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

National Institutes of Health (NIH)

Components of Participating Organizations

National Heart, Lung, and Blood Institute (NHLBI)

National Cancer Institute (NCI)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute on Aging (NIA)

Funding Opportunity Title

Stimulating Access to Research in Residency (StARR) (R38 Independent Clinical Trial Not Allowed)

Activity Code

R38 Education Projects

Announcement Type

Reissue of RFA-HL-18-023

Related Notices

See Notices of Special Interest associated with this funding opportunity

NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022

March 16, 2022 - Notice of Correction to Eligibility and Application Types in RFA-HL-23-006, " Stimulating Access to Research in Residency (StARR) (R38 Independent Clinical Trial Not Allowed)". See Notice NOT-HL-22-013.

March 4, 2022 - NHLBI Announces Availability of Frequently Asked Questions (FAQs) for RFA-HL-23-006. See Notice NOT-HL-22-011.

February 04, 2022 - Notice of Correction to Specific Areas of Research Interest of Participating Institutes and Centers In RFA-HL-23-006. See Notice NOT-HL-22-009.

  • February 04, 2022 - Notice of Correction to Eligibility Information in RFA-HL-23-006. See Notice NOT-HL-22-008.

Funding Opportunity Announcement (FOA) Number

RFA-HL-23-006

Companion Funding Opportunity

None

Assistance Listing Number(s)

93.837, 93.838, 93.839, 93.840, 93.233, 93.394, 93.395, 93.396, 93.397, 93.398, 93.399, 93.855, 93.866

Funding Opportunity Purpose

The purpose of this program is to recruit and retain outstanding, postdoctoral-level health professionals who have demonstrated potential and interest in pursuing careers as clinician-investigators. To address the growing need for this critical component of the research workforce, this funding opportunity seeks applications from institutional programs that can provide outstanding mentored research opportunities for Resident-Investigators and foster their ability to transition to individual career development research awards. The program will support institutions to provide support for up to 2 years of research conducted by Resident-Investigators in structured programs for clinician-investigators with defined program milestones.

Key Dates
Posted Date

January 18, 2022

Open Date (Earliest Submission Date)

February 15, 2022

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

March 15, 2022, March 15, 2023, March 15, 2024

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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

AIDS Application Due Date(s)

May 16, 2022, May 16, 2023, May 16, 2024

All applications are due by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on the listed date(s).

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

Scientific Merit Review

July 2022, July 2023, July 2024

Advisory Council Review

October 2022, October 2023, October 2024

Earliest Start Date

December 1, 2022

Expiration Date

May 17, 2024

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions will not be reviewed


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

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

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


  4. Table of Contents

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


    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

     

    Purpose

    The overall goal of the Stimulating Access to Research in Residency (StARR) program is to provide clinicians with in-depth research experiences early in their careers, in order to recruit, retain and accelerate independence of a pool of clinician-investigators with both clinical and research experience necessary to perform basic, clinical and/or translational research.

    Applications are encouraged that propose well-designed institutional programs that will provide Resident-Investigators with research opportunities that can stimulate investigative curiosity and foster transition to additional research and career development, while also meeting requirements for medical board, dental or veterinary specialty eligibility. Applicant Institutions must provide written evidence from a Board recognized by the ABMS, the ADA CODA, or the ABVS indicating that the overall structure of research and clinical activities outlined in the application leads to participant eligibility for medical board certification.

    This FOA is intended to support Institutional programs that propose effective interactions with the residency director(s), institutional research leaders, and medical boards and optimize access to existing institutional research resources. Program Resident-Investigators identified by the institution will be health professionals with medical, dental or veterinary doctoral degrees (i.e., MD, DVM, DDS, DO, MBBS, or equivalents) with or without additional PhD degrees, with promise and interest in careers as clinician investigators.

    This award supports institutional programs of mentored research opportunities designed for Resident-Investigators to engage in research projects with experienced investigators for a minimum of one contiguous year, and a maximum of two years, with the goal of accelerating the transition of participating residents to subsequent research and career development support. The NIH encourages institutions to recruit and retain individuals from groups currently underrepresented in the biomedical sciences, and to enhance the diversity of the clinician-investigator workforce.  See, Notice of NIH's Interest in Diversity, NOT-OD-20-031; see also Policy Supporting the Next Generation Researchers Initiative, NOT-OD-17-101. 

    Institutional Research in Residency programs may complement ongoing research training and education occurring at the applicant institution, but the proposed research experiences must be distinct from those programs currently receiving Federal support (e.g., T32, T90, R25, K12, KL2) and cannot be used to replace or circumvent Ruth L. Kirschstein National Research Service Award (NRSA) programs.

