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)

Funding Opportunity Title
Postbaccalaureate Research Education Program in Diabetes, Endocrinology and Metabolic Diseases (R25 Independent Clinical Trial not Allowed)
Activity Code

R25 Education Projects

Announcement Type
New
Related Notices

June 6, 2023 - Notice of Change to the Letters of Intent Due Date for "RFA-DK-22-037: Postbaccalaureate Research Education Program in Diabetes, Endocrinology and Metabolic Diseases (R25 Independent Clinical Trial not Allowed)". See Notice NOT-DK-23-029

NOT-OD-22-189 - Implementation Details for the NIH Data Management and Sharing Policy

NOT-OD-22-195 - New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023

NOT-OD-22-198 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023

NOT-OD-19-109 - Requirement for ORCID iDs for Individuals Supported by Research Training, Fellowship, Research Education, and Career Development Awards Beginning in FY 2020.

NOT-OD-23-012 - Reminder: FORMS-H Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available

Funding Opportunity Announcement (FOA) Number
RFA-DK-22-037
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.847
Funding Opportunity Purpose

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The overarching goal of this R25 program is to support educational activities that encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research.

To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on:

  • Courses for Skills Development
  • Research Experiences

This Funding Opportunity Announcement (FOA) provides support to eligible, domestic institutions to develop and implement Postbaccalaureate Research Education Programs in Diabetes, Endocrinology and Metabolic Diseases (DEM). These post-baccalaureate research programs will incorporate extensive research experiences and well-designed courses for skills development to prepare recent college graduates from diverse backgrounds, including those from underrepresented groups, to transition into and complete rigorous, research-focused biomedical doctoral degree programs (e.g., Ph.D. or M.D./Ph.D.). The long-term goal of post-baccalaureate participants admitted to the program should be pursuing a career focused on DEM-related research. Eligible applicants for the R25 must be research-intensive doctoral degree-granting institutions with a research base in DEM science of at least $3 million in direct costs of peer-reviewed research projects, and research opportunities for students admitted to the program must be in DEM science.

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Key Dates

Posted Date
February 27, 2023
Open Date (Earliest Submission Date)
September 25, 2023
Letter of Intent Due Date(s)

New Date - September 25, 2023 (Original Date: January 15, 2024) per issuance of NOT-DK-23-029

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
October 25, 2023 Not Applicable Not Applicable March 2024 May 2024 July 2024

All applications are due by 5:00 PM local time of applicant organization.

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

Expiration Date
October 26, 2023
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.

Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The NIH Research Education Program (R25) supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers.

The overarching goal of this R25 program is to support educational activities that encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research.

To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on:

  • Courses for Skills Development: For example, to provide advanced courses related to Diabetes, Endocrinology and Metabolic Disease (DEM) science, or research techniques, and/or courses or workshops to develop scholarly potential to prepare participants for graduate school admissions, successful completion of a research-focused doctoral degree, and careers in the biomedical research workforce.
  • Research Experiences: For example, to provide hands-on exposure to DEM-related research, to prepare participants for graduate school admissions, successful completion of a research-focused doctoral degree, and careers in the biomedical research workforce.

This FOA will support the development of Postbaccalaureate Research Education Programs in Diabetes, Endocrinology and Metabolic Diseases (PRIDE programs). These post-baccalaureate research programs will incorporate extensive research experiences and well-designed courses for skills development to prepare recent college graduates from diverse backgrounds to transition into and complete rigorous, research-focused biomedical doctoral degree programs (e.g., Ph.D. or M.D./Ph.D.). The long-term goal of post-baccalaureate participants admitted to the program should be pursuing a career focused on DEM-related research. Eligible applicants for the R25 must be research-intensive doctoral degree-granting institutions with a research base in DEM science of at least $3 million in direct costs of peer-reviewed research projects, and research opportunities for students admitted to the program must be in DEM science.

