Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Human Genome Research Institute (NHGRI)

Funding Opportunity Title
Initiative to Maximize Research Education in Genomics: Diversity Action Plan (R25 Clinical Trials Not Allowed)
Activity Code

R25 Education Projects

Announcement Type
Reissue of PAR-19-380
Related Notices
  • August 31, 2022- Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
  • August 5, 2022- Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.
  • July 22, 2019- Requirement for ORCID iDs for Individuals Supported by Research Training, Fellowship, Research Education, and Career Development Awards Beginning in FY 2020. See Notice NOT-OD-19-109.
Notice of Funding Opportunity (NOFO) Number
PAR-22-268
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.172
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 complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs.

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

  • Courses for Skills Development
  • Research Experiences

  Another overarching goal of this R25 program is to support and integrate educational and mentorship 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 genomics research.  This notice of funding opportunity (NOFO) seeks to expose undergraduate and post-baccalaureate level students to the foundational sciences relevant to genomics to enable them to pursue careers that span all areas of interest to NHGRI - genome sciences, genomic medicine, genomics and society, genomic data science, and genomics and health equity. For the purposes of this NOFO, the term “genomics” encompasses issues and activities in these five areas.

To accomplish the stated overarching goal, this NOFO will support creative educational activities with a primary focus on Research Experiences for undergraduate and/or post-baccalaureate trainees that include extensive mentorship activities. Programs should fall under the following categories: 1) summer, semester, or academic year programs for undergraduate trainees; 2) year-long program (duration of at least 12 months) for post-baccalaureate trainees. The research experiences must be based on the foundational sciences relevant to genomics: genomic sciences; genomic medicine; genomics and society; computational genomics and data science, or genomics and health equity. A secondary focus is on Courses for Skills Development.  Complementary didactic activities are encouraged, especially those academic courses that have the potential to increase opportunities for success at the next career level. The proposed research education programs must include both research experiences and courses for skills development, with primary emphasis on the former. Proposed courses should be developed in conjunction with and support research experiences to enhance skills development.

Key Dates

Posted Date
August 29, 2023
Open Date (Earliest Submission Date)
October 16, 2023
Letter of Intent Due Date(s)

30 days before application due date

The following table includes NIH standard due dates marked with an asterisk.
Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
November 15, 2023 November 15, 2023 Not Applicable March 2024 May 2024 July 2024
January 25, 2024 * January 25, 2024 * Not Applicable July 2024 October 2024 December 2024
January 27, 2025 January 27, 2025 Not Applicable July 2025 October 2025 December 2025

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
January 28, 2025
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 How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) 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 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 help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences.

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 goals of the NIH R25 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 underrepresented in 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 this NHGRI Diversity Action Plan (DAP) R25 program is to encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in genomics research.  The DAP Program seeks to expose and mentor students at the undergraduate and post-baccalaureate levels who are from diverse backgrounds, including those from underrepresented groups, to the foundational sciences relevant to genomics to enable them to pursue careers that span all areas of interest to NHGRI - genome sciences, genomic medicine, genomics and society, computational genomics and data science, and genomics and health equity. Through the DAP program, participants will gain valuable mentored research experience as well as opportunities for career development.

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

  • Research Experiences (primary focus):  These mentored research experiences must be based on the foundational sciences relevant to genomics: genomic sciences; genomic medicine; genomics and society; computational genomics and data science, or genomics and health equity. Experiences can take place during the academic school year or as summer programs.  
  • Courses for Skills Development (secondary focus) Complementary didactic activities in genomics are encouraged, especially those academic courses that have the potential to increase opportunities for success at the next career level. Courses may also relate to development of professional skills, such as scientific writing and communication, interview skills or applying to graduate or professional schools.

Background

In 2020, NHGRI engaged the scientific community to identify future research priorities and opportunities in human genomics, resulting in the 2020 Strategic Vision for Improving Health at the Forefront of Genomics. This vision outlined the guiding principles and values for human genomics, including championing a diverse workforce which includes individuals from groups that are not well represented in biomedical research (Notice of NIH's Interest in Diversity: NOT-OD-20-031), embracing interdisciplinary teams in genomic research, and increasing access to genomic medicine. NHGRI is committed to recruiting a diverse pool of qualified individuals for potential career opportunities in genome sciences, genomic medicine, computational genomics and data science, genomics and society, and genomics and health equity research. Research in these areas offers tremendous opportunities for improving human health, and for exploring some of the most profound ethical, legal and social issues (ELSI) of our time and such opportunities should be readily available.