    Background

    There is a critical workforce need for physician-scientists/clinician-investigators, i.e., those with clinical experience who conduct research and offer skills and perspectives directly related to human health, disease conditions, clinical decision-making, diagnoses, prevention, and improving health outcomes. Relatively few physicians and other health professionals are pursuing research careers, and existing opportunities may not maintain adequate numbers or diversity of physician scientists (Advisory Committee to the Director, Physician Scientist Workforce Report, 2014). The overall size of the current clinician-investigator workforce constitutes only a small proportion of all NIH-funded research investigators, and this is particularly true for early-stage clinician investigators.

    Thus new approaches are needed to recruit, prepare and retain more clinician-investigators from the large pool of potential researchers with health professional doctorates. Among today’s NIH-funded clinician-investigators, about 60% hold a single health professional degree and 40% hold both health professional and research doctorate degrees. Women and individuals from underrepresented racial and ethnic groups represent a particularly low proportion of this workforce. Each year in the United States, some 18,000 individuals earn an MD, while 600 individuals earn MD/PhDs; these data suggest that recruitment of even a slightly greater proportion of MDs, and retention of more MDs and MD/PhDs in research careers could significantly enhance the clinician-investigator workforce.

    New approaches are also needed to enhance research opportunities during clinical training periods (residency), as this period of graduate medical education typically offers limited opportunities to acquire the research skills and experience needed for a career as a clinician-investigator. To enhance the research experience, several medical board-approved graduate medical residency programs have developed what are variously described as ‘fast track,’ ‘short track,’ ‘accelerated,’ or ‘research pathway’ approaches in their specialties. These programs balance protected time for research with clinical requirements, and medical boards approve either institutional programs or individual plans for board eligibility. Available outcomes indicate that the clinical competency of pathway graduates is comparable to those participating in standard residency programs. Many research pathway graduates subsequently hold positions in academic medicine, report research activity, and contribute substantial professional effort in research as clinician-investigators. However, available information indicates a need for more opportunities to participate in research during residency.

    For health professionals who recognize the critical need to develop new understanding and therapeutic modalities for diseases, research in residency can provide valuable experience and an early “on-ramp” to a research career. It is also recognized that many MDs/health professionals as well as MD/PhDs have had previous research experience, and research in residency provides an opportunity to build upon prior research experiences. It is anticipated that Resident-Investigators supported by this FOA will be engaged in experimental approaches, form mentor-mentee relationships and gain additional research experience needed to enhance competitiveness for subsequent individual research and career development awards.

    Program Components

    Institutional Programs

    This FOA will support Institutional Programs that propose to engage Resident-Investigators in research. Institutional Programs applications submitted in response to this FOA should be characterized by:

    • Research projects that include concepts of hypothesis-based, rigorous and reproducible research, the fulfillment of discovery, and achievement of designated research milestones
    • Support for Resident-Investigators for 80% of PGY salary for a minimum of one contiguous year of research and a maximum of two years during residency training
    • Support for a minimum of two and a maximum of four Resident-Investigators each year

    Institutional Programs that propose to support residents from more than one training specialty (e.g., internal medicine, pediatrics, pathology, radiology, etc.) to promote cross-disciplinary interaction are strongly encouraged.

    Institutional Awards

    This FOA will provide support for supplementary research and professional development activities that will contribute to successful research, including:

    • Research supplies and technical support, including but not limited to biostatistics consultation and/or research technician effort to complete research objectives
    • Registration and material for short-term courses or workshops that provide research skills such as data science, implementation science or clinical trials, or others as necessary for the project
    • Participation in workshops on oral and written communication of research and grant writing related to the research project
    • Travel to attend scientific conferences and NIH-sponsored workshops and present research findings
    • Support for skill-building needed for research supervision and effective mentoring of clinician-investigators for research preceptors; preceptor skill-building should include topics such as aligning goals and expectations, effective communication, time management, mentoring for a diverse and inclusive workforce, understanding the flow of research funds flow in an academic health center, building a successful research team, job negotiation, identifying grant opportunities, navigating an IRB and/or animal protocol, as appropriate for the research project

    Funded programs are expected to provide evidence of accomplishing their research experience and career development objectives in progress reports and upon renewal, to make participant outcomes outcomes publicly available, and are strongly encouraged to disseminate successful practices for fostering clinician-investigators to the broader training community.

    Resident-Investigators are anticipated to have varied research backgrounds, that, in combination with achieving the StARR program objectives, will lead to continued research activity with potential support from the "Stimulating Access to Research in Residency Transition Support" individual K38. Consideration of other career development awards is also encouraged, such as appointment to institutional KL2 or K12 awards, or individual mentored career development awards including the K08 and K23. In some circumstances subsequent postdoctoral T32 or F32 National Research Service Award support may be considered, or other awards as well.

    Resident-Investigators are encouraged to apply for loan repayment for qualified educational debt in return for research engagement, if eligibility criteria are met (https://www.lrp.nih.gov/eligibility-programs).

    Resident-Investigators may also consider graduate medical research fellowships within the NIH intramural program https://www.cc.nih.gov/training/gme1.html.

