National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute of Nursing Research (NINR)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Human Genome Research Institute (NHGRI)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
National Center of Complementary and Intergrative Health (NCCIH)
National Eye Institute(NEI))
National Institute on Aging (NIA)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Participation Added March 6, 2024 (NOT-AR-24-014)
R01 Research Project Grant
- November 07, 2024 - This PAR has been reissued as PAS-25-190.
- April 3, 2024 - Notice of NIAMS' Participation in "PAR-22-181, Research Opportunities for New and "At-Risk" Investigators to Promote Workforce Diversity (R01 Clinical Trial Optional)". See Notice NOT-AR-24-014
- March 6, 2024 - Notice of Clarification of NIMH Specific Areas of Research Interest in PAR-22-181 Research Opportunities for New and "At-Risk" Investigators to Promote Workforce Diversity (R01 Clinical Trial Optional). See Notice NOT-MH-24-375
- August 11, 2023 - Notice of Correction to Other Submission Requirements and Information in PAR-22-181. See Notice NOT-NS-23-106.
- April 28, 2023 - Notice of Correction to NCCIH Specific Areas of Research Interest in PAR-22-181. See Notice NOT-AT-24-005.
- April 25, 2023 - Notice of NHGRI Participation in PAR-22-181, "Research Opportunities for New and "At-Risk" Investigators to Promote Workforce Diversity (R01 Clinical Trial Optional) . See Notice NOT-HG-23-040
- April 25, 2023 - Notice of Early Expiration of RFA-HG-21-041 "New Investigators to Promote Workforce Diversity in Genomics, Bioinformatics, or Bioengineering and Biomedical Imaging Research (R01 Clinical Trial Optional)". See Notice NOT-HG-23-039
- April 20, 2023 - Notice of Participation of the National Institute on Aging (NIA) in PAR-22-181, "Research Opportunities for New and "At-Risk" Investigators to Promote Workforce Diversity (R01 Clinical Trial Optional)". See Notice NOT-AG-23-021
- January 5, 2023 - Notice of NIBIB’s Withdrawal form Participation in RFA-HG-21-041 New Investigators to Promote Workforce Diversity in Genomics, Bioinformatics, or Bioengineering and Biomedical Imaging Research (R01 Clinical Trial Optional). . See Notice NOT-EB-22-014
- January 5, 2023 - Notice of NIBIB's Participation in PAR-22-181, " NCCIH, NEI, NIAAA, NIDA, NIMH, NINR, and NINDS Research Opportunities for New and "At-Risk" Investigators to Promote Workforce Diversity (R01 Clinical Trial Optional) . See Notice NOT-EB-22-015
- NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available
- October 14, 2022 - Notice of Change to the Expiration date for PAR-22-181 "NCCIH, NEI, NIAAA, NIDA, NIMH, NINR, and NINDS Research Opportunities for New and "At-Risk" Investigators to Promote Workforce Diversity (R01 Clinical Trial Optional)". See Notice NOT-NS-23-033
- September 20, 2022 - Notice of Change to Key Dates for PAR-22-181 "NIDA, NIMH, NINR, and NINDS Research Opportunities for New and "At-Risk" Investigators to Promote Workforce Diversity (R01 Clinical Trial Optional)". See Notice NOT-NS-23-027
- September 14, 2022 - Notice of NEI Participation in PAR-22-181. See Notice NOT-EY-22-016
- September 14, 20-22 - Notice of Change to the title of PAR-22-181. See Notice NOT-NS-23-024
- September 14, 20-22 - Notice of NIAAA Participation in PAR-22-181, "NIDA, NIMH, NINR, and NINDS Research Opportunities for New and "At-Risk" Investigators to Promote Workforce Diversity (R01 Clinical Trial Optional)". See Notice NOT-AA-22-015
- NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
- September 7, 2022 - Notice of NCCIH Participation in PAR-22-181, "NIDA, NIMH, NINR, and NINDS Research Opportunities for New and "At-Risk" Investigators to Promote Workforce Diversity (R01 Clinical Trial Optional)" . See Notice NOT-AT-22-030
- August 4, 2022 - Notice of NINR Participation in PAR-22-181, "NIDA, NIMH, and NINDS Research Opportunities for New and "At-Risk" Investigators to Promote Workforce Diversity (R01 Clinical Trial Optional)". See Notice NOT-NR-22-016
- August 4, 2022 - Notice of Change to the title of PAR-22-181, "NIDA, NIMH, and NINDS Research Opportunities for New and "At-Risk" Investigators to Promote Workforce Diversity (R01 Clinical Trial Optional)". See Notice NOT-NS-22-111
See Notices of Special Interest associated with this funding opportunity
This Funding Opportunity Announcement (FOA) solicits R01 grant applications that propose independent research projects that are within the scientific mission areas of the participating NIH Institutes or Centers. This program is intended to support New Investigators and At-Risk Investigators from diverse backgrounds, including those from groups underrepresented in the health-related sciences. Investigators from diverse backgrounds, including those from underrepresented groups (e.g., see NOT-OD-20-031, Notice of NIH’s Interest in Diversity), are encouraged to work with their institutions to apply for support under this program. Investigators from categories A and B are particularly encouraged to work with their institutions to apply.
