Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)

Funding Opportunity Title
Program to Advance the Career Development of Scientists from Diverse Backgrounds Conducting Nutrition, Obesity, Diabetes, and Related Research (U24 Clinical Trial Optional)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
New
Related Notices

  • March 26, 2021 - Notice of Extension of Application Due Date for RFA-DK-20-034. See Notice NOT-DK-21-017.
  • Funding Opportunity Announcement (FOA) Number
    RFA-DK-20-034
    Companion Funding Opportunity
    None
    Number of Applications

    Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

    Assistance Listing Number(s)
    93.847
    Funding Opportunity Purpose

    The purpose of this Funding Opportunity Announcement is to enhance the diversity of the research workforce who are available to successfully compete for independent research funding from NIH in the areas of nutrition, obesity, diabetes, and related conditions. This program will establish a consortium providing professional development, mentoring, networking, pilot and feasibility funds, and other opportunities designed to advance the career development of post-doctoral scholars and early career faculty from diverse backgrounds, including those from groupsnationally underrepresented in biomedical and behavioral research, who intend to pursue a research career focused on nutrition, obesity, diabetes, and/or related conditions. The program will be administered through research institutions with substantial existing NIH funding within the research mission of NIDDK.

    Key Dates

    Posted Date
    March 19, 2021
    Open Date (Earliest Submission Date)
    June 14, 2021
    Letter of Intent Due Date(s)

    June 14, 2021

    Application Due Dates Review and Award Cycles
    New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
    July 14, 2021 Not Applicable Not Applicable November 2021 January 2022 April 2022

    All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

    Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

    Expiration Date

    New Date July 15, 2021 per issuance of NOT-DK-21-017. (Original Expiration Date: June 18, 2021 )

    Due Dates for E.O. 12372

    Not Applicable

    Required Application Instructions

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

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

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

    There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

    1. Use the NIH ASSIST system to prepare, submit and track your application online.
    2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

    3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


    4. Table of Contents

    Part 2. Full Text of Announcement

    Section I. Funding Opportunity Description

    Purpose

    This Funding Opportunity Announcement (FOA) will establish a consortium of programs providing professional development, mentoring, networking, pilot and feasibility funds, and other opportunities designed to advance the career development of post-doctoral scholars and early career faculty/academic investigators from diverse backgrounds, including those from groups nationally underrepresented in biomedical and behavioral research, who intend to pursue research careers in nutrition, obesity, diabetes, and related conditions. The program will be administered through research institutions and partners with substantial existing NIH funding for research within the mission of NIDDK. The ultimate goal of this program is to enhance the diversity of the pool of investigators who are available to successfully compete for independent research funding from NIH and other research funding organizations in the areas of nutrition, obesity, diabetes, and related conditions.


    Background

    Every facet of the United States scientific research enterprise—from basic laboratory research to clinical and translational research to policy formation–requires highly advanced training, exceptional research skills and competencies, and creativity. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams, as scientists and trainees from diverse backgrounds and life experiences bring different perspectives and individual enterprise to address complex scientific problems. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help advance the NIH mission (see Notice of NIH’s Interest in Diversity).

    The United States has seen an increase in the number of Ph.D. degrees in the biomedical and behavioral sciences earned by scientists from backgrounds traditionally underrepresented in the biomedical sciences (Gibbs et al., 2016); however, the attrition of scientists from underrepresented groups from academic research remains a problem (Valantine, Lund & Gammie, 2016). Significant racial and ethnic disparities also exist in NIH grant funding, and this disparity is compounded by a lower rate of success for women from underrepresented groups (URGs) compared to men from underrepresented groups (Ginther et al. 2011, Hoppe et al. 2019, Erosheva et al. 2020.)

    NIDDK’s mission includes support for research, training, health information dissemination, and other programs with respect to nutrition, obesity, diabetes, and related conditions, including research on health disparities and health equity. These diseases and their complications tend to disproportionately burden members of some racial and ethnic minority groups in the United States (https://www.cdc.gov/pcd/issues/2019/18_0579.htm; https://www.cdc.gov/diabetes/pdfs/library/Diabetes-Report-Card-2019-508.pdf). Continued support for formative research and for the development of interventions to prevent and treat obesity and diabetes in groups at high risk for these chronic illnesses is critical, but success will ultimately require multidisciplinary teams with distinct perspectives, expertise, and innovative ideas. Given the importance of scientific workforce diversity and sustaining multidisciplinary teams with interest in diseases within NIDDK’s mission, particularly nutrition, obesity, diabetes, and related conditions, it is imperative to promote efforts to advance the career development of scientists from diverse backgrounds, including those from underrepresented groups (URGs), in these specific fields.

