Part 1. Overview Information

Key Dates

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the 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

This U2C funding opportunity announcement (FOA) is a National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) initiative to establish a novel national Stakeholder Engagement Innovation Center for advancing equity in type 1 diabetes research (SEIC-T1D). A primary goal of the SEIC-T1D is to accelerate equitable engagement of diverse stakeholders (specifically people from NIH designated health disparities populations) in T1D research; particularly those from diverse communities that experience diabetes-related health disparities, and live within the healthcare and social systems that negatively impact community members and patients health. The SEIC-T1D will establish a network consisting of diverse, multidisciplinary research investigators with expertise in T1D and community-engaged methods, community experts with lived experiences, and representatives of various health and other organizations deemed essential for addressing disparities and advancing health equity in T1D early detection and treatment.

Background

Approximately 1.9 million people are currently living with T1D in the United States. Although the majority of people living with T1D self-identify as non-Hispanic White approximately one third of people living with T1D fall outside of that cultural group (as ascertained from new onset SEARCH for diabetes in youth data in the U.S.). Furthermore, according to the CDC, incidence rates of new onset T1D in youth are rising across all groups but are rising more in Black, Hispanic, and Asian/Pacific Island populations compared to Whites. Data indicate that people with T1D with backgrounds underrepresented in biomedical and behavioral research have worse glycemic control and increased morbidity and acute complications from their diabetes than peers of non-underrepresented backgrounds. In addition, people with T1D that experience disparities are less likely to be prescribed or adopt recent advances in diabetes technology, a cornerstone of advanced diabetes management. Unfortunately, these populations are often hardly reached and are not engaged in NIH-funded research in crucial ways that would ultimately benefit them. For example, recent systematic review data indicate that although non-Hispanic Blacks comprise 9.3% of people living with T1D in the U.S., cumulative published clinical trials in T1D demonstrate only 2.2% representation of non-Hispanic Black people.

Promoting health equity research has been prioritized at the NIH to address long-standing inequities observed across many diseases. The NIDDK has initiated new efforts to address health disparities and advance health equity. One fundamental equity approach involves meaningful inclusion of diverse people and communities in developing the research priorities and activities that involve them, particularly NIH designated health disparities populations which are historically marginalized populations, and those with the highest proportion of diabetes-related morbidity and mortality. Unfortunately, as the statistics describe above, these populations are often hardly reached nor engaged in NIH-funded research resulting in notable disparities in research participation which is interrelated to the stark disparities in health outcomes.

Stakeholder engagement that involves trust building and the use of culturally appropriate research designs, questions, and materials (i.e., outreach, recruitment, retention, and informed consent documents) is an important method to enhance and assess research outcomes including participation goals, health specific outcomes and sustainability. Strategies for effective stakeholder engagement vary based on the research complexity, questions, objectives, focus population(s), and needs. Examples of methods used to enhance stakeholder engagement include person-centered approaches such as design consultancy models and community engagement studios that involve customized community input sessions focused on specific cores or all aspects of a research project.

Finally, while meaningful, equitable stakeholder engagement is important for achieving project milestones such as achieving recruitment and retention targets and sustainability of successful interventions, it is not sufficient for achieving health equity. Additional strategies of meaningful stakeholder engagement with goals of achieving health equity include research principles embedded in certain methodologies (e.g., community-based participatory research), allotting time required to appropriately identify community, people living with T1D, family members and caregivers affected by T1D, or other stakeholder research needs and priorities, and tailoring strategies for equitable partnership development between researchers and community-based organizations and other organizations to ensure mutually beneficial processes and outcomes.

Key Terms, Definitions, Uses in this FOA

Diverse: Includes, but is not limited to race, ethnicity, socioeconomic status, age, background, geographic location, gender identity, sexual orientation, and mental or physical ability.

Equitable Engagement: A bi-directional relationship/interaction focused on empowering diverse communities which requires trust, respect, cultural humility, that results in inclusivity, accessibility, and shared decision-making about matters that affect or have the potential to affect all stakeholder groups involved.

Partnership Hub: An organizing principle where a centralized entity is established to coordinate and collaborate at national, regional, and local levels to broaden outreach to diverse communities and organizations across the country, catalyze innovation in stakeholder engagement, and facilitate the development of needed research resources. The Partnership Hub works in conjunction with partner/satellite institutions ( spokes ) such as affiliated local, regional, national community groups or organizations, faith-based institutions, community health centers, healthcare provider groups, healthcare/medical research institutions, and academic health centers that are integrated into the proposed activities to achieve the goals of the FOA.

Stakeholders: People, communities, or organizations with diverse characteristics and backgrounds who are impacted by or have a direct interest in the research design, process, and/or outcomes. Includes people living with T1D, research participants, family members and caregivers affected by T1D, health care providers, people representing health care systems and other systems, advocacy groups, and scientific professional organizations.

Stakeholder Engagement Studio: A consultative model of engagement that allows researchers to obtain project-specific input from relevant stakeholders, especially community members, people living with T1D, and/or organizations, when appropriate, to enhance the research and promote equity. A community engagement studio model with similar objectives was developed in 2009 by the Meharry-Vanderbilt Community Engaged Research Core of the Vanderbilt Institute Clinical and Translational Science Award and has been leveraged to inform similar resources at multiple institutions across the country.

Core Users: Principal investigators or other investigators of a research team who use the core services and resources provided by the SEIC-T1D.

