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.

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications for the Community Partnerships to Advance Science for Society (ComPASS) Coordination Center (CCC). The CCC will provide administration, coordination, data, and research capacity-building and training support to the ComPASS consortium. In addition to the CCC, the consortium includes Community-led, Health Equity Structural Intervention (CHESI) projects that intervene on structural factors that create and perpetuate health inequities and Health Equity Research Hubs to provide localized technical assistance to the community-led health equity structural interventions. This FOA seeks to fund a single Coordination Center as an integral part of the ComPASS Program.

Background

Despite longstanding investments to reduce and eliminate health disparities, racial and ethnic minority populations, and other NIH-designated populations with health disparitiescontinue to bear a disproportionate burden of adverse health outcomes across diseases and conditions. Health disparities are long-standing and deeply rooted in structures, systems, and policies that create social and economic advantage and disadvantage, limiting the optimization of health for racial and ethnic groups and other populations experiencing health disparities . These reinforcing and inequitable systems are the fundamental causes of poor and differential health outcomes and thus must be addressed to make meaningful and sustained improvements in health. Ultimately, a paradigm shift to advance health equity is required. In absence of this, we will continue to fall short in eliminating health disparities and creating a healthier nation for all.

Social determinants of health (SDOH) are a major contributor to health disparities and operate on a continuum from fundamental structural causes to individual and family circumstances. Structural SDOH reflect the economic and social resources and opportunities that influence an individual's access to health-promoting living and working conditions and to healthy choices (Braveman, 2011). Research identifies the conditions and environments in which people are born, grow, live, work, age, and play as critical SDOH that influence health outcomes across the life course. Meanwhile, individual-level SDOH comprise individual and family social and economic circumstances such as income, educational attainment, and housing. Addressing fundamental, structural causes of health disparities offers the greatest opportunity to advance health equity and eliminate health disparities and are consequently the focus of the ComPASS Program.

Structural Interventions and Multi-Sectoral Partnerships

To advance health equity, innovative structural interventions that attempt to alter the social, physical, economic, and/or political environments that influence health behaviors and outcomes are critical (Brown, et al., 2019). Such innovative intervention approaches provide opportunities to address the broader system and societal factors and conditions that influence the ability to live healthy lives. Structural interventions might include addressing the root causes of economic instability, limited educational and employment opportunities, and lack of community resources. To accelerate progress toward reducing health disparities and advancing health equity, research efforts must squarely focus on the structural drivers of health disparities that contribute to the disproportionate burden of disease among populations experiencing health disparities. Because structural factors span multiple sectors and systems, interventions must be created in partnership with organizations such as those within the areas of education, housing, transportation, commerce, agriculture, economic and urban development, justice, human and social services, clinical care and public health. Multisectoral partnerships that transcend historical siloes maximize the opportunity to address structural factors and advance health equity.

Community-Led Research

Community engaged approaches are recognized as key research strategies to address health disparities and advance health equity. Communities and researchers working collaboratively as equal partners, in all phases of the research process, enhances the quality of interventions and better ensures research questions, methods, and approaches are responsive to community needs, values, practices, and priorities. Research developed, implemented, and disseminated by community, changes the process by which research has traditionally been conducted and presents new opportunities to advance health for the impacted populations experiencing health disparities.

Community-led research requires a transformation in the processes and practices that govern research engagement. The traditional approach is one that involves academic organizations leading research efforts with engagement from community partners. This research opportunity is intended to foster community-led prioritization of research and structural health solutions in collaboration with researchers and other relevant partners. This unique approach of community organizations identifying and intervening on structural contributors to disease aligns with NIH’s goal to enhance acceptability and sustainability of effective interventions to improve health and sustain positive impacts.

The Community Partnerships to Advance Science for Society (ComPASS) Program

The Community Partnerships to Advance Science for Society (ComPASS) Program is intended to make greater advances in promoting health and preventing disease among disproportionately impacted populations. The impetus for ComPASS is the increasing recognition that advancing health equity is a complex challenge that extends beyond the reach of traditional health care settings, organizations, or research agendas. Rather than tackling health disparities by disease and condition or in a single population group, an NIH-wide strategy has been created within ComPASS to foster efforts to address structural causes of differential health outcomes, which will impact multiple diseases and conditions through several pathways.

ComPASS aims to be catalytic and cross-cutting in its integration of multisectoral partnerships, comprised of community organizations; local, state, Tribal, and federal governments; academic institutions and research organizations; and the private sector to address structural inequities that enable health disparities to persist. The program is transformative in its focus on structural health equity interventions given the evidenced impact of structural inequities on health outcomes. ComPASS will focus on cultivating community trust and partnerships, building research capacity among community and relevant partners, and enhancing community organization readiness and competitiveness for future funding, contributing to greater diversity and inclusion in research. ComPASS is intended to serve as an initial launch to a longer-term and sustained commitment to eliminating health disparities and advancing health equity through development, testing and implementation of structural interventions.

ComPASS Goals and Objectives

The first overall goal of the ComPASS Program is to catalyze, develop, and rigorously assess Community-led, Health Equity Structural Interventions that leverage multisectoral partnerships to advance health equity. A second overall goal of ComPASS is to develop a new health equity research model for community-led, multisectoral structural intervention research across NIH and other federal agencies.

