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

The purpose of The Interventions that Address Structural Racism to Reduce Kidney Health Disparities Funding Opportunity Announcement (FOA) is to support Intervention Sites that will work collaboratively with a Research Coordinating Center (RCC) in a Consortium to develop and test meaningful interventions that aim to dismantle or mitigate the effects of structural racism to reduce kidney health disparities.

Background

Dismantling structural racism and mitigating its harmful social consequences are essential to achieve health equity for people with kidney disease. Structural racism is widely and increasingly recognized as a fundamental cause of the stark racial and ethnic disparities in health outcomes for individuals with chronic kidney disease (CKD) and end-stage renal disease (ESRD) in the United States. Specifically, Blacks/African Americans, Native and Hispanic Americans, as well as Native Hawaiian and Pacific Islanders, experience a disproportionate burden of CKD and ESRD, including more rapid progression from CKD to ESRD, higher incidence and prevalence of ESRD, and lower rates of home dialysis and transplantation.

Structural racism is embedded in societal, institutional, organizational, and governmental systems through formal and informal processes, procedures, and practices, limiting opportunities and resources to marginalized racial and ethnic communities. As a result, these marginalized racial and ethnic groups experience greater exposure to adverse social determinants of health (SDOH). SDOH, defined by the World Health Organization as the conditions in which people are born, grow, work, live, and age, span multiple domains, including economic stability, education access and quality, healthcare access and quality, neighborhood and built environment, and social and community context (https://health.gov/healthypeople/priority-areas/social-determinants-health). Adverse SDOH, or social risks, lead to poor outcomes in CKD (and other disease areas) by reducing access to health promoting resources and increasing risk of detrimental exposures. Specific social risks of interest in CKD and ESRD include, but are not limited to, residential segregation, housing insecurity and inadequacy, food insecurity, inadequate health care, limited access to transportation, and financial resource deprivation, among many others.

Research is urgently needed to develop, implement, and evaluate interventions that address social risks and the upstream unjust systems, policies, and laws that generate and perpetuate social and health inequities in marginalized racial and ethnic populations with CKD and ESRD. Because structural racism operates across multiple socioecological levels (e.g., individual, interpersonal, community, societal) and impacts multiple domains (e.g., biological, behavioral, socio-cultural, environmental, physical environment, health system), interventions must be designed and implemented across multiple socioecological domains and levels of influence to mitigate structural racism and the social and health inequities it perpetuates.

Additionally, authentic engagement and meaningful partnership with communities who experience structural racism are essential to effective health equity interventions. Failing to ensure research is founded on the wishes and realities of the people who will be most affected by the intervention(s) may ultimately produce more harm than benefit. In addition, community-engaged research brings to bear the lived experience and expertise of the affected communities, which may yield interventions that are more likely to be appropriate, acceptable, and feasible.

Key Definitions for the FOA

Structural Racism refers to the Totality of ways in which societies foster racial discrimination, through mutually reinforcing inequitable systems (in housing, education, employment, earnings, benefits, credit, media, health care, criminal justice, and so on) that in turn reinforce discriminatory beliefs, values, and distribution of resources, which together affect the risk of adverse health outcomes . (Bailey ZD et al, Lancet. 2017; 389:1453-1463)

NIH-designated Racial/Ethnic Groups who experience Health Disparities include American Indians/Alaska Natives, Asian Americans, Blacks/African Americans, Hispanics/Latinos, and Native Hawaiians and Pacific Islanders (see https://www.nimhd.nih.gov/about/overview/).

Multi-level refers to the multi-dimensional framework of determinants relevant to understand minority health and address health disparities. This concept is further described under the National Institute of Minority Health and Health Disparities Research Framework (https://www.nimhd.nih.gov/about/overview/research-framework/).

Intervention refers to a manipulation of the subject or subject's environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. (https://grants.nih.gov/policy/clinical-trials/glossary-ct.htm#I)

Research Scope and Objectives

The Interventions that Address Structural Racism to Reduce Kidney Health Disparities FOA invites applications for Intervention Sites that will conduct one or more studies and will work collaboratively with a Research Coordinating Center (RCC) in a Consortium. The Consortium will support community-engaged clinical trials to test novel interventions that dismantle or mitigate the effects of structural determinants that perpetuate inequities in the care and outcomes of people living with kidney disease. Studies proposed by successful applicants may be substantially revised by the Steering Committee prior to being undertaken by the Consortium, including the potential of harmonizing intervention components and data collection measures across Intervention Sites. The Consortium also will help to foster collaborations between investigators with expertise in kidney health disparities and health equity research and patients, community members, community-based organizations, and other key stakeholders.

