Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Office of Strategic Coordination (Common Fund)

This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative ( through the NIH Office of the NIH Director, Office of Strategic Coordination ( All NIH Institutes and Centers participate in Common Fund initiatives. The FOA will be administered by the National Institute of Dental and Craniofacial Research (NIDCR), ( on behalf of the NIH.

Funding Opportunity Title
Transformative Research to Address Health Disparities and Advance Health Equity at Minority Serving Institutions (U01 Clinical Trial Allowed)
Activity Code

U01 Research Project Cooperative Agreements

Announcement Type
Related Notices
  • August 25, 2021 - Notice of Intent to Re-issue RFA-RM-21-022 Transformative Research to Address Health Disparities and Advance Health Equity at Minority Serving Institutions (U01 Clinical Trial Allowed)". See Notice NOT-RM-21-032
  • May 21, 2021 - Notice of Addition of Information for RFA-RM-21-022. See Notice NOT-RM-21-028.
  • April 13, 2021 - Notice of Addition of Requested Institutional Information for RFA-RM-21-022. See Notice NOT-RM-21-026.
  • April 12, 2021 - Notice of Pre-Application Webinar for Funding Opportunities on Transformative Research to Address Health Disparities and Advance Health Equity. See Notice NOT-RM-21-025.
Funding Opportunity Announcement (FOA) Number
Companion Funding Opportunity
RFA-RM-21-021 , U01 Research Project (Cooperative Agreements)
Assistance Listing Number(s)
Funding Opportunity Purpose

The Transformative Research to Address Health Disparities and Advance Health Equity at Minority Serving Institutions initiative is soliciting applications to support collaborative investigative teams or individual scientists who propose unusually innovative research projects, which, if successful, would have a major impact in developing, implementing, or disseminating innovative and effective interventions to prevent, reduce, or eliminate health disparities and advance health equity. No preliminary data are required. Projects must clearly demonstrate, based on the strength of the logic, a compelling potential to produce a major impact in addressing health disparities and advancing health equity.

Key Dates

Posted Date
March 26, 2021
Open Date (Earliest Submission Date)
April 28, 2021
Letter of Intent Due Date(s)

April 28, 2021

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
May 28, 2021 Not Applicable May 28, 2021 July 2021 August 2021 September 2021

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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.

No late applications will be accepted for this Funding Opportunity Announcement

Expiration Date
May 29, 2021
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 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.

Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description


This FOA requests research grant applications to support collaborative investigative teams or individual scientists who propose unusually innovative research projects, which, if successful, would have a major impact in developing, disseminating, or implementing innovative and effective interventions and/or strategies that prevent, reduce, or eliminate health disparities and inequities. Research addressing community-prioritized research questions, cross-cutting issues such as social determinants of health across sectors, multiple levels and systems that contribute to health disparities, and/or priority areas of multiple NIH Institutes and Centers are particularly encouraged. Applicants may propose projects addressing any disease, condition, or health-related topic with demonstrated health disparities/inequities, including but not limited to:

  • Chronic disease related outcomes (e.g. cardiovascular disease, diabetes, many others)
  • COVID-19 disparities
  • Alzheimer's Disease and Related Dementias disparities
  • Cancer disparities
  • Maternal morbidity and mortality disparities
  • Mental health, substance misuse, and stigma around seeking treatment
  • Multimorbidity/comorbidity
  • Behavior change

Although applicants will be able to propose their own ideas within this sphere, NIH has a special interest in developing, understanding, and deploying interventions that address social determinants of health disparities. Although a formative observational component may be necessary for some projects, each project is required to include an intervention component. Projects that include multilevel interventions are strongly encouraged. To be considered transformative, projects should reflect ideas substantially different from mainstream concepts and have high potential to lead to major improvements in health through the development, implementation, or dissemination of highly innovative interventions to address health disparities and advance health equity. Innovative interventions could take many forms, including technology. Note that "innovation" can include development and testing of a novel intervention; new implementation and/or dissemination strategies for evidence-based interventions; and/or novel examination of program and policy interventions designed to address health disparities and advance health equity that provide innovative insight into their effectiveness.