SEIC-T1D Goals

The Stakeholder Engagement Innovation Center for Advancing Health Equity in Type 1 Diabetes Research (SEIC-T1D) will provide highly specialized research resources to accelerate use of appropriate methods and meaningful and equitable engagement of diverse stakeholders. The stakeholders will include communities and people living with T1D that experience diabetes-related health disparities, and the organizations and people that impact their health and are essential for promoting health equity, to improve NIDDK mission-related T1D research. Specific goals are to support T1D investigators or investigative teams to facilitate or improve:

1) Use of appropriate research methodologies with potential for addressing health disparities and promoting equity such as community-engaged research methods, implementation science, and pragmatic effectiveness trials which may allow researchers to better identify/address barriers to care and other health promoting resources, and optimal outcomes;

2) Use of key equity approaches such as strength-based perspectives, incorporating community members research priorities, values, lived experiences, and their health promoting resources and challenges into the research; and avoiding unintended stigmatization, tokenism, and harmful implicit bias in the research efforts;

3) The science of engagement involving outreach, communications, recruitment and retention strategies, and principles of reciprocity that would benefit clinical trial research;

4) Equitable stakeholder partnership development between researchers and community-based organizations, members, or other entities to promote research efforts that involve mutually beneficial processes, metrics, and outcomes; and

5) Dissemination of effective practices for equitable engagement with stakeholders, including effective strategies for sharing research findings with diverse communities, lessons for improving the adoption and scalability of efficacious and evidence-based interventions, and tailored health communications to reduce T1D-related disparities and promote health equity.

The SEIC-T1D will focus on initiating and building a robust infrastructure for delivering expert research engagement resources to improve uptake of appropriate research principles and methods to improve equity, and stakeholder engagement in developing research studies, and in mitigating obstacles with research studies that are not meeting proposed targets (e.g., challenges with delayed recruitment and retention, insufficient participatory research methods). Consultations should be made available to the T1D research community through a minimum of two core services: 1) stakeholder engagement studios whereby the Center designs customized consultation sessions to provide varied stakeholder or community input on the research objectives and approaches; and 2) structured, expert research consultations with center faculty at any stage of the investigator's (i.e., core user's) grant writing or research project. It is anticipated that the number of engagement studios and research consultations may be limited in scope in the first two grant years while the SEIC-T1D builds the infrastructure and capacity to deliver them (unless infrastructure already exists). In addition, the Center will be responsible for compiling registries of stakeholder members (community members, care takers, and people living with T1D, family members, organizations and people that impact their health, etc.) willing to serve as engagement studio experts for various T1D research topics.

The SEIC-T1D will leverage existing partnerships and establish new ones, as needed, across U.S. geographic regions with diverse communities and organizations representing populations at risk for or living with T1D, especially underserved communities and those with diabetes-related health disparities. These partnerships will be leveraged to conduct engagement studios and research consultations to engage communities and address specific T1D health equity research objectives. It is anticipated that some of these activities will occur (in-person or remotely) at the awardee’s institution while a portion will occur at partner or satellite institutions in the Partnership Hub. These partnerships will include linkages between networks representing experts with various disciplines, other institutions, community partners, health departments, and human service organizations and should be based on the Center’s framework and assessed needs of the user base (i.e., the SEIC-T1D research customers). The SEIC-T1D will establish a Partnership and Outreach Fund to support additional partnership development with diverse stakeholders to meet the needs of the T1D research community as new opportunities arise.

The SEIC-T1D is expected to prioritize outreach and services to core users who are funded by or pursuing grant funding by the NIDDK. The information gathered from the engagement studios and research consultations should also be of use and made readily accessible to NIDDK-relevant investigators (e.g., posting on the SEIC-T1D website).

SEIC-T1D Structure

The SEIC-T1D will be structured with three required cores: Administrative Core, Stakeholder Engagement Studio Core, and the Research Consultation Services Core.

Administrative Core: The director of the Administrative Core, who is the Program Director/Principal Investigators (PDs/PIs) of the application, should be assisted by one or more Associate Directors who will be involved in the administrative, scientific, or enrichment efforts of the Center and who will serve as Acting Center Director in the absence of the Director. A process must be in place to recommend a successor to the Director, if a successor becomes necessary. The Center’s Administrative Core will provide the overall framework and direction for the center as well as management and coordination of center activities. All requests from investigators for services will be reviewed by the Administrative Core and sent to the appropriate core for action.

The Administrative Core responsibilities will include but are not limited to:

• Oversight of center budgets;
• Ongoing evaluation of staffing needs;
• Management of the Partnership and Outreach Fund;
• Execution of subawards/subcontracts for the Partnership Hub, including establishment of new community partnerships to be supported by the SEIC-T1D Partnership and Outreach Fund, and compensation for the time and expertise provided by studio community participants;
• Prioritization and distribution of service requests from NIDDK-funded core users or those pursuing NIDDK grant opportunities for services as needed to maintain efficient center workflows;
• Development of a public website, communication/training materials, and other dissemination tools to facilitate outreach and engagement with the T1D research community;
• Development and implementation of an evaluation plan to assess utility and impact of the center for the T1D research community;
• Management of travel to meetings and conferences for center staff; and
• Development and execution of an annual meeting to convene center and partnership hub staff.
  

Stakeholder Engagement Studios Core: The overall goal of the stakeholder engagement studios is to provide a customized format and structured setting for multidisciplinary researchers to gain valuable stakeholder (e.g., community member, person living with T1D, health organization) insight about the T1D community-engaged research objectives and approaches. Engagement studios will also be used to strengthen equitable partnership development for multi-institutional and multidisciplinary teams, and to inform how to incorporate health equity frameworks and/or principles in research study development. The aim is to strengthen and simplify the process of obtaining needed stakeholder input and participation needed in grant applications and research projects to better address T1D-related disparities and advance health equity. Engagement studios require skilled facilitation, strategic preparation (with center director, navigators, facilitators, coordinators, etc.), and development of protocols to ensure the desired outcomes.

