National Institutes of Health (NIH)
National Human Genome Research Institute (NHGRI)
R25 Education Projects
April 6, 2023 - Notice to Extend the Expiration Date of RFA-HG-22-004: Genome Research Experiences to Attract Talented Undergraduates into Genomic Fields to Enhance Diversity (R25 Clinical Trial Not Allowed). See Notice NOT-HG-23-031
NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available
NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
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
Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The overarching goal of this NHGRI R25 program is to support educational activities that encourage undergraduates from diverse backgrounds, including those from groups underrepresented in the biomedical workforce, to pursue further training and careers in the scientific, medical, ethical, social and/or legal areas of genomics research. To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on:
- Research Experiences
- Courses for Skills Development
This Genome Research Experiences to Attract Talented Undergraduates into the Genomic Field to Promote Diversity (GREAT) Program will support collaborative institutional partnerships that provide research education programs for undergraduates enrolled at minority-serving institutions (MSIs) or Institutional Development Award (IDeA)-eligible institutions. A partnership will include a MSI or IDeA-eligible institution, and one or more research-intensive institutions or organizations with a suitable research base for graduate-level training in scientific areas of interest to NHGRI.
June 1, 2022; June 1, 2023
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| July 01, 2022 | Not Applicable | Not Applicable | November 2022 | January 2023 | April 2023 |
| July 01, 2023 | July 01, 2023 | Not Applicable | November 2023 | January 2024 | April 2024 |
| July 01, 2024 | July 01, 2024 | Not Applicable | November 2024 | January 2025 | April 2025 |
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
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 (e.g., see Notice of NIH's Interest in Diversity), 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 R25 program is to support educational activities that encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research.
The overarching goal of this NHGRI R25 program is to support educational activities that encourage undergraduates from diverse backgrounds, such as those from groups underrepresented in the biomedical workforce, to pursue further training and careers in the scientific, medical, ethical, social and/or legal areas of genomics research. To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on:
- Research Experiences: Activities should provide undergraduates with exposure to research in NHGRI mission areas, to reinforce their intent to graduate with a science or social science degree, and prepare them for graduate school admissions and/or research careers that contribute to the field of genomics.
- Courses for Skills Development: Complementary didactic activities designed expressly for participants in this program are required, especially activities that have the potential to increase opportunities for success at the next career level. The field of genomics is data driven. Special courses/seminars/workshops that introduce participants to fundamental knowledge in genomic data sciences, such as bioinformatics, machine learning, statistics, etc., are especially encouraged. Didactic activities that educate students on the impact of genomics on society are also expressly encouraged.
Need for the Program
The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral and clinical sciences research workforce. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation; enhancing global competitiveness; contributing to robust learning environments; improving the quality of research; advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research; and enhancing public trust.
Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and to enhance the participation of individuals from diverse groups, including those nationally underrepresented in biomedical, clinical, behavioral, and social sciences research, such as racial and ethnic minorities, those from socioeconomically disadvantaged backgrounds, and individuals with disabilities (see NOT-OD-20-031). Although the NIH currently provides multiple opportunities to develop research careers and improve participation for individuals from groups with lower representation in the biomedical and behavioral sciences, reports from the National Science Foundation (NSF) and others, provide strong evidence that diversity remains an ongoing challenge that must be addressed at every level of the educational pipeline.
According to U.S. Census Bureau data, underrepresented racial/ethnic groups comprised 37% of the U.S. population in 2018 for the age range of 18-24 years old. For that same year, the NSF Survey of Women, Minorities, and Persons with Disabilities in Science and Engineering reported that of the U.S citizens and permanent residents who were awarded bachelor’s degrees in science or engineering, 21% were from underrepresented groups (URG), and for those awarded doctoral degrees, 14% were from underrepresented groups. NSF data also showed that of those who specifically earned their doctoral degree in the genetics/genomics field, only 9% were from underrepresented groups. Thus, the undergraduate to graduate transition continues to be a transition point where science and engineering students from underrepresented groups leave the research enterprise, with the subfield of genetics/genomics having less URG representation overall.