Three initiatives will be used to achieve the ComPASS Program goals:

• The Community-Led, Health Equity Structural Interventions (CHESIs) will develop, implement, assess, and disseminate co-created community-led, health equity structural interventions in partnership with research organizations, by intervening upon structural factors that produce and perpetuate health disparities. Approximately, 20-25 CHESIs will be awarded.
• The ComPASS Coordination Center (CCC) will lead overall program management and coordination of administrative, data, capacity-building, partnership, training, and the National Health Equity Research Assembly (HERA) activities.
• The Health Equity Research Hubs (Hubs) will be funded in FY 2024 and provide localized technical assistance and scientific support, as well as partnership support and research capacity-building and training previously designed in collaboration with the CCC. Five Hubs will be awarded.

Through these initiatives, the ComPASS goals will be achieved by:

• Supporting community organizations and their research partners in co-creating research to evaluate community-led, health equity structural interventions.
• Engaging multisectoral partnerships, both locally and nationally, in advising, guiding, and sustaining the community-led health equity structural interventions.
• Building the research capacity in structural intervention research and implementation, community-led research, and sustainability among community organizations and their research partners.
• Developing methods for capturing social determinants of health information and collecting and analyzing data to evaluate outcomes from community-led health equity structural interventions.
• Disseminating promising approaches resulting from the community-led health equity structural interventions.

ComPASS Coordination Center (CCC) This Opportunity

The CCC will be responsible for managing cross-consortium functions, including effective communication, collaboration, and coordination across the CHESIs and Hubs. The Center will comprise three core functions, 1) administration and coordination; 2) data collection, management, and assessment, and 3) research capacity-building and training.

The administration and coordination function will focus on developing the overall organizational framework of ComPASS, providing and managing the administrative and logistical support for all program activities including the ComPASS consortium (i.e., CHESI awardees, the Hubs, and other scientists and groups as appropriate) in collaboration with NIH scientific staff, and fostering synergy across activities and functions. The data and assessment function will manage data infrastructure and collection; common data elements, in collaboration with the CHESI and Hub awardees; data harmonization; and data storing, access, security, and sharing for the ComPASS Program. The CCC will also assist in standardizing data analysis and monitoring data sharing progress. An additional function of the data core is to coordinate metadata/data models and/or provide a service that maps ComPASS data models to a common data model/schema that would facilitate the harmonization of ComPASS data across CHESI projects, assist projects with identifying appropriate repositories for the data, and with ensuring deposition of data to those repositories. All data collected as part of ComPASS activities will be used to achieve the overall goals of ComPASS and to determine health impacts. Also, the CCC is expected to publicly share de-identified data from the ComPASS Program in accordance with NIH Policy for Data Management and Sharing and the Responsible Management and Sharing of American Indian/ Alaska Native Participant Data. Dissemination of other material such as conceptual models, tools, and resources will align with the CCC milestones. The purpose of the research capacity-building and training function is to enhance the capabilities of community organizations and their partners to conduct health equity structural intervention research in collaboration with relevant multisectoral entities and to make meaningful positive impacts on improving health outcomes among populations with health disparities. This function will identify and facilitate common research capacity-building and training needs and opportunities for CHESI awardees and their research partners to support the planning, implementation, assessment, and dissemination of the CHESIs projects.

Central to the CCC is the establishment and management of the National Health Equity Research Assembly (HERA). The National HERA will comprise an invited group of federal and non-federal members such as those in the transportation, housing, urban planning, and public health sectors to provide vital consultation on the development and implementation of the CHESI projects. These national level representatives will facilitate successful research collaborations and opportunities as well as consult on the sustainability of the interventions and their potential policy levers. Local HERAs will also be established by the CHESIs, based on consultation from the National HERA and the needs of the specific CHESI. Each intervention project will have a local HERA comprised of Tribal (as appropriate), state, regional, local government, and relevant private sector partners to provide contextualized support to guide the development, implementation, assessment, dissemination, and sustainability of the interventions at the local level.

Administration and Coordination

The administration and coordination function includes facilitating the work of the ComPASS consortium in collaboration with NIH scientific staff for the overall management of the ComPASS Program. Specific responsibilities will include, but are not limited to the following:

• Provide leadership, expertise, and project management of ComPASS administration, reporting, coordination, engagement, outreach, dissemination, and sustainability activities.
• Establish and initiate the ComPASS consortium and National HERA and create a governance structure to organize how the entities will operate (e.g., roles and responsibilities, decision-making).
• Support collaboration and communication among the ComPASS CHESI PIs, NIH Program Staff, the ComPASS Steering Committee (ComPASS PIs and NIH Program Staff), ComPASS Executive Committee (Steering Committee Co-Chairs and NIH Program Staff), Data Safety and Monitoring Board (DSMB) if needed, the National HERA, other ComPASS committees and/or Work Groups to be determined, and logistics and management support such as organizing meetings and maintaining quality documentation, tracking, and reporting of collaboration and communication activities.
• Develop administrative and organizational structures and processes (e.g., for publications) for the management of administration, communication, coordination, and data functions and to promote multisectoral partnerships, collaboration, dissemination/outreach, and effective planning activities for community-led structural intervention research.
• Provide scientific and technical assistance to CHESI awardees for intervention planning and dissemination activities (e.g., intervention planning, human subjects, and measurement).
• Develop a compendium of structural intervention strategies, policies, and programs identified from the existing evidence-base and the National and Local HERAs that will support the CHESI planning process.
• Develop a health equity research model to advance community-led multisectoral structural intervention research across federal agencies.
• Plan, facilitate, and manage ComPASS consortium annual meetings (in-person or virtual, as appropriate).
• Maintain quality documentation of ComPASS activities and prepare and distribute reports and data summaries to consortium members, NIH Program Staff and Project Scientist(s), and other identified partners on progress, publications, presentations, and innovations across the CCC.
• Provide technical assistance to the CHESI awardees and the Hubs in facilitating ComPASS-wide capacity-building and intervention assessments.
• Develop and facilitate topic-specific and relevant Communities of Practices (CoPs) and peer mentoring opportunities to support and enhance partnership, community/partner engagement, data handling and processing, and other activities relevant to the planning, implementation, and assessment of community-led, health equity structural intervention research.
• Coordinate activities between the Hubs to ensure optimal management, cross-collaboration, and shared resources and tools.
• Develop and implement a quality and modern Information Technology system to support all phases and activities of ComPASS.
• Support the Institutional Review Board (IRB) process for the CHESI awards. The CCC will assist awardees and their partners in identifying an IRB (e.g., research partner’s IRB, Tribal IRB, school district IRB, Health Equity Research Hub IRB, or an independent IRB that supports research conducted by community organizations). In this capacity, the CCC will create a process to streamline protocol development by creating a standardized template, providing technical support for developing the intervention protocol, and by developing other processes and tools as necessary.
• Develop and manage Data Safety and Monitoring Boards for the CHESI projects if needed.

Data Collection, Management and Assessment

The data and assessment function will manage data infrastructure, collection, integration, storing, security, access, sharing, and analysis for the ComPASS Program. Data collected from ComPASS activities and awardees will be used to study program goals, inputs, activities, outputs, and impacts.

Specific responsibilities will include, but are not limited to the following:

• Provide leadership and expert coordination, collaboration, and technical assistance to support all ComPASS-wide data activities.
• Data Collection and Sharing: Develop and implement a data collection and sharing protocol, in accordance with NIH policy, that includes a collaborative decision-making process with CHESI projects and the development of necessary agreements to include Tribal IRB agreements and approved Tribal data management and sharing plans. The CCC must establish appropriate data sharing policies and data access procedures consistent with the provision of data to the public with a minimal embargo period, taking all steps needed to protect the information while maximizing accessibility. The CCC should be prepared for handling datasets with different access requirements (i.e., controlled access and open-acess) and to work with different classes of users. Applicants are expected to implement already established authorization and authentication services, such as the NIH Research Auth Service (https://datascience.nih.gov/researcher-auth-service-initiative).
  • Implement standard ontologies, terminologies, and controlled vocabularies for use across ComPASS. Monitor data sharing activities to ensure effective data management practices and maximization of appropriate sharing of scientific data generated from the ComPASS Program. See NOT-OD-21-013: Final NIH Policy for Data Management and Sharing and NOT-OD-22-064: Responsible Management and Sharing of American Indian/ Alaska Native Participant Data for additional details. Implement quality assurance policies and procedures for ComPASS research and data activities.
• Common Data Elements: Identify, coordinate the development of, and collect common data elements (CDEs) from CHESIs that can be used in models, schemas, and ontologies to standardize the collection of common measures on SDOH, health outcomes, and other important variables across CHESI projects and to make program generated the datasets harmonized and interoperable. All data, CDEs and data repositories/models/schemas must be created in close collaboration with all consortia members. Refer to the PhenX SDOH Toolkit for examples of SDOH and other related measures.
  • Assist awardees with defining and measuring common health outcomes (e.g., primary and secondary).
• Data Analysis: Develop and implement a data analysis plan to conduct ComPASS-wide analyses (e.g., descriptive, comparative, cross-intervention, and mechanistic).
  • Support any comparative and ComPASS-wide analyses and provide additional expertise to Hubs, as needed.
  • Provide methodological and statistical consultation on cross ComPASS consortium project design and analytics, as needed.
• Data Quality: Develop and document the necessary management and distribution infrastructures to support data entry, verification, quality control, data validation (data checking and query resolution), and data integrity for all CHESI projects.
  • Create and implement infrastructures, plans, policies, and agreements for data management, storage, quality control, documentation, use, and access.
  • ComPASS website: Create content for the ComPASS public-facing website that will be used to share program updates and opportunities for data collaboration and sharing of relevant initiative resources. Also, develop a password-protected portal for use by only ComPASS awardees to facilitate controlled access to the ComPASS data, collaboration, information sharing, and partnership activities. Establish a ComPASS intervention tool that will share promising and successful CHESI intervention strategies, programs, policies, and health equity research models on the public-facing website.
  • Prepare CCC-specific internal and public-facing data reports and summaries for distribution to consortia members, NIH staff, other identified partners, and the general public.
• Data Security: Monitor and manage data security. Data security encompasses confidentiality, data integrity, availability, and use. Data security protection and proper stewardship of human, clinical, and other sensitive information stored and distributed is of the utmost importance. The NIH security best practices and provisions should be implemented to protect the privacy and confidentiality of research participants and prevent unauthorized data access.
• Establish and maintain Data and Safety Monitoring Boards for CHESI projects, if needed.
• Create and implement an assessment plan and conceptual framework/logic model to study ComPASS Program activities at the local/community, Hub, and CCC/National HERA levels and corresponding health and policy impacts. The plan should also include an annual assessment of successful and effective engagement across and between the CHESIs, CCC, and Hubs.

