EXPIRED
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
National Eye Institute (NEI)
National Human Genome Research Institute (NHGRI)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child and Human Development ( NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Library of Medicine (NLM)
National Center for Complementary and Integrative Health (NCCIH)
Office of The Director, National Institutes of Health (OD)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Research on Women's Health (ORWH)
National Institute of Environmental Health Sciences (NIEHS)
NIH BRAIN Initiative (https://braininitiative.nih.gov/)
Applicants should carefully note which NIH Institutes and Centers (ICs) participate in this funding opportunity announcement (FOA) and view their instructions in the "Specific Areas of Research Interest" section below. ICs that do not participate in this FOA will not consider applications for funding. Consultation with NIH Scientific/Research staff before submitting an application is strongly encouraged.
R01 Research Project Grant
See Notices of Special Interest associated with this funding opportunity
See Section III. 3. Additional Information on Eligibility.
The NIH Research With Activities Related to Diversity (ReWARD) Program's overarching goal is to enhance the breadth and geographical location of research and research-related activities supported by NIH. The ReWARD program provides support for the health-related research of scientists who are making a significant contribution to Diversity, Equity, Inclusion, and Accessibility (DEIA) and who have no current NIH research project grant funding. The ReWARD program provides funding for both the scientific research and the DEIA activities of investigators. The grant will support scientific research in areas related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) and ongoing DEIA activities focused on enhancing diversity in the biomedical research enterprise within the United States and territories.
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 |
June 05, 2023 * | July 05, 2023 * | September 07, 2023 * | November 2023 | January 2024 | April 2024 |
October 05, 2023 * | November 05, 2023 * | January 07, 2024 * | March 2024 | May 2024 | July 2024 |
February 05, 2024 * | March 05, 2024 * | May 07, 2024 * | July 2024 | October 2024 | December 2024 |
June 05, 2024 * | July 05, 2024 * | September 07, 2024 * | November 2024 | January 2025 | April 2025 |
October 05, 2024 * | November 05, 2024 * | January 07, 2025 * | March 2025 | May 2025 | July 2025 |
February 05, 2025 * | March 05, 2025 * | May 07, 2025 * | July 2025 | October 2025 | December 2025 |
June 05, 2025 * | July 05, 2025 * | September 07, 2025 * | November 2025 | January 2026 | April 2026 |
October 05, 2025 * | November 05, 2025 * | January 07, 2026 * | March 2026 | May 2026 | July 2026 |
February 05, 2026 * | March 05, 2026 * | May 07, 2026 * | July 2026 | October 2026 | December 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.
The NIH UNITE initiative was established to identify and address structural racism within the NIH-supported and the greater scientific community. The aims are to establish an equitable and civil culture and reduce barriers to racial equity (Collins, et al., Cell 2021, Bernard, et al., Nature Medicine 2021). UNITE is comprised of five committees with separate but coordinated objectives on tackling the problem of racism and discrimination in science, while developing methods to promote diversity and inclusion.
NIH recognizes that scientists who assume additional academic service, outreach, and mentoring duties to promote Diversity, Equity, Inclusion, and Accessibility (DEIA) are not always appropriately recognized or rewarded for these activities and thus this work can significantly inhibit the individual’s scientific research career. The ReWARD program provides funding for the scientific research and DEIA activities of Program Directors/Principal Investigators (PDs/PIs) who have a record of making significant, sustained, and impactful contributions to enhancing DEIA and who are not a PD/PI on an NIH research project grant at the time of the award. PDs/PIs of active major NIH research grants are encouraged to determine if they are eligible for the NIH DEIA mentorship supplement program. The ReWARD program is intended for individuals with a balanced approach to advancing scientific research and promoting DEIA. PDs/PIs who intend to devote their funded efforts almost exclusively to scientific research are encouraged to apply for the parent R01. PDs/PIs who intend to devote their funded efforts almost exclusively to DEIA activities or to propose activities on the scale of an institutional training program are encouraged to explore the variety of funding opportunities offered to enhance diversity in the biomedical research workforce.
