Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Minority Health and Health Disparities (NIMHD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of Nursing Research (NINR)

Funding Opportunity Title
Clinical Research Education and Career Development (CRECD) Program (R25-Independent Clinical Trial Not Allowed)
Activity Code

R25 Education Projects

Announcement Type
Reissue of PAR-16-350
Related Notices

October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available. See Notice NOT-OD-22-018.

September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice NOT-OD-21-181.

August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022. See Notice NOT-OD-21-169.

August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170

April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-OD-21-109

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
PAR-21-347
Companion Funding Opportunity
None
Number of Applications

Only one application per institution is allowed. See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.307, 93.361, 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 R25 program is to support educational activities that encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research 

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

  • Research Experiences
  • Courses for Skills Development

Key Dates

Posted Date
October 19, 2021
Open Date (Earliest Submission Date)
November 15, 2021
Letter of Intent Due Date(s)

November 15, 2021

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
December 15, 2021 December 15, 2021 Not Applicable March 2022 May 2022 July 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.

Expiration Date
December 16, 2021
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 encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research.

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

  • Courses for Skills Development: CRECD awards will support implementation of and participation in courses/curricula to enhance knowledge in how to design, plan and operationalize clinical research with a focus on the science of minority health and health disparities. The goal of the program is for postdoctoral clinically trained health professionals to develop clinical epidemiological research skills and to promote the development of trained and independent clinical researchers who can conduct clinical research activities in areas that are in accordance with NIMHD’s mission in addressing health disparities among underserved populations. . Such courses may include methodological courses with an emphasis on epidemiological research methods, biostatistics, and clinical research. Additional courses may include clinical research ethics, principles of community-engaged research, qualitative methods, methods in data science, and other courses needed to prepare participants to conduct health disparities research in clinical settings.
  • Research Experiences: To help develop a diverse cadre of clinical and translational scientists interested in pursuing careers in clinical and/or population health research, particularly on diseases and conditions that disproportionately impact populations that experience health disparities. CRECD awards will provide research and related experiences not available through formal NIH training mechanisms for postdoctoral-level medical, dental, nursing, and other clinical or mental health fellows and clinical early stage investigators (ESIs, see https://grants.nih.gov/policy/early-investigators/index.htm) who are part of the translational, patient-oriented and/or population health research workforce.

Background

NIH is committed to increasing and sustaining the diversity of the biomedical research workforce. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. 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.

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 researchers, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

Despite tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. This program is to support educational activities that enhance the diversity of the clinical research workforce with an emphasis on clinical, behavioral and population sciences. This program encourages institutions to diversify their student and faculty populations and thus to enhance the participation of individuals currently underrepresented in the clinical and behavioral sciences research enterprise, as described in NOT-OD-20-031.

NIMHD Interest in Diversity

The NIMHD’s mission is to conduct and support research, training, health information dissemination, and other programs with respect to minority health and health disparities. This funding opportunity seeks to facilitate the education of participants from diverse backgrounds, including those underrepresented in biomedical research to pursue clinical research, translational and/or patient-oriented research, particularly on diseases that disproportionately impact populations that experience health disparities https://www.nimhd.nih.gov/about/overview/.

By increasing the number of participants from underrepresented groups pursuing advanced education in clinical research, NIMHD strives to ensure that the future generation of minority health and health disparities researchers draws from the entire pool of talented individuals, bringing different aptitudes, perspectives, creativity, and experiences to address complex scientific problems.

Need for the Program

There is a critical need for trained clinical researchers in several health areas that disproportionately affect health disparities and underserved populations. Published reports from the Association of American Medical Colleges (AAMC), the National Academies of Sciences, the American Federation For Medical Research, the National Science Foundation (NSF) and others provide evidence that there is a need to replenish and diversify the U.S. workforce, especially the clinical research community, whose small numbers are insufficient to meet the increasing needs for clinical research (see Ginther et al., http://science.sciencemag.org/content/333/6045/1015.full and https://ncses.nsf.gov/pubs/nsf19304/, https://www.aamc.org/data-reports).