This FOA is intended to support clinical trials that propose to test community-engaged interventions that aim to dismantle structural racism or mitigate its effects in one or more marginalized NIH-designated Racial/Ethnic Groups with a high burden of kidney disease disparities, including disparities in social and health risks, care, and outcomes. Applicants are strongly encouraged to propose multi-level, multi-component interventions that encompass multiple domains and multiple levels. Applications should provide clear justification of how the proposed intervention dismantles or mitigates the effects of structural determinants that perpetuate inequities in the social and health risks, care, and outcomes of people living with kidney disease. Applications are strongly encouraged to employ an antiracism lens to guide their intervention development and implementation. In addition, the proposed intervention(s) should be guided by thoughtful consideration of strategies to foster rapid dissemination and implementation of the intervention(s) into clinical and/or community practice, which may be accomplished through use of a theoretical/conceptual dissemination & implementation framework.

Applications are expected to use community engagement approaches in designing and implementing the study and to clearly describe the process they will use to facilitate meaningful sustainable collaboration and authentic partnerships with patients, caregivers, community members, community-based organizations, clinicians, advocacy groups, and other relevant stakeholders throughout the research process. Applicants should describe in detail the role and extent of partnerships. Applicants are strongly encouraged to propose sustainable interventions that address one or more issues considered to be a high priority for the community/ies most affected by the intervention(s), to include implementation strategies that are adaptable and responsive to community needs, and to include effective communication and dissemination activities to inform the community of the project and its findings. Study budgets should include funds for community collaborations and partnerships to be fully engaged in the research design and implementation, as appropriate.

Applications should include a multidisciplinary research team with diverse perspectives and backgrounds (https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp) and with relevant expertise, which may include nephrologists, social scientists, behavioral medicine experts, healthy equity and disparities researchers, public health practitioners, biostatisticians, ethicists, clinical trialists, people with kidney disease, and community-based organization representatives. At least one principal investigator named on the grant should have substantial experience in community-engaged health equity research. Applicants should have a history of successful recruitment and retention of participants within the populations of focus.

To facilitate establishing common data elements (CDE) for the Consortium, applicants are strongly encouraged to consider use of the PhenX Social Determinants of Health (SDOH) Assessments Collection (https://www.nimhd.nih.gov/programs/collab/phenx/) and the NIH CDE repository (https://cde.nlm.nih.gov/home).

Types of interventions to consider include, but are not limited to:

• Multi-level, multi-component interventions that address structural racism to reduce kidney health disparities across multiple domains [health insurance coverage, availability and accessibility of health care services, organizational structure/culture/priorities, financial/provider incentives, delivery of health services/models of care (e.g., self-management support or training; use of patient navigators or community health workers; telehealth services; clinicians/staff-patient interactions that promote trust, respect, enhanced communication, education, or shared decision making), social medical care integration] to improve health care outcomes.
• New or adapted programs, interventions, organizational or local policies or implementation strategies of evidence-based interventions or practices that address structural racism and/or mitigate adverse social and environmental factors resulting from structural racism (e.g., economic instability, food insecurity, housing insecurity, transportation, access to health care, etc.) in community or clinical settings for people living with kidney disease.
  

Primary and secondary outcomes may include, but are not limited to:

• Patient-centered and psychosocial outcomes: changes in patients perceptions of health-related quality of life, symptom control, psychosocial status, functional status, or social support; patient activation, self-efficacy, kidney health knowledge/awareness; interactions with health systems (trust/respect/satisfaction); patients perceptions of discrimination, levels of stress or allostatic load.
• Health and behavioral outcomes: changes in access to care; medication/treatment adherence; achievement of kidney-related health targets or achievement of care goals; cardiovascular risk factors; and kidney health measures.
• Organizational and community-level outcomes: changes in health and social disparities or changes in health system norms/practices relevant to kidney health and health care.
• Implementation measures: acceptability, adoption, fidelity, and/or sustainability of the intervention(s).
  