Not applicable
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| September 08, 2022 | October 06, 2022 | January 7, 2023 | March 2023 | May 2023 | July 2023 |
| January 06, 2023 | February 07, 2023 | May 7, 2023 | July 2023 | October 2023 | December 2023 |
| May 05, 2023 | June 06, 2023 | September 7, 2023 | November 2023 | January 2024 | April 2024 |
| September 06, 2023 | October 06, 2023 | January 7, 2024 | March 2024 | May 2024 | July 2024 |
| January 09, 2024 | February 06, 2024 | May 7, 2024 | July 2024 | October 2024 | December 2024 |
| May 06, 2024 | June 06, 2024 | September 7, 2024 | November 2024 | January 2025 | April 2025 |
| September 06, 2024 | October 08, 2024 | January 7, 2025 | March 2025 | May 2025 | July 2025 |
| January 08, 2025 | February 06, 2025 | May 7, 2025 | July 2025 | October 2025 | December 2025 |
| May 05, 2025 | June 06, 2025 | September 7, 2025 | November 2025 | January 2026 | April 2026 |
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
- Use the NIH ASSIST system to prepare, submit and track your application online.
- Use an institutional system-to-system (S2S) solution to prepare and submit your application
to Grants.gov and eRA Commons to track your
application. Check with your institutional officials regarding availability.
- Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
Background
The National Institutes of Health (NIH) recognizes the need to diversify the scientific workforce by enhancing the participation of individuals from diverse backgrounds, including those from groups identified as underrepresented (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html) in the biomedical, clinical, behavioral and social sciences research workforce.
Diversity at all levels from the kinds of science to the regions in which it is conducted to the backgrounds of the people conducting it contributes to excellence in research training environments and strengthens the research enterprise.
Need for the Program
NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce. NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from minority and other health disparity populations into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities. For more information, see Notice of NIH's Interest in Diversity, NOT-OD- 20-031(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html).
Notice of NIH's Interest in Diversity
Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further the NIH mission.
Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.
Underrepresented Populations in the U.S. Biomedical, Clinical, Behavioral and Social Sciences Research Enterprise
In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral and social sciences, such as:
A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis
(see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27) and the report Women, Minorities, and Persons with Disabilities in Science and Engineering (http://www.nsf.gov/statistics/women/). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be demonstrated convincingly to be underrepresented by the grantee institution should be encouraged to participate in this opportunity. For more information on racial and ethnic categories and definitions, see the OMB Revisions to the Standards for Classification of Federal Data on Race and Ethnicity (https://obamawhitehouse.archives.gov/omb/fedreg_1997standards).
B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended (http://www.ada.gov/pubs/adastatute08.htm). See NSF data at, https://www.nsf.gov/statistics/2017/nsf17310/static/data/tab7-5.pdf.
C. Individuals from disadvantaged backgrounds, defined as those who meet two or more of the following criteria:
1. Were or currently are homeless, as defined by the McKinney-Vento Homeless Assistance Act (Definition: https://nche.ed.gov/mckinney-vento/);
2. Were or currently are in the foster care system, as defined by the Administration for Children and Families (Definition: https://www.acf.hhs.gov/cb/focus-areas/fostercare;
3. Were eligible for the Federal Free and Reduced Lunch Program for two or more years (Definition: https://www.fns.usda.gov/school-meals/income-eligibility-guidelines);
4. Have/had no parents or legal guardians who completed a bachelor’s degree (see https://nces.ed.gov/pubs2018/2018009.pdf);
5. Were or currently are eligible for Federal Pell grants (Definition: https://www2.ed.gov/programs/fpg/eligibility.html);
6. Received support from the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) as a parent or child (Definition: https://www.fns.usda.gov/wic/wic-eligibility-requirements).