    Causes of disease, disability and premature death continue to persist, especially in high-risk and vulnerable populations. Therefore, the next generation of diverse biomedical and behavioral researchers must be prepared to tackle research questions that address preventable risks factors, such as obesity, insufficient nutrition, and chronic disease. The Office of Disease Prevention (ODP) is particularly interested in research that addresses the leading risk factors for premature mortality and morbidity, strengthens research to address health disparities, and includes dissemination and implementation science methodologies. The ODP Strategic Plan FY2019-2023 highlights prevention research priority topics that have emerged as key areas which may be of relevance to this funding opportunity announcement.

    Research Objectives

    This FOA seeks to support a consortium of independent but collaborative programs designed to advance the career development of post-doctoral scholars and early career faculty/academic investigators from diverse backgrounds, including those from underrepresented groups (URGs), who are conducting biomedical and behavioral research on nutrition, obesity, diabetes, and/or related conditions. To participate in this consortium, applicant institutions and partners must have a track record of existing NIH-funded research project grants and research resource grants/Centers with a scientific and mentoring focus on nutrition, obesity, diabetes, and/or related conditions. The program should be designed such that it will enhance the diversity of the pool of researchers who are available to successfully compete for independent research funding from NIH and other research funding organizations in nutrition, obesity, diabetes, and related conditions.

    Awardees will engage in a consortium of collaborative programs recruiting early career scientists from diverse backgrounds, including underrepresented groups, to participate in a cohort-based comprehensive career-building opportunity, including activities such as but not limited to:

    • Research career, professional and leadership development,
    • Career progression strategies such as job search skills, networking with peers and senior investigators; and developing collaborations with other members of the scientific community;
    • Research skill-building and laboratory management;
    • Education and experience in pedagogical skill development and mentoring;
    • Grant writing, appropriate administrative and other support relevant to preparation and submission of research grant applications, and grant management; and
    • Pilot and Feasibility (P&F) funding opportunities.
       

    It is expected that cohorts will consist of eligible candidates at the early stages of their careers, including faculty/academic investigators and senior post-doctoral scholars. Post-doctoral scholars should be interested in pursuing a career in biomedical or behavioral research in nutrition, obesity, diabetes, and/or related conditions. Faculty/academic investigators would include individuals with faculty, research, and/or other relevant appointments who are interested in seeking independent NIH funding to support their research. Each awardee institution in the consortium will be expected to recruit two cohorts (one cohort enrolled in year 2 and a second cohort enrolled in years 3-4, as appropriate) of ~5-10 candidates per cohort from diverse backgrounds, including URGs, for a total of 10-20 candidates per awardee institution over the full project period. Recruitment of scholars or investigators with interests across the research spectrum from basic biomedical or clinical sciences, behavioral or social sciences, health disparities and health equity, health services research, or other disciplines relevant to nutrition, obesity, diabetes and related conditions as prospective candidates for this program is encouraged. Applicants have the option but are not required to propose to focus on a broad theme(s) relevant to their scientific, research funding, and mentoring base in nutrition, obesity, diabetes, and/or related conditions, which may influence cohort recruitment priorities, programmatic approaches, or mentoring.

    The program is not intended to provide direct salary support for enrolled cohort members but rather will provide support for personnel, including investigators and staff, necessary to implement the program. Awardees may choose to provide limited salary support for select mentors to participate in the program, as appropriate. Cohort members may have and are expected to pursue NIH grant funding and may currently hold or participate in training grants, fellowship awards, career development awards, or small/pilot grants from NIH, other Federal agencies, or private foundations. In addition, the enrolled cohort members will be strongly encouraged to become members of NIDDK’s Network for Minority Health Research Investigators and attend the annual meetings: https://www.niddk.nih.gov/research-funding/research-programs/diversity-programs/network-minority-health-research-investigators-nmri.