As a leading authority in the field of genomics, NHGRI’s Strategic Vision is to be at the Forefront of Genomics by accelerating scientific and medical breakthroughs that improve human health and well-being. We do this by driving cutting-edge research, developing new technologies, and studying the impact of genomics on society. 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 will allow those who participate in NHGRI-supported research activities to be well positioned to contribute to biomedical research in the future. For the purposes of this GREAT research education program, the term genomics encompasses issues and activities in all of these foundational areas of research that are of interest to NHGRI (see Strategic Vision). As noted in the 2020 Strategic Vision, one of the guiding principles and values for human genomics is championing a diverse genomics workforce. The promise of genomics cannot be fully achieved without attracting, developing, and retaining a diverse workforce, which includes individuals from groups that are currently underrepresented in the genomics enterprise.
The NHGRI’s 2021 Building a Diverse Genomics Workforce: An NHGRI Action Agenda , details the institute's vision for training, employing, and retaining a diverse genomics workforce. The GREAT program is intended to address a major goal of that action agenda, which is to develop and support training programs and networks that connect undergraduate and graduate education to careers in genomics, and in particular, to ensure that undergraduate minority-serving institutions are aware of and tightly connected to that network.
Programmatic Approach for GREAT Program
The focus of this GREAT Program is to provide exposure to genomics research to undergraduate students enrolled at MSIs or IDeA-eligible institutions. The program will complement these research experiences with activities to reinforce the student’s intent to graduate and prepare them for graduate school admissions and/or careers in genomics research. For the purposes of this program, the term genomics encompasses issues and activities in the scientific, medical, computational, ethical, social and/or legal areas of genomics research that are of interest to NHGRI (see the NHGRI Strategic Vision).
The proposed GREAT Program will provide support for MSIs or institutions in IDeA-eligible states to implement collaborative approaches to genomics research education for students from diverse backgrounds. Through this program, these institutions will establish partnerships with research-intensive institutions or organizations that have a prominent genomics research training environment. Collaborating institutions will work together to design and implement an education program that includes genomics research experiences primarily at the research-intensive institutions/organizations.
Each collaborative partnership must include:
- One baccalaureate degree-granting Minority-Serving Institution or an Institution in an IDeA-eligible state to serve as the awardee institution. For specific eligibility requirements, see Section III. Eligibility Information. The Institution will have responsibility for the conduct and oversight of the award, along with the flexibility to determine the optimal configuration with its partner(s) to have the maximum impact.
- One or more partnerships supported by subaward with either a Higher Education Institution or Non-Profit/For-Profit Organization with a research-intensive genomics training environment as evidenced by a strong base of NIH or NHGRI extramurally-funded or privately-funded research in genomics. Higher Education Institutions are limited to domestic PhD-granting colleges/universities that receive greater than $7.5 million (total costs) of NIH Research Project Grant (RPG) funding per year over the past 3 fiscal years.
For other aspects of the partnership, mentoring and other educational activities are expected to be conducted at each collaborating component in order to maximize impact of the program. Collaborators should collectively consider all factors that are likely to improve exposure, knowledge, and competency in the scientific, medical, ethical, social and/or legal areas of genomics research for participating students. It is expected that long-term collaborations will be developed to allow faculty and students to have substantive and continuous interactions for the duration of the funded project period and beyond. Lastly, a plan to address any geographical constraints should be developed to ensure students can receive effective mentoring and research educational activities from all collaborating institutions.
Applicants will be expected to develop a genomics research education program where students will be supported for up to two years (part-time during the academic year and full-time in the summer) to conduct genomics research with participating faculty. The goal should be for each student to complete a full two-year research education program, where a significant portion of the research experience for each student takes place at the research-intensive institutions; however, research at the MSI or IDeA-eligible institutions is also encouraged if the research projects and environment are well aligned with NHGRI’s scientific mission. Students must have already completed one academic year of post-secondary education to be eligible; however, completion of two academic years is preferred for participation in the program. The undergraduate students will be supported for up to 15 hours/week during the academic year and 40 hours/week during the summer. While the intent of the FOA is to support enrolled college students during a two-year time period, an allowed exception is to continue support for an individual after graduation through a summer research experience if the student has already participated a year or more in the program.
In addition to research experiences, programs are expected to provide students with outstanding mentoring and education in other critical skills such as leadership, scientific writing and presentation skills, training in rigor and reproducibility and time management. There should be dedicated efforts at providing not only technical expertise, but advice, insight, and professional career skills to students in the program. It is encouraged that mentors will work with participants to design individualized development plans (IDPs) that are compatible with participants needs and experience. Dual mentoring is encouraged, with one faculty mentor focused more on scientific mentoring and another on career mentoring, and with mentors at each collaborating institute represented. Additionally, near-peer mentoring is encouraged (e.g. a graduate student who is working with an undergraduate student on a research project). After students complete their research education experience, follow-up mentoring should be conducted for nine months or more.