7. Grew up in one of the following areas: a) a U.S. rural area, as designated by the Health Resources and Services Administration (HRSA) Rural Health Grants Eligibility Analyzer (https://data.hrsa.gov/tools/rural-health), or b) a Centers for Medicare and Medicaid Services-designated Low-Income and Health Professional Shortage Areas (https://www.qhpcertification.cms.gov/s/LowIncomeandHPSAZipCodeListingPY2020.xlsx?v=1) (qualifying zip codes are included in the file). Only one of the two possibilities in #7 can be used as a criterion for the disadvantaged background definition.
D. Literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields. (See
e.g., From the NIH: A Systems Approach to Increasing the Diversity of Biomedical Research Workforce (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5008902/). Women have been shown to be underrepresented in doctorate-granting research institutions at senior faculty levels in most biomedical-relevant disciplines, and may also be underrepresented at other faculty levels in some scientific disciplines (See data from the National Science Foundation National Center for Science and Engineering
Statistics: Women, Minorities, and Persons with Disabilities in Science and Engineering, special report available at https://www.nsf.gov/statistics/2017/nsf17310/, especially Table 9-23, describing science, engineering, and health doctorate holders employed in universities and 4-year colleges, by broad occupation, sex, years since doctorate, and faculty rank).
Upon review of NSF data, and scientific discipline or field related data, NIH encourages institutions to consider women for faculty-level, diversity-targeted programs to address faculty recruitment, appointment, retention or advancement.
Proposed Scope and Objectives:
Section 404M of the Public Health Service Act (added by Section 2021 in Title II, Subtitle C, of the 21st Century Cures Act, P.L. 114-255, enacted December 13, 2016), entitled, Investing in the Next Generation of Researchers, established the Next Generation Researchers Initiative within the Office of the NIH Director. This initiative is intended to promote and provide opportunities for new researchers and earlier research independence, and to maintain the careers of at-risk investigators. In particular, subsection (b) requires the Director to Develop, modify, or prioritize policies, as needed, within the National Institutes of Health to promote opportunities for new researchers and earlier research independence, such as policies to increase opportunities for new researchers to receive funding, enhance training and mentorship programs for researchers, and enhance workforce diversity; and subsection (c) requires the Director to Carry out other activities as appropriate, to promote the development of the next generation of researchers and earlier research independence. See, The NIH Policy Supporting the Next Generation Researchers Initiative (NOT-OD-17-101). The NIH Advisory Committee to the Director (ACD) offered a number of recommendations to NIH on the Next Generation Researchers Initiative". Among those: the Committee recommended special funding consideration for at-risk investigators. These are researchers who developed meritorious applications who would not have significant NIH research funding if the application under consideration is not awarded.
The objective of this program is consistent with the provisions of the 21st Century Cures Act and the recommendations from the NIH ACD and will support research from New Investigators and At-Risk Investigators from diverse backgrounds, including investigators from underrepresented racial and ethnic groups, in order to enhance the diversity of R01-funded investigators. Investigators from diverse backgrounds, including those from underrepresented groups (e.g., see NOT-OD-20-031, Notice of NIH’s Interest in Diversity), are encouraged to work with their institutions to apply for support under this program. Investigators from categories A and B are particularly encouraged to work with their institutions to apply.
Specific Areas of Research Interest:
NIA
The mission of the National Institute on Aging (NIA) is to support and conduct biological, clinical, behavioral, social, and economic research on aging; foster the development of research and clinician scientists in aging; provide research resources to facilitate innovative aging research; and disseminate information about aging and related advances in research to the public, health care professionals, and the scientific community, among a variety of audiences. NIA will support meritorious applications that focus on aging research, in addition to Alzheimer’s disease (AD) and AD-related dementia (ADRD). A strategic priority of NIA is understanding the environmental, sociocultural, behavioral, and biological drivers of health inequities and disparities related to aging as well as AD/ADRD. NIA also supports research to develop strategies for the improvement of health among midlife and older adults, including adults from racial minority groups and other populations that experience health inequities/disparities. Studies that draw data from across the lifespan are especially encouraged and applicants are expected to factor sex as a biological variable into research designs, analyses, and reporting in vertebrate animal and human studies. These priorities are outlined in NIA’s strategic directions for health disparities research and in the AD+ADRD Research Implementation Milestones related to health disparities, as well as reflected within NIA’s Health Disparities framework.