The ReWARD program will support scientific research in areas related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) and ongoing DEIA activities focused on enhancing diversity in the biomedical research enterprise within the United States and territories. Note that the biomedical research enterprise includes a range of research, including basic science, behavioral, social science, and translational and clinical research and will be described hereafter as biomedical research. The long-term goal of this program is to enhance diversity in the biomedical research workforce.
Promoting diversity in the extramural scientific workforce is critical to the success of the NIH mission and is consistent with the mandates of the 21st Century Cures Act. While scientific workforce diversity is integral to the NIH mission, expanding the pool of academic investigators from nationally underrepresented backgrounds in the biomedical research workforce has remained an elusive goal (see Policy Supporting Next Generation Researchers Initiative). For example, while the United States has seen a significant increase in the number of Ph.D. degrees in the biomedical sciences earned by scientists from historically underrepresented racial and ethnic groups in the biomedical research workforce, corresponding increases in the ranks of the faculty in basic science departments (Gibbs, et al., eLife 2016; Valantine, Lund & Gammie, CBE-Life Sciences Education, 2016) or NIH-funded investigators (Hoppe et al, 2019; Lauer, 2020) have not occurred. Similarly, women have earned a majority of biomedical Ph.Ds. since 2008 (NSF data), but only approximately 1/3 of NIH-funded PD/PIs are women (NIH Databook).
Scientists who assume substantial academic service, outreach, and mentoring duties to promote DEIA often experience career setbacks and difficulty supporting their research efforts because of the time they devote to their substantial DEIA efforts (Rodr guez et al., 2015; Gewin 2020; Faucett et al., 2022) . Supporting and recognizing DEIA efforts are likely to increase the retention of individuals from underrepresented groups in the biomedical research workforce. For example, studies suggest that underrepresented researchers who experience the altruistic or communal value of conducting biomedical research feel more psychologically involved with their research over time and this may contribute to retention (Diekman et al., 2010; Thoman et al, 2015). In addition, many successful DEIA-promoting programs are located at under-resourced institutions that serve students from diverse backgrounds. These institutions generally have lower levels of funding from NIH than do higher-resourced institutions. A program to promote the research projects of PDs/PIs who make significant contributions to DEIA efforts may serve the dual purposes of broadening the pool of researchers conducting biomedical research as well as the research settings in which NIH-funded biomedical investigations are conducted, while at the same time enabling these researchers and institutions to continue or expand their important DEIA activities. Broadening the institutions that participate in NIH-funded research would also increase access to research experiences for students from across the country, which would increase the pool of talented researchers available to the Nation in the future, including from groups currently underrepresented in biomedical research.
ReWARD funding will support research in areas related to the programmatic interests of one or more of the participating NIH Institutes and Centers (see below) and ongoing DEIA activities focused on enhancing diversity in the biomedical research enterprise within the United States and territories. NIH intends to support ReWARD renewals through future re-issuances of this funding announcement.
NIH encourages institutional support of individuals who receive ReWARD funding (e.g., through protected time for the proposed activities, additional staff, resources and/or infrastructure enhancements) and requires an institutional letter of support (see Letters of Support in Part 2. Section IV.2).
Because this funding is intended for individuals with no current NIH research project grant funding at the time of the award (e.g., individuals who may have faced career setbacks or delays), PDs/PIs applying to the ReWARD program are not expected to have extensive publications and preliminary data. However, investigators should have robust research aims and strategies that are rigorous, feasible, and likely to push forward the boundaries of scientific discovery. DEIA activities that focus solely on research mentoring or training within the PD/PI's normal duties, are not likely to rise to the level of significant, sustained, and/or impactful DEIA contributions supported within the goals of this program.
The NIH recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse 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 populations participate in, and benefit from research, and enhancing public trust.
