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)

Funding Opportunity Title
Helping to Accelerate Research Potential (HARP) (UE5 - Clinical Trial Not Allowed)
Activity Code

UE5 - Education Projects - Cooperative Agreements

Announcement Type
New
Related Notices

NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022

Funding Opportunity Announcement (FOA) Number
RFA-DK-22-002
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.847
Funding Opportunity Purpose

The NIH Research Education Cooperative Agreements Program (UE5) supports research education activities in the mission areas of the NIH. The overarching goal of this Helping to Accelerate Research Potential (HARP) UE5 program is to complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs. The main objective of the HARP UE5 program is to provide opportunities and mentorship for current NIDDK grantees, especially postdoctoral scholars and junior faculty from diverse backgrounds, to enhance their skills in areas that are critical for establishing and maintaining successful independent academic research careers.

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

  • Courses for Skills Development
  • Mentoring Activities

The HARP UE5 program aims to develop a network of mentors and scholars, with the expectation that scholars will apply for a career stage-appropriate NIH research project grant (e.g., R01 or R01-equivalent grant for junior faculty scholars; K grant for postdoctoral scholars) after their participation in the program. The scholars of the HARP UE5 program will be assigned by NIDDK staff and UE5 recipients will not be responsible for the recruitment of scholars.

Key Dates

Posted Date
July 28, 2022
Open Date (Earliest Submission Date)
October 30, 2022
Letter of Intent Due Date(s)

October 30, 2022

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
November 30, 2022 Not Applicable Not Applicable March 2023 May 2023 July 2023

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
December 01, 2022
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

The NIH Research Education Cooperative Agreements Program (UE5) supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers. The overarching goals of the NIH UE5 program are to: (1) complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs; (2) encourage individuals from diverse backgrounds, including those from groups underrepresentedin the biomedical and behavioral sciences, to pursue further studies or careers in research; (3) help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences; and (4) foster a better understanding of biomedical, behavioral and clinical research and its implications.

The overarching goal of the Helping to Accelerate Research Potential (HARP) UE5 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral, and clinical research needs. The main objective of the HARP UE5 Program is to provide opportunities and mentorship for current NIDDK grantees, especially postdoctoral scholars and junior faculty from diverse backgrounds, to enhance their skills in areas that are critical for establishing and maintaining successful independent academic research careers.

The HARP UE5 program aims to develop a network of mentors and scholars, with the expectation that scholars will apply for a career stage-appropriate NIH research project grant (e.g., R01 or R01-equivalent grant for junior faculty scholars; K grant for postdoctoral scholars) after their participation in the program.

To accomplish the stated overarching goal, this Funding Opportunity Announcement (FOA) will support creative educational activities with a primary focus on Courses for Skills Development and Mentoring Activities (as described below under Program Goal).

Background

Every facet of the United States scientific research enterprise—from basic laboratory research to clinical and translational research to policy formation—requires superior intellect, creativity and a wide range of skill sets and viewpoints. 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, including those from underrepresented groups, who will help to further NIH's mission. 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 interests 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 research, enhancing public trust, and increasing the likelihood that health disparities and the needs of underserved populations are addressed in biomedical research. See, Notice of NIH's Interest in Diversity, NOT-OD-20-031.

Need for the Program

The mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is to conduct and support medical research and research training and to disseminate science-based information on diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders, and obesity; and kidney, urologic, and hematologic diseases, in order to improve health and quality of life. The NIDDK maintains a vigorous investigator-initiated research portfolio, supports pivotal clinical studies and trials, promotes a steady and diverse pool of talented new investigators, fosters exceptional research training and mentoring opportunities, and ensures knowledge dissemination through outreach and communications. Analysis of the NIDDK portfolio shows that a small proportion of our supported investigators come from nationally underrepresented backgrounds, especially in the NIH research project grant R01 pool.