Background

NIH recognizes the need for diversity in the scientific workforce . As noted in NOT-OD-20-031, research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.. However, in spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIDDK is committed to ensuring that future generations of researchers will be drawn from the entire pool of talented individuals. Barriers to maximizing diversity of the biomedical workforce exist on multiple levels; the goal of this RFA is to increase opportunities for recently graduated individuals from diverse backgrounds, including those from underrepresented groups, who majored in science during college to obtain additional training to be competitive for doctoral degree programs. The reasons that some individuals may not apply for or be accepted into doctoral programs are complex. However, some reasons may include financial barriers that limit their ability to attend research-intensive academic institutions during college or take advantage of available research opportunities during the academic year or summer (e.g., because of the need to work to pay for their college education). Lack of exposure to research may also limit self-efficacy, which may be further diminished by the lack of the diversity some individuals may see in the scientific workforce. Post-baccalaureate programs may address some of these issues by augmenting research experiences, mentoring, and providing community to enhance self-efficacy and sense of belonging to the research workforce. Indeed, multiple reports (e.g., ACD Working Group on Diversity in the Biomedical Workforce, 2012;PCAST Report, 2012;From College to Careers: Fostering Inclusion of Persons with Disabilities in STEM, 2014;Increasing College Opportunity for Low Income Students, 2014;Barriers and Opportunities for 2-Year and 4-Year STEM Degrees, 2016; and Indicators for Monitoring Undergraduate STEM Education, 2018) recommend supporting programs that encourage the recruitment, training, and mentoring of students from nationally underrepresented groups who are interested in science as a means to effectively build a diverse and competitive scientific workforce.

Program Objective

The PRIDE program will provide institutions with the resources to support and provide research experiences and courses for skills development to research-oriented postbaccalaureate participants from diverse backgrounds, including those from underrepresented groups who, following the completion of the program, will apply to and complete a rigorous research-based doctoral degree program in a field directly related to DEM. Programs will implement evidence-informed approaches to biomedical research education and mentoring to enhance diversity in the biomedical research workforce. Each program supported by this FOA must provide 1) a dedicated DEM-related research experience for the post-baccalaureate participants; 2) mentoring for each participant; 3) skills development as needed, including additional coursework; and 4) meaningful inclusion and integration of participants into the awardee’s research community. The expectation is that the experience will provide the post-baccalaureate participants with technical and professional skills needed to successfully pursue a doctoral degree in DEM-related science while enhancing science identity, self-efficacy, and a sense of belonging among the cohort members in the biomedical research community. Funded programs are expected to promote inclusive research and academic environments at all levels (i.e., laboratory, department, institution, etc.) where researchers from all backgrounds are and feel integrated into and supported by the biomedical research community.

The program should allow post-baccalaureate participants to develop:

  • a broad understanding of DEM science,
  • the ability to think critically and independently,
  • a strong foundation in scientific reasoning, hypothesis testing, rigorous research design, experimental methodology and data analysis/interpretation,
  • an understanding and commitment to scientific integrity,
  • the ability to work effectively in teams and promote inclusive and supportive research environments,
  • communication skills, including presentation of results, and manuscript development, and
  • an understanding of the requirements and opportunities for a scientific research career.

These achievements will culminate in (a successful) application to a doctoral degree program (Ph.D. or M.D., Ph.D.).

Program Components

Research: Post-baccalaureate participants must be involved in independent research projects in DEM science. The participants are not to be viewed as a technician, but should be engaged in meaningful independent research which will allow them to learn to pose and answer scientific questions. Participants should be integral contributors to the research project in which they are involved and have the opportunity to present research results and co-author papers. They should also be fully integrated into the laboratory/department/division in which the work is being conducted and have the opportunity not only to interact directly with the primary research mentor, but with doctoral students, post-doctoral fellows and other faculty/investigators who could support their growth as scientists. The research experience must occupy a minimum of 75% effort each of the two years of the program.

Coursework: The other 25% of time may be used, as necessary, for coursework or other activities promoting skills development. Formal coursework for academic credit should be directly related to requirements for admission to a doctoral degree program. Other development activities may include seminars, workshops, lectures, or other activities offered by the home program of the participant or one of the other funded R25 programs. These supplemental activities should be approved and/or developed keeping in mind the ultimate goal the successful application to (and subsequent completion of) a rigorous research-focused doctoral degree program.