Need for the Program

NIH's ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission. However, despite advancements in scientific research, some populations have not had access to cutting-edge research and training opportunities, and do not participate fully in the biomedical sciences research workforce.

The promise of genomics cannot be fully achieved without attracting, developing, and retaining a diverse workforce, which includes individuals from groups that are  underrepresented in the genomics enterprise. The overall objective of the DAP Program is to support a pool of undergraduates and post-baccalaureates from diverse backgrounds, including those from underrepresented groups, to help them successfully transition to the next stage of their research career in a genomics-related field.   

NIH encourages institutions to diversify their student and faculty populations, through means consistent with applicable law, to enhance the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral and social sciences, as described in the Notice of NIH’s Interest in Diversity, NOT-OD-20-031. Potential applicants are encouraged to seek out strategies and resources for recruitment and retention of trainees from diverse backgrounds, including those from underrepresented groups.

Participants from engineering, mathematics, computer science, physics, chemistry, biology, biostatistics, bioinformatics, bioethics, social and behavioral sciences, law, and the humanities, pre-heath professional, and other relevant science programs who have an interest in genomics should be encouraged to participate in the program.

Programmatic Approach

As a leading authority in the field of genomics, NHGRI’s mission is to accelerate scientific and medical breakthroughs that improve human health and well-being. We do this by supporting resources, approaches, and technologies that accelerate genomic research . This requires expertise in the foundational sciences relevant to genomics--biomedical, physical, mathematical, and computer and engineering sciences, biostatistics, epidemiology, bioinformatics, bioethics, social and behavioral sciences, law, and the humanities.  Thus, research education in these areas complemented by training and mentorship will allow those who participate in NHGRI-supported research activities to be well positioned to contribute to biomedical research in the future. Programmatic activities include, but are not limited to, providing authentic research experiences, courses for skills development, and additional mentoring -- activities proven to increase persistence in STEM fields (cited in PCAST Report, 2012Graduate STEM Education for the 21st Century, 2018, and The Science of Effective Mentorship in STEMM, 2019).

It is assumed that the institutions that apply for this award will:

           - have faculty with broad experiences in one or more of the five areas of genomics relevant to NHGRI:  genomic sciences, genomic medicine, computational genomics and data science, genomics and society, or genomics and health equity;

           - have experienced mentors who have worked or demonstrate willingness to work with individuals from diverse backgrounds, including groups underrepresented in the biomedical, behavioral, and clinical research workforce; and

           - be able to demonstrate that related research education or training programs at their institution will work collaboratively with the DAP  program to ensure a smooth transition of DAP participants to the next career phase.

The guiding principles of what can be supported under this Notice of Funding Opportunity are that participants:

           - should be exposed to appropriate didactic training in the foundational disciplines of genomics in order to develop critical thinking skills as appropriate for their career level and research focus

           - should receive research experiences that do not focus solely on any particular disease or groups of diseases, but provide skills and knowledge that are generally applicable to a variety of biomedical research questions

           - are prepared to use this knowledge and these experiences to move to the next stage of their career 

           - are provided with high-quality mentoring, ideally from a diverse team of mentors spanning different career stages, and

           - are in a research environment where they will have an opportunity to select from a variety of genomic research experiences and mentors.

The types of research experiences that can be supported under this award include:

           - up to two years of summer, yearlong or semester research experiences and courses for skills development for undergraduate students, with the objective of pursuing a research or health-professional doctoral degree in one of the foundational sciences relevant to genomics

           - up to two years of part-time support for post baccalaureate research and courses for skills development, with the objective of applying to a graduate research or health professional program; participants may take academic courses, but may not be enrolled in a formal graduate program.

The duration of the research experiences, follow-on plans to transition participants to other support mechanisms, and their transition to the next career stage are important considerations in DAP programs. PDs/PIs should limit participant selection to eligible individuals who are committed to a research career.