Studies show that robust mentorship is an important predictor of success for researchers, including the ability to successfully obtain research funding. Indeed, effective mentoring is critical for career advancement in biomedical research, particularly at early career stages and for individuals from underrepresented backgrounds. A National Academy of Sciences, Engineering, and Medicine (NASEM) report on the Science of Effective Mentorship in Science, Technology, Engineering, Mathematics, and Medicine (STEMM) highlights mentorship as a catalytic factor in an individual’s participation, persistence, and success in STEMM, especially for individuals from underrepresented backgrounds (NASEM, 2019). Although mentorship has a positive effect on individuals who are from underrepresented backgrounds, they are less likely to receive mentoring than well-represented individuals (NASEM, 2019). Thus, the purpose of this FOA is to support mentorship—defined as a professional, working alliance in which individuals work together over time to support the personal and professional growth, development, and success of the relational partners through the provision of career and psychosocial support (NASEM, 2019)—which is a key recommendation highlighted in the NASEM report and one that aligns well with the NIDDK Strategic Plan for Research and cross-cutting theme of strengthening workforce diversity and training.

Program Goal

The overarching goal of the HARP UE5 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral, and clinical research needs.

To accomplish the stated overarching goal, this FOA will support the following:

  • Courses for Skills Development: For example, courses focused on skills related to the career advancement of the current NIDDK-funded scholars. The short courses are expected to enhance the skills and competencies related to the career development needs of the scholars. The proposed courses may address, but are not limited to:
    • Developing administrative, managerial and/or mentorship skills (e.g., to guide students and technical personnel);
    • Identifying appropriate research funding opportunities and applying for funding (grantsmanship skills);
    • Enhancing leadership, project management, and collaborative skills needed for the productive conduct of research programs;
    • Managing career challenges and expectations and academic advancement;
    • Balancing teaching, research, service, and work-life balance.

These courses could be in-person or provided electronically.

  • Mentoring Activities: For example, activities focused on tailored, culturally responsive one-on-one mentoring, as well as peer mentoring for the NIDDK-funded scholars. The proposed mentoring activities may include, but are not limited to:
    • Developing individual development plans, mentoring compacts, mentoring maps, and mentoring plans (NASEM, 2019);
    • Convening regular meetings with the appropriate leaders at the institutions where the current NIDDK-funded scholars conduct research to exchange ideas and improve mentoring relationships;
    • Facilitating and encourage peer mentoring.


The HARP UE5 program is meant to facilitate the development and mentorship of NIDDK-funded postdoctoral scholars and junior faculty from diverse backgrounds so that they may transition to research independence. It is expected that after the conclusion of the program, scholars will have applied for a career stage-appropriate NIH research project grant (e.g., R01 or R01-equivalent grant for junior faculty scholars; K grant for postdoctoral scholars).

The participants of the HARP UE5 program will be scholars selected through the following NIDDK-supported programs: Small Grants for New Investigators to Promote Diversity in Health-Related Research (R21) (i.e., junior faculty and early stage investigators) and Research Supplements to Promote Diversity in Health-Related Research (i.e., postdoctoral scholars and junior faculty). The Small Grants for New Investigators to Promote Diversity in Health-Related Research (R21) is an NIDDK-led funding opportunity that provides support to new investigators from diverse backgrounds to conduct small research projects that are within the scientific mission areas of the NIDDK. The Research Supplements to Promote Diversity in Health-Related Research is a trans-NIH administrative supplement program and funding opportunity that provides support to candidates from diverse backgrounds to conduct research activities on a parent award.

Therefore, the UE5 recipients are not responsible for the selection of the scholars (i.e., mentees who participate in this UE5 program), and instead will develop cohorts of HARP scholars assigned by NIDDK staff (see below in the Cooperative Agreement section). Each UE5 recipient will be assigned a cohort of approximately four to five scholars each year, with some scholars transitioning out and being replaced by new scholars in years 3-4.

UE5 recipients are expected to provide professional development and enhance the professional networks of the HARP scholars conducting research in areas specific to the mission of the NIDDK. UE5 recipients are expected to provide metrics for successful outcomes of the proposed educational and mentoring activities.

During the course of the award period, the UE5 recipients will attend an annual meeting with NIH staff and/or other interested parties to review progress and share outcomes. The scholars who will participate in this HARP UE5 program are expected to attend an annual networking meeting. UE5 recipients will be responsible for paying travel expenses for the annual meeting and the annual networking meeting for the scholars from the award budget. UE5 recipients and NIH staff will work together to plan these meetings. In addition to these meetings, it is highly recommended that UE5 recipients participate in and interact with other mentoring networks and programs (e.g., the Network of Minority Health Research Investigators (NMRI) and NIDDK-supported mentors).