    Specific Areas of Research Interest of Participating Institutes and Centers

     

    The participating NIH Institutes have provided a brief outline of their interests as they relate to the goals of this FOA. These mission statements are intended to indicate the breadth of the biomedical areas of interest. See Staff Contacts for more details.
     

    The National Heart, Lung, and Blood Institute (NHLBI) supports a broad research and training portfolio in the treatment and prevention of heart, lung, blood, and sleep diseases and disorders. The NHLBI is tasked with combating not only the major causes of death and disability but also rare disorders such as congenital heart disease, sickle cell disease, thalassemia, and pulmonary fibrosis. The NHLBI’s research programs span the entire research spectrum comprising fundamental discovery science, early translation research, clinical investigations, population science research, and translation research that moves fundamental discoveries into clinical and public health practice in real-world settings. Visit "Charting the future together: The NHLBI Strategic Vision for research priorities that will help accelerate research and scientific advances over the next decade" https://www.nhlbi.nih.gov/about/documents/strategic-vision. To achieve the goals related to this FOA, NHLBI is interested in applications from institutions seeking to provide research opportunities to clinician residents (with MD or equivalent degrees) who intend to pursue careers as clinician-scientists committed to research in heart, lung, blood, or sleep diseases or disorders.

    The National Cancer Institute (NCI) supports research in all areas of cancer biology and investigates the biological aspects of every form of cancer, carrying out studies that range from targeted, long-running projects that are revealing the microscopic details of cell processes to high-risk, innovative research that holds promise for providing key insights into tumor development; research in cancer surveillance, epidemiology, health services, behavioral science, and cancer survivorship; research to assess a person's risk of developing cancer and to find ways to reduce that risk; research focuses across the continuum between the initiation of the cancer process and the occurrence of the invasive disease, with the goal of detecting changes and intervening early in the cancer process to prevent disease and death; research that facilitates the path to clinical application of promising cancer detection, diagnosis, and treatment methods; it also expedites the initial small-scale and subsequent large-scale testing of new anticancer agents, biomarkers, imaging tests, and other therapeutic interventions in patients; cancer health disparities and community-based participatory research; research in HIV/AIDS and HIV malignancies.

    The National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. For more than 60 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions. Specifically, our areas of study are HIV/AIDS, infectious diseases, and allergy, immunology, and transplantation research. Applications for this program would be appropriate for NIAID if they propose research experiences for clinical residents and fellows in the fields of biomedical research (including translational research) in these NIAID mission-relevant areas.

    The National Institute on Aging supports research to advance our understanding of the nature of aging and the aging process, as well as diseases and conditions associated with growing older, in order to extend the healthy, active years of life. NIA’s Division of Aging Biology supports molecular, cellular, and genetic research on the mechanisms of aging. The Division of Behavioral and Social Research supports social, behavioral, and economic research on the processes of aging at both the individual and societal level, including cross-disciplinary research, at multiple levels from genetics to cross-national comparative research, and at stages from basic through translational. The Division of Geriatrics and Clinical Gerontology supports clinical and translational research on health and disease in the aged, and research on aging over the human lifespan, including its relationships to health outcomes, with foci that include translational research for the development of new interventions for age-related conditions, prevention and treatment of multiple chronic conditions in the elderly, and studies that help to promote evidence-based geriatric care and inform policies affecting older adults. The Division of Neuroscience supports collaborative research to further the understanding of neural and behavioral processes associated with the aging brain. Research on dementias of old age—in particular Alzheimer’s Disease and Related Dementias (ADRD) disease—is one of the program’s highest priorities. Note: The NIA will support only investigators in clinical fellowship under this FOA. Investigators interested in research support as early career faculty are encouraged to consider NIA's GEMSSTAR program.

    Special Note: Because of the differences in individual Institute and Center (IC) program requirements for this FOA, prospective applicants are strongly encouraged to consult the Table of IC-Specific Information, Requirements and Staff Contacts, to make sure that their application is appropriate for the requirements of one of the participating NIH ICs.

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

    Section II. Award Information
    Funding Instrument

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

    Application Types Allowed

    New
    Resubmission
    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.

    The following NIH components intend to commit the following amounts:

    NHLBI intends to commit total costs of $29,553,000 over seven years including $5,911,000 in fiscal years 2023 through 2025 to support up to 16 new awards. NHLBI intends to commit costs of $23,640,000 over six years in fiscal years 2024 through 2029 to support up to 64 Type 5 renewal awards.

    NCI intends to commit total costs of $15,422,500 over seven years to support up to three new awards in fiscal years 2023 through 2025 and in fiscal years 2024 through 2029 to support up to 12 Type 5 renewal awards.

    NIAID intends to commit total costs of $14,385,000 over seven years including $2,877,000 to support up to eight new awards in fiscal years 2023 through 2025. NIAID intends to commit costs of $11,508,000 over six years in fiscal years 2024 through 2029 to support up to 32 Type 5 renewal awards.