To support the best science, NIH encourages inclusivity in research. Examples of structures that promote diverse perspectives include but are not limited to:
This FOA requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application (see further below). Applicants are strongly encouraged to read the FOA instructions carefully. Applications must include a PEDP submitted as an Other Attachment on the Other Project Information form (see Section IV).
NCCIH will support research that is well aligned with the NCCIH Strategic Plan. Research areas funded by the institute broadly fall into three therapeutic areas, including nutritional, psychological, and physical approaches. These may include the array of chemical space occupied by natural products derived from plants, fungi, bacteria, marine organisms, or animals; as well as mind and body approaches such as yoga, massage therapy, meditation, mindfulness-based stress reduction, spinal/joint manipulation, acupuncture, and music-based interventions. NCCIH is interested in research that takes a transdisciplinary approach that integrates natural, social, and health sciences and transcends traditional boundaries to investigate the multifactorial process of whole person health restoration. Applications proposing a clinical trial must follow the Consolidated Notice on NCCIH Clinical Trials Policies as only mechanistic clinical trials will be accepted by NCCIH through this FOA.
Potential applicants are strongly encouraged to consult with the NCCIH Scientific Research staff listed below prior to developing and submitting an application.
NEI will support applications that address or seek fundamental knowledge related to visual function, including but not limited to cellular and molecular neuroscience, imaging, genetics, development, basic and translational research on vision including how the visual system works from the eyes to the brain in health and disease. NEI encourages an emphasis on understanding and addressing health disparities that are experienced by vulnerable populations. NEI will not support clinical trials that are greater than minimal risk on this funding opportunity. Minimal risk is defined as the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Please refer to https://www.nei.nih.gov/grants-and-training/funding-opportunitiesto find the appropriate NIH or NEI-specific FOA for clinical trials. All investigators are encouraged to contact the NEI Scientific Program Officer in advance of submission.
NHGRI supports resources, approaches, and technologies that accelerate genomic research focused on the structure and biology of genomes; the genomics of disease; the implementation and effectiveness of genomic medicine; computational genomics and data science; the impact of genomic technology, advances, and implementation on health disparities and health equity; and ethical, legal, and social issues related to genomic advances. NHGRI recognizes the importance of diversity in the genomic workforce, without which the promise of genomics cannot be fully achieved.
In general, NHGRI supports studies that provide generalizable methods and knowledge. Approaches that are comprehensive across the genome or are generalizable across variants, tissues, diseases, or function may be in scope for NHGRI to the extent they address priority areas described in the NHGRI 2020 Strategic Vision and on the web pages for the research mission of NHGRI’s Extramural Divisions and Offices:
Applications for studies relevant only to a particular disease or organ system should be directed to the appropriate Institute or Center. Applications whose primary scientific objective is to understand a single biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention, will not be in scope for NHGRI.
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 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.
NIDA supports innovative research addressing critical issues of neuroscience, genetics, behavior, prevention, treatment, epidemiology, etiology, health services, HIV/AIDS, and co-occurring opportunistic infections (e.g., viral hepatitis C, tuberculosis, sexually transmitted infections) associated consequences in substance-using populations, medication development, or other research areas relevant to drug abuse. NIDA priorities are further described in the NIDA Strategic Plan (see Director's Message | National Institute on Drug Abuse (NIDA) (nih.gov) ) and on the NIDA Notice of Special Interest webpage (see Search All Funding Opportunities | National Institute on Drug Abuse (NIDA) (nih.gov) ). Applicants are encouraged to contact a program official to discuss the proposed application.
NIDCD supports biomedical research, behavioral research, and research training in the normal and disordered processes of hearing, balance, taste, smell, voice, speech, and language. Applicants are strongly encouraged to learn more about NIDCD’s mission areas at Extramural Research. NIDCD’s priorities are further described in NIDCD’s 2023-2027 Strategic Plan . Potential applicants are strongly encouraged to discuss their research plans with Program Staff in relevant areas.