Design, analysis, and sample size for studies:

Projects should utilize rigorous research designs (e.g., randomized controlled trials, stepped wedge designs, multiphase optimization strategy (MOST) designs, pragmatic clinical trials, interrupted time series, dynamic wait list design, hybrid effectiveness-implementation designs, sequential multiple assignment trial (SMART) designs, and adaptive designs). Group and individual randomization may not be feasible in nor acceptable to participants in some community-based interventions among populations who experience health disparities or express research distrust. Applicants should use methods that are appropriate given their plans for assignment of participants and delivery of interventions.

Applications must include a Plan for Enhancing Diverse Perspectives (PEDP) submitted as Other Project Information as an attachment (see Section IV). 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 (https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp).

Applications Not Responsive to this FOA

Applications that include the following types of projects will be considered nonresponsive and withdrawn:

• Projects that do not focus on individuals or populations with CKD or ESRD.
• Projects without a primary focus on addressing structural racism within NIH-designated racial/ethnic groups with marked disparities in the US.
• Projects that conduct research in communities or settings without a high burden of kidney health disparities.
• Projects that do not propose intervention research (e.g., observational study).
• Projects that are exclusively qualitative.
• Projects that do not demonstrate a strong equitable relationship or engagement strategy with populations and stakeholders of interest (e.g., patients, community organizations, health care systems, and other institutions).
• Projects testing novel drug therapies, such as Phase 1-3 drug studies.
• Studies using animal models.
• Projects that propose data collection or testing of interventions outside of the U.S.
• Projects that include prohibited policy lobbying or advocacy activities (see https://grants.nih.gov/grants/lobbying_guidance.htm for more information).
• Projects that do not include a data sharing plan with the Research Coordinating Center.

Applicants are strongly encouraged to contact and discuss their proposed research/aims with Program staff listed on this FOA well in advance of the application receipt date to better determine appropriateness and interest.

This award will include up to 1 year for planning activities to foster authentic community engagement/partnership and demonstrate applicant’s capacity to achieve project goals:

• Establish community advisory board
• Refine patient and community-stakeholder-engaged research needs
• Facilitate authentic engagement and collaboration with people with kidney disease, caregivers, and other community members in all aspects of research process
• Study protocol(s) finalized by the Steering Committee
• Demonstrate capacity to implement the intervention(s), finalize protocol, and achieve approval from the Institutional Review Board (IRB) and the Data Safety Monitoring Board (DSMB)
  

Consortium Structure

The Intervention Site and RCC investigators will work closely together to achieve the goals of the Consortium, including the design, planning, execution, and analysis of one or more interventions. Studies proposed by the successful applicants may be substantially revised prior to being implemented regarding the research project(s) to be undertaken by the Consortium, including the potential of harmonizing intervention components and data collection measures, or developing a unifying study across Intervention Sites. Patient, community, and/or other key stakeholders at the local and national level will be involved in the planning and execution of studies. The final study protocol(s) will be designed by the Intervention Sites and RCC Principal Investigators and approved by the Steering Committee, then the DSMB and the NIDDK, and then submitted for IRB review and approval.

Intervention Sites

The responsibilities of each Intervention Site are: recruitment of participants for the intervention study or studies; engagement of patient, community members and other relevant stakeholders in all aspects of the research process; local institutional review board (IRB) review and approval (or single IRB approval/reliance as appropriate) of final study protocol(s)); collection of data according to the approved protocol(s), initial quality control of data, timely transmission of data to the RCC (where not otherwise prohibited such as by Tribal sovereignty); analysis, interpretation and publication of study data; and participation in Steering Committee meetings and meetings with the Data Safety and Monitoring Board (DSMB) and the NIDDK.

Research Coordinating Center (RCC)

The RCC will be responsible for the overall organization, research coordination, data management (including quality assurance and quality control), and data analyses for the Consortium. The RCC will have a lead role in collaborative efforts to develop and refine the final study design(s) and protocol(s) for the Consortium projects, which may include the potential of harmonizing intervention components and data collection measures to be implemented at each of the Intervention Sites or developing a unifying study across all Intervention Sites; and obtaining single IRB approval/reliance, as appropriate, of final study protocol(s). The RCC applicants should have well-documented experience in managing multi-center, multi-institutional clinical trials and should include research and training expertise in interventional research, implementation science, community-engagement, health equity research, and kidney research.

