Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

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)

Eunice Kennedy Shriver National Institute of Child Health 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)

Tribal Health Research Office (THRO)

National Institute on Minority Health and Health Disparities (NIMHD) - November 13, 2024 Participation added (NOT-MD-25-004)

National Institute of Biomedical Imaging and Bioengineering (NIBIB) - November 13, 2024 Participation added (NOT-EB-24-018)

National Institute of Nursing Research (NINR) - November 15, 2024 Participation added (NOT-NR-25-005)

NIH BRAIN Initiative (https://braininitiative.nih.gov/)

Applicants should carefully note which NIH Institutes and Centers (ICs) participate in this notice of funding opportunity (NOFO) and view their instructions in the "Specific Areas of Research Interest" section below. ICs that do not participate in this NOFO will not consider applications for funding. Consultation with NIH Scientific/Research staff before submitting an application is strongly encouraged.

Funding Opportunity Title
Research With Activities Related to Diversity (ReWARD) (R01 Clinical Trial Optional)
Activity Code

R01 Research Project Grant

Announcement Type
Reissue of PAR-23-122
Related Notices

    See Notices of Special Interest associated with this funding opportunity

  • November 15, 2024 - Notice of Participation of the National Institute of Nursing Research (NINR) in PAR-25-117, "Research With Activities Related to Diversity (ReWARD) (R01 Clinical Trial Optional)". See Notice NOT-NR-25-005.
  • November 14, 2024 Notice of Change to Participating NIH Institutes, Centers, and Offices in PAR-25-117 "Research With Activities Related to Diversity (ReWARD) (R01 Clinical Trial Optional)". See Notice NOT-GM-25-011.
  • November 13, 2024 - Notice of NIBIB Participation in PAR-25-117: "Research With Activities Related to Diversity (ReWARD) (R01 Clinical Trial Optional)". See Notice NOT-EB-24-018.
  • November 13, 2024 - Notice of Participation of NIMHD in PAR-25-117," Research With Activities Related to Diversity (ReWARD) (R01 Clinical Trial Optional)". See Notice NOT-MD-25-004.
  • April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084.
  • August 31, 2022- Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
  • August 5, 2022- Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.
Funding Opportunity Number (FON)
PAR-25-117
Companion Funding Opportunity
None
Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.859, 93.172, 93.853, 93.867, 93.242, 93.310, 93.279, 93.173, 93.865, 93.121, 93.273, 93.846, 93.307, 93.286, 93.361
Funding Opportunity Purpose

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 DEIA activities focused on enhancing diversity in the biomedical research enterprise within the United States and territories.

This Notice of Funding Opportunity (NOFO) requires a Plan for Enhancing Diverse Perspectives (PEDP).

Key Dates

Posted Date
November 06, 2024
Open Date (Earliest Submission Date)
January 05, 2025
Letter of Intent Due Date(s)

Not Applicable

The following table includes NIH standard due dates marked with an asterisk.
Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
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
June 05, 2026 * July 05, 2026 * September 07, 2026 * November 2026 January 2027 April 2027
October 05, 2026 * November 05, 2026 * January 07, 2027 * March 2027 May 2027 July 2027
February 05, 2027 * March 05, 2027 * May 07, 2027 * July 2027 October 2027 December 2027
June 05, 2027 * July 05, 2027 * September 07, 2027 * November 2027 January 2028 April 2028
October 05, 2027 * November 05, 2027 * January 07, 2028 * March 2028 May 2028 July 2028

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.

Expiration Date
January 08, 2028
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) 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.

IMPORTANT: Per NOT-OD-24-086 updated application forms (FORMS-I) will be used for this opportunity. The updated forms are not yet available and will be posted 30 calendar days or more prior to the first application due date. Once posted, you will be able to access the forms using one of the following submission options:

  1. NIH ASSIST
  2. An institutional system-to-system (S2S) solution
  3. Grants.gov Workspace
Table of Contents

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background and Purpose

NIH recognizes that scientists who assume additional academic service, outreach, and mentoring duties to promote DEIA are not always appropriately recognized or rewarded for these activities and thus this work can significantly inhibit the individual’s scientific research career. For definitions of diversity, equity, inclusion, and accessibility, refer to the June 25, 2021 Executive Order on Diversity, Equity, Inclusion, and Accessibility in the Federal Workforce. 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 activities focused on promoting DEIA 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 enterprise.