    NIA intends to commit total costs of $7,500,000 over six years including $1,500,000 to support up to two new awards per fiscal year in FY2023 and FY2024. NIA intends to commit costs of $6,000,000 in fiscal years 2024 through 2028 to support up to 16 Type 5 renewal awards.

    Award Budget

    Institutional award budgets are composed of administrative costs, Resident-Investigator's salaries, travel, and supplementary research funds, as described below.

    Award Project Period

    Awards for institutional programs are for project periods up to five years in duration; an individual Resident-Investigator must be supported for a minimum of one and a maximum of two years.

    Other Award Budget Information
    Personnel Costs

    Administrative Costs for Institutional Program. Up to $20,000 per year may be requested for administrative costs. This could include salary for the institutional PD/PI or support personnel, travel of the institutional PD/PI to the NIH-sponsored workshop, or to defray costs for external advisory committee travel and time (if requested).

    Resident-Investigator Costs

    Resident-Investigators Compensation in Institutional Program: Remuneration for Resident-Investigators is through salary and fringe benefits. The total salary requested must be based on a full-time appointment, and be consistent with the postgraduate year (PGY) salary structure at the institution. There must be an employee-employer relationship between the Resident-Investigators and the institution. During the research period, Resident-Investigators will be paid 80% of their base PGY salary level set by the Institution. A minimum of two residents should be supported in each year of the program.

    Resident-Investigators salary should be calculated for the months of full-time research engagement over a year:

    In one example, a participant engages in research for a year at a salary of $60,000, with a monthly salary of $5,000; the award will support 80% effort over 12 months, which equates to 9.6 person-months; the budget figure for this Resident-Investigators would be $48,000 ($5,000 x 9.6).

    Resident-Investigators Supplementary Research Funds in Institutional Program: Up to $20,000 per year, per Resident-Investigator, may be requested and must be justified and consistent with the stage of development of the participant and the proportion of time to be spent in research and/or professional development activities. Supplementary Research Funds may be used to defray costs for registration for short-term courses or workshops to obtain research skills, to support skill development for research preceptors of clinician-investigators, research supplies, or where well-justified, for technical support to contribute to the participating Resident-Investigator's research continuity. Funds may NOT be used for tuition for courses leading to a degree, materials leading to clinical qualifications, or equipment.

    Other Program-Related Expenses

    Resident-Investigators Travel in Institutional Program: Up to $3,000 each year may be requested for each Resident-Investigator to attend or present research findings at domestic scientific conferences, and to support attendance at a NIH-sponsored workshop. Requests for travel to scientific meetings or workshops must be carefully justified, with specific examples. Expenses for foreign travel must be exceptionally well-justified.

    Add information as needed

    Indirect Costs

    Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.

     

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Higher Education Institutions

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

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

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

    Nonprofits Other Than Institutions of Higher Education

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

    For-Profit Organizations

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

    Governments

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

    Other

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

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

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

    Foreign Institutions

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

    Required Registrations

    Applicant Organizations

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

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

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

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

    Eligible Individuals (Program Director/Principal Investigator)

    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.  See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

    Multiple PD/PIs are not allowed.

    The Institutional PD/PI should be an established clinician-investigator in a relevant scientific area and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI must have a regular, full-time appointment (i.e., not adjunct, part-time, or emeritus) at the applicant institution. This person should hold a health professional degree (e.g., MD, DVM, DDS or equivalents), have an appointment in a clinical department related to at least one of the residency programs proposed for participation, have clearly demonstrated education/mentoring experience and have a strong recent history of NIH funding. Exceptional individuals without a clinical doctorate and with demonstrated leadership and mentoring experience in clinical departments may also serve as PD/PI. If the sponsoring institution is a hospital affiliated with a medical or dental school, the PD/PI must have an appointment in both the medical/dental school and at the sponsoring institution.

    The Institutional PD/PI will design and provide oversight for the entire program. The PD/PI is expected to monitor and assess the program annually, and submit all documents and reports as required.   
       

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

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

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

    A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

    A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

    An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

    Research Preceptors

    Research preceptors should have research expertise and a successful track record of mentoring clinician-investigators. Co-preceptors may be considered whenever one preceptor has limited experience. Where possible, clinician-investigators with various educational backgrounds, as well as those from backgrounds underrepresented in biomedical science should have opportunities to serve as preceptors and/or meet with both preceptors and Resident-Participants to discuss effective research career strategies.

    Resident-Investigators

    For the purposes of this Funding Opportunity, Resident-Investigators include individuals with health professional doctoral degrees (e.g., MD, DO, MBBS, DDS, DMD, OD, ND, DVM; with or without a research doctorate) engaged in graduate medical education consisting of advanced clinical training (herein referred to as “residency”).

    Resident-Investigators are required to have a full-time appointment at the applicant institution, and to commit a minimum of 9.6 person-months (80% effort to research over 12 months) of the residency.