    Individual awardees will be charged with developing and implementing a career-building program appropriate for the cohorts of early career scientists enrolled at their and their collaborators’ institution(s). Applicant institutions are strongly encouraged to develop collaborations and to partner with Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions (HSIs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and/or Asian American Native American Pacific Islander-serving institutions to recruit prospective candidates for the cohort and to expand the mentoring pool. During year 1 of the project, members of the consortium will develop independent programs with common consortium-wide program components and activities. Recruitment of cohorts will occur during years 2-4 with the program for each cohort implemented over a minimum of two years. Fostering interaction beyond the 2-year period for each cohort is encouraged, as appropriate. Year 5 will include wrap-up activities, such as but not limited to convening both cohorts together to support program participants’ career development goals and transitions; promoting scientific exchanges; collaboratively evaluating the program; and disseminating program outcomes, best practices, and other materials. Each institutional awardee will be required to sponsor a pilot and feasibility (P&F) program throughout the project period to provide opportunities for cohort members to compete for P&F funds to support the generation of preliminary data necessary to apply for independent research funding from NIH and other funding organizations. Enrolled cohort members at each awardee institution should also receive group and individual-mentored experiences (a primary mentor along with support from other appropriate mentors).

    Applicants for this program must have a demonstrated track record of recruiting, mentoring, training, and supporting early career scientists conducting research in nutrition, obesity, diabetes, and related conditions, including those from underrepresented groups. Applicants must also demonstrate a track record of excellence in sustained Federally-funded research in these topic areas, such as but not limited to research project grants (including R01s, R21s, P01s, etc.), training grants, and/or research resource or Center grants, etc. Applicants at institutions with more than one relevant NIH-funded infrastructure/services grants [such as Centers (P30, P50, U54, etc.) or Clinical Translational Science Award (CTSA) awards], training (such as T- or F-awards) grants, mentoring programs, or other grants relevant to nutrition, obesity, diabetes, and or related conditions are expected to demonstrate a strong collaborative multidisciplinary research approach and discuss how these programs will interact and collaborate. Partnerships with professional societies, other funding organizations, and the broader research community are encouraged.

    Awardees will be expected to provide evidence of accomplishing the objectives in progress reports and to disseminate successful mentoring and other skills development practices to the broader research community. Wherever appropriate, awardees will be expected to obtain feedback from cohort participants to help identify program strengths and weaknesses; to provide suggestions for improvements on program administration; to indicate the likelihood of utilizing the knowledge and/or skills gained for future education and career development; to provide suggestions for future programming to improve program effectiveness; and to describe any programmatic changes developed from such feedback. Awardees will also be expected to develop the programmatic activities and evaluation plan early in the planning phase.
     

    Pilot and Feasibility (P&F) Program

    Each grantee institution will be required to manage a P&F program to provide seed grant funding support for cohort members to generate the preliminary data necessary to successfully compete for independent research funding from NIH and other funding organizations. Enrolled cohort members should also have the opportunity to apply for small grants for applicable research expenses such as supplies, equipment, publication page charges, travel, or relevant course work (biostatistics, principles of clinical research, etc.). It is envisioned that the P&F program would operate throughout the 5-year project period. Efforts to expand the P&F program (number of P&F awards, budget amounts) through matching or other appropriate funding sources are encouraged. P&F grants may be awarded to eligible investigators outside of the parent institution/consortium. Applicants are not expected to either invite applications or propose specific P&F projects that would be funded through the P&F Program for the purposes of this application; therefore, it is expected that any Human Subjects Research Studies will be 'delayed onset'.

    The interest of the ODP in this FOA is to promote the development of independent, highly skilled prevention scientists through career development, mentoring, and pilot and feasibility funding for scientists who are prepared to address the complex process of bridging research and practice in a variety of real-world settings. More specifically, the ODP is interested in building capacity and skills in research design, measurement, data analysis, and other prevention science methods. Therefore, awardees are strongly encouraged to solicit and award at least one P&F project per year involving prevention intervention research that addresses leading risk factors for morbidity and mortality.


    Oversight Plan for P&F Programs involving HS research

    Although all P&F projects should be monitored for productivity, programs that fund P&F projects involving Humans Subjects Research must develop a detailed, formal plan for assuring compliance with all relevant NIH regulations. The plans for implementation of this oversight plan must be included in the application, as appropriate for either clinical studies or clinical trials. Do not duplicate information already provided in the PHS Human Subjects Clinical Trial Information form.