NIDA
NIDA will support applications that address or seek fundamental knowledge related to addiction sciences, including, but not limited to: cellular and molecular neuroscience, neuroimaging, genetics, medication and treatment development, development of new and improved strategies to prevent substance use and its consequences, neuroimmune signaling, neuropathology in brain systems, cognitive processes, population neuroscience, HIV and drugs of abuse (including basic discovery science research as well as applied research on delivery of HIV and substance use prevention and treatment services to persons who use drugs), medication development, epidemiology, identifying the biological, environmental, behavioral, and social causes and consequences of substance use and addiction across the lifespan, and implementation science, including secondary data analysis. In all these and related areas of addiction sciences research, NIDA encourages an emphasis on understanding and addressing health disparities which are experienced by vulnerable populations. Only applications that fall within the scientific mission of NIDA will be considered for funding (https://nida.nih.gov/about-nida/strategic-plan/directors-message).
NIMH
The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. NIMH supports research on topics that include basic neuroscience and behavioral science, and translational application of brain and behavior relationships in healthy and diseased states. Mental disorders may be defined according to existing diagnostic criteria or along dimensions of neurobehavioral functioning according to the NIMH Research Domain Criteria (RDoC) framework. If existing diagnostic criteria are to be used, investigators should include plans for addressing heterogeneity within the diagnostic category or categories. Applications considered for funding by the NIMH must fall within the areas of priority detailed in the NIMH Strategic Plan and the NIMH Strategic Research Priorities. It is recommended that investigators contact NIMH Scientific/Research staff well in advance of submitting applications to discuss the match to NIMH priorities. NIMH supports mechanistic clinical trials that focus on biomarker studies that may provide information about physiological function, target engagement of therapeutics, and/or the impact of therapeutic responses. These types of studies do not have as a primary aim to establish the efficacy or effectiveness of the intervention.
NIMH considers two major categories of mechanistic trials (though there may be others):
- Mechanistic clinical trials using an intervention of known efficacy. These clinical trials utilize an efficacious intervention to investigate the pathophysiology, and/or psychopathology of mental disorders or the mechanisms of therapeutic responses; and to advance biomarkers of basic neurobiological processes. In such studies: (1) the primary aims do not involve establishing efficacy/effectiveness, and (2) the intervention chosen has already been demonstrated to have efficacy.
- Mechanistic clinical trials utilizing an experimental manipulation: These studies utilize experimental manipulation and are primarily focused on understanding brain function in healthy individuals or those with mental disorders by measuring responses to the experimental manipulation. They are not intended to inform on the improvement of the health status of the individual or a group of individuals either by better understanding the mechanism of action of an intervention or a measurable improvement in health.
See the Consolidated Notice on NIMH Clinical Trials Policies, NOT-MH-20-105, for a summary of NIMH’s polices on support for mechanistic clinical trials.
NINDS
NINDS will support applications that address or seek fundamental knowledge about the brain and nervous system by supporting and conducting research on the healthy and diseased brain, spinal cord, and peripheral nerves and to use that knowledge to reduce the burden of neurological disease. NINDS supports basic, translational, and clinical research. NINDS also encourages activities focused on understanding and addressing disparities in neurologic health, healthcare, and health outcomes in disparate populations, including racial and ethnic minorities, the geographically disadvantaged, sex and gender minorities, and others who have been historically underserved, marginalized, and adversely affected by persistent inequality and socioeconomic disadvantage.
Only applications that fall within the scientific mission of the NINDS will be considered for funding (https://www.ninds.nih.gov/About-NINDS/Who-We-Are/Mission) and the NINDS Strategic Plan (https://www.ninds.nih.gov/About-NINDS/Strategic-Plans-Evaluations/Strategic-Plans/NINDS-Strategic-Plan-and-Priorities/Neuroscience-Research).