NIMHD recognizes this need and realizes that it can be overcome through the development of programs dedicated to education and training to enhance knowledge and skills in the conduct of clinical and translational research in institutions whose historical mission is educating and training individuals from groups underrepresented in the biomedical sciences. As a result, those institutions would greatly enhance their potential to contribute to research advances that are necessary to reduce disparities in health and disease and promote health equity, experienced by members of diverse underserved communities.

Purpose/Objectives:

The purpose of the Clinical Research Education and Career Development (CRECD) Program is to expand the national capability to improve diversity of the research workforce in the health sciences by developing education and research experiences in clinical, behavioral and population sciences through providing grant support to low resourced institutions whose historical mission is educating and training individuals from groups underrepresented in the biomedical sciences that offer doctorate or professional degrees in the health professions or in a health-related science. These institutions historically have educated and trained professionals from diverse backgrounds who provide health care to health disparities populations and are uniquely positioned to engage these populations in research and in the translation of research advances into culturally appropriate, measurable, and sustained improvements in health outcomes.

The primary goals of the CRECD program are to (1) support courses for skill development to educate postdoctoral participants in clinical research and develop clinical research skills; and (2) support research experiences to develop a group of clinical researchers who have the necessary knowledge and skills to pursue clinical research and can become part of translational, population health and/or patient-oriented research, particularly on diseases that disproportionately impact minority and health disparity populations.

The CRECD award's project period is up to five years consisting of two components : (1) Component I to establish or improve existing courses incorporating a focus on minority health, health disparities and methodological courses with an emphasis on epidemiological research methods, biostatistics, and clinical research and offer structured didactic program and short term mentored research project to enhance participants research skills and to promote the development of trained and independent clinical researchers who can conduct clinical research activities ; (2) Component II to provide mentored research experiences through pilot research projects for participants that completed the CRECD Component I program and other adequately trained early career scientists to conduct clinical research in minority health and health disparities. The goal is to provide mentoring in research skill development to scholars to become independent clinical, behavioral and population health investigators. During Component II, participants are strongly encouraged to submit applications for K08, K23 and/or R series awards. The goal is to promote the development of trained and independent clinical researchers who can conduct clinical research activities in areas that are in accordance with NIMHD’s mission in addressing health disparities among underserved Americans.

The Program Director/Principal Investigator (PD/PI) leads a multi-disciplinary CRECD Advisory Committee (CAC) to design, develop, implement and evaluate the progress of Component I participants and the CRECD participants who are continuing through Component II of the clinical research education and mentored research experience. Evaluation of the program will include tracking the participants' career trajectories with a focus on their research productivity, the retention of the participants at the institution, and the impact of the program at the institutional level toward inclusive excellence.

Component I: Didactic program courses and short-term research experiences for skills development in clinical research

  • Component I will allow selected participants who are postdoctoral candidates, junior faculty, clinical or research fellows, and those with health professional doctoral degrees in clinical research areas such as medical, dental, nursing, pharmacy and other health professions, to complete requirements including course work and a short-term research experience. These didactic courses can be part of an existing Master’s degree program at the institute, however obtaining a degree is not a requirement for this component.
  • The program must include multi-disciplinary, didactic course work and collaborative clinical and/or translational research experiences for participants to enhance their research skills.
  • The program must include curricula/courses for rigorous research methods that emphasize the science of minority health and health disparities. These courses may include methodological courses such as epidemiological research methods, principles of community engaged research, qualitative methods, statistics, methods in data science, and other courses needed to prepare participants to conduct health disparities research in clinical settings.
  • The course work will include topics on how to address and navigate barriers and challenges, balancing clinical and research careers for participants.