The career outcome goal for individuals supported by DAP programs is to remain in genomics-related research.  DAP programs should make available structured, career development mentoring and learning opportunities (e.g., workshops, discussions, Individual Development Plans) and networking to provide participants knowledge of various potential career directions and ease the transition to the next stage of their chosen career. Evidence-informed approaches to career development, mentoring, and program evaluation will also be crucial in ensuring that the research education program will prepare trainees for a range of genomics-related research careers.These careers include research-intensive careers in various sectors, e.g., academic institutions, government agencies, non-profit organizations, for-profit businesses, and private foundations. Evidence-informed approaches are encouraged to draw from existing literature as well as institution-specific evaluations of related training programs.

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.

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
Renewal
Resubmission

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 NOFO.

Clinical Trial?

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

Funds Available and Anticipated Number of Awards

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

Award Budget

Application budgets are limited to $325,000 direct costs per year and need to reflect the actual needs of the proposed project. 

Award Project Period

The total project period 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. (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).

Personnel costs must be directly associated with the program and should be well-justified, reasonable, and may not exceed 30% of the total direct costs in any year of the project period.

Items that may NOT be supported with DAP funds include:

-Salaries and fringe benefits for the program faculty;

-Salary and support for central institutional administrative personnel (e.g., budget officers, grant assistants, and building maintenance personnel), which are usually paid from institutional overhead charges;

-Salary and support for administrative activities such as institutional public relations or health and educational services.

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.

Individuals supported by NIH training and career development mechanisms (K, T, or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by an R25 program, as participants, but may not receive salary or stipend supplementation from a research education program.

Because the R25 program is not intended as a substitute for an NRSA institutional training program (e.g.,T32), costs to support full-time participants (supported for 40 hours/week for a continuous, 12-month period) are not allowable.

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.

TUITION REMISSION: For post-baccalaureates, tuition remission for a course deemed necessary to enhance the academic preparedness for graduate studies may be requested.  Tuition remission must be specifically justified and may not exceed the in-state tuition cost at institutions that also have out-of-state tuition charges.

TRAVEL: Participants are strongly encouraged to attend at least one NHGRI Research Training and Career Development Annual Meeting while supported on this program.  Travel costs may be requested to attend this meeting.  If this is requested, then travel costs to attend a second scientific meeting may also be requested.  For postbaccalaureate and summer programs, funds may be requested to cover the costs of travel between the place of residence and the training institution. Recruitment travel costs are limited to $3,000 per year. PI/PD and key staff are expected annually to attend the NHGRI Research Training and Career Development Meeting; travel funds should be requested.

HOUSING – For summer programs, support may be requested to augment the cost of housing at the program site. Contributions to, or coverage of, housing by the institution should be addressed in the Institutional Environment and Commitment section of the application.

EVALUATION: Program evaluation costs are limited to $5,000 per year.

Total expenses in the “Other Program-Related Expenses” category may not exceed 10% of the total direct costs in any year of the project period.

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 NOFO.

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)

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

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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted 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 their 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/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

The PD/PI must have significant research funding from NIH (e.g. multiple research grants, a large center grant, or cooperative agreement, etc.) in at least one of the areas relevant to NHGRI's research programs - genome sciences, genomic medicine, genomics and society research, computational genomics and data science or genomics and health equity.

2. Cost Sharing

This NOFO 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.

NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications)

Only one award will be made per institution for activities that focus in one of five areas - genome sciences, genomic medicine, genomics and society, computational genomics and data science, and genomics and health equity. Institutions that already have an award in one of these five areas are not eligible to apply for an award in the same area, but can apply for an award in a different area.  Institutions that have more than one NHGRI-supported R25 diversity program and/or T32 program must demonstrate coordination and collaboration such that there is synergy amongst the programs.

Program Faculty

Researchers from diverse backgrounds, including individuals from underrepresented groups, are encouraged to participate as preceptors/mentors. Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award.

Because participants are expected to have the opportunity to pursue their research and educational experiences focused on a variety of genomic research topics, it is expected that the program faculty will have significant research programs in one or more of the five research areas relevant to genomics: genome sciences, genomic medicine, genomics and society, computational genomics and data science, and genomics and health equity .

