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
NIEHS Research Intensive Short Courses and Educational Opportunities (NIEHS RISE) (R25 Clinical Trial Not Allowed)
Activity Code

R25 Education Projects

Announcement Type

New

Related Notices
None
Funding Opportunity Announcement (FOA) Number
RFA-ES-20-015
Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) 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 complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs.

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

  • Courses for Skills Development

The intent of this FOA is to encourage applications to develop and conduct short-term research education activities with the goal of improving knowledge and skills needed to conduct environmental health research. Short courses submitted under this FOA are expected to include relevant intensive hands-on training in environmental health science topics. In addition to in-person instruction, courses that incorporate innovative or novel education models, such as project-based learning or virtual instruction, are encouraged.

Key Dates

Posted Date
July 20, 2020
Open Date (Earliest Submission Date)
October 30, 2020
Letter of Intent Due Date(s)

30 days prior to application due date

Application Due Date(s)

November 30, 2020, November 29, 2021, November 28, 2022

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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March 2021, March 2022, March 2023

Advisory Council Review

May 2021, May 2022, May 2023

Earliest Start Date

July 2021, July 2022, July 2023

Expiration Date
November 29, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The NIH Research Education Program (R25) supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers. The overarching goals of the NIH R25 program are to: (1) complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs; (2) encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research; (3) help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences; and (4) foster a better understanding of biomedical, behavioral and clinical research and its implications.

The overarching goal of this R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs.

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

  • Courses for Skills Development: Immersive short courses with relevant hands-on educationalexperiences in advanced approaches and/or emerging topics in environmental health sciences. Examples include, but are not limited to, advanced courses in a specific discipline or research area, or specialized research methods, topics or techniques.

Background

The mission of NIEHS, as described in the NIEHS Strategic Plan 2018-2023 (https://www.niehs.nih.gov/about/strategicplan/index.cfm), is to discover how the environment affects people in order to promote healthier lives. NIEHS seeks to do this by supporting rigorous environmental health sciences research and the translation of environmental health science findings into knowledge that can inform individual and public health actions to improve outcomes. To accomplish this goal requires a highly qualified and diverse environmental health science workforce that has received training in cutting-edge tools, methods and approaches for scientific discovery. To adopt and adapt new methods and approaches, environmental health scientists need access to training and continuing educational opportunities throughout their career. Researchers need both theoretical training as well as hands-on training and practical experience working with new approaches or methods to successfully adopt or adapt new skills. In addition to the needs of researchers with a background in environmental health science, researchers who would like to incorporate environmental exposures in their research may face additional barriers in training due to the inherently interdisciplinary nature of the environmental health sciences and the need for training that specifically addresses the nuances of incorporating environmental exposures.

Receiving training in novel or advanced tools, methods and/or approaches can be challenging for many scientists, who may have limited time for, or access to formal training at their home institutions. Environmental health sciences encompasses a wide range of fields from basic mechanistic research and toxicology to public health, social sciences and epidemiology, which means that, at any given institution, there may be limited availability for specialized environmental health sciences training in advanced and/or novel topics. These challenges contribute to the limited current opportunities for environmental health scientists or those who would like to incorporate new methods or research strategies into their research programs to receive short-term formal hands-on education in environmental health, specific tools, methods using advanced and/or novel tools, as well as emerging or high/priority topics in environmental health sciences.

NIEHS RISE

This funding opportunity announcement (FOA) will support short courses for skills development that address advanced or novel approaches, methods, and/or emerging topics in environmental health sciences to facilitate the adoption and/or adaptation of these skills or concepts by researchers interested in environmental health sciences. Short courses should be directed at a national audience, with the intent of attracting a pool of participants drawn from a wide range of institutions differing in geography, size and mission. Courses supported by the NIEHS RISE program should include relevant hands-on and practical educational experiences related to the conduct of environmental health research. The methods and format for these courses may vary due to the content, however, it is expected that participants will leave the program with a strong, working knowledge of the subject matter.