Administration and Meetings

Data Safety and Monitoring Board (DSMB)

A DSMB will be appointed by the NIDDK at the beginning of the funding period, to provide input on the study design(s) and protocol(s) prior to their implementation. The DSMB will monitor the research efforts and the safety and progress of the studies. The DSMB will advise primarily the NIDDK as well as the Consortium investigators. The DSMB will include experts from multiple disciplines with relevant expertise, which may include health equity and disparities researchers, biostatisticians, nephrologists, primary care clinicians, social scientists, behavioral medicine experts, ethicists, people with kidney disease, and/or others with relevant expertise. The DSMB will review study protocols prior to implementation and will monitor study progress and safety of the participants in the studies (including quality assurance/quality control metrics, recruitment, study feasibility, and stopping criteria).

Steering Committee (SC)

The SC will consist of Program Directors/Principal Investigators (PDs/PIs) from each of the sites and the NIH Project Scientists, as well as at least one patient participant representative appointed by NIDDK. The SC will hold regular meetings as determined by needs of the Consortium. It will designate subgroups and working groups and all PDs/PIs are expected to participate actively in these groups. The Steering Committee will serve as the governing body of the Consortium and decisions will be determined by majority vote, including decisions to accept the final protocols and other actions pertaining to the governance, design and implementation of matters pertaining to the Consortium and the successful achievement of the goals of the FOA (see section VI, #2, Cooperative Agreement Terms and Conditions of Award Areas of Joint responsibility). SC responsibilities include providing input on and approval of all studies developed by Consortium members prior to study implementation; review and approval of all data analyses, public presentations and publications of research conducted within the Consortium; and development of policies and procedures for submission and approval of research applications using Consortium resources.

Community Advisory Committee (CAC)

The Intervention Sites and RCC will each identify at least two representatives of the population most affected by the interventions to serve on a CAC, which will provide feedback to the Consortium regarding the design and conduct of the studies. At least one NIDDK and one RCC member will staff the CAC.

Executive Committee (EC)

An EC will be comprised of the Steering Committee Chair, RCC PDs/PIs, NIH Program Staff, and a patient representative. Additional Project site investigators and other support personnel may participate in the EC as needed. The Executive Committee will make operational decisions for the Consortium between SC meetings by means of weekly conference calls.

Awardees will meet to finalize the Consortium study protocol(s). Both Intervention Sites and RCC awardees and Community Advisory Council should be prepared to participate in conference calls immediately after funding and should plan to attend the first Steering Committee meeting in the Bethesda, Maryland / Washington DC area or virtually, if necessary, in July/August 2023.

Subsequent 1-2 day in-person or virtual SC meetings will be conducted every 3-4 months for the first year and twice yearly or more often as needed thereafter in the Bethesda MD / Washington DC area or virtually. Applicants should budget accordingly.

Awardees must agree to abide by the Network Duality of Interests Policy and Procedures and may need to develop procedures to require study investigators and others associated with the study to identify financial and other conflicts of interest on a routine basis, at least annually, and to share this information with the NIDDK Program staff.

Alignment with NIDDK Strategic Plan and Priorities

This FOA aligns with the Mission and Vision of the NIDDK Strategic Plan for Research, including the theme of empowering a multidisciplinary workforce, engaging diverse stakeholders, and pursuing pathways to health for all. Specifically, this FOA aligns with the Scientific goals 2, 3, and 4 and Cross-cutting topics of reducing health disparities and increasing health equity among racial and ethnic minority populations and others who are underserved and strengthening research workforce diversity and training.

The NIDDK strongly encourages Research on Sex/Gender Differences, Sexual and Gender Minority-Related Research and Race/Ethnic Diversity (see NOT-DK-22-003).

Technical Assistance Webinar

NIDDK will conduct a Technical Assistance webinar for prospective applicants; details are forthcoming through a future guide notice.

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

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign 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.

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:

John F. Connaughton, Ph.D.
Chief, Scientific Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7797
Email: [email protected]

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Plan for Enhancing Diverse Perspectives (PEDP): The filename Plan for Enhancing Diverse Perspectives.pdf should be used.

