Clinical-Community Linkages to Address Unmet Social Needs and Adverse Social Determinants of Health to Advance Health Equity among Populations Experiencing Health Disparities: The Bridge-to-Care Initiative (R01 Clinical Trial Optional)

Clinical-Community Linkages to Address Unmet Social Needs and Adverse Social Determinants of Health to Advance Health Equity among Populations Experiencing Health Disparities: The Bridge-to-Care Initiative (R01 Clinical Trial Optional) is sponsored by National Institutes of Health (NIH).

This initiative aims to advance research that leverages healthcare-community partnerships to address unmet health-related social needs among individuals and families and adverse social determinants of health (SDOH) within communities. It supports projects that reimagine traditional care delivery to include social context, making meaningful improvements in health, eliminating health disparities, and advancing health equity.

Expired RFA-NR-24-003: Clinical-Community Linkages to Address Unmet Social Needs and Adverse Social Determinants of Health to Advance Health Equity among Populations Experiencing Health Disparities: The Bridge-to-Care Initiative (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 ) 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.

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention ( ODP ) Sexual and Gender Minority Research Office ( SGMRO ) Funding Opportunity Title Clinical-Community Linkages to Address Unmet Social Needs and Adverse Social Determinants of Health to Advance Health Equity among Populations Experiencing Health Disparities: The Bridge-to-Care Initiative (R01 Clinical Trial Optional) R01 Research Project Grant 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 Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) Funding Opportunity Purpose Care delivery has traditionally approached a patient’s health as separate and distinct from their social context. This practice must be reimagined to make meaningful improvements in health, eliminate health disparities, and advance health equity.

The purpose of the Bridge-to-Care Initiative is to advance research that leverages healthcare-community partnerships to address unmet health-related social needs among individuals and families and adverse social determinants of health (SDOH) within 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) 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 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. 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 Innovative systems and models of healthcare delivery that holistically consider the context of people’s lives and living conditions have the potential to significantly improve health, especially among populations disproportionately impacted by adverse social determinants of health (SDOH).

This funding opportunity solicits research to advance the development and expansion of interventions and programs that leverage existing or create new healthcare-community partnerships to address unmet health-related social needs among individuals and families and adverse SDOH within communities.

Partnerships might include, for example, a collaboration between a community clinic and a food bank to address food insecurity, or a partnership between an urgent care facility and a community-based violence prevention organization to prevent or mitigate the health sequela of violence within a defined geographical area.

Bridge-to-Care invites applications focused on improvements in a broad range of health outcomes that reflect health or functional status, health conditions, quality of life, morbidity and mortality, and/or health behaviors. Linkage to or utilization of social services to address social needs or SDOH are not acceptable outcomes for this funding opportunity, but could be studied as mechanisms by which health outcomes are achieved.

This initiative focuses on populations that experience health disparities, including racial and ethnic minority populations, people with lower socioeconomic status, underserved rural populations, sexual and gender minority populations, people with disabilities, and any subpopulations that can be characterized by the intersection of two or more of these descriptors.

Key Definitions for This NOFO Healthcare-community partnership refers to a mutually beneficial process of working collaboratively with and through organizations that provide clinical care and organizations that provide goods, services, resources, and support within a defined community.

Effective partnerships do not serve simply as referral mechanisms to resources and services, but rather as mutually beneficial and equitable collaborations with shared goals.

Healthcare organizations include any organization where patients get physical or behavioral healthcare, including but not limited to Federally Qualified Health Centers (FQHCs) and other community clinics, school-based health centers, public health departments, primary care or urgent care facilities, hospitals, free and charitable clinics, mobile clinics, Veteran Administration facilities, and correctional healthcare clinics.

Community organizations refer to non-academic organizations that provide goods, services, support, resources, or advocacy to members of a defined community. Examples include community or faith-based organizations, local businesses, neighborhood authorities and associations, labor unions, patient or consumer advocacy groups, school districts, law enforcement or criminal justice agencies, or social service agencies.

Governmental organizations at the local, regional, tribal, state, or federal level fall within this definition. Social needs are individual- or family-level prioritized social factors such as low income, food insecurity, social isolation, or housing instability.

Social needs-targeted care refers to activities in clinical settings that seek to address patients’ social needs directly—for example, helping patients access income assistance if they lack financial resources, or linking them with transportation, food, or housing support.

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. There is increased recognition that healthcare alone cannot address the full range of factors that influence health.