    The following elements or procedures are required as part of the oversight plan:

    • Development and implementation of appropriate data and safety monitoring plans,
    • Documentation of IRB approval,
    • Registration of all clinical trials in clinicaltrials.gov,
    • Development and monitoring of appropriate milestones,
    • Oversight of participant recruitment and retention,
    • Results reporting in www.clinicaltrials.gov, as appropriate, and
    • Planning for dissemination of research results.
       

    Consortium Activities and Governance

    Awardees will be expected to collaborate in consortium-wide activities. A Steering Committee will be convened as the governing body to support planning and oversight of the Consortium. The Steering Committee will be comprised of the Program Directors/Principal Investigators (PDs/PIs) of each U24 award and the NIDDK Project Scientist(s). The Steering Committee will collaborate to share best practices; develop relevant common programming; provide networking and other opportunities; and to develop an evaluation for the overall and program-specific components of the consortium. The consortium will hold at least one face-to-face meeting per year. It is envisioned that the consortium members will spend year 1 developing and sharing programming plans, refining strategies to recruit eligible candidates to participate in the program, and identifying opportunities for joint programming and networking. The consortium will be expected to encourage relevant interactions between the cohorts at all of the participating awardee institutions throughout the project period. The Steering Committee will also establish defined metrics to permit evaluation of the program components. It is expected that the Steering Committee will disseminate best practices, recommendations, and lessons learned from the program to the broader research community and to inform NIDDK of potential future directions and the field.

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

    Section II. Award Information

    Funding Instrument

    Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

    Application Types Allowed
    New

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

    Clinical Trial?

    Optional: Accepting applications that either propose or do not propose clinical trial(s).

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    NIDDK and ODP intend to commit $1,600,000 in FY2022 and $2,600,000 in FY2023-2026 to fund up to 3 awards that will comprise the consortium for the program described in the FOA.

    .

    Award Budget

    Application budgets are limited to $350,000 in Direct Costs in FY2022 and up to $575,000 in Direct Costs in FY2023-2026 exclusive of indirect costs on subcontracts.

    Award Project Period

    The maximum project period is 5 years.

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

    Section III. Eligibility Information

    1. Eligible Applicants

    Eligible Organizations

    Higher Education Institutions

    • Public/State Controlled Institutions of Higher Education
    • Private Institutions of Higher Education

    The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

    • Hispanic-serving Institutions
    • Historically Black Colleges and Universities (HBCUs)
    • Tribally Controlled Colleges and Universities (TCCUs)
    • Alaska Native and Native Hawaiian Serving Institutions
    • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

    Nonprofits Other Than Institutions of Higher Education

    • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
    • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

    For-Profit Organizations

    • Small Businesses
    • For-Profit Organizations (Other than Small Businesses)

    Local Governments

    • State Governments
    • County Governments
    • City or Township Governments
    • Special District Governments
    • Indian/Native American Tribal Governments (Federally Recognized)
    • Indian/Native American Tribal Governments (Other than Federally Recognized)

    Federal Governments

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

    Other

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

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

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

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

    Required Registrations

    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.

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • 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.
    • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and SAM registration in order to complete the Grants.gov registration.

    Program Directors/Principal Investigators (PD(s)/PI(s))

    All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

    Eligible Individuals (Program Director/Principal Investigator)

    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

    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.

    The PD(s)/PI(s) should be an established investigator conducting research in nutrition, obesity, diabetes, and related conditions with recent peer-reviewed research publications and successful competition for research support in one or more of these topic areas who is capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are encouraged to apply. The PD(s)/PI(s) will be responsible for identification and recruitment of candidates into the program and for the overall direction, management, administration, and evaluation of the program. The PD(s)/PI(s) will be expected to monitor and assess the program and submit all documents and reports as required.

    The NIDDK encourages multiple PD(s)/PI(s), particularly when each brings a unique perspective and areas of expertise that will enhance the program. Additional PD(s)/PI(s), including individuals with experience in areas such as science education, program evaluation, mentoring, and career development for early-career scientists, may be included to achieve the goals of the program.

    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

    Only one application per institution (normally identified by a unique DUNS number or NIH IPF number) is allowed.