Mentoring: In addition to the research project itself, the participant must be well-integrated into the laboratory/division/program in which the research is occurring, so that the post-baccalaureate participant will be immersed in the scientific environment and benefit from both informal and formal mentoring. Participants should feel they are in a safe environment, where they can present their work, ask questions, and seek help. The research mentor, in conjunction with the R25 program principal investigator or designee, must design an individual development plan for each participant, which will be re-evaluated at defined intervals, to make adjustments as needed and ensure that the participant is making progress toward achieving the goals of the program as well as their personal goals. Programs should build on the strengths of participants and should not reflect deficit models of career development (i.e., those that focus primarily on remediation of perceived weaknesses). It is expected that mentoring activities will include support and guidance to the participants for applying to doctoral degree programs during the 2nd year in the program. It is the intention of NIDDK to fund three programs, with each program recruiting four post-baccalaureate students, with the intention of building cohorts for mentoring and support at both the local and national levels. The R25 awardees are expected to organize an annual national meeting of all post-baccalaureate participants with at least one faculty member from each program to facilitate faculty as well as peer-peer mentoring.

Promoting Diversity: Applicants must describe how they will recruit participants, who may not come solely from their own institution. Each funded program will be expected to create formal relationships with undergraduate-focused institutions from which eligible students who are interested in scientific research careers can be recruited. These institutional relationships should be bi-directional (e.g., there should discussion of how to reach out to potential participants, how to develop and evaluate applications, etc.).

Given that these are fundamentally institutional awards, it is expected that applicants will describe existing plans or programs to enhance diversity at all research levels and to promote inclusive, safe, and supportive research environments (Supporting a Safe and Respectful Workplace at Institutions that Receive NIH Funding | grants.nih.gov). Specifically, funded programs should have institutional and departmental environments where individuals from all backgrounds are welcomed and feel integrated into and supported by the biomedical community. Programs are also expected to ensure environments are free from harassment and intimidation, and that institutional practices prioritize scientific rigor and safety.(Expectations, Policies, and Requirements | grants.nih.gov).

Evaluation: It is expected that post-baccalaureate participants in the program will successfully apply to and complete rigorous, DEM-related research doctoral programs. R25 applicants must describe how they will evaluate the success of their program, including predetermined goals and metrics. This includes not only feedback from participants and mentors; evaluation should include assessment of long-term success (i.e., successful completion of Ph.D. or M.D., Ph.D. programs, and subsequent career development, not simply acceptance into a doctoral program).

This RFA does not allow appointed participants to lead an independent clinical trial but does allow them to obtain research experience in a clinical trial led by a mentor.

Research education programs may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those training and education programs currently receiving Federal support. R25 programs may augment institutional research training programs (e.g., T32, T90) but cannot be used to replace or circumvent Ruth L. Kirschstein National Research Service Award (NRSA) programs. Applicants with other funded research education programs must describe how these programs will be distinct and how they will complement each other.

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

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

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?

Not Allowed: Only accepting applications that do not propose clinical trial(s).

Funds Available and Anticipated Number of Awards

NIDDK intends to commit $1.2 million in FY2024 to fund 3 awards.

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

The total direct costs for each application are limited to $375,000 annually, but need to reflect the actual needs of the proposed project. It is expected that each program will recruit four new post-baccalaureate participants in year 1 and again in year 3.

Award Project Period

The maximum project period is four years.

Other Award Budget Information

Personnel Costs

Individuals designing, directing, and implementing the research education program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with participants are considered a regular part of an individual's academic duties, then any costs associated with the mentoring and other interactions with participants are not allowable costs from grant funds).

Salary support for the PD/PI and other individuals overseeing and/or administering the program is limited to a maximum of $100,000 in direct costs annually.

Salary support through the R25 may not be provided for program mentors/research supervisors.

Participant Costs

Participants may be compensated for participation in activities specifically required by the proposed research education program, if sufficiently justified. Participant costs must be itemized in the proposed budget.

Allowable participant costs depend on the educational level/career status of the individuals to be selected to participate in the program.

While generally not an allowable cost, with strong justification, participants in the research education program may receive per diem unless such costs are furnished as part of the registration fee. Participants may also receive funds to defray partial tuition and other education-related expenses.

Expenses for foreign travel must be exceptionally well justified.

Other Program-Related Expenses

Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included in the proposed budget. These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution.

Remuneration for the post-baccalaureate participants is through salary and benefits at the Post-graduate Year0 level. Registration fees or tuition may also be provided if required to support the goals of the program for the participants.