Individual research educationawards funded through this program are intended to cover a range of topics, methods and approaches in environmental health sciences. Some topics and gap areas that could be addressed by these courses are:

  • Concepts and methods for studying emerging and/or high priority chemicals, classes of chemicals or mixtures (e.g., air pollution, endocrine disruptors)
  • Practical applications of new technologies and sensors for exposure assessment
  • Methods for studying gene x environment interactions by incorporating environmental exposures into studies using population-based model organisms
  • Advancing toxicology research through the use of organs-on-a-chip
  • Modernizing neurotoxicology by incorporating state-of-the art neuroscience methods
  • Application of qualitative methodologies and methods to environmental health science (e.g., ethnographic approaches to better understand the impact of environmental exposures on individuals and the communities in which they live)
  • Dissemination & Implementation (D&I) research in environmental health sciences (e.g., fidelity to and adaptation of environmental health interventions to mitigate exposures)

Short course engagement of diverse audiences

A secondary goal of this program is to increase opportunities for hands-on research educationand skills development in the environmental health sciences for researchers from a wide-range of fields, career stages and institutions. Each course should draw participants from a national audience of researchers interested in environmental health sciences, which includes researchers from across career stages and size and type of institutions, as well as those from diverse and underrepresented backgrounds. This will give researchers from institutions that do not have environmental health curricula or deep expertise access to training from experts in advanced approaches and methods. While the specific target audience may vary for each course, programs intended for a local, regional or career stage specific audiences are not appropriate for this FOA.

Short course format

The NIEHS RISE program will support recurring (e.g., one per year or more frequent) short courses of no less than a week and no more than a month that include hands-on in person research educationin novel and/or advanced approaches geared towards the environmental health sciences. In addition to the in-person component, courses are encouraged to utilize virtual and remote-learning tools as appropriate. Programs that propose shorter courses (e.g., bootcamps, workshops), curricula development or mentoring activities are not appropriate for this FOA. Moreover, this FOA is not intended to fund conferences or other workshops that were previously funded by, or are appropriate for support by, the R13/U13 mechanism.

In all components of the program, applicants are encouraged to incorporate best practices for science training and education. Modern pedagogy (e.g., project-based or experiential models) and educational tools (e.g., online lectures or networking), can help enhance the experience of students/participants and enable them to better apply their new skills to their research questions. Examples include, but are not limited to, using project-based learning to focus on appropriate study designs for a new technology, or reducing time spent in lectures by providing access to webinars prior to the in-person course. It is expected that the goal of the supported courses is to enable participants to return to their home institutions and begin to adopt what they have learned as part of the program into their research, such that researchers are more fully incorporating cutting-edge tools, methods, and approaches for environmental health sciences into their research projects.

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

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New
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.

Clinical Trial?

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

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIEHS intends to commit approximately $650,000 in FY 2021 to fund 3 awards.

Award Budget

Application budgets must reflect the actual needs of the proposed project, and are limited to $200,000 direct costs per year.

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).

Participant Costs

Participants may be paid if specifically required for the proposed research education program and sufficiently justified. Participant costs must be itemized in the proposed budget.

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

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

Expenses for foreign travel must be exceptionally well justified.

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

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

Other Program-Related Expenses

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

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 and expenditures for equipment), rather than on the basis of a negotiated rate agreement.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

  • 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)
  • 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 Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Required Registrations

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • 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.
  • 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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.

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.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

 

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. 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 NOT-OD-11-101)

 

Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as preceptors/mentors. Faculty should have research expertise and experience relevant to the proposed program. Faculty must be committed to continue their involvement throughout the total period of the participant's involvement in this award.

 

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

 

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:

Alfonso Latoni, Ph.D.
Telephone: 984-287-3279
Fax: 301-480-3704
Email: alfonso.latoni@nih.gov

Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information Component

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

Facilities & Other Resources. Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support.

Other Attachments.

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 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”.

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

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

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

R&R Budget

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

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

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

PHS 398 Research Plan

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

 

Research Strategy 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
 

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

The applications must provide a detailed description of the proposed research education program, including the stated goal of the short course, the relevance of the proposed course to the mission of NIEHS, and a justification for how this program addresses an unmet need in environmental health sciences training. The justification must describe the critical needs, missing from other offerings available to a national audience, that will be filled by this short course. Further, the application should justify the frequency of course offering and size of participant pool that would be expected to benefit from the course. The methodology of instruction and hands-on activities that will provide an in-depth and practical understanding of the approaches, methods, tools and techniques should be described. Any additional strategies or participant engagement that will be integrated, such as online coursework, refresher activities, or networking opportunities after participants return to their home institutions should also be described. This description should include timelines and durations of 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.

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.

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. Identify the career levels for which the proposed program is planned. Applications should describe how the educational activities will enhance the research capabilities of the participants. Applications should also describe the recruitment and selection process by which a national and diverse cohort of participants will be chosen.

Institutional Environment and Commitment. Describe the institutional environment, reiterating the availability of facilities and educational resources (described separately under “Facilities & Other Resources”), that can contribute to the planned Research Education Program. Evidence of institutional commitment to the research educational program is required. A letter of institutional commitment must be attached as part of Letters of Support (see below). Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.

Recruitment Plan to Enhance Diversity  (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 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 grantee institution should be encouraged to participate in this program. 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/).

Women have been shown to be underrepresented in doctorate-granting research institutions at senior faculty levels in most biomedical-relevant disciplines, and may also be underrepresented at other faculty levels in some scientific disciplines (See data from the National Science Foundation National Center for Science and Engineering Statistics: Women, Minorities, and Persons with Disabilities in Science and Engineering, special report available at https://www.nsf.gov/statistics/2017/nsf17310/, especially Table 9-23, describing science, engineering, and health doctorate holders employed in universities and 4-year colleges, by broad occupation, sex, years since doctorate, and faculty rank).

 Upon review of NSF data, and scientific discipline or field related data, NIH encourages institutions to consider women for faculty-level, diversity-targeted programs to address faculty recruitment, appointment, retention or advancement.

New 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 backgrounds and may wish to include data in support of past accomplishments.

Renewal applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period, including successful and unsuccessful recruitment strategies. Information should be included on how the proposed plan reflects the program’s past experiences in recruiting individuals from underrepresented groups.

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

Applications lacking a 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.

Applicants are encouraged to view the NIEHS Partnerships for Environmental Public Health (PEPH) Evaluation Metrics Manual which provides approaches to measure and document program success and to build a common evaluation language that grantees and program staff can use when discussing programs. For more information about the PEPH Metrics Manual, please see: https://www.niehs.nih.gov/pephmetrics.

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.

 

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

 

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.

 

Only limited Appendix materials are allowed. Follow the instructions for the Appendix as described in the SF424 (R&R) Application Guide.

 

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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 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. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following:

The goal of this R25 program is to support educational activities that center on intensive hands-on short courses to provide participants with knowledge and skills in emerging and/or advanced topics and approaches for environmental health sciences research.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to strongly advance research education by fulfilling the goal of this R25 Education Program, in consideration of the following review criteria and additional review criteria, as applicable for the project proposed.

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

 

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

Will participants in this education program acquire knowledge, skills, and experience in topics associated with advanced approaches, methods and techniques in environmental health sciences and/or emerging or high priority environmental chemicals that can be applied to current and future research projects? Will the unique educational opportunity in emerging issues expand and complement existing educational programs in environmental health sciences?

 

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 an established expert in a relevant area of environmental health sciences or specific approach, method or technique? If the PD/PI is not an established investigator in the scientific area proposed, are there program directors who will provide outstanding scientific leadership and a plan for how the scientific and administrative leadership will collaborate for a successful program?

 

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

Does the proposed short course create an innovative approach and/or unique educational opportunity to gain mastery of a research area or set of skills? Are the proposed concepts, approaches, methodologies, tools, or technologies novel for relevant areas of environmental health sciences? Adaptations of existing research education programs may be considered innovative under special circumstances, e.g., the addition of unique components.

 

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?

Is the primary focus of the proposed short course on intensive, hands-on activities that will provide an in depth and practical understanding of techniques and analytic approaches, and expertise? Will these hands-on activities, together with integrated, didactic and discussion-based activities, provide participants with a mastery of the focused research area, subject matter and relevant experimental design? Does the applicant provide a comprehensive description of the skills development, course objectives, course descriptions, course content, hands-on-education activities, and a timeline for implementation? Are the approach and criteria for participant selection likely to produce a cohort that is well-qualified and diverse with respect to gender, individuals from nationally underrepresented groups, geography and home institutions? Is the proposed plan for evaluation likely to provide valuable information for evolution and improvement of the program?

 

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

Are the institutional support, equipment and other physical resources available to the participants adequate for the development and implementation of quality hands-on-educational activities ?

Additional Review Criteria

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

 

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the  categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

 

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

 

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

 

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

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

 

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

 

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

 

Not Applicable

 

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

 

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.

 

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:

  • 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.
  • Will receive a written critique.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National 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 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 grantee’s business official.

Awardees 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.

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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.

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 “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, awardees 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.

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 awardees 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 $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Failure by the grantee 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 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, 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 – Award Term and Conditions for Recipient Integrity and Performance Matters.

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 NIEHS expects to use the following evaluation measures:

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

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)

Amanda E. Garton, Sc.M., M.S.P.P.

National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3260
Email: amanda.garton@nih.gov

Peer Review Contact(s)

Alfronso Latoni, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3279
Email: alfonso.latoni@nih.gov

Financial/Grants Management Contact(s)

James R. Williams
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3338
Email: james.williams3@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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