    The NIH will not accept duplicate or highly overlapping applications under review at the same time.  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 NOT-OD-11-101).

    .

    Section IV. Application and Submission Information

    1. Requesting an Application Package

    The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    2. Content and Form of Application Submission

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

    Letter of Intent

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

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

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

    The letter of intent should be sent to:

    John 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 Application Submission

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

    SF424(R&R) Cover

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

    SF424(R&R) Project/Performance Site Locations

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

    SF424(R&R) Other Project Information

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

    Facilities & Other Resources. Describe the research environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program.
     

    Other Attachments.

    Faculty Mentor Base: The title of this attachment should be “Faculty Mentor Base.pdf”.

    Applicants must provide a brief overview (not to exceed 6 pages) of the program faculty who may serve as mentors. The program faculty should have strong records as researchers, including recent publications and successful competition for research support in the area(s) of the proposed research program. Program faculty should also have a record of research mentoring, including successful, former trainees who have established productive careers relevant to the mission of NIDDK. Programs are encouraged to build a diverse team of mentors that includes, for example, faculty from underrepresented groups, women, persons with disabilities, and faculty at different career stages (i.e., junior as well as senior faculty). (See the Notice of NIH's Interest in Diversity.) Mentors should have research expertise and professional experience relevant to the proposed program, for example a record of independent research funding and career progression in a research-intensive academic institution.

    The attachment should also include a narrative (not to exceed 6 pages) of examples of potential program faculty. For up to 12 program faculty members, the following should be provided for each member and should not exceed a half-page per program faculty member: faculty member name; degree(s); faculty rank (e.g. Associate Professor); primary academic department/program; a brief description of the faculty member’s research interests relevant to the proposed program; current research support with grant #, title, and dollar amount (direct costs); # of postdoctoral fellows and/or junior faculty currently engaged in full-time, mentored research training in the faculty member’s research group; # of postdoctoral fellows and/or junior faculty under the faculty member’s primary supervision during the past 10 years; provide the # of postdoctoral and/or junior faculty during the last 10 years and who currently are engaged in a research-intensive or research-related career. Experience in the recruitment and mentoring of underrepresented groups should be included in the individual narratives, when applicable. Individual biographical sketches for possible faculty mentors should not be included in the application.
     

    Applications lacking the “Faculty Mentor Base” attachment will not be reviewed.

    The filename provided for this “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.
     

    SF424(R&R) Senior/Key Person Profile

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

    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 underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

    For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator (PD/PI) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide. The NIDDK encourages multiple PD(s)/PI(s), particularly when each brings a unique perspective and skill set that will enhance the program. Additional PD(s)/PI(s), including individuals with experience in areas such as science education, program evaluation, mentoring, and career development for early-career scientists, may be included to achieve the goals of the program.

    Researchers from diverse backgrounds, for example individuals from underrepresented racial and ethnic groups, persons with disabilities, and women are encouraged to participate as Program investigators and mentors. Mentors should have research expertise and professional experience relevant to the proposed program, for example a record of independent research funding and career progression in a research-intensive academic institution.

    R&R Budget

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

    The PDs/PIs must commit at least 1.8 person months on the award annually. For programs with multiple PD/PIs, each PD/PI must contribute at least 1.2 person-months effort. In addition to person month effort for the PD(s)/PI(s), applicants may propose to provide limited person month effort for key faculty mentors with appropriate justification. Applicants are expected to request salary support for personnel necessary to administer the program.

    Applicants should budget for travel expenses for cohort members, speakers, and program leadership to attend one in-person meeting per year at other awardee institutions and for travel to major scientific meetings. Applicants may request funds for research skills development and experiences, attending scientific workshops, or other relevant educational and/or coursework opportunities for program participants.

    Applicants must request funds to support P&F projects with a minimum of $100,000 in direct costs in year 1 and a minimum of $325,000 per year in years 2-5 to support both P&F research grants and a small grant program for supplies or other needs. ‘Small grants’ (up to $10,000) may support applicable research expenses such as supplies, equipment, publication page charges, travel, or relevant course work (biostatistics, principles of clinical research, etc.) Each individual P&F project budget will be limited to a maximum of $50,000 per year with an option to submit a renewal application for a 2nd year. It is expected that awardees will fund a minimum of 5 projects per year in years 2-5. Applicants are strongly encouraged to develop a plan to permit awarding funds for P&F projects to cohort members who may be located at institutions outside of the applicant institution(s) or consortium.