Participants will be required to devote a minimum of 9 person-months (75% of full-time professional effort) to research, and the remaining 3 person-months (25% effort) will be for further academic development. For the participant to receive this compensation, the following conditions must be met:

  • The participant must be performing necessary work relevant to the proposed research experience.
  • There must be an employee-employer relationship between the participant and the university.
  • The total compensation must be reasonable for the work performed.

Travel for participants to attend or present a scientific paper at a domestic scientific conference, and attendance at the annual national cohort meeting run by the R25 awardees is also allowed.

The R25 recipients are expected to organize an annual national meeting of all post-baccalaureate participants with at least one faculty member from each program to facilitate faculty as well as peer-peer mentoring. Travel for one faculty member to attend this national meeting at another recipient’s location may be included.

Indirect Costs

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, expenditures for equipment and consortium costs in excess of $25,000), rather than on the basis of a negotiated rate agreement.

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)

Governments

  • 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

Institutional eligibility for this FOA is limited to research-intensive institutions that have an average research base in DEM science of at least $3 million per year over the past three years in direct costs of peer-reviewed research projects. Institutions must have strong biomedical Ph.D. degree programs in DEM-related science and have research opportunities for students admitted to the program in DEM science.

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other Federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving federal support. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.

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.

  • System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with 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

Only one application per institution (normally identified by having a unique entity identifier (UEI) or NIH IPF number) is allowed

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.

Program Faculty

Programs are encouraged to build a broadly diverse team of preceptors/mentors that includes, for example, faculty at different career stages (i.e., junior as well as senior faculty). 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.

The selected faculty should be trained researchers in the DEM-related biomedical sciences as demonstrated by recent publications and research support. When building a team of mentors, programs should include faculty who are committed to training, mentoring, fostering diversity, and providing supportive and inclusive research environments. Mentors must be committed to continue their involvement throughout the total period of the mentee's participation in this award.

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Participants

The PRIDE applicant institution will select the PRIDE participants who will receive salary support. It is the responsibility of the institution to establish the qualifications of the participants before they are supported by the program.

To receive salary support, the participant must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additionally, participants must have a baccalaureate degree that prepares them to pursue a research-focused biomedical doctoral degree from an accredited college or university awarded no more than 24 months prior to applying to PRIDE program; participants must not be currently enrolled in a degree program. Parental, medical, or other well-justified leave for personal or family situations is not included in the 2-year eligibility limit, nor is national service (e.g., Peace Corps, or service in the National Guard or Armed Forces Reserves). All individuals selected as participants should intend to apply to research-focused biomedical doctoral degree programs (e.g., Ph.D. or M.D./Ph.D.) during or immediately following completion of the PRIDE program.

The overarching goal of this program is to develop a diverse pool of well-trained postbaccalaureate participants who will transition into and complete rigorous, research-focused biomedical doctoral degree programs specifically focused on DEM science. Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH strategy to identify, develop, support and maintain the quality of our scientific human capital. Applicants to this FOA are strongly encouraged to promote program applications from participants who will enhance diversity on a national basis.

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 will not be reviewed.

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 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

Follow all instructions provided in the SF424 (R&R) Application Guide.

SF424(R&R) Project/Performance Site Locations

Follow all instructions provided in the SF424 (R&R) Application Guide.

SF424(R&R) Other Project Information Component

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

Facilities & Other Resources. Describe the educational 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. List all thematically related sources of support for research training and education following the format for Current and Pending Support.

Other Attachments.

Program Faculty Biosketches: Biosketches of all PRIDE Program faculty must be included. The personal statement should describe a commitment to scientific rigor, training, mentoring, as well as promoting diverse, inclusive, safe, and supportive scientific environments. Please upload all of the biosketches as a single pdf and name your file Program Faculty Biosketches.pdf .

Applications lacking a "Program Faculty Biosketches" attachment will be considered incomplete and will not be reviewed.

DEM Research Base. The file name DEM Research Base.pdf must be used. Applicants should provide a table showing the DEM-related research support of all participating faculty members. Please follow the instructions outlined for Data Table 4 here: All Training Tables (Undergraduate Programs).

Applications that lack the DEM Research Base attachment will be considered incomplete and will not be reviewed.

No other data tables are permitted in the "Other Attachments" section of the application. Inclusion of additional Training Data Tables will result in application withdrawal before peer review.

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

SF424(R&R) Senior/Key Person Profile Expanded

Follow all instructions provided in the SF424 (R&R) Application Guide.

R&R Budget

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

  • Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.
  • Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program.
PHS 398 Cover Page Supplement

Follow all instructions provided in the SF424 (R&R) Application Guide.

PHS 398 Research Plan

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

Research Strategy

Research Strategy section should be used to upload the Research Education Program Plan, which must include the following components described below:

  • Proposed Research Education Program
  • Program Director/Principal Investigator
  • Program Faculty
  • Program Participants
  • Institutional Environment and Commitment
  • Recruitment Plan to Enhance Diversity
  • Plan for Instruction in the Responsible Conduct of Research
  • Evaluation Plan

Research Education Program Plan

Proposed Research Education Program. While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the training program.

The plan should describe an integrated set of activities that will develop a diverse pool of well-trained post-baccalaureate scientists who have the technical, operational and professional skills required to conduct DEM research in an ethically responsible and rigorous manner, and to transition into and succeed in rigorous doctoral degree programs.

The following items must be included in this section:

Program Rationale, Objectives, and Overall Research Education Plan: Applications should describe the following:

  • The rationale for the proposed program. The application should describe and summarize outcomes of recent (past 5 years) and current institutional efforts to promote diversity and to create inclusive research environments, and how the program will enhance, but not duplicate, these efforts.
  • The program mission (i.e., broad statement of purpose of the program), and objectives (i.e., specific measurable outcomes the program intends to achieve). Objectives should include, but not be limited to, overall program completion rates, percentage of participants who will complete the program in two years, the rate of transitioning into and completing research-focused biomedical doctoral degree programs, and career trajectories of participants. The program-specific mission and objectives should align with the Overarching Objective of this funding opportunity announcement described above.
  • How the research experiences and courses for skills development will accomplish the specific program mission and objectives. Explain how these research education activities are designed to develop the technical, operational, and professional skills of participants.
  • How the activities will employ evidence to inform approaches to post-baccalaureate participant learning, mentorship, inclusion, and professional development.
  • Representative examples of research education programs for individual participants. Examples may include laboratory experiences, courses for skills development, and other activities, such as seminars, journal clubs, mini-committee meetings, etc. Discuss how the national-level activities across all funded programs can be leveraged to enhance mentoring and career development.
  • The rationale and strategies used for selecting participants and a clear description of why the participants selected need additional preparation prior to applying to and attending research-oriented doctoral degree programs. Priority should be given to participants without access to substantive prior research experiences.
  • The activities that will build a strong cohort of research-oriented postbaccalaureate participants while enhancing the science identity, self-efficacy, and a sense of belonging among the cohort members.

Career Development. The application should describe:

  • How each participant's program will be guided, and how the participant's performance will be monitored and evaluated. Discuss the anticipated time required to complete the research education program.
  • The strategies that will be used to develop the appropriate individual development plan for each participant to leverage their unique assets and address their specific points of development to enhance their ability to transition into and successfully complete a research-oriented DEM-related doctoral degree program.
  • How participants will be matched with a research experience and mentor(s) (e.g., mini-rotations, faculty forums, and/or interviews).
  • How participants will be provided with adequate and appropriate information regarding the variety of careers in the biomedical research workforce for which their training would be useful, and with an understanding of the different kinds of graduate programs, differences and similarities among these programs and advantages and disadvantages to joining different types of graduate programs.
  • How participants will learn the skills, knowledge, and steps needed to attain positions in the sectors of the biomedical research workforce that are of interest to them.

Program Oversight, Participating Faculty Selection, and Mentor Training. The application should include the planned strategy and administrative structure to oversee and monitor the program and to ensure appropriate participant progress. The application should describe how the participating faculty are trained to ensure the use of approaches to teaching, training, and mentoring practices that promote the development of participants from all backgrounds, including participants from underrepresented groups in the biomedical sciences (e.g., NIH's Interest in Diversity). The application should describe the following:

  • How the program will ensure that participating faculty employ the highest standards of scientific rigor and impart those standards to program participants.
  • How the program will ensure that participating faculty reinforce and augment the curricular material on responsible conduct of research and methods for enhancing reproducibility.
  • The mechanism for matching participants with the appropriate participating faculty (e.g., mini-rotations, faculty forums, and/or interviews).
  • How the program will ensure that participating faculty engage in activities that promote participant career development.
  • A process to monitor mentoring, including oversight of the effectiveness of the participant/faculty match, and a plan for removing faculty displaying unacceptable mentorship qualities from the research education program (the application may include the appendix labeled Conflict Resolution Protocols to provide details of the plan).