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 2-pages 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 traditionally under-represented 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.

Applications lacking the Plan for Enhancing Diverse Perspectives are incomplete and will not be reviewed.

Milestone Plan: The filename "Milestone Plan.pdf" should be used.

1. 1. Applicants should provide a timeline and milestones for the project. This is separate from the timeline and milestones for the PEDP. Milestones are objectives that create go/no-go decision points in the project and must include clear and quantitative criteria for success. Milestones should function as indicators of continued progress, thus revealing emergent difficulties, and will be used to evaluate the application not only in peer review, but also when considering the awarded project for funding of non-competing award years. Timelines must state when metrics for assessment of progress will be achieved.
   2. Milestones should include efforts to build and strengthen community partnerships and dissemination of findings to community partners
   3. Applicants should provide appropriately detailed (quantitative) criteria by which milestone achievement will be assessed.
   4. Applicants should provide a detailed timeline for the anticipated attainment of each milestone and the overall objective.

These milestones will be negotiated at the time of the award, as appropriate. If at any time the study fails to make progress towards meeting milestones, the NIDDK may consider adjusting support or negotiating an orderly close out of the award.

The Milestone plan is a separate document from the Study Timeline. Applications that lack the Milestone Plan are considered incomplete and will not be peer reviewed.

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

Applicants should budget for 3 meetings in the Bethesda, Maryland area in the first year, and at least two meetings a year in subsequent years.

PEDP implementation costs:

Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm).

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy:

Application for Intervention Sites should consider and submit:

1. Background and Significance
   1. Describe the target community or population and the avoidable disparities that will be reduced or eliminated by the proposed intervention(s).
   2. Describe the significance of the intervention(s) and how it is focused on dismantling structural racism or mitigating the health effects of structural racism.
2. Preliminary Data
   1. Describe the findings of the community-engaged approaches used to identify and inform the proposed intervention(s).
3. Approach
   1. Propose and justify an approach to study the proposed intervention(s) over the five-year project period specified in this FOA. Applicants should detail how they would structure outcomes given an opportunity for extended follow-up.
   2. Discuss issues related to sustainability and/or implications for implementing and/or disseminating the intervention(s), if successful, to other marginalized racial and ethnic groups.
   3. Discuss the specific outcomes that will be assessed to examine both intended and unintended consequences of the intervention(s) (e.g., include evaluation to ensure the intervention(s) does not worsen health inequities).
   4. Discuss plans to ensure the capture of data that measures social determinants of health to assess social risks of participants (e.g., access to care, food insecurity, housing insecurity, transportation, income, literacy, perceived discrimination, measures of stress/allostatic load, access to linguistically appropriate care).
   5. Acknowledge and discuss the responsibilities of the site as part of a multi-center collaborative project.
   6. Identify any impediments that could require modification to the research plan and timeline with a discussion of alternative approaches.
4. Activities and Management of the Multidisciplinary Team
   1. Describe the process to facilitate meaningful collaboration and authentic partnerships with patients, community and other relevant stakeholders throughout the research process including details on the nature and extent of partnerships (e.g., clearly describe the roles of partners and provide evidence of support), particularly how the proposed intervention(s) is driven by community input and needs, how the institutional environment will facilitate community or stakeholder engagement, and how the study team will facilitate implementation and dissemination of results to the community where appropriate.
   2. Include letters of support from all key collaborators and community stakeholders. When required, Tribal resolutions should be included with the application, if possible, but before funds are awarded in all cases.
   3. Clearly describe the formal organizational structure of the multidisciplinary team, including lines of authority and responsibility and how they will work collaboratively with Consortium RCC PDs/PIs in the planning, implementation and analysis of all major studies and activities.
   4. Document the collaborative nature of the research team and emphasize the qualifications, past performance, and experience of the key personnel.
   5. Discuss how the diverse expertise of the team members increases the capability for innovation, the ability to anticipate new directions, and the flexibility to redirect research when needed.
   6. Discuss how the site will promote active participation in all relevant Consortia activities.
   7. Confirm willingness to share all data (where not otherwise prohibited such as by Tribal sovereignty) and discuss how data will be harmonized with ongoing and new efforts.

