Research to improve health and promote health equity in rural populations (R01 Clinical Trial Optional)

Research to improve health and promote health equity in rural populations (R01 Clinical Trial Optional) is sponsored by National Institutes of Health (NIH). This initiative supports research to develop, adapt, or implement intervention strategies addressing social determinants of health (SDOH) to improve health and promote health equity in rural populations, which experience high rates of morbidity, disability, and premature death.

Expired RFA-NR-24-005: Strategies to Improve Health Outcomes and Advance Health Equity in Rural Populations (R01 Clinical Trial Optional) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Nursing Research ( NINR ) National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS ) National Institute of Mental Health ( NIMH ) National Institute on Minority Health and Health Disparities ( NIMHD ) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.

The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research ( OBSSR ) Sexual and Gender Minority Research Office ( SGMRO ) Office of Nutrition Research ( ONR ) Funding Opportunity Title Strategies to Improve Health Outcomes and Advance Health Equity in Rural Populations (R01 Clinical Trial Optional) R01 Research Project Grant March 12, 2024 Pre-Application Webinar for RFA-NR-24-005: Strategies to Improve Health Outcomes and Advance Health Equity in Rural Populations (R01 Clinical Trial Optional).

See Notice NOT-NR-24-008 August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity See Part 2, Section III. 3.

Additional Information on Eligibility. Assistance Listing Number(s) 93. 361, 93.

242, 93. 307, 93. 846 Funding Opportunity Purpose The purpose of this initiative is to support research to improve health and promote health equity in rural populations.

Rural populations experience high rates of many causes of morbidity and disability, and high and increasing rates of premature death. Meaningful and sustained improvements in the health of rural populations require effective solutions to address the underlying causes.

Applications responding to this Notice of Funding Opportunity (NOFO) should develop, adapt, or implement intervention strategies addressing social determinants of health (SDOH) to improve health and promote health equity in rural populations.

This funding opportunity encourages studies that use a wide range of methodological approaches that enhance access to, and acceptability and effectiveness of, interventions in rural populations, such as community-engaged research approaches that build on the strengths of rural communities.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn. Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material .

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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).

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

Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide , follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information 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 Rural Americans make up around 20% of the U.S. population. By multiple measures, adults and children living in rural areas have worse health than those living in more urbanized areas. Adults are more likely to die from the five U.S. leading causes of death (heart disease, cancer, accidental injuries, chronic lower respiratory disease, and stroke) than their urban counterparts.

Children in rural areas are less likely to be vaccinated and their parents are more likely to report difficulties meeting basic needs. Many resources to protect and improve health across the lifespan are less available to rural populations than more urbanized populations. Rural communities across the U.S. are diverse and vary greatly in multiple ways that impact health.

Social determinants of health (SDOH) ( https://www. ninr. nih.

gov/researchandfunding/nih-sdohrcc#tabs2 ), or 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, vary across geographies from neighborhoods to regions and nations.

SDOH include the quality and affordability of available food and housing, access to healthcare, employment opportunities that provide a living wage, and telecommunication and transportation infrastructures that facilitate access to resources needed to support health, wellbeing, and economic prosperity.

These and other SDOH influence individual and family circumstances like low income and food insecurity that, through a variety of pathways, influence health in rural communities and contribute to health inequities for marginalized rural populations, including people of color, immigrants, sex and gender minority people, and people with disabilities.

Understanding that social determinants of health can promote, maintain, or hinder health, research is needed to advance solutions that leverage those factors that have positive impacts, as well as mitigate or eliminate factors with negative impacts on rural health. Many interventions that address social determinants of health are developed, tested, and implemented only in urbanized areas.

Relatively few researchers seek to develop, adapt, and/or implement interventions designed specifically to meet the needs of people living in rural communities. The 2021 National Academies report on Population Health in Rural America focused attention on the changing demographics and social determinants of health in rural America.

The need for implementation of evidence-based strategies to improve rural health was highlighted, and there was a call for research that addresses social factors and health needs, as well as the gaps in the healthcare system. Other recent reports in the health research literature, and the NIH Rural Health Day Seminars ( https://videocast. nih.

gov/watch=48966 ), have emphasized the need for research to incorporate innovative research designs and approaches relevant to rural communities. This funding opportunity will support research to develop, adapt, or implement intervention strategies addressing SDOH to improve health and promote health equity in rural populations.