Stakeholder engagement studios differ from focus groups in that research data are not collected from the participating community members. Community representatives will participate in interactive sessions designed to provide input into the proposed research questions, needs/approaches for broader community or lived experience engagement and outreach/participation, and study demographic populations.

Engagement Studio activities will include but are not limited to the following:

• Developing effective engagement strategies, including equitable partnership development with multi-institution or agency teams, community members, people living with T1D, and the organizations and the people who impact their health;
• Providing insights into community and community members /patients personal T1D needs as well as their perspectives, culture, strengths and challenges, literacy levels, language translation needs, history, and past experiences with research;
• Providing expertise needed to develop, test, and refine the acceptability of research aims to community members and people living with T1D, and how best to employ health equity frameworks and reciprocity principles into the research;
• Evaluating research methods, outreach, cultural/linguistic appropriateness materials, participation and retention strategies, informed consents, ethical considerations, return on results, and translation of research findings into practice, dissemination methods and tools;
• Establishing metrics of engagement; and
• Managing logistical needs to conduct engagement studios effectively across all phases (i.e., preparation phase, studio appointments, post-studio appointment activities).
  

Research Consultation Services Core: In addition to activities supported by the engagement studios core, Center users may request structured, expert consultations with faculty experts at any stage of the grant writing or research project process when an engagement studio consultation is not appropriate or possible. While consultations may be requested at any stage of the research (e.g., ideation stage, mitigating recruitment obstacles), they are optimally useful before the research proposal is finalized.

Research consultation activities will include but are not limited to:

• Providing expertise on principles and methods of community-engaged research, mixed qualitative-quantitative methodology, and relevant analyses;
• Addressing barriers and challenges related to outreach and engagement, recruitment, and retention;
• Assisting investigators with developing equitable engagement strategies, establishing metrics of engagement, and utilizing a health equity framework and/or principles in research;
• Providing expertise in efficacy and effectiveness pragmatic trial methodologies to advance health equity;
• Providing expertise on cultural/linguistic appropriateness of research documents for clinical studies and trials (e.g., recruitment materials, consent documents, surveys);
• Collaborating to identify, adopt, and utilize new and evidence-based tools and resources for engagement of diverse stakeholders;
• Disseminating educational and training resources on best practices and principles of successful stakeholder engagement; and
• Managing logistical needs to conduct research consultations effectively across all phases (i.e., preparation phase, consultation appointments, post-consultation appointment activities).
  

The primary governing body of the SEIC-T1D will be the Steering Committee, comprised of the PDs/PIs of the U2C, the PD/PIs of each core and the NIDDK Project Scientist (PS). The Steering Committee will develop policies and procedures for the Center, ensure the policies are properly implemented, and progress is appropriately monitored. The NIDDK PS will assist the Steering Committee in designing and carrying out the Center’s objectives and both the NIDDK PS and PO will participate in overall performance monitoring. The Steering Committee will be responsible for recommending deployment of awards from the Center’s Partnership and Outreach Fund to support new research needs, subject to final approval by the NIH.

Establishment of the SEIC-T1D is expected to attract diverse health equity experts to NIDDK-funded research on T1D and promote innovative stakeholder-engaged research. 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 (e.g., 2.2, 3.4, 4.1, 4.2. and 4.3) and Cross-cutting Topics (e.g., health disparities and health equity) of the Strategic Plan.

Investigative teams with relevant expertise in T1D and existing engagement studio models, engagement studio-like activities, and/or an infrastructure (including established networks with diverse people, communities, and/or organizations) that could be leveraged for establishing a SEIC-T1D are encouraged to apply. Where possible and applicable, applicants are also encouraged to leverage skills and collaborations with NIH-funded centers at their institutions/consortium (e.g., Centers for Diabetes Translation Research [CDTRs], Diabetes Research Centers [DRCs], Clinical and Translational Science Awards [CTSAs]). Potential applicants are strongly encouraged to consult NIDDK program staff prior to submission to determine relevance to NIDDK.

Applications that propose cores to primarily direct biomedical behavioral or clinical research are not responsive to this opportunity and will not be reviewed.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

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

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 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 or an institutional system-to-system solution. A button to apply using ASSIST is 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 Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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:?NIDDKLetterofIntent@mail.nih.gov

Page Limitations

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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: Required
• Administrative Core: Required
• Stakeholder Engagement Studio Core: Required
• Research Consultation Services Core: Required
  

Overall Component

When preparing your application, use Component Type Overall .

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

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

The applicant is required to provide detailed information and timelines for completing all necessary planning activities. Milestones should be easily measurable and realistic. Milestones may include, as applicable, but are not limited to:

• Launching teams
• Training Center staff
• Launching public facing communications such as Center website
• Initiation of engagement studios
• Initiation of consultation services
• Growing user base
• Initiation of fee-for-service/charge back system
  

These milestones will be negotiated at the time of the award, as appropriate.

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Introduction to Application: An introduction to Application is required in the Overall component.

Specific Aims: Provide the broad strategic vision, goals, long-term objectives, and the overall structure of the proposed SEIC-T1D to support the Center’s users and T1D research community on a national level.

Research Strategy: The Research Strategy should include the following sections.

Center leadership, management and oversight: Describe the expertise and experience provided by the Center leadership and key personnel in bringing together diverse experts and stakeholders needed to establish a national Center framework and deliver studio and research consultation core services on a range of T1D health disparities and equity research areas, including relevant scientific research methodologies for health equity research (i.e., community-engaged/-based participatory research, implementation science, mixed methods, pragmatic clinical trials).