Several key features of this FOA are designed to emphasize to applicants and peer reviewers that Transformative Research to Address Health Disparities and Advance Health Equity at Minority Serving Institutions applications are very different from conventional, investigator-initiated research applications. These applications focus on the significance of the problem, the novelty of the hypothesis and/or the proposed methodology, and the magnitude of the potential impact rather than on preliminary data or experimental details. Reviewers will be instructed to emphasize the significance and innovation of the application in their evaluations. Applicants and reviewers should keep the goal of the Transformative Research to Address Health Disparities and Advance Health Equity at Minority Serving Institutions initiative in mind throughout the process to develop, implement, and/or disseminate innovative interventions and strategies that address health disparities and advance health equity.

In order to support the most innovative and impactful research, the NIH recognizes the need to promote a diverse research workforce (see NOT-OD-20-031 for NIH Interest in Diversity). In addition to supporting transformative research projects to address health disparities and advance health equity, this initiative also seeks to support research capacity building at institutions that enroll significant numbers of students from backgrounds nationally underrepresented in biomedical research, award baccalaureate and/or graduate degrees in biomedical sciences, and receive limited NIH Research Project Grant funding, as described in Section III. Eligibility Information. Researchers at institutions that do not meet the criteria described in Section III. Eligibility Information may consider RFA-RM-21-021.

This initiative is funded through the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress.


Racial and ethnic minorities and other groups that experience health disparities continue to bear disproportionate burdens of disease and illness, despite scientific and technological discoveries that have improved the health of the U.S. population overall. Social determinants of health the conditions in which people are born, grow, live, work, and age shape individual, community, and population health and wellbeing across the life course. Populations that experience health disparities generally have higher levels of cumulative exposure to adverse social and structural factors such as poverty, lower-quality education, less access to healthy food, chronic and acute psychosocial stress, less access to health care resources, and lifelong exposure to discrimination and structural racism, in addition to physical, biological and environmental hazards. Conversely, access to the health promoting aspects of the environment, such as opportunities for health-enhancing physical activity and buffers against hazardous exposures, is often disproportionately lower in these populations. Inequitable distribution of health-promoting social determinants across various populations is understood as a significant contributor to persistent and pervasive health disparities and inequities. A focus on health equity calls for reducing or eliminating factors that put populations experiencing health disparities at a disadvantage, and for increasing factors that increase the likelihood for achieving positive health outcomes. Investigators interested in developing projects related to the impact of structural racism and discrimination on minority health and health disparities may also be interested in considering NOT-MD-21-016.

Tackling the complex drivers of health disparities requires strong partnerships between researchers, community representatives, community organizations, health service providers, public health agencies, policymakers, and other stakeholders to ensure that relevant and culturally/contextually appropriate research is conducted and, just as importantly, that findings can be translated into sustainable community- and system-level changes that promote health equity. In addition to engaging vulnerable populations and/or populations at increased risk through culturally acceptable approaches, interventions and implementation strategies to reduce health disparities must address the life circumstances and social and structural environments that may pose challenges to reducing health risks. Interventions are not likely to produce sustained reductions in population health risk if they are solely focused on individual-level knowledge, attitudes, behaviors, or risk factors. Multilevel intervention components that address two or more levels of influence on health and behavioral outcomes and that involve peers, social networks, partners, family members, school systems, community members, community- or faith-based organizations, healthcare systems, community clinics, and service providers, are strongly encouraged.

For the purposes of this FOA, intervention projects and implementation or dissemination strategies must include a focus on one or more NIH-designated populations that experience health disparities in the US, which include Blacks or African Americans, Hispanics or Latinos, American Indians and Alaska Natives, Asian-Americans, Native Hawaiians and Other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities (SGM). NIH is especially interested in disparities or inequities demonstrating a compelling public health need (for example, COVID-19-related reductions in life expectancy for Black and Latino populations are 3-4 times larger than for Whites, see Andrasfay and Goldman, 2021; Arias et al., 2021). Projects assessing whether intervention effects differ across populations should incorporate health determinants such as social, institutional, or environmental factors so as to avoid pejorative contrasts and interpretations. Given heterogeneity within health disparity populations, within-group comparisons of intervention effects are encouraged that allow for discovery of health risk and resilience factors overlooked in comparative research. Projects may include populations outside the U.S. if the purpose is to understand intervention mechanisms and/or impact to address health disparities in the U.S.