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

The following modifications also apply:

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

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 NIDDK. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Use of Common Data Elements in NIH-funded Research

NIDDK encourages 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" (https://cde.nlm.nih.gov/home) 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.

For this particular announcement, note the following:

The project proposed in the application may not be the final study conducted in the actual trial. However, the planned study will enable reviewers to evaluate the applicant's ability to identify critical scientific questions, rigorously design a study, recruit study participants, and conduct the proposed study.

Reviewers are asked to especially consider the justification of the following:

• Proposed intervention(s)
• Community-engagement approach at all stages of the project
• Recruitment plans
• Retention and follow-up plans
• Plans to monitor/maintain intervention fidelity
• Data analysis plans
• Plan for Enhancing Diverse Perspectives (PEDP)

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

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

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

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

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

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

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 Part 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 resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The Program Director(s)/Principal Investigator(s) will have the primary responsibility for:

1. Developing the research design and study protocol, including the definition of objectives and approaches, sample size and power calculations, and establishing procedures for participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, and publication of results.

2. Establishing a Steering Committee to implement, coordinate and manage the project(s). Recipient(s) will name investigators to serve as members on a Steering Committee and other subcommittees, as appropriate, meeting periodically. Recipients will be required to accept and implement the common protocol(s) and procedures approved by the Steering Committee.

3. Designating Protocol Chairs. The Program Directors/Principal Investigators (for studies involving multiple protocols) shall designate a single Protocol Chairperson (if the Program Director/Principal Investigator does not assume this role) for each protocol to be carried out by the study group. The Protocol Chairperson shall function as the scientific coordinator for the protocol and shall assume responsibility for obtaining approval to implement the protocol from the Steering Committee and for developing and monitoring the protocol. Significant modifications to approved protocols must be approved by the Steering Committee.

4. Implementing collection of data specified by the study protocol. For a multi-center study, each recipient/site is required to ensure that data will be submitted expeditiously to the Data Coordinating Center. Additionally, individual investigators/sites must demonstrate the ability to implement the strategy specifically designed for their individual study population.

5. Establishing procedures for data quality, completeness, and security. Recipients are responsible for ensuring accurate and timely assessment of the progress of each study, including the development of procedures to ensure that data collection and management are: (1) adequate for quality control and analysis; (2) for clinical trials, as simple as appropriate in order to facilitate cooperation/referral of study participants by physicians to avoid unnecessary expense; and (3) sufficiently staffed across the participating institutions. For research involving multiple sites, a plan for analysis of pooled data will be developed by the Steering Committee.

6. Submitting interim progress reports, when requested or agreed upon by both parties, to the NIDDK Program Official including as a minimum, summary data on protocol performance. For coordinated multiple awards or a multi-site single award, the NIDDK Program Official may require additional information from individual recipients/sites. Such reports are in addition to the required annual noncompeting continuation progress report.

7. Reporting of the study findings. Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies. The recipient must also be adherent to the Study Publication and Presentation Policy. The NIDDK will have access to and may periodically review all data generated under an award. NIH staff may co-author publications of findings with recipients consistent with NIH and study policies.

8. Any third-party collaboration (including but not limited to interactions with organizations from industry, academia, and nonprofit institutions) should be governed by a research collaboration agreement (e.g., Clinical Trial Agreement, Research Collaborative Agreement, etc.) or any third-party contract mechanism(s) with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement, applicable NIH/NIDDK policies and procedures, and with written approval from NIDDK Program staff. Any relevant proposed third-party agreements related to the network studies between the recipient and the third-party will be provided to the NIDDK Program staff and NIDDK Technology Advancement Office for review, comment, and approval to assure compliance with NIH/NIDDK policies and network policies. Further, at the request of the NIDDK Program staff, any other network-relevant third-party agreements must be shared with NIDDK. Failure to comply with this term may prompt action in accordance with NIH Grants Policy Statement, Section 8.5 titled: Special Award Conditions and Remedies for Noncompliance (Special Award Conditions and Enforcement Actions , and Section 8.5.2, titled: Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding Support , noncompliance with the terms and conditions of award will be considered by the funding IC for future funding and support decisions and may result in termination of the award.

