Part 1. Overview Information

Key Dates

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.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

This funding opportunity solicits research to examine the pathways through which social determinants of health (SDOH), and related biological, psychological, and behavioral factors impact health and health disparities at intersections of privileged and/or oppressed social statuses such as race, ethnicity, socioeconomic status, sexual orientation, and ability. SDOH is a required pathway of focus. Observational research, evaluation studies, simulation studies, and predictive modeling studies are of interest. Also of interest are mixed-methods studies that combine quantitative and qualitative data to contextualize intersectional forms of privilege and oppression. Projects using longitudinal study designs are encouraged.

The primary populations of focus for the Axes Initiative are those that experience health disparities in the U.S., including racial and ethnic minority populations, people with lower socioeconomic status, underserved rural populations, sexual and gender minority populations, and people with disabilities. Inclusion of social statuses such as gender and gender identity, sex assigned at birth, national origin, and immigration status are also of interest. Studies must clearly convey the populations of interest for the proposed research and how the populations comprise intersecting statuses that are privileged or have been oppressed.

Key Definitions

Intersectionality: The complex, cumulative way in which the effects of interlocking forms of privilege or oppression (e.g., racism, sexism, classism) converge or intersect to advantage some individuals, communities, or populations and disadvantage others.

Social status: A person’s standing or importance in relation to other people within a society.

Social determinants of health: Social determinants of health (SDOH) are the conditions in which people are born, grow, learn, work, play, live, and age, and the wider set of structural factors shaping the conditions of daily life. These structural factors include social, economic, and legal forces, systems, and policies that determine opportunities and access to high quality jobs, education, housing, transportation, built environment, information and communication infrastructure, food, and health care; the social environment; and other conditions of daily life. See https://www.ninr.nih.gov/researchandfunding/nih-sdohrcc#tabs2 for additional detail on the NIH SDOH Conceptualization.  

Background 

Intersectionality, which has conceptually expanded in focus over the decades, illuminates the importance of considering how individual experiences are differentially shaped by the intersection of one’s social status in society. Simultaneous systems of privilege and oppression (e.g., racism, sexism, classism) are key drivers of good health and prosperity, but also of poor health and hardship. Membership in majority groups based on axes of race, ethnicity, gender identity, socioeconomic status, and sexual orientation affords access to systems and conditions of privilege. In contrast, members of minority groups live within systems of oppression that limit access to health-promoting resources, services, and opportunities. These systems of privilege and oppression do not operate independently at a single axis (e.g., race) but instead intersect at multiple axes (e.g., race, class, sex assigned at birth) to manifest in systematically different conditions of daily life and, in turn, wide and unjust variations in health and quality of life. For example, the lived experience of an Afro-Latina woman cannot be understood from the perspective of a separate and distinct axis (ethnicity), but rather requires recognition that such experiences are shaped by the simultaneous impacts of her intersecting social statuses (i.e., Black, female, Latino). Thus, an intersectional lens is necessary to fully account for the health-promoting or compromising conditions experienced by individuals and populations at the convergence of social statuses. Overall, intersectional research can uncover how social statuses intersect to create new and complex health exposures and experiences for individuals and populations that would be otherwise obscured when assessed independently.

To date, most intersectional health research has simply documented that health disparities exist at axes of social statuses. However, there is less empirical knowledge about the underlying causes of these disparities. Expanding intersectionality research to identify the pathways and mechanisms underlying health disparities moves the field beyond simply documenting health disparities into pinpointing the factors that contribute to unjust and avoidable variations in health outcomes at these intersections. SDOH play a key role in determining the health trajectory of individuals, families, communities, and entire populations. Thus, SDOH are central to understanding intersectional health disparities. Moreover, there is a need for a multilevel intersectional approach to understand not only the pathways through which SDOH impact health outcomes, but also the related biological, psychological, and behavioral pathways and mechanisms at axes of privilege and oppression. Knowledge derived from this line of research can inform targeted approaches to interrupt the pathways that influence downstream SDOH health impacts. Lastly, in the extant literature only a narrow set of social statuses are documented, with the greatest proportion examining axes of race, ethnicity, and gender. This knowledge gap presents an opportunity to expand our understanding of the health of people who hold other privileged and oppressed social statuses to identify paths to reducing health disparities and advancing health equity.

