTLE) Program (UE5/T34)
The purpose of the Tribal Undergraduate to Graduate Research Training and Leadership Experiences (TURTLE) program is to fund federally recognized American Indian/Alaska Native (AI/AN) Tribes, tribal colleges or universities, Tribal health programs, or Tribal organizations to identify and develop a pool of scientists to conduct research on AI/AN health and health disparities. Through this funding opportunity, NIGMS provides support for a phased award to eligible AI/AN Tribal Entities to develop and implement effective training and mentoring activities for research-oriented individuals earning a bachelor's degree in a biomedically-relevant field at a variety of institutions across the United States and territories. The overall purpose is to support the development of individuals who have the technical, operational, and professional skills required to conduct AI/AN health research in a culturally appropriate, ethically responsible and rigorous manner, to complete a bachelor's degree in a biomedical field, and ultimately to transition into careers in the biomedical research workforce.
Mechanisms that Impact Cancer Risk after Bariatric Surgery (R01 Clinical Trial Optional)
Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) invites applications for support of investigator-initiated studies addressing mechanisms by which bariatric surgery impacts cancer risk. The program seeks to draw in talented scientists who study bariatric surgery to investigate its effects on cancer, rather than shorter-term outcomes such as weight loss and diabetes. This R01 grant mechanism supports investigator-initiated research projects and may optionally include clinical trials. The funding opportunity is designed to advance understanding of the biological mechanisms linking bariatric surgery to changes in cancer risk, providing critical insights into cancer prevention and control strategies.
Mechanisms that Impact Cancer Risk after Bariatric Surgery (R21 Clinical Trial Not Allowed)
Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) invites applications for support of investigator-initiated studies addressing mechanisms by which bariatric surgery impacts cancer risk. This funding opportunity seeks to draw in talented scientists who study bariatric surgery to investigate its effects on cancer, rather than shorter term outcomes such as weight loss and diabetes. The goal of this NOFO is to support proof of concept studies for feasibility and exploratory development. Feasibility must not have already been developed in the literature or with preliminary data. This R21 mechanism is designed for early-stage research and exploratory projects that can demonstrate feasibility and lay the groundwork for more extensive studies.
Imaging - Science Track Award for Research Transition (I/START) (R03 Clinical Trial Optional)
This Notice of Funding Opportunity Announcement (NOFO) is designed to encourage and facilitate the entry of investigators to the area of brain imaging research. This NOFO will support both newly independent investigators and established investigators who are seeking to develop and adopt neuroimaging tools and methodologies in their research programs and conduct small 'proof-of-concept' studies relevant to substance use disorders and addiction. This NOFO is intended to support Small Research Grant (R03) projects that can be carried out in a short period of time with limited resources. The program aims to lower barriers for researchers entering the field of neuroimaging, particularly in the context of substance abuse and addiction research. The funding provides support for early-stage projects that can demonstrate feasibility and generate preliminary data for future larger-scale studies.
HEAL Initiative: Studies to Enable Analgesic Discovery (R61/R33 - Clinical Trial Not Allowed)
This funding opportunity is part of a suite of NOFOs within the NIH HEAL Initiative to support the development of safe, effective, and non-addictive therapeutics to treat pain. The goal is to encourage initial translational efforts that will support a drug discovery program and advance projects to the point where they meet the entry criteria for the Pain Therapeutics Development Program. The scope will be focused on development of assays to support a distinct testing funnel, screening efforts to identify hits, and initial characterization of hits and potential therapeutic agents (including small molecules, biologics, and natural products). This is an R61/R33 phased innovation award where clinical trials are not allowed. The program aims to advance pain research and therapeutic development as part of the broader NIH Helping to End Addiction Long-term (HEAL) Initiative.
BRAIN Initiative: Optimization of Instrumentation and Device Technologies for Recording and Modulation in the Nervous System (U01 Clinical Trials Not Allowed)
This Notice of Funding Opportunity (NOFO) seeks applications to optimize instrumentation and device technologies for recording and modulation of neural cells and circuits, to address major challenges and to enable transformative understanding of dynamic signaling in the central nervous system. It is expected that the proposed technologies and approaches have previously demonstrated their transformative potential through initial proof-of-concept testing, and are ready for accelerated refinement through iterative engineering and end-user feedback, appropriate for a path towards sustainable dissemination and user-friendly incorporation into routine neuroscience research. Applications may propose development of instrumentation hardware and/or devices and associated software. Approaches may utilize any modality such as optical, electrical, magnetic, or acoustic recording/manipulation, to target neuronal electrical signals or other forms of neural activity, including intracellular signaling and engagement of non-neuronal cells in circuit function. The aim of the proposed technologies should be to reduce major barriers to conducting neurobiological experiments, including considerations of cost and ease of access, and to enable new discoveries for understanding neural circuit function. Technologies should address major challenges associated with recording and modulating CNS activity, at cellular or circuit resolution, and should contribute to an overall ecosystem of technologies spanning multiple spatial and temporal scales in any region throughout the CNS. The approaches should be compatible with experiments in behaving animals, with an expectation that they will be validated with in vivo experiments during the course of the project.
BRAIN Initiative: New Technologies and Novel Approaches for Recording and Modulation in the Nervous System (R01 Clinical Trial Not Allowed)
This Notice of Funding Opportunity (NOFO) seeks applications for proof-of-concept testing and development of new technologies and novel approaches for recording and modulation of neural cells and circuits, to address major challenges and enable transformative understanding of dynamic signaling in the central nervous system. Preliminary feasibility data are not required, and it is expected that the proposed research may be high-risk, but if successful could profoundly change the course of neuroscience research. Applications may propose development of instrumentation hardware and/or devices and associated software, and/or molecular constructs for sensing and manipulating neural activity. Approaches may utilize any modality such as optical, electrical, magnetic, or acoustic recording/manipulation, to target neuronal electrical signals or other forms of neural activity, including intracellular signaling and engagement of non-neuronal cells in circuit function. The aim of the proposed technologies should be to reduce major barriers to conducting neurobiological experiments, including considerations of cost and ease of access, and to enable new discoveries for understanding neural circuit function. Technologies should address major challenges associated with recording and modulating CNS activity, at cellular or circuit resolution, and should contribute to an overall ecosystem of technologies spanning multiple spatial and temporal scales in any region throughout the CNS. The approaches should be compatible with experiments in behaving animals, with an expectation that they will be validated with in vivo experiments during the course of the project. Proposed validation experiments must focus on demonstrating the capabilities and potential impact of the technology, rather than advancing the state of biological knowledge as the primary project goal. Applications are encouraged to integrate multiple approaches, and where appropriate, to leverage a variety of domains of expertise from biological, chemical, and physical sciences, engineering, computational modeling, and statistical analysis.
NICHD Resource Program Grants in Bioinformatics (P41 Clinical Trial Not Allowed)
The purpose of this Notice of Funding Opportunity (NOFO) is to support the continued operation, maintenance, and dissemination of unique database bioinformatics resources that are of major importance to the research community using animal models of embryonic developmental processes. These grants will support ongoing development and enhancement of the resources, user training and services, provision of community generated data storage and curation, wide dissemination of the tools and/or resources, and expansion of interoperability with other NIH bioinformatics resources. This program aims to maintain critical bioinformatics infrastructure that enables research in child health and human development through animal model systems. The funding supports both the technical maintenance of databases and the community services needed to maximize their research impact.
Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development of Disorders of the Nervous System (UG3/UH3 Clinical Trial Optional)
The Blueprint Neurotherapeutics Network (BPN) invites applications from neuroscience investigators seeking support to advance their small molecule drug discovery and development projects into the clinic. Participants in the BPN are responsible for conducting all studies that involve disease- or target-specific assays, models, and other research tools and receive funding for all activities to be conducted in their own laboratories. Applicants will collaborate with NIH-funded consultants and can augment their project with NIH contract research organizations (CROs) that specialize in medicinal chemistry, pharmacokinetics, toxicology, formulations development, chemical synthesis including under Good Manufacturing Practices (GMP), and Phase I clinical testing. Projects can enter either at the Discovery stage, to optimize promising hit compounds through medicinal chemistry to the Development stage, to advance a single development candidate through Investigational New Drug (IND)-enabling toxicology studies and phase I clinical testing. Alternatively, projects can enter at the Development stage and progress in a shorter period to IND enabling toxicology studies and phase I clinical testing. BPN awardee Institutions retain their assignment of IP rights and gain assignment of IP rights from the BPN contractors for drug candidates developed in this program.
BRAIN Initiative: Reagent Resources for Brain Cell Type-Specific Access to Broaden Distribution of Enabling Technologies for Neuroscience (U24 Clinical Trial Not Allowed)
This Notice of Funding Opportunity Announcement (NOFO) from the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is intended to support establishment of facilities at minority-serving institutions (MSIs) and Institutional Development Award (IDeA)-eligible institutions for scaled production and distribution of brain cell type-specific access and manipulation reagents. Reagents will be initially developed in pilot resource projects for brain cell type-specific access and manipulation across vertebrate species from the BRAIN Initiative Armamentarium project. Awardees under this NOFO will work with the other Armamentarium awardees to manufacture and distribute the resources for use throughout the neuroscience community. It is envisioned that the awardees will work both with the Armamentarium community as well as with the neuroscience research community to optimize the use of new reagents. The types of reagents to be produced and distributed could include but are not limited to viral vectors, nucleic acid constructs, and nanoparticles designed for selective access to and manipulation of brain cell types. Such reagents will enable neuroscientists to probe circuit function with high precision in experimental animals and ex vivo human tissue and cells. Facilities are needed to contribute to the production and distribution of BRAIN Initiative Armamentarium project reagents broadly to neuroscience users.
NIH Support for Conferences and Scientific Meetings (Parent R13 Clinical Trial Not Allowed)
The purpose of the NIH Research Conference Grant (R13) is to support high quality conferences that are relevant to the public health and to the scientific mission of the participating Institutes and Centers. This funding opportunity announcement supports conferences across a wide range of health-related research topics under the NIH mission, including cancer research, mental health, aging, infectious diseases, cardiovascular research, neurosciences, and many other biomedical and behavioral research areas. The R13 grant mechanism is specifically designed to support conference activities rather than individual research projects, and clinical trials are not allowed under this announcement.
Blueprint Neurotherapeutics Network (BPN): Biologic-based Drug Discovery and Development for Disorders of the Nervous System (UG3/UH3 Clinical Trial Optional)
The Blueprint Neurotherapeutics Network for Biologics (BPN-Biologics) provides support for biologic-based therapeutic discovery and development, from lead optimization through phase I clinical testing. This Funding Opportunity Announcement (FOA) supports preclinical discovery and development of potential therapeutic Biotechnology Products and Biologics including, but not limited to, large biologic macromolecules such as proteins, antibodies, and peptides, gene-based therapies including oligonucleotide- and viral-based approaches, cell therapies, and novel emerging therapies such as microbial and microbiome therapies. Applicants will collaborate with NIH-funded consultants and can augment their project with NIH contract research organizations (CROs) that specialize in manufacturing, scaling, pharmacokinetics, toxicology, and Phase I clinical testing. BPN-Biologics awardee institutions retain their assignment of intellectual property rights and gain assignment of IP rights from the BPN-Biologics contractors, thereby controlling the patent prosecution and licensing negotiations for biotherapeutic candidates developed in this program. The program supports the development of innovative biologic-based treatments for disorders of the nervous system through a comprehensive, collaborative approach that provides both funding and specialized expertise.
Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)
The purpose of this Program Announcement (PAR) is to enable clinical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of biomarker measurements within the clinical population of interest to establish the positive and negative predictive values of the candidate biomarker consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified. This funding mechanism uses the U01 cooperative agreement instrument, which allows for substantial involvement from NIH staff in the conduct of the research.
Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders(U01 Clinical Trial Optional)
The purpose of this notice of funding opportunity (NOFO) is to support rigorous analytical validation of method(s) used for measuring biomarkers for neurological and neuromuscular disorders for use in clinical trials or clinical practice. Applicants must justify the unmet need for the biomarker(s) and measurement methods and specify one or two context(s) of use for the biomarker(s). Activities supported include optimizing and evaluating the accuracy, precision, reportable range, and analytical sensitivity and specificity of the detection method across multiple sites and operators and establishing reference intervals and quality control procedures. Multi-site applications are expected but not required. This U01 cooperative agreement supports research programs that involve significant scientific or programmatic interaction with NIH staff during the conduct of the project.
Research Experiences and/or Mentoring Networks through Research Education to Enhance Clinician-Scientists' Participation in NIDCDs Research (R25 Clinical Trial Not Allowed)
The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The overarching goal of this R25 program is to support educational activities that help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences. This funding opportunity is specifically focused on enhancing clinician-scientists' participation in research conducted by the National Institute on Deafness and Other Communication Disorders (NIDCD). The program aims to develop research education programs and mentoring networks that will prepare and encourage clinicians to engage in research related to deafness and communication disorders. This R25 grant mechanism is designed to strengthen the research workforce by providing structured educational experiences that bridge clinical practice and research careers in the NIDCD mission areas.
Limited Competition: CCRP Initiative: Promoting a Basic Understanding of Chemical Threats to Skin (R34 Clinical Trial Not Allowed)
This Notice of Funding Opportunity (NOFO) intends to support fundamental research that will contribute to basic understanding of skin injuries caused by chemicals that have been identified as public health threats, with an emphasis on investigating the commonalities of such injuries and identifying potential shared signaling pathways and therapeutic targets for medical countermeasure development. The program aims to advance knowledge in dermatological responses to chemical threats and support the development of medical countermeasures through basic scientific research. This is a limited competition R34 grant mechanism that does not allow clinical trials.
Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed)
This Notice of Funding Opportunity (NOFO) aims to accelerate the pace of translation of NCI-supported methods, assays, and technologies to the clinic. The focus is on the adaption and clinical validation of molecular, cellular, and imaging biomarkers for cancer detection, diagnosis, prognosis, monitoring, and prediction of response in treatment, as well as markers for cancer control and prevention. Research applications may support the acquisition of well-annotated specimens from NCI-supported or other clinical trials or observational cohorts/consortia for the purpose of clinical validation of the assay. Research projects encourage multi-disciplinary interaction among scientific investigators, assay developers, clinicians, statisticians, and clinical laboratory staff. Clinical laboratory scientists and statistical experts are highly encouraged to comprise integral parts of the application. This NOFO is not intended to support early-stage development of technology or the conduct of clinical trials, but rather the adaption and validation of assays to the point where they could be integrated into clinical trials as investigational assays, tools, or devices.
Interventions to expand cancer screening and preventive services to ADVANCE health in populations that experience health disparities (R01, Clinical Trial Required)
The Office of Disease Prevention (ODP) and participating National Institutes of Health (NIH) Institutes, Centers, and Offices (ICs) are issuing this R01 to solicit applications to address barriers and facilitators that impede use or uptake of cancer screening and preventive services in populations that experience health disparities. Interventions should include screening, preventive services, or other healthcare processes, including timely follow-up of abnormal findings, and referral to accessible care. Projects are encouraged to leverage collaborations with community partners and service providers. Interventions should address barriers and facilitators at two or more of the following levels: patient, clinician, healthcare setting, and neighborhood/community.
Continuation or Revision of NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (UH3 Clinical Trial Required)
This funding opportunity supports competing renewal or competitive revision of ongoing clinical trials supported by the National Institute of Dental and Craniofacial Research (NIDCR). The cooperative agreement (UH3) mechanism requires substantial programmatic involvement between the NIH and the award recipient during performance of the activity. This program is specifically designed for continuation or revision of clinical trials that are already in progress and supported by NIDCR. Applicants must be conducting clinical trials in oral health, dental diseases, and craniofacial disorders research. The funding mechanism provides support for clinical trial implementation and ongoing research activities that align with NIDCR's mission to improve oral, dental, and craniofacial health.
Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 Clinical Trials Not Allowed)
Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to accelerate the adoption and validation of molecular/cellular/imaging markers (referred to as 'markers' or 'biomarkers') and assays for cancer detection, diagnosis, prognosis, monitoring, and prediction of response or resistance to treatment, as well as markers for cancer prevention and control. This NOFO will also support the validation of pharmacodynamic markers and markers of toxicity. Applicants to this NOFO must have an assay(s) whose performance has been analytically validated in specimens similar to those for the intended clinical use of the marker(s) and assay(s). As chemotherapies and/or radiation therapies are increasingly combined with immunotherapies to enhance the durability of anti-cancer responses, assays for measuring multiple markers, including immune markers, can be developed and validated simultaneously. The UH3 mechanism will support the clinical validation of established assays for up to 3 years using specimens from retrospective or prospective clinical trials or studies. This NOFO may be used to validate existing assays for use in other trials, observational studies, or population studies. Efforts to harmonize clinical laboratory tests, including investigation into the performance and reproducibility of assays across multiple clinical laboratories, are also appropriate for this funding opportunity. Projects proposed for this NOFO will require multi-disciplinary interaction and collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientists.
Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed)
Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) invites applications to support the validation of molecular/cellular/imaging markers (referred to as markers or biomarkers) and assays for cancer detection, diagnosis, prognosis, monitoring, and prediction of response or resistance to treatment, as well as markers for cancer prevention and control. This FOA supports investigator-initiated research for both analytical and clinical validation of assays to be used in cancer treatment, control, or prevention trials supported by the NCI. The program also supports the validation of pharmacodynamic markers and markers of toxicity. Applicants should have assays that work on human samples and whose importance is well justified for development into clinical assays. The UH2 phase supports analytical validation of assays for these molecular/cellular/imaging markers, which must be achieved within 2 years before assays may undergo clinical validation. The UH3 phase supports clinical validation of analytically validated assays for up to 3 years using well-annotated biospecimens from retrospective or prospective clinical trials or studies. This NOFO may be used to validate existing assays for use in other cancer clinical trials, observational studies, or population studies. Efforts to harmonize clinical laboratory tests, including investigation into the performance and reproducibility of assays across multiple clinical laboratories, are also appropriate for this funding opportunity. Projects proposed for this NOFO require multi-disciplinary collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientists.
Emerging Global Leader Award (K43 Independent Clinical Trial Not Allowed)
This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial. The purpose of the Fogarty Emerging Global Leader Award is to provide research support and protected time (three to five years) to an early career research scientist from a low- or middle-income country (LMIC) who holds a junior faculty position at an LMIC academic or research institution. This intensive, mentored research career development experience is expected to lead to an independently funded research career at the LMIC institution or in another LMIC. The FOA invites applications from LMIC scientists from any health-related discipline who propose career development activities and a research project that is relevant to the health priorities of their country under the mentorship of LMIC and U.S. mentors.
Emerging Global Leader Award (K43 Independent Clinical Trial Required)
The Emerging Global Leader Award (K43) is a research training program from the National Institutes of Health designed to support early-career researchers from Low- and Middle-Income Countries (LMICs). This program provides mentored research career development awards to help emerging scientists establish independent research careers focused on health issues relevant to their home countries. The K43 award requires an independent clinical trial component and aims to build research capacity in LMICs through intensive mentored research experiences. Applications must be submitted by academic education or research institutions located in World Bank-defined low-income, lower-middle-income, or upper-middle-income countries. The program aligns with NIH's clinical trials policy and supports research across multiple health domains including neurosciences, cardiovascular diseases, cancer, mental health, environmental health, and other critical areas. The award focuses on developing the next generation of global health researchers who will conduct high-quality research in their home countries and contribute to addressing health disparities worldwide.
Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3 Clinical Trial Required)
This notice of funding opportunity (NOFO) encourages applications for investigator-initiated multi-site clinical trials (e.g., efficacy, effectiveness, or pragmatic trials) to study the effects of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions), and/or multicomponent interventions that include physical, psychological, and/or nutritional approaches in NCCIH-designated areas of high research priority. Clinical Coordinating Centers (CCC) should develop and implement the proposed fully powered multi-site clinical trial (Phase III and beyond). The objective of a CCC application is to present the scientific rationale and a comprehensive scientific and operational plan for the clinical trial. CCC applications are expected to describe plans for project management, participant recruitment and retention strategies, performance milestones, scientific conduct, and dissemination of results. CCC applications submitted under this NOFO will utilize a two-phase, milestone-driven cooperative agreement (UG3/UH3) funding mechanism. An accompanying Data Coordinating Center (DCC) application (U24), submitted under PAR-24-087 proposing a data analysis and data management plan for the clinical project is required. Both a CCC application and a corresponding DCC application need to be submitted simultaneously for consideration by NCCIH.
Data Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative U24 Clinical Trial Required)
This notice of funding opportunity (NOFO), utilizing the U24 grant funding mechanism, encourages applications for a collaborating Data Coordinating Center (DCC) application that accompanies an investigator-initiated multi site clinical trial (Phase III and beyond) application submitted under companion PAR-21-243. The DCC application must be specific to the companion Clinical Coordinating Center (CCC) application. The objective of the DCC application is to propose a comprehensive plan that provides overall project coordination, and administrative, data management, and biostatistical support for the proposed clinical trial. Both a DCC application and a corresponding CCC application need to be submitted simultaneously for consideration by NCCIH. Trials for which this NOFO applies must be relevant to the research mission of NCCIH and considered a high priority by the Center.
NIDCD Early Career Research(ECR) Award (R21 Clinical Trial Optional)
The NIDCD Early Career Research (ECR) Award (R21) is intended to support both basic and clinical research from scientists who are beginning to establish an independent research career. It cannot be used for thesis or dissertation research. The research must be focused on one or more of the areas within the biomedical and behavioral scientific mission of the NIDCD: hearing, balance, smell, taste, voice, speech, or language. The NIDCD ECR Award R21 grant mechanism supports different types of projects including secondary analysis of existing data; small, self-contained research projects; development of research methodology; translational research; outcomes research; and development of new research technology. Irrespective of the type of project, the intent of the NIDCD ECR Award R21 is for the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) to obtain sufficient preliminary data for a subsequent R01 application.
Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Development and Validation of Model Systems to Facilitate Neurotherapeutic Discovery (R61/R33 Clinical Trial Not Allowed)
This funding opportunity announcement encourages the development and validation of animal models and human/animal tissue ex vivo systems that recapitulate the phenotypic and physiologic characteristics of a defined neurological or neuromuscular disorder. The goal is to promote a significant improvement in the translational relevance of animal models or ex vivo systems that will be utilized to facilitate future development of neurotherapeutics. Ideally, models proposed would have the potential to provide feasible and meaningful assessments of efficacy following therapeutic intervention that would be applicable in both preclinical and clinical settings. This FOA is part of a suite of Innovation Grants to Nurture Initial Translational Efforts (IGNITE) Program focused on enabling the exploratory and early stages of drug discovery.
Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Assay Development and Neurotherapeutic Agent Identification (R61/R33 Clinical Trial Not Allowed)
This funding opportunity announcement (FOA) encourages research grant applications to develop in vitro and/or ex vivo assays and conduct iterative screening efforts to identify and characterize potential therapeutic agents for neurological or neuromuscular disorders. This FOA is part of a suite of Innovation Grants to Nurture Initial Translational Efforts (IGNITE) to advance projects to the point where they can meet the entry criteria for the Blueprint Neurotherapeutics Network (BPN) or other translational programs. The program aims to support early-stage translational research that bridges the gap between basic science discoveries and clinical applications in neuroscience. Projects funded under this mechanism will focus on assay development and the identification of neurotherapeutic agents for disorders affecting the nervous system and neuromuscular function.
BRAIN Initiative: Brain Behavior Quantification and Synchronization- Next Generation Sensor Technology Development (U01 Clinical Trial Optional)
This Notice of Funding Opportunity (NOFO) solicits applications for next generation sensor and bioelectronic device development that will synchronize with brain recordings. The sensor and neural recording data will be used to generate new computational models of behavior in human and animal models. There has been a lack of quantitative approaches and models to understand the complexity of human and animal behavior in naturalistic settings. This NOFO focuses on the development of next generation sensors to acquire data and synchronize it with simultaneous brain recordings to build computational models. The program aims to advance neuroscience research through innovative sensor technologies that can better capture and analyze behavioral data in coordination with brain activity measurements.
NIDCR Drug, Biologic, Device and/or Procedure Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)
This funding opportunity supports UG3/UH3 phased, cooperative agreement research applications to plan and implement clinical trials within the mission of the National Institute of Dental and Craniofacial Research (NIDCR). The program uses a phased approach with UG3 representing the planning phase and UH3 representing the implementation phase of clinical trials involving drugs, biologics, devices, and/or procedure interventions related to oral diseases and disorders research. This cooperative agreement mechanism allows for substantial NIH scientific and programmatic involvement with the awardee during performance of the activities.
Limited Competition: Renewal of Existing NINDS-Supported Clinical Trial Cooperative Agreement Awards (U01 - Clinical Trials Required)
This limited competition Notice of Funding Opportunity (NOFO) invites renewal applications of existing NINDS-supported clinical trial cooperative agreement awards (U01) requiring additional time and resources to complete the clinical trial. The program is offered by the National Institutes of Health through the National Institute of Neurological Disorders and Stroke (NINDS) and supports the continuation of ongoing clinical trials in neuroscience and neurological disorders. This is a restricted competition opportunity specifically designed for renewal of existing cooperative agreement awards, not for new applicants. The funding is provided through cooperative agreements which involve substantial programmatic involvement between the recipients and NIH during the performance of the activities.
Development of Biomarkers or Composite Biomarkers for Neurological and Neuromuscular Disorders (R61/R33 - Clinical Trial Optional)
The overarching purpose of this Funding Opportunity Announcement (FOA) is to promote the discovery and/or early evaluation of strong candidate biomarkers and biomarker signatures that can be used as tools to facilitate the clinical development of neurotherapeutics and their use in clinical practice. Specifically, the focus of this FOA is on the identification and initial biological, analytical and clinical evaluation of biomarkers and biomarker signatures for neurological and neuromuscular disorders. Although research supported by this FOA can include animal studies, it must also include preliminary human evaluation using carefully standardized human samples or datasets. The goal of this initiative is to deliver candidate biomarkers or biomarker signatures that are ready for definitive analytical and clinical validation studies. This is an R61/R33 phased innovation award mechanism that supports the development and validation of biomarkers for neurological and neuromuscular disorders.
Pilot Projects Investigating Understudied Proteins Associated with Rare Diseases (R03 Clinical Trial Not Allowed)
The purpose of this notice of funding opportunity (NOFO) is to solicit applications for pilot projects to elucidate a role for understudied proteins in rare disease. Awards will support generation of preliminary data and/or tools around eligible understudied protein(s). A list of eligible proteins is provided and are members of druggable protein families that have a known association with a rare disease. This NOFO is intended to jumpstart research on understudied proteins that are associated with rare diseases and provide applicants with sufficient funding to perform basic biochemical and/or biological work to further the characterization of understudied proteins within the context of rare disease. The funding mechanism is an R03 grant, which supports small research projects that can be carried out in a short period of time with limited resources.
Limited Competition: Basic Instrumentation Grant (BIG) Program (S10 Clinical Trial Not Allowed)
The Basic Instrumentation Grant (BIG) Program encourages applications from groups of NIH-supported investigators to purchase a single piece of new, costly, specialized, commercially available instrument or an integrated instrumentation system. The BIG Program is limited to institutions that have not received S10 instrumentation funding of $500,001 or greater in any of the preceding 3 Federal fiscal years. The minimum award is $25,000 and the maximum award is $350,000. There is no maximum price limit for the instrument itself. Instruments supported include, but are not limited to, basic cell sorters, confocal microscopes, ultramicrotomes, gel imagers, or computer systems. This program aims to support research infrastructure by providing access to specialized scientific equipment for NIH-supported investigators at institutions with limited prior S10 funding.
High-End Instrumentation (HEI) Grant Program (S10 Clinical Trial Not Allowed)
The High-End Instrumentation (HEI) Grant Program encourages applications from groups of NIH-supported investigators to purchase or upgrade a single item of high-end, specialized, commercially available instruments or integrated systems. The minimum award is $750,001. There is no maximum price limit for the instrument; however, the maximum award is $2,000,000. Instruments supported include, but are not limited to, nuclear magnetic resonance spectrometers, X-ray diffractometers, mass spectrometers, high throughput robotic screening systems, DNA and protein sequencers, biosensors, electron and light microscopes, flow cytometers, and biomedical imagers. This program is designed to support research infrastructure for groups of NIH-supported investigators to enhance their research capabilities through access to state-of-the-art equipment.