Research Capacity-Building and Training

The research capacity-building and training function will develop, identify, and facilitate common research capacity-building and training of ComPASS awardees and their research partners to support the capacity of community organizations and their partners to lead the development, implementation, and assessment of community-led structural interventions and to foster future capacities to conduct health equity research.

Specific responsibilities will include, but are not limited to the following:

• Conduct a research capacity-building and training needs assessment with ComPASS awardees and their research partners to identify training needs and opportunities (e.g., didactic, experiential, and community-based) to facilitate and support all phases of ComPASS.
• Use needs assessment results, and in collaboration with NIH Program Staff and Project Scientist(s), develop and implement virtual and in-person, research capacity-building training and curricula that provide technical assistance and scientific support in multidisciplinary knowledge, skill-building, and educational areas. These trainings may include, but are not limited to implementation science; health equity structural intervention design, approaches, frameworks, and conceptual models; structural racism; cultural and implicit bias; scientific writing and presenting; community-led and -engaged research; program evaluation; effective science and health communication; and study design and analytic approaches to assess multi-level interventions (e.g., group- or cluster-randomized trials, stepped wedge group- or cluster-randomized trials, group- or cluster regression discontinuity designs, econometrics, interrupted time-series, and others).
  • Trainings should be team-based and interdisciplinary in focus and can include receipt of a certificate of completion or documentation to demonstrate training competency. Additionally, experiential, continuing education, and other professional development opportunities will be available to CHESI awardees and their research partners.
• Prepare and distribute CCC-specific reports and data summaries to consortia members, NIH Program Staff and Project Scientist(s) and other partners on research capacity-building and training innovations and progress.
• Develop and share capacity-building and training content, curricula, knowledge, skill-building, and educational resources on the ComPASS public-facing website.
• Provide coordination support to the Hubs on the development and implementation of research capacity-building, training, and technical assistance needed to support specific intervention activities associated with the respective Hub.

First Year Planning Activities

First year planning activities include, but are not limited to:

• Developing consortium committees, structures, policies, and procedures for the smooth governance of all ComPASS committees.
• Developing administrative and organizational structures and processes for ComPASS communication, coordination, partnership, and data functions.
• Developing the logistics, infrastructures, governing principles, and procedures to facilitate and sustain the National HERA.
• Developing a ComPASS communication plan to ensure seamless communication and coordination across all initiatives and Committees.
• Developing a ComPASS data plan including data collection, management, sharing, storage, access, quality control, analysis, and security activities.
• Developing a ComPASS technical assistance plan.
• Providing scientific support and technical assistance to awardees in structural intervention and study design development.
• Developing a planning guide for ComPASS awardees to use during the intervention planning phase.
• Developing and implementing a ComPASS research and capacity-building plan that includes identifying and providing research and capacity-building trainings for ComPASS awards and research partners.
• Developing a ComPASS public-facing website.
• Developing a ComPASS-wide assessment plan.
• Developing a detailed timeline with concrete milestones for all ComPASS goals, objectives, and activities.
• Planning and facilitating ComPASS kick-off and annual meetings.

Formation and Governance of the ComPASS Consortium

The consortium comprises the three ComPASS initiatives: the CCC, CHESI projects, and the Hubs. Immediately following the award, the PDs/PIs and NIH Program Staff will form the ComPASS Steering Committee (SC). Consortium governance rests with the Steering Committee and the SC is subject to oversight by the NIH Common Fund. Consortium members are expected to participate in the development of consortium-wide policies and abide by all policies developed by the SC and approved by NIH staff. The SC, and in particular the co-chairs of the SC, will work cooperatively and interactively, during all phases of the ComPASS program to promote collaboration, and information and resource sharing across the ComPASS Program.

Technical Assistance Webinar

All applicants are strongly encouraged to contact NIH Staff to discuss the alignment of their proposed work with the goals of this FOA and the overall ComPASS Program. A Technical Assistance Webinar will be held for potential applicants from 3:00PM Eastern to 4:00PM Eastern Time on November 10, 2022. NIH staff will be available to answer questions related to this FOA. Webinar information will be shared on the ComPASS website and slides will be made available on the website for those unable to attend.?A list of frequently asked questions (FAQs) related to the program will also be available on the ComPASS website. The information session is open to all prospective applicants and participation is not required to apply.