Component II: Mentored clinical research experiences

  • To further develop scholars who will pursue careers as independent clinical research scientists, Component II will provide funds to support a mentored clinical/translational research experience through pilot research projects. This additional research experience should allow the participant to continue working toward establishing his/her own independent research program as a clinical research scientist leading to applications for individual mentored career development (K) or research grant (R series) awards from NIH.
  • To support the development of post-doctoral fellows, junior faculty, and other early stage investigators in clinical sciences through a Pilot Project Program throughout the CRECD award period.
  • Component II will provide competitive funding to solicit, review and select pilot projects for scholars who have completed their research training or Component I of the program.
  • The participants should propose a research project in an area(s) that is in accordance with the research interests of the NIMHD. Each participant should be assigned at least one lead mentor from the Project Faculty. Institutions can set aside funds for a competitive application process for research projects for Component II scholars. Projects should be designed for appropriate research scope with direct costs up to $75,000 per year.
  • Applicants are encouraged to provide plans for how each research pilot project application will be solicited, reviewed, scored and recommended by the CRECD Project leadership, institutional CAC and the PD/PI. It is expected that participants who completed the research educational activities are eligible to apply for these projects.
  • For programs with already established courses, Component I participants are eligible to participate in Component II of the award if they have acquired the minimum set of courses and necessary skills in Component I to conduct research.
  • The participant, mentor(s) and the PD/PI will be responsible for all aspects of the program, including monitoring progress of scholars and reporting them annually.

Evaluation of the program with set metrics is encouraged to monitor progress, track participants' career trajectories, how the research education program and mentored research project funding support influences future research careers, hiring of participants at the institution after the program support and the impact of the program on the institutional inclusive environment and research capacity.

Research Scope:

CRECD applications are intended to reflect the plans and priorities of the participating NIH Institutes and Centers as well as the clinical research education program available to participants and how it relates to one or more of the areas of interest.

NIMHD Specific Research Areas

The National Institute on Minority Health and Health Disparities (NIMHD) supports research on the many aspects of minority health and health disparities—— from biological and population sciences to clinical, behavioral, and translational research, as well as research on health care services, health systems and workforce development. NIMHD focuses on the full continuum of causes of health disparities and the interventions to address these causes. Projects must include a focus on one or more of the following NIH-designated populations that experience health disparities in the United States: African Americans, Latinos/Hispanics, American Indians and Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, low socioeconomic status, underserved rural populations, and sexual and gender minorities (SGMs). Comparison groups/populations may also be included as appropriate for the research questions posed. NIMHD encourages projects that use approaches encompassing multiple domains of influence (e.g., biological, behavioral, sociocultural, environmental, physical environment, health system) and multiple levels of influence (e.g., individual, interpersonal, family, peer group, community, societal) to understand and address health disparities (see the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html, for more information).

NIMHD also encourages to use standardized measures for conducting health disparities research such as the Phenx tool kit. Projects are expected to incorporate research strategies to address individual and structural social determinants of health (SDOH) (See: PhenX SDOH toolkit: https://www.phenxtoolkit.org/collections/view/6)

Applicants are encouraged to use research methods that are appropriate for proposed intervention research. Additional information on research method resources are available at https://researchmethodsresources.nih.gov/. The Research Methods Resources website provides investigators with important research methods resources to help them satisfy the NIH's clinical research requirements for trials.

NIDCR Specific Research Areas

A goal of the NIDCR is to enhance the quantity, quality, and impact of clinical research performed by oral health disparities researchers to meet the nation’s oral health needs. To achieve this goal, the NIDCR is interested in supporting research training and career development of a diverse biomedical, clinical, and behavioral research workforce committed to reducing and eliminating disparities in dental, oral, and craniofacial diseases (DOC) and in promoting oral health equity. For the CRECD program, the NIDCR is interested in supporting postdoctoral and junior faculty candidates who: 1) enroll in didactic courses that align with or augment existing institutional advanced degree programs, such as a ,
Master in Epidemiology or in Clinical Investigation, and 2) pursue research experiences focused on reducing and eliminating oral health disparities and inequities in underserved populations disproportionately affected by DOC conditions.