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 HARP consortium. The Steering Committee will be comprised of the Program Directors/Principal Investigators (PDs/PIs) of each HARP UE5 award and NIH staff members. For details on the composition and responsibilities of the HARP consortium Steering Committee, see Section VI.2 under Cooperative Agreement Terms and Conditions of the Award.

Applications Not Responsive to this FOA

Applications that do not propose to develop career development and mentoring activities will not be considered responsive to this FOA. Applications that propose research mentoring experiences will not be considered responsive to this FOA. Applications that are not responsive to this FOA will not be peer reviewed.

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?

Not Allowed: Only accepting applications that do not propose clinical trials.

Funds Available and Anticipated Number of Awards

NIDDK intends to commit $875,000 in Fiscal Year 2023 to fund up to 5 awards.

Award Budget

Although the size of an award may vary with the scope of the research education program, the total direct costs per award are limited to $150,000 annually.

The participants of the HARP UE5 program will be current NIDDK grantees, postdoctoral scholars and junior faculty from diverse backgrounds, supported by the Small Grants for New Investigators to Promote Diversity in Health-Related Research (R21) and the Research Supplements to Promote Diversity in Health-Related Research (referred to as Diversity Supplement). The length of funding is up to three years for the R21 scholars and one to two years for Diversity Supplement scholars. Accordingly, each UE5 recipient will begin with ~4-5 scholars and grow to ~10, with some scholars transitioning out and being replaced by new scholars during years 3-4.

Award Project Period

The total project period for each award in response to this funding opportunity may not exceed 5 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.

PD(s)/PI(s) will be expected to devote at a minimum 2.4 person months (or 20% full time professional effort). For programs with multiple PD/PIs, each PD/PI must contribute at least 1.8 person-months effort.

Participant Costs
Participants (i.e. HARP scholars participating in the research education activities) 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.

The assigned NIDDK scholars are expected to receive educational experiences supported by the UE5 program as participants, but may not receive salary or stipend supplementation from the UE5 program.

UE5 recipients will be responsible for paying travel expenses for participants to attend the annual networking meeting. 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.

UE5 recipients will be responsible for paying travel expenses for the annual meeting from the award budget.

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)

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.

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

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

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

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.

The PD(s)/PI(s) should be established investigator(s) conducting research in NIDDK-relevant mission areas and should have professional experience relevant to the proposed program, e.g., a track record of mentoring and training the next generation of the biomedical research workforce, demonstrated commitment to the training of individuals from diverse backgrounds, a record of independent research funding, recent peer-reviewed research publications, and career progression in a research-intensive faculty career. The PD(s)/PI(s) should be capable of providing both administrative and training leadership to the development and implementation of the proposed 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 programmatic activities. Additional PD(s)/PI(s), including individuals with experience in areas such as science education, pedagogy, mentoring and career development for early-career scientists and scientists from underrepresented backgrounds, 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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Program Faculty

Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as Program Faculty, serving as instructors, advisors, preceptors, mentors, etc.  Program Faculty should have research and education expertise and experience relevant to the proposed program.  Those serving as mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award.

Participants

The participants of the HARP UE5 program will be current NIDDK grantees, postdoctoral scholars and junior faculty from diverse backgrounds, supported by the Small Grants for New Investigators to Promote Diversity in Health-Related Research (R21) and the Research Supplements to Promote Diversity in Health-Related Research (referred to as Diversity Supplement). NIDDK staff will assign these scholars to UE5 recipients.

Unless strongly justified on the basis of exceptional relevance to NIH, research education programs should be used primarily for the education of U.S. citizens and permanent residents.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

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.
  • A minimal effort of 2.4 person-months is required for all designated PD(s)/PI(s) and cannot be reduced below that level during the project period. For programs with multiple PD/PIs, each PD/PI must contribute at least 1.8 person-months effort.
  • Program coordinators are allowed as long as their role is clearly defined and significantly different from the roles of the PDs/PIs. The duties and responsibilities of the program coordinators, with strong justification, must be included in the budget justification.
  • Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program. Include funds requested to partially reimburse participants for their transportation, housing, and per diem expenses to attend the annual networking meeting.
  • Include in the "Travel" section of the budget funds for transportation, housing and per diem costs for PD(s)/PI(s) and other senior/key persons to attend the annual Steering Committee meeting.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy: The Research Strategy section must 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
  • Plan for Instruction in the Responsible Conduct of Research
  • Evaluation Plan
  • Dissemination Plan