Projects must document or demonstrate throughout the research process meaningful collaboration and partnership with local community-engaged leaders that represent the communities/populations of focus and that will be essential for development of feasible and acceptable approaches as well as acceptance, uptake, and sustainability of interventions and strategies proposed. Applicants should provide details on the nature and extent of their partnerships, including clearly describing the roles of partners and providing evidence of support from partner organizations.

Key Definitions for this FOA

Multilevel Intervention: An intervention at two or more levels of influence on health and behavioral outcomes, including policy (governing bodies or others who establish policies, rules, or guidelines), community (a group of people living in a defined geographic area or having particular characteristics in common, structural, and/or environmental determinants of health), organizational (large healthcare systems, community health clinics, public health organizations, community-based organizations, social services, schools, workplaces, other service providers, etc.), interpersonal (e.g., health communication, social supports, relationships with others), and individual (e.g., community residents, employees, caregivers, family members, providers). See the NIMHD Research Framework,, for examples of health determinants at different levels of influence).

Dissemination research is defined as the scientific study of targeted distribution of information and intervention materials to a specific public health or clinical practice audience. The intent is to understand how best to communicate and integrate knowledge and the associated evidence-based interventions.

Implementation research is defined as the scientific study of the use of strategies to adopt and integrate evidence-based health interventions into clinical and community settings to improve individual outcomes and benefit population health.

Research Objectives

Projects are expected to propose exceptionally innovative and transformative activities that are urgently needed to prevent, reduce, or eliminate health disparities and advance health equity. Projects may prospectively test new or adapted interventions (referred to as prospective interventions), evaluate existing or ongoing community-based interventional programs or policies to generate significantly novel insights, or conduct innovative dissemination and implementation research. Projects should be designed to test hypotheses about mechanisms of action that account for an intervention’s effects; mechanisms may operate at any level of analysis. Implementation science offers the opportunity to examine flexible and equitable implementation of innovative and effective evidence-based interventions across settings and populations to eliminate health disparities and advance health equity. Applications to this funding announcement encourage bridging the equitable reach, delivery, and implementation of evidence-based interventions in communities and populations experiencing health disparities. Innovative approaches to identifying, understanding, and developing strategies for overcoming barriers to the adoption, adaptation, integration, scale-up and sustainability of evidence-based interventions, tools, policies, and guidelines are needed. Also within scope is the examination of elimination of interventions that are ineffective, unproven, low-value, or harmful in advancing health equity.

To advance the equitable dissemination, implementation, access, and availability of health interventions, this Funding Announcement encourages the development, testing, and rapid cycle evaluation of intervention and implementation strategies that incorporate social determinants of health and social needs in adoption, adaptation, fidelity, acceptability, cost, and sustainability of evidence-based interventions in chronic disease prevention. Projects should include a dynamic evaluation component to ensure that the intervention or implementation does not worsen health disparities or inequalities. Implementation strategies and outcomes should be evaluated as addressing inequities. Implementation research aims should be guided by equity-oriented theoretical models and frameworks. NIH has a strong interest in examination of social determinants of health within intervention designs and outcomes, with intervention projects addressing two or more social determinants of health particularly desirable. Multilevel approaches and transdisciplinary and intersectoral collaborations (e.g. transportation, housing, food systems) are encouraged.

Methodological innovations that leverage rapid cycle testing, pragmatic trials, adaptive approaches (e.g. Multiphase Optimizing Strategy (MOST) and Sequential Multiple Assignment Randomized Trial (SMART) designs, human centered design), in addition to stakeholder or practitioner engagement approaches, will be responsive to this initiative. Modeling studies that evaluate the impact of specific interventions and implementation strategies to identify leverage points on costs and prioritizing strategies, particularly across the broad multi-sector nature of social determinants to inform scale up of interventions across communities and contexts, would also be responsive.