Progress in intersectionality research will require methods suited to identifying complex pathways and mechanisms through which social and other determinants of health impact individual and population health. However, much of the existing quantitative literature is limited by theoretical and methodological weaknesses such as the use of analytic methods that do not account for the complexity of intersectional inquiry, the use of intersectionality lenses that are not embedded within systems of privilege and oppression, or a combination of these factors. The dearth of rigorous quantitative intersectionality research prohibits comprehensive identification of the most salient and impactful proximal and distal factors that compromise health.

Largely, applying an intersectional lens would advance efforts to achieve greater precision in understanding social inequities simultaneously across systems that advantage some and disadvantage others. Analytical examination intended to reveal factors that are most ascribed to differential health outcomes across and within social statuses is needed to inform and reform interventions, practices, and public policies to adequately address the experiences of populations living within systems of oppression. Acknowledging that, for example, racism and not race, classism and not class, homophobia and not sexual orientation are the underlying causes of poor health is central to advancing health equity.  

Research Objectives

The Axes Initiative invites applications to examine the pathways and mechanisms through which SDOH, and related biological, psychological, and behavioral factors impact health and health disparities at intersections of privileged and oppressed social statuses such as race, ethnicity, socioeconomic status, sexual orientation, and ability. SDOH is a key pathway of interest, therefore examination of federal, state, local, or organizational level policies, programs, or practices, and/or conditions of daily life (e.g., concentrated disadvantage, quality employment and education, housing, and food) on health outcomes at intersections of social statuses is required. Studies can also incorporate individual and family economic and social circumstances to elucidate proximal pathways and mechanisms through which SDOH influence health. Studies that incorporate novel methods, measures, and analytical approaches that account for the complexity of intersectionality research are encouraged.

The primary populations of focus for the Axes Initiative are those that experience health disparities in the U.S., including racial and ethnic minority populations, people with lower socioeconomic status, underserved rural populations, sexual and gender minority populations, and people with disabilities. Inclusion of social statuses such as gender and gender identity, sex assigned at birth, national origin, and immigration status are also of interest. Studies must clearly convey the populations of interest for the proposed research and how the populations comprise intersecting statuses that are privileged and/or have been oppressed.

All studies must be guided by an intersectionality framework to identify the hypothesized pathways and mechanisms between intersecting social statuses and health outcomes. As appropriate, involvement of the priority populations in the research process, through for example formation of a community advisory board, focus groups and interviews, listening sessions, or community forums, to increase the relevance and resonance of study findings are encouraged. Observational research, evaluation studies, simulation studies, and predictive modeling studies are of interest. Also of interest are mixed-methods studies that combine quantitative and qualitative data to contextualize intersectional forms of privilege and oppression. Projects using longitudinal study designs are strongly encouraged. Projects may utilize primary data collection and/or analysis of secondary data from project-specific or publicly available data sources at the federal, state, local, or organizational level and across sectors such as healthcare, human and social services, housing, justice, commerce, transportation, economic development, and education. The primary health outcome may reflect health or functional status, quality of life, and morbidity and mortality, including outcomes relevant for specific health conditions.

Examples of projects that may be supported by the Axes Initiative include, but are not limited to: 

• Comparative studies that examine similarities and differences in pathways and mechanisms of health and health disparity impacts across intersectional statuses.
• Studies that focus on embodiment or biological embedding, i.e., how exposure to various forms of privilege and oppression converge to affect SDOH experienced by people at intersections of social statuses and, in turn, affect underlying biological processes (e.g., epigenome, allostatic load, inflammation, microbiome, neurological signatures).
• Longitudinal and life course studies that examine pathways and mechanisms over time and across generations at intersections of social statuses.
• Studies that examine the multilevel pathways and mechanisms through which concentrated disadvantage impacts health at different intersections of social statuses.
• Studies that examine pathways and mechanisms to explain unexpected positive health outcomes across intersecting social statuses.
• Studies that identify protective factors at multiple levels (e.g., individual, interpersonal, institutional, community, societal) and the ways these protective factors buffer effects of oppression on health disparities.
• Studies that examine the differential impact of policies and laws at the federal, state, and/or local levels at varied axes of privilege and oppression.
• Simulation studies that estimate the impacts of strategies to ameliorate adverse  SDOH to reveal pathways or mechanisms of action that  affect change at the individual, community, and population levels. 