Research Education Program Plan

Proposed Research Education Program. Each application must describe the rationale, goals and measurable objectives of activities proposed. The application must describe the short-, medium-, and long-term goals for participants that the activities are designed to address and how these outcomes will be measured (see the Evaluation Plan section below). Applicants are strongly encouraged to consult individuals with evaluation experience from the outset of research education program planning. The application must describe how the proposed activities will synergize scholars' career development plans and will address the needs of scholars. Applications should include a description of the following areas:

  • Cohort formation and activities: NIDDK intends to support nine scholars from the Small Grants for New Investigators to Promote Diversity in Health-Related Research (R21) and 12 scholars from the Research Supplements to Promote Diversity in Health-Related Research. The Small Grants for New Investigators to Promote Diversity in Health-Related Research is an NIDDK-led funding opportunity (R21) that provides support to new investigators from diverse backgrounds to conduct small research projects that are within the scientific mission areas of NIDDK. The Research Supplements to Promote Diversity in Health-Related Research (referred to as the Diversity Supplement) is a trans-NIH administrative supplement program that provides support to candidates from diverse backgrounds to conduct research activities on a parent award. The length of funding is up to three years for the R21 scholars and one to two years for Diversity Supplement scholars. Accordingly, each HARP UE5 recipient will begin with ~4-5 scholars and grow to ~10, with some scholars transitioning out and being replaced by new scholars during years 3-4. Applications should describe: 1) activities that will enhance the sense of community among the scholars who will be conducting research at institutions across the nation, 2) how the newly selected scholars will be integrated into the program and how the activities will align with the needs of the scholars according to their career development stage, and 3) strategies that will be used to develop a strong, mutually supportive network within and among each cohort of scholars.
  • Courses for skills development: Provide the underlying rationale and evidence supporting the proposed courses in professional skills development. Describe the educational concepts and principles on which the courses are based and the overall strategy, methodology, and analyses to be employed. Describe delivery format (e.g., in-person, online, or a combination). Courses should be designed to enhance skills appropriate to transition into and advance within independent academic research careers, e.g., academic job search strategies, communication skills, grant proposal preparation, scientific publishing, laboratory management, budgeting, hiring, mentoring, managing career challenges and expectations, leadership development, academic advancement, and balancing teaching, research, and service. Describe plans to ensure activities will synergize with the scholars who may have institutional mentors.
  • Activities for addressing factors associated with persistence: Applicants should utilize the substantial pedagogical literature concerning predictors of success in research careers when designing activities to address these factors. Examples of activities include reducing stereotype threat, diminishing imposter feelings, overcoming microaggressions, navigating structural barriers to career advancement, utilizing cultural assets, and achieving life-work balance.
  • Mentoring Activities: Describe plans to provide tailored, culturally responsive mentoring, including any group or peer mentoring, and professional development of the assigned NIDDK scholars. Describe the process for engaging the institutional mentors or sponsors of the NIDDK-funded scholars.


Potential applicants are also encouraged to utilize best practices and information developed and supported through the National Research Mentoring Network for design and implementation of strategies (https://www.nigms.nih.gov/training/dpc/Pages/nrmn.aspx).


Program Director/Principal Investigator. The PD(s)/PI(s) should have demonstrated commitment to training and mentoring the next generation of the biomedical research workforce, as well as involvement in efforts to enhance diversity. As applicable, describe the experience of the PD(s)/PI(s) in efforts to enhance diversity and promote inclusive environments. Describe any training the PD(s)/PI(s) have received or will receive on how to effectively mentor individuals from diverse backgrounds, including those from groups underrepresented in biomedical research.


Program Faculty. The research education program should recruit academic biomedical researchers to provide the scholars with additional mentors. 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.