Prospective interventions may test new or adapted programs, interventions, or policies in a variety of community settings in the U.S., such as places of residence, community-based organizations, healthcare systems, child welfare and human service settings, workplaces, businesses, stores and restaurants, schools, criminal justice settings, faith-based organizations, public works and facilities, recreational settings, and green spaces. Applicants are strongly encouraged to propose activities at the appropriate stage of intervention development in an effort to maximize potency, fidelity, and implementation in community contexts. Approaches may include randomized control trials (RCTs) (e.g., individual-level RCT, group or cluster RCT, stepped wedge RCT, stepped wedge group or cluster RCT pragmatic RCT), pragmatic trials, adaptive designs (e.g., multiphase optimization strategy (MOST), sequential multiple assignment randomized trials [SMART]), implementation trials (including hybrid effectiveness/implementation designs), and quasi-experimental designs. A focus on interventions that do not solely target individuals but also address the upstream determinants or social needs that influence individual functioning and health outcomes is strongly encouraged. Projects may use quantitative, qualitative, or mixed methods approaches.

Natural experiments may examine programs, interventions, or policies that have been or will be implemented in the U.S. (regardless of NIH funding) by states/territories, cities, counties, tribal communities, healthcare systems, public health departments, school systems, employers, or other organizations. Projects including multiple sites, locations, or settings are encouraged to allow for the analysis of variability across and within settings. Studies that compare outcomes across populations in the U.S. with other countries are also allowed, if the comparison elucidates intervention mechanisms to reduce health disparities in the U.S. Projects that evaluate outcomes at multiple levels (e.g., community and individual) are strongly encouraged. Projects may use quantitative, qualitative, or mixed method approaches. In addition to examination of health behaviors or health outcomes, examination of secondary outcomes that address unintended consequences of a policy or program, degree of implementation (including acceptance, uptake, spread, and sustainability), and implementation barriers and facilitators, are encouraged.

Study Design

Design, Analysis, and Sample Size for Studies to Evaluate Group-Based Prospective Interventions: Randomized clinical trials are not required for this FOA. Investigators who choose to evaluate the effect of an intervention on a health-related biomedical or behavioral outcome by assigning participants to study arms may, but are not required to, propose a study in which (1) groups or clusters are assigned to study arms and individual observations are analyzed to evaluate the effect of the intervention, or (2) participants are assigned individually to study arms but receive at least some of their intervention in a real or virtual group or through a shared facilitator. Such studies may, but are not required to, propose a parallel group- or cluster-randomized trial, an individually randomized group-treatment trial, a stepped-wedge design, or a quasi-experimental version of one of these designs. In these studies, special methods may be warranted for analysis and sample size estimation, particularly for small or hard to reach populations where traditional experimental randomization is not possible without impacts on bias or contamination. Applicants should consider design and analysis issues, and show that their methods are appropriate given their plans for assignment of participants and delivery of interventions. Additional information is available at

Other Potential Study Designs: Randomized controlled trials may not be possible in all innovative research designs, e.g., where it is not possible to assign participants to high versus low discrimination condition or in small sample size communities where cross intervention contamination is likely to occur or be a problem. Alternative rigorous research designs that provide robust evidence of intervention effectiveness include quasi-experimental designs, such as multiple baseline or repeated measures design, interrupted time series design, or stepped-wedge cluster randomized designs in which all subjects receive the intervention. Further, hybrid effectiveness-implementation designs allow early observational investigation of implementation processes while also testing intervention effectiveness. Investigators should justify their research and analytic design selection and provide adequate evidence of their ability to execute a rigorous and appropriate analysis of randomized or non-randomized study data.

Technical Assistance

NIH staff intend to hold a Pre-Application Webinar for all interested prospective applicants. Webinar date and other details will be posted on NIH staff will be available to answer questions related to this FOA. Additional resources, including Frequently Asked Questions, will be available at In addition to the website, information will also be distributed to a listserv for this initiative; interested parties can sign up using this link: Prospective applicants are also encouraged to reach out to NIH staff listed on this FOA with questions.

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed

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.

Clinical Trial?