NIDCR supports research and research training to advance fundamental knowledge about dental, oral, and craniofacial (DOC) health and disease, and to translate these findings into prevention, early detection, and treatment strategies that improve overall health for all individuals and communities across the lifespan. Strategic Priorities are laid out in NIDCR Strategic Plan 2021-2026. Of particular interests for this FOA are:
Through this FOA, NIDCR may support clinical trials only of minimal risk to study participants, and for assessing feasibility and acceptability of the trial design. All potential applicants are encouraged to contact NIDCR Scientific/Research Contact listed in this FOA.
NIGMS supports basic research that increases our understanding of biological processes and lays the foundation for advances in disease diagnosis, treatment, and prevention. NIGMS' research mission is aimed at understanding the principles, mechanisms, and processes that underlie living organisms, often using research models. NIGMS does not support research that is relevant to the diseases, organ systems, or stages of life within the mission areas of other NIH Institutes and Centers. NIGMS accepts investigator-initiated applications for clinical trials using the R01 mechanism with the following considerations and limitations (see NOT-GM-22-027 and Investigator-Initiated Applications for Clinical Trials (R01) for further details).
NIH BRAIN Initiative is aimed at revolutionizing our understanding of the human brain, by accelerating the development and application of innovative technologies. Grant applications that fall into one or more of the seven high-priority research areas, including neuroethics, will be considered for funding. Research projects that develop new tools and approaches in the following areas are of particular interest:
NIMH supports research on topics that include but are not limited to basic neuroscience and behavioral science; translational application of brain and behavior relationships in healthy and diseased states; and preventive, treatment and services interventions. 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 also supports clinical trials involving preventive, therapeutic, and services interventions. All applications that propose clinical trials are expected to comport with NIMH’s experimental therapeutics approach to intervention development and testing. That is, the scope of work must include specification of targets/mechanisms and assessment of intervention induced changes in the presumed targets/mechanisms that are hypothesized to account for the intervention’s outcomes. In this manner, the results of the trial will advance knowledge regarding therapeutic change mechanisms and be informative regardless of trial outcomes (e.g., in the event of negative results, information about whether the intervention was successful at engaging its targets can facilitate interpretation).
See the Consolidated Notice on NIMH Clinical Trials Policies , NOT-MH-20-105, for a summary of NIMH’s policies on support for clinical trials. Applications that do not comport with MH Clinical Trials Policies will not be accepted.
NIMHD supports the study of many aspects of minority health and health disparities from biological and population sciences to clinical, behavioral, and translational research, as well as research on health care services, health systems and workforce development. NIMHD focuses on the full continuum of causes of health disparities and the interrelation of these causes. NIMHD projects must include a focus on one or more of the following populations that NIH designated as experiencing health disparities in the United States and its territories: African Americans, Latinos/Hispanics, American Indians and Alaska Natives, Asian Americans, Native Hawaiians and Pacific Islanders, less privileged socioeconomic groups, underserved rural populations, and sexual and gender minorities. NIMHD encourages projects that use approaches encompassing multiple domains of influence (e.g., biological, behavioral, sociocultural, environmental, physical environment, health system) and multiple levels of influence (e.g., individual, interpersonal, family, peer group, community, societal) to understand and address health disparities (see the NIMHD Research Framework for more information). Studies using animal models or exclusively basic science, or studies based outside the U.S. or its territories will not be supported by NIMHD under this FOA.
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. NINDS generally expects a minimum effort of 2.4 calendar months (or 20% effort) towards research on an R01.
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 service 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 the 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. 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.
NLM supports research that incorporates innovative biomedical informatics and data science approaches that harness the digital healthcare ecosystem and has the potential to reduce health disparities while improving access to care, continuity of care, and/or health outcomes. Further, NLM is interested in research that leverages health data and develops novel approaches (e.g., clinical decision support systems; machine learning/artificial intelligence) that account for systematic biases and blind spots in health data and the development of tools and approaches that may be tailored for diverse populations.