Program Participants. The participants of the HARP UE5 program will be current NIDDK grantees, postdoctoral scholars and junior faculty from underrepresented backgrounds, supported by the Small Grants for New Investigators to Promote Diversity in Health-Related Research (R21) and the Research Supplements to Promote Diversity in Health-Related Research. The educational training and scientific background of these scholars will be broad and comprise of NIDDK scientific mission areas, specifically in diabetes, endocrinology, and metabolic diseases; digestive diseases and nutrition; and kidney, urologic, and hematologic diseases. The scholars may comprise of physician-scientists, biomedical and behavioral scientists, and researchers from other scientific disciplines. Applications should describe how proposed activities will benefit scholars from diverse backgrounds and scientific training.


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 must 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. 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.


Evaluation Plan. Applications must include a plan for evaluating the activities supported by the award and the extent to which the measurable objectives will be accomplished. Therefore, an application must include measurable objectives for the proposed activities (as described in the Proposed Research Education Program section). The evaluation plan must explain how each outcome(s) will be measured. The application must specify baseline metrics, as well as measures to gauge the short-, medium-, and long-term success of the research education award in achieving its objectives.

The metrics are expected to move beyond participant satisfaction, self-reporting of perceived skills gained, or self-reporting of effectiveness. Programs are encouraged, when appropriate, to measure psychosocial indicators of progress (e.g., science identity, a sense of belonging in the research community, self-efficacy in navigating the academic job search or first year as an independent investigator, etc.); however, these indicators should be linked to measurable outcomes (e.g., academic positions; career advancement, peer-reviewed publications; scientific presentations; honors/awards; leadership positions; external grant funding).

The NIDDK believes that tracking participants is critical to any outcome evaluation and recommends the development of mechanisms to track the activities and career status of program participants annually during the project period and beyond. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements as well as describe how changes to the program design to reflect the feedback from participants will occur.


Dissemination Plan. A specific plan should be provided to disseminate nationally any findings resulting from or materials developed under the auspices of the research education program, e.g., sharing course curricula and related materials via web postings, presentations at scientific meetings, and workshops.


Letters of Support: Organizational Commitment. (Three page maximum) Applications must include a letter as a PDF attachment from a Senior Administration Official at the applicant organization. This should be a signed letter on organizational letterhead, and it should describe the applicant organization’s commitment to the planned program.  The letter should provide evidence of commitment to the research education program. Appropriate commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program. The letter should describe how the organization ensures that proper policies, procedures, and oversight are in place to prevent discriminatory harassment and other practices; responds appropriately to allegations of discriminatory practices, including any required notifications to the Department of Health and Human Services Office of Civil Rights (see NOT-OD-15-152); and adopts and follows institutional procedure for requesting NIH prior approval of a change in the status of the Program Director/Principal Investigator (PD/PI) or other senior/key personnel if administrative or disciplinary action is taken that impacts the ability of the PD/PI or other key personnel to continue his/her role on the NIH award described in the research education program application (also see NOT-OD-18-172 regarding policy on change in PD/PI status). 

If the applicant proposes a multi-site research education project, the applicant organization must document the requisite administrative/technical capacity to support the management of a proposed collaborative multisite project.  All collaborative arrangements must be clearly described, and the applicant must provide assurances it is aware of NIH consortium policy and prepared to establish the necessary agreements.

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:

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 all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

Blank evaluation forms/instruments should be submitted as a single document.  

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIDDK, 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. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following:
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.

 

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

 

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? 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?

 

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

 

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in 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?

 

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

 

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 appropriate is the prior experience of the PD(s)/PI(s) of this proposed research education program, including administrative leadership, track record of mentoring and training the next generation of the biomedical research workforce, demonstrated commitment to the training of individuals from diverse backgrounds, a record of independent research funding, recent peer-reviewed research publications, and career progression in a research-intensive faculty career?

 

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 for this FOA: How well does the proposed plan ensure robust and appropriate professional development and mentoring for scholars? How well does the research education plan address how the proposed activities will synergize with scholars' career development plans? How will the activities enhance the sense of community among the scholars and strengthen their cohorts?

 

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?

 

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 organizational commitment? Is there evidence that the faculty have sufficient organizational support to create a sound educational environment for the participants? Where appropriate, is there evidence of collaboration and buy-in among participating programs, departments, organizations, and institutions?

 

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?

Specific to this FOA: How likely will the proposed research education and mentoring program provide scholars opportunities for skills development and enhanced mentoring and professional networking to facilitate their transition into, and success in, independent research-intensive faculty careers?