For applications proposing a clinical trial, note the following definitions and restrictions for this funding announcement:
- Clinical trials are research studies in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. For this funding announcement, only the following types of clinical trials will be supported:
- Mechanistic trials, defined as studies designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention (i.e., HOW an intervention works, but not IF it works or is safe).
- Basic Experimental Studies with Humans (BESH), defined as basic research studies involving humans that seek to understand the fundamental aspects of phenomena.
- Clinical trials that seek to answer specific questions about safety, tolerability, clinical efficacy, effectiveness, clinical management, and/or implementation of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions, preventive, therapeutic, and services interventions will not be supported under this FOA. Please refer to https://www.ninds.nih.gov/Funding/Find-Funding-Opportunities to find the appropriate NIH or NINDS-specific FOA for such clinical trials. In many cases, small interventional trials exploring an intervention are within scope of PAR-21-236: NINDS Exploratory Clinical Trials (U01 Clinical Trial Required). However, applicants are strongly encouraged to speak with the assigned Scientific/Research Contact prior to application.
- For further clarification on how NIH defines the different types of clinical trials, please refer to the following resources:
Applicants are strongly advised to consult with the appropriate IC Scientific/Research staff prior to submitting an application with human subjects to determine the appropriate funding opportunity.
Per NOT-OD-16-011, the NIH expects applicants to apply rigor in designing and performing scientific research according to the NIH Principles and Guidelines for Reporting Preclinical Research.
NINR
The National Institute of Nursing Research (NINR) supports research to solve pressing health challenges and inform practice and policy - optimizing health and advancing health equity into the future. NINR discovers solutions to health challenges through the lenses of health equity, social determinants of health, population and community health, prevention and health promotion, and systems and models of care. Only applications that fall within these areas as detailed in the NINR 2022 2026 Strategic Plan will be considered. Drawing on the strengths of nursing’s holistic, contextualized perspective, core values, and broad reach, NINR funds multilevel and cross-sectoral research that examines the factors that impact health across the many settings in which nurses work, including homes, schools, workplaces, clinics, justice settings, and the community. Observational, intervention, and implementation research are of interest.
NIAAA
NIAAA will support applications that seek fundamental knowledge about the effecrts of alcohol on health and well being, and will apply that knowledge to improve diagnosis, prevention and treatment of alcohol related problems including alcohol use disorder, across the lifespan. NIAAA supports basic, translational and clinical research. Topics of interest include but are not limited to genetics, neuroscience, epidemiology, prevention and treatment of alcohol use disorder and alcohol related health conditions. NIAAAA also encourages activities focused on understanding and addressing disparities in the impact of alcohol use on health, heatlhcare accessand health outcomes in disparate popupulations. This includes racial and ethinc minorties, the geographically disadvantaged, sex and gender minorities and others who have been historically underserved, marginalized and adversely affected by prepsistent inequality and socioeconomic disadvantage.
NCCIH
NCCIH supports research regarding the use of complementary and integrative health approaches including natural products, mind and body interventions, and multicomponent interventions focused on whole person health. NCCIH is also interested in research studying mind and body approaches to manage stress, mild anxiety, or depression, or pain, and to improve adherence to treatment and prevention regimens to promote health outcomes. Natural products include botanicals, pre/probiotics, and products marketed as dietary supplements. Mind and body approaches include various meditation approaches (e.g., mindfulness), hypnosis or guided imagery, meditative movement approaches (e.g., yoga, tai chi, qi-gong), body-based approaches (e.g., spinal manipulation, massage, mobilization, acupuncture), a combination of these approaches (e.g., meditation and yoga, such as in mindfulness-based stress reduction MBSR), or complex interventions including music and art therapy. Research on whole person health includes multicomponent interventions designed to improve health in multiple interconnected domains: biological (including multiple organs and systems), behavioral, social, and environmental. NCCIH will not accept single-site or multi-site efficacy or effectiveness research through this FOA (please see NCCIH Clinical Trial Funding Opportunities instead). Applicants are strongly encouraged to discuss their plans with NCCIH Scientific/Research contact and to consult the NCCIH Strategic Plan to ensure their application addresses NCCIH scientific priorities prior to developing and submitting an application.
NEI
The mission of the National Eye Institute (NEI) is to eliminate vision loss and improve quality of life through vision research. The NEI has framed its current strategic plan around this mission which addresses multiple opportunities as challenges in the vision field.