    Funding for program evaluation should be requested to allow for generation of reports or publications regarding identification of barriers, lessons learned, and future opportunities.

    R&R Subaward Budget

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan

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

    Specific Aims: The specific aims should reflect the integrated approach that clearly presents the goals of the program.

    Research Strategy: Applicants should provide an overview and strategic vision for how the program will advance the careers of scientists from diverse backgrounds, including those from underrepresented groups, conducting nutrition, obesity, diabetes, and related research, at the applicant institution(s) and collaborating institution(s). This section should address the institutional track record of supporting multidisciplinary research mentoring in nutrition, obesity, diabetes, and related conditions; evidence of collaborative, interdisciplinary research; and the institutional approach to fostering the careers of post-doctoral and early career faculty, particularly individuals from underrepresented groups. Applicants should describe a clear mission statement and discrete goals for their program, describing strategies aimed at professional and scientific career development and milestones for success.

    Applicants should also provide the following information:

    • Plan for recruiting postdoctoral scholars and/or early career faculty/academic investigators from diverse backgrounds, including those from underrepresented groups to participate in the cohorts;
    • Proposed plan for implementing a mentoring program, enhancing the scientific and professional networks of program participants, offering grant- and scientific- writing education, assuring appropriate research skills and leadership development opportunities, and developing professional development programs;
    • Description of the process for orienting and selecting mentors for program participants, plan for appropriate oversight of mentoring activities, and plan to train and expand the pool of appropriate and effective mentors;
    • Plan for collaborating and integrating the applicant institution’s Program into relevant existing diversity and mentoring programs and offices within the applicant institution(s) and any proposed collaborating institution(s), as appropriate; 
    • Process for the competitive solicitation and review of P&F applications and a description of the oversight and monitoring procedures for funded P&F awards;
    • Plans to track progress of cohort members. Tracking should include, but is not limited to, the following metrics: career outcomes, grant applications/awards, research experiences, peer-reviewed publications, scientific presentations, honors/awards, and leadership positions in current institution and/or professional organizations; and
    • Plans for developing milestones; collecting data; evaluating the productivity of the program; and disseminating best practices, recommendations, and lessons learned to the broader research community.
       

    Include a brief description of the applicant institution’s history and amount of funding (#, type, and source of grants) for nutrition, obesity, diabetes, and related research according to Federal vs other funding organizations. Provide details on any NIH-funded Centers, Research Infrastructure/Resource Grants, and Training Grants in particular, as well as investigator-initiated grants (R01s, P01s, R21s, etc.). Discuss the applicant institution’s (including any partners) commitment to the program including any existing institutional programs designed to support diversifying and retaining the research workforce.

    The PI(s)/PD(s) must also state his/her willingness to participate in Consortium activities, including sharing of relevant materials, participating in Steering Committee and relevant sub-committee meetings, developing common Program workshops and meetings, and completing a consortium-wide evaluation plan.
     

    Letters of Support: A letter(s) from the PD(s)/PI(s) of any related NIH/NIDDK T32, K12, KL2 or other training/career development institutional awards at the applicant institution or its partner(s) should be included that acknowledges and briefly details how the PD(s)/PI(s) the program intends to promote cohesive interactions between the programs. If collaborative linkages are being developed between any NIH/NIDDK research resource or Center award(s) (P30, U54, etc.) or CTSA and the proposed Program, a letter(s) of agreement from the PD(s)/PI(s) of the Center(s) and/or CTSA should be included.

    Include all assurance letters including institutional commitments and outside collaborations, if such plans are listed in application.

    The Letters of Support attachment should begin with a table of letter authors, their institutions, and the type of each letter (institutional commitment or resources, collaboration, or role in the project).
     

    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.

    Appendix:
    Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
    PHS Human Subjects and Clinical Trials Information

    When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

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

    If the Program's P and F Program will accept projects that include Human Subjects research, the justification should include a description of the broad areas of Human Subjects research that would be eligible for P and F support in addition to other relevant information. Likewise, if the P and F Program will accept Clinical Trial projects, the Justification should include a description of the types of Clinical Trials that would be permitted as well as the areas of science that would be eligible in addition to other relevant information. Applicants should provide institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects.
     