NINR Specific Research Areas

The National Institute of Nursing Research (NINR) supports research that builds the scientific foundation for nursing practice and policy across clinical and community settings, and advances the prevention, detection, and management of disease and disability. Drawing on nursing’s holistic perspective, NINR funds observational, intervention, and translational research that integrates factors at multiple levels to identify their role in health, health improvement and health inequities in the many settings where nurses practice, including homes, schools, clinics, workplaces, and criminal justice settings. NINR encourages research to improve the health of individuals, families, and populations, translating science in order to maximize the impact of findings on practice and policy. Potential applicants are encouraged to discuss their research plans with the Program Staff in relevant areas.

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

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New
Renewal

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.

Award Budget

The maximum budget is $500,000 in direct costs per year. The application budget needs to reflect the actual needs of the proposed project.

Award 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).

The Program Directors/Principal Investigators may request salary support for leadership, management, coordination, and evaluation of the CRECD program, in accordance with the effort commitment. This commitment should be at least a 2.4 person months or twenty percent effort (combined for PDs/PIs on Multi-PD/PI applications). Faculty critical to the design, development, implementation, and refinement of the specialized courses essential to the didactic needs of the CRECD program may be provided salary support in accordance with the proposed level of effort.

In general, for CRECD Advisory Committee members, it is assumed that these activities are within the normal scope expected of academic faculty and are supported by the applicant institution.

Typically, there will be one Lead Mentor per participant. While mentors may not receive salary compensation from the grant, moderate expenses associated with the mentor’s laboratory or didactic activities that are directly attributable to the CRECD program may be charged to the grant.

Limited administrative and clerical salary costs associated distinctly with the CRECD program that are not normally provided by the applicant organization may be direct charges to the grant only when specifically identified and justified.

Funds up to 5% of direct costs may also be requested for evaluation of the CRECD program.

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.

Allowable costs for Component I participants:

Participants can be provided up to $50,000 in direct costs per year per participant for the following types of expenditures: (a) tuition remission and fees related to courses, (b) travel to research meetings and (c) research expenses, such as supplies, technical personnel, statistical services and computer time. Costs must be specifically documented for each individual participant and must be directly related to the participant's educational and research activities.

Salary support can be determined on an individual basis for conducting research. The recipient institution may supplement the NIH contribution to an appointee's salary up to a level that is consistent with the institution's salary scale.

Allowable costs for Component II participants:

Participants can be provided up to $75,000 in direct costs per year per participant, including a research support allowance and salary and fringe benefits for conducting mentored clinical and/or patient-oriented research through pilot projects and other activities related to the development of a successful research career. During Component II, participants are strongly encouraged to submit applications for K08, K23 and/or R series awards.

Travel funds may be requested for the PD/PI and participants to attend an annual CRECD grantee meeting in Bethesda, Maryland.

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)
  • To be eligible for this FOA, applicant institutions must be institutions in the United States or its territories which award doctorate degrees in the health professions or the sciences related to health and have a historical mission of educating and training individuals from groups that have been shown by the National Science Foundation (see http://www.nsf.gov/statistics/wmpd/) to be underrepresented in biomedical research enrolled in their graduate or professional programs.
  • The applicant institution must have received less than $10 million per year (total costs) in R01 grant support from the NIH averaged over the past three fiscal years.
  • Institutions must have a documented track record of recruiting, retaining, training, and graduating underrepresented students as defined by NSF (see above), which has resulted in the demonstrable outcome of increasing the institution's contribution to the national pool of graduates from underrepresented backgrounds who pursue biomedical research careers.

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.

  • 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

Number of Applications

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

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

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review.