Center services: Summarize all of the services, resources, and expertise provided by the proposed: Administrative Core, Stakeholder Engagement Studio Core, and the Research Consultation Services Core. Describe a health equity framework and/or principles that will be used to inform studio and consultation services provided. Include a process for prioritizing core users with NIDDK funding or those preparing to submit grants in response to NIDDK funding opportunities as well as describing how requests for services will be reviewed and decided upon for acceptance. Describe a plan to advertise and promote the SEIC-T1D services as a national resource to T1D researchers, particularly those focused on addressing health disparities and/or promoting health equity. Include details about the SEIC-T1D website and information that will be provided.

Center partnerships and outreach: Describe existing, established and intended partnerships with organizations that will facilitate the ability of the SEIC-T1D to meet the Center’s goals and objectives, including forming a Partnership Hub. The Partnership Hub is an organizing principle where a centralized entity is established to coordinate and collaborate at national, regional, and local levels to broaden outreach to diverse communities and organizations across the country. The Partnership Hub works in conjunction with partner/satellite institutions ( spokes ) such as affiliated local, regional, national community groups or organizations, faith-based institutions, community health centers, healthcare provider groups, healthcare/medical research institutions, and academic health centers that are integrated into the proposed activities.

Describe a plan to evaluate the need for new expertise, partnerships, or other resources for SEIC-T1D users and the process for forming and implementing new partnerships that will leverage skills and resources at other institutions to enhance the Center's capacity and capabilities. Include information on the process of assessing or re-evaluating the needs of Center users focused on T1D health disparities and health equity research, and how evolving needs may be met.

Letters of Support: Include any letters of support for the proposed SEIC-T1D from any partnering institution officials, subcontractors, or consultants. Letters must address the commitment of the applicant or parent institution and any proposed collaborating organizations to achieve the SEIC-T1D goals. The parent institution is expected to recognize the Center as a formal organization core and provide the documented evidence of space dedicated to the needs of the Center, faculty recruitment, salary support for investigators or technical personnel, dedicated or shared equipment, or other financial support proposed for the Center. The parent institution should provide assurance of its commitment to continuing support of the SEIC-T1D in the event of a change in directorship. A letter of support that mentions all cores by name should be considered a general letter of support and included once, in the Overall section only. Letters of support for individual cores must be included in the appropriate core of the application.

For SEIC-T1D activities to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the partner/collaborator as well as the off-site institutional officials, should be submitted with the application.

Where relevant, appropriate letters of support from the PD/PI of an NIH-funded Center or CTSA at the applicant institution should be included with the application detailing plans for appropriate integration, harmonization, enhancement of SEIC-T1D activities through cooperation with other NIH supported core facilities at the applicant institution.

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, should address a Data Sharing Plan.

• Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

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 (Overall)

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

Administrative Core

When preparing your application, use Component Type Admin Core.

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates
  

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the core.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of cores in which they participate. When a Senior/Key person is listed in multiple cores, the Biographical Sketch can be included in any one core.
• If more than 100 Senior/Key persons are included in a core, the Additional Senior Key Person attachments should be used.
• One Center Director(s) (PD/PI) should be identified to be responsible for the scientific and administrative leadership of the SEIC-T1D.
• The Center Director(s) should have strong expertise in diverse stakeholder engagement activities, community-engaged research, and evidence-based dissemination approaches. The person must be able to coordinate, integrate, and provide guidance for new partnership development. Because the SEIC-T1D has a large and complex administrative structure, the PD/PI must have strong leadership abilities and demonstrated proficiency in managing large, multi-core programs.
• One or more Associate Directors should be named who will be involved in the administrative, training, or implementation efforts of the SEIC-T1D and will serve as Acting Director in the absence of the Director.
• In this core, also provide biographical sketches for any consultants. In the Senior/Key Profiles section, list those Senior/Key persons in the Project Role of "Other" with Category as "Consultant" or "Advisory Committee". New applications should NOT contact potential External Advisory Committee (EAC) members nor provide names or biographical sketches for EAC members; overall qualifications and areas of scientific expertise for the EAC members may be included.
  

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

The budget to support administrative activities of the Administrative Core should not exceed $350,000 direct costs/year. The budget for the Administrative Core should include an additional $100,000 to be set aside in each of years 1-5 for the SEIC-T1D Partnership and Outreach Fund that will be restricted and require prior approval for use from NIDDK. All costs for the SEIC-T1D Partnership and Outreach Fund are inclusive of subaward F&A and any consortium F&A. Additional funds may be made available to the Partnership and Outreach Fund in future years to address increasing demands from the NIDDK research community. The SEIC-T1D Steering Committee will be responsible for recommending deployment of awards from the Center’s Partnership and Outreach Fund to support new research needs, subject to final approval by the NIH.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Specific Aims: List the broad, long-range objectives of the Administrative Core.

Research Strategy: Describe how the proposed core activities will contribute to meeting the goals of the SEIC-T1D. Explain the strengths of key personnel and the environment.