Shared Instrumentation Grant (SIG) Program (S10 Clinical Trial Not Allowed)
The Shared Instrument Grant (SIG) Program encourages applications from groups of NIH-supported investigators to purchase or upgrade a single item of high-priced, specialized, commercially available instruments or integrated instrumentation system. The minimum award is $50,000 with a maximum award of $750,000, though there is no maximum price limit for the instrument itself. Instruments supported include, but are not limited to: light microscopes, biomedical imagers, mass spectrometers, nuclear magnetic resonance spectrometers, flow cytometers, DNA and protein sequencers, biosensors, and X-ray diffractometers. This program is designed to enhance research infrastructure by providing shared access to high-quality instrumentation for NIH-supported research groups. The program supports public and private institutions of higher education, nonprofits with and without 501(c)(3) status, and other eligible organizations including Hispanic-serving Institutions, Historically Black Colleges and Universities, and Tribally Controlled Colleges and Universities.
Computational Approaches to Curation at Scale for Biomedical Research Assets (R01 Clinical Trial Not Allowed)
The National Library of Medicine (NLM) seeks to accelerate access to, and availability of, secure, complete datasets and computational models that can serve as the basis for transformative biomedical discoveries. This R01 grant program focuses on developing innovative at-scale computational approaches that increase the speed and scope of curation processes for data mining and knowledge discovery from growing quantities of biomedical data being produced from ongoing data science advances. The program supports research projects that develop computational methodologies to enhance the curation of biomedical research assets, enabling more efficient organization, annotation, and accessibility of scientific data. This is a clinical trial not allowed funding opportunity.
Dissemination and Implementation Research in Health (R01 Clinical Trial Optional)
The purpose of this Notice of Funding Opportunity (NOFO) is to support studies that will identify, develop, and/or test strategies for overcoming barriers to the adoption, adaptation, integration, sustainability, scale-up, and spread of evidence-based interventions, practices, programs, tools, treatments, guidelines, and policies. Conversely, there is a benefit in understanding circumstances that create a need to stop or reduce (de-implement) the use of practices that are ineffective, unproven, low-value, or harmful. In addition, studies to advance dissemination and implementation research methods and measures are encouraged. Applications that focus on re-implementation of evidence-based health services that may be disrupted amidst disasters (e.g., pandemics) remain relevant. All applications must be within the scope of the mission of one of the participating NIH Institutes and Centers.
Translational Neural Devices (R61/R33 - Clinical Trial Optional)
The purpose of this Notice of Funding Opportunity is to encourage investigators to pursue translational activities and small clinical studies to advance the development of therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk study or Institutional Review Board approval for a Non-Significant Risk study, as well as a subsequent small clinical study. The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments due to the novelty of the device or its intended use. This is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress.
Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Natural Products (Collaborative UG3/UH3 Clinical Trial Required)
This Notice of Funding Opportunity (NOFO) encourages cooperative agreement applications for investigator-initiated, multi-site, clinical trials (Phase III and beyond) to study the effects of natural products including botanicals, probiotics, and products marketed as dietary supplements in NCCIH designated areas of high research priority. Natural products include promising nutritional regimens that standardize the amount of a specific naturally occurring nutritional compound such as omega-3 fatty acids, anthocyanidins, or polyphenols with compelling preliminary evidence. Applicants should describe plans for a Clinical Coordinating Center to develop and implement the proposed multi-site clinical trial. The objective is to provide the scientific rationale and a comprehensive scientific and operational plan for the clinical trial. Applications are expected to describe plans for project management, participant recruitment and retention strategies, performance milestones, scientific conduct, and dissemination of results. Clinical Coordinating Center applications submitted under this NOFO will utilize a two-phase, milestone-driven, cooperative agreement (UG3/UH3) funding mechanism. An accompanying Data Coordinating Center application, submitted under PAR-24-125, proposing a data analysis and data management plan for the clinical project is required. Both a Clinical Coordinating Center application and a corresponding Data Coordinating Center application need to be submitted simultaneously for consideration by NCCIH.
Biomedical Research Environment and Sponsored Programs Administration Development (BRE-SPAD) Program (UC2- Clinical Trial Not Allowed)
The Biomedical Research Environment and Sponsored Programs Administration Development (BRE-SPAD) Program aims to promote broad participation in the biomedical research ecosystem by supporting resource limited organizations to conduct research, enhance the research environment, and increase sponsored programs administration capacity. This program intends to support eligible, domestic organizations with limited research resources and few biomedical doctoral students. The program provides funding through cooperative agreements to help institutions build their research capacity and strengthen their sponsored programs administration capabilities.
Dissemination and Implementation Research in Health (R03 Clinical Trial Not Allowed)
The purpose of this Funding Opportunity Announcement (FOA) is to support studies that will identify, develop, and/or test strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, practices, programs, tools, treatments, guidelines, and policies. Conversely, there is a benefit in understanding circumstances that create a need to stop or reduce (de-implement) the use of practices that are ineffective, unproven, low-value, or harmful. In addition, studies to advance dissemination and implementation research methods and measures are encouraged. This R03 mechanism supports small research projects with limited scope and budget. All applications must be within the scope of the mission of one of the participating NIH Institutes and Centers. The program aims to bridge the gap between research discoveries and their real-world application in health settings.
Natural Product Multi-Site Clinical Trial Data Coordinating Center (Collaborative U24 Clinical Trial Required)
This Notice of Funding Opportunity (NOFO), utilizing the U24 grant funding mechanism, encourages applications for a collaborating Data Coordinating Center (DCC) application that accompanies an investigator-initiated multi-site clinical trial (Phase III and beyond) application. The DCC application must be specific to the collaborating Clinical Coordinating Center (CCC) application. The objective of the DCC application is to propose a comprehensive plan that provides overall project coordination, and administrative, data management, and biostatistical support for the proposed clinical trial. Both a DCC application and a corresponding CCC application need to be submitted simultaneously for consideration by NCCIH. Trials for which this NOFO applies must be relevant to the research mission of the NCCIH (National Center for Complementary and Integrative Health) and considered a high priority by the Center. The funding supports multi-site clinical trials focused on natural products and complementary and integrative health research.
Screening and Functional Validation of Genomic Variants Associated with Human Congenital Anomalies (R01 Clinical Trial Not Allowed)
Rapid advances in genotyping and next generation sequencing technologies have led to the identification of genetic variants that are associated with a wide variety of congenital defects including human congenital anomalies (HCAs), intellectual developmental disabilities (IDDs) and inborn errors of metabolism (IEMs). Large quantities of genomic data collected from pediatric congenital anomalies cohorts are available to the research community through several databases such as the Database of Genotypes and Phenotypes (dbGaP), the Gabriella Miller Kids First Data Resource Portal, the European Genome-Phenome Archive and Clinical Genome Resource (ClinGen). The purpose of this initiative is to promote the screening, functional validation and characterization of congenital anomaly-associated genetic variants identified through public facing databases and individual efforts using in-silico tools, appropriate animal models, in vitro systems or multi-pronged approaches. This initiative addresses a challenging gap between identifying sequence variations of potential interest and recognizing which of those variations have functional effects on the phenotype of interest.
Dissemination and Implementation Research in Health (R21 Clinical Trial Optional)
The purpose of this Funding Opportunity Announcement (FOA) is to support studies that will identify, develop, and/or test strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, practices, programs, tools, treatments, guidelines, and policies. Conversely, there is a benefit in understanding circumstances that create a need to stop or reduce (de-implement) the use of practices that are ineffective, unproven, low-value, or harmful. In addition, studies to advance dissemination and implementation research methods and measures are encouraged. All applications must be within the scope of the mission of one of the participating NIH Institutes/Centers. This R21 grant mechanism supports exploratory/developmental research and is designed for projects where preliminary data may be limited.
Pilot Effectiveness Trials for Post-Acute Interventions and Services to Optimize Longer-term Outcomes (R01 Clinical Trial Required)
NIMH seeks applications for pilot effectiveness projects to evaluate the preliminary effectiveness of therapeutic and service delivery interventions for the post-acute management of mental health conditions that are matched to the stage of illness in terms of both their focus (e.g., consolidating and maintaining gains from initial treatment, managing residual symptoms/impairment, preventing relapse, promoting adherence and appropriate service use) and intensity/burden. In this pilot phase of effectiveness research, the trial should be designed to evaluate the feasibility, tolerability, acceptability, safety, and potential effectiveness of the approach; to address whether the intervention engages the target(s)/mechanisms(s) that is/are presumed to underlie the intervention effects; and to obtain preliminary data needed as a pre-requisite to a larger-scale effectiveness trial (e.g., comparative effectiveness study, practical trial) designed to definitely test the effectiveness of interventions to improve post-acute outcomes. This Notice of Funding Opportunity (NOFO) supports pilot effectiveness research to evaluate the feasibility, tolerability, acceptability, safety and preliminary indications of effectiveness of post-acute phase intervention approaches and inform the design of definitive effectiveness trials.
Effectiveness Trials for Post-Acute Interventions and Services to Optimize Longer-term Outcomes (R01 Clinical Trial Required)
NIMH seeks applications for research projects to evaluate the effectiveness of therapeutic and service delivery interventions for the post-acute management of mental health conditions affecting youth, adults, and older adults. This Notice of Funding Opportunity (NOFO) encourages clinical trials to establish the effectiveness and test hypotheses regarding moderators, mediators, and mechanisms of action of post-acute phase therapeutic and services interventions that are matched to the stage of illness in terms of both their focus (e.g., consolidating and maintaining gains from initial treatment, managing residual symptoms/impairment, preventing relapse, promoting adherence and appropriate service use) and intensity/burden for promoting optimal longer-term outcomes. This NOFO is intended to support effectiveness trials testing post-acute phase interventions that are statistically powered to provide a definitive answer regarding the study intervention's effectiveness. The funding instrument is an R01 grant, which requires clinical trials as part of the research design.
Enhancing Mechanistic Research on Precision Probiotic Therapies (R61/R33 Clinical Trial Optional)
The purpose of this notice of funding opportunity (NOFO) is to support highly innovative mechanistic research to accelerate precision probiotic interventions using a milestone-driven, biphasic award mechanism, R61/R33 Phased Innovation Award. Specifically, this NOFO solicits applications that will characterize person-specific features affecting probiotic responses to identify subgroups of probiotic responders and to enhance probiotic clinical outcomes. The ultimate goal of this NOFO is to identify, understand, and develop strategies to address barriers in precision probiotic therapies to account for the heterogenicity in humans that causes inconsistent probiotic responses. The first phase, funded by the R61, will provide for up to 2 years to identify unique host biological patterns (e.g., native microbiome, immune system, gender, diet, age, genetic background, lifestyle, and health history) that are correlated with heterogeneity of probiotic clinical effects using observational or secondary data analysis studies. The second phase, funded under the R33, will support studies to assess the ability of the unique patterns determined in the R61 phase to detect the improvement of probiotic responsiveness in rigorously designed mechanistic studies in relevant animal models or in human subjects. The combined R61/R33 should not exceed 5 years. Transition from the R61 to the R33 phase of the award will be administratively reviewed and will be determined based on successful completion of Transition Milestones that need to be clearly specified in the R61 phase application.
Enhancing Mechanistic Research on Precision Probiotic Therapies (R33 Clinical Trial Optional)
The purpose of this notice of funding opportunity (NOFO) is to support highly innovative mechanistic research to accelerate precision probiotic interventions. Specifically, this NOFO solicits R33 applications that will characterize person-specific features affecting probiotic responses to identify subgroups of probiotic responders and to enhance probiotic clinical outcomes. The ultimate goal is to identify, understand, and develop strategies to address barriers in precision probiotic therapies to account for the heterogenicity in humans that causes inconsistent probiotic responses. This NOFO will support studies to assess the ability of the unique patterns of host biology (e.g., native microbiome, immune system, gender, diet, age, genetic background, lifestyle, and health history) that are correlated with probiotic usage to detect the improvement of probiotic responsiveness. Well-suited applications must offer rigorously designed mechanistic studies using relevant/innovative animal models or in human subjects. This NOFO is intended to support projects where potential host biological patterns that are correlated with probiotic usage have been identified, as demonstrated with supportive preliminary data, but require further mechanistic studies to test for their causality or predictability.
CCRP Initiative: NIH Countermeasures Against Chemical Threats (CounterACT) Basic Research on Chemical Threats that Affect the Nervous System (R01 Clinical Trial Not Allowed)
This funding opportunity invites applications for basic research projects on chemical warfare agents, toxic industrial chemicals, and pesticides that have primary or secondary effects on the nervous system. Chemical threats are toxic compounds that could be used in a terrorist attack or accidentally released from industrial production, storage, or shipping. Projects supported by this NOFO are expected to generate data that elucidate mechanisms of toxicity of these agents, possible new manifestations of toxic exposures, and potential new targets for therapeutic development. The program is part of the NIH CounterACT (Countermeasures Against Chemical Threats) initiative, focusing on understanding how these chemical threats affect the nervous system and identifying pathways for developing countermeasures. This R01 grant mechanism supports basic research and explicitly excludes clinical trials.
Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Neurotherapeutic Agent Characterization and In vivo Efficacy Studies (R61/R33 Clinical Trial Not Allowed)
This NOFO provides funding to conduct pharmacodynamic, pharmacokinetic, and in vivo efficacy studies to demonstrate that proposed therapeutic agent(s) have sufficient biological activity to warrant further development to treat neurological or neuromuscular disorders that fall under the NINDS mission. Therapeutic agents include small molecules, biologics or biotechnology-derived products. This FOA is part of a suite of Innovation Grants to Nurture Initial Translational Efforts (IGNITE) to advance projects to the point where they can meet the entry criteria for the Blueprint Neurotherapeutics Network or other translational programs. The grant mechanism is R61/R33, which is a phased innovation award designed to support high-impact projects. Clinical trials are not allowed under this funding opportunity.
Cancer Prevention and Control Clinical Trials Planning Grant Program (U34 Clinical Trials Optional)
The purpose of this funding opportunity is to facilitate well planned clinical trials across the cancer prevention and control spectrum aimed at improving prevention/interception, cancer-related health behaviors, screening, early detection, healthcare delivery, management of treatment-related symptoms, supportive care, and the long-term outcomes of cancer survivors. Although the scientific literature or preliminary data may provide the rationale for conducting a clinical trial, investigators often lack critical information about the study population, accrual challenges, intervention, outcome/endpoints, data/statistical challenges or operational risks necessary to finalize the trial protocol completely. These information gaps can result in multiple protocol changes before and after trial start-up, leading to the need for additional time and expenses that may prevent study completion. The suitability and feasibility of new trial designs, which minimize infrastructure and reduce costs may need to be tested in the context of a particular intervention, at-risk group, symptom or venue. Preparatory studies may fill information gaps and address unknowns, improving trial design and knowledge of trial feasibility and thus saving NCI time and money.
Cancer Prevention and Control Clinical Trials Planning Grant Program (R34 Clinical Trials Optional)
The purpose of this FOA is to facilitate well planned clinical trials across the cancer prevention and control spectrum aimed at improving prevention/interception, cancer-related health behaviors, screening, early detection, healthcare delivery, management of treatment-related symptoms, supportive care, and the long-term outcomes of cancer survivors. Although the scientific literature or preliminary data may provide the rationale for conducting a clinical trial, investigators often lack critical information about the study population, accrual challenges, intervention, outcome/endpoints, data/statistical challenges or operational risks necessary to finalize the trial protocol completely. These information gaps can result in multiple protocol changes before and after trial start-up, leading to the need for additional time and expenses that may prevent study completion. Further, the suitability and feasibility of new trial designs, which minimize infrastructure and reduce costs may need to be tested in the context of a particular intervention, at-risk group, symptom or venue. Preparatory studies may fill information gaps and address unknowns, improving trial design and knowledge of trial feasibility and thus saving NCI time and money.
BRAIN Initiative: Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional)
This NIH funding opportunity encourages investigators to pursue translational activities and small clinical studies to advance the development of therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study, as well as a subsequent small clinical study. The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments due to the novelty of the device or its intended use. This FOA is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress. The program is part of the BRAIN Initiative and focuses specifically on next-generation devices for recording and modulation in the human central nervous system.
BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional)
This funding opportunity encourages investigators to pursue small clinical trials to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain. Clinical studies may consist of acute or short-term procedures deemed Non-Significant Risk (NSR) by an IRB, or Significant Risk (SR) studies requiring an Investigational Device Exemption (IDE) from the FDA, such as chronic implants. The clinical trial should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical trial is expected to provide information that cannot be practically obtained through additional non-clinical assessments due to the novelty of the device or its intended use. As part of the BRAIN Initiative, NIH has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements with device manufacturers willing to make such devices available, including devices not yet market approved but appropriate for clinical research.
NIA Academic Leadership Career Award (K07 Independent Clinical Trial Not Allowed)
The objective of the NIA Academic Leadership Career Award (K07) is to provide support for established investigators who have the expertise and leadership skills to enhance aging and/or Alzheimer's Disease (AD) and Alzheimers Disease Related Dementias (ADRD) research capacity within their academic institution. Through this award, investigators will endeavor to develop research and educational infrastructure, mentorship, and career development activities in support of new or emerging areas of aging and/or AD/ADRD research. These may include, but are not limited to, courses, curricula, research support, pilot funding, travel awards, visiting scholars, or networks. This Notice of Funding Opportunity (NOFO) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by another investigator.
Molecular Imaging of Inflammation in Cancer (R01 Clinical Trial Not Allowed)
The purpose of this Notice of Funding Opportunity (NOFO) is to invite research grant applications (R01) for the development and use of current and emerging molecular imaging methods to gain fundamental insights into cancer inflammation in vivo. The motivation for this initiative is that much of current imaging research into the role of inflammation in cancer is largely based on in vitro and ex vivo methods with limited utilization of imaging approaches that could lead to significant new insights relevant to dynamic cancer and inflammation interactions. Utilization of molecular imaging probes in pre-clinical and clinical investigations for precise temporal resolution at the molecular and cellular level are valuable approaches for identification and characterization of in vivo inflammatory cellular physiology in cancers and of molecular changes in response to treatment. This FOA encourages applications that focus on developing integrated imaging approaches to interrogate the role of inflammation in cancer through strong cross-field collaboration between cancer basic science researchers and imaging scientists. These collaborations are expected to advance science and understanding of cancer inflammation interactions.
Integration of Imaging and Fluid-Based Tumor Monitoring in Cancer Therapy (R01 Clinical Trial Optional)
Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) seeks research project (R01) grant applications describing projects that integrate imaging and fluid-based tumor monitoring (liquid biopsy) assays during cancer therapy in patients to determine the optimal use of those modalities in the characterization of therapy response and/or emergence of resistance. This funding opportunity supports research that combines advanced imaging techniques with liquid biopsy methods to better understand cancer treatment effectiveness and the development of treatment resistance in patients undergoing therapy. The program aims to optimize the use of these complementary monitoring approaches to improve cancer care outcomes.
Research Projects to Enhance Applicability of Mammalian Models for Translational Research (R01 Clinical Trial Not Allowed)
Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) invites applications for projects to expand, improve, or transform the utility of mammalian cancer and tumor models for translational research. The NCI intends to encourage submission of projects devoted to demonstrating that mammalian models or their derivatives used for translational research are robust representations of human biology, are appropriate to test questions of clinical importance, and provide reliable information for patients' benefit. These practical goals contrast with the goals of many mechanistic, NCI-supported R01 projects that employ mammals, or develop and use mammalian cancer models, transplantation tumor models, or models derived from mammalian or human tissues or cells for hypothesis-testing, non-clinical research. Among many other possible endeavors, applicants in response to this FOA could propose demonstrations of how to overcome translational deficiencies of mammalian oncology models, define new uses of mammalian models or their genetics for unexplored translational challenges, advance standard practices for use of translational models, test approaches to validate and credential models, or challenge current practices for how models are used translationally.
Clinical Characterization of Cancer Therapy-induced Adverse Sequelae and Mechanism-based Interventional Strategies (R01 Clinical Trial Optional)
The purpose of this Funding Opportunity Announcement (FOA) is to support collaborative research projects designed to address adverse sequelae of cancer therapies that persist and become chronic comorbidities or develop as delayed posttreatment effects. This FOA supports basic, translational, and clinical research projects that seek to identify the mechanisms of therapy-induced adverse sequelae, clinically characterize the adverse sequelae, or translate the mechanistic understanding into therapeutic approaches to prevent or minimize the development of long-term sequelae. Research projects should focus on mechanistic studies with translational endpoints and longitudinal clinical phenotyping to identify and validate clinical endpoints (biomarkers, imaging, patient-reported outcomes, or combined elements) for future use in clinical trials that will evaluate the efficacy of interventions designed to prevent or reduce specific adverse sequelae.
Assay development and screening for discovery of chemical probes, drugs or immunomodulators (R01 Clinical Trial Not Allowed)
Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) solicits applications for identification of small molecules that function to elucidate the biology of disease as chemical probes or function as agonists or antagonists of disease target(s) for therapy or immunotherapy. The NOFO is intended to support discovery research for the identification of validated hits relevant to health-related outcomes of participating NIH Institutes. Stages of discovery research covered by this NOFO include: 1) assay development for specific biological targets and disease mechanisms relevant to the mission of participating NIH Institutes with the intent to screen for small molecule compounds that show potential as probes for use in advancing knowledge about the known targets, identifying new targets, or as pre-therapeutic leads; 2) screen implementation high throughput target-focused approaches or moderate throughput phenotypic- and fragment-based approaches to identify initial screening hits; 3) hit validation, including implementation of secondary assays that are orthogonal to the primary assay, advanced cheminformatics analysis and initial medicinal chemistry inspection to prioritize the hit set, and follow-up assays to characterize mode and mechanism of action of the validated hits; 4) hit-to-lead optimization, including SAR to optimize target engagement, selectivity and to minimize chemical liabilities, ADME, PK and PD studies, and, if appropriate, in vivo modeling to test efficacy or biological effects.
Natural History of Disorders Screenable in the Newborn Period (R01 Clinical Trial Optional)
This Notice of Funding Opportunity (NOFO) encourages applications that will expand knowledge of the natural history of disorders that currently are, or may become, part of statewide newborn screening programs. A comprehensive understanding of the natural history of a condition is necessary to facilitate appropriate interventions for infants identified by newborn screening. Characterization of the sequence and timing of symptom development provides information crucial for developing targeted, age-appropriate treatments and for establishing a baseline against which to assess novel interventions. The program aims to establish genotype-phenotype correlations and identify modifying genetic, epigenetic, or environmental factors to enhance understanding of clinical outcomes. Comprehensive data will facilitate identifying underlying biological mechanisms, understanding genetic and clinical heterogeneity, improving diagnostic accuracy, facilitating clinical trials, managing and treating symptoms, furnishing physicians and families with predictive information, and establishing data collection systems or patient registries to collect longitudinal data on child and family outcomes following newborn screening.
Development and Application of PET and SPECT Imaging Ligands as Biomarkers for Drug Discovery and for Pathophysiological Studies of CNS Disorders (R01 Clinical Trial Optional)
This Notice of Funding Opportunity (NOFO) invites research grant applications that propose the development and evaluation of novel radioligands for positron emission tomography (PET) or single photon emission computed tomography (SPECT) imaging in human brain and the incorporation of, pilot or clinical feasibility evaluation from previously collected data in pre-clinical studies. These studies are expected to provide the requisite data needed to advance promising PET ligands for use in clinical research. The program supports the development of innovative imaging biomarkers that can be used for drug discovery and for understanding the pathophysiology of central nervous system (CNS) disorders. Funded projects will contribute to advancing neuroimaging technologies that enable better diagnosis, treatment monitoring, and understanding of brain disorders.
Stimulating Hematology Investigation: New Endeavors (SHINE) (R01 Clinical Trial Not Allowed)
The Stimulating Hematology Investigation: New Endeavors (SHINE) program is intended to promote innovative, high-quality nonmalignant hematology research relevant to the missions of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Aging (NIA), and the National Heart, Lung, and Blood Institute (NHLBI). Investigator-initiated research project grant applications (R01s) in specific areas of basic and early translational hematology research are invited to this program that supports growth in the nonmalignant hematology research domain. Specific emerging topics that are at the leading edge of the field will change over time and will be updated annually through the NIH Guide to Grants and Contracts.
Bioengineering Partnerships with Industry (U01 Clinical Trial Optional)
This Funding Opportunity Announcement (FOA) solicits applications from research partnerships formed by academic and industrial investigators to accelerate the development and adoption of promising bioengineering tools and technologies that can address important biomedical problems. The objectives are to establish these tools and technologies as robust, well-characterized solutions that fulfill an unmet need and are capable of enhancing our understanding of life science processes or the practice of medicine. Awards will focus on supporting multidisciplinary teams that apply an integrative, quantitative bioengineering approach to developing technologies. The goal of the program is to support technological innovations that deliver new capabilities which can realize meaningful solutions within 5 to 10 years.
Assay Development and Screening for Discovery of Validated Chemical Hits for Brain Disorders (R01 Clinical Trial Not Allowed)
The objective of this Notice of Funding Opportunity (NOFO) is to stimulate research in 1) discovery and development of novel, small molecules for their potential use in studying disease treatment relevant to psychiatric disorders; and 2) to generate new insight into the biology of relevant diseases and processes that have yet to be validated as important drug targets. This R01 grant supports fundamental research to develop assays and screen chemical compounds that could lead to new therapeutic approaches for brain disorders and mental health conditions. The program specifically excludes clinical trial activities and focuses on the discovery phase of drug development and target validation.
Academic-Industrial Partnerships (AIP) to Translate and Validate In Vivo Imaging Systems (R01 Clinical Trial Optional)
Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to stimulate translation of scientific discoveries and engineering developments in imaging, data science and/or spectroscopic technologies into methods or tools that address contemporary problems in understanding the fundamental biology, potential risk of development, diagnosis, treatment, and/or disease status for cancer or other disease. This R01 grant opportunity supports academic-industrial partnerships focused on translating imaging systems into clinical or research applications. The program aims to bridge the gap between technological innovation and practical implementation in cancer research and diagnosis.
Population Approaches to Reducing Alcohol-related Cancer Risk (R01 Clinical Trial Optional)
This Notice of Funding Opportunity (NOFO) aims to support research on interdisciplinary population approaches to increasing awareness of the relationship between alcohol and cancer risk, understanding and changing social norms related to alcohol consumption, developing and/or evaluating alcohol policy approaches, and the development, testing, and implementation of population-level interventions to reduce alcohol-related cancer risk. Applications that address multiple levels of consumption, such as moderate and heavy drinking, are of particular interest, as well as those focusing on alcohol use disorder (AUD) from the perspective of cancer prevention and control. The program seeks to advance scientific understanding of how population-level strategies can effectively reduce cancer risk associated with alcohol consumption through evidence-based interventions and policy development.
Personal Health Informatics for Delivering Actionable Insights to Individuals (R01 Clinical Trial Optional)
The purpose of this Notice of Funding Opportunity (NOFO) is to advance the development of novel informatics and data science approaches that can help individuals understand and improve their health through actionable insights. NLM seeks applications that further the science of personal health informatics by providing meaningful and actionable insights to individuals through innovative personal health data collection, integration, analysis, and personalized risk assessments and interpretation. Applications seeking to advance the understanding of how informatics tools, systems, and platforms can best present the results, interpretation, and limitations of personalized assessments for the benefit of individuals are encouraged. Applications should include end user engaged approaches and real-world evaluation to inform the design of generalizable, reusable, and scalable personal health informatics tools, systems, and platforms for the benefit of individuals in understanding and improving their health.
Innovative Research in Cancer Nanotechnology (IRCN; R01 Clinical Trial Not Allowed)
Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) encourages applications promoting transformative discoveries in cancer biology and/or oncology through the use of nanotechnology. Proposed projects should address major barriers in cancer biology and/or oncology using nanotechnology and should emphasize mechanistic studies toward fundamental understanding of nanomaterial and/or nanodevice interactions with biological systems. These studies should be performed in context of research concerning the delivery of nanoparticles and/or nano-devices to desired and intended cancer targets in vivo and/or characterization of detection and diagnostic devices in vitro. IRCN awards are expected to produce fundamental knowledge to aid future and more informed development of nanotechnology-based cancer interventions. The clinical translation of these interventions is outside of the scope of this NOFO.