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 Animal 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.

 

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Not applicable.

 

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).

 

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) (4) Software Dissemination.

 

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.

 

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

 

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 format of instruction (a plan with only on-line instruction is acceptable for this FOA); 2) Subject Matter - the breadth of subject matter, as appropriate for a given short course, 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 given Short Course; and 5) Frequency of Instruction –instruction must oprovided for each offering of the Short Course.  See also: NOT-OD-10-019. 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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIDDK, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

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

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

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

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

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

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.

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, 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be a 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 remains 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 has been and will remain with the awardees 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:

  • Defining the overall objectives and directions for the HARP UE5 award, including oversight on the development and implementation of the courses for skills development, mentoring, and networking activities.
  • Managing the programmatic activities such as:
    • Handling the logistics of participant registration for courses and associated payments/reimbursements for non-federal participants (if in person);
    • Contracting the facilities that will host the courses and provide housing for course faculty, staff, and participants (if in person);
    • Developing and administering course-specific evaluation instruments to course participants, faculty, and administrators;
    • Analyzing course-specific evaluation data and presenting the results at annual Steering Committee meetings, professional conferences and/or in publications;
    • Collecting HARP-specific evaluation data and participating in HARP-specific analyses, presentations, and publications.
    • Ensuring that interactions with other UE5 awardee teams meet the HARP goals and objectives;
    • Adhering to the decisions and recommendations of the Steering Committee to the extent compatible with applicable grant regulations;
    • Serving as a voting member on the Steering Committee; and
    • Co-organizing and attending the annual meetings.
  • Contributing to the cooperative nature of the HARP program, recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.


Recipients(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current DHHS, PHS, and NIH policies.


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

One or more designated NIDDK program staff members will have substantial involvement as Project Scientist(s) for the HARP UE5 program.

The role of the Project Scientist(s) will be to facilitate, but not to direct, the HARP UE5 project activities.

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

  • Serve as a member of the Steering Committee, as described below in "Areas of Joint Responsibility";
  • Serve as a liaison to the UE5 recipients identifying relevant NIH expertise and/or resources related to NIH and NIDDK funding mechanisms and initiatives, various NIH programs designed to help junior investigators, and other resources, expertise, or skills that may be relevant to optimizing the content of the courses, designing the strategies to reach targeted audiences, etc.;
  • Provide technical assistance to UE5 recipients and/or access to NIH technical resources that may be needed for the HARP UE5 program (e.g., for the efficient identification of early career stage, NIDDK-funded investigators, including their general research profiles, geographical distribution, etc.); and
  • Assist the UE5 recipients with the promotion of the courses and reaching the targeted investigators.

The NIDDK 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 make assignments of scholars to UE5 recipients. The Program Official will not partake of the duties of the Project Scientist.

While HARP UE5 recipients will retain custody of the data and resources developed under these awards, the NIDDK will have access to all data, course materials, evaluation data, etc., and may periodically review these data.

The NIDDK reserves the right to reduce the budget or withhold an award in the event of substantial recipient underperformance or other substantial failure to comply with the terms of award.


Areas of Joint Responsibility include:

A Steering Committee will be convened to serve as the HARP consortium main governing board. The Steering Committee will be composed of the following voting members:

  • One representative from each UE5 award (a PD/PI or a designee) who will each have one vote;
  • NIDDK Project Scientist(s) who will have collectively one vote;

The chair and co-chair of the Steering Committee will be selected from the representatives of all HARP UE5 recipients.

Additional NIH and 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 Steering Committee will meet monthly by teleconference and annually in person. In addition to Steering Committee members, the annual meeting is expected to include additional investigators from each UE5 recipient team, as determined by the respective PDs/PIs.

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

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


Dispute Resolution

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

3. Reporting

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

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

Section VII. Agency Contacts

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

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: 301-637-3015

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)

Katrina Serrano, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-480-7855
Email: katrina.serrano@nih.gov

Peer Review Contact(s)

Michele L. Barnard, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8898
Email: BarnardM@EXTRA.NIDDK.NIH.GOV

Financial/Grants Management Contact(s)

Tommy Gunter
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-3447
Email: tommy.gunter@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.

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.