See Section VIII. Other Information for award authorities and regulations.
Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
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 number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Application budgets are not limited but need to reflect the actual needs of the proposed scientific research project and DEIA activities.
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
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
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.
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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: 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.
This FOA is open to all eligible PDs/PIs who have a track record of making significant, sustained, and impactful contributions to enhancing DEIA in the biomedical research enterprise and who are not at the time of award a PD/PI on an NIH research project grant (RPG).
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:
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.
Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
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.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Other Attachments: The application must include the following 2 attachments. Applications lacking the 2 attachments will not be reviewed. Please use the filenames suggested below. The filename provided for each document added to the section Other Attachments will be the name used for the bookmark in the electronic application in eRA Commons.
1. Diversity Statement (2-page maximum):The application must include a diversity statement from the PD/PI applying for the R01 award. The Diversity Statement provides an opportunity to expand upon, but not duplicate information in the biosketch. The Diversity Statement should include a detailed description of the PD/PI's commitment to diversity as well as any past or present activities to enhance DEIA in the biomedical research enterprise such as activities to support individuals from diverse backgrounds, including those from groups underrepresented in the biomedical research workforce (e.g., certain racial/ethnic groups, persons with disabilities, students from disadvantaged backgrounds, women, as described in the NIH Notice of Interest in Diversity). The statement should describe the outcomes and impact of past DEIA activities. Of particular interest are activities related to addressing structural and systemic barriers that limit the diversity and inclusivity of the biomedical research enterprise.
DEIA activities that focus solely on research mentoring or training within the PD/PI's normal duties, are not likely to rise to the level of significant, sustained, and/or impactful DEIA contributions supported within the goals of this program. The statement may include evidence of working effectively with scientists from a wide variety of backgrounds, promoting inclusive, safe, equitable and accessible scientific biomedical research environments.
This attachment should be titled Diversity Statement. Applications lacking a Diversity Statement will not be reviewed.
2. Plan for Enhancing Diverse Perspectives (PEDP) (1-page maximum): All applications must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP should include a timeline and milestones for relevant components that will be considered as part of the review.
Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:
For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/pedp-key-elements-and-examples.
This attachment should be titled Plan for Enhancing Diverse Perspectives. Applications lacking the PEDP will not be reviewed.
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide must be followed.
Biographical Sketch: In addition to the instructions, the PD/PI should describe the following in the biosketch:
The DEIA information included in the biosketch may be expanded upon in the Diversity Statement attachment.
R&R or Modular Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
The application should describe the allowable costs associated with the research project and DEIA activities. For the PEDP implementation costs, applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7).
R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Research Plan
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: In addition to the scientific specific aims in alignment with a participating ICO's research mission, succinctly list the specific aim(s) of the DEIA proposed activities (e.g., training, mentoring, networking, cohort-building, career development, or psychosocial intervention to support entry and persistence of individuals from diverse backgrounds, including those from underrepresented groups in the biomedical research enterprise). DEIA activities must focus on enhancing diversity in the biomedical research enterprise within the United States and territories. State concisely the broader goals of the proposed DEIA activities and summarize the expected outcome(s), including the impact that the results of the proposed activities will have on the biomedical research enterprise.
Research Strategy: Preliminary data (i.e., data not yet published by the PD/PI) for the proposed scientific research are neither expected nor required. The feasibility of the proposed research may be demonstrated through literature citations or data from sources other than the PD/PI's original research.
In addition to the scientific research strategy focusing on the specific aims in alignment with a participating ICO's mission, include the strategy for effectively maintaining or implementing the DEIA activities to achieve the stated DEIA specific aim(s). The DEIA strategy should follow the format detailed in the SF424 (R&R) Application Guide.