Participants

Participants must be citizens or noncitizen nationals of the United States or have been lawfully admitted for permanent residence at time of appointment. 

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 NOFO. 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 How to Apply - Application Guide, except where instructed in this Notice of Funding Opportunity 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:

Lucia A. Hindorff, PhD, MPH
National Human Genome Research Institute, NIH
Telephone: 240-271-1509
Email:  hindorffl@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 NOFO.

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. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.

 Other Attachments.

An Advisory Committee is not a required component of a Research Education program. However, if an Advisory Committee is intended, provide a plan (1-page maximum) for the appointment of an Advisory Committee to monitor progress of the research education program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Renewal applications with Advisory Committees should include the names of all committee members during the past project period. Please name your file “Advisory_Committee.pdf”.

Tables. The DAP is an institutional program and as such applicants must provide details about the institution and its setting using Data Tables 2, 4, and 8D (http://grants.nih.gov/grants/funding/424/datatables.htm). 


The following Tables are required for new applications:
Training Table 2. Participating Faculty Members, Undergraduate and/or Predoctoral Training Table, as applicable (Programs that include post-baccalaureate participants should include information on faculty mentoring of post-baccalaureates on the Undergraduate Training Table.) 
Training Table 4. Research Support of Participating Faculty Members

The following Tables are required for renewal applications:
Training Table 2. Participating Faculty Members, Undergraduate and/or Predoctoral Training Table, as applicable (Programs that include post-baccalaureate participants should include information on faculty mentoring of post-baccalaureates on the Undergraduate Training Table.) 
Training Table 4. Research Support of Participating Faculty Members
Training Table 8D (Part I only). Program Outcomes: Undergraduate (for postbaccalaureate and undergraduate students)

Please name your files "Table 2-Undergraduate.pdf", "Table 2-Predoctoral.pdf", Table 4.pdf", or "Table 8D.pdf" as appropriate.  

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.
  • Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.
  • Use Section A and B for Personnel Costs.
  • Use Section E for Participant Support Costs to include all allowable categories of funds requested to support participants in the program, including participant travel.
  • For Other Program-Related Expenses, use Sections D (PI/staff travel) and F (other costs).  
  • Program coordinators are allowed as long as their roles in the program implementation are clearly defined and significantly different from the roles of the PDs/PIs. The duties and responsibilities of the program coordinators must be well described in the budget and must include a strong justification. The number of person months must be strongly justified in relation to the number of program participants.
  • Although graduate students are ineligible to participate in DAP programs as trainee participants, they may serve in a program support role (e.g., assist with program coordination or serve as mentor). Only one graduate student may be supported at any time. 
  • Costs of consultants for evaluation of the program is allowed; however, if the evaluator is an employee of the applicant institution, the cost must be included in the category of key personnel salary (effort listed in person months). Employees cannot be consultants unless it is allowed by institutional policy and the person is consulting in a field distinctly separate from their "normal" field of work.
  • The total compensation package for participants should be reasonable for the work performed and consistent with the compensation paid to all participants in similar circumstances, regardless of the source of support for the activity.

The following account summarizes some of the UNALLOWABLE costs under the DAP Program but is not an all-inclusive list. Please see 45 CFR ยง75, Subpart E "Cost Principles" for a complete list of costs that may be deemed unallowable under this program:

  • Undergraduate and graduate student tuition, housing, or food, during the academic year.
  • Food and beverage costs (NOTE: Travel per diem costs provided in accordance with an institution's written travel policies to cover incidental meal expenses is permissible).
  • Foreign travel.
  • Costs for textbooks, laptops, incentives, memberships, or subscriptions to internet services or journals.
  • Support for faculty research (all faculty mentors are expected to have their own research support).
  • Equipment.
  • Alterations and renovations.
  • Consortium/contractual arrangements.
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 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
  • Institutional Environment and Commitment
  • Recruitment Plan to Enhance Diversity 
  • Plan for Instruction in the Responsible Conduct of Research
  • Evaluation Plan
  • Dissemination 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. As a reminder, applicants may choose to address one or more of the activities listed in Section I. Funding Opportunity Description.