Need for the Program

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 (Rodríguez 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 resource-limited organizations that serve students from diverse backgrounds. 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 organizations to continue or expand their important DEIA activities. Broadening the types of organizations 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.

Program Considerations

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 organizational support of individuals who receive ReWARD funding (for example, through protected time for the proposed activities, additional staff, resources and/or infrastructure enhancements) and requires an organizational letter of support (see Letters of Support in Part 2. Section IV.2).

Because this award is intended to support individuals with no current NIH research project grant funding support at the time of the award (for example, individuals who may have faced career setbacks or delays), PDs/PIs who work with their organizations to apply 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.

Specific Areas of Research Interest

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.

NIAMS will support applications that address research into the causes, treatments, and prevention of arthritis and musculoskeletal and skin diseases. The Institute’s core mission areas are (1) systemic rheumatic and autoimmune diseases; (2) skin biology and diseases; (3) bone biology and diseases; (4) muscle biology and diseases; and (5) joint biology, diseases, and orthopedics. Within these mission areas, NIAMS supports research at multiple levels, ranging from basic studies of the molecular mechanisms underlying disease processes, to preclinical research in model systems, to translational studies, and finally to clinical and epidemiological research.

NIAMS seeks to continue its commitment to building and maintaining the scientific workforce. Attracting and maintaining a robust, diverse scientific workforce is critical to the NIAMS mission. 

NIAMS will only support applications that fall within one of NIAMS supported scientific programs. Clinical trial applications will be considered low priority for funding through this NOFO.

It is recommended that investigators contact NIAMS Scientific/Research staff well in advance of submitting applications to discuss relevance to NIAMS priorities. 

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.

NICHD invites applications that will address questions relevant to the NICHD mission and align with the NICHD Strategic Plan. NICHD supports research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. The NICHD's broad and diverse research portfolio includes research related to conception and pregnancy; typical and atypical development in childhood; childhood trauma, injury, and critical illness; the transition from adolescence to adulthood; reproductive health; rehabilitation; intellectual, developmental, and physical disabilities; and population dynamics across the lifespan.

Applications assigned to NICHD must address one or more NICHD priority populations.  These include:

  1. Infants, children and adolescents, including individuals transitioning from pediatric to adult health care providers
  2. Pregnant, peripartum, postpartum and lactating persons
  3. Individuals of reproductive age with regards to gynecologic and reproductive health care
  4. Individuals of any age with intellectual and developmental disabilities
  5. Individuals of any age with physical disabilities

Applications to NICHD that address the mission and priorities of other institutes that are not participating in this NOFO will not be prioritized for funding by NICHD.

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 NOFO are:

  1. Innovations in DOC disease prevention, early detection and diagnosis, and precision treatment
  2. Implementation of evidence-based discoveries into sustained clinical practices to reduce health disparities and inequities
  3. Support for future generations of DOC researchers and oral health professional scholars to address unmet clinical needs by capturing emergent scientific and technological advances
  4. Partnerships across sectors to develop and sustain a diverse and robust research workforce in DOC sciences

Through this NOFO, 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 NOFO.

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:

  • Discovering cell type diversity in the brain
  • Mapping brain circuits at multiple scales 
  • Monitoring the brain in action 
  • Demonstrating causality between brain activity and behavior, 
  • Developing new theoretical and data analysis tools to understand brain function
  • Developing innovative technologies to understand the human brain specifically
  •  Neuroethics

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 leads scientific research to improve minority health and reduce health disparities. NIMHD supports the study of many aspects of minority health and health disparities in humans from biological and population sciences to behavioral, and translational research, as well as research on health care services, health policy, health systems and workforce development. NIMHD focuses on the full continuum of factors that contribute to health disparities and their interrelations.  Projects submitted to NIMHD must include a focus on one or more of the following NIH-designated populations experiencing health disparities in the United States and its territories: racial and/or ethnic minority populations, less privileged socioeconomic status (SES), underserved rural populations, persons with disabilities, and sexual and gender minority (SGM) groups. Projects focused on rural populations, SGM groups, and people with disabilities are encouraged to examine intersections with race and/or ethnicity, and/or SES. Comparison groups/populations may also be included as appropriate for the research questions posed. 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). NIMHD strongly encourages the use of established demographic and social determinants of health (SDOH) measures from the SDOH Collection of the PhenX Toolkit 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 funding opportunity.  