Key Definitions for this FOA

Community Organization: A non-Federal, non-academic, non-research organization that provides 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, public health departments, regional/local and public healthcare systems, school districts, law enforcement or criminal/juvenile justice agencies, social service agencies, or departments of commerce, labor, transportation, housing, recreation. Governmental organizations at the local, regional, tribal, or state level fall within this definition. It is important to note that academic research centers, academic healthcare organizations, and private healthcare organizations do not fall within this definition and would not be eligible for this opportunity.

Community Engaged Research: Research that requires working collaboratively with and through those who share similar situations, concerns, or challenges in the research process (NAM, 2022).?Approaches to community engagement include participatory action research, community-based participatory research, team science, empowerment evaluation approaches, community asset mapping, and citizen science.

Health Disparity: A health disparity is a health difference that adversely affects disadvantaged populations, based on one or more of the following health outcomes (Minority Health and Health Disparities: Definitions and Parameters:

• Higher incidence and/or prevalence and earlier onset of disease
• Higher prevalence of risk factors, unhealthy behaviors, or clinical measures in the causal pathway of a disease outcome
• Higher rates of condition-specific symptoms, reduced global daily functioning, or self-reported health-related quality of life using standardized measures
• Premature and/or excessive mortality from diseases where population rates differ
• Greater global burden of disease using a standardized metric

Health Equity: Health equity is when every person has a fair and just opportunity to attain their full health potential and no one is disadvantaged from achieving this potential because of social position or other socially determined circumstances (Health Equity | CDC).

NIH-designated Populations that Experience Health Disparities: Racial and ethnic populations, less privileged socioeconomic status (SES), underserved rural populations, sexual and gender minorities (SGM), and any subpopulations that can be characterized by two or more of these descriptions. (Minority Health and Health Disparities: Definitions and Parameters.)

Social Determinants of Health (SDOH): Social determinants of health (SDOH) encompass both structural and individual factors. Structural factors include are the conditions and the environments in which people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks. Healthy People 2030 groups SDOH into five domains: economic stability; education access and quality; health care access and quality; neighborhood and built environment; and social and community context. (Healthy People 2030).

Structural Interventions: Interventions that attempt to change the social, physical, economic, or political environments that may shape or constrain health behaviors and outcomes, altering the larger social context by which health disparities emerge and persist. (Structural Interventions to Reduce and Eliminate Health Disparities).

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

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

Section III. Eligibility Information

1. Eligible Applicants

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

• U.S. Territory or Possession

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• 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 full SAM and 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 his/her 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.

Together, the CCC PI(s) and staff should have relevant expertise that must include statistics and/or econometrics, data and compute platform development and data and team science. The team may include experts in community-based participatory research, community-engaged research, health equity, health disparity, research capacity-building and training as well as experts in experimental and quasi-experimental study design and implementation. Together, the CCC PI(s) and staff should have the following minimum qualifications of experience and expertise:

• Planning, developing, and executing multiple community-based studies, and the special consent and IRB procedures needed for the conduct of structural-level and community-engaged/led intervention research.

• A broad range of clinical trial study design (i.e., experimental and quasi-experimental design and implementation) and statistical expertise (e.g., econometrics), particularly with health disparity, health equity and community-engaged/led intervention research.

• Designing data collection and management systems, including distributed data entry, and capabilities and experience with research performance and data quality control systems.

• Project management and knowledge of workflow and research team practices in the planning and implementation of community clinical trials.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 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 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 FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Shalanda Bynum, Ph.D., M.P.H.
National Institute of Nursing Research (NINR)
Email: CFComPASS@od.nih.gov

Page Limitations

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

Instructions for Application Submission

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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:

• Each applicant should submit base budget estimates for all years including budgets for staff/personnel including biostatistical and data science support for data activities including scientific manuscript development.
• Support for the activities of the Steering Committee, National HERA, data repository, IRB support and the DSMB through provision of materials/documentation support, meeting planning (including annual meetings), logistics, and conference call coordination.
• Include travel costs for the Center PIs and key personnel of the CCC to attend annual ComPASS consortium meetings.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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 and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.

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.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Applicants should discuss items such as, but not limited to the following:

Significance

• Outline and describe the goals and significance of the CCC and its role in achieving the overall objectives of the ComPASS Program.
• Identify any challenges for the ComPASS intervention projects and the CCC and propose strategies for addressing these challenges.