Non-Responsive Applications

Projects NOT responsive to this opportunity:

• Projects that do not focus on intersectional social statuses.
• Projects that only use individual- or interpersonal-level data.
• Projects that do not incorporate an intersectionality framework to guide research questions and interpretations.
• Projects that do not focus on populations experiencing health disparities in the U.S.
• Projects that do not include a Plan for Enhancing Diverse Perspectives.
   

Areas of Interest of Participating Institutes, Centers, and Offices (ICOs)

National Cancer Institute (NCI)

NCI invites applications relevant to the priorities described in this NOFO and that support the National Cancer Plan. NCI is interested in observational research applications that will advance scientific understanding about the mechanisms through which conditions of the social and/or built environment influences cancer control inequities among populations that experience health disparities using an intersectionality framework. Of specific interest are intersectional research projects relevant to cancer control and centered on sexual orientation, gender identity, and/or people assigned female at birth. Studies of factors and outcomes at two or more levels (e.g., individual, interpersonal, healthcare teams, healthcare system, community, payer, policy) are encouraged.

Research areas of interest to NCI may include, but are not limited to:

• Multilevel studies that elucidate modifiable factors linking environmental exposures (i.e., chemical, physical, biological, and/or social) to cancer disparities at varying intersections of social status.
• Research on structural factors (i.e., policies, economic, legal, and/or social systems) that shape the environmental conditions of communities and, in turn, affect underlying biological and/or behavioral processes that contribute to cancer inequities at intersections of social statuses.
• Studies that examine the differential impact of laws, policies, and practices relevant to cancer control across intersectional social statuses.

National Institute of Mental Health (NIMH)

The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. NIMH is interested in applications (not clinical trials) relevant to priorities described in this NOFO and that support the NIMH Strategic Plan for Research. NIMH Division of AIDS Research is also interested in applications relevant to the priorities described in the NIH Strategic Plan for HIV and HIV-Related Research by NIH Office of AIDS Research (NIH OAR; https://www.oar.nih.gov/hiv-policy-and-research/strategic-plan).

HIV/AIDS Areas of Research Interest
While the areas of intersectional social-structural determinants of health are vast, it is expected that some may be more amenable to HIV-related research questions than others. Therefore, applicants in collaboration with their relevant communities and stakeholders should carefully consider their non-intervention research aims in determining which intersectional social-structural factors they propose to examine. Proposed research must be in the context of their impact on HIV prevention or treatment outcomes.

Specific areas of research interest may include, but are not limited to:

• Multilevel studies that elucidate the mechanisms and causal pathways between intersectional social-structural factors and HIV outcomes to inform future interventions.
• Studies that use innovative approaches to identify modifiable intersectional social-structural factors across various sectors (e.g., economic security, housing security, food access, transportation, healthcare) and provide evidence-based simulation or prediction of the impact of effective interventions delivered in real-world settings to address these barriers to improve HIV outcomes and reduce HIV disparities.
• Studies that examine relevant laws, policies, and practices that reinforce intersectional social-structural determinants and identify social-structural interventions for development and testing to improve HIV outcomes and reduce HIV disparities.

Division of Services and Intervention Research (DSIR) Areas of Research Interest
For the purposes of this NOFO, the Division of Services and Intervention Research (DSIR) is particularly interested in (but not limited to) projects that explicitly align to Goals 3.2, 3.3, and 4 of the NIMH Strategic Plan for Research, aimed at improving treatment, services and outcomes for people with mental illnesses or autism spectrum disorders.