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 research 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. For the DEIA aim, NINDS is primarily interested in supporting activities that further STEM workforce development. 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 NOFO. Please refer to NINDS Find Funding Opportunities web page to find the appropriate NIH or NINDS-specific NOFO 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 (See: the NINDS mission statement and the NINDS Strategic Plan). 

NINR supports research aligned with our mission and strategic priorities, conducted by scientists from any discipline. 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. 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 practice, including homes, schools, workplaces, clinics, justice settings, and the community. Observational, intervention, and implementation research are of interest.

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. 

THRO: The mission of the Tribal Health Research Office (THRO) is to improve Native health, enhance capacity for health research in Native communities, and promote opportunities for future American Indian and Alaska Native (AI/AN) researchers. THRO supports biomedical and behavioral research that addresses critical issues relevant to the health and benefit of Tribal and AI/AN populations. THRO does not have grant-making authority or administer grants, however THRO can co-fund grants deemed scientifically meritorious after review by one of the institutes or centers (ICs) participating in this announcement. 

Plan for Enhancing Diverse Perspectives (PEDP)

The NIH recognizes that teams comprised of investigators with diverse perspectives working together and capitalizing on innovative ideas and distinct viewpoints outperform homogeneous teams. There are many benefits that flow from a scientific workforce rich with diverse perspectives, 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, the NIH encourages inclusivity in research guided by the consideration of diverse perspectives. Broadly, diverse perspectives can include but are not limited to the educational background and scientific expertise of the people who perform the research; the populations who participate as human subjects in research studies; and the places where research is done.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation.  Assessment of applications containing a PEDP are based on the scientific and technical merit of the proposed project. Consistent with federal law, the race, ethnicity, or sex of a researcher, award participant, or trainee will not be considered during the application review process or when making funding decisions.  Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.

The PEDP will be submitted as Other Project Information as an attachment (see Section IV).  Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance materials.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New
Resubmission

The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed scientific research project and DEIA activities.

Award Project Period

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 NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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).

Federal Governments

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
    Foreign Organizations

    Non-domestic (non-U.S.) Entities (Foreign Organizations) 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.

    Required Registrations

    Applicant Organizations

    Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

    • 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. The same UEI must be used for all registrations, as well as on the grant application.
    • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their 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.

    Eligible Individuals (Program Director/Principal Investigator)

    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 How to Apply-Application Guide.

    This NOFO 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 NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

    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 NIH Grants Policy Statement Section 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

    Section IV. Application and Submission Information

    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 NOFO. 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity 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 How to Apply- Application Guide and the Table of Page Limits must be followed.

    Instructions for Application Submission

    The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

    SF424(R&R) Cover

    All instructions in the How to Apply - Application Guide must be followed.

    SF424(R&R) Project/Performance Site Locations

    All instructions in the How to Apply- Application Guide must be followed.

    SF424(R&R) Other Project Information

    All instructions in the How to Apply- Application Guide must be followed.

    Other Attachments: 

    1. PD/PI Statement on Activities to Promote Diversity, Equity, Inclusion, and Accessibility in Biomedical Research Enterprise (2-page maximum): The application must include an attachment for each PD/PI describing activities to promote broad participation in the biomedical research enterprise. The statement provides an opportunity to expand upon, but not duplicate, information in the biosketch. Each statement should include a detailed description of the PD/PI's commitment to DEIA 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 (for example, 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 representation, equity, inclusivity, or accessibility in 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 and promoting inclusive, safe, equitable and accessible scientific biomedical research environments.

    Each PD/PI attachment should be titled “DEIA Statement <PD/PI last name>”. Applications lacking a statement from each PD/PI will not be reviewed.

    2. Plan for Enhancing Diverse Perspectives (PEDP)

    • In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of actionable strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. 
    • Applicants should align their proposed strategies for PEDP with the research strategy section, providing a holistic and integrated view of how enhancing diverse perspectives and inclusivity are buoyed throughout the application.
    • 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 may be no more than 2 pages in length and should include:
      • Actionable strategies using defined approaches for the inclusion of diverse perspectives in the project;
      • Description of how the PEDP will advance the scientific and technical merit of the proposed project;
      • Anticipated timeline of proposed PEDP activities;
      • Evaluation methods for assessing the progress and success of PEDP activities.