If a program coordinator or administrator position is planned to enhance oversight, a description of the person's qualifications and administrative capabilities that are essential to coordinate the program must be included in the application.

Program Director/Principal Investigator. Describe arrangements for administration of the program. Provide evidence that the Program Director/Principal Investigator is actively engaged in research and/or teaching in an area related to the mission of NIH, and can organize, administer, monitor, and evaluate the research education program. For programs proposing multiple PDs/PIs, describe the complementary and integrated expertise of the PDs/PIs, their leadership approach, and governance appropriate for the planned project.

Describe specific qualifications of the Program Director/Principal Investigator related to DEM science.

The application should expand on the information in the biosketch(es) to address how the PD/PI or PD/PI team has:

  • The administrative and training experience and skills to provide strong leadership, direction, management, and administration of the proposed research education program;
  • The time to commit sufficient effort to ensure the program’s success given other professional obligations (the application should indicate the program director’s effort in person months in the proposed program);
  • A demonstrated commitment to the development of the next generation of the biomedical research workforce, leading recruitment efforts to enhance diversity, and fostering inclusive research environments. As with all participating faculty, the PD(s)/PI(s) should have received training on how to effectively mentor participants from all backgrounds, e.g., individuals from groups underrepresented in the biomedical sciences (NIH's Interest in Diversity).

The application should also describe the administrative structure and leadership succession plan for critical positions (e.g., PD(s)/PI(s)).

Program Faculty. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as program faculty. Faculty should have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles. The proposed faculty should be conducting DEM-related science as demonstrated by recent publications and research support. Programs should include faculty who are committed to training, mentoring and providing inclusive and supportive research environments. Faculty must fully agree with the goals of the PRIDE program, which include not only providing an outstanding research experience with an opportunity to contribute significantly to an important research project, but also to fully integrate participants into their cohort of trainees and activities. Moreover, program faculty must be committed to, and having the participants in this program, participate in centralized program activities that are designed to achieve the goals and objectives of the overall program. Programs are encouraged to build a diverse team of preceptors/mentors that includes, for example, faculty from underrepresented groups (Notice of NIH's Interest in Diversity), women, and faculty at different career stages (i.e., early stage as well as senior faculty). Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award. The application should describe how the participating faculty will promote the productivity of the participants and research education program. Describe how the program has or will build a diverse team of participating faculty (e.g., individuals from underrepresented backgrounds, women, and faculty at different career stages) to help participants gain access to potential role models within the research education program and to enhance the excellence and inclusivity of the research environment.

The application should address how the participating faculty do the following:

  • Receive training in the use of effective, evidence-informed mentoring and teaching practices;
  • Cooperate, interact, and collaborate (which can include joint sponsorship of participants' research);
  • Promote the development of program participant skills in approaches to rigorous experimental design, methods of data collection, data analysis and interpretation, and reporting;
  • Provide opportunities for program participants to initiate, conduct, interpret, and present rigorous, reproducible, and responsible biomedical research with increasing self-direction;
  • Are evaluated as mentors and teachers.

Program Participants. Applications should identify the career levels for which the proposed program is planned.

Applications should describe the intended participants, and the specific educational background characteristics that are essential for participation in the proposed research education program. Provide the criteria and strategy for participant selection. Priority should be given to participants without access to substantive prior research experiences. Program participants should have the potential to strongly benefit from, and with proper support, succeed in the program and transition into rigorous research-oriented doctoral degree programs. Applications should explain why participants will strongly benefit from being in the program rather than going directly to doctoral degree-granting programs. Strategies for ensuring that participants have sufficient commitment to careers in biomedical research should be described. Applications should describe how the potential participants will be recruited. Recruitment must not be limited to students at the applicant institution. The application should describe existing or planned partnerships with undergraduate-focused institutions and how these partnerships can be leveraged for post-baccalaureate participant recruitment.

Institutional Environment and Commitment. Describe any additional aspects of the Institutional Environment and Commitment not addressed under Facilities & Other Resources or the required Institutional Commitment Letter of Support, described below. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program. This section should not duplicate information provided elsewhere.