Please address the following at a minimum, but it is not necessary to duplicate information found in other component sections of the application

Organizational Plan:

• Describe the administrative structure including the Steering Committee.
• Define interactions between the Administrative Core and other cores, including the Steering Committee activities.
• Must provide a succession plan if the Core Director should leave.
• Describe mechanisms for selecting and replacing staff within the cores.
• Describe plan for establishment and maintenance of internal communication and cooperation among the Center investigators.
• If applicable, describe collaborative plans to work with other related NIH-funded projects and programs at the applicant institution to achieve synergy and cost-effectiveness and eliminate unnecessary overlap as possible.
• Describe plans for communicating with Center users about available services including: developing and maintaining an effective SEIC-T1D website and building the Center’s reputation for effectiveness, communicating receipt of requests, and identifying the Center core and/or staff who will serve as point of contact for users.
• Describe process for determining when to deploy funds from the Partnership and Outreach Fund, once approved by the Steering Committee.
• Describe the process for the initial triage of service requests that will evaluate appropriateness to SEIC-T1D scope, and how service requests will subsequently be distributed to appropriate Center cores.
• Describe the criteria for accepting and prioritizing requests for services, including how researchers with NIDDK funding or those pursuing NIDDK funding opportunities will be prioritized. The same criteria should be applied to requests from investigators inside and outside the parent institution.
• Describe the plan for identifying and/or developing dissemination tools and methods on equitable engagement approaches with diverse stakeholders.
• Describe the plan for providing oversight of Center workflows and timelines for completion of services, managing communication of final data and information to Center users, addressing any changes needed in staffing in a timely way, and providing oversight for any billing or payment collections (see Business Plan, below).
• Describe the plan for providing oversight of the Center’s budgets; ongoing evaluation of staffing needs; management of the Partnership and Outreach Fund, including execution of subawards/subcontracts for the Partnership Hub, including establishment of new community partnerships to be supported by the SEIC-T1D; reimbursement for studio community participants.
• Describe the plan for development and execution of an annual meeting to convene Center and Partnership Hub staff (in person with PD/PS site visit or virtually).
• Describe the plan for records management. The Administrative Core should work closely with service providing cores of the Center to ensure that records are stored appropriately.
• Develop and implement a plan for monitoring and evaluating Center services (so improvements can be made in a systematic manner), productivity, and impact for the T1D research community.
  

Business Plan:

• The Center will be required to initiate and test a re-charge/fee-for-service system (to develop program income) for appropriate core services users no later than grant year 4 (if not before), although100% sustainability is not anticipated. Such a program income or reimbursement system would constitute a method of charging core users for their usage of expertise and research resources. Program income must be re-invested into direct support of Center related activities and/or expenses and may not generate a profit for the Center. Describe how the Center will maintain records of any program income and spending. Indicate how program income will be used to enhance Center activities and functions, consistent with achieving the goals of the program.
  

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, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Stakeholder Engagement Studio Core

When preparing your application, use Component Type Studios Core.

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

SF424 (R&R) Cover (Stakeholder Engagement Studio Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates
  

PHS 398 Cover Page Supplement (Stakeholder Engagement Studio Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Stakeholder Engagement Studio Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Stakeholder Engagement Studio Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Stakeholder Engagement Studio Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the core.
• State the roles and responsibilities of the Stakeholder Engagement Studio Core Director(s), roles of key personnel, including those essential for conducting studio sessions (e.g., navigators, facilitators, coordinators), and the relationship to other related cores in the institution (if applicable).
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of cores in which they participate. When a Senior/Key person is listed in multiple cores, the Biographical Sketch can be included in any one core.
• If more than 100 Senior/Key persons are included in a core, the Additional Senior Key Person attachments should be used.

Budget (Stakeholder Engagement Studio Core)

Budget forms appropriate for the specific component will be included in the application package.

The applicant has flexibility in constructing the budget for the Stakeholder Engagement Studios; however, in general, it is anticipated that at least 40% of the total Center budget will be devoted to the Stakeholder Engagement Studio Core. It is anticipated that start-up time will be required, resulting in fewer studios during the first year. By year 5, it is anticipated that at least 10 studios will be provided.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Stakeholder Engagement Studio Core)

Specific Aims: List the broad, long-range objectives of the Stakeholder Engagement Studios.

Research Strategy: Please address the following at a minimum, but it is not necessary to duplicate information found in other sections of the application.

Background and Significance: This section should describe how the proposed engagement activities will contribute to meeting the goals of the SEIC-T1D and national objectives to address diabetes-related health disparities and improve health equity in NIDDK research. Explain the strengths of key personnel and the environment, and rationale for selection of services. Describe how the stakeholder engagement studio services will address a compelling and unmet need for the research community. Describe the interaction of this core with other components/cores in the Center, and its relationship to similar activities available in the institution or elsewhere in the U.S.

Preliminary Studies: Describe stakeholder engagement or studio-like activities already conducted, and/or relevant existing infrastructure and how these activities influenced development of the proposed Center activities.

Approach:

• Provide a summary of the engagement studio activities planned for development, and/or for immediate implementation. Include a description of the processes used to design a customized studio (e.g., pre-studio meetings with the researcher), conduct the studio session, and provide actionable recommendations and suggestions to the core user (researcher); and how in-person and remotely delivered studios approaches may differ.

• Describe how the Partnership Hub will be used as a resource to enhance the makeup of the studios and the overall execution studio constulations.

• Describe the plan to develop a training protocol for key personnel conducting studios and ensure fidelity of implementation (e.g., monitoring procedures, protocol adherence).

• Describe and/or provide examples of annual capacity and expected usage. A limited number of studios is anticipated during the initiation phases of the Center unless the applicant leverages existing studio infrastructure and resources (e.g., navigators, facilitators, coordinators). The expectation is for a minimum of 10 studios to be held by year 5.

• Describe protocols developed in consultation with the Administrative Core to ensure timely communication with users and implementation of stakeholder engagement studios, including preparation and post-studio activities to appropriately design and close-out sessions with actionable recommendations to the researcher.

• Describe strategic approaches that will be employed to balance power and ensure equitable studio deliberations between the researcher/s and stakeholder/community experts.

• Describe ability and capacity to efficiently provide important stakeholder engagement services to the NIDDK T1D research community.