Modular R01s in Cancer Control and Population Sciences (R01 Clinical Trial Optional)
This Notice of Funding Opportunity (NOFO) encourages applications for research in cancer control and population sciences. The overarching goal is to provide support to promote research efforts on novel scientific ideas that have the potential to substantially advance cancer research in statistical and analytic methods, epidemiology, cancer survivorship, cancer-related behaviors and behavioral interventions, healthcare delivery, and digital health and data science, and implementation science. This R01 grant supports innovative research projects that address critical questions in cancer control and population sciences, with the flexibility to include clinical trials as an optional component.
Laboratories to Optimize Digital Health (R01 Clinical Trial Required)
NIMH seeks applications for innovative research projects to test strategies to increase the reach, efficiency, effectiveness, and quality of digital mental health interventions. This NOFO is intended to support the development of digital health test beds that leverage well-established digital mental health platforms, to rapidly refine and optimize existing evidence-based digital health interventions and conduct clinical trials testing digital mental health interventions that are statistically powered to provide a definitive answer regarding the intervention's effectiveness. The program aims to advance the field of digital mental health by creating robust testing environments for evidence-based interventions and supporting definitive clinical trials that can provide clear answers about intervention effectiveness.
NINDS Ruth L. Kirschstein National Research Service Award (NRSA) for Training of Postdoctoral Fellows (F32 Clinical Trial Not Allowed)
The purpose of this award is to support outstanding scientific training of highly promising postdoctoral candidates with outstanding mentors. Candidates are eligible to apply for support from this program from approximately 12 months prior to the start of the proposed postdoctoral position to within 12 months after starting in postdoctoral position. Based on the early timeframe of eligibility, and the discouragement of inclusion of preliminary data, this NINDS F32 seeks to foster early, goal-directed planning and to encourage applications for bold and/or innovative projects by the candidate that have the potential for significant impact. Applications are expected to incorporate strong training in quantitative reasoning and the quantitative principles of experimental design and analysis. Support by this program is limited to the first 3 years of a candidate's activity in a specific laboratory or research environment, so as to further encourage early fellowship application and timely completion of mentored training of the postdoctoral candidate in a single environment.
NIH SIREN Neurologic Clinical Trials (UG3/UH3 - Clinical Trial Required)
This announcement encourages applications for multi-center clinical trials focused on neurological emergencies. Successful applicants will collaborate and conduct the trial within the NIH SIREN Network. The NIH SIREN Clinical Coordinating Center (CCC) will work with the successful applicants to implement the proposed trial efficiently and the SIREN Data Coordinating Center (DCC) will provide statistical and data management support. The NIH SIREN hubs and their affiliated clinical sites will provide on-site implementation of the clinical protocols. The NIH SIREN Network will also be uniquely poised to collaborate with other US and international consortia necessary to conduct larger, definitive trials of promising interventions for neurological emergencies. Multi-center clinical trials in stroke treatment, recovery, or prevention supported by NINDS will be conducted in the NIH StrokeNet, and not within SIREN. Applicants do not need to be part of the existing SIREN infrastructure to apply under this FOA.
Exploratory Grants in Cancer Control (R21 Clinical Trial Optional)
This funding opportunity announcement (FOA) encourages the submission of exploratory/developmental research grant (R21) applications that focus on different aspects of cancer control by modifying behavior, screening, and understanding etiologic factors contributing to the development of cancer, and developing ways to control cancer. The overarching goal is to provide support to promote the early and conceptual stages of research efforts on novel scientific ideas that have the potential to substantially advance population-based cancer research, such as the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of cancer research (epidemiologic, biomedical, behavioral, health care delivery or clinical).
NIDCR Dentist Scientist Career Transition Award for Intramural Investigators (K22 Clinical Trial Not Allowed)
The purpose of the NIDCR Dentist Scientist Career Transition Award for Intramural Investigators (K22) program is to facilitate transition of highly qualified dentists from NIH Intramural postdoctoral research positions to extramural academic tenure-track or equivalent faculty positions at eligible institutions. The award will provide support for two years of mentored postdoctoral research training in the NIH Intramural Research Program, and three years of independent research funding at the extramural institution. This career development award is specifically designed for dentists conducting research in oral diseases and disorders, enabling them to establish independent research programs at academic institutions after completing their intramural NIH training.
Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required)
Through this notice of funding opportunity (NOFO), the National Cancer Institute (NCI) invites applications for support of investigator-initiated clinical trials that have the potential to reduce the burden of cancer through improvements in early detection, screening, prevention and interception, healthcare delivery, quality of life, and/or survivorship related to cancer. Applications submitted to this NOFO must include studies that meet the National Institutes of Health (NIH) definition of a clinical trial and provide specific clinical trial information. This NOFO does not and will not support clinical trials for studies of cancer diagnosis and/or oncologic therapy in patients. The proposed investigator-initiated projects should be related to the programmatic interests of the NCI Division of Cancer Prevention and/or the NCI Division of Cancer Control and Population Sciences. With such attributes, the proposed studies should also have the potential to improve clinical practice and/or public health.
National Cancer Institute's Investigator-Initiated Early Phase Clinical Trials for Cancer Treatment and Diagnosis (R01 Clinical Trial Required)
Through this Notice of Funding Opportunity, the National Cancer Institute (NCI) seeks research projects that implement early phase (Phase 0, I, and II) investigator-initiated clinical trials focused on cancer-targeted diagnostic and therapeutic interventions of direct relevance to the research mission of DCTD and OHAM. The proposed project must involve at least one clinical trial related to the scientific interests of one or more of the following research programs: Cancer Therapy Evaluation Program, Cancer Imaging Program, Cancer Diagnosis Program, Radiation Research Program, Complementary and Alternative Medicine Program and/or the HIV and AIDS Malignancies Research Programs. Applicants may propose to conduct an early phase trial by itself, or in combination with another research aim(s) as appropriate. This R01 grant mechanism requires a clinical trial component and supports investigator-initiated research in cancer treatment and diagnosis.
Digital Health Technology Derived Biomarkers and Outcome Assessments for Remote Monitoring and Endpoint Development (UG3/UH3 - Clinical Trial Optional)
The purpose of this Notice of Funding Announcement (NOFO) is to support development of biomarkers or clinical outcomes derived from digital health technology (DHT) for use in clinical trials for remote monitoring as primary or secondary endpoints. To improve clinical impact, increase statistical feasibility, and promote standardization, applicants will be expected to develop and test the digitally derived assessments in populations from at least three different diseases or conditions. Partnerships with non-profit patient advocacy organizations will be required. This cooperative agreement supports research in digital health technologies for biomarker development and clinical outcome assessment, with applications across multiple disease areas including aging, neurosciences, and cancer control.
Focused Technology Research and Development (R01 Clinical Trial Not Allowed)
This Notice of Funding Opportunity (NOFO) supports projects relevant to the NIGMS mission that focus solely on the development of technologies with potential to enable acquisition of biomedical knowledge. Projects should be justified in terms of technical innovation and utility of such technical innovation for impacting future biomedical research. Outcomes or products of the proposed project should significantly advance the current state of the art and be sufficiently characterized for application in addressing a broad range of biomedical research questions. This R01 grant mechanism is specifically designated as clinical trial not allowed, focusing on fundamental technology development rather than clinical applications.
Technology Development Research for Establishing Feasibility and Proof of Concept (R21 - Clinical Trial Not Allowed)
This Notice of Funding Opportunity (NOFO) supports exploratory research leading to proof of concept for the development of new technologies relevant to the NIGMS mission. Projects should entail a high degree of risk and/or novelty, and have a high future potential impact in biomedical research. The R21 mechanism is designed for early-stage technology development research that establishes the feasibility and proof of concept for innovative biomedical technologies. This funding opportunity encourages high-risk, high-reward projects that have the potential to transform biomedical research capabilities.
Environmental Health Sciences Core Centers Program (P30 Clinical Trials Optional)
This Notice of Funding Opportunity Announcement (NOFO) invites grant applications for Environmental Health Sciences Core Centers (EHSCC). As intellectual hubs for environmental health science research, the EHSCC's are expected to be the thought leaders for the field and advance the goals of the 2025-2029 NIEHS Strategic Plan. The Core Centers provide critical research infrastructure, shared facilities, services and/or resources, to groups of investigators conducting environmental health sciences research. An EHSCC enables researchers to conduct their independently-funded individual and/or collaborative research projects more efficiently and/or more effectively. The overall goal of an EHSCC is to identify and capitalize on emerging issues that advance improving the understanding of the relationships among environmental exposures, human biology, and disease. The EHSCC supports community engagement and translational research as key approaches to improving public health.
Developing novel theory and methods for understanding the genetic architecture of complex human traits (R01 Clinical Trial Not Allowed)
The goal of this NOFO is to support applications for novel theory and methods development that enable better understanding of how genetic and non-genetic factors contribute to complex trait variation across individuals, families, and populations. Approaches should be interdisciplinary drawing from the natural and social sciences, account for interdependencies across scales of biological, social, and ecological organization, and make extensive use of theory, modeling, and validation with available large-scale datasets. This R01 grant from the National Institutes of Health supports research that advances the understanding of genetic architecture and complex human traits through innovative theoretical and methodological approaches. The funding mechanism is designed to promote interdisciplinary collaboration that integrates multiple levels of biological, social, and ecological analysis.
Developing novel theory and methods for understanding the genetic architecture of complex human traits (R21 Clinical Trial Not Allowed)
The goal of this NOFO is to support R21 applications for novel theory and methods development that better delineate how genetic and non-genetic factors contribute to complex trait variation across individuals, families, and populations. Approaches should be interdisciplinary across the natural and social sciences, account for interdependencies across scales of biological, social, and ecological organization, and make extensive use of theory, simulations, and validation using available large-scale datasets. This funding opportunity announcement from the National Institutes of Health supports research that advances understanding of complex human genetic architecture through innovative theoretical and methodological approaches. The program encourages applications that integrate multiple scientific disciplines to address fundamental questions about trait variation at individual, family, and population levels.
BRAIN Initiative: Development and Validation of Novel Tools to Probe Cell-Specific and Circuit-Specific Processes in the Brain (R01 Clinical Trial Not Allowed)
The purpose of this Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is to encourage applications that will develop and validate novel tools to facilitate the detailed analysis of complex circuits and provide insights into cellular interactions that underlie brain function. The new tools and technologies should inform and/or exploit cell-type and/or circuit-level specificity. Plans for validating the utility of the tool/technology will be an essential feature of a successful application. The development of new genetic and non-genetic tools for delivering genes, proteins and chemicals to cells of interest or approaches that are expected to target specific cell types and/or circuits in the nervous system with greater precision and sensitivity than currently established methods are encouraged. Tools that can be used in a number of species/model organisms rather than those restricted to a single species are highly desired. Applications that provide approaches that break through existing technical barriers to substantially improve current capabilities are highly encouraged.
Development of Animal Models and Related Biological Materials for Research (R21 Clinical Trial Not Allowed)
This notice of funding opportunity (NOFO) encourages innovative research to develop, improve, characterize, and preserve animal models as well as animal model related biological materials, technologies, and new approach methodologies (NAMs) for studies relevant to human health and disease. This NOFO also seeks projects aimed at improving the diagnosis and control of diseases that could confound or interfere with animal use in biomedical research. The proposed project must have broad applicability to multiple NIH Institutes or Centers (ICs) to align with the NIH-wide mission of the Office of Research Infrastructure Programs (ORIP). The proposed studies must include animal models and explore multiple body systems or multiple categories of diseases. Applications that develop models focused on a specific disease or area of research, or only propose studies primarily relevant to a single NIH IC, will be considered not acceptable to this NOFO and will be withdrawn.
Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grant (Parent T32)
The National Institutes of Health (NIH) awards Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grants (T32) to eligible, domestic institutions to develop and/or enhance predoctoral and postdoctoral research training, including short-term research training. The program helps ensure that a highly trained workforce is available to meet the needs of the Nation's biomedical, behavioral, and clinical research agenda. Research training programs are expected to incorporate engaging, didactic, research, and career development elements to prepare trainees for careers that will have a significant impact on the health-related research needs of the Nation. Programs proposing only short-term predoctoral research training should apply to the Kirschstein-NRSA Short-Term Institutional Research Training Grant Program (T35) instead. This Funding Opportunity Announcement (FOA) does not allow appointed Trainees to lead an independent clinical trial but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor.
NICHD Small Research Grant Program (R03 Basic Experimental Studies with Humans Required)
The NICHD Small Research Grant Program (R03 Basic Experimental Studies with Humans Required) supports clinical trials that fall within the NICHD mission and also meet the criteria for basic science experimental studies involving humans (BESH), referred to in NOT-OD-18-212 as prospective basic science studies involving human participants. These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that should submit under this NOFO include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. The program is administered by the National Institute of Child Health and Human Development (NICHD) as part of the National Institutes of Health. This funding opportunity (PA-25-126) provides support for basic experimental research involving human participants that aligns with NICHD's mission to ensure that every person is born healthy and wanted, that women suffer no harmful effects from reproductive processes, and that all children have the chance to achieve their full potential for healthy and productive lives, free from disease or disability.
NICHD Small Research Grant Program (R03 Clinical Trial Required)
The NICHD Small Research Grant Program (Clinical Trial Required) supports clinical trials that fall within the NICHD mission. This NIH grant program provides funding for small research projects focused on child health and human development through clinical trial research. The program is designed to support investigators conducting clinical trials in areas aligned with the National Institute of Child Health and Human Development's research priorities. Applications are accepted through a program announcement system with funding available through grants.nih.gov.
NIDA Research Education Program for Clinical Researchers and Clinicians (R25 Clinical Trial Not Allowed)
The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this NIDA R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation's biomedical, behavioral and clinical research needs. This NOFO is intended to support research education activities that enhance the knowledge of substance use and substance use disorder research. The program is intended for those in clinically focused careers and/or those training for careers as clinicians/health service providers, clinical researchers, or optimally a combination of the two. This mechanism may not be used to support non-research-related clinical training.
Cellular and Molecular Biology of Complex Brain Disorders (R21 Clinical Trial Not Allowed)
This Notice of Funding Opportunity (NOFO) encourages research on the biology of high confidence risk factors associated with complex brain disorders, with a focus on the intracellular, transcellular and circuit substrates of neural function. For the purposes of this NOFO, the term complex can refer to a multifactorial contribution to risk (e.g., polygenic and/or environmental) and/or highly distributed functional features of the brain disorder. Studies may be either hypothesis-generating (unbiased discovery) or hypothesis-testing in design and may utilize in vivo, in situ, or in vitro experimental paradigms, e.g., model organisms or human cell-based assays. While behavioral paradigms and outcome measures can be incorporated into the research design to facilitate the characterization of intracellular, transcellular and circuit mechanisms, these are neither required nor expected. Studies should not attempt to model disorders but instead should aim to elucidate the neurobiological impact of individual or combined risk factor(s), such as the affected molecular and cellular components and their relationships within defined biological process(es). The R21 activity code is intended for early stage, high-risk, exploratory approaches or to establish proof-of-concept where there is little or no preliminary data. The resulting paradigms, component pathways and biological processes should be disseminated with sufficient detail to enrich common and/or federated data resources to bridge the gap between disease risk factors, biological mechanism and therapeutic target identification.
Schizophrenia and related disorders during mid- to late-life (R01 Clinical Trial Optional)
Although the majority living with schizophrenia and related disorders are over 35 years old, including those first diagnosed and those aging with the illness, the mechanisms underlying the generation and trajectory of the illness remain poorly understood. The purpose of this initiative is to advance translational research to better understand the emergence and trajectory of schizophrenia and related disorders in mid to late life, and to identity targets for future development of prevention and treatment efforts. This R01 grant supports clinical trial optional research in mental health focusing on individuals in mid to late life with schizophrenia and related psychiatric disorders.
Cellular and Molecular Biology of Complex Brain Disorders (R01 Clinical Trial Not Allowed)
This Notice of Funding Opportunity (NOFO) encourages research on the biology of high-confidence risk factors associated with complex brain disorders, with a focus on the intracellular, transcellular, and circuit substrates of neural function. Studies may be either hypothesis-generating or hypothesis-testing in design and may utilize in vivo, in situ or in vitro experimental paradigms, including model organisms or human cell-based assays. Studies should aim to elucidate the neurobiological impact of individual or combined risk factors, such as the affected molecular and cellular components and their relationships within defined biological processes. The resulting paradigms, component pathways, and biological processes should be disseminated with sufficient detail to enrich common and/or federated data resources to bridge the gap between disease risk factors, biological mechanism and therapeutic target identification. This R01 activity code is for applications to further develop lines of inquiry where feasibility or proof-of-concept has been established.
Schizophrenia and related disorders during mid- to late-life (R21 Clinical Trial Optional)
Although the majority living with schizophrenia and related disorders are over 35 years old, including those first diagnosed and those aging with the illness, the mechanisms underlying the generation and trajectory of the illness remain poorly understood. The purpose of this initiative is to advance translational research to better understand the emergence and trajectory of schizophrenia and related disorders in mid to late life, and to identity targets for future development of prevention and treatment efforts. This R21 grant mechanism supports exploratory and developmental research projects in this critical area of mental health.
Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R01 Clinical Trial Optional)
This National Institutes of Health funding opportunity supports translational and clinical research to advance precision medicine in pregnant women, lactating women, and children through the development of novel tools, models, and other technologies that could have a direct clinical or health impact. The program aims to enhance the understanding of the underlying mechanisms of drug action, including the role of pediatric ontogeny and the dynamic physiological changes that occur during pregnancy and lactation. It also seeks to discover and develop novel therapeutics or enhance the usage of existing drugs or drug repurposing for safer and more effective medications in pregnant and lactating women, neonates, and children. The overall goal is to improve safe and effective precision therapeutics for pregnant and lactating women, fetuses, neonates, and children, including those with disabilities.
Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R21 Clinical Trial Optional)
The purpose of this notice of funding opportunity (NOFO) is to support translational and clinical research to advance precision medicine in pregnant women, lactating women, and children through the development of novel tools, models, and other technologies that could have a direct clinical or health impact. The program aims to enhance the understanding of the underlying mechanisms of drug action, including the role of pediatric ontogeny and the dynamic physiological changes that occur during pregnancy and lactation. Additionally, it seeks to discover and develop novel therapeutics or enhance the usage of existing drugs or drug repurposing for safer and more effective medications in pregnant and lactating women, neonates, and children. The overall goal is to improve safe and effective precision therapeutics for pregnant and lactating women, fetuses, neonates, and children, including those with disabilities.
Advancement and Innovation in Measurement of Language Development and Predictors (R01 Clinical Trial Not Allowed)
The purpose of this notice of funding opportunity (NOFO) is to encourage community-engaged research that broadens the conceptualization of qualities of the environment that can support language development in children and that focuses on the development of novel measures of children's language development. The overall goal is to build the number of strengths-focused, culturally and linguistically responsive, and generalizable tools to further our understanding of children's language development and/or impairment, and predictors thereof. This R01 grant supports research projects that develop innovative measurement approaches for assessing language development in children and environmental factors that influence it.
Advancement and Innovation in Measurement of Language Development and Predictors (R21 Clinical Trial Not Allowed)
The purpose of this notice of funding opportunity (NOFO) is to encourage community-engaged research that broadens the conceptualization of qualities of the environment that can support language development in children and that focuses on the development of novel measures of children's language development. The overall goal is to build the number of strengths-focused, culturally and linguistically responsive, and generalizable tools to further our understanding of children's language development and/or impairment, and predictors thereof. This R21 grant mechanism supports exploratory and developmental research projects that have the potential to contribute to significant scientific advances.
Basic Research in Cancer Health Disparities (R01 Clinical Trial Not Allowed)
This Notice of Funding Opportunity (NOFO) encourages grant applications from investigators interested in conducting basic, mechanistic research into the biological/genetic causes of cancer health disparities. These research project grants will support innovative studies designed to investigate biological/genetic bases of cancer disparities, such as (1) mechanistic studies of biological factors associated with cancer disparities, including those related to basic research in cancer biology or cancer prevention strategies, (2) the development and testing of new methodologies and models, and (3) secondary data analyses. This NOFO is also designed to aid and facilitate the growth of a nationwide cohort of scientists with a high level of basic research expertise in cancer health disparities research who can expand available resources and tools, such as biospecimens, patient derived models, and methods that are necessary to conduct basic research in cancer health disparities.
Basic Research in Cancer Health Disparities (R21 Clinical Trial Not Allowed)
This Notice of Funding Opportunity (NOFO) encourages grant applications from investigators interested in conducting basic, mechanistic research into the biological/genetic causes of cancer health disparities. These research project grants will support innovative studies designed to investigate biological/genetic bases of cancer health disparities, such as (1) mechanistic studies of biological factors associated with cancer health disparities, including those related to basic research in cancer biology or cancer prevention strategies, (2) the development and testing of new methodologies and models, and (3) secondary data analyses. This NOFO is also designed to aid and facilitate the growth of a nationwide cohort of scientists with a high level of basic research expertise in cancer health disparities research who can expand available resources and tools, such as biospecimens, patient derived models, and methods that are necessary to conduct basic research in cancer health disparities.
Investigator Initiated Innovation in Computational Genomics and Data Science (R01 Clinical Trial Not Allowed)
The purpose of this funding opportunity announcement (FOA) is to invite applications for a broad range of research efforts in computational genomics, data science, statistics, and bioinformatics relevant to one or both of basic or clinical genomic science, and broadly applicable to human health and disease. This FOA supports fundamental genomics research developing innovative analytical methodologies and approaches, early-stage development of tools and software, and refinement or hardening of software and tools of high value to the biomedical genomics community. Work supported under this FOA should be enabling for genomics and be generalizable or broadly applicable across diseases and biological systems. All applications should address how the methods would scale to address increasingly larger data sets.
Investigator Initiated Innovation in Computational Genomics and Data Science (R21 Clinical Trial Not Allowed)
The purpose of this funding opportunity announcement (FOA) is to invite applications for a broad range of research efforts in computational genomics, data science, statistics, and bioinformatics relevant to one or both of basic or clinical genomic science, and broadly applicable to human health and disease. This FOA supports fundamental genomics research developing innovative analytical methodologies and approaches, early-stage development of tools and software, and refinement or hardening of software and tools of high value to the biomedical genomics community. Work supported under this FOA should be enabling for genomics and be generalizable or broadly applicable across diseases and biological systems. All applications should address how the methods would scale to address increasingly larger data sets. This is an R21 grant mechanism which supports exploratory research projects.
Social disconnection and Suicide Risk in Late Life (R01 Clinical Trial Optional)
This initiative seeks to solicit applications for research projects that address the link between social disconnection including both objective social isolation as well as perceived social isolation (otherwise known as loneliness) and suicide in late-life. Emphasis is placed on research that identifies neurobiological and environmental mechanisms associated with social isolation and loneliness that increase risk for suicidal thoughts and behavior in late-life, that uses an experimental therapeutics approach to identify targets and develop and test interventions to prevent late-life suicide, and that develops new and modifies existing service delivery models to enhance social connection in late-life to prevent suicide. This is an R01 grant mechanism from the National Institutes of Health with clinical trials optional. The funding opportunity aims to advance understanding of how social isolation and loneliness contribute to suicide risk in older adults and to develop interventions that can prevent late-life suicide through enhanced social connection.
Social disconnection and Suicide Risk in Late Life (R21 Clinical Trial Optional)
This initiative seeks to solicit applications for research projects that address the link between social disconnection including both objective social isolation as well as perceived social isolation (otherwise known as loneliness) and suicide in late-life. Emphasis is placed on research that identifies neurobiological and environmental mechanisms associated with social isolation and loneliness that increase risk for suicidal thoughts and behavior in late-life, that uses an experimental therapeutics approach to identify targets and develop and test interventions to prevent late-life suicide, and that develops new and modifies existing service delivery models to enhance social connection in late-life to prevent suicide. This R21 grant mechanism supports exploratory and developmental research projects in mental health with a focus on addressing critical gaps in understanding late-life suicide risk factors and developing innovative prevention strategies.
Novel Mechanism Research on Neuropsychiatric Symptoms (NPS) in Alzheimer's Dementia (R01 Clinical Trial Optional)
The goal of this Funding Opportunity Announcement (FOA) is to encourage applications for studies that will enhance knowledge of mechanisms associated with neuropsychiatric symptoms (NPS) in persons with Alzheimer's disease (AD) or Alzheimer's disease-related dementias (ADRD). The findings are expected to advance mechanistic understanding of both biobehavioral and neurobiological pathways leading to NPS. Findings may also provide insight into novel therapeutic targets that can be advanced into interventions to treat and prevent the development of NPS in AD and/or ADRD. This R01 grant mechanism supports investigator-initiated research projects and may optionally include clinical trials.
Novel Mechanism Research on Neuropsychiatric Symptoms (NPS) in Alzheimer's Dementia (R21 Clinical Trial Optional)
This funding opportunity announcement encourages applications for studies that will enhance knowledge of mechanisms associated with neuropsychiatric symptoms (NPS) in persons with Alzheimer's disease (AD) or Alzheimer's disease-related dementias (ADRD). The findings are expected to advance mechanistic understanding of both biobehavioral and neurobiological pathways leading to NPS. Findings may also provide insight into novel therapeutic targets that can be advanced into interventions to treat and prevent the development of NPS in AD and/or ADRD. This is an R21 grant mechanism that allows for clinical trials as an optional component.
NIDCR Small Grant Program for New Investigators (R03 Clinical Trial Not Allowed)
This NIDCR Small Grant Program for New Investigators supports basic and clinical research conducted by scientists who are in the early stages of establishing an independent research career in oral, dental and craniofacial research. This R03 program supports pilot or feasibility studies and developmental research projects with the intention of obtaining sufficient preliminary data for a subsequent investigator initiated Research Project Grant (R01) or equivalent application. The program is specifically designed for early-career investigators to help them build their research foundation in dental and craniofacial sciences through small-scale exploratory studies.
Mechanisms that Impact Cancer Risk with Use of Incretin Mimetics (R01 Clinical Trial Optional)
The goal of this funding announcement is twofold: to promote preclinical and patient based studies examining the mechanism(s) through which incretin mimetics (including agonists or antagonists of GLP-1, GIP-1, or dual GLP-1/GIP-1 agents) impact cancer risk, and to draw talented scientists who understand the dynamic changes caused by these agents to investigate the mechanisms of how these agents influence cancer risk rather than shorter term outcomes such as weight loss and diabetes. The data thus far suggests that these agents may increase the risk of some, while decreasing the risk of other obesity related cancers. This is an R01 grant opportunity, which is the NIH's most commonly used grant program supporting discrete, specified, circumscribed research projects. Applicants may propose clinical trials as optional components of their research projects.
Mechanisms that Impact Cancer Risk with Use of Incretin Mimetics (R21 Clinical Trial Not Allowed)
The goal of this funding announcement is twofold: to promote preclinical and patient-based studies examining the mechanism(s) through which incretin mimetics (including agonists or antagonists of GLP-1, GIP-1, or dual GLP-1/GIP-1 agents) impact cancer risk, and to draw talented scientists who understand the dynamic changes caused by these agents to investigate the mechanisms of how these agents influence cancer risk rather than shorter term outcomes such as weight loss and diabetes. The data thus far suggests that these agents may increase the risk of some, while decreasing the risk of other obesity-related cancers. This R21 research grant mechanism supports innovative, high-risk, high-reward projects that may lack preliminary data but have the potential to lead to breakthroughs in understanding cancer mechanisms. This opportunity is specifically designed to explore the complex relationship between incretin mimetic drugs and cancer development, encouraging novel approaches to understanding these important mechanisms. The funding will support both preclinical laboratory studies and patient-based research to elucidate the biological pathways involved.