9. Any involvement of a third-party (including but not limited to industry, academia, and nonprofit institutions) in the study and network activities that includes access to any network-generated resources (i.e., data and biosamples), or study results that are not publicly available, or using the name of the network or study or the name of the NIH or NIDDK, is permitted only after written permission by the NIDDK Program staff who will consult with others at NIH and NIDDK Technology Advancement Office.

10. Study investigators are required to publish and to release publicly and disseminate results and other products of the study, in accordance with study protocols, steering committee policies on publications, and the NIDDK-approved sharing plan.

11. Maintaining confidentiality of information: The recipient(s) will maintain the confidentiality of the information developed by the investigators (i.e., protocols, data analysis, conclusions, etc.) as well as proprietary information of an individual company or other entity collaborating with the study. Any exception requires written approval from NIDDK Program staff.

12. The NIDDK has established a Central Repository to support the receipt, storage, and distribution of data, biosamples, and other resources generated in clinical studies funded by the NIH/NIDDK. When the NIDDK Central Repository is to be utilized, prior to enrolling participants, the PI or his/her designee will coordinate with the NIDDK Program and Central Repository staff to prepare for eventual archiving and distribution of the study-generated resources that are to be maintained in the Central Repository. All resources transferred to the Central Repository will be under the custodianship of the NIDDK. The study’s leadership will have proprietary control of and exclusive access to the resources per the NIDDK-approved sharing plan. Subsequently, these resources will be available to the wider scientific community in accordance with the NIH policy on Data Sharing (http://grants.nih.gov/grants/policy/data_sharing/ and, https://grants.nih.gov/policy/sharing.htm, and http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm), as well as the NIDDK policy for resource sharing, NIDDK Data Sharing Policy.

13. Study investigators are required to comply with NIH Policy on the Dissemination of NIH Funded Clinical Trial Information as stated at https://grants.nih.gov/policy/clinical-trials/reporting/understanding/nih-policy.htm. Per policy, the recipient is responsible for meeting the expectations of this policy. Refer to additional information at https://grants.nih.gov/policy/clinical-trials/reporting/index.htm.

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

An NIH Project Scientist(s) with substantial involvement will:

1. Serve as the contact point for all facets of the scientific interaction with the recipient (s). As required for the coordination of activities and to expedite progress, NIDDK may designate additional NIH staff to provide advice to the recipient on specific scientific and/or analytic issues. Such staff may include another Project Scientist or Project Coordinator, who will provide direct technical assistance to the recipients to optimize the conduct and/or analysis of the study; or who may assist in the coordination of activities across multiple sites.

2. For multi-center studies, participate in the Steering Committee that oversees study conduct. The NIH Project Scientist or Project Coordinator will be a full participant and voting member of the Steering Committee and, if applicable, subcommittees. If there are multiple NIH Project Scientists or Project Coordinators participating on the Steering Committee, one NIDDK Project Scientist will be designated to serve as the voting member of the SC representing the NIH Project Team.

3. Serve as a resource to study investigators with respect to other ongoing NIH activities that may be relevant to the study to facilitate compatibility with the NIDDK missions and avoid unnecessary duplication of effort.

4. Have substantial involvement assisting in the design and coordination of research activities for recipients as elaborated below:

a. Assisting by providing advice in the management and technical performance of the investigations, coordinating required regulatory clearances for investigational agents used in the study, which are held by NIDDK. The NIDDK may reserve the right to cross file or independently file an Investigational New Drug Application or an Investigational Device Exemption form with the FDA.

b. The NIH Project Scientist(s) or Project Coordinator(s) may coordinate activities among recipients by assisting in the design, development, and coordination of a common research or clinical protocol and statistical evaluations of data; in the preparation of questionnaires and other data recording forms; and in the publication of results.

c. Reviewing procedures for assessing data quality and study performance monitoring.

d. The NIH Project Scientist(s) or Project Coordinator(s) may be co-authors on study publications. In general, to warrant co-authorship, NIH staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; (c) participation in analysis and interpretation of study results and (d) preparation and authorship of pertinent manuscripts.

The NIDDK Program Official identified in the Notice of Award will:

1. Interact with the Program Director(s)/Principal Investigator(s) on a regular basis to monitor study progress. Monitoring may include: regular communications with the Program Director/Principal Investigator and staff, periodic site visits, observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters; as well as attendance at Steering Committee, data safety and monitoring board, and related meetings. The NIDDK retains, as an option, a periodic review of progress by researchers not involved with the study.

