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

Funding Opportunity Title

Limited Competition: Stimulating Access to Research in Residency Transition Scholar (StARRTS) (K38 Independent Clinical Trial Not Allowed)

Activity Code

K38 Early Stage Mentored Research and Career Development Award

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HL-20-006

Companion Funding Opportunity

RFA-HL-18-023, R38 Mentored Research Pathway in Residency Award

Catalog of Federal Domestic Assistance (CFDA) 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 the Stimulating Access to Research in Residency Transition Scholar (StARRTS) K38 Career Development program is to retain and support clinician investigators who have successfully completed the Stimulating Access to Research in Residency (StARR) R38 Program (RFA-HL-18-023) as resident-investigators. Individuals who are awarded K38 grants described in this FOA will be referred to as Transition Scholars. The intent of this FOA is to provide Transition Scholars with opportunities for additional research and career development during subsequent clinical fellowship or early career faculty appointments (as defined in Section III. 3. Additional Information on Eligibility). It is anticipated that the StARRTS K38 program will provide a pathway to retain the newly-created pool of clinician-investigators generated through the StARR R38 program. Transition Scholar grantees will receive support for continued research and career development opportunities in basic, clinical and/or translational research thereby providing enhanced potential to accelerate the transition to independent research careers.

Key Dates

 

Posted Date

September 9, 2019

Open Date (Earliest Submission Date)

September 17, 2019

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

November 18, 2019; October 15, 2020; October 15, 2021, by 5:00 PM local time of applicant organization.

All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s). Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

January 14, 2020; January 14, 2021; January 14, 2022, 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

April 2020, March 2021, March 2022

Advisory Council Review

May 2020, May 2021, May 2022

Earliest Start Date

July 2020, July 2021, July 2022

Expiration Date

January 15, 2022

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Career Development (K) 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 may be delayed or not accepted for review.


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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information


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

    The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals.More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

    Purpose

    The purpose of the Stimulating Access to Research in Residency Transition Scholar (StARRTS) K38 Career Development program is to retain and support clinician investigators who have successfully completed the Stimulating Access to Research in Residency (StARR) R38 Program (RFA-HL- 18-023) as resident-investigators. Individuals who are awarded K38 grants described in this FOA will be referred to as Transition Scholars. The intent of this FOA is to provide Transition Scholars with opportunities for additional research and career development during subsequent clinical fellowship or early career faculty appointments (as defined in Section III. 3. Additional Information on Eligibility). It is anticipated that the StARRTS K38 program will provide a pathway to retain the newly-created pool of clinician-investigators generated through the StARR R38 program. Transition Scholars grantees will receive support for continued research and career development opportunities in basic, clinical and/or translational research thereby providing enhanced potential to accelerate the transition to independent research careers.

    This FOA is intended to support only individuals who have successfully participated in the StARR R38 program for at least 12, and up to 24 months.. The StARRTS K38 Transition Scholar applicant can propose a research and career development plan at the same, or different department or institution as the Institutional StARR R38 research program in which he or she successfully participated.At the K38 Transition Scholar career stage, participants typically have clinical responsibilities in addition to research activities; for this reason, the proposed research activities should fall within an overall program structure consistent with appropriate medical board, dental or veterinary specialty eligibility.

    In general, research projects described in the StARRTS K38 application should fall within the mission of the NIH Institute/Center which supported the StARR R38 program in which the Transition Scholar applicant has successfully participated. In certain instances, with funds permitting, the programmatic management of the StARRTS K38 award may be transferred to another NIH Institute or Center (IC) participating in the StARR R38 program based on scientific content and according to established NIH referral guidelines.

    Background

    There is a critical workforce need for clinician-scientists/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. Despite existing opportunities, relatively few physicians and other health professionals are pursuing research careers, and current opportunities may not maintain adequate numbers or diversity of clinician-scientists (ACD Physician Scientist Workforce Report, 2014). The overall size of the current clinician-investigator workforce constitutes a small proportion of all NIH-funded research investigators, and this is particularly true for early-stage clinician-investigators.