    PHS Assignment Request Form

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

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

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

    4. Submission Dates and Times

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

    Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

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

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

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

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

    7. Other Submission Requirements and Information

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

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

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

    Important reminders:

    All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

    The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

    See more tips for avoiding common errors.

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

     

    Use of Common Data Elements in NIH-funded Research

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

    Post Submission Materials

    Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

    Section V. Application Review Information

    1. Criteria

    Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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

    Overall Impact

    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).

    Scored Review Criteria

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

    Specific to this FOA: Does the applicant provide an appropriate vision for how the program will advance the careers of scientists from diverse backgrounds, including those from underrepresented groups? Do the applicant institution and collaborators have a track record of excellence in research and mentoring in nutrition, obesity, diabetes, and related research? Do the applicant institution and collaborators have the experience and resources necessary to foster the careers of eligible early career investigators, including those from underrepresented groups?

    In addition, for applications involving clinical trials

    Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

    Investigator(s)

    Are the PD(s)/PI(s) and other personnel well suited to their roles in the Program? If the Program is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their governance and organizational structure appropriate for the Program? Does the applicant have experience overseeing selection and management of sub-awards, if needed?

    Specific to this FOA: Do the investigator and mentoring research team have a track record of involvement in, or leadership of, successful efforts to enhance diversity within the biomedical research workforce? Is there a robust plan to recruit prospective participating early career scientists from diverse backgrounds, including those from underrepresented groups? Does the PD(s)/PI(s) plan to commit sufficient effort to ensure the program’s success?

    In addition, for applications involving clinical trials

    With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

    Innovation

    Does the application propose novel organizational concepts and management strategies in coordinating the research community the Program 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: Where appropriate, is the proposed program developing or utilizing innovative approaches and latest best practices to advance the career development of early career scientists from diverse backgrounds, including those from groups underrepresented in research?

    In addition, for applications involving clinical trials

    Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

    Approach

    Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research resource the Program will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the Program, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the Program 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? Are 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?

    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?

    Specific to this FOA: Does the applicant provide a well-justified plan for recruiting eligible cohort members for the program? Does the applicant propose a strong program including mentoring, grant- and scientific- writing education, professional development, networking, and skill-building that will serve to increase success in promotion and achieve independent grant funding success? Does the applicant propose an appropriate process for inviting, reviewing, awarding, and assuring appropriate oversight of the pilot and feasibility program? Does the applicant appropriately discuss the development of a plan for dissemination of best practices, recommendations, and lessons learned?

    In addition, for applications involving clinical trials

    Does the application adequately address the following, if applicable

    Study Design

    Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

    Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

    Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

    Data Management and Statistical Analysis

    Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

    Environment

    Will the institutional environment in which the Program will operate contribute to the probability of success in facilitating the research Program it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Program proposed? Will the Program benefit from unique features of the institutional environment, infrastructure, or personnel?

    Specific to this FOA: Are adequate resources available within the scientific environment to support electronic information handling? Does the applicant provide evidence of appropriate institutional commitment, support, and resources as appropriate to identify recruit, mentor, and retain the eligible Program cohort members?

    In addition, for applications involving clinical trials

    If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

    Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

    If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

    If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

     

     

     

     

     

     

    Additional Review Criteria

    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.

     

     

     

     

    Study Timeline

    Specific to applications involving clinical trials
    Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

    Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

    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

    Additional Review Considerations

    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 the NIH Grants Policy Statement.

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

    Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

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

    ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

    Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

    Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

    Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

    2. Administrative and National Policy Requirements

    All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

    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. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/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.

    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 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

    Cooperative Agreement Terms and Conditions of Award

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

    • Development and implementation of programs or opportunities for career development, grant-writing, mentoring, and networking activities within the awardee institution, collaborators, and the consortium;
    • Recruitment, appointment, and retention of cohort members in the program and assurance of appropriate progress;
    • Creation and oversight of mentoring teams and opportunities for individual program participants;
    • Facilitation of communication and interactions across the consortium;
    • Appropriate oversight of the solicitation, selection, award, and conduct of Pilot and Feasibility Programs;
    • Adherence to the decisions and recommendations of the Steering Committee; and
    • Collection and analysis of program evaluation data.
       