As part of Institutional Environment, describe the current state of the biomedical science graduate program(s) related to DEM science. Provide the number of Ph.D. students (overall and underrepresented groups) from the DEM-relevant departments or programs in aggregate (not by department), their graduation rates for the last 5 years and their post-graduation employment. Present this data in table format within the text of this section on Institutional Environment (not in the appendix or with the data table submitted as required Attachments in Other Project Information).

Recruitment Plan to Enhance Diversity (NOT-OD-20-031):

The applicant must provide a recruitment plan to enhance diversity. Include outreach strategies and activities designed to recruit prospective participants from diverse backgrounds, e.g., those from groups described in the Notice of NIH's Interest in Diversity. Describe the specific efforts to be undertaken by the program and how the proposed plan reflects past experiences in recruiting individuals from underrepresented groups.

Applications lacking a diversity recruitment plan will not be reviewed.

Plan for Instruction in the Responsible Conduct of Research. All applications should include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). The plan should address the five, required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019 and NOT-OD-22-055. The plan should be appropriate and reasonable for the nature and duration of the proposed program. Renewal (Type 2) applications must, in addition, describe any changes in formal instruction over the past project period and plans to address any weaknesses in the current instruction plan. All participating faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.

Applications lacking a plan for instruction in responsible conduct of research will not be reviewed.

Evaluation Plan. Applications must include a plan for evaluating the activities supported by the award. The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short or long-term success of the research education award in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements.

Applications lacking an evaluation plan will not be reviewed.

Letters of Support

A letter of institutional commitment should be attached that describes the activities and resources provided by the institution that will ensure the success of the planned research education program and its participants. This section should not duplicate information provided elsewhere (e.g., Facilities & Other Resources).

There should also be a separate Institutional Eligibility letter from the Authorized Organization Representative certifying that the institution has an average research base in DEM science of at least $3 million per year over the past three years in direct costs of peer-reviewed research projects.

Additional letters of support should be provided from partner institutions, as appropriate.

Resource Sharing Plan

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

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:

When relevant, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

  • Software source code should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. Users should be permitted to modify the code and share their modifications with others.
  • The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
  • To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

Appendix

Only limited Appendix materials are allowed. Follow the 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.

PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following:

The goal of this R25 program is to support educational activities that prepare postbaccalaureates from diverse backgrounds, including those from underrepresented groups, to transition into and complete rigorous, research-based doctoral degree programs (Ph.D. or M.D., Ph.D.) in DEM-related science.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to strongly advance research education by fulfilling the goal of this R25 Education Program, 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.

Does the proposed program address a key audience and an important aspect or important need in research education? Is there convincing evidence in the application that the proposed program will significantly advance the stated goal of the program?

Is the PD/PI capable of providing both administrative and scientific leadership to the development and implementation of the proposed program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished? If applicable, is there evidence that the participating faculty have experience in mentoring students and teaching science? If applicable, are the faculty good role models for the participants by nature of their scientific accomplishments? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

Specific to this FOA: How adequate is the research base and critical mass of appropriate mentors in DEM science? How appropriate is the experience of the Program Faculty in mentoring and promoting the careers of young scientists?

Taking into consideration the nature of the proposed research education program, does the applicant make a strong case for this program effectively reaching an audience in need of the program’s offerings? Where appropriate, is the proposed program developing or utilizing innovative approaches and latest best practices to improve the knowledge and/or skills of the intended audience?

Does the proposed program clearly state its goals and objectives, including the educational level of the audience to be reached, the content to be conveyed, and the intended outcome? Is there evidence that the program is based on a sound rationale, as well as sound educational concepts and principles? Is the plan for evaluation sound and likely to provide information on the effectiveness of the program? If the proposed program will recruit participants, are the planned recruitment, retention, and follow-up (if applicable) activities adequate to ensure a highly qualified participant pool?

Specific to this FOA: How convincing is the evidence that the proposed research education program will provide participants from diverse backgrounds, including those from underrepresented groups, with the experiences and skills that will allow them to transition into and complete rigorous, research-focused biomedical doctoral degree programs?

How appropriate and detailed are the rationale and strategies for recruiting and selecting participants who would strongly benefit from being in the PRIDE program, including plans for recruiting participants from outside the awardee institution?