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

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The NIH Common Fund intends to commit approximately $24 million total in FY 2021 for this initiative, spread across RFA-RM-21-021 and RFA-RM-21-022. Approximately 10 awards per RFA are anticipated, contingent upon availability of funds and receipt of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Awards are multi-year funded with the first two years of funds disbursed in the first year of award (FY 2021). Funds for years 3 -5 of the award will be disbursed on an annual basis.

Award Project Period

The maximum project period is five years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

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)

This funding opportunity announcement is open to all institutions of higher education that:

1) award undergraduate (B.S. or B.A.) and/or graduate degrees in biomedical sciences;

2) at the time of the application, have received no more than $6 million dollars per year (total costs) from NIH Research Project Grants (RPGs) in each of the preceding two fiscal years, calculated using NIH RePORTER; and

3) enroll at least 25% of undergraduate students supported by Pell grants based on the most recent two years of data available from the Integrated Postsecondary Education Data System (IPEDS) database maintained by the National Center for Education Statistics, or are an accredited medical/health professional school with a historical mission statement that explicitly states that it was founded to educate students from nationally underrepresented backgrounds.

Foreign Institutions

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.

Required Registrations

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.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • 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.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or registration, but 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.
  • Applicants must have an active DUNS number and SAM registration in order to complete the 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 his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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.

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. 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 NOT-OD-11-101)

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Workspace or an institutional system-to-system solution. Links to apply using ASSIST or 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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:


Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

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.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

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: Do not list specific objectives of the proposed research. Instead, the specific aims page must contain a section entitled "Significance, Innovation, and Impact" and a section entitled "Insight and Rationale." The content of these two sections is described below. These two sections together should provide a cogent overview of your proposed research and its motivations.

Significance, Innovation, and Impact: What is the challenge or opportunity that is the focus of your proposed research? Why is this significant? What is the overall approach you are proposing? What are the most original or innovative aspects of your application? If successful, what would the impact be on our scientific understanding and (ultimately) health disparities and health equity?

Insight and Rationale: What is the fundamental new insight that is motivating the proposed research? What is the underlying logic or rationale that provides support for pursuing this insight despite little or no preliminary data?

Research Strategy: Organize the Research Strategy as a single document in the specified order using the instructions provided below. Start each section with the appropriate section heading as indicated. The presentation must be clear and compelling, even to those not in the immediate field of the proposed research.

Overview of research project: Describe briefly what is being proposed and why it is important. Describe briefly what is the state-of-the-art or a major challenge in the broad field of the application and how what is being proposed will advance well beyond the current status to transform the broad field. State the fundamental new insight that is driving this project.

Approach: Describe the overall approach to be pursued. No detailed experimental plan or substantial preliminary data should be provided. Though preliminary data are not required, if limited preliminary data are provided, they will be evaluated. Provision of substantial data is not aligned with the intention of the Transformative Research to Address Health Disparities and Advance Health Equity at Minority Serving Institutions program. Prominently state that, per the FOA instructions, a detailed intervention plan and substantial preliminary data are not being provided. In lieu of preliminary data, provide the underlying logic or rationale for pursuing this project in the manner proposed. Summarize what you believe to be the major challenges or risks in the project and alternate approaches that may need to be pursued. Despite the lack of detailed plans and data, the reviewers still must have a clear sense of what is being proposed and why, must be convinced that the applicants have thought very deeply about the project, and must be satisfied that the research will be conducted in a robust, rigorous, and reproducible manner. Applicants proposing clinical trials may reference but should not repeat information submitted on the PHS Human Subjects Clinical Trial Information form.

Innovation: Describe why the elements of exceptional innovation in your proposed research should be considered to be innovative compared to current approaches, paradigms, practices, or perspectives.

Appropriateness for the Transformative Research to Address Health Disparities and Advance Health Equity at Minority Serving Institutions: Why is the proposed research well suited to the goals of the Transformative Research to Eliminate Health Disparities and Advance Health Equity program rather than a more traditional research grant program?