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

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

CRECD participants are those who will receive support in the form of salaries/wages, tuition remission or fee s related to coursework, research expenses and/or travel to scientific meetings. Participants must be citizens or noncitizen nationals of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship are available in the NIH Grants Policy Statement. The program can include as participants junior faculty and postdoctoral candidates who seek to combine their clinical doctorate degree with didactic elective research methodological courses for skill development to conduct minority health and health disparities research and who want to become independent clinical investigators. Relevant clinical doctorate degrees include: M.D., D.D.S., D.M.D., D.O., O.D., N.D. (Doctor of Naturopathy), Ph.D. with clinical responsibilities, or Pharm.D. Postdoctoral appointees may include junior faculty (those within seven years of their first faculty appointment). Those individuals with a Ph.D. in nursing, clinical psychology who want to become involved in clinical research also may participate.

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.

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:

Yujing Liu, PhD
Telephone: 301-827-7815
Email: liuyujin@mail.nih.gov

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

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

CRECD Advisory Committee:

Members of the CAC, which may include external advisors, must adequately represent the disciplines, departments, and schools. CAC members recommend the recruitment and selection of participants, the establishment and effectiveness of the courses, the approval of the education and research plans and interim and long-term monitoring and effectiveness of the CRECD program.

Provide a description of how the CAC will function in providing oversight of the CRECD program including evaluation of each participant's progress, including a determination of when a participant has successfully completed the program (for Component I, certification for elective courses ; and Component II, abstracts, publications and demonstration of the efforts to seek external grant support to become independent clinical investigators), with recommendations for changes in the plan and, if necessary, termination of a participant not making adequate progress; and monitoring of the overall effectiveness of the CRECD program.

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.

Key Personnel must include the PD/PI as well as any other key persons (such as those involved in the development, implementing, directing, monitoring, evaluating, etc., who are integral to the proposed research education program) participating in the research education program. Include the PD/PI, mentors and other faculty participating in the CRECD program. Include each individual's degree and departmental affiliation (or equivalent) and, if a consortium of institutions, each person’s institutional affiliation. Provide biographical sketches for the PD/PI, mentors, and other participating faculty.

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
  • Include any travel funds requested for senior/key persons and other personnel associated with the research education program.  Include funds requested for participants to attend an annual meeting in Bethesda, Maryland
  • For Participant Costs, include allowable categories of funds requested to support participants in the research education program.  If categories in addition to those listed in this section of the form are needed, describe in Other. State the number of Participants to be supported by the proposed research education program.
  • For the budget categories other than salary, specifically identify the requested costs under each budget category (e.g., supplies, travel) for each participant by name or position (if the position is to be filled).
PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy

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

  • Proposed Research Education Program
  • Program Director/Principal Investigator
  • Program Faculty
  • Program Participants
  • Institutional Environment and Commitment
  • Diversity Recruitment Plan
  • Plan for Instruction in the Responsible Conduct of Research
  • Evaluation Plan
  • Dissemination Plan

Research Education Program Plan

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

Provide a brief description of the following to address the anticipated value-added of the CRECD program to participating institutions.

Rationale that led to identification of areas selected for improvement at the participating institutions and for incorporating particular courses for skills development and research experiences into the proposed CRECD program relevant for conducting minority health and health disparities research.

Proposed Research Education Program:

  • Provide programmatic detail on the special activities proposed, e.g., courses, curricula, seminars, workshops.

For Component I (didactic courses for skill development in clinical research), the Education and Research Experience Plan must include:

  • the background, purpose and objectives of the CRECD program.
  • a description of the requirements that participants will complete a minimum set of elective courses that could be part of existing degree programs at the institution and or any certifcation of completion of the required didactic courses.
  • a description of the proposed courses that includes an explanation of how the courses for skill development are linked to the purpose and objectives of the CRECD program and to the research career development of participants; Describe how CRECD courses are innovative relative to other courses available at the institution(s) for conducting minority health and health disparities research.
  • description of curricula/courses for rigorous research methods that emphasizes the science of minority health and health disparities. These courses may include methodological courses such as epidemiological research methods (3 quarters), biostatistics (3 quarters), principles of community engaged research methods (1 quarter), qualitative methods, health disparities research, population health, and other elective courses (e.g., clinical trials, genetic epidemiology, health policy) needed to prepare participants to conduct health disparities research in clinical settings.
  • a description of other didactic opportunities utilizing any existing courses or curricula within the institution(s) and ways to verify completion of minimum set of courses through certification of completion.
  • a description of the research activity and experiences that will be offered by the mentors to the participants in the program.
  • a description of plans that provide examples of education and research experiences for participants that will prepare them to design, implement, and participate in multidisciplinary clinical research projects focused on minority health and health disparities.
  • plans for monitoring participants' progress.
  • a description of potential pool of diverse applicants for clincial research.

For mentored research Component II:

  • provide a description of the process for selection of the pilot projects for Component II participants, and mentors, requirements of mentors and their research plans, and mentoring and research experience activities.
  • Applicants should describe the plan to solicit and review proposals for Component II of the CRECD program, prioritize the pilot projects for funding and to review their methodology and research performance. The description of the Pilot Project Program for Component II scholars should include the scope; eligibility requirements; the limit on the dollars available and the length of support per pilot project; the solicitation, submission, review, and selection criteria and process; governance, oversight and evaluation procedures; and assurances that all pilot projects supported from this grant will comply fully with all applicable Federal policies, rules, and guidelines for research involving human subjects and vertebrate animals. Do not include pilot projects in your application but plans for implementing the program.
  • Provide a description of the process reviewers, CAC and the Project PIs will use for recommending the selection and evaluation of the pilot projects, participants for the mentored research education Component II through the CRECD award.

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.

Provide a description of the role of the PD/PI in providing scientific leadership, and administrative management and coordination of the CRECD program. S/he must be actively engaged in research and/or teaching in an area related to the goals of the CRECD program.

Provide evidence that appropriate level of effort will be devoted by the program leadership to ensure the program's objectives.

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.

Provide a description of the faculty research mentors, related to the conduct of clinical research in minority health and health disparities. Provide evidence of the availability and commitment of the faculty mentors for the duration of the proposed CRECD program.

Program Participants. Applications must identify the career levels for which the proposed program is planned.

Describe the criteria and procedures for identification, selection and retention of CRECD participants into the program. Provide description of recruiting strategies, the size and diversity of the participant pool expected, and any other institutional programs that might compete for this pool (include strategies for addressing this competition).

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.

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. Appropriate institutional commitment should include the provision of adequate staff, facilities, release time for the scholars to conduct research, and educational resources that can contribute to the planned research education program. If the letter of institutional commitment is not included, the application will be considered incomplete and administratively withdrawn without review.

Progress Report (For Renewal applications only):

For renewal applications, a detailed Progress Report must be included. Applications with more than one previous funding cycle must provide information on the past consecutive funding cycles. In the report, state the original goals and specific aims, anticipated milestones and outcomes, as well as a summary of the specific accomplishments of the CRECD program.

  • Accomplishments and successes of the overall CRECD program in increasing diversity;
  • Information highlighting participants who attended and completed the program;
  • Current status and research career plans, grants awarded with source and publications for both Component I and Component II participants;
  • Courses that are already in place and those that need to be developed/adapted to address the needs of the participants and meet the objectives of the program;
  • Any novel courses developed that are critical to the education and career development of clinical investigators working in the area of minority health and health disparities. If proposing substantial changes in the CRECD courses developed, provide adequate justification;
  • Success stories of former CRECD program participants.

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 including aggregate information on the distribution of:

  • Individuals who applied for admission to the research education program,
  • Individuals who were offered admission to the research education program,
  • Individuals who participated in the research education program. 

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 must describe a detailed process and outcome evaluation plan to review and determine the effectiveness of the program. The application must describe a proposed process evaluation plan to examine the program operations to determine if they are being conducted as planned, whether output is being produced or how processes can be improved. The plan must include milestones for each key activity.

Include the parameters and criteria, timeline, and benchmarks to be used in evaluating the success of the CRECD program. The plan must include milestones for the overall program in terms of the career outcomes of participants. The outcome measures for the participants should include, progression of Component I participants towards completion of degree program; progression of the Component I and Component II participants toward a productive research career, journal papers written/published, grant proposals submitted/funded, hiring/retention of CRECD participants by the institution, and impact of the program at the institution level.

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.

The following modifications also apply:

When relevant, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application.There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

  • Software source code should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. Users should be permitted to modify the code and share their modifications with others.
  • The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
  • To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

Appendix

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH 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,, NIH. Applications that are incomplete or non-compliant will not be reviewed.

 

Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy. 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 to improve diversity for research in the health sciences by developing the research workforce in clinical and translational sciences through providing grant support to low resourced institutions whose historical mission is educating and training individuals from groups underrepresented in the biomedical sciences that offer doctorate degrees in the health professions or in a health-related science.

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?

How well does the proposed program address the NIH's intent of supporting education programs and enhance research experiences that prepare diverse - participants, including those underrepresented in biomedical research, as independent investigators in clinical and translational minority health and health disparities research?

Investigator(s)

Is the PD/PI capable of providing both administrative and scientific leadership to the development and implementation of the proposed program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished? If applicable, is there evidence that the participating faculty have experience in mentoring students and teaching science? If applicable, are the faculty good role models for the participants by nature of their scientific accomplishments? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

How strong is the evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's objectives?  Are the faculty responsible for the specialized CRECD courses adequate? Are the manner and extent of the mentor involvement in clinical research or research methods for minority health and health disparities adequate?

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?

Are the CRECD courses considered innovative relative to other curricula available at the institution(s) for supporting minority health and health disparities 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?

Do the courses provide the participants a basis to enhance their research skills? Are the proposed research activities and experiences adequate for increasing the knowledge and skill of diverse participants? Will continuation and/or expansion of an existing program enhance clinical research education at the institution? Is a qualified pool of participants for Component I and/or Component II in clinical research available? Are the criteria used for selecting these participants appropriate to meet the proposed goals of the program? To what extent are the proposed activities likely to support the development and enhance the competitiveness of diverse early-stage investigators in clinical sciences? Is the proposed plan for soliciting research proposals, evaluating and prioritizing projects, and monitoring their performance well thought out and likely to enhance investigator development for Component II of the program?

Are the evaluation plan and timeline adequate for assessing the effectiveness (process and outcome) of the program in achieving its goals and objectives? Does the evaluation plan obtain feedback from participants to help identify weaknesses and provide suggestions for program improvements?

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?

Are the institution, the PD/PI, and the faculty and mentors supportive and committed to meet the education objectives of the CRECD program? Is the CRECD Advisory Committee (CAC) membership appropriate and experienced? Are the criteria for selection of CAC members appropriate? Is the CAC's involvement adequate in recommending selection of Component I and Component II participants for the program? Are plans for monitoring the progress of Component I and Component II participants and evaluation of the program adequate? Are plans for CAC oversight of the program adequate?

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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

Not applicable.

Revisions

Not applicable.

Renewals

For Renewals, the committee will consider the progress made in the last funding period, and the success of the program in attracting individuals from diverse populations, including populations underrepresented in biomedical, behavioral and clinical research on a national basis.

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 NIMHD, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

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.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

 

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to: 

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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

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.