Letters of Support: The application must contain an institutional letter of support from the Department Chair, Dean or equivalent leadership official. This letter should describe the following:
Additional institutional support to the PD/PI may also be described, for example:
Applications lacking the institutional letter will not be reviewed.
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.
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 application forms packages.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information
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.
PHS Assignment Request Form
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
4. Submission Dates and Times
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.
6. Funding Restrictions
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.
7. Other Submission Requirements and Information
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 field of 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 provided on the application is the same identifier 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.
Applications must include the following attachments as Other Attachments on the SF424(R&R) Other Project Information form: (1) a Diversity Statement and (2) a PEDP. Applications must also include an institutional letter of support submitted as a Letter of Support on the PHS 398 Research Plan form. Applications that fail to include these 3 documents will be considered incomplete and will be withdrawn before review.
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.
1. Criteria
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.
Specific to this FOA:
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 proposed activities to make rigorous and useful/significant scientific contributions to the research field(s) involved including its impact on DEIA in the biomedical research workforce. The ReWARD program is intended for individuals with a balanced approach to advancing scientific research and promoting DEIA. Applications should be strong in both areas overall to be considered meritorious.
Reviewers will consider each of the review criteria below in relation to the program objectives and give a separate score for each. An application does not need to be strong in all categories to be judged as a high impact. For example, an application describing a solid and interesting scientific research project not viewed as paradigm-shifting, but including a highly innovative plan to enhance DEIA, may be considered strong in "Innovation".
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?
Specific to this FOA: To what extent do the DEIA efforts address an important problem or critical barrier to progress in diversifying the biomedical research enterprise? How will successful completion of the DEIA aims contribute to important enhancements of DEIA at the institutional, regional and/or national level? To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?
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 a 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?
Specific to this FOA: To what extent does the PD/PI demonstrate commitment and contributions to enhancing DEIA in the biomedical research enterprise? Consistent with the career stage, to what extent does the PD/PI demonstrate a record of working effectively with scientists from diverse backgrounds and promoting safe, inclusive, equitable and accessible scientific biomedical research environments? To what extent does the PD/PI demonstrate DEIA outcomes that are significant, sustained, positive, or impactful? To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project?
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?
Specific to this FOA: For the DEIA efforts, is an effective refinement, improvement, or new application of theoretical concepts, approaches, or interventions proposed? To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?
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?
Specific to this FOA: Is the overall strategy well-reasoned and appropriate to accomplish the DEIA specific aim(s)? Are potential problems, alternative strategies, measurable outcomes, and benchmarks for success for the DEIA efforts presented? Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?
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?
Specific to this FOA: For the DEIA efforts, will the environment in which the work will be done contribute to the probability of success? Are the institutional support and resources adequate for the project DEIA efforts? To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?
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.
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)?
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.
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.
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 Animals Section.
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.
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.
Not Applicable
Not Applicable
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.
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
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).
Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
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.
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, 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 on the basis of established PHS referral guidelines 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 consistent with applicable law:
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.6. 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).
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:
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 will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. 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.
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 judgment 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
3. 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.
4. 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 the threshold. 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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.
In carrying out stewardship of grant programs, NIH will periodically evaluate the ReWARD program, employing the representative measures identified below. In assessing the effectiveness of research project grant investments, NIH may use information from progress reports and public databases, PD/PIs, and from participants themselves. Where necessary, PD/PIs and participants may be appropriately contacted after the completion of the grant period for updates on participants subsequent outcomes.
The overall evaluation of the program will be based on metrics that may include, but are not limited to, the following:
Characteristics of the applicant and awardee pool for the program, such as:
Indicators of scientific accomplishments/productivity, such as:
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
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E-mail: [email protected]
Kelli Oster
National Institute of Nursing Research (NINR)
Telephone: 301-594-2177
Email: [email protected]
Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Email: [email protected]
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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 2 CFR Part 200.