    Novel strategies 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.

    Providing significant research opportunities during post-doctoral clinical training periods may be one strategy to enhance the clinician-investigator workforce, yet the typical graduate medical education (“residency”) period offers limited opportunity to acquire the research skills and experience needed for a career as a clinician-investigator. To increase access to more in-depth research opportunities, several medical board-approved graduate medical residency programs have developed ‘fast track,’ ‘short track,’ ‘accelerated,’ or ‘research pathway’ approaches. These programs can support longer durations of protected research time, while meeting the residency clinical requirements approved by respective medical boards. Available outcomes indicate that the clinical competency of pathway graduates is comparable to those participating in traditional residency training 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, most such programs do not offer substantive research opportunities during residency training.

    For health professionals who recognize the critical need to develop new understanding and therapeutic modalities for diseases, performing research during residency training 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 during residency provides an opportunity to build upon prior research experiences. The NIH StARR R38 program is designed to support institutional programs in facilitating unique and fulfilling research opportunities during residency training. Building on successful completion of R38-supported research in residency, additional research and career development during fellowship or early-career faculty can offer StARRTS K38 Transition Scholars essential experience in experimental approaches and additional research experience needed to enhance retention in research and competitiveness for subsequent individual

    career development and research awards.

    The StARRTS K38 program is a limited competition for individuals who have successfully completed the program described in RFA-HL-18-023 Stimulating Access to Research in Residency (StARR) R38 Program. The StARRTS K38 award is designed to sustain and support a path toward a research career . NIH anticipates that Transition Scholar StARRTS K38 awardees will continue research activity after the K38 project period ends. The future research activity  may be supported by Institutional or Individual Mentored Career Development Awards (e.g., KL2, K12, K01, K08, K23, K76, K99) or independent research project grant awards (e.g., R01, R21), depending on research background and experience.

    Program Components

    Transition Scholar awards are intended to further research and career development by providing:

    • Support for 12-24 months of mentored research and career development with the same or a new primary mentor, department, and/or institution as that of the StARR R38 research in residency program. Where relevant, co-mentors can provide additional input on research and career development.
    • An additional career mentor who can advance the Transition Scholar’s access to resources for career advancement, e.g. through professional societies and career development activities. This is intended to broaden the Transition Scholar's professional networks.
    • Strong encouragement to prepare and submit an application for a mentored research career development award (K01, K08, K23, etc.) and/or independent research award before the end of Transition Scholar participation.
    • Support to present research findings, attend scientific conferences and attend an NIH-sponsored workshop and scientific conferences.

    Awards include research development funds to cover the cost of research supplies and professional development activities that will contribute to the successful completion of research. Such funds may be used for the following as appropriate for the proposed research career development plan:

    • Registration fees for short duration courses or workshops that provide research skills such as data science, implementation science or clinical trials, or other justified research-focused skill-building activities.
    • Funds for technical support, including biostatistics consultation and/or technician time to complete research.
    • Fees for workshops on oral and written communication of research and grant writing related to the research project.
    • Funds to develop skills needed for effective research oversight and conduct; skills can include effective communication, time management, understanding 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, etc., as appropriate.

    Prospective Transition Scholars are strongly encouraged to contact the appropriate NIH Program Official as soon as a plan to pursue a fellowship or a faculty position develops. For those candidates going into subspecialty clinical fellowship, the Transition Scholar candidate is responsible for an appropriately timed submission of an application that will align with the research phase of their fellowship program. A thorough assessment of appropriate application timing based on candidate readiness is particularly important for those Transition Scholar applicants who have not yet completed the minimum 12-month R38 StARR program research requirements by submission date.

    Transition Scholars are encouraged to apply to the NIH Loan Repayment Program for qualified educational debt in return for research engagement, if eligibility criteria are met

    Specific Areas of Research Interest of Participating Institutes

    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.

    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—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.