Add more information for Proposed Research Education Program as needed. Applications must:

  • Explain the basis and rationale for the program and any educational, mentorship, career development, or evaluation principles or evidence of past success that it may be based on.
  • Provide programmatic detail and rationale for the proposed research experiences and courses for skills development and describe how these activities innovatively address the needs of program participants from diverse backgrounds.
  • Describe how each proposed activity will contribute toward realization of the specific aims.
  • Describe the milestones and benchmarks (i.e., anticipated intermediate steps toward the objectives).
  • Discuss any perceived impediments to implementing the proposed activities and alternative strategies to achieve the measurable objectives.
  • Provide concise information on the recruitment, selection and retention processes for the participants in the DAP program, including the criteria related to the students’ academic status, participants’ research education and training progress, and role of the faculty/personnel involved.
  • Describe how experiences during the summer and/or academic year will contribute toward measurable objectives and student development. Demonstrate that participants will have authentic, meaningful research experiences in the laboratories or research groups of extramurally-funded investigators who are actively engaged in genomics-related research.
  • Describe how the students will be exposed to research projects that will give them the foundational knowledge and skills that can be applied to a broader range of genomic problems.
  • Describe how the PD/PI will specifically interact with program faculty with the goal of preparing students to move successfully to the next career level.   
  • Describe how the PD/PI and program coordinator will specifically interact, and how the program coordinator will be integrated with the program faculty to facilitate the program.
  • Describe how mentors will be selected based on commitment to research training and mentoring, and not simply research productivity, and any mechanisms to monitor mentoring effectiveness.
  • If applicable, describe how the applicant will coordinate and collaborate with other NHGRI-supported R25 diversity and/or T32 programs to provide synergy amongst the programs.
  • For renewal applications, describe how this plan resulted in getting participants to their next career level.  Special attention should be paid to unique aspects of the plan that resulted in measurable outcomes.

For renewal applications, provide information on outcomes of past participants in the program, including, but not limited to, counts (numbers and percentages of participants) and summaries of the following:

  • Participants who completed the DAP program (alumni);
  • Participants who applied for admission to an academic program at their next career level;
  • Participants who enrolled in an academic program at their next career level;
  • Participants who completed an academic program at their next career level;
  • Participants who are employed in a tenure-track faculty position;
  • Participants who are employed in research-related positions;
  • Participants who are employed in non-research related positions.

The application should describe how the participating faculty are trained to ensure the use of evidence-informed teaching, training and mentoring practices that promote the development of trainees from all backgrounds including trainees from groups underrepresented in the biomedical sciences (see Notice of 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 their trainees;
  • 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 trainees with the appropriate participating faculty (e.g., laboratory rotations, faculty forums, and interviews);
  • How the program will ensure that participating faculty engage in activities that promote trainee career development (including but not limited to the utilization of Individual Development Plans) and fulfill the need of the trainees to obtain their Ph.D. degrees in a timely fashion with the skills, credentials, and experiences to transition into careers in the biomedical research workforce that are consistent with the trainees’ interests and values;
  • A mechanism to monitor mentoring, including oversight of the effectiveness of the trainee/participating faculty match, and a plan for removing faculty displaying unacceptable mentorship qualities from the training program (applicants may use the Appendix labeled “Conflict Resolution Protocols” to provide details of the plan); and

If a program coordinator or administrator position is planned to enhance oversight, a description of the person's 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.

The PD/PI assumes responsibility for the overall execution of the DAP Program and is typically responsible for placement of students in research laboratories and coordination and implementation of developmental education and mentoring activities across the different participating institutions.  Describe how the PD(s)/PI(s) will work with the program coordinator and program faculty to monitor and evaluate the progress of the individual program elements and the overall functioning of the program.

The PD/DI must have significant expertise in the foundational sciences relevant to NHGRI programs (genome sciences, genomic medicine, genomics and society, computational genomics and data science, and genomics and health equity), experience relevant to the proposed diversity program, and a history of mentoring students from diverse backgrounds.

Program Faculty. Researchers from diverse backgrounds, including individuals from groups underrepresented in genomics research workforce, 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. Applications must identify the career levels for which the proposed program is planned.

Institutions are encouraged to consider, in a manner consistent with applicable law, the extent to which the proposed participants would help achieve the overall goals of this NHGRI Diversity Action Plan R25 Program. 