NEI will support applications that address or seek fundamental knowledge related to vision sciences, including, but not limited to: cellular and molecular neuroscience, imaging, genetics, development, basic/translational research on vision including how the visual system works from the eyes to the brain in health and disease. The overarching goal is to reduce visual impairment and blindness and thus resulting in an improvement in the quality of life for people of all ages. In all these areas and related areas of vision sciences research, NEI encourages an emphasis on understanding and addressing health disparities that are experienced by vulnerable populations.
For this funding opportunity, only the following trials will be supported by NEI.
- Mechanistic trials defined as studies designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention (i.e., HOW an intervention works, but not IF it works or is safe).
- Basic Experimental Studies with Humans (BESH) defined as basic research studies involving humans that seek to understand the fundamental aspects of phenomena.
Clinical trials that seek to answer specific questions about safety, tolerability, clinical efficacy, effectiveness, clinical management, and/or implementation of pharmacologic, biologic, surgical, or device (invasive or non-invasive) interventions, preventive, therapeutic, and services interventions will not be supported under this FOA. Please refer to https://www.nei.nih.gov/grants-and-training/funding-opportunities to find the appropriate NIH or NEI-specific FOA for such clinical trials.
Applications considered for funding by the NEI must fall within the areas of emphasis detailed in the NEI Strategic Plan. (NEI Strategic Plan: Vision for the Future (PDF 22.5 MB)
NHGRI:
Relevance
There are many benefits to fostering a diverse workforce, for example promoting diversity of scientific ideas, understanding different perspectives from researchers, and maintaining cultures of inclusive excellence in the genomic research community. Enhancing the diversity of individuals participating as investigators in genomics research, may also help address the urgent need for enhanced diversity among those applying genomics in clinical care. The 2020 NHGRI Strategic Vision (PMID: 33116284 (https://pubmed.ncbi.nlm.nih.gov/33116284/)) lists Champion a diverse workforce as one of the guiding principles/values for human genomics. To pursue this, the NHGRI recently published its action agenda for building a diverse genomics workforce (Bonham, Green, 2021 (https://www.cell.com/ajhg/fulltext/S0002-9297(20)30449-3) AJHG), the result of an intensive year-long task force effort to develop a workforce diversity strategic plan and produce initiatives needed to enhance diversity, including addressing groups nationally underrepresented in the genomics research workforce. This initiative is part of that emerging portfolio of initiatives and is intended to address the third strategic goal of that action agenda, to develop and support research transition programs to independent genomic research careers.
Applicants to NHGRI may propose any research topic suitable for an R01 within the NHGRI mission as described on the NHGRI website for the Division of Genome Sciences, the Division of Genomic Medicine, and the Ethical, Legal and Social Implications Research Program.
Consent Expectations
Where human biological samples will be studied, they are expected to have been obtained using a documented informed consent process that allows for future research use and broad data sharing (NOT-HG-20-011). If new human biospecimens will be collected, or if clinical application is included in the application, the consent process should be described at a high level in the Research Plan and detailed in the Human Subjects Section.
NHGRI strongly encourages studies that propose to derive genomic data from human specimens and cell lines to obtain participant consent either for general research use through controlled access or for unrestricted access. Similarly, consent language should avoid both restrictions on the types of users who may access the data and restrictions that add additional requirements to the access request process. NHGRI acknowledges that this will not always be possible or appropriate. In addition, individual participants who do not consent to future research use or broad sharing of their data (i.e., submission of their data to a publicly accessible data repository) may still participate in the primary study if consistent with study design. Additional guidance on informed consent can be found in the NHGRI Informed Consent Resource.
NHGRI expects non-human genomic data that are subject to the NIH GDS Policy to be submitted and released on the same timeline as human genomic data.
Metadata and Phenotypic Data
Per NOT-HG-21-022 (https://grants.nih.gov/grants/guide/notice-files/NOT-HG-21-022.html), NHGRI expects applications awarded under this NOFO to share comprehensive metadata and phenotypic data associated with the study, use standardized data collection protocols and survey instruments for capturing data, as appropriate, and use standardized notation for metadata (e.g., controlled vocabularies or ontologies) to enable the harmonization of datasets for secondary research analyses.