    Recipient(s) will retain custody of and have primary rights to any materials developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

    Project Scientist: NIH Project Scientist(s) with expertise in relevant areas will:

    • Help guide the development of each program and the collaborative group by providing overall advice and coordination;
    • Identify relevant NIH expertise and/or resources related to NIH and NIDDK funding mechanisms and initiatives, various NIH programs designed to help early career investigators, and other resources, expertise, or skills that may be relevant to optimizing the content of the program, etc.;
    • Facilitate a partnership with NIH and ensure that the directions taken by the recipient are consistent with NIH missions and goals;
    • Promote communication between NIH, recipients, and the consortium, and
    • Facilitate, not direct, activities.
       

    Program Official: The NIH Program Official will be responsible for oversight of the funding announcement and the normal programmatic stewardship of the award, including participating in funding recommendations, and will be named in the award notice. The Program Official will not partake of the duties of the Project Scientist.
     

    Areas of Joint Responsibility include: A Steering Committee will be convened to serve as the main governing board. The Steering Committee will be composed of the following voting members:

    • One representative from each U24 award (a PD/PI or a designee) who will each have one vote, and
    • NIDDK Project Scientist(s) who will have collectively one vote.

    The Chair and co-Chair(s) of the Steering Committee will be selected from the representatives of all recipient(s). Additional NIDDK staff members may participate in Steering Committee meetings as non-voting members.

    The Steering Committee may decide to establish sub-committees for specific purposes. The NIDDK Project Scientist(s) may serve on such sub-committees as they deem appropriate.

    The Steering Committee will meet monthly by teleconference. Relevant joint meetings or workshops will be held at the recipient(s)' institutions.
     

    Primary responsibilities of the Steering Committee include, but are not limited to, the following activities:

    • Serving as main body overseeing the realization of the program’s goals;
    • Ensuring that the content of all courses or workshops, their participants, locations, and other salient characteristics are optimal for the goals of the Program;
    • Monitoring the overall program performance, identifying impediments to success, and developing appropriate strategies to overcome the problems;
    • Developing agendas and content for meetings;
    • Facilitating communication and fostering productive interactions across cohorts and the consortium;
    • Promoting collaborations on research education and, as appropriate, joint presentations and publications by program consortium members; and
    • Ensuring that the program consortium leverages optimally existing NIH and NIDDK resources and programs.
       

    Dispute Resolution

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

    Oversight of Pilot and Feasibility Program

    In accordance with NIH policy http://grants.nih.gov/grants/policy/hs/index.htm and the NIH Guide Announcement NOT-OD-15-129, the recipient institution is responsible for ensuring that any awarded P&F projects follow all relevant regulations and policies for Human Subjects Research. The following elements or procedures must be included in the recipient institution’s P&F program oversight plan, as appropriate for all HS research inclusive of both clinical studies and clinical trials:

    • Development and implementation of appropriate data and safety monitoring plans
    • Documentation of IRB approval
    • Registration of all clinical trials in clinicaltrials.gov
    • Development and monitoring of appropriate milestones
    • Oversight of participant recruitment and retention
    • Results reporting in clincaltrials.gov, as appropriate; and
    • Planning for dissemination of research results.
       

    3. Reporting

    When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

    Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and any changes to the Humans Subjects research oversight plan. Awardees should notify NIH of serious adverse events and unanticipated problems.

    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.

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees 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 $25,000.  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 Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions 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.

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

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

    Scientific/Research Contact(s)

    Mary E. Evans, Ph.D.
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Telephone: 301-594-4578
    Email: evansmary@niddk.nih.gov

    Melissa Green Parker, Ph.D.
    Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
    Telephone: 301-480-1161
    Email: melissa.greenparker@nih.gov

    Peer Review Contact(s)
    Michele Barnard, Ph.D.
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Telephone: (301) 594-8898
    Email: barnardm@niddk.nih.gov
    Financial/Grants Management Contact(s)

    Elizabeth Gutierrez
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Telephone: 301-594-8844
    Email: gutierrezel@niddk.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.

    Authority and Regulations

    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.


    Weekly TOC for this Announcement
    NIH Funding Opportunities and Notices
    NIH Office of Extramural Research Logo
    Department of Health and Human Services (HHS) - Home Page
    Department of Health
    and Human Services (HHS)
    USA.gov - Government Made Easy
    NIH... Turning Discovery Into Health®


    Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.