    Examples of items that advance inclusivity in research and may be appropriate for a PEDP can include, but are not limited to:

    • Partnerships with different types of institutions and organizations (e.g., research-intensive; undergraduate-focused; HBCUs; emerging research institutions; community-based organizations).
    • Project frameworks that enable communities and researchers to work collaboratively as equal partners in all phases of the research process.
    • Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as human subjects in clinical trials, including those from underrepresented backgrounds.
    • Description of planned partnerships that may enhance geographic and regional diversity.
    • Outreach and recruiting activities intended to diversify the pool of applicants for research training programs, such as outreach to prospective applicants from groups underrepresented in the biomedical sciences, for example, individuals from underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
    • Plans to utilize the project infrastructure (i.e., research and structure) to enhance the research environment and support career-advancing opportunities for junior, early- and mid-career researchers.
    • Transdisciplinary research projects and collaborations among researchers from fields beyond the biological sciences, such as physics, engineering, mathematics, computational biology, computer and data sciences, as well as bioethics.

    Examples of items that are not appropriate in a PEDP include, but are not limited to:

    • Selection or hiring of personnel for a research team based on their race, ethnicity, or sex.
    • A training or mentorship program limited to certain researchers based on their race, ethnicity, or sex.

    For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see PEDP guidance materials.

    SF424(R&R) Senior/Key Person Profile

    All instructions in the How to Apply- Application Guide must be followed.

    Biographical Sketch: In addition to the instructions, each PD/PI should describe the following in the biosketch:

    • Leadership roles in DEIA activities.
    • Honors, awards, recognition for DEIA activities.
    • Service-oriented DEIA efforts beyond the requirements of being a biomedical Principal Investigator.
    • A description of any career setbacks or delays because of DEIA activities or issues.

    The DEIA information included in the biosketch may be expanded upon in the DEIA Statement attachment (described above).

    R&R or Modular Budget

    All instructions in the How to Apply- Application Guide must be followed.

    PEDP implementation costs:

    Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7): https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm.

    R&R Subaward Budget

    All instructions in the How to Apply-Application Guide must be followed.

    PHS 398 Cover Page Supplement

    All instructions in the How to Apply- Application Guide must be followed.

    PHS 398 Research Plan

    All instructions in the How to Apply- 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 (for example, 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 specific aim(s) must focus on activities 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. The combined Specific Aims should adhere to the Table of Page Limits guidelines. Applications without distinct DEIA specific aim(s) are not responsive to this NOFO and will not be reviewed.

    Research Strategy: Preliminary data (data not yet published) 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 Research Strategy format detailed in the SF424 (R&R) Application Guide. The combined research strategies for both components should adhere to the Table of Page Limits guidelines. Applications without a distinct DEIA research strategy component are not responsive to this NOFO and will not be reviewed.

    Letters of Support: The application must contain an organizational letter of support from the Department Chair, Dean or equivalent leadership official. This letter should describe the following:

    • The organizational commitment to DEIA initiatives – for example:
      • Organizational DEIA goals and the support structures for DEIA initiatives.
      • How DEIA service is recognized during promotion and tenure.
      • How DEIA service is recognized by campus-wide acknowledgment of achievement.
    • That the time and effort requested by the PD/PI for the proposed research and DEIA activities will be provided.

    Additional organizational support to the PD/PI may also be described, for example:

    • Mentoring for PD/PI.
    • Other types of support (for example, laboratory and/or office space, administrative staff time, funding to attend scientific conferences).
    • Professional skills development and networking opportunities (for example, leadership programs, communication workshops, mentoring workshops, additional opportunities for networking, especially with organizational leadership).

    Applications lacking the organizational 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 How to Apply- Application Guide.

    Other Plan(s): 

    All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions:

    • 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.

    Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide.

    • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

    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 How to Apply- 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 How to Apply- 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 How to Apply- Application Guide must be followed.

    PHS Assignment Request Form

    All instructions in the How to Apply- Application Guide must be followed.

    3. Unique Entity Identifier and System for Award Management (SAM)

    See Part 2. 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. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

    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 How to Apply-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 Section 7.9.1 Selected Items of Cost.