    By the time of the appointment to the program, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e. possess a currently valid Permanent Resident Care USCIS Form 1-551, or other legal verification of such status.

    Level of Effort

    Resident-Investigators are required to have a full-time appointment at the applicant institution, and to commit a minimum of 9.6 person-months (80% effort to research over 12 months) of the residency.

    The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified in biomedical, behavioral, or clinical research to collaborate with the applicant.

    Section IV. Application and Submission Information
    1. Requesting an Application Package

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

    2. Content and Form of Application Submission

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

    Page Limitations

    All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

    The Research Strategy is limited to 25 pages.

    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 institutional resources and environment for clinician-investigator research. Include a description of the laboratories, participating departments, research core facilities, computer services, biostatistics staff, and any other resources to be used in the development and implementation of the proposed program.

     

    Describe the institutional research environment and the clinician-investigator workforce including faculty, research staff, graduate medical staff and students.

     

    Describe the plan for how this program will benefit from any extant NIH research, training and career development programs, affiliations with other institutions, and academic or non-profit partnerships where Resident-Investigators might engage in research.

     

    Other Attachments.

    1. Advisory Committee

    An Advisory Committee is not a required component of a Research program.  However, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the research program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will assess the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. The filename "Advisory Committee.pdf" should be used and the file attached.

     

    2. Data Tables

    Tables should be included to show: (a) participating faculty including research preceptors (including their sources of support and records in research training and research education), (b) the potential participant pool and diversity of backgrounds, (c) information about past participants and their subsequent activities. For this purpose, the following Data Tables should be used: Data Tables 2, 3, 4, 5B and 8C, Part III. These tables are not subject to a page limit. They should be compiled as a single pdf file. The filename "Data_Tables.pdf" should be used and the file attached.

     

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

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

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

    R&R Budget

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

    • Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.
    • Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support Resident-Investigator participants in the program.
    • A single consolidated budget is required, with each item clearly justified.

    Research Funds provided to supplement research supply costs and professional development activites may include:

    • Research supplies including biostatistics consultation, technician time, core facility use, or other technical components needed to complete research activities.
    • Fees for short duration courses or workshops that provide exposure to fundamental concepts of study design and analysis appropriate for the research project as well as contemporary approaches to scientific rigor (for details, see NOT-OD-16-011).
    • Fees for workshops to develop research skills including clinical trial design, bioinformatics use of large databases, or other specific training related to the research project
    • Fees for workshops to develop research-related presentation skills, publication preparation, grant-finding and grant-writing and other professional activities related to the research project
    • Fees for workshops to develop skills needed for effective research supervision of clinician-investigators, including support for effective mentoring; workshop topics might include aligning goals and expectations, effective communication, time management, mentoring for a diverse and inclusive workforce, understanding research funds flow in an academic career, building a successful research team, job negotiation, identifying grant opportunities, navigating an IRB and/or animal protocol, as appropriate for the research project.
    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan Component

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

    Research Strategy

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

    • Proposed Institutional Research Program and Milestones
    • Program Director/Principal Investigator
    • Program Research Preceptors
    • Program Resident-Investigators
    • Institutional Environment and Commitment
    • Recruitment Plan to Enhance Diversity
    • Plan for Instruction in the Responsible Conduct of Research
    • Evaluation Plan

    Research Program Plan

    Proposed Institutional Research Program and Milestones.

    Applications should describe the available research opportunities, including the research problems to be addressed, and the skills in methodology and research technology that Resident-Investigators are expected to acquire in the course of their research experiences, and how that will prepare them for careers as clinician-investigators. Include a description of how available research opportunities contribute to the concepts, treatments, or preventative interventions that drive a field.

    Less experienced Resident-Investigators may require a phased developmental period in which the award includes considerable skill-building followed by a period of supervised research. Candidates with more experience at the time of selection may already have an adequate theoretical or practical background and need a shorter developmental period.

    Because Resident-Investigators uniquely must fulfill both research goals and clinical duties, it is essential that the program description include an annotated timeline indicating planned periods of research leading to research competencies, as well as periods of clinical duties leading to specialty board-eligibility. Evidence that the proposed institutional plan for clinical and research activities in residency and fellowship is recognized as sufficient to prepare for board eligibility is required at the time of application.

    Applicant institutions must provide research and clinical activities that lead to certification. Describe how the overall structure of the proposed Institutional program of research and clinical activities will lead to participant eligibility for certification or endorsement and oversight by a Board recognized by the American Board of Medical Specialties (ABMS), or for dentists, meets the requirements for National Certifying Boards for Dental Specialists established by the Commission on Dental Accreditation (CODA) requirements, or for veterinarians, meets the requirements as recognized by the American Board of Veterinary Specialties (ABVS).  The overall structure of the Institutional Program must also include a process for determining if the StARR Resident participants will require additional residency training time to achieve compliance with the respective Boards.

    The Research Program section should include a description of the:

    Resident-Investigators Research Opportunities:

    Plans for recruitment, selection, and matching of Resident-Investigators with available research preceptors and opportunities.

    Plans to develop and implement an assessment of research competencies and milestones for Resident-Investigators with and without a research doctorate. Competencies might include analysis of information and formulation of research questions, research collaborations, data acquisition and analysis, and other research professional activities. 

    Partnership with any existing NIH research programs, other institutions, and academic or non-profit partnerships where health professionals might engage in research. For example, residents might conduct research in global health through international organizations affiliated with their home institutions, or institutions in a geographic region might partner to offer broader research experiences than possible at one institution to support a network of resident researchers.

    Participation in local, regional, national scientific meetings and an annual NIH StARR meeting.

    Other strategies designed to foster Resident-Investigators success.

    Institutional Programs must describe how they will ensure that Resident-Investigators will complete the necessary activities to achieve milestones in research in residency, to include:

    • Completion of research skill-building activities.
    • Assessment of research competencies.
    • PD/PI evaluation letter to include a written review of each Resident-Investigator's progress and promise.
    • Assistance to Resident-Investigators in the identification of an appropriate subsequent clinical fellowship and any other career milestones.           

    Institutional Program Director/Principal Investigator Describe arrangements for the leadership and administration of the program, and how the professional appointments and experience of the PD/PI will enhance these activities.  Within the design of the program, the PD/PI must identify the residency director, departmental chairs, and research deans, and their roles in the program with respect to affiliation and responsibility should be clearly described. Provide evidence that the PD/PI is actively engaged as a clinician-investigator in an area relevant to the application, with strong recent history of extramural funding.

    The PD/PI may utilize an advisory committee (if requested--see above) to monitor progress, provide recommendations on a periodic basis, and help evaluate the overall effectiveness of the program. 

    Program Research Preceptors

    Describe the available research opportunities with participating preceptors, and their responsibilities to the program. Describe how research preceptors are selected and reviewed, and the timing and types of meetings planned between Resident-Investigators and preceptors to ensure that each Resident-Investigators receives the skills and knowledge he/she requires to achieve the goals of the program. In the case where one preceptor has limited experience and thus co-preceptors are being proposed, describe the expected timing and interactions between co-preceptors and with the Resident-Investigators.

    Summarize key data from the Research Training Data Tables that highlight the characteristics of the  faculty and their research funding, as well as the educational and career outcomes of previous health professionals sponsored in research in the last five years.

    Program Resident-Investigators . Provide details about the recruitment strategies for research in residency participants. Describe recent applicants to the participating residency and fellowship program(s), including the number of applications, interviews and matched residents. Discuss any unfilled residency positions, especially if they were designed to support a research pathway.

    For residents who have matriculated to the institution, describe the overall demographic distributions, and the range of previous research and educational experiences among the cohorts. Describe the criteria and strategy for selecting the intended Resident-Investigators for this research program, and the eligibility criteria and/or specific educational background characteristics that are essential for participation.

    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.

    In addition, describe the institutional environment for clinician-investigators, including the extant clinician-investigator workforce of participating faculty, research staff, protected time for research, graduate medical staff and students, and how this program is designed to enhance that workforce.

    Describe the overall institutional research environment, including research faculty and staff, core facilities, resources, or any unique features available at the institution.

    Recruitment Plan to Enhance Diversity

    The NIH recognizes a unique interest in the diversity of the biomedical research workforce, including the clinician-investigator workforce (see, e.g., Strategies to Enhance Diversity of the Physician-Scientist Workforce, and Policy Supporting the Next Generation Researchers Initiative, NOT-OD-17-101). Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to enhance the pool of individuals from underrepresented backgrounds in the biomedical research workforce (NOT-OD-15-053).

    Applications for this funding opportunity must include a robust Recruitment Plan to Enhance Diversity of the Resident-Investigators pool. Such strategies should be evidence-based and informed by literature, data or other information in the field. Innovative approaches may build upon proven strategies that can be modified for this career/academic level (for information on data and strategies, please see https://extramural-diversity.nih.gov/building-participation/recruitment-retention).

    Applicants must formulate their plans based on available national data on diversity in medical and residency program(s), as well as their institutional accomplishments. NIH recognizes that candidates for this program are derived largely from the US medical school graduates, currently reflecting participation that is 6% Black or African American, 5% Hispanic or Latino and 48% female, and lower for American Indians and Alaska Natives, and Native Hawaiians or other US Pacific Islanders (https://www.aamc.org/data-reports/workforce/report/diversity-medicine-facts-and-figures-2019.). The diversity of residency applicants in the Electronic Residency Application Service has differed by medical specialty (https://www.aamc.org/data/facts/eras/).

    Programs are encouraged to review their web-based program descriptions to stimulate interest among candidates, to implement holistic review of residency applicants and to consider creative approaches, such as research exposure to medical students, and networking opportunities with professional societies, to build interest in their programs.

    Additional information on the required Recruitment Plan to Enhance Diversity is available at Frequently Asked Questions: Recruitment Plan to Enhance Diversity (Diversity FAQs).

    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 alsNOT-OD-10-019. The plan should be appropriate and reasonable for the nature and duration of the proposed program.

    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, and the success of the program in recruiting and retaining clinician-investigators in research-intensive or research-related careers.  The goal of this program is to increase the number of clinician-investigators, by enhanced recruitment and retention of talented residents into successful research careers.

    Institutions will be responsible for evaluating their own programs. Programs are encouraged to consider the characteristics of anticipated Resident-Investigators, the research experiences and interventions provided in the program to stimulate research careers, as well as the goals and measurable objectives to be used within the context of the NIH expectations and in line with their institutional settings and missions.

    It is essential that applications describe goals appropriate for both participants with limited prior research exposure as well as those with substantive research experience including research doctorates, and where possible, information about any appropriate comparison groups.

    Programs are also encouraged to use qualitative approaches that measure aspects of participant or preceptor satisfaction, science identity (e.g. psychological processes by which people become inspired by science) or other measures where evidence may support persistence to a clinician-investigator career.

    The application must specify baseline characteristics (e.g., Numbers of applicants, educational levels, and demographic characteristics of Resident-Investigators), as well as measures to gauge the short or long-term success of the award in achieving its objectives. Programs are encouraged to collect information to be used for evaluation of the program, including metrics that will include, but are not limited to, the following:

    Aggregate number and demographic characteristics of participants

    Subsequent educational/career progress, including:

      • Presentation of research completed in this program
      • Authorship of scientific publications in a STEM field
      • Participation in further research or career development training programs (e.g. T32)
      • Completion of a subsequent research training or career development appointment or award
      • Application of and awards granted for research funding
      • Subspecialty board passage rate
      • Subsequent employment in a research or research-related field
      • Percentage of professional effort in research

     

    Letters of Support

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

    A letter from a Board recognized by the ABMS, the ADA CODA, or the ABVS indicating that the overall structure of research and clinical activities outlined in the application leads to participant eligibility for medical board certification, must be attached as part of Letters of Support (see section above: "Proposed Institutional Research Program and Milestones".

     

    Resource Sharing Plans

    Individuals are required to comply with the instructions for the Resource Sharing Plans  as provided in the SF424 (R&R) Application Guide, with the following modification:

     

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

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

    Appendix

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

    PHS 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 form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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


    See more tips for avoiding common errors.

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

     

    Post Submission Materials

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

    Section V. Application Review Information
    1. Criteria

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

    For this particular announcement, note the following: The objective of this program is to encourage health professionals with a demonstrated potential and interest in pursuing careers as clinician-investigators.

    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?

     

    Specific to this FOA

    • Are the objectives, design and direction of the proposed research program likely to recruit, retain, and prepare Resident-Investigators for successful careers as clinician-investigators?
    • Are the available research opportunities likely to lead to improvements in scientific knowledge, technical capability, and/or clinical practice of the participants?
    • Does the proposed program provide suitable research skill-building for the background research proficiency of Resident-Investigators?
    • Is there convincing evidence that the proposed mentored research activities will increase the competitiveness of the participants to succeed as clinician-investigators?

    Investigator(s)

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

    Specific to this FOA

    • Are sufficient numbers of experienced research preceptors with appropriate expertise and funding available to support the number and level of Resident-Investigators proposed in the application?
    • Is there evidence that the participating research preceptors have experience mentoring clinician-investigators?
    • Does the PD/PI have sufficient expertise and accessibility to other program faculty and Resident-Investigators to assess Resident-Investigator research potential and provide guidance in selecting appropriate clinical fellowships and other research-focused activities?

    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?

    Specific to this FOA

    • Taking into consideration the proposed goal of providing novel and stimulating research opportunities during a demanding period of clinical training, does the application make a strong case for how its program will uniquely attract, grow, and retain a talented and diverse pool of Resident-Investigators ?
    • Is the proposed program sufficiently distinct to not duplicate, or overlap with, existing research education and/or training currently supported at the applicant institution or available elsewhere?

    Approach

    Does the proposed program clearly state its goals and objectives, including the educational level of the audience to be reached, the content to be conveyed, and the intended outcome?  Is there evidence that the program is based on a sound rationale, as well as sound educational concepts and principles? Is the plan for evaluation sound and likely to provide information on the effectiveness of the program?  If the proposed program will recruit participants, are the planned recruitment, retention, and follow-up (if applicable) activities adequate to ensure a highly qualified participant pool?