Secondary Analysis and Integration of Existing Data to Elucidate Cancer Risk and Related Outcomes (R01 Clinical Trial Not Allowed)
Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) along with other participating Institutes encourages submission of applications proposing to conduct secondary data analysis and integration of existing datasets and database resources, with the ultimate aim to elucidate cancer risk and related outcomes (e.g., risk prediction or reduction, survival, or response to treatment, etc.). The goal of this initiative is to address key scientific questions relevant to cancer by supporting the analysis of existing clinical, environmental, surveillance, health services, vital statistics, behavioral, lifestyle, genomic, and molecular profiles data. Applicants are encouraged to leverage and perform innovative analyses of the existing data. Applications may include new research aims that are being addressed with existing data, new or advanced methods of analyses, or novel combinations and integration of datasets that allow the exploration of important scientific questions in cancer research. This R01 grant mechanism supports investigator-initiated research projects that demonstrate significant potential to advance cancer research through secondary analysis of existing data.
NCMRR Early Career Research Award (R03 Clinical Trial Optional)
The National Center for Medical Rehabilitation Research (NCMRR) Early Career Research (ECR) Award (R03) is intended to support both basic and clinical research from rehabilitation scientists who are establishing independent research careers. The research must be focused on one or more of the areas within the mission of NCMRR. The NCMRR ECR Award R03 grant mechanism supports various types of projects including secondary analysis of existing data; small, self-contained research projects; development of research methodology; translational research; outcomes research; and development of new technology. Irrespective of the type of project, the intent of the NCMRR ECR Award R03 is for the Program Director(s)/Principal Investigator(s) to obtain sufficient preliminary data for a subsequent R01 application. This award is specifically designed to help early career researchers establish independent research careers in medical rehabilitation research.
NIDCR Small Research Grants for Analyses of Existing Genomics Data (R03 Clinical Trial Not Allowed)
The purpose of this NOFO is to announce support for meritorious research projects that address research questions relevant to human dental, oral, or craniofacial (DOC) biology, and diseases and conditions, through analysis of existing and publicly available genomic data, with or without other types of complementary data, using statistical and computational approaches. Data analysis for each project can be performed using existing and/or novel methods to be developed in the proposed project(s), including methods for data and metadata mining, data integration, and Artificial Intelligence (AI)/Machine Learning (ML)/Deep Learning (DL) methods. In addition to analysis of existing data, experimental or in silico work is required to validate the results of the proposed analysis, or to validate a newly developed analytic method. Projects aimed at understanding oral health disparities to inform strategies for improving health for all individuals are a priority. Projects focused on investigating and/or characterizing human biological pathways to inform identification of intervention targets or defining the pathogenicity of known genetic variants are encouraged.
NIDCR Research Grants for Analyses of Existing Genomics Data (R01) (Clinical Trial Not Allowed)
This NOFO announces support for meritorious research projects that address research questions relevant to human dental, oral, or craniofacial (DOC) biology, and diseases and conditions, through analysis of existing and publicly available genomic data, with or without other types of complementary data, using statistical and computational approaches. Data analysis for each project can be performed using existing and/or novel methods to be developed in the proposed project(s), including methods for data and metadata mining, data integration, and Artificial Intelligence (AI)/Machine Learning (ML)/Deep Learning (DL) methods. In addition to analysis of existing data, experimental or in silico work is required to validate the results of the proposed analysis, or to validate a newly developed analytic method. Projects aimed at understanding oral health disparities to inform strategies for improving health for all individuals are a priority. Projects focused on investigating and/or characterizing human biological pathways to inform identification of intervention targets or defining the pathogenicity of known genetic variants are encouraged.
Limited Competition: Small Grant Program for ORIP Special Emphasis Research Career Award (SERCA) K01 Recipients (R03 Clinical Trial Not Allowed)
The Office of Research Infrastructure Programs (ORIP) within the Division of Program Coordination, Planning, and Strategic Initiatives announces an opportunity to apply for small grant support for ORIP-supported Special Emphasis Research Career Award (SERCA) K01 recipients who have completed the first two years (24 months) of the SERCA K01 award. ORIP seeks to enhance the ability of ORIP SERCA K01 awardees to conduct research as they transition to fully independent investigator status. The R03 mechanism supports projects including pilot and feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology. The R03 is intended to support research projects that can realistically be completed in two years and that require limited levels of funding. This Funding Opportunity Announcement does not accept applications proposing clinical trials.
Chemical Countermeasures Research Program (CCRP) Initiative: Basic Research on The Deleterious Effects of Acute Exposure to Ultra-Potent Synthetic (UPS) Opioids (R01 Clinical Trial Not Allowed)
This notice of funding opportunity (NOFO) will support research towards understanding and mitigating the deleterious effects of acute exposure to Ultra-Potent Synthetic (UPS) opioids (e.g., fentanyl, carfentanil, nitazenes) and their combinations (fentanyl and xylazine). This NOFO will also support research on the persistent and/or delayed pathophysiological effects after acute exposure to such agents. The program aims to advance scientific understanding of how acute exposure to ultra-potent synthetic opioids affects human health and to develop potential countermeasures. This R01 grant mechanism supports basic research projects and does not allow clinical trials.
NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (UG3/UH3 Clinical Trial Optional)
This Notice of Funding Opportunity (NOFO) encourages applications for multi-site exploratory and confirmatory clinical trials focused on promising interventions; biomarker or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery; and ancillary studies designed to add scientific aims to active studies being conducted within StrokeNet. Successful applicants will collaborate and conduct the study within the NIH StrokeNet. Following peer review, NINDS will prioritize studies among the highest scoring to be conducted in the NIH StrokeNet infrastructure. The NIH StrokeNet National Coordinating Center (NCC) will work with the successful applicant to implement the proposed study efficiently and the National Data Management Center (NDMC) will provide statistical and data management support. The NIH StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol.
NCI Pathway to Independence Award (K99/R00 Clinical Trial Not Allowed)
The purpose of the NCI Pathway to Independence Award (K99/R00) program is to facilitate a timely transition of talented postdoctoral researchers with a research and/or clinical doctorate degree from mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. The program will provide independent NCI research support during this transition in order to help awardees to launch competitive, independent research careers. This prestigious award from the National Cancer Institute supports early career researchers as they move from postdoctoral training to faculty positions, providing funding during the critical transition period. The K99/R00 mechanism consists of two phases: the mentored (K99) phase during the postdoctoral period and the independent (R00) phase after securing a faculty position.
Academic Research Enhancement Award (AREA) for Undergraduate-Focused Institutions (R15 Clinical Trial Required)
The Academic Research Enhancement Award (AREA) for Undergraduate-Focused Institutions is designed to support small scale research grants at institutions that do not receive substantial funding from the NIH. The program emphasizes providing biomedical research experiences primarily for undergraduate students while enhancing the research environment at applicant institutions. Eligible institutions must award baccalaureate science degrees and have received no more than $6 million dollars per year of NIH support in 4 of the last 7 fiscal years. This Notice of Funding Opportunity (NOFO) supports investigator-initiated mechanistic and/or minimal risk clinical trials addressing the mission and research interests of participating NIH institutes. Minimal risk clinical trials are defined as those that do not require FDA oversight, do not intend to formally establish efficacy, and have low risks to potentially cause physical or psychological harm. The program is specifically designed to engage undergraduate students in biomedical research and strengthen research capacity at institutions with limited NIH funding. The award covers a wide range of health-related research areas including cancer research, cardiovascular diseases, drug use and addiction, mental health, aging research, human genome research, and various other biomedical fields. For institutions composed of multiple schools and colleges, the $6 million funding limit is based on the amount of NIH funding received by all the non-health professional schools and colleges within the institution as a whole.
BRAIN Initiative: Promoting Health for All Through BRAIN Technology Partnerships (R34 - Clinical Trials Not Allowed)
The goal of this funding opportunity is to increase the impact of the BRAIN Initiative by targeted dissemination and integration of validated BRAIN Initiative tools to investigators at institutions that historically have not been major recipients of NIH support. This will be accomplished by awards to PIs at resource-limited institutions (RLIs) who pair with BRAIN technologists to facilitate training and adoption of BRAIN Initiative technologies in the recipient laboratories. Goals include two-way knowledge transfer between the PI and BRAIN technologist and to increase the participation of PIs at RLIs in BRAIN Initiative relevant research. The program aims to bridge the gap between cutting-edge neuroscience technology development and its application at underserved research institutions, fostering broader participation in brain research across diverse institutional settings.
Screening, Brief Intervention and Referral to Treatment or Prevention (SBIRT/P) for alcohol, tobacco, and other drugs (ATOD) use and misuse in adult populations that experience health disparities (R01, Clinical Trial Required)
The Office of Disease Prevention (ODP) and participating National Institutes of Health (NIH) Institutes, Centers, and Offices (ICOs) are issuing this notice of funding opportunity (NOFO) seeking applications to test innovative approaches to implementing SBIRT/P for alcohol, tobacco, and other drugs (ATOD) use and misuse in adult populations that experience health disparities. SBIRT/P involves screening individuals for risk of ATOD use and misuse, briefly intervening with a conversation about harmful substance use, and referring individuals for treatment or preventive services, as needed. Proposed research should include prospective tests of SBIRT/P and should leverage collaborations with healthcare and community partners. This is an R01 grant mechanism that requires a clinical trial component.
NCCIH Multi-Site Feasibility Clinical Trials of Mind and Body Interventions (R01 Clinical Trial Required)
This notice of funding opportunity invites applications for investigator-initiated clinical trials of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions) in NCCIH-designated areas of high research priority. Applications are expected to propose a multisite feasibility clinical trial that will provide new information that is scientifically necessary for the planning and conduct of a subsequent clinical efficacy or effectiveness study, pragmatic trial, or dissemination and implementation trial within NCCIH's mission. The proposed research should demonstrate that the feasibility study is scientifically necessary to design or plan the subsequent fully powered, full-scale clinical trial. Under this R01, the data collected should be used to fill gaps in scientific knowledge, including assessing whether the intervention can be delivered with fidelity across sites, demonstrating feasibility of recruitment and retention across sites, refining protocolized multimodal interventions, and demonstrating feasibility of data collection across sites in preparation for a future fully powered, multisite efficacy or effectiveness trial. The need for multisite feasibility trials is expected to be justified by sufficient preliminary data from previous single site feasibility or acceptability trials or the published literature.
Investigator Initiated Clinical Trials of Complementary and Integrative Interventions Delivered Remotely or via mHealth (R01 Clinical Trial Required)
This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated fully remotely delivered and conducted clinical trials to assess the efficacy or effectiveness of complementary and integrative health interventions in NCCIH-designated areas of high research priority. Applications submitted under this NOFO are expected to propose a remotely delivered and conducted fully powered clinical trial with no in-person contact between research staff and study participants and may utilize mHealth tools or technologies. Applicants must provide justification for the remotely delivered approach and provide preliminary data on the feasibility and safety of the approach, along with evidence that the intervention has promise of clinical benefit. This funding opportunity supports research aligned with assistance listing 93.213 for Research and Training in Complementary and Integrative Health.
Understanding Expectancies in Cancer Symptom Management (R01 Clinical Trial Required)
This Notice of Funding Opportunity (NOFO) supports research on expectancy-generating factors and measures of their effects on expectancies and subsequent cancer symptom management outcomes; and research to identify moderators of such expectancy effects. Specifically, this NOFO will solicit mechanistic research that aims to understand how and why expectancy effects occur in a cancer context, elucidate their role in cancer symptom management, and identify patients, symptoms, cancer sites, and contexts in which expectancy effects can be leveraged to improve cancer outcomes. Expectancies are defined in this context as beliefs about future outcomes, including ones response to cancer or cancer treatment. Expectancies can be evoked by social, psychological, environmental, and systemic factors. Expectancy effects are the cognitive, behavioral, and biological outcomes caused by expectancies. Expectancy effects can be generated by expectancies held by patients, clinicians, family members, caregivers, and/or dyadic/social networks. This R01 grant mechanism supports mechanistic clinical trials required to investigate expectancy effects in cancer symptom management.
Feasibility Clinical Trials of Mind and Body Interventions for NCCIH High Priority Research Topics (R34 Clinical Trial Required)
The goal of this notice of funding opportunity (NOFO) is to support feasibility trials of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions) for conditions that have been identified by NCCIH as high-priority research topics. This funding opportunity is intended to support feasibility clinical trials that provide new information that are scientifically necessary for the planning and conduct of a subsequent clinical efficacy or effectiveness study, pragmatic trial, or dissemination and implementation trial within NCCIH's mission. NCCIH expects that applications will describe the planned future clinical trial and demonstrate that the proposed R34 research is scientifically necessary to design or plan the subsequent competitive full-scale clinical trial. The data collected should be used to fill gaps in scientific knowledge necessary to develop a competitive full-scale clinical trial, including examining feasibility and acceptability of interventions lacking published data; tailoring or adapting the content or structure of an intervention to a specific population, modality, or setting; refining the intervention to determine the most appropriate frequency or duration; determining feasibility of recruitment, retention, and data collection procedures; refining and assessing the feasibility of protocolized multi-component interventions; or examining acceptability and adherence of control conditions. The subsequent full-scale clinical trial should have the potential to make a significant impact on public health.
Utilizing the PLCO Biospecimens Resource to Bridge Gaps in Cancer Etiology and Early Detection Research (U01 Clinical Trial Not Allowed)
This Funding Opportunity Announcement (FOA) encourages the submission of applications that propose to advance research in cancer etiology and early detection biomarkers, utilizing the advantages of the unique biorepository resources of the NCI-sponsored Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial. The PLCO Biorepository offers high-quality, prospectively collected, serial pre-diagnostic blood samples from the PLCO screened arm participants, and a onetime collection of buccal cells from the control arm participants. Available data associated with the biospecimens includes demographic, diet, lifestyle, smoking, screening results, and clinical data. This FOA supports a wide range of cancer research including, but not limited to, biochemical and genetic analyses of cancer risk, as well as discovery and validation of early detection biomarkers. The proposed research project must involve use of PLCO biospecimens and should take advantage of the unique characteristics of the PLCO biospecimens.
Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R21 Clinical Trial Not Allowed)
This Notice of Funding Opportunity (NOFO) encourages applications seeking to develop the next generation of brain stimulation devices for treating mental health disorders. Applications are sought that will either develop novel brain stimulation devices or significantly enhance, by means of hardware/software improvements, the effectiveness of brain stimulation devices that are currently U.S. Food and Drug Administration (FDA)-approved or cleared. Novel devices should move beyond existing electrical/magnetic stimulation and develop new stimulation techniques capable of increased spatiotemporal precision as well as multi-focal, closed-loop approaches. Applications seeking to develop new capabilities should focus on significant enhancement of the spatial resolution, depth of delivery, and/or precision of the device. Incremental changes to existing devices are not within the scope of this announcement. Applications should be submitted by multi-disciplinary teams with a variety of expertise including systems neuroscience, engineering, clinical, and regulatory affairs.
Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R01 Clinical Trial Not Allowed)
The purpose of this Notice of Funding Opportunity (NOFO) is to encourage applications seeking to develop the next generation of brain stimulation devices for treating mental health disorders. Applications are sought that will either 1) develop novel brain stimulation devices or 2) significantly enhance, by means of hardware/software improvements, the effectiveness of brain stimulation devices that are currently U.S. Food and Drug Administration (FDA)-approved or cleared. Novel devices should move beyond existing electrical/magnetic stimulation and develop new stimulation techniques capable of increased spatiotemporal precision as well as multi-focal, closed-loop approaches. Applications seeking to develop new capabilities should focus on significant enhancement of the spatial resolution, depth of delivery, and/or precision of the device. Incremental changes to existing devices (e.g., software updates) are not within the scope of this announcement.
Catalyze: Enabling Technologies and Transformative Platforms for HLBS Research (R33 - Clinical Trials Not Allowed)
The goal of the NHLBI Catalyze Program is to provide a comprehensive suite of support and services to facilitate the transition of basic science discoveries into viable diagnostic and therapeutic candidates that have been cleared for human testing, and to develop translational researchers fluent in product development and entrepreneurship. This specific Catalyze Enabling Technologies and Transformative Platforms initiative will support rigorously validating transformative, multi-use platforms or technologies. Well-suited applications must offer the potential to significantly accelerate and/or transform the areas of early detection and screening, model development, clinical diagnosis, treatment, control, behavior, prevention or epidemiology. Proposed platforms and technologies may have widespread applicability but must be able to improve the outlook for HLBS-related diseases and disorders.
Catalyze Product Definition Medical Device prototype design/testing and disease target identification and assay development (R61/R33 - Clinical Trial Not Allowed)
The goal of the NHLBI Catalyze Program is to provide a comprehensive suite of support and services to facilitate the transition of basic science discoveries into viable diagnostic and therapeutic candidates that have been cleared for human testing, and to develop translational researchers fluent in product development and entrepreneurship. This specific Catalyze Product Definition initiative provides early stage translational support for activities required to develop and test device prototypes, identify diagnostic disease targets and develop associated assays, and develop research tools to treat HLBS diseases and disorders. This is a phased initiative for early stage projects. The R61 phase provides support to identify and test initial prototype designs, to identify a disease target and generate experimental design, and to identify, test and pilot research tools. The R33 phase provides support for continued prototype development and testing, in addition to modifying design features and user feedback, diagnostic product generation, exploration of assay components, and characterization of a load design, and research tool improvement, large trial testing and data integration. Following successful completion of the program, it is expected that the potential products will be poised to move forward for in vivo testing (optimization, safety, efficacy) with additional support from NIH and/or other federal and private programs. This initiative has a companion initiative that supports development of therapeutics and combination products and is also part of a suite of innovation grants to advance projects to the point where they can meet the entry criteria for the NHLBI Catalyze Preclinical Program.
Catalyze: Product Definition Medical Device Prototype Optimization (R33 - Clinical Trial Not Allowed)
The NHLBI Catalyze Program provides comprehensive support and services to facilitate the transition of basic science discoveries into viable diagnostic and therapeutic candidates cleared for human testing, while developing translational researchers fluent in product development and entrepreneurship. This specific Catalyze Product Definition initiative provides early stage translational support for prototype testing and design modification, assay development for diagnostic disease targets, and development of research tools for treatment of heart, lung, blood, and sleep (HLBS) diseases and disorders. Following successful completion, potential products are expected to be positioned for in vivo testing with additional support from NIH and other federal and private programs. This initiative is part of a suite of innovation grants to advance projects to meet entry criteria for the NHLBI Catalyze Preclinical Program.
Mood and Psychosis Symptoms during the Menopause Transition (R01 Clinical Trial Optional)
The purpose of this Notice of Funding Opportunity (NOFO) is to advance translational research to better understand the emergence and worsening of mood and psychotic disorders (e.g., perimenopausal depression (PMD), generalized anxiety disorder, bipolar disorder and schizophrenia) during the menopause transition (MT) in an effort to identify targets for future development of novel treatment interventions. This funding opportunity aims to advance novel and innovative translational research to better comprehend the underlying neurobiological and behavioral mechanisms of mood and psychosis disorders and related symptoms during MT. This funding opportunity encourages interdisciplinary researchers to collaborate on studies of mood and psychosis during the MT. Aspects of mood and psychosis disorders that are of interest include classic depressive symptoms in combination with menopause symptoms (e.g., hot flashes, night sweats, sleep disturbance) and psychological challenges, the role of reproductive steroids in the regulation of mood and behavior during the MT, diagnosis of mood and psychosis symptoms at menopausal stage, investigation of co-occurring psychiatric and menopause symptoms, appreciation of psychosocial factors common in midlife, and differential diagnoses. Review criteria will focus on the comprehensiveness of the neurobiology and mechanisms of action underlying mood and psychosis symptoms and hypothesis-driven work.
Mood and Psychosis Symptoms during the Menopause Transition (R21 Clinical Trial Optional)
The purpose of this Notice of Funding Opportunity (NOFO) is to advance translational research to better understand the emergence and worsening of mood and psychotic disorders during the menopause transition. This includes conditions such as perimenopausal depression, generalized anxiety disorder, bipolar disorder, and schizophrenia, with the goal of identifying targets for future development of novel treatment interventions. The funding opportunity aims to advance novel and innovative translational research to better comprehend the underlying neurobiological and behavioral mechanisms of mood and psychosis disorders and related symptoms during the menopause transition. It encourages interdisciplinary researchers to collaborate on studies of mood and psychosis during this critical period. Aspects of interest include classic depressive symptoms in combination with menopause symptoms such as hot flashes, night sweats, and sleep disturbance, the role of reproductive steroids in mood and behavior regulation, diagnosis of symptoms at various menopausal stages, investigation of co-occurring psychiatric and menopause symptoms, psychosocial factors common in midlife, and differential diagnoses. Review criteria will focus on the comprehensiveness of the neurobiology and mechanisms of action underlying mood and psychosis symptoms through hypothesis-driven work.
Seamless Early-Stage Clinical Drug Development (Phase 1 to 2a) for Novel therapeutic Agents for the Spectrum of Alzheimer's Disease (AD) and AD-related Dementias (ADRD) (UG3/UH3 Clinical Trial Required)
The purpose of this Notice of Funding Opportunity (NOFO) is to invite applications that bundle independent protocols for phase 1 clinical trials with phase 1b/phase 2a clinical trials to streamline the early-stage evaluation of promising pharmacological interventions for Alzheimer's disease (AD) and Alzheimer's disease-related Dementias (ADRD). Candidate interventions evaluated through this program, which can include small molecules or biologics, must engage non-amyloid/non-tau mechanisms and aim to address cognitive and/or neuropsychiatric symptoms in individuals across the spectrum from pre-symptomatic to more severe stages of disease. This NOFO uses the UG3/UH3 phased award mechanism and proposals must include prespecified, go/no-go safety and tolerability milestones that gate the advance from phase 1 to latter stages of clinical development.
Utilizing Invasive Recording and Stimulating Opportunities in Humans to Advance Neural Circuitry Understanding of Mental Health Disorders (R21 Clinical Trial Optional)
This Notice of Funding Opportunity (NOFO) encourages applications to pursue invasive neural recording studies focused on mental health-relevant questions. Invasive neural recordings provide an unparalleled window into the human brain to explore the neural circuitry and neural dynamics underlying complex moods, emotions, cognitive functions, and behaviors with high spatial and temporal resolution. Additionally, the ability to stimulate via the same electrodes allows for direct causal tests by modulating network dynamics. This funding opportunity aims to target a gap in the scientific knowledge of neural circuit function related to mental health disorders. Researchers should target specific questions suited to invasive recording modalities that have high translational potential. Development of new technologies and therapies are outside the scope of this NOFO. This is a reissue of RFA-20-351.
Utilizing Invasive Recording and Stimulating Opportunities in Humans to Advance Neural Circuitry Understanding of Mental Health Disorders (R01 Clinical Trial Optional)
The purpose of this Notice of Funding Opportunity (NOFO) is to encourage applications to pursue invasive neural recording studies focused on mental health-relevant questions. Invasive neural recordings provide an unparalleled window into the human brain to explore the neural circuitry and neural dynamics underlying complex moods, emotions, cognitive functions, and behaviors with high spatial and temporal resolution. Additionally, the ability to stimulate, via the same electrodes, allows for direct causal tests by modulating network dynamics. This funding opportunity aims to target a gap in the scientific knowledge of neural circuit function related to mental health disorders. Researchers should target specific questions suited to invasive recording modalities that have high translational potential. Development of new technologies and therapies are outside the scope of this NOFO.
Prevention and Intervention Approaches for Fetal Alcohol Spectrum Disorders (R61/R33 Clinical Trial Optional)
This Notice of Funding Opportunity (NOFO) focuses on prevention and intervention strategies for fetal alcohol spectrum disorders (FASD) throughout the lifespan. The intent of this NOFO is to support research that advances prevention approaches to reduce prenatal alcohol exposure and the incidence of FASD and interventions for FASD. These objectives will be accomplished with the Exploratory/Developmental Phased Award (R61/R33) mechanism, clinical trial optional. The R61 phase will support pilot studies or secondary data analysis for hypothesis development and feasibility, and research testing the hypotheses can be expanded in the R33 phase. The transition to the R33 phase will be determined by NIAAA program staff after evaluation of the achievement of specific milestones set for the R61 phase. Highest priority will be given to applications with clinical trials.
Prevention and Intervention Approaches for Fetal Alcohol Spectrum Disorders (R34 Clinical Trial Optional)
This Notice of Funding Opportunity (NOFO) for R34 planning grant applications focuses on prevention and intervention strategies for fetal alcohol spectrum disorders (FASD) throughout the lifespan. The intent of this NOFO is to support research that advances (1) prevention approaches to reduce prenatal alcohol exposure and incidence of FASD and (2) interventions for FASD. It is expected that research conducted via this mechanism will consist of studies that are a pre-requisite for preparing and submitting subsequent applications for larger scale FASD prevention or intervention studies. This planning grant opportunity is designed to support exploratory research and pilot projects that will lead to more comprehensive studies of FASD prevention and intervention.
New Approaches for Measuring Brain Changes Across Longer Timespans (R21 Clinical Trial Optional)
The purpose of this funding opportunity is to encourage multidisciplinary investigators to submit applications developing exploratory, highly novel new approaches, or innovative applications of existing approaches to measure brain activity, connectivity, genomics, or other aspects across the age spectrum of neurodevelopment. The overarching goal is to extend our understanding of brain development and aging, including studies of the neurodevelopmental origins of later health and disease, by improving repeated measures across longer epochs of the lifespan to better predict outcomes at later ages. Research can include healthy human participants of any age, specific clinical groups such those with cognitive, motor, or affective regulation challenges, and/or animal research on these domains of function. The studies can focus on longitudinal neuroanatomical or functional changes at any level, including genetics/genomics, single cells, connectomics, neural population activity patterns, and others. This funding opportunity is intended to encourage technological and conceptual innovation through this high risk, high reward funding mechanism to develop highly innovative ideas that either lack preliminary data or need additional preliminary data.
New Approaches for Measuring Brain Changes Across Longer Timespans (R01 Clinical Trial Optional)
The purpose of this funding opportunity is to encourage multidisciplinary investigators to develop new approaches or apply existing approaches in novel ways to measure brain activity, connectivity, genomics, or other aspects across the age spectrum of neurodevelopment. The overarching goal is to extend our understanding of brain development and aging, including studies of the neurodevelopmental origins of later health and disease. Research can include healthy human participants of any age, specific clinical groups such as those with cognitive, motor, or affective regulation challenges, and/or animal research on these domains of function. The studies can focus on longitudinal neuroanatomical or functional changes at any level, including genetics/genomics, single cells, connectomics, neural population activity patterns, and others. This funding opportunity is intended to encourage technological and conceptual innovation to improve repeated measures across longer epochs of the lifespan, to better predict outcomes at later ages.
The Role of Work in Health Disparities in the U.S. (R01 Clinical Trials Optional)
The purpose of this Notice of Funding Opportunity (NOFO) is to support innovative population-based research that can contribute to identifying and characterizing pathways and mechanisms through which work or occupation influences health outcomes and health status among populations with health and/or health care disparities. This R01 grant supports investigator-initiated research projects across multiple NIH institutes focusing on understanding how occupational factors contribute to health disparities in the United States. The program encourages research that examines the complex relationships between work environments, occupational exposures, employment conditions, and health outcomes in populations experiencing health disparities. Clinical trials are optional under this funding opportunity.
Navigator Emergency Department Diversion Models for Non-Urgent Mental Health Concerns (R01 Clinical Trial Required)
This NOFO builds research about the effectiveness, implementation, and optimization of family navigation ED diversion models for non-urgent mental health problems. The program is designed to utilize triage tools to identify mental health acuity, facilitate engagement in mental health services and needed resources, and provide support, knowledge about the mental health condition, and facilitate linkages/address barriers to help-seeking among families. This R01 funding opportunity requires clinical trials and is offered by the National Institutes of Health to support research that can improve emergency department diversion strategies for mental health concerns.
Navigator Emergency Department Diversion Models for Non-Urgent Mental Health Concerns (R34 Clinical Trial Required)
The purpose of this Notice of Funding Opportunity (NOFO) is to build research about the effectiveness, implementation, and optimization of family navigation ED diversion models for non-urgent mental health problems. Models of interest are designed to (a) utilize triage tools to identify mental health acuity, (b) facilitate engagement in mental health services and needed resources, and (c) provide support, knowledge about the mental health condition, and facilitate linkages/address barriers to help-seeking among families. This is a clinical trial required R34 grant mechanism from the National Institutes of Health focused on mental health research grants. The program aims to develop and test innovative approaches to divert individuals with non-urgent mental health concerns from emergency departments to more appropriate community-based care settings.