2. Review and approve protocols prior to implementation to insure they are within the scope of peer review, for safety considerations, as required by Federal regulations.

3. The NIDDK Program Official will monitor protocol progress, and may request that a protocol study be closed to accrual for reasons including: (a) accrual rate insufficient to complete study in a timely fashion; (b) accrual goals met early; (c) poor protocol performance; (d) patient safety and regulatory concerns; (e) study results that are already conclusive; (f) low likelihood of showing a benefit of the intervention (futility); and (g) emergence of new information that diminishes the scientific importance of the study question. The NIDDK will not permit further expenditures of NIDDK funds for a study after requesting closure except as specifically approved by the NIDDK.

4. Make recommendations for continued funding based on: a) overall study progress, including sufficient patient and/or data accrual; b) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or c) maintenance of high quality of research, which will allow pooling of data and comparisons across multiple cooperative agreement awards for common data elements.

5. Appoint an independent Data and Safety Monitoring Board (DSMB) as appropriate for Phase III clinical trials or other high-risk studies, or an Observational Study Monitoring Board (OSMB) for observational/epidemiologic studies; these Boards will review study progress, safety data, and interim results, as appropriate, and provide guidance to the NIDDK. The NIDDK Program Official or their Project Coordinator will serve as the Executive Secretary and/or NIDDK program representative on the DSMB/OSMB.

Areas of Joint Responsibility include:

In addition to the interactions defined above, NIH Project Scientist(s) and Recipients shall share responsibility for the following activities:

Steering Committee

A Steering Committee organized by the study investigator(s) will be the main governing body of the study.

The Steering Committee has the primary responsibility to design research activities, establish priorities, develop common protocols and manuals, questionnaires and other data recording forms, establish and maintain quality control among recipients, review progress, monitor patient accrual, coordinate and standardize data management, and cooperate on the publication of results. Major scientific decisions regarding the core data will be determined by the Steering Committee. The Steering Committee will document progress in written reports to the NIDDK Program Official and will provide periodic supplementary reports upon request.

The Steering Committee will be composed of all Program Director(s)/Principal Investigator(s), (including those of data coordinating /statistical centers, if any) and co-investigators as deemed necessary, the NIH Project Scientist(s), and at least one patient participant representative appointed by NIDDK. The final structure of the Steering Committee and voting procedures will be established at the first meeting. The NIDDK Project Scientist will have voting membership on the Steering Committee, and as appropriate, its subcommittees. The frequency of Steering Committee meetings will be dictated by a vote of the members of the Steering Committee.

A Chairperson will be selected by the Steering Committee. The Chairperson provides leadership to the Committee by conducting the Steering Committee meetings and representing the study group by interacting closely with the recipients during protocol development and implementation. The NIDDK Project Scientist may not serve as Chairperson. The NIDDK Program Official should be consulted regarding the selection of the Chairperson to provide any feedback regarding concerns regarding potential for bias or conflict of interest or lack of required expertise.

Dispute Resolution

Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NIDDK may be brought to dispute resolution. A dispute resolution panel will be composed of three members --one selected by the recipient (or the Steering Committee with the NIDDK member not voting), a second member selected by NIDDK, and the third member elected by the two prior selected members. These special dispute resolution procedures in no way affect the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16.

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: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Raquel C. Greer, M.D., M.H.S.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-402-0306
Email:[email protected]

Jenna Norton, Ph.D., M.P.H.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-7314
Email:[email protected]

Jennifer Alvidrez, PhD
Office of Disease Prevention (ODP)
Telephone: 301-827-0071
Email: [email protected]

Vanessa J Marshall, Ph.D.
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-402-1366
E-mail: [email protected]

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

Michele Barnard, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8898
Email: [email protected]

Norma DeGuzman
National Institute of Diabetes and Digestive, and Kidney Diseases (NIDDK)
Telephone: 301-480-1810
Email: [email protected]

Priscilla Grant, JD.
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-594-8412
E-mail: [email protected]

Kelli Oster
National Institute of Nursing Research (NINR)
Telephone: 301-594-2177
Email: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.