nih\sharmavir

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Environmental Health Sciences (NIEHS)

Funding Opportunity Title
Undergraduate Research Education Program (UP) to Enhance Diversity in the Environmental Health Sciences (R25 Clinical Trial Not Allowed)
Activity Code

R25 Education Projects

Announcement Type
Reissue of RFA-ES-19-010
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 R esearch Training, Fellowship, Research Education, and Career Development Awards Beginning in FY 2020. See Notice NOT-OD-19-109.
Funding Opportunity Number (FON)
RFA-ES-23-012
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.113
Funding Opportunity Purpose

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

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

  • Research Experiences

Key Dates

Posted Date
December 07, 2023
Open Date (Earliest Submission Date)
January 14, 2024
Letter of Intent Due Date(s)

30 days prior to application due date

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
February 14, 2024 February 14, 2024 Not Applicable July 2024 October 2024 December 2024

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

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

Expiration Date
February 15, 2024
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.


Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

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

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

The goal of this R25 program is to support research 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 environmental health.

Fostering diversity in the scientific research workforce is a key component of the NIH strategy to identify, develop, support and maintain the quality of our scientific human capital NOT-OD-20-031.

Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH's ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds, including those from underrepresented groups, who will help to further NIH's mission.

Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student, postdoctorate and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral and social sciences.

The NIEHS Undergraduate Research Education Program (UP) in the Environmental Health Sciences (R25) is a key activity in the implementation of the NIEHS Strategic Plan (https://www.niehs.nih.gov/about/strategicplan/index.cfm) designed to enhance the diversity of scientists engaged in NIH-funded environmental health science research. The NIEHS UP Program will provide support to appointed students from diverse backgrounds, such as those from underrepresented groups, for up to 2 years of their undergraduate education, typically beginning as rising juniors, to gain hands-on experience with research activities in the Environmental Health Sciences. The undergraduate students will be supported for up to 15 hours/week during the academic year and 40 hours/week during the summer. Students may be appointed as participants beginning the summer before their junior year though the summer after their senior or final year. Applicant programs need to demonstrate an association with a strong graduate program in the Environmental Health Sciences as evidenced by the presence of a funded NIEHS T32 Training program, a strong base of funded research in the environmental health sciences, or a graduate program with a focus on environmental health sciences research training. An applicant can propose collaboration between their undergraduate UP program and a graduate program in the environmental health sciences at another institution.

NIEHS UP (R25) programs supported by this NOFO are expected to consist of both an introduction to environmental health sciences research through experience on a research project with the participating faculty and an organized educational program (seminars, etc.) designed to acquaint the participants with the larger field of the environmental health sciences. The focus of both the research experience and the educational experiences/seminars should be within the mission interests of the NIEHS, which explores how the environment affects people’s health. Programs which propose only the research experience within the context of a university wide program for undergraduate students will not be considered responsive to this announcement.

NIEHS UP R25 student participants are expected to spend at least one summer (but ideally two) engaged in a full-time research internship in the environmental health sciences. The summer research internship may occur at the applicant institution or at a partnering research-intensive institution with a suitable research base in the environmental health sciences. Student research projects supported by a NIEHS UP R25 program should have a defined focus in the environmental health sciences, and be responsive to the mission of the NIEHS, which is distinguished from that of other Institutes by its support of research programs seeking to understand how environmental exposures alter biologic processes and affect the risk of either disease development or the distribution of disease in populations.

The number of participant positions requested by an institution should be in balance with the overall strength of the institution’s undergraduate program and the research base of environmental health science research projects. Applicant programs must have access to a base of ongoing, independently supported, peer-reviewed research projects clearly dedicated to the study of environmental health sciences or environmental medicine, a portion of which should be supported by the NIEHS.

Program Directors/Principal Investigators are responsible for the ongoing evaluation of the quality of their NIEHS UP research education program, as well as tracking student participants. It is expected that plans will be developed to obtain feedback from participants to enhance the program’s outcomes, achieve its goals, and suggest program improvements. All NIEHS UP R25 applications must describe an evaluation plan for the proposed activities and a tracking plan for participants in order to assess program activities/outcomes and to determine the effectiveness of all aspects of their proposed program.

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 financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New
Renewal

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).

Note: Appointed participants are permitted to obtain research experience in a clinical trial led by a mentor or co-mentor.

Funds Available and Anticipated Number of Awards

NIEHS intends to commit $1,215,000 in FY 2025 to fund 9 awards.

Award Budget

Application budgets may not exceed $125,000 in direct costs annually and need to reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 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).

Salaries and fringe benefits for the program mentors may NOT be supported with R25 funds.

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.

Salary - NIH will provide salary and fringe benefits consistent with institutional salary policies. Institutional salary rates which exceed the hourly minimum wage must be justified. Participants may only receive funding for the period they participate in the 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, 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.

Up to $3000 per participant may be requested for education related expenses directly for the benefit of the participant, including research costs and participant’s travel expenses to scientific meetings to present their research projects.

Funds for the PD(s)/PI(s) to travel to annual NIEHS Training Directors recipient meetings in Research Triangle Park, NC should be included in the budget request.

Equipment and room & board are not an allowable cost for this program. Other program-related expenses must be justified as required by the proposed NIEHS UP program and must not duplicate items generally available for educational programs at the applicant institution.

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)

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

  • U.S. Territory or Possession


Other

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

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 Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 SF424 (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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

  • 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 individuals from 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 of a NIEHS UP Research Education Program must be an established investigator in the environmental health sciences, have current NIEHS grant support at the time of the award, and be capable of providing both administrative and scientific leadership to the development and implementation of the proposed program.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms..

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).

Program Faculty

Researchers from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, persons with disabilities, and women 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.

Participants

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

Full-time upper level (junior or senior) undergraduate students enrolled at the recipient institution are eligible to be appointed as a participant in this program. The undergraduate participants must be able to commit full-time effort, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies, to their summer research experiences. The undergraduate students will be supported for up to 15 hours/week during the academic year. Students should not be appointed for summer-only participation.

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:

Beverly Duncan, Ph.D.
Telephone: 984-287-3740
Email: beverly.duncan@nih.gov

Page Limitations

All page limitations described in the How to Apply - Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply - 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 for the selection and 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 .

Participating Faculty Biosketches: Participating faculty should provide a personal statement within their biosketch that describes their prior mentoring and educational experience for the proposed program. Please name your file Participating Faculty Biosketches.pdf

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

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

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

R&R Budget

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

  • Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.
  • Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program.
  • Funds for the PD(s)/PI(s) to travel to annual NIEHS Training Directors recipient meetings in Research Triangle Park, NC should be included in the budget request.
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.

The Research Education Program description should include the educational and/or career level(s) of the planned participants. The number of participant positions requested by an institution should be in balance with the overall strength of the institution’s undergraduate program and the research base of environmental health science research projects.

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.

PD/PI should be an established investigator in the environmental health sciences with current NIEHS grant support. In order to facilitate collaboration and information sharing among individuals funded under this NOFO, the PD(s)/PI(s) will be expected to participate in annual NIEHS Training Directors recipient meetings. Other personnel associated with the project may also participate. These meetings will be held at or near NIEHS, in Research Triangle Park, NC.

Program Faculty. Researchers from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, persons with disabilities, and women are encouraged to participate as program faculty. Faculty should have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles.

Program Participants. Applications must describe the intended participants, and the specific educational background characteristics that are essential for participation in the proposed research education program. Identify the career level(s) for which the proposed program is planned. Describe the selection process and criteria (e.g. who will be on the selection committee; their experience evaluating such applications). Applications must include a description of the potential applicant pool based on the selection criteria established for the proposed 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.

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.

Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.

Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

Underrepresented Populations in the U.S. Biomedical, Clinical, Behavioral and Social Sciences Research Enterprise

In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral and social sciences, such as:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27) and the report Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be demonstrated convincingly to be underrepresented by the recipient institution should be encouraged to participate in NIH programs to enhance diversity. For more information on racial and ethnic categories and definitions, see the OMB Revisions to the Standards for Classification of Federal Data on Race and Ethnicity (https://www.govinfo.gov/content/pkg/FR-1997-10-30/html/97-28653.htm).

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended. See NSF data at, https://www.nsf.gov/statistics/2017/nsf17310/static/data/tab7-5.pdf.

C. Individuals from disadvantaged backgrounds, defined as those who meet two or more of the following criteria:

  1. Were or currently are homeless, as defined by the McKinney-Vento Homeless Assistance Act (Definition: https://nche.ed.gov/mckinney-vento/);
  2. Were or currently are in the foster care system, as defined by the Administration for Children and Families (Definition: https://www.acf.hhs.gov/cb/focus-areas/foster-care);
  3. Were eligible for the Federal Free and Reduced Lunch Program for two or more years (Definition: https://www.fns.usda.gov/school-meals/income-eligibility-guidelines);
  4. Have/had no parents or legal guardians who completed a bachelor’s degree (see https://nces.ed.gov/pubs2018/2018009.pdf);
  5. Were or currently are eligible for Federal Pell grants (Definition: https://www2.ed.gov/programs/fpg/eligibility.html);
  6. Received support from the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) as a parent or child (Definition: https://www.fns.usda.gov/wic/wic-eligibility-requirements).
  7. Grew up in one of the following areas: a) a U.S. rural area, as designated by the Health Resources and Services Administration (HRSA) Rural Health Grants Eligibility Analyzer (https://data.hrsa.gov/tools/rural-health), or b) a Centers for Medicare and Medicaid Services-designated Low-Income and Health Professional Shortage Areas (qualifying zipcodes are included in the file). Only one of the two possibilities in #7 can be used as a criterion for the disadvantaged background definition.

Students from low socioeconomic (SES) status backgrounds have been shown to obtain bachelor’s and advanced degrees at significantly lower rates than students from middle and high SES groups (see https://nces.ed.gov/programs/coe/indicator_tva.asp), and are subsequently less likely to be represented in biomedical research. For background see Department of Education data at, https://nces.ed.gov/; https://nces.ed.gov/programs/coe/indicator_tva.asp; https://www2.ed.gov/rschstat/research/pubs/advancing-diversity-inclusion.pdf.

D. Literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields. (See, e.g., From the NIH: A Systems Approach to Increasing the Diversity of Biomedical Research Workforce https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5008902/ ).


New and renewal applications must include a description of plans to enhance recruitment, including the strategies that will be used to enhance the recruitment of prospective participants from underrepresented groups and may wish to include data in support of past accomplishments.

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. 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 and/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 activities should include an assessment of the overall impact of the program on encouraging individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in environmental health. Applicants may find the NIEHS Evaluation Metrics Manual to provide helpful assistance in developing program metrics. See: https://www.niehs.nih.gov/research/supported/assets/docs/a_c/complete_peph_evaluation_metrics_manual_508.pdf

Applications that lack an evaluation plan will not be reviewed.

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 "Institutional Environment and Commitment" above)

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 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 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 How to Apply - 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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following:

The goal of this NIEHS Undergraduate Research Education Program (UP) in the Environmental Health Sciences (R25) program is to support research 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 environmental health.

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.

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?

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?

Specific for this NOFO: Is the PD/PI an established investigator in the environmental health sciences? Will the PD/PI have current NIEHS grant support at the time of the award?

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?

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?

Specific for this NOFO: Does the proposed program demonstrate how its implementation will provide students with research education opportunities that will develop both their research capabilities and their interest in pursuing a career in research in NIEHS mission areas?

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?

Specific for this NOFO: Are the size and breadth of the research grant base in the environmental health sciences sufficient to support the number of planned undergraduate participants, with a special emphasis on NIEHS-supported grants? Does the application demonstrate the likely availability of well-qualified students to participate in the research project? Does the application provide sufficient evidence that students have in the past or are likely to pursue careers in the biomedical or behavioral sciences?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals 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.

Training in Methods for Enhancing Reproducibility

Does the Instruction in Methods for Enhancing Reproducibility plan describe how participants 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 participant development and in a variety of formats and contexts? Does the teaching synergize with elements of the curriculum designed to enhance participants' abilities to conduct responsible research? Is there evidence that all program faculty reiterate and augment key elements of methods for enhancing reproducibility when participants are performing mentored research in their laboratories?

Resubmissions

Not Applicable.

Revisions

Not Applicable.

Renewals

For Renewals, the committee will consider the progress made in the last funding period. Does the application describe the program’s accomplishments over the past funding period(s)? Is the program achieving its educational objectives? Has the program evaluated the quality and effectiveness of the experience and is there evidence that the evaluation outcomes and feedback from particpants have been acted upon? Are changes proposed that are likely to improve or strengthen the research education experience during the next project period?

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.

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 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.

Applications from Foreign Organizations

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.

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 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.

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIEHS, 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 NOFO.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Environmental Health Sciences Council. 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: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website.

HHS recognizes that NIH 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.

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 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Data Management and Sharing

Consistent with the 2023 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

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 2 CFR 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreementsare 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 provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Other Reporting Requirements

  • 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 .
  • Recipients must submit the Data Tables 8D Undergraduate Training with the RPPR. In addition, recipients should provide a summary of participant information in Section G1 of the RPPR.
  • 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.
  • During the period of the award, recipients will be encouraged to enter participant information annually into CareerTrac, a database that NIEHS maintains to track the training history and accomplishments of participants over time. CareerTrac is intended to be a tool to enable NIH staff to evaluate the effectiveness and impact of its health research training programs and to help NIH in overall coordination of its various research training programs. In addition, CareerTrac can also be used by a PD(s)/PI(s) to conduct analyses and evaluate the effectiveness of their specific training program (e.g. reporting in Research Performance Progress Reports).The database will be made available to recipients after the award is made.
  • For those students who were enrolled in the UP program, the RPPR should include information about the duration of research education, whether those students finished the program in good standing, highlights of participants from any funded period (awards, research grants/fellowships, publications, career advancements, etc.) and their subsequent training and/or career activities.
  • A brief narrative description of the research project for each participant (current participants and those who completed participation in the previous budget period).

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 NIEHS expects to use the following evaluation measures:

For Research Experience and Mentoring Programs Involving the Following Groups:

Undergraduate Students:

  • Aggregate number 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 employment in a research or research-related field
  • Subsequent authorship of scientific publications in a STEM field
  • Subsequent participation, training and/or career in environmental health science research

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: 301-480-7075

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)

Michael C. Humble, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3272
Email: humble@niehs.nih.gov

Peer Review Contact(s)

Beverly W. Duncan, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3740
Email: beverly.duncan@nih.gov

Financial/Grants Management Contact(s)

Lisa A. Edwards
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3258
Fax: 301-480-2725
Email: archer@niehs.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.

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