HIV Prevention and Alcohol (R34 Clinical Trials Optional)
This R34 Notice of Funding Opportunity (NOFO) seeks to expand the HIV/AIDS prevention toolkit among alcohol impacted populations with a range of patterns of episodic and long-term use and associated behavioral and biological risks for HIV acquisition. The NOFO supports studies that are both necessary and sufficient to inform the planning of a clinical trial within the scope of the companion announcement HIV Prevention and Alcohol (R01 Clinical Trials Optional). Applications to this NOFO will describe the planned clinical trial and demonstrate that the proposed research is scientifically necessary to design or plan the subsequent trial. This NOFO supports research projects designed to provide results that will be sufficient to inform the future trial without further studies. The planned Phase II, III, or IV trial must be primarily intended to test the efficacy, safety, clinical management, or implementation of intervention(s) in the prevention of HIV. The R34 mechanism is intended to provide new information that answers scientific or operational questions which may be pragmatic in nature, thereby informing the final development of a clinical trial and testing of intervention tools.
HIV Prevention and Alcohol (R01 Clinical Trials Optional)
The NOFO seeks to expand the HIV/AIDS prevention toolkit among alcohol impacted populations with a range of patterns of episodic and long-term use and associated behavioral and biological risks for HIV acquisition. This includes integration of effective prevention and treatment interventions with an understanding of the overarching framework for reducing the incidence of new infections by facilitating cross-cutting informative research. This research activity includes the development and testing of new interventions and expansion of existing effective interventions as well as the implementation of these integrative preventive activities in a variety of settings and populations. Six areas of research are of primary interest related to alcohol use and related mental health and substance use comorbidities. These include but are not limited to 1) PrEP Utilization, 2) Treatment as Prevention (TasP), 3) Integration of Preventive Intervention Strategies, 4) Prevention-related Cross-cutting Research, 5) Syndemic Approaches and, 6) Implementation and Operations Research.
Full-Scale Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (R01 - Clinical Trial Required)
This funding opportunity supports clinical trials to test the effectiveness of treatment, preventive, and services interventions for mental health. The program has two main components: (1) clinical trials to test the effectiveness of optimized therapeutic and preventive interventions for use in community and practice settings; and (2) clinical trials to evaluate the effectiveness of patient-, provider-, organizational-, or systems-level services interventions to improve access, continuity, quality, equity, and/or value of mental health services. The NOFO is intended to support trials that address significant problems with potential to inform practice, are adequately powered to definitively answer primary research questions with well-justified hypotheses supported by pilot data, and examine questions regarding mediators and moderators of effects. Consistent with the NIMH experimental therapeutics approach, effectiveness trials must explicitly address whether the intervention engages the target(s)/mechanism(s) presumed to underlie the intervention effects. The collaborative R01 mechanism provides support for multisite trials when two or more sites are necessary for completion of the trial.
Pilot Hybrid Effectiveness-Implementation Trials for Mental Health Interventions (R01 Clinical Trial Required)
This funding opportunity from the National Institutes of Health's National Institute of Mental Health (NIMH) supports pilot effectiveness studies as part of NIMH's clinical trials pipeline. The program encourages two main areas of research: 1) optimizing the effectiveness of preventive and therapeutic interventions with previously demonstrated efficacy for use with broader target populations or in community practice settings, and 2) developing and preliminary testing innovative services interventions. Consistent with the NIMH experimental therapeutics approach, this program is intended to support pilot studies of intervention effectiveness or service delivery approaches that explicitly address whether the intervention engages the target(s)/mechanism(s) presumed to underlie the intervention effects. This includes examining mechanisms that account for changes in clinical/functional outcomes, changes in provider behavior, improved access or continuity of services, and other relevant factors. The opportunity requires clinical trials and follows NIMH's structured approach to developing and testing mental health interventions.
Confirmatory Efficacy Clinical Trials of Non-Pharmacological and Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required)
This NIMH funding opportunity supports confirmatory efficacy testing of non-pharmacological therapeutic and preventive interventions for mental disorders in adults and children. As part of NIMH's clinical trials pipeline NOFOs, this announcement addresses unmet therapeutic needs and is consistent with the NIMH emphasis on the experimental therapeutics approach. In this approach, clinical trials should be designed to increase knowledge of the relationship between underlying disease processes and the mechanisms of action through which any intervention produces therapeutic change. This R01 grant requires a clinical trial component and focuses on advancing interventions from earlier stage development to confirmatory efficacy testing.
First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required)
The purpose of this Notice of Funding Opportunity (NOFO) is to encourage cooperative agreement applications to support early stage clinical trials of novel mechanism of action, investigational drugs, or novel neuromodulatory devices for the treatment of psychiatric disorders in areas of unmet medical need. The NOFO will support milestone-driven early stage trials in pediatric and adult populations. First in human (FIH) and Phase II studies of novel agents must assess target engagement (brain exposure), pharmacological effects, safety, and tolerability to assess feasibility for Phase II/proof of concept (PoC) studies in psychiatric disorders. Phase II/PoC studies must evaluate the drugs impact on clinically relevant physiological systems (functional measures) and clinical indicators of effect. The NOFO also supports FIH and early feasibility studies (EFS) of novel devices to evaluate target engagement, safety, tolerability, and efficacy. The overall objective is to facilitate rapid collection of data to de-risk novel mechanism of action investigational drugs, novel drugs for use in pediatric populations with psychiatric disorders, and devices or combination treatments in order to attract private or other public funding for further clinical development as FDA-approved treatments. A key aspect of this NOFO is the formation of collaborative partnerships between the biomedical researchers and biotechnology or industry researchers to facilitate psychiatric drug or device development.
Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R33 Clinical Trial Required)
Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R33 Clinical Trial Required). As part of NIMH's clinical trials pipeline, this NOFO encourages pilot research developing and testing novel psychosocial interventions and/or targets. Consistent with NIMH's emphasis on the experimental therapeutics approach to intervention development, it intends to speed the translation of emergent research in basic, behavioral, cognitive, affect, and neuropsychological science into preventative or therapeutic interventions. This RFA will provide up to three years of support to replicate target engagement from prior studies and to test the association between target engagement and change in clinical outcome(s). The program is designed to advance mental health research through innovative psychosocial therapeutic approaches.
Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33 Clinical Trial Required)
This funding opportunity is part of NIMH's clinical trials pipeline and encourages pilot research developing and testing novel psychosocial interventions and/or targets for mental disorders. Consistent with NIMH's emphasis on the experimental therapeutics approach to intervention development, it intends to speed the translation of emergent research in basic, behavioral, cognitive, affect, and neuropsychological science into preventative or therapeutic interventions. The program provides up to two years of support (R61 phase) for evaluation of target engagement and establishment of intervention parameters, and up to three years of support (R33 phase) to replicate target engagement from prior studies and to test the association between target engagement and change in clinical outcome(s). This phased approach allows for iterative refinement of psychosocial interventions based on empirical evidence of target engagement before proceeding to full clinical outcome testing.
Early Stage Testing of Pharmacologic or Neuromodulatory Device-based Interventions for the Treatment of Mental Disorders (R33- Clinical Trial Required)
NIMH requires an experimental therapeutics approach for the development and testing of therapeutic interventions, in which studies both evaluate the clinical effect of an intervention and generate information about the mechanisms underlying a disorder or an intervention response. As part of NIMH's Clinical Trial Pipeline, this NOFO encourages early stage testing of pharmacologic interventions with novel mechanisms of actions or device-based interventions. More specifically, this NOFO is intended to support early stage testing of pharmacologic or device-based interventions using a protocol design where the presumed mechanism of action of the intervention is adequately tested, to provide meaningful information where target modulation yields a dose-dependent neurophysiological/clinical/behavioral effect. This grant supports research aimed at understanding mental health interventions through rigorous clinical trials that evaluate both efficacy and underlying mechanisms.
Early Stage Testing of Pharmacologic or Neuromodulatory Device-based Interventions for the Treatment of Mental Disorders (R61/R33 Clinical Trial Required)
NIMH requires an experimental therapeutics approach for the development and testing of therapeutic interventions, in which studies both evaluate the clinical effect of an intervention and generate information about the mechanisms underlying a disorder or an intervention response. As part of NIMH's Clinical Trial Pipeline, this NOFO encourages early stage testing of pharmacologic interventions with novel mechanisms of actions or device-based interventions. This funding opportunity is intended to support early stage testing of pharmacologic or device-based interventions using a protocol design where the presumed mechanism of action of the intervention is adequately tested, to provide meaningful information where target modulation yields a dose-dependent neurophysiological/clinical/behavioral effect. The program utilizes a phased R61/R33 mechanism requiring clinical trials to advance research on mental health treatments.
Effectiveness Trials to Test Mental Health System Interventions (R61/R33 Clinical Trial Required)
This R61/R33 concept complements NIMH's suite of clinical trial NOFOs by supporting feasibility and infrastructure development (R61) followed by well-powered clinical trials (R33) to test the effectiveness of system interventions and strategies for improving the organization, delivery, coordination, and clinical and functional outcomes of mental health services. System interventions - which may span structural, policy, organizational, and interpersonal domains - attend to issues about the access, equity, engagement/utilization, value (cost/financing), management, or quality and safety of mental health services, with the goal of improved care processes and clinical and functional outcomes. The focus of system interventions may include a variety of care settings, such as health systems and organizations, mental health and community clinics, schools, and child welfare or juvenile justice systems. This phased mechanism allows researchers to first establish feasibility and develop necessary infrastructure in the R61 phase before conducting fully-powered effectiveness trials in the R33 phase.
Academic Research Enhancement Award (AREA) for Undergraduate-Focused Institutions (R15 Clinical Trial Not Allowed)
The purpose of this Academic Research Enhancement Award (AREA) for Undergraduate-Focused Institutions is to support small scale research grants at institutions that do not receive substantial funding from the NIH, with an emphasis on providing biomedical research experiences primarily for undergraduate students, and enhancing the research environment at applicant institutions. Eligible institutions must award baccalaureate science degrees and have received no more than $6 million dollars per year of NIH support (in both direct and F and A/indirect costs) in 4 of the last 7 fiscal years. For institutions composed of multiple schools and colleges, the $6 million funding limit is based on the amount of NIH funding received by all the non-health professional schools and colleges within the institution as a whole. This program aims to strengthen the research environment and increase the number of students who pursue biomedical research careers by involving them directly in meaningful research projects. The award supports faculty members at eligible institutions to conduct health-related research.
Alcohol Health Services Research (R34 Clinical Trial Optional)
The National Institute on Alcohol Abuse and Alcoholism solicits applications for an R34 Clinical Trial Optional mechanism focusing on alcohol health services. This NOFO broadly focuses on closing the treatment gap for individuals with alcohol use disorder (AUD). There are five major areas of emphasis: (1) increasing access to treatment for AUD, (2) making treatment for AUD more appealing, (3) examining cost structures and insurance systems, (4) conducting studies on dissemination and implementation of existing evidence-based approaches to treating AUD, and (5) reducing health disparities as a means of addressing the treatment gap in AUD for health disparity populations. This funding opportunity seeks to support research that will advance understanding and improve health services delivery for individuals affected by alcohol use disorder.
Alcohol Health Services Research (R01 Clinical Trial Optional)
The National Institute on Alcohol Abuse and Alcoholism solicits applications for an R01 Clinical Trial Optional mechanism focusing on alcohol health services research. This program broadly focuses on closing the treatment gap for individuals with alcohol use disorder (AUD). There are five major areas of emphasis: (1) increasing access to treatment for AUD, (2) making treatment for AUD more appealing, (3) examining cost structures and insurance systems, (4) conducting studies on dissemination and implementation of existing evidence-based approaches to treating AUD, and (5) reducing health disparities as a means of addressing the treatment gap in AUD for health disparity populations. This funding opportunity supports research that aims to improve alcohol health services delivery, enhance treatment accessibility, and reduce disparities in care for individuals affected by alcohol use disorder.
Alcohol Treatment, Pharmacotherapy, and Recovery Research (R01 Clinical Trial Required)
The National Institute on Alcohol Abuse and Alcoholism solicits applications for an R01 Clinical Trial Required mechanism focusing on alcohol treatment and recovery research. This NOFO will focus broadly on topics relevant for treatment of and recovery from alcohol use disorder (AUD), including: medications development, precision medicine, behavioral therapies and mechanisms of behavioral change (MOBC), recovery, translational research, and innovative methods and technologies for AUD treatment and recovery. The program supports research aimed at advancing understanding and treatment approaches for alcohol use disorder through clinical trials. Eligible applicants include a wide range of entities from government organizations, educational institutions, nonprofits, tribal organizations, to both small and large businesses.
Alcohol Treatment, Pharmacotherapy, and Recovery Research (R34 Clinical Trial required)
The National Institute on Alcohol Abuse and Alcoholism solicits applications for an R34 Clinical Trial Optional mechanism focusing on alcohol health services. This NOFO will broadly focus on closing the treatment gap for individuals with alcohol use disorder (AUD); within this focus, there are five major areas of emphasis: (1) increasing access to treatment for AUD, (2) making treatment for AUD more appealing, (3) examining cost structures and insurance systems, (4) conducting studies on dissemination and implementation of existing evidence-based approaches to treating AUD, and (5) reducing health disparities as a means of addressing the treatment gap in AUD for health disparity populations. The R34 mechanism supports early-stage clinical trial development and planning activities.
NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)
This Notice of Funding Opportunity encourages UG3/UH3 phased cooperative agreement research applications to plan and implement behavioral and social intervention clinical trials. Studies appropriate for this announcement include clinical trials to develop and test behavior change interventions related to dental, oral, or craniofacial conditions. Awards made under this FOA will initially support a milestone-driven planning phase (UG3) for up to 2 years, with possible transition to a clinical trial implementation phase (UH3) of up to five years. Only UG3 projects that have met the scientific milestones and feasibility requirements may transition to the UH3 phase. The UG3 phase will permit both scientific and operational planning activities including small-scale data collection to assess the feasibility and/or acceptability of a planned behavioral or social intervention and associated study procedures. Operational planning activities include development of the final clinical protocol, intervention manual, data management system, safety and operational oversight plans, recruitment and retention strategies, and other essential documents. The UH3 phase will support the conduct of investigator-initiated intervention research at all stages, from early mechanistic research and intervention development through implementation and cost-effectiveness research.
Career Transition Award for NINDS Intramural Clinician-Scientists (K22 Clinical Trial Required)
The objective of the NIH Career Transition Award (K22) is to provide support to outstanding basic or clinical investigators to develop their independent research skills through a two phase program: an initial period involving an intramural appointment at the NIH and a final period of support at an extramural institution. This NINDS K22 is specifically designed to facilitate the transition of NINDS intramural neurologist- and neurosurgeon-scientists to independent, academic faculty positions that support clinician-scientists to engage in independently funded scientific research as well as clinical activities. The program supports career development for clinician-scientists in neuroscience and neurological disorders research, enabling them to transition from intramural NIH positions to extramural academic institutions where they can establish independent research programs while maintaining clinical activities.
Career Transition Award for NINDS Intramural Clinician-Scientists (K22 Clinical Trial Not Allowed)
The objective of the NIH Career Transition Award (K22) is to provide support to outstanding basic or clinical investigators to develop their independent research skills through a two phase program: an initial period involving an intramural appointment at the NIH and a final period of support at an extramural institution. This NINDS K22 is specifically designed to facilitate the transition of NINDS intramural neurologist- and neurosurgeon-scientists to independent, academic faculty positions that support clinician-scientists to engage in independently funded scientific research as well as clinical activities. The program supports the career development of outstanding intramural clinician-scientists in neurology and neurosurgery by providing a structured pathway from NIH intramural research to independent extramural academic positions. This award enables recipients to establish their own research programs while maintaining clinical activities in their specialized fields.
Innovative Screening Approaches and Therapies for Screenable Disorders in Newborns (R01 - Clinical Trial Optional)
This funding opportunity announcement (FOA) from the National Institutes of Health encourages research relevant to the development of novel screening approaches and/or therapeutic interventions for potentially fatal or disabling conditions that have been identified through newborn screening, as well as for "high priority" genetic conditions where screening may be possible in the near future. Having an accurate screening test, as well as demonstrating the benefits of early intervention or treatment, are important criteria for including a condition on a newborn screening panel. This FOA defines a "high priority" condition as one where screening is not currently recommended, but infants with the condition would significantly benefit from early identification and treatment. The program supports R01 research grants with clinical trials as optional components.
Innovative Screening Approaches and Therapies for Screenable Disorders in Newborns (R21 - Clinical Trial Optional)
This funding opportunity announcement encourages research relevant to the development of novel screening approaches and/or therapeutic interventions for potentially fatal or disabling conditions that have been identified through newborn screening, as well as for 'high priority' genetic conditions where screening may be possible in the near future. Having an accurate screening test, as well as demonstrating the benefits of early intervention or treatment, are important criteria for including a condition on a newborn screening panel. This FOA defines a 'high priority' condition as one where screening is not currently recommended, but infants with the condition would significantly benefit from early identification and treatment. The R21 mechanism supports exploratory and developmental research that may lead to breakthroughs in newborn screening methodologies and therapeutic approaches.
Accelerating Solutions to Improve Access and Quality of Empirically-Supported Practices for Youth Mental Health (R01 Clinical Trial Optional)
This NOFO is a call to action in response to the mental health crisis in the United States. The program seeks applications that will study methods to increase access to evidence-based interventions and services for youth mental health, including those living in rural areas, inner cities, and other under-resourced areas, and youth experiencing housing and food insecurities and outright homelessness. Applications should address research related to optimizing assessment, intervention and service strategies, overcoming challenges related to the workforce shortage, wait lists for treatment, integration of treatment and preventive interventions into settings where people are most likely to be best identified as needing care (e.g., schools, social service, pediatric medicine and justice), and service interventions that address systemic barriers to access and quality of mental health care (structural, policy, organizational, value (cost/financing), management). The grant supports research to improve the delivery and accessibility of mental health services for youth populations, with particular emphasis on underserved communities and evidence-based practices.
NIAID Career Transition Award (K22 Independent Clinical Trial Not Allowed)
The purpose of the NIAID Career Transition Award program is to assist postdoctoral fellows' transition to positions of assistant professor or equivalent and initiate a successful biomedical career as an independent research scientist. This K22 award supports researchers in establishing their independence during the critical transition from postdoctoral training to a faculty position. The program provides funding to help early-career scientists launch their independent research programs in areas related to allergy and infectious diseases research. Recipients are expected to use this award to develop their research capabilities and establish themselves as independent investigators in the biomedical research community.
Alzheimer's Drug-Development Program (U01 Clinical Trial Optional)
The goal of this Notice of Funding Opportunity (NOFO) is to provide funding support for the pre-clinical and early stage clinical (Phase I) development of novel small-molecule and biologic drug candidates that prevent Alzheimer's disease (AD), slow its progression, or treat its cognitive and behavioral symptoms. Participants in this program will receive funding for therapy development activities such as medicinal chemistry; pharmacokinetics (PK); Absorption, Distribution, Metabolism, Excretion, Toxicology (ADMET); efficacy in animal models; development of biomarkers for target engagement; formulation development; chemical synthesis under Good Manufacturing Practices (GMP); Investigational New Drug (IND) enabling studies; and initial Phase I clinical testing. This cooperative agreement supports organizations engaged in translational drug development research for Alzheimer's disease. Applications not responsive to this NOFO include research on basic mechanisms of disease or mechanisms of drug action; development of risk, diagnostic, prognostic, predictive, and prevention biomarkers, devices, non-pharmacological interventions (e.g., exercise, diet, cognitive training), repurposed drugs and combination therapies; discovery activities such as high-throughput screening and hit optimization; and stand-alone clinical trials.
NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed)
This NOFO supports, through the cooperative agreement mechanism, investigator-initiated observational studies or biomarker validation studies that require prospective collection of data/biospecimens or continued analysis of data/biospecimens collected as part of a previous NIDCR cooperative agreement. The program is offered by the National Institute of Dental and Craniofacial Research (NIDCR), part of the National Institutes of Health. The funding is provided under Assistance Listings 93.121 for Oral Diseases and Disorders Research. Eligible applicants include a wide range of organizations including government entities, nonprofits, educational institutions, small and large businesses, and other organizations. Foreign organizations are not eligible to apply, though foreign components of U.S. organizations are allowed. This cooperative agreement supports research in oral health and related biomarker studies.
NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required)
The objective of this funding opportunity is to support investigator-initiated, phase I clinical trials for diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. The proposed trial can be single or multisite. Applicants applying for funding under this NOFO should be ready to initiate the clinical trial within the first quarter of the project period. Discussion, submission, and attainment of applicable regulatory (FDA, DSMB, IRB) approvals, and establishment of drug (and placebo, if applicable) supplies, and any necessary third-party agreements should be established by the time of award. This program supports early phase clinical research to advance therapeutic and diagnostic interventions through rigorous testing and evaluation.
NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required)
The objective of this funding opportunity is to support investigator-initiated, Phase I clinical trials for diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. In addition to supporting clinical trial start-up and implementation activities, this FOA will provide support for final stage preclinical activities needed for the implementation of the proposed trial. All the activities proposed in the R61 phase must be directly related to the therapeutic/diagnostic in preparation for the clinical trial. The proposed trial can be single or multisite. This NOFO utilizes a bi-phasic, milestone-driven mechanism of award where the first phase can be used to finalize required pre-trial activities such as stability, shipping studies, and site training.
Accelerating the Pace of Substance Use Research Using Existing Data (R01 Clinical Trial Not Allowed)
The purpose of this Notice of Opportunity Announcement (NOFO) is to invite applications proposing the innovative analysis of existing social science, behavioral, administrative, and neuroimaging data to study the etiology and epidemiology of drug using behaviors (defined as alcohol, tobacco, prescription and other drug) and related disorders, prevention of drug use and HIV, and health service utilization. This FOA encourages the analyses of public use and other extant community-based or clinical datasets to their full potential in order to increase our knowledge of etiology, trajectories of drug using behaviors and their consequences including morbidity and mortality, risk and resilience in the development of psychopathology, strategies to guide the development, testing, implementation, and delivery of high quality, effective and efficient services for the prevention and treatment of drug abuse and HIV. The program invites research using existing datasets to advance understanding of substance use disorders and related health outcomes. This R01 funding mechanism supports innovative secondary data analysis projects that leverage existing data resources to generate new knowledge about drug use behaviors, prevention strategies, and treatment services.
Accelerating the Pace of Substance Use Research Using Existing Data (R21 Clinical Trial Not Allowed)
The purpose of this notice of funding opportunity (NOFO) is to invite applications proposing the innovative analysis of existing social science, behavioral, administrative, and neuroimaging data to study the etiology and epidemiology of drug using behaviors (defined as alcohol, tobacco, prescription and other drug) and related disorders, prevention of drug use and HIV, and health service utilization. This FOA encourages the analyses of public use and other extant community-based or clinical datasets to their full potential in order to increase knowledge of etiology, trajectories of drug using behaviors and their consequences including morbidity and mortality, risk and resilience in the development of psychopathology, and strategies to guide the development, testing, implementation, and delivery of high quality, effective and efficient services for the prevention and treatment of drug abuse and HIV. The R21 mechanism supports exploratory and developmental research projects that may lead to breakthrough discoveries or the development of novel techniques.
Interventions to Address Disparities in Liver Diseases and Liver Cancer (R01 - Clinical Trials Optional)
This initiative supports multi-level and/or multi-domain intervention research to reduce disparities in liver diseases and liver cancer among populations who experience health disparities in the United States. The program seeks to address healthcare disparities through research interventions targeting underserved populations. This Notice of Funding Opportunity (NOFO) is being reissued in accordance with the simplified review criteria in effect for application due dates after January 25, 2025. The grant mechanism is an R01 research grant, which is the original and historically oldest grant mechanism used by NIH. This funding opportunity falls under the Cancer Control and Minority Health and Health Disparities Research assistance listings.
Preclinical Proof of Concept Studies for Rare Diseases (R21 Clinical Trial Not Allowed)
This notice of funding opportunity (NOFO) provides funding to conduct efficacy studies in an established rare disease preclinical model to demonstrate that a proposed therapeutic agent warrants further development. In addition to preclinical efficacy, accompanying pharmacodynamic and pharmacokinetic studies would be supported. Therapeutic agents include small molecules, biologics or biotechnology-derived products. The goal of this NOFO is to spur therapeutic development for a variety of rare diseases by advancing projects to the point where they would attract subsequent investment supporting full Investigational New Drug (IND) application development or progression to clinical trials in the case of repurposing or repositioning. This R21 grant mechanism is specifically designated as clinical trial not allowed, focusing on preclinical proof-of-concept studies.
Interventions to Reduce Sleep Health Disparities (R01 - Clinical Trials Optional)
This funding opportunity supports non-pharmacological interventions to promote sleep health, reduce sleep health disparities, and examine sleep as a modifiable factor to reduce health disparities for other health outcomes among populations that experience health disparities. The program is being reissued in accordance with simplified review criteria in effect for application due dates after January 25, 2025. The R01 grant mechanism supports research projects focused on improving health outcomes through sleep-related interventions in underserved populations. Multiple NIH institutes participate in this program, including those focused on lung diseases, blood diseases, neurosciences, aging, minority health, alcohol research, cardiovascular diseases, cancer control, nursing research, and sleep disorders research.
Pilot Health Services and Economic Research on the Treatment of Drug, Alcohol, and Tobacco Use Disorders (R34 Clinical Trial Optional)
This Notice of Funding Opportunity (NOFO) encourages pilot and preliminary research in preparation for larger-scale services research effectiveness trials. Relevant trials may test a wide range of approaches, including interventions, practices, and policies designed to optimize access to, and the quality, effectiveness, affordability and utilization of drug, tobacco, or alcohol use disorder treatments and related services, as well as services for comorbid medical and mental disorder conditions. Relevant approaches may include both those that are novel, and those that are commonly used in practice but lack an evidence base. This NOFO provides resources for assessing the feasibility, acceptability, and utility of these approaches, in addition to usual trial preparation activities. The program supports pilot studies that will inform the design and implementation of future large-scale health services research trials focused on substance use disorder treatment.
Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools (R15 Clinical Trial Not Allowed)
The Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools stimulates basic and clinical research in educational institutions that provide baccalaureate or advanced degrees for a significant number of the Nation's research scientists, but that have not been major recipients of NIH support. REAP grants create opportunities for scientists and institutions otherwise unlikely to participate extensively in NIH research programs to contribute to the Nation's biomedical and behavioral research effort. These grants support small-scale research projects proposed by faculty members of eligible domestic institutions, expose undergraduate and graduate students at health professional schools or graduate schools to meritorious research projects, and strengthen the research environment of the applicant institution. Eligible institutions must award NIH-relevant baccalaureate or advanced degrees in health professions and have received less than $6 million per year of NIH support in 4 of the last 7 fiscal years.
Limited Competition: NCATS Clinical and Translational Science Award (CTSA) Program Research Education Grants Programs (R25 - Clinical Trial Not Allowed)
The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The overarching goal of this R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation's biomedical, behavioral and clinical research needs. This is a limited competition opportunity specifically for institutions participating in the NCATS Clinical and Translational Science Award (CTSA) Program. The program focuses on developing educational initiatives that strengthen research training capacity in clinical and translational science. Eligible applicants are limited to public and state institutions of higher education. This funding opportunity does not allow clinical trials.
BRAIN Initiative: New Concepts and Early-Stage Research for Recording and Modulation in the Nervous System (R21) (Clinical Trial Not Allowed)
A central goal of the BRAIN Initiative is to understand how electrical and chemical signals code information in neural circuits and give rise to sensations, thoughts, emotions and actions. This FOA seeks applications for unique and innovative technologies that are in an even earlier stage of development, including new and untested ideas that are in the initial stages of conceptualization. The support provided under this FOA might enable calculations, simulations, computational models, or other mathematical techniques for demonstrating that the signal sources and/or measurement technologies are theoretically capable of meeting the demands of large-scale recording or manipulation of circuit activity in humans or in animal models. The support might also be used for building and testing phantoms, prototypes, in-vitro or other bench-top models in order to validate underlying theoretical assumptions in preparation for future testing in animal models.