Research must address social determinants of health, along with community priorities, needs, and preferences, in the development, adaptation, or implementation of interventions. Interventions or implementation strategies seeking to either mitigate or eliminate the impacts of adverse social determinants of health and/or bolster positive social determinants of health are of interest.

Investigators are encouraged to leverage community strengths in intervention design. Community-based participatory research (CBPR) or other community-engaged approaches may be useful for understanding community priorities, needs, and preferences, as well as for leveraging strengths of and knowledge embedded in rural communities.

Research studies should seek to improve health outcomes and must be guided by a conceptual framework that identifies hypothesized pathways between the intervention and health outcome(s). The primary outcome may reflect health or functional status, health conditions, quality of life, well-being, morbidity and mortality, and/or health behaviors.

Individual-, population-, system-, and multi-level interventions could be responsive to this NOFO. Successful, evidence-based interventions may be adapted to specific rural communities and tested for acceptability and efficacy or effectiveness. Pragmatic and implementation studies are welcome, including hybrid effectiveness/implementation studies of adapted interventions or intervention bundles.

Examples of topics of interest include, but are not limited to: Intervention studies focused on improving outcomes in conditions or risks that occur at higher rates in rural populations Development, adaptation, and implementation of interventions that address social determinants of health ( https://www. ninr. nih.

gov/research/nih-sdohrcc#tabs2 ) in marginalized populations living in rural or remote areas of the United States such as migrant workers, immigrants, people with disabilities, racial and ethnic minority groups, people of low income, and sexual and gender minority groups Implementation studies to advance the reach, effectiveness, and sustainability of evidence-based interventions in rural communities or in identified marginalized rural populations Adaptation of technologies to address structural barriers to health in rural areas (e.g., healthcare resource shortages and telecommunication limitations that affect access to specialty care or pharmacy services) Interventions that seek to improve health by addressing limited access to healthy foods, places for physical activity, or housing options in rural communities Studies that develop, test, and/or implement firearm injury prevention intervention(s) to address the disproportionate burden of morbidity and mortality due to firearm injury in rural communities Service and care models that build upon places of social interaction in rural communities, such as churches, schools, libraries, and grocery stores Non-Responsiveness Criteria Applications that are deemed non-responsive will not be reviewed.

This includes: Applications that do not include a Plan for Enhancing Diverse Perspectives Applications to study populations or regions outside the United States Research projects that do not include a U.S. rural population. For the purposes of this NOFO, rural population is defined as: individuals living or working in a rural area, or communities or systems located in a rural area.

Rural areas are defined according to the Health Resources & Services Administration (HRSA) definition : All non-metro counties, as defined by the Office of Management and Budget; all metro census tracts with Rural-Urban Commuting Area (RUCA) codes 4-10; and large area metro census tracts of at least 400 square miles in an area with population density of 35 or less per square mile with RUCA codes 2-3; and outlying metro counties without a UA.

For more detail on the addition of outlying metro counties, read the Federal Register Notice, Revised Geographic Eligibility for Federal Office of Rural Health Policy Grants . The HRSA Rural Health Grants Eligibility Analyzer can be used to determine which counties and locations are rural areas. HRSA also provides data files to identify rural areas by county, census tract, and those using a zip code approximation.

Remote areas, defined by USDA Frontier and Remote (FAR) Area Code 4, are considered both rural and remote; therefore, the definition of rural above will be used for eligibility. The USDA provides data files and maps using the FAR codes. Rural and remote areas may include American Indian and/or Alaska Native Tribal populations.

Research projects that do not include a health outcome as the primary outcome Research projects that do not address social determinants of health as conceptualized by the NIH Applications that do not include a conceptual framework that identifies hypothesized pathways between the intervention and outcome(s) Construction and major renovations costs are unallowable through this RFA.

Applications that propose to use grant funds to support construction or major alteration and renovation projects will be considered non-responsive.

Areas of Interest of Participating Institutes, Centers, and Offices (ICOs) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases.