SDOH have profound and prolonged influences on the ability to attain optimal health across a wide range of health, functioning, and quality of life outcomes. Unmet social needs are associated with poor health outcomes, reduced use of primary and preventive care, and increased use of urgent and emergency care.

The Centers for Medicare & Medicaid Services (CMS) recommends that healthcare organizations move towards an improved model of care that integrates services and resources that promote health and address the factors that limit its optimization.

Innovating and reimagining how care is delivered and the role of healthcare organizations in addressing population health offers a greater opportunity to holistically meet the needs of individual patients, their families, and the communities that they serve. To accomplish this goal more effectively, healthcare-community partnerships are emerging as a critical way to advance health and health equity.

Such partnerships better enable healthcare organizations to comprehensively address patient and population health by offering services that are otherwise unavailable in the clinical setting or by collaboratively creating new health-promoting resources within communities. In turn, community organizations continue to fulfill their mission by expanding the opportunity to improve the lives of the people that they serve.

It is important to note that effective community partnerships do not serve simply as referral mechanisms to resources and services, but rather as mutually beneficial and equitable collaborations with shared goals. Social needs-targeted care is a strategy that can be more widely implemented to improve health within patient populations.

This strategy leverages the clinical encounter to address patients’ social needs related to food, housing, income, transportation, and other factors.

A growing number of healthcare organizations have incorporated social needs screening and referral into routine care, but this practice is infrequent, especially in low-resourced healthcare settings; is inconsistently implemented; and does not demonstrate effective partnerships with community organizations in efforts to better ensure that needs are met.

There is also an opportunity for healthcare organizations to address SDOH to make a broader impact on improving health and advancing health equity for the populations that they serve. A review of literature outlining investment in programs to address SDOH found that an increasing number of healthcare organizations are committing to community programs and efforts that address conditions of daily living.

Despite these efforts, there is limited evidence on the impact of such programs on improving health outcomes and limited consideration about opportunities for their widespread adoption and sustainability. To more fully realize the potential of healthcare-community partnerships to advance health and health equity, gaps in scientific knowledge around effectiveness and implementation must be closed.

Specifically, the literature illuminates the need to expand understanding of the health impact of leveraging healthcare-community partnerships to address social needs and SDOH.

There is also a need for research to help guide healthcare organizations to move beyond social needs resource lists to increased coordination and provision of holistic care by leveraging existing or creating new services and resources within the clinical or community setting.

In addition, rigorous research is needed, for example, to identify the best implementation strategies to address social needs in low-resourced healthcare settings where a large proportion of patients experiencing unmet social needs might seek care. The Bridge-to-Care Initiative aims to fill these scientific knowledge gaps.

Bridge-to-Care will support research that leverages healthcare-community partnerships to address the social circumstances and conditions that influence health. Studies must be guided by a conceptual framework identifying hypothesized pathways between the intervention or program and outcome(s). Research designs that allow for the assessment of mechanisms through which the intervention or program impacts health outcomes are encouraged.

Specific studies of interest include: Intervention research to address unmet health-related social needs and adverse SDOH in the clinical or community setting by linking to existing services and resources or by collaboratively creating new health-promoting services and resources.

Evaluation research that assesses the health impact of existing or upcoming interventions and programs that leverage healthcare-community partnerships to address individual or family unmet health-related social needs or adverse SDOH within communities.

The populations of focus for this initiative are those experiencing 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, people with disabilities, and any subpopulations that can be characterized by the intersection of two or more of these descriptors.

Partnerships : Bridge-to-Care requires the establishment, expansion, and/or evaluation of healthcare-community partnerships to enable the effective and efficient ability to address individuals’ and families’ unmet health-related social needs and adverse SDOH within communities.

Effective partnerships do not serve simply as referral mechanisms to resources and services, but rather as mutually beneficial and equitable collaborations with shared goals. Community partners can include, but are not limited to, those in the housing, transportation, food system, economic development, education, social services, and criminal legal system sectors.

Applicants should provide details on the nature and extent of their partnerships, including clearly describing the roles of partners and providing evidence of support from partner organizations. Primary Outcome : All studies must explicitly examine the impact of the intervention or program on a health outcome.

Health outcomes may reflect health or functional status, health conditions, quality of life, morbidity and mortality, and/or health behaviors. Linkage to social services or utilization of services to address social needs or SDOH are not acceptable outcomes for this funding opportunity but could be studied as mechanisms.