Exploratory Clinical Trial Grants in Arthritis and Musculoskeletal and Skin Diseases (R61 Clinical Trial Required)
This Exploratory Clinical Trial Grants program (PAR-24-279) from the National Institutes of Health's National Institute of Arthritis and Musculoskeletal and Skin Diseases supports clinical trial research in arthritis, musculoskeletal, and skin diseases. The R61 mechanism requires clinical trials and represents a re-issue of PAR-24-035, updated to reflect the NIH's Simplifying Review of Research Project Grant Applications policy changes. The program aims to advance clinical research in these disease areas through exploratory clinical trials. This funding opportunity welcomes applications from a wide range of eligible organizations including higher education institutions, nonprofits, for-profit organizations, small businesses, tribal organizations, and government entities. The program uses the R61 grant mechanism specifically designated for clinical trial research.
Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01 Clinical Trial Not Allowed)
This funding opportunity announcement supports clinical observational studies in musculoskeletal, rheumatic, and skin diseases through the R01 mechanism. The program was re-issued to incorporate Simplifying Review of Research Project Grant Applications changes. This PAR does not allow clinical trials and is specifically focused on observational research in these disease areas. The program is offered by the National Institutes of Health under the Arthritis, Musculoskeletal and Skin Diseases Research assistance listing. Applications are accepted through November 2, 2026.
Limited Competition: Mentored Research Career Development Program Award in Clinical and Translational Science Awards (CTSA) Program (K12 Clinical Trial Optional)
The National Center for Advancing Translational Sciences (NCATS) will award Institutional Research Career Development (K12) programs through the Clinical and Translational Science Awards (CTSA). The purpose of this Notice of Funding Opportunity (NOFO) is to encourage institutions to propose creative and innovative institutional research career development programs designed to prepare an outstanding heterogeneous pool of promising later stage postdoctoral fellows and junior faculty scholars who have made a commitment to independent clinical and translational science research careers. The program is designed to facilitate timely career advancement and continued engagement in research across sectors including academia, industry, nonprofit and government. This is a limited competition K12 award program specifically for tenure-track or equivalent faculty positions within the CTSA network.
Limited Competition: High Impact Specialized Innovation Programs in Clinical and Translational Science (RC2 Clinical Trials Optional)
The purpose of the High Impact Specialized Innovation Programs (SIPs) is to support the development and demonstration of unique hub capabilities, research platforms and/or resources to address in a timely manner critical gap areas and/or roadblocks in clinical and translational science at awarded UM1 Clinical and Translational Science Awards (CTSA) Program Hubs (PAR-24-272). Successful programs supported through this funding opportunity are expected to lay a strong foundation for future adoption and/or dissemination of capabilities to additional CTSA Program Hubs. This funding opportunity is limited to institutions with existing CTSA Program Hub awards and aims to advance clinical and translational science infrastructure and capabilities.
Exploratory/Developmental Bioengineering Research Grants (EBRG) (R21 Clinical Trial Not Allowed)
Through this engineering-oriented Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to encourage submissions of exploratory/developmental Bioengineering Research Grant (EBRG) applications to demonstrate feasibility and potential utility of new capabilities or improvements in quality, speed, efficacy, operability, costs, and/or accessibility of solutions to problems in basic biomedical, pre-clinical, or clinical research, clinical care delivery, or accessibility. This R21 grant mechanism is designed for exploratory and developmental research projects that represent early-stage investigations and are not permitted to include clinical trials. The program seeks innovative bioengineering approaches to cancer research challenges across the research continuum from basic science through clinical applications.
HEAL Initiative-Early-Stage Discovery of New Pain Targets Within the Understudied Druggable Proteome (R03 Clinical Trial Not Allowed)
The purpose of this notice of funding opportunity (NOFO) is to solicit applications for pilot projects to identify new druggable targets for pain within the understudied druggable proteome. Awards will support generation of preliminary data and/or tools around eligible understudied protein(s) listed in this NOFO. This NOFO is intended to jumpstart research on understudied proteins within the context of pain and pain management and provide applicants with sufficient funding to perform basic biochemical and/or biological work to further the characterization of understudied proteins to identify new druggable targets for pain. This NOFO is part of the NIH Helping to End Addiction Long Term (HEAL) initiative to accelerate the development of novel medications to treat all aspects of the opioid addiction cycle, including progression to chronic use, withdrawal symptoms, craving, relapse, and overdose.
Limited Competition: Small Grant Program for the NCATS Clinical and Translational Science Award (CTSA) Program (R03 Clinical Trial Optional)
The purpose of this Notice of Funding Opportunity (NOFO) is to enhance the capability of NCATS CTSA Program KL2 scholars and recipients of re-entry supplements supported by the CTSA Program to conduct research as they complete the transition to fully independent academic translational scientists. These R03 grants will support different clinical and translational science research projects, including pilot and feasibility studies; secondary data analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology. Research proposed in the R03 application may or may not include patient-oriented research. The R03 is intended to support research projects that can be carried out in a short period of time with limited resources and that provide preliminary data to support submission of a subsequent R01, or equivalent, application. This is a limited competition opportunity specifically designed for CTSA Program KL2 scholars and re-entry supplement recipients transitioning to independent research careers in translational science.
Limited Competition: Clinical and Translational Science Award (CTSA) Program: Collaborative and Innovative Acceleration Award (UG3/UH3 Clinical Trial Optional)
The CTSA Collaborative and Innovative Acceleration Award (CCIA) aims to accelerate the pace of translational research by supporting the collaborative development, dissemination, and sustainable implementation of innovative solutions across the CTSA Program Consortium and beyond. This Notice of Funding Opportunity (NOFO) invites investigator-initiated applications to develop, demonstrate, and disseminate innovative new approaches, technologies, resources, or models that increase the impact of research across diseases, transform the field of translational science, and bring more treatments for all people more quickly. The program is offered through the National Institutes of Health and supports public and state institutions of higher education to advance translational science research.
Risk and Protective Factors of Family Health and Family Level Interventions (R01 Clinical Trial Optional)
The purpose of this initiative is to advance the science of minority health and health disparities by supporting research on family health and well-being and resilience. The NIMHD Research Framework recognizes family health, family well-being, and family resilience as critically important areas of research to decrease disparities and promote equity. This R01 grant mechanism supports research that examines the risk and protective factors affecting family health outcomes, with optional clinical trial components. The program aims to reduce health disparities and promote health equity through family-level interventions and research.
Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 Clinical Trial Not Allowed)
Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to support extramural research to investigate and mitigate challenges facing clinical assay development and subsequent analytical validation due to preanalytical variability in tumor tissue biopsies, blood biospecimens utilized as liquid biopsies, or other biospecimens. Extramural research funded under this NOFO may include investigations of preanalytical variability associated with the procurement and study of small biopsies (core biopsies, small excision samples), blood utilized for liquid biopsies, tissue swabs, tissue secretions, pleural and esophageal aspirates, feces, or bodily fluids like sweat, urine, CSF, breast milk and saliva. Investigator-designed experiments will explore how different biospecimen preanalytical conditions affect emerging and clinically relevant biomarkers quantified by a variety of testing platforms. The results from this research program will improve the understanding of how analytical quantification of clinically relevant biomarkers is affected by variation in biospecimen collection, processing, and storage procedures. The overall goal is to expedite biomarker clinical assay development through evidence-based standardization of biopsy handling practices.
Institutional Training Programs to Advance Translational Research on Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) (T32 Clinical Trial Not Allowed)
The specific purpose of this Notice of Funding Opportunity (NOFO) is to promote the development of a diverse, interdisciplinary workforce needed to conduct translational research on Alzheimer's disease and Alzheimer's-related dementias from target discovery through clinical development. This NOFO will support institutional training programs for predoctoral and postdoctoral level researchers with diverse educational backgrounds (i.e., basic biology, translational and clinical research, data science). The program invites eligible institutions to develop interdisciplinary training programs that will provide trainees with the knowledge and skills in data science, disease biology, behavioral research, and traditional and emerging drug discovery disciplines necessary to conduct rigorous and cutting-edge basic, translational, and clinical research for AD/ADRD.
Leveraging Network Infrastructure to Conduct Innovative Research for Women, Children, Pregnant and Lactating Women, and Persons with Disabilities (UG3/UH3 - Clinical Trial Optional)
The purpose of this Notice of Funding Opportunity (NOFO) is to leverage NICHD clinical research Network infrastructure relevant to infants, children, women, pregnant and lactating women, and persons with disabilities to conduct innovative, multisite, investigator-initiated clinical trials and observational studies. This NOFO will utilize a bi-phasic (UG3/UH3), milestone-driven mechanism consisting of a start-up phase (UG3) and a full enrollment and clinical trial implementation phase (UH3). Applications submitted in response to this NOFO must address specific aims and milestones for both the UG3 and UH3 phases. A UG3 project (phase I) that meets its milestones will be administratively considered by NICHD and prioritized for transition to the UH3 award (phase II). This NOFO provides an opportunity to leverage NICHD clinical research Network infrastructure as a platform for investigator-initiated innovative hypotheses by any investigator in the extramural community. Applications must be submitted as investigator-initiated, multi-Project Director/Principal Investigator (PD/PI) grant applications in conjunction with the respective NICHD-supported Network Data Coordinating Center (DCC), or equivalent as determined by the NICHD.
D-START: Data Science Track Award for Research Transition (D/START) (R03-Clinical Trial Optional)
Data science is an important cross-cutting research approach in the 2022 - 2026 NIDA Strategic Plan and increasing the capacity of experts in addiction related data science is critical. The purpose of this Notice is to facilitate the entry of investigators to the area of addiction-related data science, including newly independent data scientists or established investigators seeking to incorporate novel and cutting-edge data science methodologies into their research programs for the first time. Through this opportunity, investigators will propose to apply emerging data science methods to answer critical questions requiring advanced data analytic strategies. Projects should be small in scale and answer specific research questions or provide preliminary data for a larger scale project. Applicants are encouraged to use existing datasets, follow FAIR principles, and, when applicable, attend to ethical concerns in the conduct of research involving human subjects. Ultimately, the aim is to expedite the development of robust research programs focused on the convergence of innovative data science techniques and addiction research, with initial projects serving as precursors for subsequent, more expansive research projects.
NIDCD Research Grants for Translating Basic Research into Clinical Practice (R01 Clinical Trial Optional)
This Funding Opportunity Announcement (FOA) is intended to provide an avenue for basic scientists, clinicians and clinical scientists to jointly initiate and conduct translational research projects which translate basic research findings into clinical tools for better human health. The scope of this FOA includes a range of activities to encourage translation of basic research findings which will impact the diagnosis, treatment and prevention of communication disorders. Connection to the clinical condition must be clearly established and the outcomes of the grant must have practical clinical impact. This R01 grant supports translational research that bridges basic science discoveries with clinical applications in the field of deafness and communication disorders.
Supporting Talented Early Career Researchers in Genomics (R01 Clinical Trial Optional)
This Funding Opportunity Announcement is intended to identify and support research projects by exceptionally promising Early Stage Investigators with a long-term career interest in pursuing innovative research in genomics. This opportunity is open to research in all areas relevant to the mission of NHGRI, including genomic sciences, genomic medicine, genomic data science, and ethical, legal, and social implications of genomics. The program aims to foster the development of a diverse workforce of early career researchers who will advance genomic research and its applications.
Toward Translation of Nanotechnology Cancer Interventions (TTNCI; R01 Clinical Trial Not Allowed)
Through this Notice of Funding Opportunity (NOFO), entitled 'Toward Translation of Nanotechnology Cancer Interventions' (TTNCI), the National Cancer Institute (NCI) encourages applications for advanced pre-clinical research, supporting translation of nanotechnology-based cancer diagnostics and therapeutics. TTNCI awards are designed to mature experimental nanomedicines relying on nanoparticles and nano-devices which demonstrate strong potential to improve cancer treatment effectiveness due to the combination of nanoparticle/nano-device structural design and/or therapeutic/diagnostic cargo which is delivered. TTNCI awards are expected to enable further development of proposed nanotechnology-based interventions to the stage in which they could continue on a developmental path towards the NCI Experimental Therapeutics (NExT) and other NCI translational programs. This grant supports advanced preclinical research aimed at translating nanotechnology-based cancer interventions from experimental stages toward clinical applications.
NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)
This Notice of Funding Opportunity Announcement (NOFO) supports studies that are both necessary and sufficient to inform the planning of a Phase II-IV clinical trial within NHLBI's mission. The NHLBI expects that applications to this NOFO will describe the planned clinical trial and demonstrate that the proposed (R34) research is scientifically necessary to design or plan the subsequent trial. This NOFO will support research projects designed to provide results that will be sufficient to inform the future trial without further studies. The planned Phase II, III, or IV trial must be primarily intended to test the efficacy, safety, clinical management, or implementation of intervention(s) in the prevention and/or treatment of heart, lung, blood, and sleep disorders. In contrast to the study start up or preparation phase of NHLBI funding opportunities for clinical trials, the R34 mechanism is intended to provide new information that answers a scientific or operational question(s) which may be pragmatic in nature and, therefore, informs the final development of a Phase II-IV clinical trial. Regardless of the results of the R34, support of the proposed future clinical trial will require a new application.
NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)
The NIH Small Research Grant Program supports small research projects that can be carried out in a short period of time with limited resources. This program supports different types of projects including pilot and feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology. This Notice of Funding Opportunity does not accept applications proposing clinical trials. The R03 mechanism is designed for preliminary studies and projects that require limited funding and can be completed within two years. Awards provide up to $50,000 per year in direct costs for up to two years.
NIH Exploratory/Developmental Research Project Grant (Parent R21 Clinical Trial Not Allowed)
The NIH Exploratory/Developmental Grant (R21) supports exploratory and developmental research projects by providing support for the early and conceptual stages of these projects. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research. This funding opportunity is designed to encourage new exploratory and developmental research projects that have the potential for high impact in biomedical and behavioral research. The R21 grant mechanism is intended for projects that are in their early stages and may be untested but offer potentially transformative results. This parent announcement allows for broad application across multiple research areas under NIH, excluding clinical trials.
NIH Exploratory/Developmental Research Project Grant (Parent R21 Clinical Trial Required)
The NIH Exploratory/Developmental Grant supports exploratory and developmental research projects by providing support for the early and conceptual stages of these projects. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research. This Parent Notice of Funding Opportunity requires that at least one clinical trial be proposed. The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions. Some ICs only accept applications proposing mechanistic studies that meet NIH's definition of a clinical trial through this funding opportunity announcement.
NIH Exploratory/Developmental Research Project Grant (Parent R21 Basic Experimental Studies with Humans Required)
The NIH Exploratory/Developmental Grant supports exploratory and developmental research projects by providing support for the early and conceptual stages of these projects. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research. This Parent Notice of Funding Opportunity is for basic science experimental studies involving humans, referred to as prospective basic science studies involving human participants. These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that should submit under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers based on their scientific missions.
NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
The NIH Research Project Grant (R01) supports discrete, specified, circumscribed research projects in areas representing the specific interests and competencies of investigators. The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers based on their scientific missions. This parent funding opportunity announcement provides support for biomedical and behavioral research across a wide range of health-related fields. This Notice of Funding Opportunity does not accept applications proposing clinical trials. The R01 mechanism is NIH's most commonly used grant program and supports health-related research and development based on the mission of the NIH.
NIH Research Project Grant (Parent R01 Clinical Trial Required)
The NIH Research Project Grant (R01) supports a discrete, specified, circumscribed project in areas representing the specific interests and competencies of the investigator(s). This Parent Notice of Funding Opportunity Announcement requires that at least one clinical trial be proposed. The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions. This funding opportunity covers a broad range of health research areas including cardiovascular diseases, diabetes, mental health, aging, infectious diseases, neurosciences, and many other biomedical research fields. The R01 is the original and historically oldest grant mechanism used by NIH, and it is designed to support discrete, specified research projects with clearly defined objectives and methodologies.
NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)
The NIH Research Project Grant supports a discrete, specified, circumscribed project in areas representing the specific interests and competencies of the investigator(s). This Parent Notice of Funding Opportunity is for basic science experimental studies involving humans, referred to in NOT-OD-18-212 as prospective basic science studies involving human participants. These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that should submit under this NOFO include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. Studies conducted with specific applications toward processes or products in mind should submit under the appropriate Clinical Trials Required or Clinical Trial Optional NOFO. The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions.
Translational Efforts to Advance Gene-based Therapies for Ultra-Rare Neurological and Neuromuscular Disorders (U01 - Clinical Trial Optional)
The Ultra-Rare Gene-Based Therapy (URGenT) network supports Investigational New Drug (IND)-enabling studies and planning activities for First-in-Human (FIH) clinical testing of gene-based or transcript-directed therapeutics, such as oligonucleotides and viral-based gene therapies, for ultra-rare neurological or neuromuscular disorders. The goal of this announcement is to accelerate the development of a promising clinical candidate with robust biological rationale and demonstrated proof of concept (POC) data for the intended approach in a model system relevant to a specified patient population towards an IND filing and the initiation of a clinical trial. This cooperative agreement funding mechanism provides support for comprehensive translational research efforts that bridge the gap between laboratory discoveries and clinical applications. The program specifically targets therapeutic development for conditions affecting the nervous system and muscles that have extremely small patient populations, where traditional pharmaceutical development may not be economically viable.
Limited Competition: Ruth L. Kirschstein National Research Service Award (NRSA) Predoctoral Research Training Grant for the Clinical and Translational Science Awards (CTSA) Program (T32 Clinical Trial Not Allowed)
The National Center for Advancing Translational Sciences (NCATS) will award Ruth L. Kirschstein National Research Service Award (NRSA) Predoctoral Institutional Research Training Grants for the Clinical and Translational Science Awards (CTSA) Program (T32) to eligible institutions to create, provide, and disseminate clinical and translational science training and career support programs for individuals seeking a PhD or an equivalent research health professional degree and help ensure a heterogenous pool of clinical and translational scientist trainees who are equipped with the knowledge, skills and abilities (KSAs) to advance diagnostics, therapeutics, clinical interventions, and behavioral modifications aimed at improving health and support meaningful translational science research projects that address demonstrable needs among stakeholder communities. This institutional training grant supports predoctoral research training in clinical and translational science, preparing the next generation of researchers to advance translational medicine. The program emphasizes developing a diverse cohort of trainees with the competencies needed to conduct impactful translational research.
Limited Competition: Ruth L. Kirschstein National Research Service Award (NRSA) Postdoctoral Research Training Grant for the Clinical and Translational Science Awards (CTSA) Program (T32 Clinical Trial Not Allowed)
The National Center for Advancing Translational Sciences (NCATS) will award Ruth L. Kirschstein National Research Service Award (NRSA) Postdoctoral Institutional Research Training Grants for the Clinical and Translational Science Awards (CTSA) Program (T32) to eligible institutions. This program aims to create, provide, and disseminate clinical and translational science training and career support programs that enhance postdoctoral research training of individuals with doctoral degrees. These degrees include, but are not limited to: D.M.D., DC, DO, DVM, OD, DPM, ScD, EngD, DrPH, DNSc, DPT, PharmD, ND (Doctor of Naturopathy), DSW, PsyD, as well as doctoral degrees in nursing research. The program helps ensure a heterogeneous pool of clinical and translational scientists trainees who are equipped with the knowledge, skills and abilities to advance diagnostics, therapeutics, clinical interventions, and behavioral modifications that improve health and support meaningful translational science research projects that address demonstrable needs among stakeholder communities.
Early Immune System Development and Ontogeny (R01 Clinical Trial Optional)
The purpose of this Notice of Funding Opportunity (NOFO) is to further elucidate the mechanisms of early immune development in utero, during the early post-natal period and during early childhood in neonates, infants, and children and adolescents with or without in-utero exposure to HIV or Anti-Retroviral Therapeutics (ART). This initiative aims to understand intricate mechanisms of immune cells at the maternal-fetal interface, T and B cell development and maturation in offspring, and local immune responses and the role of systemic immunity. This R01 grant supports research in pediatric immunology and early human development, focusing on understanding how the immune system develops from prenatal stages through childhood. The program particularly emphasizes research related to HIV exposure and antiretroviral therapy effects on immune development.
Cutting-Edge Basic Research Awards (CEBRA) (R21 Clinical Trial Optional)
The National Institute on Drug Abuse (NIDA) Cutting-Edge Basic Research Award (CEBRA) is designed to foster highly innovative or conceptually creative research related to the etiology, pathophysiology, prevention, or treatment of substance use disorders (SUDs). It supports high-risk and potentially high-impact research that is sparse or not included in NIDA's current portfolio that has the potential to transform SUD research. The proposed research should: 1) develop and/or adapt revolutionary techniques or methods for addiction research or that show promising future applicability to SUD research; and/or 2) test an innovative and significant hypothesis for which there are scant precedent or preliminary data and which, if confirmed, would transform current thinking. This R21 mechanism supports exploratory and developmental research that may lead to breakthrough discoveries in substance use disorder research.
Translational Bioinformatics and Experimental Approaches to Advance Drug Repositioning and Combination Therapy Development for Alzheimers Disease and Related Dementias (R01 Clinical Trial Not Allowed)
This Notice of Funding Opportunity (NOFO) invites applications that propose to use mouse models to conduct rigorous preclinical testing of drugs or drug combinations currently used for other conditions, as well as investigational drugs at various stages of clinical development, predicted to be efficacious in AD/ADRD. This initiative will also support preclinical testing of repurposable or investigational drug candidates in combination with non-pharmacologic interventions leading to robust translational outcomes. The central goal is to establish robust proof of concept that will enable rational drug repurposing and combination therapy development for the treatment and prevention of Alzheimer's Disease and related dementias. The program seeks to advance translational bioinformatics and experimental approaches to identify promising therapeutic candidates through preclinical validation.
Innovative Mental Health Services Research Not Involving Clinical Trials (R01 Clinical Trials Not Allowed)
The purpose of this Notice of Funding Announcement (NOFO) is to encourage innovative research that will inform and support the delivery of high-quality, continuously improving mental health services to benefit the greatest number of individuals with, or at risk for developing, a mental illness. This announcement invites applications for non-clinical trial R01-level projects that address NIMH strategic priorities for mental health services research. The program supports research focused on understanding and improving mental health service delivery systems, implementation of evidence-based practices, and access to quality mental health care across diverse populations and settings.
Innovative Pilot Mental Health Services Research Not Involving Clinical Trials (R34 Clinical Trial Not Allowed)
This Notice of Funding Announcement (NOFO) from the National Institutes of Health encourages pilot research that is not an immediate precursor to testing a service intervention but is consistent with NIMH priorities for services research. The program recognizes that some mission-relevant areas of services research do not involve clinical trials. This is an R34 grant mechanism focused on innovative pilot mental health services research. The funding supports research aligned with the National Institute of Mental Health's strategic priorities in mental health services, excluding clinical trial activities. Eligible applicants include a broad range of organizations including government entities, educational institutions, nonprofits, for-profit businesses, tribal organizations, and other qualifying entities.
Academic-Industrial Partnerships for Translation of Technologies for Diagnosis and Treatment (R01 - Clinical Trial Optional)
Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to stimulate efforts to translate scientific discoveries and engineering developments into methods or tools that address problems in basic research to understand disease, or in applied research to assess risk, detect, prevent, diagnose, treat, and/or manage disease. The rationale is to deliver new capabilities to meet evolving requirements for technologies and methods relevant to the advance of research and delivery of care in pre-clinical, clinical and non-clinical settings, domestic or foreign, for conditions and diseases within the missions of participating institutes. This R01 grant mechanism supports academic-industrial partnerships focused on translating technologies for cancer diagnosis and treatment.
Academic-Industrial Partnerships for Translation of Technologies for Diagnosis and Treatment (R01 - Clinical Trial Not Allowed)
Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to stimulate efforts to translate scientific discoveries and engineering developments into methods or tools that address problems in basic research to understand disease, or in applied research to assess risk, detect, prevent, diagnose, treat, and/or manage disease. The rationale is to deliver new capabilities to meet evolving requirements for technologies and methods relevant to the advance of research and delivery of care in pre-clinical, clinical and non-clinical settings, domestic or foreign, for conditions and diseases within the missions of participating institutes. This R01 grant supports academic-industrial partnerships focused on translating technologies for diagnosis and treatment, with clinical trials not allowed under this mechanism.
Ruth L. Kirschstein National Research Service Award (NRSA) Short-Term Institutional Research Training Grant (Parent T35)
The National Institutes of Health (NIH) will award Ruth L. Kirschstein National Research Service Award (NRSA) Short-Term Institutional Research Training Grants (T35) to eligible, domestic institutions to develop and/or enhance research training opportunities for predoctoral students interested in careers within biomedical, behavioral, or clinical research workforce. Many NIH Institutes and Centers use this NRSA program exclusively to support intensive, short-term research training experiences for health professional students (medical students, veterinary students, and/or students in other health-professional programs) during the summer. This program is also intended to encourage training of graduate students in the physical or quantitative sciences to pursue interests in research careers by short-term exposure to, and involvement in, the health-related sciences. The training should be of sufficient depth to enable the trainees, upon completion of the program, to have a thorough exposure to the principles underlying the conduct of biomedical research.
Substance Use/Substance Use Disorder Dissertation Research Award (R36 Clinical Trials Not Allowed)
The goal of this NOFO is to support doctoral candidates from a variety of academic disciplines for up to two years for the completion of the doctoral dissertation research project. Research projects should align with NIDA funding priorities. This award will facilitate the entry of promising new investigators into the field of substance use/substance use disorder (SU(D) research, enhancing the pool of highly talented SU(D) researchers. The program provides funding support specifically for dissertation research focusing on drug use and addiction research, helping doctoral students complete their research and enter the field as qualified researchers.
NEI Research Grant for Vision-Related Secondary Data Analysis (R21 Clinical Trial Not Allowed)
The goal of this funding opportunity announcement (FOA) is to fund meritorious vision-related research projects that involve secondary data analyses using existing database resources. This R21 grant mechanism supports projects that utilize existing vision health data to advance research in vision science. The development of statistical methodology necessary for improving methods to analyze vision health data using existing vision data may also be proposed. This program is offered by the National Eye Institute (NEI), part of the National Institutes of Health, to support exploratory research in vision health through the analysis of previously collected data resources.
Cooperative Agreement for In Vivo High-Resolution Imaging for Inner Ear Visualization (U01 Clinical Trial Required)
This funding opportunity aims to support high risk clinical trials for the development of in vivo high-resolution structural and functional imaging technologies for the living human inner ear. Proposed projects should focus on improving the resolution of current imaging techniques or developing new imaging techniques that can visualize inner ear structures in vivo with significantly greater detail and accuracy than currently possible. Structural and functional aspects, including visualizing dynamic elements, are important to developing new and improved techniques. Projects may also focus on developing new imaging probes or contrast agents that can enhance visualization of the inner ear structures. Research supported in response to this RFA is expected to significantly advance the ability to visualize auditory and vestibular components, such as hair cells, otoliths, membranes, ions, and vasculature, in detail in awake patients in a clinical setting using non-invasive techniques. To achieve this goal, a multidisciplinary team approach that takes advantage of the expertise of each team member is highly encouraged. Studies in humans must be proposed to develop, advance, or test the needed technology.
In Vivo High-Resolution Imaging for Inner Ear Visualization (R01 Clinical Trial optional)
This funding opportunity aims to support the development of in vivo high-resolution structural and functional imaging technologies for the living human inner ear. Proposed projects should focus on improving the resolution of current imaging techniques or developing new imaging techniques that can visualize inner ear structures in vivo with significantly greater detail and accuracy than currently possible. Both structural and functional aspects, including visualizing dynamic elements are important to development of new and improved techniques. Projects may also focus on developing new imaging probes or contrast agents that can enhance visualization of the inner ear structures. Ultimately, research supported in response to this RFA is to encourage technologies that allow structures such as hair cells, otoliths, membranes, ions, and vasculature to be viewed in detail in awake patients in a clinical setting using non-invasive techniques. To achieve this goal, a multi-disciplinary team approach that takes advantage of the expertise of each team member is highly encouraged. Studies in humans and intermediate studies in animals, but not non-mammalian species, may be proposed to develop or advance the needed technology.
NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required)
The National Institute on Deafness and Other Communication Disorders (NIDCD) is committed to identifying effective interventions for the treatment or prevention of communication disorders by supporting well designed and well executed clinical trials. This funding opportunity announcement (FOA) supports a cooperative agreement between an NIDCD Project Scientist and an investigator to support a clinical trial that meets any of the following criteria: requires FDA oversight, is intended to formally establish efficacy, or has a higher risk to potentially cause physical or psychological harm. The program supports clinical research focused on communication disorders including conditions related to hearing, balance, smell, taste, voice, speech, and language. This cooperative agreement mechanism provides substantial programmatic involvement between NIDCD staff and the investigator during the performance of the supported project.
NIDCD Research Dissertation Fellowship for Au.D. Audiologists (F32)
The purpose of the NIDCD Research Dissertation Fellowship for Au.D. Audiologists (F32) program is to support a comprehensive, rigorous biomedical research training, and dissertation research leading to a research doctorate (i.e., Ph.D.) in the biomedical, behavioral, or clinical sciences. This fellowship is specifically designed for audiologists with Au.D. degrees who are pursuing research doctorates. The program provides financial support for advanced biomedical research training and dissertation work in fields related to deafness and communication disorders. The fellowship aims to develop the next generation of research scientists in these critical areas of health research.
Trailblazer Award for New and Early Stage Investigators (R21 Clinical Trial Optional)
This Trailblazer Award is an opportunity for NIH-defined New and Early Stage Investigators to pursue research programs that integrate engineering and the physical sciences with the life and/or biomedical sciences. A Trailblazer project may be exploratory, developmental, proof of concept, or high risk-high impact, and may be technology design-directed, discovery-driven, or hypothesis-driven. Importantly, applicants must propose research approaches for which there are minimal or no preliminary data. A distinct feature for this FOA is that no preliminary data are required, expected, or encouraged. However, if available, minimal preliminary data are allowed. Preliminary data are defined as material which the applicant has independently produced and not yet published in a peer-reviewed journal. All preliminary data should be clearly marked and limited to one-half page, which may include one figure. Applications including data more than one-half page or more than one figure will be considered noncompliant with the FOA instructions and will not go forward to review. This award supports early career researchers to pursue innovative, high-risk, high-impact research at the intersection of engineering, physical sciences, and biomedical sciences.
Advancing HIV/AIDS Research within the Mission of the NIDCD (R01 Clinical Trial Optional)
The purpose of this Funding Opportunity Announcement (FOA) is to stimulate HIV/AIDS research within the scientific mission areas of the National Institute on Deafness and Other Communications Disorders (NIDCD). Applications should address high priority HIV/AIDS research outlined by the NIH Office of AIDS Research (OAR) in the areas of hearing, balance, taste, smell, voice, speech, and language. This R01 grant mechanism supports research projects that are investigator-initiated and focused on advancing knowledge in these communication disorder areas as they relate to HIV/AIDS. For applications proposing a clinical trial, only low risk clinical trials will be supported. The program is designed to foster innovative research approaches that align with both NIDCD's mission and the broader NIH priorities for HIV/AIDS research. Eligible applicants include a wide range of institutions including universities, nonprofits, small businesses, tribal organizations, and government entities. Applications are accepted through a recurring deadline schedule, with the opportunity closing on November 5, 2027.
Advancing HIV/AIDS Research within the Mission of the NIDCD (R21 Clinical Trial Optional)
The purpose of this Notice of Funding Opportunity (NOFO) is to stimulate HIV/AIDS research within the scientific mission areas of the National Institute on Deafness and Other Communications Disorders (NIDCD). Applications should address high priority HIV/AIDS research outlined by the NIH Office of AIDS Research (OAR) in the areas of hearing, balance, taste, smell, voice, speech, and language. For applications proposing a clinical trial, only low risk clinical trials will be supported. This funding opportunity is designed to encourage exploratory and developmental research projects that may lead to breakthroughs in HIV/AIDS research specifically related to communication disorders and sensory systems. The program aims to support innovative approaches to understanding and addressing the impact of HIV/AIDS on the auditory, vestibular, taste, smell, and speech-language systems. Eligible applicants include a broad range of institutions and organizations across education, business, nonprofit, and government sectors.
Joint NINDS/NIMH Exploratory Neuroscience Research Grant (R21 Clinical Trial Not Allowed)
The Joint NINDS/NIMH Exploratory Neuroscience Research Grant program supports exploratory and innovative research projects, which fall within the missions of the National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute of Mental Health (NIMH). Awards provide support for the early and conceptual stages of neuroscience research projects. These studies often assess the feasibility of novel avenues of investigation and involve considerable risk, but have the potential to bring about breakthroughs in the understanding of important areas of neuroscience, or to the development of novel techniques, agents, methodologies, or models of high value to the neuroscience community. While this funding opportunity accepts clinical trials, only applications proposing mechanistic clinical trials or studies or basic experimental studies with humans (BESH) will be considered for funding. The R21 grant mechanism is designed to encourage exploratory research with high risk and high reward potential.
Pilot Studies of Biological, Behavioral and Social Mechanisms Contributing to HIV Pathogenesis Within the Mission of NIDDK (R21 Clinical Trial Not Allowed)
This Notice of Funding Opportunity invites applications for innovative basic and translational pilot research projects within the mission of the NIDDK that are aligned with NIH HIV/AIDS research priorities. The program supports research addressing multiple overarching priorities including elucidation of unique pathophysiological mechanisms contributing to HIV comorbidities, coinfections, and complications affecting organs, tissues, and processes within the mission of the NIDDK. The opportunity also supports interrogations into biological mechanisms underlying HIV reservoirs in NIDDK-relevant tissues, which are important for developing strategies for long-term viral suppression or eradication. Additionally, the program addresses health-impeding social determinants of health that may affect complications or viral reservoirs within NIDDK's mission through multiple pathways.
Priority HIV/AIDS Research within the Mission of NIDDK (R01 Clinical Trial Optional)
This Notice of Funding Opportunity (NOFO) seeks to stimulate HIV/AIDS research within the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) that align with the HIV/AIDS research priorities outlined by the NIH Office of AIDS Research (OAR). The program focuses on research at the intersection of HIV/AIDS and conditions within NIDDK's mission areas including diabetes, digestive diseases, and kidney diseases. This R01 grant mechanism supports investigator-initiated research projects and allows for optional clinical trials. The program encourages applications from a wide range of eligible institutions including universities, nonprofits, small businesses, and government entities.
Unveiling Health and Healthcare Disparities in Non-Communicable and Chronic Diseases in Latin America: Setting the Stage for Better Health Outcomes Across the Hemisphere (R01 - Clinical Trials Not Allowed)
This Notice of Funding Opportunity (NOFO) supports innovative, collaborative, and multi-disciplinary research focused on clinical epidemiology, evaluation of public and/or health care policies, and validation of measurements that address health and health care disparities related to non-communicable and chronic diseases (NCDs) with the highest disease burden and mortality in Latin America and among U.S. Hispanics/Latinos. Multi-disciplinary research teams are expected to meaningfully collaborate with key partners that must include at least one Principal Investigator or Multiple Principal Investigator from institutions in Latin America. The program aims to advance understanding of health disparities and improve health outcomes across the hemisphere through rigorous research partnerships.
Small R01s for Clinical Trials Targeting Diseases within the Mission of NIDDK (R01 Clinical Trial Required)
This Notice of Funding Announcement (NOFO) encourages the submission of pilot and feasibility clinical trials conducted in humans that will lay the foundation for larger clinical trials related to the prevention and/or treatment of diseases and conditions within the mission of NIDDK. The program will support small, short-term proof-of-concept clinical trials in humans to acquire preliminary data regarding the effects of the intervention, as well as feasibility data related to recruitment and retention, and study conduct. Applications for clinical trials submitted under this NOFO should have clearly described aims and objectives and have a high likelihood that the trial findings will lead to more definitive, hypothesis-driven trials to improve understanding, diagnosis, prevention or treatment of the diseases studied and have the potential to impact clinical practice and/or public health. Preliminary data regarding intervention efficacy are not required.
HEAL Initiative: Pain Research Enhancement Program (PREP) (R15 Clinical Trial Optional)
The HEAL Initiative Pain Research Enhancement Program (PREP) is an R15 grant program designed to support rigorous basic and mechanistic pain research at institutions that have not been major recipients of NIH research funding. The purpose of this initiative is threefold: First, it supports the efforts by R15-eligible Principal Investigators to conduct rigorous basic and/or mechanistic pain research projects. Second, it promotes integrated, interdisciplinary research partnerships between R15-eligible PIs and additional investigators from U.S. domestic institutions. Third, it enhances the pain research environment at the R15-eligible institution for health professional trainees or undergraduate and/or graduate students by actively engaging them in the proposed pain research projects. This program is part of the broader HEAL (Helping to End Addiction Long-term) Initiative and addresses critical pain research needs while building research capacity at eligible institutions.
Development and Testing of Novel Interventions to Improve HIV Prevention, Treatment, and Program Implementation for People Who Use Substances (R34 Clinical Trial Required)
This notice of funding opportunity (NOFO) encourages formative research, intervention development, and pilot-testing of interventions. Primary scientific areas of focus include the feasibility, tolerability, acceptability and safety of novel or adapted interventions that target HIV prevention, treatment or services research for people who use drugs. For the purposes of this NOFO, 'intervention' may include behavioral, social, or structural approaches, as well as combination biomedical and behavioral approaches that prevent the acquisition and transmission of HIV infection, or improve clinical outcomes for persons living with HIV. The program supports research organizations in developing and testing interventions specifically designed to address HIV in populations affected by substance use.
Limited Competition: Small Grant Program for NIDDK K01/K08/K23/K25 Recipients (R03 Clinical Trial Optional)
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) announces a program that provides NIDDK-supported K01, K08, K23, and K25 recipients the opportunity to apply for Small Grant (R03) support at some point during the latter years of their award period of their K award. Through the use of this mechanism, the NIDDK is seeking to enhance the capability of its K01, K08, K23, and K25 award recipients to conduct research as they complete their transition to fully independent investigator status. The R03 grant mechanism supports different types of projects, including pilot and feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology. The R03 is, therefore, intended to support research projects that can be carried out in a short period of time with limited resources and that may provide preliminary data to support a subsequent R01, or equivalent, application.
NEI Clinical Research Study Planning Grant Program (R34 Clinical Trial Not Allowed)
The NEI supports large-scale clinical vision research projects, including randomized clinical trials and epidemiologic studies on eye/vision conditions. This clinical research planning grant funding opportunity supports applicants in their planning efforts to conduct collaborative clinical research. The grant may be used to support the development of a study protocol and Manual of Procedures (MOP), as well as to conduct preliminary studies to refine study procedures or document recruitment potential. The grant must not be used to generate data on the effects of a proposed intervention. This NEI NOFO is applicable to both epidemiologic and clinical trial research studies. At the time of submission, applications requesting support for these activities are expected to provide detailed information regarding the study rationale, design, analytic methods, protocols and procedures, facilities and environment, organizational structure, and collaborative arrangements.
Ethical, Legal and Social Implications (ELSI) Small Research Grant (R03 Clinical Trial Optional)
This Notice of Funding Opportunity (NOFO) invites Small Research Grant (R21) applications to study the ethical, legal, and social implications (ELSI) of human genetics and genomics. The program supports small research projects, particularly those involving single investigators. Of particular interest are projects proposing normative or conceptual analyses, including focused legal, economic, philosophical, anthropological, or historical analyses of new or emerging issues. Applications may propose studies using either single or mixed methods, with direct involvement of key stakeholders encouraged where appropriate. This mechanism can be used for the collection of preliminary data and secondary analysis of existing data. The program aims to advance understanding of the societal impacts of genetic and genomic research and technologies.
Interventions on Health and Healthcare Disparities on Non-Communicable and Chronic Diseases in Latin America: Improving Health Outcomes Across the Hemisphere (R01 - Clinical Trial Required)
The purpose of this Notice of Funding Opportunity (NOFO) is to support innovative and interdisciplinary research teams focused on clinical, health services, and/or community-based interventions that address health and healthcare disparities related to non-communicable and chronic diseases (NCDs) with the highest burden and mortality in Latin America and among U.S. Hispanics/Latinos. Multidisciplinary research teams would be expected to meaningfully collaborate with key partners that must include at least one PI or MPI from institutions in Latin America. This R01 research grant requires clinical trials and aims to improve health outcomes across the hemisphere through evidence-based interventions targeting chronic disease disparities. The program emphasizes interdisciplinary collaboration between U.S. and Latin American institutions to develop and test interventions that can be implemented in diverse healthcare settings.
Ethical, Legal and Social Implications (ELSI) Research (R01 Clinical Trial Optional)
The purpose of this NOFO is to invite Research Project (R01) applications that propose to study the ethical, legal, and social implications (ELSI) of human genetics and genomics. Applications may propose studies using either single or mixed methods. Approaches may include but are not limited to empirical qualitative and quantitative methods, as well as conceptual, legal, and normative analyses. Direct involvement of key stakeholders where appropriate is encouraged. This Notice of Funding Opportunity (NOFO) requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application. Applications without a PEDP will not be reviewed.
Ethical, Legal and Social Implications (ELSI) Exploratory/Developmental Research Grant (R21 Clinical Trial Optional)
The purpose of this NOFO is to invite Exploratory/Developmental Research Grant (R21) applications that propose to study the ethical, legal, and social implications (ELSI) of human genetics and genomics. Applications may propose studies using either single or mixed methods. Approaches may include but are not limited to empirical qualitative and quantitative methods, as well as conceptual, legal, and normative analyses. Direct involvement of key stakeholders where appropriate is encouraged. Of particular interest are studies that explore the implications of new or emerging genomic technologies or novel uses of genomic information.
NCI Pathway to Independence Award (K99/R00 Clinical Trial Required)
The purpose of the NCI Pathway to Independence Award (K99/R00) program is to facilitate a timely transition of talented postdoctoral researchers with a research and/or clinical doctorate degree from mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions. The program will provide independent NCI research support during this transition in order to help awardees to launch competitive, independent research careers. This award is specifically for projects that require clinical trials and supports researchers in cancer research fields as they establish their independence.
National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders (U01 Clinical Trial Optional)
This Notice of Funding Opportunity (NOFO) encourages applications to advance the discovery, preclinical development, and proof of concept (PoC) testing of new, rationally based candidate agents and neurostimulation approaches to treat mental disorders, substance use disorders (SUDs) or alcohol use disorder (AUD), and to develop novel ligands and circuit-engagement devices as tools to further characterize existing or to validate new drug/device targets. Partnerships between academia and industry are strongly encouraged. This NOFO uses the U01 cooperative agreement mechanism to support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies. Projects seeking support for a research program of multiple projects directed toward a specific major objective, basic theme or program goal, requiring a broadly based, multidisciplinary and often long-term approach should consider the companion U19 FOA.
National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders (U19 Clinical Trial Optional)
This funding opportunity announcement encourages applications to advance the discovery, preclinical development, and proof of concept (PoC) testing of new, rationally based candidate agents and neurostimulation approaches to treat mental disorders, substance use disorders (SUDs) or alcohol use disorder (AUD), and to develop novel ligands and circuit-engagement devices as tools to further characterize existing or to validate new drug/device targets. Partnerships between academia and industry are strongly encouraged. This FOA supports a research program of multiple projects directed toward a specific major objective, basic theme or program goal, requiring a broadly based, multidisciplinary and often long-term approach. The program is specifically designed for cooperative agreements that involve substantial NIH programmatic involvement throughout the life of the project. This is a reissue of PAR-20-119 focused on advancing therapeutic discovery and development in mental health and substance use disorders through collaborative, multi-project research teams.
Short Courses on Innovative Methodologies and Approaches in the Behavioral and Social Sciences (R25 Clinical Trials Not Allowed)
The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The overarching goal of this R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nations biomedical, behavioral and clinical research needs. This funding opportunity announcement focuses on courses for skills development in innovative methodologies and approaches in the behavioral and social sciences. The program provides support for creative educational activities that enhance research education and workforce development in NIH mission areas.
Intervention Research to Improve Native American Health (R34 Clinical Trial Optional)
The purpose of this notice of funding opportunity (NOFO) is to support research on interventions to improve health in Native American (NA) populations. This includes 1) etiologic research, where there is a significant gap in knowledge, that will directly inform intervention development or adaptations, 2) research that develops, adapts, or tests the efficacy or effectiveness of health promotion and disease prevention interventions, 3) research that tests culturally informed treatment or recovery interventions and 4) where a sufficient body of knowledge on intervention efficacy exists, research on dissemination and implementation that develops and tests strategies to overcome barriers to the adoption, integration, scale-up, and sustainability of effective interventions. Existing data suggest that significant acute and chronic disease inequities exist for NA populations. Concurrently, NA populations experience unique sociopolitical, historical, and environmental stressors and risks that may exacerbate health conditions and/or impact the effectiveness of existing solutions to address the conditions. They also possess unique strengths and resiliencies that can mitigate stressors or inform intervention strategies. Through this initiative, intervention and related research is sought to build upon community knowledge, resources, and resilience to test science-based, culturally appropriate solutions to reduce morbidity and mortality through identification and remediation of precursors to diseases and disorders and through culturally informed treatment. Interventions should be designed with a consideration for sustainability within the communities where they are tested, and have the flexibility to be readily adapted, disseminated, and scaled up to other communities where culturally appropriate. For the purposes of this NOFO, NA includes the following populations: Alaska Natives, American Indians (whose ancestral lands fall at least partially within the U.S. main land).
NIGMS National and Regional Resources (R24 - Clinical Trial Not Allowed)
This Notice of Funding Opportunity (NOFO) encourages applications for support of resources that will provide access to state-of-the-art equipment, technologies, research tools, materials, organisms, software, and/or services to a substantial regional (multi-state) or national user base. Only those resources with technical capabilities that fall within the NIGMS-supported program areas are eligible for awards. The resources should already be established or may be formed through consolidation of existing local or regional facilities. The intent is to provide resource access to investigators without regard to the specific biomedical focus of their research, while not duplicating or replacing resources supported by sources such as other NIH Institutes and Centers (ICs) or host institutions. The resource is expected to be maintained or upgraded to current best practices, make its capabilities and availability known to the biomedical research community through a robust web presence and outreach activities, and provide user training and support.
Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship for Students at Institutions with NIH-Funded Institutional Predoctoral Dual-Degree Training Programs (Parent F30)
This Notice of Funding Opportunity (NOFO) supports students at institutions with NIH-funded institutional predoctoral dual-degree training programs. The purpose of the Kirschstein-NRSA, dual-doctoral degree, predoctoral fellowship (F30) is to enhance the integrated research and clinical training of promising predoctoral students, who are matriculated in a combined MD/PhD or other dual-doctoral degree training program (e.g. DO/PhD, DDS/PhD, AuD/PhD, DVM/PhD), and who intend careers as physician/clinician-scientists. Candidates must propose an integrated research and clinical training plan and a dissertation research project in scientific health-related fields relevant to the missions of the participating NIH Institutes and Centers. The fellowship experience is expected to clearly enhance the individual's potential to develop into a productive, independent physician/clinician-scientist. This NOFO is designed specifically for candidates proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial, but does allow candidates to propose research experience in a clinical trial led by a sponsor or co-sponsor.
Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship (Parent F31)
The Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship (Parent F31) enables promising predoctoral students to obtain individualized, mentored research training from outstanding faculty sponsors while conducting dissertation research projects in scientific health-related fields relevant to the missions of the participating NIH Institutes and Centers. The proposed mentored research training must reflect the candidate's dissertation research project and is expected to clearly enhance the individual's potential to develop into a productive, independent research scientist. This program supports graduate students pursuing research in diverse health-related fields including drug use and addiction, aging, environmental health, medical library science, complementary and integrative health, oral diseases, alcohol research, deafness and communication disorders, vision research, minority health and health disparities, child health and human development, cardiovascular diseases, sleep disorders, nursing research, blood diseases, allergy and infectious diseases, diabetes and kidney diseases, cancer research, neurosciences and neurological disorders, arthritis and musculoskeletal diseases, lung diseases, and technological innovations to improve human health. This Notice of Funding Opportunity does not allow candidates to propose to lead an independent clinical trial but does allow candidates to propose research experience in a clinical trial led by a sponsor or co-sponsor.
Ruth L. Kirschstein National Research Service Award (NRSA) Individual Postdoctoral Fellowship (Parent F32)
The Ruth L. Kirschstein National Research Service Award (NRSA) Individual Postdoctoral Fellowship (Parent F32) is designed to support research training of highly promising postdoctoral candidates who have the potential to become productive, independent investigators in scientific health-related research fields relevant to the missions of the participating NIH Institutes and Centers. This fellowship program emphasizes exceptional mentorship as a core component of the training experience. The program aims to develop the next generation of independent biomedical and behavioral researchers by providing comprehensive postdoctoral training in health-related scientific fields. Applications must incorporate exceptional mentorship plans and demonstrate the candidate's potential for becoming a productive, independent investigator in their chosen research area.
Ruth L. Kirschstein National Research Service Award (NRSA) Individual Senior Fellowship (Parent F33)
The National Institutes of Health (NIH) awards senior individual research training fellowships to experienced scientists who wish to make major changes in the direction of their research careers or who wish to broaden their scientific background by acquiring new research capabilities as independent investigators in research fields relevant to the missions of participating NIH Institutes and Centers. This fellowship program is designed for senior researchers seeking to redirect their careers or expand their scientific expertise through advanced training opportunities. The program supports independent investigators across multiple NIH institutes focusing on areas including sleep disorders, environmental health, drug use research, cardiovascular diseases, arthritis and musculoskeletal diseases, biomedical research, lung and blood diseases, oral health, and other trans-NIH research areas.
Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship for Students at Institutions Without NIH-Funded Institutional Predoctoral Dual-Degree Training Programs (Parent F30)
This Notice of Funding Opportunity (NOFO) supports students at institutions without NIH-funded institutional predoctoral dual-degree training programs. The purpose of the Kirschstein-NRSA, dual-doctoral degree, predoctoral fellowship (F30) is to enhance the integrated research and clinical training of promising predoctoral students, who are matriculated in a combined MD/PhD or other dual-doctoral degree training program (e.g. DO/PhD, DDS/PhD, AuD/PhD, DVM/PhD), and who intend careers as physician/clinician-scientists. Candidates must propose an integrated research and clinical training plan and a dissertation research project in scientific health-related fields relevant to the missions of the participating NIH Institutes and Centers. The fellowship experience is expected to clearly enhance the individual's potential to develop into a productive, independent physician/clinician-scientist. This NOFO is designed specifically for candidates proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial, but does allow candidates to propose research experience in a clinical trial led by a sponsor or co-sponsor.
Support for Research Excellence (SuRE) Award (R16 Clinical Trial Not Allowed)
The SuRE program supports research capacity building at eligible higher education institutions by funding investigator-initiated biomedical research in basic, social, clinical, behavioral, or translational science that falls in the mission areas of the NIH. The purpose of SuRE awards is to provide support for investigator-initiated research at resource-limited institutions by full-time faculty who are not currently funded by any NIH Research Project Grants (RPGs) with the exception of SuRE or SuRE-First awards. The program aims to furnish students with high-quality undergraduate and/or graduate research experiences, and to enhance the institutional scientific research culture. This funding opportunity does not allow clinical trials and is specifically designed to build research capacity at institutions that may have limited resources for conducting biomedical research.
Support for Research Excellence First Independent Research (SuRE-First) Award (R16 - Clinical Trial Not Allowed)
The SuRE program supports research capacity building at eligible higher education institutions through funding investigator-initiated biomedical research in basic, social, clinical, behavioral, or translational science that falls in the mission areas of the NIH. The purpose of SuRE-First awards is to provide support for investigator-initiated research at resource-limited institutions by full-time faculty who have not had any prior independent, peer-reviewed, external research grants. The program aims to furnish students with high-quality undergraduate and/or graduate research experiences, and to enhance the institutional scientific research culture. This funding opportunity supports early-career faculty members at institutions with limited research resources to establish their independent research programs while contributing to student training and institutional capacity building.
Expanding the Target Landscape by Drugging the Undruggable (R21 Clinical Trial Not Allowed)
The purpose of this Notice of Funding Opportunity (NOFO) is to solicit applications for exploratory and early-stage projects that focus on undruggable target classes within intractable human disease. Applicants will identify a human disease relevant undruggable target class and develop a method or agent that is selective for one or more targets within that target class. This NOFO is intended to jumpstart research that demonstrates innovative strategies to modulate targets that cannot be addressed by established therapeutic types, furthering the development of methods and/or agents selective for undruggable target classes. This R21 exploratory grant supports early-stage research and does not allow clinical trials.
Blueprint MedTech Translator (UG3/UH3 - Clinical Trial Optional)
The purpose of this announcement is to encourage investigators to pursue translational activities and clinical feasibility studies to advance the development of therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, as well as a subsequent clinical feasibility study. The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments due to the novelty of the device or its intended use. This FOA is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress. Participants in Blueprint MedTech receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants to receive assistance with specialty areas including regulatory, reimbursement, intellectual property, commercialization, and strategic partnerships. Participants can also augment their project with NIH contract research organizations that specialize in large animal testing, sterilization testing, biocompatibility assessment, manufacturing, and medical monitoring. Individuals, institutions, or businesses developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this NOFO or any of the companion opportunities. The program focuses specifically on disorders affecting the nervous or neuromuscular systems and supports the pathway from prototype development through clinical feasibility testing.
NIDCR Dual Degree Dentist Scientist Pathway to Independence Award (K99/R00 Clinical Trial Not Allowed)
The purpose of the NIDCR Dual Degree Dentist Scientist Pathway to Independence Award (K99/R00) program is to develop and maintain a strong cohort of independently funded dentist scientists dedicated to improving dental, oral and craniofacial health. This program is designed to facilitate a timely transition of outstanding dual degree dentist scientists from mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions by providing support for two years of mentored training and three to five years of independent research. An option for five years of independent (R00) support is available to accommodate clinical training in a dental specialty program at no more than 3 person-months effort (25% full-time professional effort) in any year of the R00 phase. This program supports candidates who hold both a dental degree and a research doctoral degree, helping them establish independent research careers focused on oral health and craniofacial research.
Environmental influences on Child Health Outcomes (ECHO) Cohort Data and Biospecimen Access (X01 Clinical Trial Not Allowed)
The purpose of this Program Announcement with Special Receipt, Referral, and/or Review Considerations (PAR) is to solicit applications to access limited identifiable data or biospecimens from the ECHO Cohort to study high-priority areas of maternal and child health. This funding opportunity is offered by the National Institutes of Health to support researchers seeking to utilize ECHO Cohort resources for advancing knowledge in maternal and child health research. The program provides access to valuable cohort data and biospecimens that can be leveraged to investigate environmental influences on child health outcomes.
Tobacco Regulatory Science Small Grant Program for New Investigators (R03 Clinical Trial Optional)
This Notice of Funding Opportunity (NOFO) aims to support new biomedical, behavioral, and social science investigators who are in the early stages of establishing independent careers in tobacco regulatory research. The R03 grant mechanism supports different types of projects, including pilot and feasibility studies, secondary analysis of existing data, small, self-contained research projects, development of research methodology, and development of new research technology. Applicants are encouraged to conduct projects that ultimately have the potential to inform regulations on tobacco product manufacturing, distribution, and marketing. Research projects must address one or more High-Priority Research Topic(s) related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. The awards under this NOFO will be administered by NIH using funds made available through FDA CTP and the FSPTCA. Research results from this NOFO are expected to generate findings and data directly relevant to informing the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.
Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Basic Experimental Studies with Human Required)
The Stephen I. Katz Early Stage Investigator Research Project Grant supports an innovative project that represents a change in research direction for an early stage investigator (ESI) and for which no preliminary data exist. Applications submitted to this funding opportunity must not include preliminary data but must include a separate attachment describing the change in research direction. The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions. This funding opportunity is specifically for basic science experimental studies involving humans, referred to as prospective basic science studies involving human participants. These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that should submit under this program include studies that prospectively assign human participants to conditions (experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind.
Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Clinical Trial Not Allowed)
The Stephen I. Katz Early Stage Investigator Research Project Grant supports an innovative project that represents a change in research direction for an early stage investigator (ESI) and for which no preliminary data exist. This R01 grant mechanism is specifically designed for ESIs who are embarking on new research directions without prior work in that area. Applications submitted to this Notice of Funding Opportunity (NOFO) must not include preliminary data. Applications must include a separate attachment describing the change in research direction. The program covers multiple health research areas under the National Institutes of Health including cardiovascular diseases, cancer research, diabetes, mental health, infectious diseases, aging research, environmental health, and many other biomedical research fields.
Stimulating Access to Research in Residency (StARR) (R38 Independent Clinical Trial Not Allowed)
The overall goal of the Stimulating Access to Research in Residency (StARR) program is to provide resident clinicians in training with in-depth research experiences early in their careers, in order to recruit, retain and accelerate independence of a pool of clinician-investigators with both clinical and research experience necessary to perform basic, clinical and/or translational research. This NIH program aims to support physician trainees during their residency to develop strong research foundations. The program facilitates the development of clinician-investigators who can bridge clinical practice with scientific research, addressing critical healthcare challenges through evidence-based inquiry. By providing protected research time and support during residency training, the StARR program helps establish a pipeline of physician-scientists capable of conducting impactful biomedical research.
Native American Research Centers for Health (NARCH) Planning Grants (R34 - Clinical Trial Not Allowed)
The Native American Research Centers for Health (NARCH) Planning Grants program supports federally recognized American Indian/Alaska Native (AI/AN) Tribes, Tribal colleges and universities, Tribal health programs, or Tribal organizations to plan and conduct preparatory work for developing competitive NARCH applications. This R34 planning grant mechanism is designed to help eligible AI/AN Tribal entities strengthen their research capacity and prepare for future health research center applications. The program aims to build research infrastructure and capacity within Tribal communities to address health disparities and improve health outcomes for Native American populations.
NIA Expanding Research in AD/ADRD (ERA) Postbaccalaureate Research Education Program (R25 Independent Clinical Trial Not Allowed)
This Notice of Funding Opportunity Announcement (NOFO) invites R25 applications to support the development and implementation of research education programs for recent baccalaureates from all backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences. It is essential to expand and broaden the skilled Alzheimer's Disease (AD) and Alzheimer's Disease and Related Dementias (ADRD) research workforce and provide exposure to AD/ADRD research to individuals early in their careers. The proposed research education programs will support intensive research experiences in the AD/ADRD field with the goal of preparing recent baccalaureates to transition into strong, research-focused advanced degree programs or competitive private sector research careers in AD-related disciplines. This grant supports the development of research education programs specifically targeting recent college graduates to build capacity in Alzheimer's disease and related dementias research, with emphasis on recruiting individuals from underrepresented backgrounds in biomedical and behavioral sciences.
NIA Expanding Research in AD/ADRD (ERA) Summer Research Education Program (R25 Independent Clinical Trial Not Allowed)
This Notice of Funding Opportunity (NOFO) invites R25 applications to support the development and implementation of summer research education programs for high school students, undergraduates, or science teachers from all backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences. It is essential to expand and broaden the skilled Alzheimer's Disease (AD) and Alzheimers Disease Related Dementias (ADRD) research workforce and provide exposure to AD/ADRD research to individuals early in their careers. The proposed research education programs will support intensive summer research experiences in the AD/ADRD field with the goal of exposing participants to AD/ADRD research and encourage further study or participation in biomedical and behavioral research. This NOFO does not allow participants to lead an independent clinical trial, but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor.
Development of Interventions to Prevent and Treat Substance Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)
The purpose of this Funding Opportunity (NOFO) is to solicit grant applications to support research on the discovery and development of interventions to prevent and/or treat substance use disorders (SUDs) and overdose, including medications and medical devices to treat co-morbid SUDs. This includes preclinical and clinical research studies that will have high impact and quickly yield the necessary results to advance candidate interventions closer to regulatory approval or clinical adoption. This NOFO will utilize the UG3/UH3 activity code. The program focuses on advancing candidate interventions through regulatory pathways, emphasizing both prevention and treatment approaches for substance use disorders and overdose. The cooperative agreement mechanism allows for substantial NIH involvement in the project.
NIDCD Clinical Research Center Grant (P50 Clinical Trial Optional)
The National Institute on Deafness and Other Communication Disorders (NIDCD) invites applications for Clinical Research Center Grants designed to advance the diagnosis, prevention, treatment, and amelioration of human sensory and communication disorders. For this announcement, Clinical Research is defined as research involving individuals with a sensory and/or communication disorder, or data/tissues from individuals with a sensory and/or communication disorder. Examples of such research include but are not limited to, studies of the prevention, pathogenesis, pathophysiology, diagnosis, treatment, management or epidemiology of a disease or disorder of hearing, balance, smell, taste, voice, speech, or language. Although the intent is that all the research will involve individuals with sensory and/or communication disorders or data/tissues from individuals with sensory and/or communication disorders, when the clinical research goal(s) warrant(s) limited departures from this intent, alternatives are possible with appropriate and strong scientific justification and in consultation with NIDCD staff. Applications may propose a low-risk clinical trial but are not required to (optional).
BRAIN Initiative: Theories, Models and Methods for Analysis of Complex Data from the Brain (R01 Clinical Trial Not Allowed)
The Theories, Models and Methods (TMM) initiative supports the development of computational tools for understanding dynamic brain circuits that are made broadly accessible to the greater research community. This program supports applications focused on tool building and dissemination in the domain of theories about neural circuit mechanisms, models of circuit structure and function, and computational methods of analysis spanning across scales from neurons to behavior. The development of novel theories, computational models and methods for understanding brain function will help characterize fundamental principles of brain function and organization, characterize cellular and circuit-level neural computations over time in different regions, and understand how interactions of multiple brain circuits enable flexible behaviors and contribute to brain-wide neural dynamics. These tools will be critical for developing treatments such as closed loop systems for brain disorders including Parkinson's disease and major depressive disorder.
Community-Partnered Nursing Research Centers (P20 Clinical Trial Optional)
The purpose of this initiative is to support the development of innovative research centers to foster nursing-led programs that promote community-partnered research to address persistent health challenges. Center applications developed in response to this RFA should propose strategies to strengthen the research infrastructure by establishing or expanding centralized research resources in School or College of Nursing (SON/CON), developing and enhancing nurse-led interdisciplinary teams, and building expertise in community-partnered research through conducting pilot research that applies NINR's research lenses. Center strategies should be informed by NINR's mission and should meaningfully engage the community throughout all activities. This P20 program aims to build nursing research capacity and infrastructure while fostering collaborative partnerships between academic nursing programs and their communities to advance health equity and address persistent health disparities.
Advancing Research on the Application of Digital Health Technology to the Management of Type 2 Diabetes (R01- Clinical Trail Required)
This notice of funding opportunity (NOFO) invites applications designed to examine the efficacy and clinical effectiveness of multimodality digital health technology approaches to the remote management of diabetes. The program seeks to advance research on digital health technologies that can improve diabetes management and patient outcomes. This R01 grant mechanism is designed to support research projects with clinical trial requirements, focusing on innovative approaches to diabetes care using digital health tools. The funding supports comprehensive research initiatives that evaluate the effectiveness of digital health interventions in managing Type 2 Diabetes.
NHLBI TOPMed: Omics Phenotypes of Heart, Lung, and Blood Disorders (X01 - Clinical Trial Not Allowed)
This Notice of Funding Opportunity (NOFO) invites applications to use NHLBI-funded TransOmics for Precision Medicine (TOPMed) program to generate a large volume of integrated genetic and multi-omics data to facilitate discovery of the molecular mechanisms of Heart, Lung, Blood, and Sleep (HLBS) disorders. No funding will be provided under this NOFO. The genomic data and related phenotypic data will be deposited in a public NIH-designated controlled-access database such as the database for Genotypes and Phenotypes (dbGaP) and NHLBIs BioData Catalyst (BDC). The overall goal is to move from simply cataloguing genetic associations to understanding how genetic factors contribute to HLBS diseases at the molecular and cellular levels. This transformation will help move TOPMed from genetic Map to Mechanism with potential applications of AI and ML tool sets where possible, enabling functional genomics research that will accelerate mechanistic personalized medicine.
Clinical Trial Readiness for Rare Diseases, Disorders, and Syndromes (R21 Clinical Trial Not Allowed)
This Notice of Funding Opportunity (NOFO) invites researchers to submit applications for support of clinical projects that address critical needs for clinical trial readiness in rare diseases. The initiative seeks applications that are intended to facilitate rare diseases research by enabling efficient and effective movement of candidate therapeutics or diagnostics toward clinical trials, and to increase their likelihood of success. This could be through the development and testing of rigorous biomarkers and clinical outcome assessment measures, or by defining the presentation and course of a rare disease to enable the design of upcoming clinical trials. The program supports projects that prepare the groundwork for future clinical trials in rare disease populations, focusing on pre-clinical trial activities rather than conducting actual clinical trials. Eligible applicants include a wide range of organizations including educational institutions, government entities, nonprofits, and for-profit organizations, though foreign entities are not eligible.
Mind and Body Interventions to Restore Whole Person Health via Emotional Well-Being Mechanisms (R61/R33 Clinical Trial Required)
The National Center for Complementary and Integrative Health (NCCIH) announces this Notice of Funding Opportunity (NOFO) to solicit applications for research on how mind and body interventions through psychological and/or physical inputs (e.g., mindfulness meditation, yoga, acupuncture, massage, and other brain and/or body based interventions) impact mechanisms of emotional well-being (EWB) and their associations with whole person health (WPH), consistent with the NIH priority to address the health needs of the American people and improve their well-being. The NOFO will support rigorous and well-powered mechanistic research studies that are supported by strong preliminary data. The studies should examine the effects of mind and body interventions on innovative mechanisms of EWB (as the primary outcome), as well as the associated relationship with the Whole Person Health Index (WPHI, as a secondary outcome). To enhance research safety, rigor, and efficiency of NIH-funded mechanistic clinical trials, this initiative will use a two-phased award funding mechanism (R61/R33). The funding will support an initial phase (R61) to establish feasibility benchmarks for the proposed mechanistic clinical trial(s), followed by a second phase (R33) to complete the full-scale trials, which will be contingent upon successful completion of R61 milestones. Applications should provide preliminary data that are comparable in quality and quantity to those expected for an R01 proposal.
Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
Current recipients of specific types of NIH research grants may apply for administrative supplements to provide additional funding to a currently funded grant to meet increased costs that are within the scope of the peer-reviewed and approved project, but that were unforeseen when the new or competing renewal application was awarded. Applications for administrative supplements are considered prior approval requests and will be routed directly to the Grants Management Officer of the parent award. There is no guarantee that funds are available from the awarding IC or for any specific grant. Therefore, prior to submission, applicants must discuss potential requests with the awarding ICO grants and program officials. The proposed supplement must provide for an increase in costs due to unforeseen circumstances, and all additional costs must be within the scope of the peer reviewed and approved project. To be eligible, the parent award must be active (not in a cost extension), and the research proposed in the supplement must be accomplished within the competitive segment.
Cancer Center Support Grants (CCSGs) for NCI-designated Cancer Centers (P30 Clinical Trial Optional)
This Notice of Funding Opportunity (NOFO) invites applications for P30 Cancer Center Support Grants (CCSGs) to support NCI-Designated Cancer Centers. CCSGs support three types of Cancer Centers: 1) Comprehensive Cancer Centers, which demonstrate reasonable depth and breadth of research activities in each of three major areas: basic laboratory; clinical; and prevention, control and population-based research, and which have substantial transdisciplinary research that bridges these scientific areas; 2) Clinical Cancer Centers, which are primarily focused on basic laboratory; clinical; and prevention, cancer control, and population-based research; or some combination of these areas, and 3) Basic Cancer Centers, which focus on basic laboratory research. The purpose of all types of NCI-Designated Cancer Centers is to capitalize on all institutional cancer research capabilities, integrating meritorious research into a single transdisciplinary research enterprise across all institutional boundaries. Cancer Centers supported through this NOFO are expected to serve as major sources of discovery of the nature of cancer and of development of more effective approaches to prevention, diagnosis, and therapy; to contribute significantly to the development of Shared Resources that support research; to collaborate and coordinate their research efforts with other NCI-funded programs and investigators; and to disseminate research findings for the benefit of the community. For New (Type 1) applications, institutions must have a funding base of $10,000,000 (Clinical Cancer Centers) or $6,000,000 (Basic Cancer Centers) in annual direct costs of NIH cancer-focused funding. For Renewal (Type 2) applications, institutions must have a funding base of at least $10,000,000 in annual direct costs of peer-reviewed, cancer-related funding. The grant supports transdisciplinary cancer research programs that integrate institutional capabilities and contribute to cancer research advancement.
Resource-Related Research Projects for Development of Models and Related Materials for Studying Human Health and Diseases (R24 Clinical Trials Not Allowed)
The Office of Research Infrastructure Programs (ORIP) encourages grant applications aimed at developing, characterizing, or improving research models of human health and diseases; developing biology based new approach methodologies (NAMs) applicable to human health and diseases; or improving access to information about or generated from the use of models of human disease. The models, including NAMs, and related biological materials developed must be broadly applicable to the scientific interests of two or more NIH Institutes or Centers (ICs) and must evaluate diseases and processes that impact multiple organ systems in order to align with the ORIP's NIH-wide mission and programs. Applications must describe the need for and the potential impact of the proposed resources on the research community across a range of scientific disciplines supported by multiple NIH ICs. Applications to develop models that relate strictly to a specific disease or a select area of research or that do not have a broad impact on the NIH-wide research community will not be accepted. Projects that predominantly address the research interests of one NIH IC but are only peripherally related to the research interests of other ICs will also not be accepted.
Informatics, Coordination and Service Center for the Mutant Mouse Resource and Research Centers (U42 Clinical Trial Not Allowed)
This Notice of Funding Opportunity provides continuing support for the Informatics, Coordination and Service Center (ICSC) unit of the Mutant Mouse Resource and Research Centers (MMRRC) consortium. The ICSC is expected to provide informatics and coordinating services to the MMRRC consortium and biomedical researchers. Important functions include improvement, development, and maintenance of the Consortium's in-house data management systems in a format that may facilitate their integration with other animal and non-animal resource databases and community standards for information accessibility and interoperability. Additional services include maintenance and further development of a public website portal and Customer Service Center; operation of the order processing system; review and processing of applications from donating investigators; facilitation of interactions with biomedical investigators, informatics services, database activities, and the archive of MMRRC documents and files; coordination of requests to donate and order mouse strains; oversight of marketing efforts; and completion of monthly and yearly metrics reports. The ICSC will host and actively participate in the monthly teleconference, annual consortium meeting, and compose reports and summaries from these forums as requested by MMRRC consortium members or NIH staff. Of special interest is the Center's close coordination with efforts to develop new approach methodologies (NAMs) that complement traditional animal-based research, including cell culture, organoids, computational models, and microphysiological systems. Proposed activities should include collection and analysis of comparative information on the use of NAMs that enhance the predictive power of human disease models and support their integration with traditional models.
Animal and Biological Material Resource Centers (P40 Clinical Trial Not Allowed)
This Notice of Funding Opportunity (NOFO) encourages grant applications for Animal and Biological Material Resource Centers. These Centers provide support for special colonies of laboratory animals and associated services, as well as other resources such as informatics tools, reagents, cultures (cells, tissues, and organs) and genetic stocks that serve the biomedical research community in a variety of research areas on a local, regional, and national basis. The goal of projects supported by this NOFO is to provide research resources that facilitate optimization and enhancement of scientific rigor, transparency, and experimental reproducibility of biomedical research. Proposed Animal and Biological Material Resource Centers must have broad application to multiple NIH Institutes or Centers (ICs) to align with the ORIP's NIH-wide mission. This funding opportunity is designed to support both continuation of existing resources and to develop new ones when appropriate. Of special interest is a requirement of the Center's close coordination with efforts to develop new approach methodologies (NAMs) that complement traditional animal-based research. These include cell culture, organoids, computational models, and microphysiological systems. Applied Research Component should include studies to generate comparative data to increase applicability of NAMs and promote integration of the most predictive human disease models.
Limited Competition Renewal for the Continuation of the Liver Cirrhosis Network: Clinical Research Centers (U01 Clinical Trial Required)
This is a Notice of Funding Opportunity (NOFO) for a Limited Competition that will invite applications from eligible organizations to apply. The program is designed to support the continuation of the Liver Cirrhosis Network Clinical Research Centers. This limited competition funding opportunity is intended to fund organizations who are current grant recipients of RFA-DK-20-003. In accordance with NIH standard peer-review processes, the applications will be peer-reviewed, and only meritorious applications will be considered. The program requires clinical trials and is funded through cooperative agreements, allowing for substantial NIH involvement in the conduct of the research. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) will support clinical research centers focused on liver cirrhosis research. Eligible organizations include a broad range of entities including for-profit businesses, nonprofits, educational institutions, and government entities, though foreign organizations are not eligible to apply.
Opportunities for Collaborative Research at the NIH Clinical Center (U01 Clinical Trial Optional)
The goal of this program is to support collaborative translational research projects aligned with NIH efforts to enhance the translation of basic biological discoveries into clinical applications that improve health. It encourages high quality science demonstrating the potential to result in understanding an important disease process or lead to new therapeutic interventions, diagnostics, or prevention strategies within the research interests and priorities of the participating NIH Institutes/Centers. The program seeks to broaden and strengthen translational research collaborations between basic and clinical researchers both within and outside NIH to accelerate and enhance translational science by promoting partnerships between NIH intramural investigators and extramural investigators. It provides support for extramural investigators to take advantage of the unique research opportunities available at the NIH Clinical Center by conducting clinical research projects in collaboration with NIH intramural investigators.
Institutional Network Award for Promoting Kidney, Urologic, and Hematologic Research Training (U2C - Clinical Trial Not Allowed)
Responding to the needs of the scientific community to bolster a vibrant and sustainable research workforce, the Division of Kidney, Urologic, and Hematologic Diseases (KUH) at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has incorporated additional flexibilities for institutional training programs serving the mission interests of non-malignant kidney, urologic, and hematologic diseases, encompassing both adult and pediatric conditions. The purpose of this notice of funding opportunity is to invite applications for Institutional Network Awards (U2C-TL1) to recruit, train, and retain the next generation of researchers and provide them with the coordinated support, resources, and networks they need to succeed and lead. To maximize integration and promote a highly connected trainee community, institutions are invited to submit a single, unified U2C-TL1 application. Representation across all kidney, urologic, and hematologic disciplines is not expected or required. If feasible, applications may include multiple departments within and across institutions. It is expected that each U2C-TL1 award will actively participate in the Kidney, Urology and Hematology Research-Training Network (KUHR-TN), a nationwide coalition of individual U2C-TL1 awards.
Maximizing Investigators' Research Award (MIRA) (R35 - Clinical Trial Optional)
The Maximizing Investigators' Research Award (MIRA) provides support for individual investigators for research within the scientific mission of NIGMS via a single grant. The program aims to increase the stability of funding for NIGMS-supported investigators, enhancing their ability to take on ambitious scientific projects and approach problems more creatively. It also increases flexibility for investigators to follow important new research directions within the NIGMS mission as opportunities arise, rather than being bound to specific aims proposed in advance of the studies. MIRA seeks to more widely distribute funding among the nation's highly talented and promising investigators to increase overall scientific productivity and the chances for important breakthroughs. The program is designed to reduce the time spent by researchers writing and reviewing grant applications, allowing them to spend more time conducting research, and to reduce the administrative burden associated with managing multiple NIGMS research grants. This NOFO invites applications from eligible NIGMS-funded investigators and from New Investigators proposing research that is aligned with NIGMS' scientific mission. The NOFO also allows renewal applications from all current MIRA grantees (including those previously funded as Early-Stage Investigators). The program enables investigators to devote more time and energy to mentoring junior scientists in a more stable research environment.
NIGMS Institutional Biomedical Undergraduate Research Training (BURT) Program (T34)
The goal of the Institutional Biomedical Undergraduate Research Training (BURT) program is to strengthen research training environments and develop a pool of well-trained students who complete their baccalaureate degrees in biomedically-related fields and transition into and complete biomedical, research-focused higher degree programs (such as Ph.D. or M.D./Ph.D.). This funding announcement provides support to eligible, domestic organizations to develop and implement effective, evidence-informed approaches to biomedical undergraduate training and mentoring to help build a strong biomedical research workforce for the nation. Applicant organizations must enroll undergraduate students and have received NIH Research Project Grant (RPG) funding averaging less than $50 million in total costs per year over the last three fiscal years. The program accepts applications in two tracks: Single Site (to support trainees from a single baccalaureate-degree granting organization) and Community College Partnerships (to support community college trainee development through collaborations between at least one associate-degree granting organization and at least one baccalaureate-degree granting organization). The proposed research training programs will incorporate didactic, research, and career development elements to prepare trainees for careers that will have a significant impact on the health-related research needs of the nation. This is a training grant program (T34) offered through the National Institute of General Medical Sciences (NIGMS) at the National Institutes of Health.
Single Source Renewal for the Continuation of the Liver Cirrhosis Network: Scientific and Data Coordination Center (U24 Clinical Trial Optional)
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) is seeking a Single Source renewal application to continue scientific service as the Scientific and Data Coordination Center for the Liver Cirrhosis Network. This Notice of Funding Opportunity (NOFO) invites applications from an eligible organization to apply. The application will undergo peer-review and will only be funded if it is meritorious. In accordance with NIH standard peer-review processes, only meritorious applications will be considered for funding. This is a cooperative agreement with an expected award amount of $1,850,000 for one recipient.
NIH Collaborative International Research Project (Parent PF5 Clinical Trial Optional)
The National Institutes of Health (NIH) seeks to advance its mission by maintaining strong, productive, and secure international research collaborations in support of the NIH mission. The NIH Collaborative International Research Project (Parent Announcement) supports international research collaborations. This opportunity specifically implements an award structure of prime domestic awards with independent foreign awards that are linked to the prime. This structure provides NIH with oversight capacity for international collaborations, and allows NIH to track international funding. This funding opportunity is specifically designed for NIH to support funded international collaborations between a domestic prime organization and foreign organizations. All collaborative international research project applications must include at least 1 international subproject. The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes, Centers and Offices (ICOs) based on their scientific missions. The application will be evaluated as a whole, and the international subproject(s) will be evaluated on whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing United States resources, and whether the proposed project has specific relevance to the mission and objectives of the ICO and has the potential for significantly advancing the health sciences in the United States.
Pilot Projects Enhancing Utility and Usage of Common Fund Data Sets (R03 Clinical Trial Not Allowed)
This funding opportunity from the National Institutes of Health aims to support projects that demonstrate and enhance the utility of selected Common Fund data sets. Many valuable and widely available data sets have been generated by multiple Common Fund programs. The purpose of this NOFO is to announce the availability of funding to demonstrate and enhance the utility of these data resources, including generating hypotheses and catalyzing discoveries. Award recipients are expected to provide feedback on the utility of the Common Fund data resources. The program seeks to maximize the value of existing Common Fund data sets and promote their use in advancing biomedical research. Projects should focus on innovative approaches to analyzing, integrating, or applying these data sets to generate new insights and scientific discoveries.
The Metastasis Research Network (MetNet): MetNet Research Projects (U01 Clinical Trial Not Allowed)
The National Cancer Institute's (NCI) Metastasis Research Network (MetNet) is a collection of U54 Research Centers that support using systems-level approaches to understand pressing questions in metastasis. The overall goal of the MetNet is to advance our understanding of metastasis as a whole body, systems-level problem to develop a comprehensive and cohesive picture of the processes involved. Through this Notice of Funding Opportunity (NOFO), the NCI invites applications for MetNet Research Projects. These Research Projects should be defined as discrete entities that use systems-level approaches to address gaps and opportunities in metastasis research to integrate into the MetNet and complement ongoing research across the Network. This cooperative agreement funding opportunity supports research that advances understanding of metastasis through systems-level approaches and integrates with the broader MetNet research network.
National Centers for Cryo-electron Tomography (cryoET) (R24 -Clinical Trial Not Allowed)
This Notice of Funding Opportunity (NOFO) is for support of National Centers for Cryoelectron Tomography (CryoET) to provide nationwide access to advanced cryoET instrumentation and technical support, and to assist investigators in acquiring the skills needed to perform cryoET studies. The program aims to establish centers that will serve the research community by offering access to cutting-edge cryo-electron tomography technology and expertise. These centers will support investigators across the nation in conducting advanced structural biology research using cryoET techniques. The funding is provided through the R24 mechanism and clinical trials are not allowed under this opportunity.
BRAIN Initiative: Research Resource Grants for Technology Integration and Dissemination (U24 Clinical Trial Not Allowed)
This notice of funding opportunity (NOFO) supports efforts to disseminate resources for integration into neuroscience research practice. The resource(s) should be relevant to the goals of the BRAIN Initiative as outlined in 'BRAIN 2025: A Scientific Vision' and 'The BRAIN Initiative 2.0: From Cells to Circuits, Toward Cures' and shared broadly to the neuroscience community. The resource(s) should address compelling needs of neuroscience researchers that are otherwise unavailable or impractical in their current form. Activities must include dissemination of an existing resource, and may include one or more of the following: distribution of tools and reagents; user training on the usage of new technologies or techniques; providing access to existing technology platforms and/or specialized facilities; minor improvements to increase the scale/efficiency of resource production and delivery; minor adaptations to meet the needs of a user community.
Impact of Initial Influenza Exposure on Immunity in Infants (U01 Clinical Trial Not Allowed)
The purpose of this notice of funding opportunity (NOFO) is to support the establishment or continuation of longitudinal infant cohorts to determine and compare how initial and repeated natural influenza infections and/or influenza vaccinations shape infant and childhood immunity to future influenza exposures. The goal of this research is to understand how these exposures influence immune responses to subsequent influenza infections and/or vaccines and provide key information to facilitate design of durable, broadly protective influenza vaccines. This cooperative agreement supports research into influenza immunity development in infants and children through longitudinal cohort studies.
Advancing Bioinformatics, Translational Bioinformatics and Computational Biology Research (R01 Clinical Trial Optional)
The National Library of Medicine (NLM) seeks applications for research projects that drive groundbreaking innovation and advanced development in the fields of bioinformatics, translational bioinformatics, and computational biology. The primary goal of this initiative is to support the creation and implementation of cutting-edge methods, tools, and approaches that can transform the landscape of biomedical data science. This NOFO aims to address the growing need to leverage transformative technologies — such as artificial intelligence (AI), machine learning, and large-scale computational platforms — to extract actionable knowledge from vast, diverse, and complex biological datasets. By enabling more effective interpretation and integration of multi-dimensional biological and biomedical data, this research will ultimately contribute to improving individual and population health outcomes.
Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)
This Notice of Funding Opportunity (NOFO) supports applications to develop and conduct investigator-initiated single site clinical trials including efficacy, comparative effectiveness, pragmatic and/or dissemination and implementation science clinical trials. Trials using innovative designs such as platform trials, adaptive, and Bayesian designs are encouraged. These trials may include ones that test different therapeutic, behavioral, dissemination and implementation science clinical trials and/or prevention strategies. Trials must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial. This NOFO utilizes a bi-phasic, milestone-driven mechanism of award. The objective of the application is to present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes it. The application should address project management, participant recruitment and retention, performance milestones, scientific conduct of the trial, and dissemination of results. The multiple PD/PI model is strongly encouraged but not required. Applicants are encouraged to include a PD/PI with expertise in biostatistics, clinical trial design, and coordination.
Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required)
This Notice of Funding Opportunity (NOFO) supports applications for a collaborating Data Coordinating Center (DCC) for investigator-initiated multi-site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. Trials using innovative designs such as platform trials, adaptive, and Bayesian designs are encouraged. These trials may include ones that test different therapeutic, behavioral, and/or prevention strategies. The NOFO utilizes a milestone-driven cooperative agreement mechanism of award and runs in parallel with a companion NOFO for a collaborating Clinical Coordinating Center (CCC). The objective of the DCC application is to present a comprehensive plan to provide overall project coordination, administration, data management, and biostatistical support for the clinical trial proposed in the collaborating CCC application. The application should also describe its approaches to collaborate with the CCC on implementation of the clinical trial community engagement plan. Both a DCC application and a collaborating CCC application must be submitted on the same application due date for consideration by NHLBI.
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- Active Now
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- Source Domain
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