NIBIB
NIBIB interests include the development and integration of advanced bioengineering, sensing, imaging, and computational technologies for the improvement of human health and medical care. An application is not within the NIBIB mission if its principal focus is the development of a technology with the goal of understanding basic biological function or pathological mechanisms. Additionally, NIBIB only supports projects developing platform technologies that are applicable to a broad spectrum of disorders and diseases. However, applicants may propose research that utilizes only a single tissue, organ, or physiological condition as a model system to facilitate the development of what is expected to be a more broadly applicable enabling technology. Potential applicants are encouraged to contact the appropriate Program Director in their scientific program area of interest (https://www.nibib.nih.gov/research-funding) to determine if their research fits within the NIBIB mission.
For applications proposing clinical trials, NIBIB funding of clinical trials will be in accordance with NOT-EB-21-005 NIBIB Guidance for Support of Clinical Trial Applications." Briefly, NIBIB will only support mission-focused early-stage clinical trial applications, i.e., feasibility, Phase I, first-in-human, safety, or other small clinical trials, that inform early-stage technology development. NIBIB will not support applications proposing pivotal, Phase II, III, IV, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern. Also, mechanistic trials are not supported unless the primary focus of the project is on technology development.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Resubmission
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
The following NIH components intend to commit the following amounts for the duration of this PAR:
NIA’s number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
NINDS intends to commit up to $10 million per fiscal year, approximately 25 awards, dependent on award amounts
NIDA intends to commit up to $5 million per fiscal year, 12-15 awards, dependent on award amounts
NIMH intends to commit up to $5 million per fiscal year, 12-15 awards, dependent on award amounts
NINR intends to commit up to $1 million per fiscal year, 2-3 awards, dependent on award amounts
NIAAA intends to commit up to $1.5 million per fiscal year, 2-3 awards, dependent on award amounts
NCCIH intends to commit up to $400,000 per fiscal year, 1 award, dependent on award amounts
NHGRI’s number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Future year amounts will depend on annual appropriations.
NIBIB's number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Future year amounts will depend on annual appropriations.
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
1. Eligible Applicants
Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Local Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
- System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
- NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
- Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
- eRA Commons - Once the unique organization identifier (UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
- Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. See, Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
The overarching goal of this program is to enhance the diversity of New Investigators and At-Risk Investigators conducting research within the mission of the participating NIH Institutes and Centers. Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH strategy to identify, develop, support, and maintain the quality of our scientific human capital. Despite tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student, postdoctoral, and faculty populations to enhance the participation of individuals from groups identified as underrepresented in the biomedical sciences (e.g., see the Notice of NIH's of Interest in Diversity). Investigators from diverse backgrounds, including those from underrepresented groups (e.g., see NOT-OD-20-031, Notice of NIH’s Interest in Diversity), are encouraged to work with their institutions to apply for support under this program. Investigators from categories A and B are particularly encouraged to work with their institutions to apply.
Institutions applying must ensure that individuals identified as the PD/PI meet either the eligibility criteria A or B below (i.e., status as a New Investigator or At-Risk Investigator). For applications with multiple PDs/PIs , each individual serving as PD/PI is required to meet one of theeligibility criteria A or B, i.e., must be either a New or At Risk Investigator. New Investigator and At-Risk status will be verified by NIH at the time of application.
A. New Investigator (NI)
For the purpose of this FOA, an investigator is considered a New Investigator (NI; https://grants.nih.gov/policy/early-investigators/index.htm) if he/she has not competed successfully for substantial, NIH independent funding from NIH. A "substantial" research award is a research grant award excluding smaller grants that maintain Early Stage Investigator (ESI)/NI status (see full list of awards here). PD/PI of NIH Training-Related and Mentored Career Awards are still considered New Investigators if the NIH awards are in any of the following categories: fellowships (F awards), individual or institutional career awards (K awards), loan repayment contracts (L30, L32, L40, L50, L60), and all training grants (T32, T34, T35, T90, D43).
OR
B. At-Risk Investigator
For the purpose of this FOA, an investigator is considered an At-Risk Investigator if he/she has had prior support as a Principal Investigator on a substantial independent research award and, unless successful in securing a substantial research grant award in the current fiscal year, will have no substantial research grant funding in the following fiscal year. A "substantial" research award is a research grant award excluding smaller grants that maintain ESI/NI status (see here).
By the time of award, the PD/PI (or for a multiple PDs/PIs application, all PDs/PIs) must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).