Research Strategy

• Describe approaches, plans, and strategies on how the proposed CCC will fulfill core CCC functions as described in Section I. Funding Opportunity Description, including leading and coordinating the administration and coordination activities and the National HERA; data coordination, collection, management, and assessment; capacity-building and training activities; and supporting outreach, project collaboration, and partnership activities.
• Describe how the CCC will advance the planning and development of CHESI projects.
• Describe how the CCC will assess ComPASS activities, develop an evidence-based framework/model, and disseminate resources and tools for developing and implementing (disease-agnostic) structural level interventions to address health disparities and advance health equity.
• Describe how the CCC will ensure effective and impactful coordination and implementation of administrative, Committee, data, and evidence-based research capacity-building and training activities including annual meetings and other necessary elements.
• Describe the overall design and structure of the CCC including its management structure (e.g., subawards and consultants), integration of components and any possible subcontracts (especially with community-based organizations with specific expertise in this area) needed to manage and facilitate the ComPASS Coordination Center and Consortium.
• Provide an organizational chart of the tasks for what will be accomplished overall and for each CCC function and the types of staff associated with each task and their respective roles and responsibilities.
• Describe any relevant expertise and resources proposed for fulfilling the role of and accomplishing the goals of the ComPASS Coordination Center.
• Demonstrate the availability of infrastructure, capabilities, resources, and institutional support needed to achieve the goals of the ComPASS Coordination Center are available. (e.g., Information Technology capacities to effectively perform data activities and develop and disseminate virtual training modules). The plan should also demonstrate that the infrastructure and personnel (e.g., coordinating and contracting outside the entity) are readily available to accomplish the objectives and activities of the CCC.
• Describe and demonstrate prior experience in oversight of community-based/engaged/led clinical trials and projects; development of data resources, management platforms, computational analysis, common data elements, and data repositories; experience in capacity-building and training related to health disparity and community-engaged intervention research; and management of administrative logistics and outreach/dissemination activities.
• Describe any special strengths of the PD/PI or the Institution that would be relevant to the CCC role in the ComPASS Program.
• Describe the Resource Sharing Plan and discuss how the Plan aligns with NIH requirements.

Milestones and Timeline: In addition, a timeline (or Gantt chart) including milestones is required for all applications. Milestones are intermediate steps towards the completion of concrete goals. They must include clear and quantitative criteria for success. Yearly specific and quantitative milestones are required in order to provide clear indicators of a project's continued success or emergent difficulties and will be used to evaluate the application not only in peer review but also in consideration of the awarded project for funding of non-competing award years. The application should include clearly specified, well-defined milestones, quantitative go/no go decision points, and timelines for assessing progress. The milestones and timeline should be included as an attachment, filename labeled as "Milestones and Timeline" and submitted under the Other Attachments section of the R&R Other Project Information form.

Multiple PD/PI Leadership Plan

Include a plan for multiple PD/PI leadership for the CCC, if applicable. Provide specific details for each PD/PI role and their responsibilities.

Letters of Support

Include letters of support from partnering institutions, appropriate leaders of institutional component services, Tribal communities, or outside collaborators/subcontractors with clear statement of roles/responsibilities. The application must include a statement from the applicant institution (senior institutional official) describing the commitment to the planned program, senior and junior investigators, all proposed staff, and infrastructure needed. Submitted letters should directly demonstrate the ability of the proposed coordination center to fulfill the roles and responsibilities specified in this funding opportunity announcement.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

The Resource Sharing Plan will be evaluated as part of the Approach criterion. In the Resource Sharing Plan, applicants should indicate a statement of willingness to abide by all policies related to resource sharing developed by the ComPASS Steering Committee and approved by NIH staff. Awardees are expected to develop such policies as members of the ComPASS Steering Committee in collaboration with NIH and should indicate their willingness to participate in the development of such policies and to abide by them. These policies will remain consistent with NIH policies on data and resource sharing.

NIH's vision for the CCC is that it will become a long-term resource of high value to the larger biomedical community. It is therefore important that the CCC is built to be portable and sustainable. Programmatic preference will be given to designs that can easily be transferred and maintained beyond this funding cycle. Applicants are asked to describe a vision for how the valuable resources generated by the program can be maintained beyond the funding period as part of the application.

Also, include information in the Resource Sharing Plan on the following:

• Public Access: The NIH Common Fund intends to maximize the availability of publications and the sharing of underlying data for the ComPASS Program and encourages publication of preprints and the use of open access journals. Applicants should describe their proposed process for making resulting publications and to the extent possible, the associated data immediately and broadly available to the public or provide a justification if such sharing is not possible. Underlying primary data are expected to be made as widely and freely available as possible while safeguarding the privacy of participants and protecting confidential and proprietary data. Applicants are encouraged to use existing, open licensing approaches and preprint repositories, and may include anticipated charges for publication or data sharing and resources that may be needed to support a proposed Resource Sharing Plan in the budget plan of their application.
• Data Security: Data security encompasses confidentiality, data integrity, and availability. Confidentiality includes managing data access to maintain data security and making data accessible to authorized users only for authorized purposes. Data security protection and proper stewardship of human genomic, phenotypic, clinical, and other sensitive information stored and distributed is of the utmost importance. The NIH security best practices and provisions should be implemented to protect the privacy and confidentiality of research participants and prevent unauthorized access to data. Investigators are expected to develop policies and procedures for notifying NIH, managing, and mediating any loss of data or compromise of data confidentiality.
• FAIRness: Implementation of FAIR (Findable, Accessible, Interoperable, Reusable) Principles is essential for the success of ComPASS. Consistent with achieving these principles, the NIH expects that information such as collected data, technical protocols, and any other metadata collected under this FOA is to be rapidly deposited as appropriate into the ComPASS Coordination Center (CCC) and in a recognized and reusable format. The CCC must establish appropriate data sharing policies and data access procedures taking all steps needed to protect the information while maximizing accessibility and make the data available to the public as promptly as possible consistent with the provision of minimal embargo periods. Applicants should describe their plan for sharing and documenting data, metadata, protocols, software code and algorithms, while ensuring that privacy and confidentiality of participants/donors. The CCC will serve as the central access point for information regarding data and tools being developed by the ComPASS Consortium. The Consortium will be expected to work closely with the Common Fund Data Ecosystem (https://www.nih-cfde.org/) to adopt and implement existing standards (as applicable) selected by CFDE for data sharing, privacy preservation, de-identification, genomic and phenotype harmonization, and other data standards as feasible. Programmatic priority will be given to applications that utilize, harmonize, or build on the tools, schema and standards used by CFDE as well as other similar NIH programs and international organizations such as the NIH Cloud Platform Interoperability (NCPI) and the Global Alliance for Genomics and Health (GA4GH). It is expected that the CCC will meet periodically with CFDE program leaders to ensure these tools, schema, and standards are being implemented appropriately to assess FAIRness and ensure data and resources from ComPASS are interoperable with other Common Fund resources. In addition, NIH staff will work closely with ComPASS awardees to leverage other NIH initiatives such as the Researcher Auth Service (https://datascience.nih.gov/researcher-auth-service-initiative).
• Sustainability: Applicants are asked to describe a vision for how the valuable resources generated by the program can be maintained beyond the funding period as part of the application.

After initial review, NIH staff will conduct an administrative review of the Resource Sharing Plan and may negotiate modifications to the plan with the prospective awardee. The final negotiated plan will become a term and condition of award.

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.

Delayed Onset Study

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

PHS Assignment Request Form

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

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to 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 Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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 FOA 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 SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

Use of Common Data Elements in NIH-funded Research

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

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.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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

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

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 policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

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

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

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

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
  
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

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

The following special terms of the award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 75, 2 CFR 200, and other HHS, PHS, and NIH grant administration policies.

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

1. PD(s)/PI(s) Responsibilities:

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

• All aspects of the study, including determining/modifying approaches, designing protocols, proposing project milestones for the core CCC functions, and overseeing the conduct of the CCC activities.
• Working with the CHESI PIs to establish a data collection timeline and maintain quality control.
• Planning/coordinating and facilitating meetings of the Steering Committee, National HERA, ComPASS Coordination Center Executive Committee, and other subcommittees or Work Groups as needed, one of which is an annual meeting (conditions permitting) in Bethesda, MD.
• Preparing abstracts, presentations, and publications and collaborating with all ComPASS awardees on making the public and research and academic professionals aware of the program.
• Establishing reporting timelines and providing periodic reports and data in a timely fashion and in standard format, as agreed upon by the ComPASS Executive Committee and NIH.
• Adhering to the NIH policies regarding intellectual property, data security and release, and other policies that might be established during the ComPASS Program.
• Submitting updates to NIH Program Officers(s), Project Scientist(s) and the Common Fund on progress and problems.
• Participating as voting member(s) of the ComPASS Program Steering Committee.
• Implementing guidelines and procedures developed by the ComPASS Program Steering Committee.
• Participating in teleconferences with NINR program staff, as needed.
• Retaining custody of and have primary rights to the data, technologies, and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
• Being prepared for annual administrative site visits or virtual visits by NIH staff.
• Agreeing to participate in the collaborative activities of the consortium and agreeing not to disclose confidential information obtained from other members of the consortium including, without limitation, unpublished data, informatics tools, protocols, data analysis, confidential exchanges between members of the consortium, as well as any confidential information received by third party collaborators.
• Supporting the registration of clinical trial studies through ClinicalTrials.gov (https://clinicaltrials.gov/).

In addition to standard annual Research Performance Progress Report (RPPR) submissions, Principal Investigators may be expected to supply additional progress-related information to the National Institute of Nursing Research (NINR).

Common Fund and NINR program staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

2. ComPASS Coordination Center: Committees

Specific responsibilities of the NIH will include the following:

Definitions:

• ComPASS Coordination Center Executive Committee (EC): The PIs of the CCC and involved NIH staff as Program Officials (POs) and Project Scientists (PSs) will form the CCC EC. The CCC EC will guide the activities of the CCC.
• ComPASS Steering Committee (SC): The PIs of the ComPASS Community-led, Health Equity Structural Intervention, the Coordination Center awards (the Health Equity Research Hubs in Year 2) and involved NIH staff acting as Program Officials (POs), Project Scientists (PSs) and the OSC Program Leader will form the ComPASS Steering Committee which will govern the activities of the program recipients. The ComPASS Steering Committee will be coordinated and administrated by the CCC. The SC will work cooperatively and interactively, during all phases to promote collaborations, as well as information and resource sharing across the ComPASS program. The co-chairs will be independently appointed by the NIH in collaboration with the ComPASS SC. The SC co-chairs will preside at all SC meetings. Scientific direction will be in compliance with NIH research policies and procedures. The governance structure will be co-created by SC members and NIH staff. For votes, the CCC award will have one vote and each Community-Led Health Equity Structural Intervention award will have one vote. All Federal staff together will have one vote. The SC will review and approve policies and procedures developed by the SC. The SC decisions will be made by a majority vote. The SC will include the Health Equity Research Hubs, which, together, will have one vote. The Health Equity Research Hub awards begin 1 year after the formation of the SC.
• ComPASS Consortium: ComPASS awardees, the NIH Working Group and other relevant scientists and groups the SC agrees to include within the consortium. The consortium structure is meant to efficiently and effectively guide all the funded projects to meet the overall goals of the ComPASS Program.