    7. Other Submission Requirements and Information

    Applications must be submitted electronically following the instructions described in the How to Apply - 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 NOFO 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 How to Apply - Application Guide.

    See more tips for avoiding common errors.

    Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.

    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 DEIA Statement for each PI/PD and (2) a PEDP. Applications must also include an organizational 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.

    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.

    Mandatory Disclosure

    Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

    Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected].

    Post Submission Materials

    Applicants are required to follow the instructions for post-submission materials, as described in the policy

    Section V. Application Review Information

    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:

    • The application need not have extensive background materials or preliminary information for the scientific research plan. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance scientific knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.
    • Reviewers should assess the PD/PI's demonstrated track record and proposed plans with respect to advancing and promoting DEIA in the biomedical research enterprise in the United States and territories and the PD/PI’s institutional context (e.g., resources, teaching requirements). Because this funding is intended to support individuals who may have faced career setbacks or delays because of DEIA activities, and in some cases, institutional context, reviewers should note that PD/PIs should not be expected to have extensive publications but should instead be evaluated on whether their aims and strategies are rigorous and feasible and the scientific question(s) are likely to advance the field of study. Similarly, early career stage applicants may not have yet published independently as senior or corresponding authors, and the absence of these publications should not be viewed as a weakness. Applications should be evaluated with respect to the PD/PI’s career stage and any career setbacks due to DEIA activities.
    • While any information in the application relevant to the program goals can be included as part of the review process, the race, ethnicity, or sex (including gender identity, sexual orientation, or transgender status) of a PD/PI or individuals a PD/PI plans to support may not, in and of themselves, be used as factors in the evaluation of applications or in providing critiques, scores, or funding recommendations.
    Overall Impact

    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 scored review criteria and additional review criteria (as applicable for the project proposed).  An application does not need to be strong in all categories to be judged likely to have a major scientific impact. As part of the overall impact score, reviewers should consider and indicate how the plan to enhance diverse perspectives affects the scientific merit of the project.

    Scored Review Criteria

    Reviewers will evaluate Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate criterion score. 

     

    Significance

    • Evaluate the importance of the proposed research in the context of current scientific challenges and opportunities, either for advancing knowledge within the field, or more broadly. Assess whether the application addresses an important gap in knowledge in the field, would solve a critical problem, or create a valuable conceptual or technical advance.
    • Evaluate the rationale for undertaking the study, the rigor of the scientific background for the work (e.g., prior literature and/or preliminary data) and whether the scientific background justifies the proposed study.

    Innovation

    • Evaluate the extent to which innovation influences the importance of undertaking the proposed research. Note that while technical or conceptual innovation can influence the importance of the proposed research, a project that is not applying novel concepts or approaches may be of critical importance for the field.
    • Evaluate whether the proposed work applies novel concepts, methods or technologies or uses existing concepts, methods, technologies in novel ways, to enhance the overall impact of the project.

    Specific to this NOFO

    • Evaluate whether the application provides sufficient information for the rationale for the proposed work. Note that appropriate justification for the proposed work may be provided through literature citations, or data from other sources, and does not need to be the PD/PI's preliminary data.
    • Evaluate the extent to which the DEIA efforts address an important problem or critical barrier to progress in promoting DEIA in the biomedical research enterprise within the United States and territories. 
     

    Approach

    • Evaluate the scientific quality of the proposed work. Evaluate the likelihood that compelling, reproducible findings will result (rigor) and assess whether the proposed studies can be done well and within the timeframes proposed (feasibility).

    Rigor:

    • Evaluate the potential to produce unbiased, reproducible, robust data.
    • Evaluate the rigor of experimental design and whether appropriate controls are in place.
    • Evaluate whether the sample size is sufficient and well-justified.
    • Assess the quality of the plans for analysis, interpretation, and reporting of results.
    • Evaluate whether the investigators presented adequate plans to address relevant biological variables, such as sex or age, in the design, analysis, and reporting.
    • For applications involving human subjects or vertebrate animals, also evaluate:
      • the rigor of the intervention or study manipulation (if applicable to the study design).
      • whether outcome variables are justified.
      • whether the results will be generalizable or, in the case of a rare disease/special group, relevant to the particular subgroup.
      • whether the sample is appropriate and sufficiently diverse to address the proposed question(s).
    • For applications involving human subjects, including clinical trials, assess the adequacy of inclusion plans as appropriate for the scientific goals of the research. Considerations of appropriateness may include disease/condition/behavior incidence, prevalence, or population burden, population representation, and/or current state of the science.