2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
3. Additional Information on Eligibility
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
- A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
- A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
- An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).
1. Requesting an Application Package
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
2. Content and Form of Application Submission
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Facilities & Other Resources: Although this FOA seeks to support New Investigators and At-Risk Investigators at any independent career stage, please include the description of the institutional investments in the success of the investigator described in the SF424 (R&R) Application Guide for Early Stage Investigators.
Other Attachment (Institutional Eligibility Letter): Eligibility information must be submitted by the applicant's institution in a letter certifying that the PD/PI satisfies the eligibility criteria listed under Section III. "Eligible Individuals (Program Director/Principal Investigator)."
This letter must be on institutional letterhead and the signatures (or digital signatures) from an Authorized Organization Representative (AOR) and the PD(s)/PI(s) are clearly legible. Name the PDF formatted letter EligibilityCertification.pdf . Applications without the Institutional Letter will be deemed incomplete and withdrawn. Eligibility information provided in the Institutional Letter will be evaluated at time of application.
In addition to the eligibility information above, an applicant institution must include a statement explaining how participation of the identified PD/PI(s) would further the goals of the New and At-Risk Investigators to Promote Workforce Diversity Research program, consistent with the Notice of NIH's Interest in Diversity (NOT-OD-20-031 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html). Information provided in this Institutional Letter will be evaluated at time of application.
All instructions in the SF424 (R&R) Application Guide must be followed.
R&R or Modular Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Other Plan(s):
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
3. Unique Entity Identifier and System for Award Management (SAM)
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
5. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or non-compliant will not be reviewed.
Other Budget Information
Reasonable Accommodations: As part of this award, funds may be requested to make changes or adjustments in the research setting that will make it possible for a qualified individual with a disability to perform the essential functions associated with his/her role on the project. The accommodations requested under this program must be directly related to the performance of the proposed role on the research project and must be appropriate to the disabilities of the individual. Some types of accommodations that might be provided under this award include: specialized equipment, assistive devices, and personnel such as readers, interpreters, or assistants. In all cases, the total funds for accommodations requested must be reasonable. Costs for reasonable accomodations is not included in the direct cost limits.
Requests of $500,000 or more for direct costs in any year
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
1. Criteria
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Approach
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
Additional Review Criteria
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Study Timeline
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
Not applicable
Revisions
Not applicable
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Not Applicable
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
- Scientific and technical merit of the proposed project as determined by scientific peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
1. Award Notices
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:
- Federalwide Research Terms and Conditions
- Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
- Acknowledgment of Federal Funding
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity , sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
- Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
- For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
- HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
- For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Not Applicable
Data Management and Sharing
Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.
Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
3. Reporting
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Stacy Carrington-Lawrence, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-6402
Email: [email protected]
Aria Davis Crump, Sc.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-0881
Email: [email protected]
Michelle Jones-London, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-451-7966
Email: [email protected]
Brittany Haynes, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-496-2767
Email: [email protected]
Shalanda A. Bynum, PhD, MPH
National Institute of Nursing Research (NINR)
Telephone: 301-755-4355
Email: [email protected]
Laura Kwako, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-8507
Email: [email protected]
Beda Jean-Francois
National Center for Complementary & Integrative Health (NCCIH)
Telephone: 202-313-2144
Email: [email protected]
Neeraj Agarwal, PhD
National Eye Institute (NEI)
Telephone: 301-435-8155
Email:[email protected]
Jyoti Dayal, M.S.
National Human Genome Research Institute (NHGRI)
Telephone: 301-480-2307
Email: [email protected]
Albert Avila, Ph.D.
National Institute on Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-496-8804
Email: [email protected]
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Jeni Smits
National Institute on Aging (NIA)
E-mail: [email protected]
Pamela Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-253-8927
Email: [email protected]
Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]
Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email: [email protected]
Kelli Oster
National Institute of Nursing Research (NINR)
Telephone: 301-594-2177
Email: [email protected]
Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4707
Email: [email protected]
Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: [email protected]
Karen Robinson-Smith
National Eye Institute (NEI)
Telephone: 301-435-8178
Email: [email protected]
Natalie Linear
National Human Genome Research Institute (NHGRI)
Telephone: 301-827-0611
Email: [email protected]
Albert Avila, Ph.D.
National Institute on Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-496-8804
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.
and Human Services (HHS)