For this award, NIH staff has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

NIH Program Officer (PO) - The primary PO will be from NINR and will be responsible for the normal scientific and programmatic stewardship, including monitoring progress and compliance with general statutory, regulatory, or policy requirements; discussing and approving milestones and significant changes to the project; and technical assistance to correct performance and facilitate interactions. The PO must approve in advance and in writing annual milestones and any significant changes to the award. The PO also has the option to recommend, following consultation with the Project Scientist(s), External Program Consultants or the NIH Working Group, restricting an award based on progress towards milestones and implementation of policies or collaboration between members of the consortium, or generation of data or resources for use by consortium members or the wider community. The secondary PO will be a Program Leader from the Common Fund Data Ecosystem (CFDE) program, who will be responsible for data oversight of the CCC. This PO will provide programmatic stewardship on data collection and management activities and consult with the primary PO on monitoring progress and compliance for these activites. This PO will also ensure effective collaboration between the CCC and the CFDE program to ensure tools, schema, and standards are being implemented appropriately to ensure data and resources from ComPASS are interoperable with other Common Fund resources and that FAIR principles are adhered to by the CCC. The Program Officers will not co-author publications with the CCC PIs. The program officer from NINR will also be responsible for making funding recommendations and otherwise providing programmatic approvals and recommendations, following consultation with the secondary program officer. POs will have programmatic authority, including fiscal oversight, over the CCC and receive input from other NIH staff acting as Project Scientists. POs will closely monitor progress of all the awards made in their initiative and report back as part of the Work Group meetings.

NIH Project Scientist (PS) At least three NIH Program Staff will serve as Project Scientists (PSs) for the CCC. There is one PS for each of the three core functions of the CCC: 1) administration and coordination, 2) data management and assessment, and 3) research capacity-building and training. The PSs will serve as the scientific representatives of the NIH to the investigators under the policies and procedures of the other transactions and cooperative agreement mechanisms. The PSs will provide substantial NIH scientific, programmatic involvement with the awardee that is anticipated during the performance of the activities supported by a cooperative agreement, including reviews of milestones. The PSs will work closely with the PO, the Steering Committee, and the PIs of CHESI projects to maximize progress towards the goals of the program. It is expected that the PSs will participate in teleconferences with PDs/PIs and key personnel of the CCC and attend relevant ComPASS meetings in-person or virtually. Consistent with ICO publication policies, PSs may contribute, as appropriate, to scientific manuscripts and other scientific and scholarly activities (e.g., oral presentations, poster presentations) resulting from the ComPASS Program.

Additionally, an agency program official or IC program director will be responsible for the standard scientific and programmatic stewardship of the award and will be named in the award notice.

The NIH Program Official(s) may recommend the termination or curtailment of an activity in the event the proposed activities fail to evolve within the intent and purpose of this initiative.

Areas of Joint Responsibility include:

The establishment of the National HERA represents an area of joint responsibility. The National HERA will serve in a consultative role by advising the CCC on structural interventions, data resources, grant activities and innovations. The CCC will coordinate regular meetings of the National HERA. At the regular National HERA meetings, the CCC will share CHESI project information to support identifying potential synergistic research collaborations and opportunities between National HERA members and CHESI projects. The CCC will record and disseminate minutes from the National HERA meetings to the Steering Committee. The CCC will consider all suggestions provided by the National HERA to achieve ComPASS Program goals.

Also, close interaction among the participating investigators will be required, as well as significant involvement from the NIH, to manage, assess, and support the ComPASS program. As part of the Consortium’s SC, awardees agree to governance, through voting and decision making. The CCC will facilitate monthly meetings of the Steering Committee. One of these meetings must be an in-person meeting, travel conditions permitting, in Bethesda, MD or surrounding areas. Frequency of meetings in succeeding years may be adjusted by the Steering Committee at the beginning of each budget period. The CCC leadership will be required to accept and implement policies approved by the Steering Committee

Conflict/Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the 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.

3. 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.

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. NIH FOAs 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 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

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: http://grants.nih.gov/support/ (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: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Shalanda A. Bynum, Ph.D., M.P.H.
National Institute of Nursing Research (NINR)
Telephone: 301-755-4355
Email: shalanda.bynum@nih.gov

Center for Scientific Review (CSR)
Email: FOAReviewContact@csr.nih.gov

Brian Albertini
National Institute of Nursing Research (NINR)
Telephone: 301-594-6869
Email: albertib@mail.nih.gov

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 45 CFR Part 75 and 2 CFR Part 200.