• Describe the plan for tracking studio appointments, measurable impacts (e.g., grant submissions with improved equitable stakeholder engagement or community-engaged research methods improved, mitigated recruitment/retention challenges, etc.), and implementing an evaluation of the studio model to integrate improvements in a systematic manner (if not already described in the Administrative Core).
  

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, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Stakeholder Engagement Studio Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Research Consultation Services Core

When preparing your application, use Component Type Consultations Core.

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

SF424 (R&R) Cover (Research Consultation Services Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Consultation Services Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Consultation Services Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Research Consultation Services Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries

Research & Related Senior/Key Person Profile (Research Consultation Services Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the core.
• State the roles and responsibilities of the Research Consultation Services Core Director, roles of key personnel, and the relationship to other related cores in the institution (if applicable).
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of cores in which they participate. When a Senior/Key person is listed in multiple cores, the Biographical Sketch can be included in any one core.
• If more than 100 Senior/Key persons are included in a core, the Additional Senior Key Person attachments should be used.
  

Budget (Research Consultation Services Core)

Budget forms appropriate for the specific component will be included in the application package.

The applicant has flexibility in constructing the budget for the Research Consultation Services; however, in general, it is anticipated that at least 30% of the total budget will be devoted to the Research Consultation Services core. It is anticipated that start-up time will be required, resulting in fewer consultations during the first year. By year 5, it is anticipated that at least 15 consultations will be provided.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research Consultation Services Core)

Specific Aims: List the broad, long-range objectives of the Research Consultation Services core of the Center.

Facilities and Other Resources: Describe the facilities and resources that will be available to the Research Consultation Services core.

Research Strategy: Please address the following at a minimum, but it is not necessary to duplicate information found in other sections of the application.

Background and Significance: This section should describe how the proposed consultation services will contribute to meeting the goals of the SEIC-T1D and national objectives to improve diabetes-related health disparities in NIDDK research. Explain the strengths of key personnel and the environment, and rationale for selection of services. Describe how the consultation services will address a compelling and unmet need for the research community. Describe the interaction of this core with other cores in the Center, and its relationship to similar activities available in the institution or elsewhere in the U.S.

Preliminary Studies: Describe any research consultation activities in areas related to the SEIC-T1D mission already conducted and how these activities influenced development of the proposed Center activities.

Approach:

• Provide a summary of the consultation activities planned for development, and/or for immediate implementation that align with the Center’s vision and goals. Include a description of the processes used to plan a consultation (e.g., pre-session activities), conduct the consultation session, and provide actionable recommendations and suggestions to the researcher; and how in-person and remotely delivered consultations approaches may differ.
• Describe if or how the Partnership Hub will be used for the execution of consultation activities.
• Describe and/or provide examples of consultation services to be provided, including annual capacity and expected usage. The expectation is for at least 15 consultations to be held by year 5.
• Describe protocols developed in consultation with the Administrative Core to ensure timely communication to users and provision of research consultation services, including pre- and post-consultation activities to appropriately design and close-out sessions with actionable recommendations to the researcher.
• Describe ability to empower researchers from the T1D scientific community to engage appropriate stakeholders to improve health equity research focused on T1D.
• Describe a plan for tracking consultations and measurable impact (e.g., user surveys, applied or attained grant(s), mitigated recruitment /retention challenges, improved participation of community members or people living with T1D in the research, publications, etc.).
  

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, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Research Consultation Services Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

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) using ASSIST or other electronic submission systems. 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.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

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, 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" (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

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.

Reviewers will be asked to evaluate the following individual sections. The overall impact score is not the average for these cores.

• Administrative Core, including strength of leadership, management, steering committee structure, business plan and lines of communication between the administrative staff, steering committee, Partnership Hub, and core users.
• Stakeholder Engagement Studio Core, including qualification of key personnel, the ability and capacity to harness key stakeholder involvement into core activities, processes proposed for monitoring protocol fidelity and measurement of user impact of provided studios.
• Research Consultation Services Core, including qualification of key personnel, the potential of the consultation services to empower researchers from the T1D scientific community to use relevant research methods and meaningfully engage appropriate stakeholders to improve health equity research, proposed plan for tracking consultations and measuring impact of consultation services.
  

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.

Significance

Does the proposed Center address the needs of the research resource that it will serve? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research resource?

Specific to this FOA: How well does the proposed Center address the research community needs of the core resources (i.e., engagement studios and research consultation services) that it will coordinate and serve? How well does the proposed Center structure and function address the needs of the communities that it will serve? How likely will the activities proposed for the Center meet those needs? What is the likelihood that the Center will increase efficiency, promote new equitable research directions and facilitate interactions and collaborations among the Center users (investigators) and community stakeholders?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing clinical T1D research? Do the investigators demonstrate significant experience with coordinating collaborative clinical research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

Specific to this FOA: How detailed and applicable are the experiences, training, and competencies of the investigator team explained? How applicable and supportive is the demonstrated experience and/or ongoing record of accomplishments in managing community-engaged research and incorporating health equity framework and/or principles within the Center leadership and key personnel? How experienced are the investigators in managing diverse scientific and community-based networks that are anticipated for the Center? To what extent do they have experience in research methods appropriate for advancing health equity, community-engaged/-based participatory research, pragmatic clinical trials and implementation science? To what extent do the investigators demonstrate significant experience with coordinating collaborative clinical type 1 diabetes research?

Innovation

Does the application propose novel organizational concepts or management strategies in coordinating the research resource the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts and management strategies proposed?