Is there a clear mechanism for matching the participants with appropriate participating faculty, and for monitoring mentoring, including oversight of the effectiveness of the participant/faculty match?

Are the proposed activities likely to build a strong cohort of research-oriented individuals while enhancing the science identity, self-efficacy, and a sense of belonging among the cohort members (e.g., meaningful interactions of the participants with other members of the research laboratory or department; opportunities for participants to present their work and/or contribute to the work of others, etc.)?

Does the application describe an effective strategy and administrative structure to oversee and monitor the program to ensure appropriate and timely progress for the participants?

How clear are the plans for creating an individual development plan and evaluating progress of each post-baccalaureate participant, ensuring that mentoring is appropriate, and making adjustments as necessary?

Will the scientific and educational environment of the proposed program contribute to its intended goals? Is there a plan to take advantage of this environment to enhance the educational value of the program? Is there tangible evidence of institutional commitment? Is there evidence that the faculty have sufficient institutional support to create a sound educational environment for the participants? Where appropriate, is there evidence of collaboration and buy-in among participating programs, departments, and institutions?

Specific to this FOA: How clear is the institutional commitment to promoting diversity at all levels of the research environment and of fostering excellence in mentoring?

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.

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.

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.

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 Animals Section.

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.

Not applicable

Not applicable

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.

Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of prospective participants from underrepresented groups. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Taking into account the specific characteristics of the proposed research education program, the level of participant experience, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also: NOT-OD-10-019 and NOT-OD-22-055. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Not applicable

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review, and a Data Management and Sharing Plan is not applicable for this FOA.

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable. If support for development, maintenance, or enhancement of software is requested in the application, the reviewers will comment on the proposed software dissemination plan.

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), 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 NIDDK. 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.
  • Consideration of geographic diversity across PRIDE centers

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

Institutional Review Board or Independent Ethics Committee Approval: Recipient 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.

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, including of note, but not limited to:

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 will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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

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.

3. Data Management and Sharing

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

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.

Programs that involve participants should report on education in the responsible conduct of research and complete a Trainee&nnbsp;Diversity Report, in accordance with the RPPR Instruction Guide.

NIH FOAs outline intended research goalsand 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 200.301.

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 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.

Failure by the recipient institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

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

Other Reporting Requirements

  • The institution must submit a completed Statement of Appointment (PHS Form 2271) for each participant appointed full time for eight weeks or more or the equivalent. Recipients must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
  • Participant Termination Notice: Within 30 days of the end of the total support period for each participant, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each participant appointed full time for eight weeks or more, or the equivalent.

A final RPPR 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.

5. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH or its Institutes and Centers will periodically evaluate their R25 research education programs, employing the measures identified below. In assessing the effectiveness of its research education investments, NIH may request information from databases, PD/PIs, and from participants themselves. Where necessary, PD/PIs and participants may be contacted after the completion of a research education experience for periodic updates on participants subsequent educational or employment history and professional activities.

Upon the completion of a program evaluation, NIH and its ICs will determine whether to (a) continue a program as currently configured, (b) continue a program with modifications, or (c) discontinue a program.

In evaluating this research education program, NIDDK expects to use metrics that may include, but are not limited to, the following:

Characteristics of the applicant and participant pool in the PRIDE program:

  • Aggregate number and demographics characteristics
  • Geographic distribution and baccalaureate institution

Indicators of scientific accomplishment:

  • Peer-reviewed publications
  • Presentations at scientific meetings
  • Professional recognition

Measures of career progression:

  • Enrollment in a DEM-oriented doctoral degree research program (Ph.D. or M.D., Ph.D.)
  • Degree completion
  • Subsequent research activities
  • Subsequent research grant funding

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: https://www.era.nih.gov/need-help (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: 301-637-3015

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

SBA Company Registry (Questions regarding required registration at the SBA Company Registry and for technical questions or issues)
Website to Email: http://sbir.gov/feedback?type=reg

Scientific/Research Contact(s)

J. Rafael Gorospe, M.D., Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-2556
Email: gorospejr@mail.nih.gov

Peer Review Contact(s)

Tori Stone, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-827-0994
Email: tori.stone@nih.gov

Financial/Grants Management Contact(s)

Eunica Haynes
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: (301) 827-4018
Email: Haynese@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.

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 and 2 CFR Part 200.

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