Timeline: The Transformative Research to Address Health Disparities and Advance Health Equity at Minority Serving Institutions project must be designed to have deliverables by the end of the project period that have the potential for transformative impact. The project should not be framed as initiating a line of research that will have the potential for transformative impact only after subsequent periods of support. Provide a timeline within the project period for the proposed research indicating points where intermediate objectives will be assessed, the measurable outcomes that will be used to monitor progress, and the timing and process for reaching decisions regarding the course and direction of the continuing research effort. Given the high degree of risk involved in applications submitted under the Transformative Research to Address Health Disparities and Advance Health Equity at Minority Serving Institutions program, it is anticipated that investigators will need to continually reassess approaches based on intervention outcomes and potentially alter course to meet project goals. Possible alternative paths that may be followed at critical junctures in the project plan should be indicated on the timeline.

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.

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
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

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 (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 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 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 Component of the SF424(R&R) Application Package. 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 DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

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.

For this particular announcement, note the following:
The Transformative Research to Address Health Disparities and Advance Health Equity at Minority Serving Institutions Award is designed to support research projects with the potential to have a profound effect on health disparities research. Each project is expected to develop innovative methods, to employ standard methods in innovative ways, or to test exceptionally original ideas. As such, conventionally detailed intervention plans and extensive preliminary data are not provided. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge, understanding, or capability.

In addition, for applications involving clinical trials:
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.

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 review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.


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 policy be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Does the study have clear transformative potential? Is the proposed research exceptional in terms of its consequences for the field and meeting public health need? Is the paradigm being challenged or proposed fundamental to the field? Does the project address issues that are critical and relevant to one or more populations experiencing health disparities? Does the project address issues related to sustainability and/or implications for implementing and/or disseminating the intervention, if successful, to other health disparity populations? Reviewers should note that research results may not generalize to other samples or populations.

In addition, for applications involving clinical trials

For all CT FOAs, add the following questions, after the standard questions for the Significance criterion.

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?


Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Because of the unique nature of conducting research in populations experiencing health disparities and inequities, research productivity may not be reflected by research publications but can include contributions to public health such as dissemination of findings to community partners, community outcomes of previous research, and efforts to build relationships and trust with community leaders.

In addition, for applications involving clinical trials

For all CT FOAs, add the following questions, after the standard questions for the Investigator(s) review criterion.

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?


Does the application challenge and seek to shift current policy 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?

Does the application provide novel or innovative insights into improving the health of one or more populations experiencing health disparities?

In addition, for applications involving clinical trials

For all CT FOAs, add the following questions, after the standard questions for the Innovation review criterion.

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?


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?

Does the research use a community engaged approach or cultural constructs that reflect the desires of the community and engage the community in research design and conduct?

In addition, for applications involving clinical trials

For all CT FOAs, add the following questions, after the standard questions for the Approach review criterion.

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?


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?

Does the project provide evidence of community engagement and support, as appropriate?

In addition, for applications involving clinical trials

For all CT FOAs, add the following questions, after the standard questions for the Environment review criterion.

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria

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

Study Timeline

Study Timeline

For FOAs that allow but do not require clinical trials ("CT-optional FOAs"), include the heading below. These questions should be placed below any FOA-specific questions that apply to both CT and non-CT applications.

Specific to applications involving clinical trials

For all CT FOAs, add the following questions, before the Human Subjects Protections criterion.

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.


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.


Not Applicable


Not Applicable


Not Applicable

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.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

Is adequate budget allocated for community partners to be integrated into the research planning, design, implementation, and dissemination?

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the Council of Councils. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
    • Despite inherent scientific and technical risk, the potential for the research to result in scientific breakthroughs of high significance to one or more health disparity populations
    • Unusually cross-cutting science
    • Scientific balance in the portfolio of research supported by the Transformative Research to Eliminate Health Disparities and Advance Health Equity initiative

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 VI. Award Administration Information

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.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA. 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 Protocol Registration and Results System Information Website ( NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see

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 awardee 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 and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see and

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 or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) 2 CFR Part 200 Administrative Regulations, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, NIH Grants Policy Statement (which implements the aforementioned HHS Regulations (45 CFR Part 75), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or adopt a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipientsfor the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have primary responsibility for:

  • Providing scientific leadership for all aspects of the study, including planning, any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, dissemination of data, tools, and technologies, and collaboration with other investigators. The PD(s)/PI(s) agrees to accept close coordination, cooperation, and participation of NIH staff in those aspects of scientific and technical management of the study as stated in these terms and conditions;
  • Finalizing study design milestones, including a robust statistical plan for analysis, with NIH staff by November 30, 2021.
  • Upon implementation of the study, following the procedures required by the agreed-upon study design regarding study conduct and monitoring, participant management, data collection, quality control, and statistical analysis;
  • Providing summaries of progress toward goals and milestones at least yearly, as requested by NIH. The milestones will be reviewed annually (and at other times, if necessary), and new milestones will be negotiated, as needed by working with the NIH staff as appropriate.
  • Retaining custody of and having primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies;
  • Managing involvement of industry or any other third party in the study. Except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by the NIH;
  • Making all study materials, procedure manuals, and final datasets available in the public domain, managed by the recipient institution. Recipients are expected to publish and publicly disseminate results, data, and other products of the study, concordant with NIH governance policies and protocols. Publications and oral presentations of work performed under this agreement will require appropriate acknowledgment of support by the NIH/Common Fund;
  • Obtaining prior written approval of the NIDCR Grants Management Specialist, in consultation with the Program Officer and Project Scientist, for changes in any of the key personnel identified in the Notice of Grant Award.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

A Project Scientist from the most relevant NIH IC will be assigned. The Project Scientist will:

  • Consult with the PD(s)/PI(s) regarding study design milestones prior to finalizing the study design and as needed thereafter;
  • Serve as a resource to provide scientific/programmatic support by providing input on experimental and clinical approaches and study protocols, and advising in the management and operational aspects of study development and implementation;
  • Provide scientific and programmatic support to the PD(s)/PI(s) as the Project Scientist deems necessary, including contributing to data analysis, key personnel selection, and promoting the availability of data and resources;
  • Participate on teleconferences or other discussions with PDs/PIs to monitor study development and implementation progress, adherence to the study protocol, conduct of the study, and recruitment and retention of study participants;
  • Review the progress of the study through consideration of routine reporting, site visits, oversight committee recommendations, etc. This review may include, but not be limited to, compliance with the study protocol, achievement of participant enrollment targets, and the timeliness and quality of data reporting;
  • Periodically review reports of study progress. NIH staff may use information obtained from the data for the preparation of internal reports on the activities of the study. However, recipients will retain custody of and have primary rights to all data developed under these awards, subject to Government right of access consistent with HHS, PHS, and NIH policies.

The Project Scientist will not make decisions about the funding of this project and will not be involved in any special reviews of the project that make recommendations about funding.

An NIH Program Official will be assigned. The NIH Program Official will:

  • Carry out continuous review of all activities to ensure that the objectives are being met and that all regulatory, fiscal, and administrative matters are handled according to NIH guidelines;
  • Have the option to withhold support to a participating institution if technical performance requirements/milestones are not met;
  • Conduct special reviews of the project as the Program Official deems necessary. NIH may engage outside experts to assist in these reviews. If concerns about the project arise and are not resolved, NIH may reduce or restrict the budget or reduce the term of support to phase out the project.
  • Perform other duties required for normal program stewardship of grants.

The NIH reserves the right to terminate or curtail a study or any portion of a project in the event of (a) substantive changes in the project not approved in advance, (b) use of funds for activities not within the scope of the award, (c) failure to make sufficient progress toward the project milestones, (d) failure to comply with the terms and conditions of the award or establish necessary statutory, regulatory, policy approval required for conducting the project, or (e) ethical or conflict of interest issues.

Areas of Joint Responsibility include:

None, all responsibilities are divided between awardees and NIH staff as described above.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. Members will be: a designee chosen by the PD/PI, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees 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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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: (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: (preferred method of contact)
Telephone: 301-945-7573 Customer Support (Questions regarding registration and Workspace)
Contact Center Telephone: 800-518-4726

Scientific/Research Contact(s)

Stephanie Courchesne-Schlink
Office of the Director (OD)
Telephone: 301-451-6387

Peer Review Contact(s)

Aruna Behera, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-6809

Financial/Grants Management Contact(s)

Dede Rutberg, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798

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 45 CFR Part 75.

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