    Feasibility:

    • Evaluate whether the proposed approach is sound and achievable, including plans to address problems or new challenges that emerge in the work. For proposed studies in which feasibility may be less certain, evaluate whether the uncertainty is balanced by the potential for major advances.
    • For applications involving human subjects, including clinical trials, evaluate the adequacy and feasibility of the plan to recruit and retain an appropriately diverse population of participants. Additionally, evaluate the likelihood of successfully achieving the proposed enrollment based on age, racial, ethnic, and sex/gender categories.
    • For clinical trial applications, evaluate whether the study timeline and milestones are feasible.

    Specific to this NOFO

    • Evaluate whether the application proposes a balanced approach to advancing scientific research and promoting DEIA in the biomedical research enterprise within the United States and territories.
     

    Investigator(s)

    Evaluate whether the investigator(s) have demonstrated background, training, and expertise, as appropriate for their career stage, to conduct the proposed work. For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan to facilitate coordination and collaboration.

    Environment

    Evaluate whether the institutional resources are appropriate to ensure the successful execution of the proposed work.

    Specific to this NOFO

    • Evaluate each PD/PI in the context of the career stage, any career setbacks due to DEIA activities, and the organizational environment. When evaluating the investigator(s) background, training, and expertise to conduct the proposed scientific work, note that applicants may not have certain measures of productivity such as extensive publications. Similarly, early career stage applicants may not have yet published independently as senior or corresponding authors, and the absence of these publications should not be viewed as a weakness.
    • Evaluate to what extent each PD/PI demonstrates having promoted DEIA activities and outcomes that are significant, sustained, positive, or impactful and beyond research mentoring or training activities within the PD/PI's normal duties. Consider whether each PD/PI has a strong record of working effectively with scientists from diverse backgrounds and promoting safe, inclusive, equitable and accessible scientific biomedical research environments. Reviewers should assess the PD/PI's track record with respect to advancing and promoting DEIA in the biomedical research enterprise. 
    Additional Review Criteria

    As applicable for the project proposed, reviewers will consider the following additional items while determining scientific and technical merit, but will not give criterion scores for these items, and should consider them in providing an overall impact score.

     

    For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, 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, 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 research includes Vertebrate Animals, evaluate the involvement of live vertebrate animals 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. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

     

    When the proposed research includes Biohazards, evaluate whether specific materials or procedures that will be used are significantly hazardous to research personnel and/or the environment, and whether adequate protection is proposed.

     

    As applicable, evaluate the full application as now presented.

     

    As applicable, evaluate the progress made in the last funding period.

     

    As applicable, evaluate the appropriateness of the proposed expansion of the scope of the project.

    Additional Review Considerations

    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.

     

    For projects involving key biological and/or chemical resources, evaluate the brief plans proposed for identifying and ensuring the validity of those resources.

     

    Evaluate 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 NOFO. 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.

    • Scientific and technical merit of the proposed project, including the PEDP, as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities.

    Please note that NIH will not consider race, ethnicity, age, or gender of a researcher, award participant, or trainee, even in part, in making its funding decisions.

    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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

    Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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.

    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 Section 2.4.4 Disposition of Applications.

    Section VI. Award Administration Information

    1. Award Notices

    A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

    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.

    Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

    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

    The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

    All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

    Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support

    Cooperative Agreement Terms and Conditions of Award

    Not Applicable

    3. Data Management and Sharing

    Consistent with the 2023 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 Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

    • Awardees will provide updates at least annually on implementation of the PEDP.

    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 Section 8.6 Closeout. NIH NOFOs 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 2 CFR Part 200.301.