Research areas include rheumatology, orthopaedics, dermatology, metabolic bone diseases, heritable disorders of bone and cartilage, inherited and inflammatory muscle diseases, and sports and rehabilitation medicine.

In the context of this NOFO, the NIAMS is interested in applications that support the exploration of strategies to address social determinants of health to improve quality of health and promote equity in rural populations in the NIAMS mission-relevant disease areas. Research in community health care settings is particularly encouraged. Clinical trial applications will not be supported for this NOFO.

Applicants interested in clinical trials should visit the NIAMS clinical research website where a list of current NIAMS clinical trials specific NOFOs is available: https://www. niams. nih.

gov/grants-funding/conducting-clinical-research/investigator-clinical-trial-policies . Applicants are encouraged to discuss potential applications with the appropriate NIAMS program director.

National Institute of Mental Health (NIMH) Develop and test new mental health preventive, treatment, and services interventions and/or strategies for implementing interventions with established effectiveness, with a focus on the challenges faced in rural areas as primary mechanisms (factors that impact the useability of evidence-based practice, cultural fit of these practices, implementation and access barriers, and service/system challenges, such as workforce limitations).

Develop and test multi-level mental health interventions that address structural, system and policy challenges that contribute to mental health disparities. Identify rural area factors that mediate or moderate intervention and/or implementation effectiveness.

Examine/adapt parameters of evidence-informed lethal means safety interventions (e.g., dose, duration, method of administration) that impact generalization of efficacious interventions to rural practice settings.

Investigate whether and to what extent financing mechanisms, policies, regulations, and healthcare system rules optimize patient-level outcomes, and identify mutable factors and policy interventions that can improve mental health outcomes in rural areas. All applications that propose clinical trials should follow the NIMH’s experimental therapeutics approach to intervention development and testing (see https://www. nimh.

nih. gov/funding/opportunities-announcements/clinical-trials-foas/index. shtml ).

That is, the scope of work should include specification of targets/mechanisms (for intervention testing) and societal factors/system factors (for service and implementation studies) and assessment of intervention induced changes in the presumed targets/mechanisms/societal/system factors that are hypothesized to account for the intervention’s outcomes and access to the intervention.

Depending on the research question, a variety of methodologically rigorous approaches may be indicated.

For example, for studies that involve testing and comparing alternative strategies, designs may include randomized controlled trials (RCTs) and variants (e.g., stepped wedge cluster randomized trial designs), quasi-experimental designs with non-randomized comparison groups, time-series designs, and other designs of equivalent rigor and relevance.

Considerations for selecting a research design for the proposed study include the scientific question that the study is designed to answer, practical constraints, ethical issues, and the tradeoff between maximizing internal and external validity; the design that is proposed should be justified, accordingly, in the application.

NIMH is committed to supporting research that reduces disparities and advances equity in mental health interventions, services, and outcomes.

Accordingly, this NOFO encourages research studies that examine approaches that can be used to reduce disparities for racial and ethnic minority groups, individuals limited by language or cultural barriers, sexual and gender minorities, individuals living in rural areas, socioeconomically disadvantaged persons, persons living with disabilities, and other underserved groups.

NIMH encourages a deployment-focused model of intervention and services design and evaluation that takes into account the perspective of relevant stakeholders (e.g., service users, providers, administrators, payers) and the key characteristics of the settings (e.g., resources, including workforce capacity; existing clinical workflows) that are intended to implement optimized mental health interventions.

This attention to end-user perspectives and characteristics of intended clinical and/or community practice settings is intended to ensure the resultant interventions and service delivery strategies are acceptable to consumers and providers, the approaches are feasible and scalable in the settings where individuals are served, and the research results will have utility for end users.

NIMH encourages research on potentially scalable preventive, therapeutic, and services interventions that focuses on practice-relevant questions. Accordingly, collaborations between academic researchers and clinical or community practice partners or networks are encouraged.

Studies should capitalize on practice infrastructure, including but not limited to SAMHSA-supported 988 Suicide and Crisis Lifeline services and training infrastructure, and when possible, NIMH encourages applications that leverage existing research resources (e.g., practice-based research networks such as the NIMH-sponsored Mental Health Research Network (MHRN), NIMH-supported ALACRITY and Practice-based Suicide Prevention Research Centers , institutions with Clinical and Translational Science Awards).