Applications must:

  • Include a description (including size) of the potential applicant pool from the participating institutions based on the selection criteria established for the proposed DAP program;
  • Describe the process for recruitment and selection of the program-supported participants (examples of accepted indicators include, but are not limited to, previous academic success, practical research experience, written statements that express interest and commitment and letters of recommendations from faculty, research supervisors and/or other community leaders that speak to the applicant’s merit and interest in genomics research);
  • Describe the retention strategies and follow-up activities that would ensure students from diverse backgrounds, including groups  underrepresented in the biomedical, behavioral, and clinical research workforce, remain engaged and are receiving high quality mentorship and guidance within the program.

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.

Provide evidence that for the duration of this grant the institution will have a significant number of peer-reviewed research projects, (e.g. multiple research grants, a large center grant, or cooperative agreement, etc.) in one or more of the following areas: genome sciences, genomic medicine, genomics and society, computational genomics and data science, and genomics and health equity, in order to provide participants with a variety of experiences. Demonstrate that research and educational experiences will focus on the relevance of the foundational genomic disciplines to the research and not focus on particular disease(s) or health conditions.

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  underrepresented 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.

New applications must include a description of Recruitment Plans to Enhance Diversity, including the strategies that will be used to promote the recruitment of prospective trainees from underrepresented groups, and may wish to include data in support of past accomplishments.

Information should be included on how the proposed plan reflects the program’s past experiences in recruiting individuals from underrepresented groups.

For those individuals who participated in the research education program, the report should include information about the duration of education and aggregate information on the number of individuals who finished the program in good standing. 

Applications lacking a Recruitment Plan to Enhance Diversity will not be reviewed.

Plan for Instruction in the Responsible Conduct of Research. All applications must 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 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. Funded programs are expected to report on outcomes through annual progress reports and renewal applications.   Applicants are encouraged to adapt evidence-based approaches to evaluation, such as those based on the literature or on institution-specific evaluation of related programs . Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements.

The Evaluation Plan should describe:

  • The evaluation or assessment process, including specific measurable objectives, to determine: 
    • Whether the overall program is effective in meeting its training mission and objectives
    • How well participants are prepared to advance to the next career level in genomics research, and 
    • Whether the scientific research climate is inclusive, safe, and supportive of trainee development ;
  • 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. 
  • Plans for being responsive to outcomes analyses, critiques, surveys and evaluations; and Activities to identify and evaluate  the career outcomes of trainees 

Dissemination Plan. A specific plan must 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, workshops.

Letters of Support

A letter of institutional commitment must be attached as part of Letters of Support (see section above:”Institutional Environment and Commitment."

Resource Sharing Plan
Note: Effective for due dates on or after January 25, 2023, a Data Management and Sharing Plan is not applicable for this NOFO.

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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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, NIH. Applications that are incomplete or non-compliant 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.

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 research 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?

Does the DAP application provide a value-added aspect that other student development programs ongoing at the institutions do not provide? Does the research plan show potential 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  the fields of genome sciences, genomic medicine, genomics and society, genomic data science, or genomics and health equity?

 

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?

Will the program faculty collectively provide the expansive type of research and didactic experiences in genomics research so that the experiences received are not focused on any particular disease, diseases or health conditions? Are individuals with the right expertise in the foundational sciences relevant to genome sciences, genomic medicine and/or genomics and society involved in the development and management of the program? Do the PD/PI and key personnel maintain an appropriate level of involvement to ensure the substantial and unique added value critical to research in genome sciences, genomic medicine, computational genomics and data science, genomics and society, or genomics and health equity? Does the program coordinator have the expertise to implement activities that are essential for the success of the participants and their anticipated career? Is the program coordinator sufficiently integrated with the PD/PI and with the program faculty participating in the DAP program? Is selection of the program faculty based on a commitment to training and mentoring, and not simply research productivity? If courses for skill development are proposed, do the instructors have appropriate expertise? 

 

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?

For renewal applications, were any innovations implemented by the grantee successful?

Where appropriate does the program complement and synergize with other NIH-supported programs?

 

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?