    5. Evaluation

    In carrying out stewardship of grant programs, NIH will periodically conduct a retrospective evaluation of 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 retrospective 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:

    • DEIA activities
    • Geographic distribution
    • Investigator demographics
    • Organization types
    • Scientific topics of supported research

    Indicators of scientific accomplishments/productivity, such as:

    • Outcomes of individuals involved in the DEIA activities
    • Peer-reviewed research publications and citations
    • Presentations at scientific conferences (talks, posters, etc.)
    • Patent activity among grantees

    Section VII. Agency Contacts

    We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

    Application Submission Contacts

    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: https://www.era.nih.gov/need-help (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]

    Scientific/Research Contact(s)

    National Institute of General Medical Sciences (NIGMS)
    Email: [email protected]

    Isaah Vincent
    NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
    Phone: (301) 402-2446
    E-mail: [email protected]

    Sheila Caldwell, PhD
    Tribal Health Research Office
    Phone: 301-480-3527
    email: [email protected]

    Michelle Jones-London, PhD
    National Institute of Neurological Disorders and Stroke (NINDS)
    Telephone: 301-451-7966
    Email: [email protected]

    Ebony B Madden
    NHGRI - NATIONAL HUMAN GENOME RESEARCH INSTITUTE
    Phone: 301-503-5620
    E-mail: [email protected]

    Elizabeth Powell, PhD
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)
    Telephone: 301-443-0786
    Email: [email protected]

    Lillian Shum, PhD
    NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
    Phone: 301-594-0618
    E-mail: [email protected]

    Brett Miller, PhD​​​​​​​
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
    Telephone: 301-496-9849
    Email: [email protected] 

    Brittany Haynes
    National Institute of Mental Health (NIMH)
    Phone: (301) 496-2767
    Email: [email protected]

    Aria Crump
    NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
    Phone: 301-443-6504
    E-mail: [email protected]

    Susan L Sullivan
    NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
    Phone: 301-496-8683
    E-mail: [email protected]

    Neeraj Agarwal
    NEI - NATIONAL EYE INSTITUTE
    Phone: 301-435-8155
    E-mail: [email protected]

    Sundania J.W. Wonnum, PhD
    National Institute on Minority Health and Health Disparities (NIMHD)
    Phone: 301-402-1366
    Email: [email protected]

    Utibe R. Bickham-Wright, PhD
    National Institute on Minority Health and Health Disparities (NIMHD)
    Phone: 301-402-1366
    Email: [email protected]

    Albert Avila, Ph.D.
    National Institute of Biomedical Imaging and Bioengineering (NIBIB)
    Telephone: 301-838-1720
    Email: [email protected]

    Sylvia E. Long, PhD, CPH
    National Institute of Nursing Research (NINR)
    Telephone: 240-276-6136
    Email: [email protected]

    Peer Review Contact(s)

    Center for Scientific Review (CSR)
    Email: [email protected]

    Financial/Grants Management Contact(s)

    Justin Rosenzweig
    National Institute of General Medical Sciences (NIGMS)
    Email: [email protected] 

    Chief Grants Management Officer
    National Institute of Neurological Disorders and Stroke (NINDS)
    Email: [email protected]

    Deanna L Ingersoll
    NHGRI - NATIONAL HUMAN GENOME RESEARCH INSTITUTE
    Phone: 301-435-7858
    E-mail: [email protected]

    Judy Fox
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)
    Telephone: 301-443-4704
    Email: [email protected]

    Gabriel Hidalgo, MBA
    NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
    Phone: 301-827-4630
    E-mail: [email protected]

    Margaret Young
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
    Telephone: 301-642-4552
    Email: [email protected]

    Tamara Kees
    National Institute of Mental Health (NIMH)
    Phone: (301) 443-8811
    E-mail: [email protected]

    Pamela G Fleming
    NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
    Phone: 301-480-1159
    E-mail: [email protected]

    Samantha J Tempchin
    NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
    Phone: (301) 435-1404
    E-mail: [email protected]

    Karen Robinson Smith
    NEI - NATIONAL EYE INSTITUTE
    Phone: 301-435-8178
    E-mail: [email protected]

    Leslie Littlejohn
    NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
    Phone: 301-594-2545
    Email - [email protected]

    Priscilla Grant, JD
    National Institute on Minority Health and Health Disparities (NIMHD)
    Phone: 301-594-8412
    Email: [email protected]

    Jenna Briggs
    National Institute of Nursing Research (NINR)
    Telephone: 301-480-0639
    Email: [email protected]

    Section VIII. Other Information

    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.

    Authority and Regulations

    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 2 CFR Part 200.

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