     

    Specific to this FOA

    • Does the strategy to be used adequately consider the varied research backgrounds of the Resident Participants?
    • Will research and research skill-building activities provide an appropriate foundation for subsequent research activity?
    • Are the program activities/interventions to be used likely to enhance Resident-Investigators’ careers as clinician-investigators?
    • Are appropriate plans in place to ensure that research preceptors provide mentorship appropriate for clinician-investigators?
    • When applicable, is there adequate documentation describing the responsibilities of the advisory committee with regard to the provision of input, guidance and oversight of the program? 

    Environment

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

    Specific to this FOA

    • Where appropriate, is there evidence of collaboration and buy-in among participating residencies, divisions/departments, and other programs within the institution?  
    • Are the activities adequately integrated with the institution’s other programs to prepare clinician investigators?
    • Are the research facilities, resources (e.g. equipment, laboratory space, computer resources, subject populations), and professional development opportunities (e.g. seminars, workshops, professional development opportunities) adequate and appropriate?
    • Is there appropriate institutional commitment to fostering the participant’s mentored research toward his/her research career goals? Will the proposed activities engage and enhance the existing clinician-investigator workforce?
    • Does the institutional environment for clinician-investigators in which the program will be conducted contribute to the probability of success?
    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

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

    Renewals

    For Renewals, the committee will consider the progress made in the last funding period.

    Revisions

    Not Applicable

    Additional Review Considerations

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

    Recruitment Plan to Enhance Diversity

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

    Training in the Responsible Conduct of Research

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

    Applications from Foreign Organizations

    Not Applicable

    Select Agent Research

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

    Resource Sharing Plans

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

    Budget and Period of Support

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

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.


    As part of the scientific peer review, all applications:

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

    Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

    Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the national Advisory Council of the participating Institutes/Centers. The following will be considered in making funding decisions:

    • Scientific and technical merit of the proposed project as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities.  
    3. Anticipated Announcement and Award Dates

    After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date. 

    Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

    Section VI. Award Administration Information
    1. Award Notices

    If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

    A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient’s business official.

    Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

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

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee 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.

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

     

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

     

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

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

    3. Reporting

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

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

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

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

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

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

    A final RPPR and the expenditure data portion of the Federal Financial Report are required for closeout of an award as described in the NIH Grants Policy Statement.

     

    4. Evaluation

    In carrying out its stewardship of human resource-related programs, the NIH or its Institutes and Centers will periodically evaluate their R38 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 Resident-Investigators themselves.  Where necessary, PD/PIs and Resident-Investigators may be contacted after the completion of a research education experience for periodic updates on Resident-Investigators’ subsequent educational or employment history and professional activities.

    Upon the completion of a program evaluation, NIH and its ICs will determine whether to (a) continue a program as currently configured, (b) continue a program with modifications, or (c) discontinue a program.

    In evaluating this research education program the participating Institutes/Centers expects to use the following evaluation measures:

    • Aggregate number and demographic characteristics of Resident-Investigators
    • Subsequent educational/career progress, including:
      • Subsequent presentations of research completed in this program
      • Subsequent authorship of scientific publications in a STEM field
      • Subsequent participation in research
      • Subsequent application/award for research funding
      • Subsequent board passage rate
      • Subsequent employment in a research or research-related 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: https://grants.nih.gov/support/index.html(preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

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

    Scientific/Research Contact(s)

    David Schopfer
    National Heart Lung and Blood Institute (NHLBI)
    Telephone: 301-402-3833
    Email: david.schopfer@nih.gov

    Mark Damico, Ph.D.
    National Cancer Institute (NCI)
    Telephone: 240-276-5630
    Email: damicomw@mail.nih.gov

    Roya Kalantari, PhD
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 301-594-5945
    Email: roya.kalantari@nih.gov

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

    Peer Review Contact(s)

    Director, Office of Scientific Review
    National Heart, Lung, and Blood Institute (NHLBI)
    Telephone: 301-435-0270
    Email: nhlbichiefreviewbranch@nhlbi.nih.gov

    Referral Officer
    National Cancer Institute (NCI)
    Telephone: 240-276-6390
    Email: ncirefof@dea.nci.nih.gov

    Ann-Marie Brighenti, Ph.D.
    National institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 301-761-3100
    Email: ann-marie.brighenti@nih.gov

    Ramesh Vemuri, Ph.D.
    National Institute on Aging (NIA)
    Telephone: 301-402-7700
    Email: ramesh.vemuri@nih.gov

    Financial/Grants Management Contact(s)

    Andrea Greene
    National Heart, Lung, and Blood Institute (NHLBI)
    Telephone: 301-435-0166
    Email:? andrea.greene@nih.gov

    Sean Hine
    National Cancer Institute (NCI)
    Telephone: 240-276-6291
    Email: hines@mail.nih.gov

    Kalaya M. Goffigan
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: (301)761-7159
    Email: Kalaya.Goffigan@nih.gov

    Jessi Perez
    National Institute on Aging (NIA)
    Telephone: 301-403-7739
    Email: jessi.perez@nih.gov

    Section VIII. Other Information

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

    Authority and Regulations

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

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