Specific to this FOA: How well does the application propose novel or the essential organizational concepts and management strategies necessary to coordinate the research resources for each core and research communities the Center will maintain and serve? To what extent are collaborators with reach to diverse community and lived-experience networks, and multidisciplinary investigators involved to support the Center’s goals?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research resource the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the resource, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the resource is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the resource? Is an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

Specific to this FOA: How appropriate is the administrative organization proposed for the Admin Core for the following (a) coordination of the Partnership Hub and collaborations; (b) request for core services and workflows across the cores; (c) establishment and maintenance of internal communication and cooperation among the Center investigators; (d) mechanisms for selecting and replacing staff within the cores; (e) mechanism for reviewing the use and tracking of, and administering of funds for the Partnership and Outreach Fund; (e) management capabilities, including fiscal administration, procurement, personnel management, planning, budgeting, and other appropriate capabilities?

How diverse and deep are the planned community engagement partnerships and to what extent does this reach increase or limit the potential impact of the Center? How strong are current community partnerships or how likely are strong partnerships to be formed for the proposed Center? How likely will successful completion of the aims of this Center bring unique advantages or capabilities into T1D clinical research? How detailed and forward thinking is the plan for Center evaluation and improvement?

How appropriate is the plan for expanding capacity and ultimately delivering the minimum required engagement studio and research consultation core services (10 and 15 respectively, in year 5)? Is the number of planned core services appropriate for a Center with existing relevant studio or infrastructure, if relevant? How appropriate and feasible is the plan to initiate and test a re-charge/fee-for-service system by grant year 4?

How clear are the milestones presented? How appropriate and feasible are they?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Environment

How likely will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research resource it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? To what extent are resources available within the scientific environment to support electronic information handling?

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.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

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 theNIH 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.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that 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.

Prior Approval of Pilot Projects

Recipient-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.

• The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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 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.html and https://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 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 2 CFR 200, 45 CFR Part 75, 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 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 SEIC-T1D program consists of a Center, a Steering Committee, and an External Advisory Committee.

• Recipient(s) will be primarily responsible for defining the objectives and approaches, planning, conduct, analysis, and publication of results, interpretations, and conclusions of Center activities conducted under the terms and conditions of the cooperative agreement award.
• The Program Director/Principal Investigator (PD/PI) will assume responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of the research supported under this Funding Opportunity Announcement (FOA) in accordance with the terms and conditions of award, as well as all pertinent laws, regulations, and policies.
• Recipient(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current DHHS, PHS, and NIH policies.
• Recipients are responsible for their staff in maintaining confidentiality of the information as developed by the consortium, including, without limitation, study protocols, data analysis, conclusions, etc. per policies approved by the Steering Committee (SC) as well as any confidential information received by third party collaborators.
• Recipients must analyze, publish and/or publicly release and disseminate results, data, and other products of the study in a timely manner, concordant with the approved plan for making quality-assured data and materials available to the scientific community and the NIH, consistent with NIH policies and achieving the goals of the FOA.
• Recipient(s) will be required to participate in a cooperative and interactive manner with members of the consortium including designated NIH staff (e.g., Program Official, Project Scientist).
• Recipients must share data, materials, models, methods, information, and unique research resources that are generated by the projects in concordance with SEIC-T1D policies in order to facilitate progress. When appropriate, and in accordance with NIH policies, as well as NIDDK policies, recipients will be expected to collaborate; share novel reagents, biomaterials, methods and models and resources; and share both positive and negative results that would help guide the research activities of the community of researchers accessing the SEIC-T1D.
• Recipient(s) agree to establish agreements amongst themselves that address the following issues: (1) procedures for data sharing among consortium members and data sharing with industry partners; (2) procedures for safeguarding confidential information, including without limitation, any data generated by the consortium as well as information and/or data received from external collaborators; (3) procedures for addressing ownership of intellectual property that result from aggregate multi-party data; (4) procedures for sharing bio-specimens under an overarching MTA amongst consortium members that operationalizes material transfer in an efficient and expeditious manner; (5) procedures for reviewing publications, determining authorship, and industry access to publications.
• 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, network policies, 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 recipient and 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.
• Recipients must agree to comply with the processes and goals as delineated within the FOA.
• Upon completion or termination of the research project(s), the recipients are responsible for making all study materials and procedures broadly available (e.g., putting into the public domain) or making them accessible to the research community according to the NIH-approved plan submitted for each project, for making data and materials available to the scientific community and the NIH for the conduct of research.
• Recipient(s) agree to the governance of the study through a Steering Committee:
  • The PD/PI or contact PD/PI in the case of multi-PD/PI awards, will serve as a voting member of the Steering Committee and will attend all meetings of the Steering Committee.
  • Each full member will have one vote.
  • The recipient will be responsible for accepting and implementing the goals, priorities, procedures, protocols, and policies agreed upon by the Steering Committee and Subcommittees.
  • Recipients must serve on SEIC-T1D subcommittees as needed. Subcommittees will report progress at Steering Committee Meetings and/or lead discussions at the Annual Meetings.

• Recipients may be asked to scientifically review applications for special opportunity pool funds, as it is deemed appropriate.
  