To facilitate the ultimate translation into practice, NIMH encourages research and clinical approaches that incorporate the use of routinely collected data (e.g., electronic medical records, patient registries, other administrative databases) to increase the efficiency of participant recruitment (i.e., more rapid identification and enrollment) to facilitate the collection of practice-relevant data (e.g., clinical characteristics; stakeholder-relevant outcomes, including mental health and general health care utilization; data on longer-term outcomes; data regarding the value and efficiency of intervention approaches).

AIDS-related applications will not be considered by NIMH for this RFA. National Institute on Minority Health and Health Disparities (NIMHD) The mission of NIMHD is to lead scientific research to improve minority health and reduce health disparities in populations that experience health disparities. Of specific interest are intervention studies that focus on the intersectionality of race/ethnicity and/or low SES with rural populations.

See https://jamanetwork. com/journals/jama-health-forum/fullarticle/2812750 for more information.

NIMHD encourages projects that use approaches encompassing multiple domains of influence (e.g., biological, behavioral, sociocultural, environmental, physical environment, health system) and multiple levels of influence (e.g., individual, interpersonal, family, peer group, community, societal) to understand and address health disparities in accordance with NIMHD Research Framework, https://www. nimhd. nih.

gov/about/overview/research-framework. html .

Sexual & Gender Minority Research Office (SGMRO) For this NOFO, SGMRO encourages research across the life course that explores and addresses the health needs of SGM populations living in rural settings to support the maintenance or improvement of health and health outcomes among SGM communities and SGM people who are members of other populations that experience health disparities and inequities.

When appropriate, SGMRO encourages consideration and incorporation of relevant concepts (e.g., minority stress, social safety, intersectionality, stigma), research strategies (e.g., community-led or -engaged research, trauma-informed research, strengths-based approaches), and frameworks (e.g., SGM Health Disparities Research Framework , NIMHD Research Framework ).

Plan for Enhancing Diverse Perspectives This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as described in NOT-MH-21-310 , 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 material .

The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions. See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. 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 number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. The National Institute of Nursing Research (NINR) intends to commit $3,000,000 in FY 2024 to fund 3-4 awards, depending on receipt of meritorious awards and availability of funds.

Application budgets are limited to less than $500,000 per year in direct costs, and need to reflect the actual needs of the proposed project. The scope of the proposed project should determine the project period. The maximum project period is 5 years.

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

Eligibility Information 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession 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 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 not allowed. 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 NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually .

The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process. The same UEI must be used for all registrations, as well as on the grant application.

eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.

Grants. gov – Applicants must have an active SAM registration in order to complete the Grants. gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role.

Obtaining an eRA Commons account can take up to 2 weeks. Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.

Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities , NOT-OD-22-019 .

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide . This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1. 2 Definition of Terms.

3. Additional Information on Eligibility 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 How to Apply - Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. 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: Chief, Scientific Review Branch All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO. 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 In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity.

The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section.

The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review.

Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to: Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based). Description of any planned partnerships that may enhance geographic and regional diversity.

Plan to enhance recruiting of women and individuals from groups historically underrepresented in the biomedical, behavioral, and clinical research workforce. Proposed monitoring activities to identify and measure PEDP progress benchmarks. Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.

Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds. Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s). Publication plan that enumerates planned manuscripts and proposed lead authorship.

Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds. For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative. nih.

gov/about/plan-enhancing-diverse-perspectives-pedp SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply - Application Guide must be followed. 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 ). 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.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: The Research Plan should indicate how the application addresses issues that are meaningful to rural communities, systems, or people.

The Research Plan should also describe the study team's expertise in conducting research in rural settings, as well as whether and how the team members from different backgrounds are included to enhance the success of the proposed research within rural communities.

The research plan must describe how social determinants of health and community priorities, needs, and preferences are integrated into the development, adaptation, or implementation of health interventions. The Research Plan should also describe the conceptual framework and hypothesized pathways between the intervention and improved health outcomes.

Finally, the Research Plan should address the feasibility of the proposed approach within the rural setting and the acceptability of the approach to rural populations. Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply