Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Office of Research on Women’s Health (ORWH)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. ORWH may co-fund applications assigned to those Institutes/Centers.

National Institute on Aging (NIA)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute on Drug Abuse (NIDA)
National Institute on Minority Health and Health Disparities (NIMHD)
National Library of Medicine (NLM)
National Institute of Dental and Craniofacial Research (NIDCR)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers listed above.  ORWH and the following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research (OBSSR)
Office of AIDS Research (OAR)

Sexual & Gender Minority Research Office (SGMRO)

Funding Opportunity Title

Galvanizing Health Equity Through Novel and Diverse Educational Resources (GENDER) Research Education R25 (R25 Clinical Trial Not Allowed)

Activity Code

R25 Education Projects

Announcement Type

New

Related Notices

August 12, 2022 - Notice of the Participation of the National Institute of Dental and Craniofacial Research (NIDCR) in RFA-OD-22-015. See Notice NOT-DE-22-015.

August 4, 2022 - Notice of Correction for RFA-OD-22-015: Galvanizing Health Equity Through Novel and Diverse Educational Resources (GENDER) Research Education R25 (R25 Clinical Trial Not Allowed). See Notice NOT-OD-22-187

July 22, 2019 - Requirement for ORCID iDs for Individuals Supported by Research Training, Fellowship, Research Education, and Career Development Awards Beginning in FY 2020. See Notice NOT-OD-19-109

Funding Opportunity Announcement (FOA) Number

RFA-OD-22-015

Companion Funding Opportunity

None

Assistance Listing Number(s)

 93.313; 93.866; 93.846; 93.279; 93.307; 93.879; 93.310, 93.121

 

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 ORWH R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation’s diverse 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 and Curriculum or Methods Development.            

Key Dates
Posted Date

July 14, 2022

Open Date (Earliest Submission Date)

September 27, 2022

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

October 27, 2022 and June 27, 2023

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)

January 7, 2023 and September 7, 2023

All applications are due by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related 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.

Scientific Merit Review

March 2023 and November 2023

Advisory Council Review

May 2023 and January 2024

Earliest Start Date

July 2023 and April 2024

Expiration Date

September 8, 2023

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow 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 the 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 will not be reviewed


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 1. Overview Information
    Part 2. Full Text of the Announcement
    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information


    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 over-arching goal of this ORWH R25 program is to support educational activities that complement and/or enhance the training of a diverse workforce to meet the nation’s biomedical, behavioral and clinical research.  To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on:

    Courses for Skills Development: For example, advanced undergraduate courses in a specific discipline or research area, courses on clinical procedures or specialized research techniques, or community-based courses on topics of relevance to sex and/or gender and health. Specifically, this FOA aims to support courses that develop skills in multidimensional and intersectional health-related research and healthcare delivery. The format of the courses may involve a traditional in-person approach, online activities, a hybrid of both approaches, or other methods.   

    Curriculum or Methods Development: For example, undergraduate STEMM curricula focused on sex and gender in medicine, advanced curricula to improve biomedical, social and behavioral or clinical science education, or development of novel methods or instructional approaches such as graphic medicine. Proposed curricula or methods should have high potential to improve biomedical, social and behavioral, or clinical research education. Specifically, this FOA aims to support innovative curricula or methods at the undergraduate level or higher that integrate knowledge of sex and gender influences into health-related training or enhance understanding of sex and gender influences on health.

    Background

    Sex is a biological variable, “based on a cluster of anatomical and physiological traits (sex traits) which include external genitalia, secondary sex characteristics, gonads, chromosomes, and hormones.” (National Academies of Sciences, Engineering, and Medicine, 2022). Gender is a multidimensional psychosocial construct that integrates roles, behaviors, expressions, and identities of girls, women, boys, men, and gender-diverse people. Gender encompasses multiple domains: gender identity, gender roles, gender relations, and gender equity and inequity.

    Advancing Science for the Health of Women requires a well-trained, diverse, and robust workforce, which is the engine of scientific progress. As articulated in the 2019-2023 Trans-NIH Strategic Plan for Women’s Health Research, breakthroughs in women’s health research require intentional integration of sex and gender considerations into all NIH research, at every stage of the biomedical research continuum. A paradigm shift in women’s health research from inclusion of women to intentional integration of sex and gender will require development of new skills and innovative methodologies. This RFA is to support courses for skills development and the development of courses, curricula, or methods related to how health is influenced by sex, as a biological variable, and/or gender, as an identity, social, cultural, or structural variable.

    Existing data suggests that sex and gender are underexplored in medical school curricula (e.g., Song MM, Jones BG & Casanova RA, 2016; Jenkins MR et al, 2016; Thande NK et al, 2019; Rydberg A et al, 2021) and curricula for allied health professions (Stickley L et al, 2016).  Courses, curricula, and methods on sex and gender-based variables can help fill existing research gaps in research for many female-specific disorders and conditions (e.g., menopause), disorders or conditions that disproportionately affect women (e.g., osteoporosis or autoimmune disorders), or disorders of conditions that have different presentations or interventions in women than men (e.g., acute myocardial infarction).

    To enhance knowledge of sex and/or gender influences on health and disease among all scientists, clinicians, and other health professionals and accelerate the translation of that knowledge into practice, courses and curricula can target participant audiences at any career stage, including biomedical researchers; health care providers; undergraduate students; graduate students; medical, dental, veterinary, nursing, and other allied health professional students; postdoctoral scholars; and/or members of the lay community involved in the dissemination of health information.

    Awardee PD/PIs will be expected to attend an annual PD/PI meeting held by ORWH during the term of the award, with the purpose of allowing participating PD/PIs to share knowledge and insights into developing engaging and informative educational activities & presenting an overview of the activities they have developed, results of pilot testing, and plans for outreach and evaluation to the wider education community. 

    Courses:

    Courses supported by this FOA should develop, implement, evaluate, and disseminate education and training to advance health-related research on sex (as a biological variable); gender (as a social determinant of health); and/or the consideration of interactions between sex and gender. Courses that take an intersectional approach to explore how sex and gender interact with other identity categories (e.g., race, ethnicity, sexual orientation, and others) to create disparate outcomes for certain individuals, groups, and communities, are strongly encouraged.  Although courses can focus on a specific application (e.g., trauma informed care) or methodology (e.g. intersectional health research), applicants should also consider how that specific application can be of relevance to sex and gender research broadly.

    Applicants are expected to define and describe the learning objectives for courses, how the proposed course will advance understanding of sex or gender influences on health, and how knowledge gained by participants or enrollees will advance the field of women’s health. Applicants are expected to describe how impact will be measured, as priority will be given to innovative and highly impactful activities. Applicants should review relevant fields and clearly describe how proposed activities will fill gaps identified in training, skills, and/or methods for studying sex and gender influences on health and/or improve the health of women.

    Training courses can be of varying lengths (1 week to 16 weeks), but the duration of the training and the format (online, in-person, or some combination) must be justified based on the learning objectives. The development and implementation of fully or predominantly remote training programs is encouraged. Courses delivered primarily in-person are expected to include online adjuncts (lesson plans, readings, slide sets, etc.) that can be made broadly available to research, clinical, and community partners.  Courses that include in-person activities should describe contingency plans to offer such activities remotely in case in-person activities are not possible due to pandemic or other disaster situations beyond the control of the PD(s)/PI(s). In such situations, prior approval from the ORWH Program Officer will be required to offer the course remotely.

    Courses can be developed for integration into existing curricula or training programs at the grantee's institution; however, a clear dissemination plan for making course material accessible and available to researchers in the field should be described. The aim of this R25 program is for supported activities to benefit the fields of women’s health and sex- and gender-specific medicine, meaning that plans to sustain the course beyond the immediate participants and the end of the project period should be clearly described.  Supported courses will be made freely available, at no cost to the broader community, through the ORWH website.

    It is expected that courses may require up to two years to develop, test, refine, and improve prior to being deployed to the target participant audience.

    Curriculum or methods development:

    Curricula and methods development activities supported by this FOA should advance understanding of sex and/or gender influences on health, for example, intersectional methods and approaches for studying sex and/or gender. Activities can integrate knowledge of sex and gender influences into existing trainings or develop novel methods or curricula. Supported curricula will be made freely available, at no cost to the broader community, through the ORWH website; programs must be self-sustaining at the end of the award period.

    Applicants are expected to define and describe the goals and objectives of the proposed curriculum or methods development program, including a rationale for the activities and a clear description of how the activities will advance the field.

    It is expected that curricula and methods may require up to two years to develop, pilot, and disseminate prior to evaluation and refinement in subsequent years of the award. While proposed curricula or methods can be developed for use at the grantee institution, it is expected that they will also be readily adaptable by the larger research education community. To this end, activities will be made available to the extramural and academic communities via the ORWH website.

    Potential topics

    As sex and gender influence multiple domains of health, courses, curricula, and methods covering a broad range of topics are appropriate for this FOA, as long as sex, gender, or both is a primary domain of focus. Educational topics for courses and curricula or methods development that are of high interest to ORWH include, but are not limited to:

    Multidimensional and intersectional approaches:

    • Intersectional research methods in health research
    • Models of trauma-informed care (generally, or in specific settings)
    • Culturally competent OB/GYN health models for transgender men and gender diverse individuals
    • Gender- and gender-identity based violence (screening, interventions, prevention)
    • Female-specific conditions (e.g., fibroids, cervical cancer, endometriosis, ovarian cancer, PCOS)
    • Screening, diagnosis, prevention, and treatment of comorbidities in women
    • Multimorbidity in women
    • HIV and women, including HIV cure, prevention, and treatment
    • Social, environmental, and/or structural factors affecting the health of women
    • Multidimensional and intersectional research of sex and/or gender, geography and socioeconomic disparities in screening, prevention, diagnosis, interventions, management and comorbidities of COPD and cardiovascular disease
    • Enhancing understanding and uptake of sex and/or gender-specific policies & guidelines (Inclusion across the lifespan policy, NIH Sex as a Biological Variable Policy, SAGER Guidelines)

    Life course perspectives:

    • Women’s health in the transition from adolescence to adulthood
    • Women’s health in midlife
    • Aging, frailty, and menopause
    • Gender and psychological health
    • Cultural and ethical competency in clinical practice, education and research
    • Sex and gender-based asthma incidence, diagnosis, intervention and management during transition from childhood to adulthood and menopause
    • Sex and gender differences in detection, diagnosis, management, and treatment of Alzheimer’s disease and Alzheimer’s disease-related dementias (AD/ADRD), as well as outcomes related to AD/ADRD, including the incidence, prevalence, risk factors, health care utilization, caregiving for people living with AD/ADRD

    Innovative methodologies:

    • Data science and informatics to advance the health of women
    • Graphic medicine
    • Methodologies for studying gender inequity in health-related research
    • Transdisciplinary methodologies to advance the health of women
    • Factoring sex and/or gender into research design
    • Methods to evaluate structural sexism, gender norms, relational power dynamics, and gender inequities in health
    • Novel methodologies for studying sex and/or gender differences in rare heart, lung and blood diseases and sleep disorders  (e.g., pulmonary artery hypertension)
    • Community-focused, culturally-responsive education programs focusing on sex and/or gender differences of heart, lung and blood diseases and sleep disorders
    • Gender-transformative public health approaches

    Advocacy & community-based education:

    • Community-based, culturally-responsive women’s health education programs
    • Curricula for community-based birth workers and/or full spectrum doulas
    • Capacity-building for the next generation of women’s health advocates
    • Community-based participatory research
    • Reporting and communicating sex- and/or gender-related science
    • Community-focused training curricula on conditions with differential gender effects (e.g., HIV; substance use disorder)
    • Community-engaged research

    Other topics in alignment with the Trans-NIH Strategic Plan for Women's Health Research (https://orwh.od.nih.gov/about/trans-nih-strategic-plan-womens-health-research)

    The NIH encourages all programs to foster the participation of individuals from backgrounds underrepresented in biomedical and behavioral research, including individuals from underrepresented racial and ethnic groups, individuals with disabilities, and persons from disadvantaged backgrounds. See, Notice of NIH's Interest in Diversity, NOT-OD-20-031.  Therefore, all applicants are strongly encouraged to involve a diverse group of faculty and mentors, and their applications must include a Recruitment Plan to Enhance Diversity. In addition, applicants are strongly encouraged to consider and describe how the methodologies and approaches being taught in the proposed course can be reliably and validly applied across diverse groups, including gender-diverse individuals, as well as how to address potential structural influences and/or consequences for communities/subpopulations that are disproportionally impacted by disease burden.

    Projects must include evaluation of the activities proposed and projects must disseminate user-friendly course materials to the broader scientific community. (See Section IV, Evaluation Plan and Dissemination Plan).

     

    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)

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

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

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

    ORWH intends to commit approximately $600,000 in FY2023 and $600,000 in FY2024 to fund 3 awards per receipt date.

    Award Budget

    Application budgets are limited to $150,000 in direct costs per year 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 4 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 compensated for participation in activities specifically required by the proposed research education program if sufficiently justified. Participant costs must be itemized in the proposed budget

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

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

    Expenses for foreign travel must be exceptionally well justified.

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

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

    Other Program-Related Expenses

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

    Indirect Costs

    Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, expenditures for equipment, and consortium costs in excess of $25,000), rather than on the basis of a negotiated rate agreement.

     

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Higher Education Institutions

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

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

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

    Nonprofits Other Than Institutions of Higher Education

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

    For-Profit Organizations

    Small Businesses

    For-Profit Organizations (Other than Small Businesses)

    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)
    • Eligible Agencies of the Federal Government
    • U.S. Territory or Possession

    Other

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

    The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

    Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other Federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving federal support. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.

    Foreign Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
    Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
    Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

    Required Registrations

    Applicant Organizations

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

    • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
      • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
      • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process.  SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
    • eRA Commons - Once the unique organization identifier (UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

    Eligible Individuals (Program Director/Principal Investigator)

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

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

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

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

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

    Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as 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.

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

    Letter of Intent

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

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

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

    The letter of intent should be sent to:

    Elizabeth Barr, Ph.D.
    Office of Research on Women's Health (ORWH)
    Telephone: 301-402-7895
    Email: elizabeth.barr@nih.gov

    Page Limitations

    All page limitations described in the SF424 (R&R) 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 Component

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

    Research Strategy

    The Research Strategy section must be used to upload the Research Education Program Plan, which must include the following components described below:

    • Proposed Research Education Program
    • Program Director/Principal Investigator
    • Program Faculty
    • Program Participants
    • 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.             

     

    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 identify the career levels  for which the proposed program is planned.        

     

    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 diverse backgrounds, e.g., those from groups described in the Notice of NIH's Interest in Diversity.  Describe the specific efforts to be undertaken by the program and how the proposed plan reflects past experiences in recruiting individuals from underrepresented groups. 

    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.  

     
    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 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.

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

    Letters of Support

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

    Resource Sharing Plans

    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 Assignment Request Form

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

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

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

    4. Submission Dates and Times

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


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


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

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

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

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

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

    7. Other Submission Requirements and Information

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

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

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

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

    The applicant organization must ensure that the unique entity identifier  provided on the application is the same number 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 components of participating organizations, 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 complement and/or enhance the training of a workforce to meet the nation’s diverse biomedical, behavioral and clinical research needs.

    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.

    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? Is the program poised to achieve provide measurable progress in understanding of sex and/or gender influences on health? 

    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?  

    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?

    Will the proposed program contribute to culture or paradigm shift that will benefit women's health research?

    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? 

    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?  

    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.

    Evaluation Plan

    Is the evaluation plan appropriate for the project goals? Are mechanisms in place participants to provide feedback to help identify weaknesses and to provide suggestions for improvements?

    Dissemination Plan

    Does the application describe a national dissemination plan, appropriate for the project goals? Is there evidence that the dissemination plan is feasible?

    Protections for Human Subjects

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

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

    Inclusion of Women, Minorities, and Individuals Across the Lifespan 

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

     

    Vertebrate Animals

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

    Biohazards

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

    Resubmissions

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

    Renewals

    Not applicable

    Revisions

    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.

    Recruitment Plan to Enhance Diversity

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

    Training in the Responsible Conduct of Research

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

    Applications from Foreign Organizations

    Not applicable.

    Select Agent Research

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

    Resource Sharing Plans

    Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan. If support for development, maintenance, or enhancement of software is requested in the application, the reviewers will comment on the proposed software dissemination plan.

    Budget and Period of Support

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

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, 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 on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NLM Advisory 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 recipient’s business official.

    Recipients must comply with any funding restrictions described in Section IV.5. 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, Recipients, and Activities, including of note, but not limited to:

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

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

     

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

    Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.   

    In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

    3. Reporting

    When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted. Programs that involve participants should report on education in the responsible conduct of research and complete a Trainee Diversity Report, in accordance with the RPPR Instruction Guide.  

     NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR 200.301.

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

    Failure by the recipient institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

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

    Other Reporting Requirements
    • The institution must submit a completed Statement of Appointment (PHS Form 2271) for each participant appointed full time for eight weeks or more or the equivalent. Recipients must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
    • Participant Termination Notice: Within 30 days of the end of the total support period for each participant, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each participant appointed full time for eight weeks or more, or the equivalent.

    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 ORWH expects to use the following evaluation measures:

    For Courses for Skills Development:

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

    For Programs Focusing on Curriculum or Methods Development:

    • Aggregate number and demographic characteristics of participants exposed to the new curricula or methods
    • General educational level of participants
    • Effectiveness of the new curricula or methods assessed by skills/competencies gained compared to existing curricula or methods
    • Dissemination and/or adoption of the new curricula or methods

     

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

    General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-637-3015

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    Elizabeth Barr, Ph.D.
    Office of Research on Women's Health (ORWH)
    Telephone: 301-402-7895
    E-mail: elizabeth.barr@nih.gov

    NIA Training Office
    National Institute on Aging (NIA)
    E-mail: NIATraining@mail.nih.gov

    Xincheng Zheng (Ted), M.D, Ph.D.
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
    Telephone: (301) 594-4953
    E-mail: zhengx4@mail.nih.gov

    Sunila Gopi Nair
    National Institute on Drug Abuse (NIDA)
    Telephone: 301-827-6832
    E-mail: sunila.nair@nih.gov

    Deborah G. Duran, PhD
    National Institute on Minority Health and Health Disparities (NIMHD)
    Telephone: 301-594-9809
    E-mail: durande@mail.nih.gov

    Leslie Marshall, Ph.D.
    Office of AIDS Research
    Telephone: (301) 402-1839
    E-Mail: leslie.marshall@nih.gov

    Christopher Barnhart, PhD
    Sexual & Gender Minority Research Office (SGMRO)
    Telephone: 301-594-8983
    E-mail: christopher.barnhart@nih.gov  

    Anissa Brown, PhD
    National Institute of Dental and Craniofacial Research
    Telephone: (301) 594-4805
    Email: anissa.brown@nih.gov

    Peer Review Contact(s)

    Elaine Sierra-Rivera, PhD
    Center for Scientific Review (CSR)
    Telephone: 301-435-1043
    Email: 
    riverase@csr.nih.gov

    Financial/Grants Management Contact(s)

    Samantha J Tempchin
    National Library of Medicine (NLM)
    Telephone: 301-496-4222
    E-mail: tempchins@mail.nih.gov

    E C Melvin
    National Institute on Aging (NIA)
    Telephone: (301) 594-3912
    E-mail: e.melvin@nih.gov

    Pamela G Fleming
    National Institute on Drug Abuse (NIDA)
    Telephone: 301-480-1159
    E-mail: pfleming@mail.nih.gov

    Priscilla Grant, JD
    National Institute on Minority Health and Health Disparities (NIMHD)
    Telephone: 301-594-8412
    E-mail: pg38h@nih.gov

    Diana Rutberg, MBA
    National Institute of Dental and Craniofacial Research (NIDCR)
    Telephone: 301-594-4798
    Email: rutbergd@mail.nih.gov

    Section VIII. Other Information

    Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

    Authority and Regulations

    Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.

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