Specific areas of research interest may include, but are not limited to:

• Multilevel studies that elucidate the mechanisms and causal pathways between intersectional social-structural factors and mental health outcomes to inform future interventions.
• Studies that use innovative approaches to identify modifiable intersectional social-structural factors across various sectors (e.g., economic security, housing security, food access, transportation, healthcare) and provide evidence-based simulation or prediction of the impact of effective interventions delivered in real-world settings to address these barriers to improve mental health outcomes and reduce disparities.
• Studies that examine relevant laws, policies, and practices that reinforce intersectional social-structural determinants and identify social-structural interventions for development and testing to improve mental health outcomes and reduce disparities.

NIMH encourages a deployment-focused model of intervention design and testing that takes into account the perspective of relevant end-users (e.g., service users, providers, administrators, payers) and the key characteristics of the settings (e.g., resources, including workforce capacity; existing clinical workflows).  To this end NIMH strongly encourages meaningful inclusion of end-users in the research (e.g., member of an advisory panels and/or inclusion as key personnel).  This attention to end-user perspectives is intended to help ensure the research findings will have clear utility to communities, practices, and/or policy makers who may benefit from those findings.

Non-responsive criteria:

• Applications proposing the following will be considered non-responsive and will not be reviewed by NIMH:
  • Applications that propose a clinical trial
  • Applications for HIV/AIDS that do not include an HIV prevention or treatment outcome

Office of Research on Women's Health (ORWH)

ORWH is part of the Office of the Director, NIH, and works with the 27 NIH Institutes and Centers to advance rigorous research of relevance to the health of women. ORWH does not award grants but co-funds women’s health-related applications and research projects that have received an award from one of the participating NIH Institutes and Centers (ICs) listed in the announcement. Applications seeking ORWH co-funding should ensure that the proposed work is aligned with at least one goal and objective outlined in the NIH-Wide Strategic Plan for Research on the Health of Women (https://www.nih.gov/women/strategicplan).

For this announcement, ORWH supports intersectional research projects centered on cisgender and transgender women, gender-diverse people, or people assigned female at birth.

Pre-Application Webinar

NINR held a Pre-Application Webinar for prospective applicants for the Axes Initiative on Tuesday, May 21, 2024. For applicants who were unable to attend the webinar, a recording is archived on the event website.

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

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

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

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.

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.

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 and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

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.

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.

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:

[email protected]

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

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.

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.

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:

The Research Strategy section must include the following information:

• Detail how the proposed research examines pathways and mechanisms through which social determinants of health (SDOH) impact health.
• Clearly describe the intersecting population(s) of interest.
• Indicate and discuss the intersectionality framework used to guide the project’s research questions and interpretations.
   

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.

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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

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 NOFO, note the following:

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 for Enhancing Diverse Perspectives affects the scientific merit of the project.

Reviewers will consider 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 factor score. 

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.

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.

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 policies and practices, 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 NOFO.

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 reviewers will not consider race, ethnicity, age, or gender of a researcher, award participant, or trainee, even in part, in providing critiques, scores, or funding recommendations. NIH will not consider such factors 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:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
  • HHS recognizes that NIH 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 NOFO.

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. 

Successful recipients under this NOFO agree that:

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and 
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

Not Applicable

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.

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: 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]

Dionne Godette-Greer, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-827-0095
Email: [email protected]

Gregory Greenwood, Ph.D.
Division of AIDS Research
National Institute of Mental Health
Telephone: 240-669-5532
Email: [email protected]

Jennifer Humensky, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
Telephone: 301-480-1265
Email: [email protected]

For inquiries related to the built environment and cancer, contact:

Behnoosh Momin, DrPH, MS, MPH
National Cancer Institute (NCI)
Telephone: 240-789-3981
Email: [email protected]

For inquiries related to the social environment and cancer, contact:

Amanda M. Acevedo, PhD
National Cancer Institute (NCI)
Telephone: 240-276-5896
Email: [email protected]

Elizabeth Anne Barr
ORWH - Office of Research on Women's Health
Phone: 301-402-7895
E-mail: [email protected]

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

Ron Wertz
National Institute of Nursing Research (NINR)
Telephone: 301-594-2807
Email: [email protected]

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: [email protected]

Crystal Wolfrey
National Cancer Institute
Telephone: 240-276-6277
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.

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.