In addition, the annual progress report should provide a summary report of the evaluation of the CRECD Advisory Committee, and a description of the research and career progress of each participant. These annual reports will be closely monitored by the NIMHD and CRECD participating ICs' Program Staff to ensure that the grant is achieving the goals of the Program. Progress reports must contain the following information:

  • Progress of individual participants: A brief paragraph for each participant describing the research and didactic training experiences completed and ongoing, as well as the specific future plans for satisfying the Core Requirements of the Program;
  • A report from the CAC summarizing the recommendations of the CAC during the last year, evaluating the performance of the program in meeting its objectives and the intent of the CRECD program, evaluating the effectiveness of recruitment strategies, and providing recommendations for improving the program (e.g., new mentors, changes in Core Requirements, changes in recruitment strategies etc.) (3-5 page limit).
  • Describe what has been learned through the program evaluation and any changes made in the program as a result of the evaluation. You may append your assessment tools (i.e., questionnaires) to the Progress Report. Include answers to the following questions in your update (3-5 page limit):
  • What were the significant unexpected outcomes (positive or negative) of your CRECD Program’s activities? 2) What were the challenges or obstacles your Program encountered in reaching its goals and what are your plans to overcome these challenges? 3) What has been the impact of the program on the institutional culture toward clinical research? 4) What were the best products of your CRECD (new courses, techniques, scientific findings, other)?
  • Success of the participants who have completed the CRECD program:This information is essential for assessing the effectiveness of this program and must be provided in the progress report. The participants should be tracked after the completion of this program for periodic updates on various aspects of their employment history, publications, support for research grants or contracts, honors and awards related to scholarly activity, and other information helpful in evaluating the impact of the program. Applications with more than one previous funding cycle should provide information on a minimum of past two consecutive funding cycles.

All publications from CRECD activities supported entirely or in substantial part by NIH should include the following or comparable acknowledgment of support: "The project/study described was supported by Grant Number R25 MD _xxxxx_ (list names of the participating ICs). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of NIH."

NIH FOAs outline intended research goals

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

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

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

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

Other Reporting Requirements

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

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. The evaluation of the overall CRECD program is distinct from each individual award’s outcome evaluation.  While both address “success”, they differ in scope (individual award vs. national program, different timelines) and metrics (PD/PI defined vs. programmatic goals specified below).

In evaluating this research education program NIMHD expects to use the following evaluation measures that will include, but are not limited to:

  • Career outcomes of CRECD participants in terms of publications that impact health disparities;
  • Contributions made in the field of clinical research impacting areas in health disparities, among others;  
  • Does the CRECD program develop a diverse group of clinical research scientists?
  • Are these institutions able to create a stable environment for education and skills development of underrepresented clinical researchers who can address health disparities?
  • Does participation in CRECD affect the career outcomes of participants – do they pursue clinical research careers? Are they retained by the supporting institution after the CRECD award?
  • What are the best practices and noteworthy outcomes in educating and mentoring participants to become clinical research investigators?

For Courses for Skills Development:

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

For mentored research experiences: :

  • Aggregate number and demographic characteristics of participants
  • Subsequent educational/career progress of participants, including: 
  • Subsequent participation in research
  • Subsequent employment in a research or research-related field
  • Subsequent authorship of scientific publications in a STEM field
  • Subsequent independent research grant support from NIH or another source    

  •  

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://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)

Replace this text with Staff Contact Name

Rina Das, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-496-3996
Email: dasr2@mail.nih.gov

Lynn M King, PhD
National Institute Of Dental & Craniofacial Research (NIDCR)
Phone: 301-594-5006
email: lynn.king@nih.gov

David Banks, PhD, MPH, MSSW, RN
National Institute of Nursing Research (NINR)
Telephone: 301-496-9558
Email: david.banks@nih.gov

 

Peer Review Contact(s)

Yujing Liu, PhD.

National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-827-7815
Email:liuyujin@mail.nih.gov

Financial/Grants Management Contact(s)

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

Diana Rutberg, MBA
National Institute Of Dental & Craniofacial Research (NIDCR)
Phone: (301) 594-4798
email: diana.rutberg@nih.gov

Randi Freundlich
National Institute of Nursing Research (NINR)
Telephone: 301-594-5974
Email: freundlichr@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.

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