NIH realizes that quality mentorship is critical to the recruitment and retention of scientists, including those from underrepresented backgrounds, and encourages program activities to improve the caliber of mentorship. As recommended in the 2018 NASEM report on graduate education, "modules for faculty to learn how to advise and mentor students from different backgrounds and to raise awareness and accountability about their role in changing the training and mentoring environment" should be a component of a well-designed program. For example, case-based scenarios may be used to educate mentors on various relevant ethical, professional and cultural issues facing students today, effective communication and mentoring compacts, and effective tools for mentors to address cultural awareness.
Courses for skills development should be integrated across the partnering institutions and uniquely designed to increase undergraduate students interest in and preparation to enter Ph.D. degree programs in genomics or a genomics-related field of scientific interest to NHGRI. Depending on the strength of the applicant institution, it is expected that academic and curriculum enhancement activities may vary in how they are formalized and integrated; various strategies, rooted in education research, may be utilized. These approaches may include, but are not limited to: core genomics coursework tailored to students backgrounds and needs; curriculum for specialized research techniques; collaborative learning experiences and group activities to convey the excitement and relevance of genomics to students; advisement regarding the number, level, and sequence of courses that students should take to be competitive for graduate school programs in genomics; seminars emphasizing scientific reading comprehension, writing, and oral presentation skills; and research career seminars to help prepare students for the transition from undergraduate to graduate school.
The expected outcome of the GREAT program is enhanced participation of individuals from diverse backgrounds in the NHGRI research workforce who can bring their unique experiences, perspectives and innovation to addressing human disease or the ethical, legal or social implications of genomics research. Other desired program outcomes include completion of bachelor’s degrees, transition to graduate programs in research mission areas relevant to NHGRI, and achievement of subsequent research funding, such as an NHGRI individual fellowship or career development award. Throughout the program, NHGRI will actively monitor the progress towards these outcomes. NHGRI will hold regular meetings with PD/PIs, and PD/PIs and student participants are expected to attend the NHGRI Research Training and Career Development Annual Meeting. The scientific meeting is held in the Spring each year and is a venue for NHGRI-funded trainees and student participants to present their research, network, learn more about the genomics field, and participate in academic and career enhancing activities.
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.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
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 FOA.
Not Allowed: Only accepting applications that do not propose clinical trial(s).
Need help determining whether you are doing a clinical trial?
NHGRI intends to commit $1,000,000 in total costs per year in FY23 and FY24 to fund ~3 awards yearly. The actual number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
An applicant may request direct costs of up to $350,000 per year. Because the nature and scope of the proposed research education program will vary from application to application, it is anticipated that the size of each award will also vary.
The total project period for an application submitted in response to this funding opportunity may not exceed 5 years.
Individuals designing, directing, and implementing the research education program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with participants are considered a regular part of an individual's academic duties, then any costs associated with the mentoring and other interactions with participants are not allowable costs from grant funds).
Salary support for the PD/PI or combination of multiple PDs/PIs is limited to 4.0 person months (i.e., 33% on a 12-month basis), depending on person months devoted to the administration of the program.
Program coordinators are encouraged and allowed as long as their role is clearly defined and significantly different from the roles of the PDs/PIs. The duties and responsibilities of the program coordinators must be included in the budget justification.
Administrative and clerical salary costs distinctly associated with the program that are not normally provided by the applicant organization may be directly charged to the grant only when specifically identified and justified. Costs are limited to 1.2 person months (10% on a 12-month basis).
Salaries and fringe benefits for program faculty mentors may NOT be requested.
Personnel costs must be directly associated with the program and should be well-justified and reasonable.
Total expenses in this category may not exceed 40% of the total direct costs in any year of the project period.
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.
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 tuition for courses directly related to GREAT program goals. Salary is allowed for research experiences at a rate of up to $15/hour, and for up to 15 hours/week during the academic year and 40 hours/week during the summer. Support for students is not provided for time spent by the students passively participating in GREAT-sponsored non-research activities, e.g., group learning activities, attendance at conferences, etc. Participants are expected to attend at least one NHGRI Research Training and Career Development Annual Meeting while supported on this program. Travel for attendance to this meeting must be included in the proposed budget. For summer research experiences for non-local participants, funds may be requested to cover the costs of housing, food and travel between the place of residence and the partnership institution. Total expenses in this category must be a minimum of 50% of the total direct costs in any year of the project period.
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.
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.
Consultant costs for program evaluation are limited to $5,000 direct costs per year.
PD/PI(s) and key staff are expected annually to attend the NHGRI Research Training and Career Development Meeting. Travel funds should be requested and are limited to $3,000 direct costs for total staff per year.
Funds can be requested for PD/PI(s) and key staff to travel to partnership sites, and is limited to $15,000 direct costs for total staff per year.
Please see Section IV.2 R&R Budget for more specifics including unallowable costs.
Total expenses in this category may not exceed 20% of the total direct costs in any year of the project period.
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, expenditures for equipment and consortium costs in excess of $25,000), rather than on the basis of a negotiated rate agreement.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
1. Eligible Applicants
Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Governments
- U.S. Territory or Possession
1) Only one lead/applicant institution that:
a) Awards undergraduate (B.S. or B.A.) degrees in STEM fields; and
b) at the time of the application, has received no more than $7.5 million dollars per year (total costs) from NIH Research Project Grants (RPGs) in each of the preceding three fiscal years, calculated using NIH RePORTER; and one of the following:
c) has a historical and current mission to educate undergraduate students from any of the populations that have been identified as underrepresented in biomedical research as defined by the National Science Foundation (NSF; see http://www.nsf.gov/statistics/wmpd; i.e., African Americans or Blacks, Hispanic or Latino Americans, American Indians, Alaska Natives, Native Hawaiians, U.S. Pacific Islanders, and persons with disabilities), or
d) is from an IDeA-eligible state (see https://www.nigms.nih.gov/Research/DRCB/IDeA for a current list); and enrolls at least 40% of undergraduate students supported by Pell grants based on the most recent two years of data available from the Integrated Postsecondary Education Data System (IPEDS) database maintained by the National Center for Education Statistics.
2) One or more research-intensive higher education, doctoral-degree institutions or non-profit/for-profit organizations to be supported by subaward(s). Research-intensive is defined as having an existing genomics or genomics-related program and a significant number of potential mentors with NIH R01 or equivalent extramural research support (institutions) or private funds (organizations). Also, institutions must receive more than $7.5 million dollars per year (total costs) from NIH Research Project Grants (RPGs) in each of the preceding three fiscal years, calculated using NIH RePORTER.
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.
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.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
- Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
- System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
- 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.
- eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
- Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.
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 knowledgeable 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 proposed PD/PI should hold a research or clinical doctoral degree (e.g., Ph.D., M.D., or equivalent), and have clearly demonstrated training/mentoring credentials. The PD/PI must have a regular, full-time appointment (i.e., not adjunct, part-time, retired, or emeritus) at the applicant institution, and be actively engaged in research and/or teaching in an area directly related to the mission of the NHGRI. Early-stage investigators are eligible to serve as PD/PIs, as long as doing so will not detract from their research program and career advancement.
2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
3. Additional Information on Eligibility
Number of Applications
Only one application per institution (normally identified by having a UEI number or NIH IPF number) is allowed.
The NIH will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
- A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
- A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
- An application that has substantial overlap with another application pending appeal of initial peer review.
Program Faculty
Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as preceptors/mentors. Mentors should have research expertise and experience relevant to NHGRI’s scientific mission. Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award.
Participants
Participants must be citizens or noncitizen nationals of the United States or have been lawfully admitted for permanent residence at the time of appointment. Also, participants must be (a) full-time matriculated students in a baccalaureate degree program at the lead applicant institutions, and (b) have completed one academic year at the lead applicant institution (rising sophomore). An exception is to continue support for a student after graduation if the student has already participated a year or more in the GREAT program. Support could be extended so they can participate through the next summer research experience, if it falls within the two-year time period individuals are allowed to participate in the program.
1. Requesting an Application Package
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
2. Content and Form of Application Submission
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions will not be reviewed.
Letter of Intent
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
- Descriptive title of proposed activity
- Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
- Names of other key personnel
- Participating institution(s)
- Number and title of this funding opportunity
The letter of intent should be sent to:
Ebony Madden, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-503-5620
Email: [email protected]
Note: Effective for due dates on or after January 25, 2023 a Data Management and Sharing Plan is not applicable for this FOA.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
Follow all instructions provided in the SF424 (R&R) Application Guide.
Follow all instructions provided in the SF424 (R&R) Application Guide.
Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:
Facilities & Other Resources. Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support.
Other Attachments.
Advisory Committee (1-page maximum): Provide a plan 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 assess the overall effectiveness of the program. To avoid conflicts in the review process, proposed Advisory Committee members should be named in the application only if they have been invited to participate at the time the application is submitted. Once the application has been submitted, potential Advisory Committee members should not be contacted prior to receiving an award. Please name your file Advisory_Committee.pdf .
Tables: The GREAT program is an institutional program and as such applicants must provide details about the institution and its setting using Undergraduate Data Tables 2 and 4 (https://grants.nih.gov/grants/forms-f/data-tables.htm).
Training Table 2. Participating Faculty Members
Training Table 4. Research Support of Participating Faculty Members
Please name your files "Table 2.pdf" and Table 4.pdf".
The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.
Follow all instructions provided in the SF424 (R&R) Application Guide.
Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:
- Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.
- Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program.
- The following account summarizes some of the UNALLOWABLE costs under the GREAT Program but is not an all-inclusive list:
- Undergraduate housing or food during the academic year;
- Food and beverage costs at events (NOTE: Meal expenses for non-local participants to attend summer research experiences is permissible. Also, travel per diem costs provided in accordance with an institution's written travel policies to cover incidental meal expenses at conferences is permissible);
- Recruitment travel;
- Costs for incentives, memberships, or subscriptions to journals;
- Salary support for faculty research;
- Purchase of equipment and laptops at research-intensive partnership institutions (NOTE: these items are allowable for the lead/applicant institution);
- Costs to support existing seminars, meetings, workshops or courses for a wider audience. (NOTE: Registration fee costs for GREAT participants to attend such events are allowable if the subject matter is directly related to the GREAT program goals. Costs for DEVELOPMENT of such events are allowable if the target audience is primarily for GREAT participants and is hosted at the lead institution).
Follow all instructions provided in the SF424 (R&R) Application Guide.
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
- Diversity Recruitment Plan
- 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.
Applications must:
- Use an evidence-based approach to justify activities proposed in the research plan. Applicants should review the substantial pedagogical literature concerning predictors of success in research careers and examine additional data/report resources at https://extramural-diversity.nih.gov/diversity-reports and http://uiai.uccs.edu/.
- Address the overall goals and specific measurable objectives (including anticipated milestones defined as anticipated intermediate steps toward the objectives) that the institution expects to accomplish in preparing students to enter and complete Ph.D. degrees in genomics research and/or pursue careers in the scientific, medical, ethical, social and/or legal areas of genomics research.
- Provide programmatic detail and rationale on the proposed research experiences and courses for skills development and describe how these activities will enrich the research skills and/or competence of participants so that they may further engage in genomics research.
- Describe how the research education plan will be integrated across the partnering institutions, including plans for coordination and communication between the sites.
- Discuss any perceived impediments to implementing the proposed activities and alternative strategies to achieve the measurable objectives.
- Provide the number of participants to be supported and concise information on the selection and retention process for the participants in the GREAT program, including the criteria related to the students academic status, participants research education and training progress, and role of the faculty/personnel involved.
- Demonstrate that participants will have authentic, meaningful research experiences in the laboratories or research groups of investigators who are actively engaged in genomics-related research. This exposure to research should occur part-time during the academic year at the home institution or one of the partnering institutions and full-time during the summer at partnering institutions.
- Describe the mentoring activities, including efforts at providing not only technical expertise, but advice, insight, and professional career skills that will advance the broad career goals of the students from diverse backgrounds. Describe any activities aimed at improving the caliber of mentorship.
- Include a timetable for completing the planned activities.
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.
In particular, provide evidence that the PD/PI is actively engaged in research and/or teaching in an area related to the mission of the NHGRI. For early-stage investigators, there should be a statement of assurance that their research program and career advancement will not be impacted by duties as PD/PI.
Describe how the PD(s)/PI(s) will assume responsibility for the overall execution of the GREAT Program, including 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 program faculty and, if applicable, program coordinator(s) to monitor and evaluate the progress of the individual program elements and the overall functioning of the integrated program.
Program Faculty. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as program faculty. Faculty should have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles.
For this FOA the Program Faculty may also serve as Mentors. All Program Faculty must conduct research that is relevant to NHGRI’s scientific mission. There should be clear involvement of faculty at both lead and partner institutions, with appropriate faculty coordination across institutions.
Program Participants.
Applications must describe the intended participants, and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program. It is the responsibility of the institutions to establish the selection criteria for the students before they are allowed to participate in the program, and to establish selection criteria that will ensure a highly qualified applicant pool. Selection of program-supported participants is expected to take into consideration whether the participation would help achieve the overall goals/objectives of the NHGRI GREAT Program, which is to support a diverse pool of undergraduate participants to help them successfully enter and complete Ph.D. degree programs in genomics or a genomics-related field.
Undergraduate students from engineering, mathematics, computer science, physics, chemistry, biology, psychology, sociology, bioethics and other relevant science and humanities programs who have an interest in genomics should be encouraged to participate in 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.
The application must include a description of specific support (financial, in-kind, or otherwise) to be provided to the program. This could include support of course implementation, support for additional participants in the program, release time for the Program Director(s) and participating faculty, or any other creative ways to improve and enhance the research education program. Institutions should clearly state the alignment of enhancing scientific workforce diversity to its mission and accountability to promote a climate of inclusion for participants within the institutional program. The applicant institution must document the requisite administrative/technical capacity, and support for the management of a collaborative multi-site research education and research training project. All collaborative arrangements must be clearly described and agreements included in the application as letters of support.
The application specifically should provide a description of any cost sharing for off-site summer research experiences being provided by the GREAT partnering institutions. The applicant should clearly indicate any support (financial and otherwise) being provided by the off-site institution(s) to assist in covering or defraying costs associated with the participants summer research training experiences. Providing funds for summer travel, food and modest housing arrangements for participants in the off-site summer programs by partnering institutions is encouraged.
Recruitment Plan to Enhance Diversity (NOT-OD-20-031):
The applicant must provide a recruitment plan to enhance diversity. Include outreach strategies and activities designed to recruit prospective participants from diverse backgrounds, e.g. those from groups described in the Notice of NIH's Interest in Diversity. Describe the specific efforts to be undertaken by the program and how the proposed plan reflects past experiences in recruiting individuals from underrepresented groups.
Applications lacking a diversity recruitment plan will not be reviewed.
Plan for Instruction in the Responsible Conduct of Research. All applications 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. The plan should be appropriate and reasonable for the nature and duration of the proposed program. Renewal (Type 2) applications must, in addition, describe any changes in formal instruction over the past project period and plans to address any weaknesses in the current instruction plan. All participating faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.
Applications lacking a plan for instruction in responsible conduct of research will not be reviewed.
Evaluation Plan. Applications must include a plan for evaluating the activities supported by the award. The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short or long-term success of the research education award in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements.
Evaluation plans must also include the following: 1) Measures of effectiveness in outreach and dissemination of research education opportunities; 2) measures to monitor individual student progress and satisfaction during the course of their participation in the program; 3) measures to monitor the effectiveness of faculty mentoring; 4) the number of GREAT participants entering into graduate degree programs in genomics; and 5) the extent to which the program increases interest in NHGRI mission areas. The evaluation should also include a plan for assessing whether the program overall and its environments are effective, inclusive, safe and supportive for students while participating in the program. Applicants are expected to propose how they will implement their evaluation plan and ensure that lessons learned are applied throughout the grant period. See Section VI. Award Administration Information, 4. Evaluation for a list of suggested key questions/metrics to include in a monitoring/evaluation plan that NHGRI will use to determine whether the GREAT program goals or outcomes have been met in a future evaluation.
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."
Letters of collaboration from partner sites must be provided by authorized officials from the partner institutions addressing their institutional commitment to the proposed project and GREAT program goals. As applicable, key faculty or senior investigators at partner organizations who will have substantial involvement in curriculum development, teaching, research training and mentoring, or other activities should submit letters.
Resource Sharing Plans
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
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.
3. Unique Entity Identifier and System for Award Management (SAM)
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.
4. Submission Dates and Times
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
5. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental review.
6. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
7. Other Submission Requirements and Information
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NHGRI Referral Office by email at {[email protected]} when the application has been submitted. Please include the FOA number and title, PD(s)/PI(s) name(s), and title of the application.
1. Criteria
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
The goal of this R25 program is to support educational activities that encourage undergraduate students from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further training and careers in the scientific, medical, ethical, social and/or legal areas of genomics research.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to strongly advance research education by fulfilling the goal of this R25 Education Program, in consideration of the following review criteria and additional review criteria, as applicable for the project proposed.
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.
Significance
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?
Will the proposed GREAT program significantly improve the lead institutional baseline number of students that enter and complete graduate Ph.D. programs in genomics, and/or pursue careers in the scientific, medical, ethical, social and/or legal areas of genomics research?
Does the proposed program provide evidence of the effect it will have on the enrichment of the research skills and/or competence of participants so they may further engage in genomics research?
Investigator(s)
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?
Is the PD/PI(s) actively engaged in research and/or teaching in an area related to the mission of the NHGRI?
Is there a description of how the PD/PI(s) will work with program faculty and, if applicable, program coordinator(s) to monitor and evaluate the progress of the individual program elements and the overall functioning of the integrated program?
Is there evidence that all Program Faculty are conducting research that is relevant to NHGRI’s scientific mission?
Is there clear involvement of faculty at both lead and partner institutions, with appropriate faculty coordination across institutions?
Innovation
Taking into consideration the nature of the proposed research education program, does the applicant make a strong case for this program effectively reaching an audience in need of the program’s offerings? Where appropriate, is the proposed program developing or utilizing innovative approaches and latest best practices to improve the knowledge and/or skills of the intended audience?
Does the program use innovative methods in mentoring?
Approach
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?
Do the proposed research experiences and courses for skills development meet the needs of participating students from diverse backgrounds, and are they designed to support their competitiveness for completion of a Ph.D. degree in a genomics field?
Does the program demonstrate that participants will have meaningful research experiences in genomics-related laboratories?
Are the requirements and timetable for completing the planned activities, and the size and caliber of the participant pool appropriate to achieve the described program goals?
Is the mentoring plan sufficient to support the scope of this program? Are the selection criteria for participants and retention strategies clearly described and appropriate for ensuring that the program meets its goals?
Environment
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?
Is there evidence of commitment and integrationacross the collaborating institutions? Are adequate plans provided for coordination and communication between the sites?
Do the institutions or organizations have experience providing educational opportunities to students from diverse backgrounds, including those underrepresented in biomedical research?
Is there evidence that the program and its environments are effective, inclusive, safe and supportive?
Is an Advisory Committee presented and is the proposed expertise adequate?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
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.
Not Applicable
Not Applicable
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review, and a Data Management and Sharing Plan is not applicable for this FOA.
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.
Recruitment Plan to Enhance Diversity
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.
Training in the Responsible Conduct of Research
Taking into account the specific characteristics of the proposed research education program, the level of participant experience, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also: NOT-OD-10-019. The 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.
Applications from Foreign Organizations
Not Applicable
Select Agent Research
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan.
If support for development, maintenance, or enhancement of software is requested in the application, the reviewers will comment on the proposed software dissemination plan.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Group convened by NHGRI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned 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 submitted in response to this FOA. 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.
- Geographical distribution of program sites.
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.
1. Award Notices
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient’s business official.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:
- Federalwide Research Terms and Conditions
- Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
- Acknowledgment of Federal Funding
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
- Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
- Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
- HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
- Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
3. Reporting
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.
Programs that involve participants should report on education in the responsible conduct of research and complete a Trainee Diversity Report, in accordance with the RPPR Instruction Guide.
NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR 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 with the RPPR.
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.
4. 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:
- Aggregate number and demographic characteristics of participants
- Participants feedback on the program
- New knowledge or skills acquired
- Subsequent educational/career progress, including:
- Successful completion of an undergraduate degree in a STEM or social science field;
- Enrollment in an advanced degree program in a field relevant to the NHGRI mission;
- Successful completion ofan advanced degree program in a field relevant to the NHGRI mission;
- Subsequent participation in research in a field relevant to the NHGRI mission;
- Subsequent employment in a research field relevant to the NHGRI mission.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
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
Ebony Madden, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-503-5620
Email: [email protected]
Rudy Pozzatti, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-8739
Email: [email protected]
Deanna Ingersoll
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7858
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.
and Human Services (HHS)