Are the activities commensurate with the program goals?  Will the activities facilitate participants moving successfully to the next phase of their educational or career program? Are the types of research experiences and education clearly articulated for the appropriate career level of the participant? Are genomic science, genomic medicine, computational genomics and data science, genomes and society, or genomics and health equity topics prominently integrated into planned activities? How does the plan take advantage of the research infrastructure of the applicant institution and other similar programs supported by NHGRI and the PD's/PI's institution? What is the value added and does this program differ from ongoing activities? If courses for skill development are proposed, are they well justified and likely to result in a greater probability that the participants will transition to the next stage of a research career in STEM or genomics?

For renewal applications, how successful was the program in supporting participants to progress to the next phase of their career in genomics research? Do they show evidence of participants applying to and being accepted in the next stage? Do they show evidence of participants having publications/abstracts resulting from their research experience in the program?

 

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?

Collectively, do the research groups provide access to a broad set of research experiences in genome sciences, genomic medicine computational genomics and data science, genomics and society, and/or genomics and health equity so that the participants can use the skills, knowledge and expertise to function in any research program focused on genomics? Does the institution have sufficient and varied peer-reviewed research projects in the areas of interest to sustain an infrastructure consistent with the intent and duration of this program? If applicable, are the plans to coordinate and collaborate with other NHGRI-supported R25 diversity and/or T32 programs adequate such that there will be synergy amongst the programs? Does the institution have the potential to sustain an intense research program in genome sciences, genomic medicine and/or genomics and society for at least ten years?

Additional Review Criteria

Not applicable.

 

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.

 

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

 

Does the Instruction in Methods for Enhancing Reproducibility plan describe how trainees will be instructed in principles important for enhancing research reproducibility including, at a minimum, evaluation of foundational research underlying a project (i.e., scientific premise), rigorous experimental design, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, data and material sharing, record keeping, and transparency in reporting? Are the rigor and transparency components sufficiently well integrated into the overall curriculum? Are they taught at multiple stages of trainee development and in a variety of formats and contexts? Does the teaching synergize with elements of the curriculum designed to enhance trainees' abilities to conduct responsible research? Is there evidence that all program faculty reiterate and augment key elements of methods for enhancing reproducibility when trainees are performing mentored research in their laboratories?

 

For Renewals, the committee will consider the progress made in the last funding period in accomplishing the goals of the program.

 

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.

 

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.

 

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

 

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., 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.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. 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 2.4.4 Disposition of Applications.

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 NOFO 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 Assurance of Compliance form (HHS 690)) in which the recipient agrees, as a condition of receiving the grant, to administer 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. 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 NOFO.

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 and financial statements as required in the NIH Grants Policy Statement. 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 Diversity Report, in accordance with the RPPR Instruction Guide.

NIH NOFOs 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 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.
  • Awardees must submit the Data Table 8D. Program Outcomes: Undergraduate i n Section B.4 of the Research Performance Progress Report (RPPR) for undergraduate and post-baccalaureate participants. Sample and table description can be found at  https://grants.nih.gov/grants/forms/data-tables.htm .

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 NHGRI  expects to use the following evaluation measures:

For Research Experience and Mentoring Programs Involving the Following Groups:

Undergraduate Students and Postbaccalaureates:

  • Aggregate number and demographic characteristics of participants
  • Subsequent educational/career progress, including:
    • Successful completion of an undergraduate degree in a STEM field
    • Enrollment in an advanced degree program in a STEM field
    • Subsequent research grant support from NIH or other sources
    • Participation in the biomedical research workforce
    • Participation in the genomics research workforce

For Courses for Skills Development:

  • Aggregate number and demographic characteristics of participants
  • Educational level of participants
  • Content
  • Participants’ feedback on the program
  • New knowledge or skills acquired

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)

Lucia Hindorff, PhD, MPH
National Human Genome Research Institute (NHGRI)
Telephone: 240-271-1509 
Email: hindorffl@mail.nih.gov  

Peer Review Contact(s)

Rudy Pozzatti, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-8739
Email: rudy.pozzatti@nih.gov 

Financial/Grants Management Contact(s)

Devon Bumbray-Quarles 
National Human Genome Research Institute (NHGRI)
Telephone: 301-451-7928
Email: Devon.Bumbray-Quarles@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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