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

• The NIDDK will designate program staff, including a Program Official and a Grants Management Specialist to provide normal program stewardship and administrative oversight of the cooperative agreement. The Program Official and Grants Management Specialist will be named in the Notice of Grant Award.
• An NIH IC Project Scientist [or Project Coordinator, or Project Collaborator] will be substantially involved in this project above and beyond the normal stewardship of an NIH IC Program Official as follows:
  • The NIH Project Scientist(s) will coordinate and facilitate the research projects, attend, and attend and participate in all meetings of the SEIC-T1D (Steering Committee).
  • The NIH Project Scientist(s) will be a member(s) of the Steering Committee and, as determined by that committee, and its Subcommittees as needed. Only one NIH Project Scientist will vote on the Steering Committee. Other designated NIH program staff attending the steering committee meetings will be an ex officio (non-voting) member(s).
  • The NIH Project Scientist, and other designated NIH program staff will help the Steering Committee develop and draft operating policies.
  • The NIH Project Scientist(s) and Program Official will review the scientific progress, cooperation in carrying out research, and maintenance of high quality research in each of the individual research project(s), and review the project(s) for compliance with operating policies developed by the SEIC-T1D (Steering Committee), and may recommend to the NIH to continue funding; withhold support or restrict an award for lack of scientific progress or failure to adhere to policies established by the SEIC-T1D (Steering Committee). Review of progress may include regular communications with the PD/PI and NIH staff, periodic site visits for discussions with recipient research teams, fiscal review, and other relevant matters. The NIH retains the option of periodic external review of progress.
  • The NIDDK reserves the right to terminate or curtail any study or any individual award in the event of (a) substantial shortfall in data collection or submission, quality control, or other major breach or a study protocol or SEIC-T1D policy and procedure, (b) substantive changes in a study protocol that are not in keeping with the objectives of the FOA, and/or a human subject ethical issues that may dictate a premature termination.
  • The NIH Project Scientist(s) and Program Official will review and approve applications of the Special Opportunity Funds to ensure that they are within the scope of SEIC-T1D as described in the FOA and NIH guidelines.
  • The NIH will name additional scientific consultants as necessary from within the NIH whose function will be to assist the Project Scientist(s) and the Steering Committee in carrying out the goals and aims of the approved studies. The NIH will have one vote for any key committees, regardless of the number of NIH personnel involved.
  • The Project Scientist(s) will have substantial scientific programmatic involvement in quality control, preparation of publications, research coordination and performance monitoring. The Project Scientist(s) will have the same access and privileges to any data generated by the recipient. The dominant role and primary responsibility for these activities resides with the recipients for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the recipients and the NIDDK Project Scientist(s).
  • The NIH Project Scientist(s) serve as a resource with respect to other ongoing NIH activities that may be relevant to the SEIC-T1D to coordinate activities among recipients by assisting in the design, development, and coordination of (a) common research protocol(s) and statistical evaluations of data and in the publication of results.
  • The NIH Project Scientist(s) may review procedures for assessing data quality and monitor study performance.
  • The NIH Project Scientist(s) may be (a) co-author(s) on study publications. In general, to warrant co-authorship, the NIH staff must have contributed to one or more of 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.
    

Areas of Joint Responsibility include:

Through the Recipient, (Steering Committee) and NIH staff, the study members will cooperatively develop and implement processes to submit information and data to the Administrative Core, determine criteria and processes for quality control of information and data to be posted for the research community, refine scientific objectives, and implement research advances to facilitate the goals of the study, consistent with NIH policies and achieving the goals of the program as described in the FOA.

• Steering Committee (SC)

• The Steering Committee (SC) composed of each of the PD/PI(s) for the U2C, including Contact PD/PI(s) in the case of multi-PD/PI grants, directors of the Stakeholder Engagement Studios and Research Consultation Services Cores of the Center, and the NIH Project Scientist(s) will be the main governing board of the study (SEIC-T1D). Each full SC member will have one vote; NIH/NIDDK will have a single vote. All major scientific and policy decisions will be determined by (voting policies as established by the SC at the initial meeting). This committee will operate to develop collaborative protocols, identify impediments to success and strategies to overcome them, develop shared tools for disseminating information about the projects, and identify opportunities for sharing techniques, materials, information and tools developed within each individual project.
• NIDDK staff, in concert with the SC, will have the option to redirect research activities within the U2C grant(s) if it is considered beneficial to the overall program.
• The SC may, as it deems necessary, invite additional, non-voting scientific consultants to meetings at which research priorities and opportunities are discussed.
• There will be (an initial) meeting and one in person Steering Committee meeting annually, in addition to regular virtual meetings. These meetings will incorporate participation and recommendations of the External Consultants when determined by the SC.
• A Chairperson will be selected by the Steering Committee. In collaboration with the Administrative Core and the NIH Project Scientists, the Chairperson is responsible for coordinating the SC activities, preparing meeting agendas, and chairing meetings. The NIDDK Project Scientist may not serve as Chairperson. The NIDDK Program Official shall be consulted to provide any feedback regarding potential concerns for bias or conflict of interest or lack of required expertise.
• The SC, including the Project Scientist(s), is responsible for establishing and implementing processes and criteria for recommending special projects for consideration for special opportunity funds by NIH staff.
• Each research project recipient and the CC recipient agree to the governance of the U2C through the SC.
• The NIH Project Scientist(s) may work with recipients on issues coming before the Steering Committee and, as appropriate, other committees.

• External Advisory Panel

• An independent panel of External Advisory Panel members may be established by the SC. The External Advisory Panel will review periodically interim progress of the U2C and report to the SC. Members of the External Advisory Panel may be asked, on an ad hoc basis, to participate in the peer review of applications for new research initiatives that utilize special opportunity pool funds (i.e., Partnership and Outreach Fund).
  

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 recipient. This special dispute resolution procedure does not alter the recipient'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.

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 75and 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: 301-480-7075

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

Miranda Broadney, M.D., M.P.H.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-6841
Email: Miranda.Broadney@nih.gov

Beena Akolkar, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 240-593-1733
Email: akolkarb@extra.niddk.nih.gov

Cheryl K. Nordstrom, PhD, M.P.H.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-402-6711
Email: Cheryl.Nordstrom@nih.gov

Todd Le
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301- 594-7794
Email: toddle@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.

This FOA is supported under the authority of P.L. 116-260, Consolidated Appropriations Act, 2021; Section 302. Diabetes Programs.