Individual- or Family-Level Social Needs Interventions: Studies examining the health impact of new or adapted interventions conducted in healthcare settings, in partnership with community organizations, that screen for patient or family health-related social needs (e.g., food, utilities, housing, transportation, employment, education, financial strain, safety) and aim to address unmet patient or family social needs.

Examples of projects supported in this category include, but are not limited to, leveraging existing or creating new healthcare-community partnerships to develop and assess the effectiveness of social-needs targeted care interventions that promote health by: Utilizing a community health worker, navigator, or case manager to facilitate the provision of social needs care for patients and/or their families Addressing food insecurity at the patient or family level Focusing on the prevention or treatment of intimate partner violence Focusing on the additive and synergistic health effects of addressing one or multiple unmet social needs Utilizing implementation science to identify, understand, and develop strategies for overcoming barriers to the adoption, adaptation, integration, scale-up, and sustainability of social needs programs in clinical settings Interventions to Address SDOH: Studies that leverage healthcare-community partnerships to improve health by addressing adverse SDOH within communities.

This may include new or adapted interventions focused on expanding the availability and accessibility of community-level social and economic resources or reducing exposure to community-level hazards. Primary health outcomes in this category should be assessed at the individual level, and secondarily at the community level, if appropriate.

Examples of projects supported in this category include, but are not limited to, studies that develop and evaluate the effectiveness of interventions that leverage healthcare-community partnerships to promote health by: Advancing the availability of affordable nutrient-rich food in the community Improving the availability or quality of green spaces or recreational spaces Improving community conditions through community revitalization investment projects Improving economic stability, such as through increased job opportunities or quality employment Improving housing access, quality, or affordability Improving education quality and completion Reducing community-level violence, including firearm violence Evaluation of Interventions/Programs to Address Social Needs or SDOH: Studies that evaluate the health impact of existing or upcoming interventions or programs at the federal, tribal, state, local, or organizational level that leverage healthcare-community partnerships to address individual or family unmet health-related social needs or adverse SDOH within communities.

Programs of interest include those aimed at addressing social needs related to food insecurity, housing instability, and/or economic circumstances or programs to address adverse SDOH within communities to mitigate the impact of concentrated poverty, neighborhood violence, education quality, employment opportunities, etc. Examples of projects supported in this category include, but are not limited to studies that evaluate: Health impacts of demonstration projects aimed at addressing social needs or SDOH Health impacts of new standards of care, changes in health insurance coverage, expansion of access to social services, and other factors that influence social needs or SDOH Effects of programs designed to improve access to or quality of housing, transportation, and food on health within communities Health impacts of infrastructure changes related to housing, transportation, the food environment, or the built environment on health outcomes Non-Responsive Applications Studies considered non-responsive for this announcement are those that: Do not focus on a health outcome - Linkage to or utilization of social services to address social needs or SDOH are not acceptable primary outcomes Do not include a healthcare-community partnership Do not focus on a population at higher risk of morbidity or mortality based on race, ethnicity, SES, rurality, sexual orientation, and/or ability status Do not incorporate a conceptual framework Do not include a Plan for Enhancing Diverse Perspectives Focus on populations outside of the U.S. 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.

Technical Assistance Webinar NINR will hold a Pre-Application Webinar for prospective applicants for the Bridge-to-Care Initiative on Thursday, February 15, 2024 from 1:00–2:00pm ET. Please register to attend the webinar at https://us02web. zoom.

us/webinar/register/WN_MIH0VGSMQM-uOQp7aea4XA#/registration . Attending the technical assistance webinar is encouraged for all potential applicants, but is not required for submission of an application. Prospective applicants are also encouraged to reach out to the NIH staff listed on this funding opportunity with specific questions.

For applicants unable to attend the webinar, a recording will be archived on the event website . 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 SF424 (R&R) 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. NINR intends to commit $4 million in FY 2024 to fund 4-6 awards.

Application budgets are not limited but need to reflect the actual needs of the proposed project. Although application budgets are not limited, applicants proposing budgets of $500,000 or more in direct costs in any one year (excluding consortium F&A) are strongly encouraged to discuss the research project application with the listed NINR Scientific/Research Contact before submitting the application.

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 allowed. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. 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 SF424 (R&R) 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 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: National Institute of Nursing Research (NINR) 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 SF424 (R&R) Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide must be followed. 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 SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: 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 SF424 (R&R) 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 SF424 (R&R) Application Guide, with the following additional instructions: If you answered “Yes” to the question “Are Human Subjects Involved?

” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed. PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM) See Part 2. Section III.

1 for