    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. The institute 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 translational research, clinical investigations, population science research, and translational research that moves fundamental discoveries into clinical and public health practice in real world settings. Visit the NHLBI Strategic Vision for research priorities that will help accelerate research and scientific advances over the next decade. To achieve the goals related to this FOA, NHLBI is interested in applications from clinicians (with MD or equivalent degrees) who intend to pursue research in the investigation of heart, lung, blood or sleep diseases for careers as clinician-scientists.

    The National Cancer Institute (NCI) supports and facilitates basic 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 focus 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 to gain research experiences in the fields of biomedical research (including translational research) in these NIAID mission-relevant areas.

    Note: This FOA is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants to this FOA are permitted to propose to gain research experience in a clinical trial led by a mentor or co-mentor.

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

    Section II. Award Information
    Funding Instrument

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

    Application Types Allowed

    New

    Resubmission

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

    Clinical Trial?

    Not Allowed: Only accepting applications that do not propose clinical trials

    Note: Applicants may propose to gain experience in a clinical trial led by a mentor/co-mentor as part of their research career development.

    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 up to $1,367,280 in FY 2020, up to $2,962,440 in FY 2021, and up to $4,215,780 in FY 2022. NHLBI intends to support up to 12 new awards in FY 2020, up to 26 new awards in FY 2021, and up to 37 new awards in FY 2022.

    NIAID intends to commit up to $1,125,000 in annual total costs in FY 2020, FY 2021, and FY 2022 to support up to 9 new K38 awards per fiscal year.

    NCI intends to commit total costs of up to $213,300 in FY 2020, up to $955,800 in FY 2021, and up to $1,595,500 in FY 2022. The NCI intends to support up to 2 new awards in FY 2020, up to 4 new awards in FY 2021, and up to 6 new awards in FY 2022.  

    NIA intends to commit total costs of up to $120,000 per year in FY 2020, FY 2021, and FY 2022 to support up to one new award per fiscal year.

    Award Budget

    Award budgets are composed of salary and other program-related expenses, as described below..

    Award Project Period

    The total project period may not exceed 2 years.

    Other Award Budget Information
    Salary

    NIH will contribute up to $60,000 per year toward the salary of the career award recipient. Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide (see also NOT-OD-17-094).  

    Transition Scholar Compensation: The total salary requested must be based on a full-time appointment and be consistent with the postgraduate year (PGY) salary structure at the applicant institution. During a research year, Transition Scholars in clinical fellowships will be paid 75% of their base PGY salary level set by the institution.

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

    For example, a scholar engages in research for a year at a PGY salary of $75,000, with a monthly salary of $6,250; the K38 award will support 75% effort over 12 months, which equates to 9.0 person-months; the budgeted salary for this participant would be $56,250 ($6,250 x 9.0 or 75% of $75,000).

    Transition Scholars who are early career faculty applicants (as defined in Section III: eligibility information), total salary requested must be based on a full-time appointment. During a research year, Transition Scholar faculty will be paid 50% of their base salary up to a maximum of $60,000. The award will support 50% effort over 12 months, which equates to 6.0 person-months.

    Further guidance on budgeting for career development salaries is provided in the SF 424 (R&R) Application Guide. The total salary may not exceed the legislatively mandated salary cap. See: http://grants.nih.gov/grants/policy/salcap_summary.htm.

    Other Program-Related Expenses

    Transition Scholar Research Funds: Up to $20,000 per research year may be requested for research and career development. Research funds may be used to defray costs for registration for short-term courses or workshops to obtain research skills, to support research-related supervisory and mentor skill development for clinician-investigators, or where well-justified, for technical support and/or personnel to contribute to the transition scholar’s research continuity. Funds may NOT be used for tuition for courses leading to a degree, fees required for clinical board certification, or equipment.

    Transition Scholar Travel: Up to $3,000 each year may be requested for each Transition Scholar 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.

    Indirect Costs

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

    NIH grant 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

    Only fellowship programs recognized by the Accreditation Council for Graduate Medical Education (ACGME) may be included in the proposed program. For Dental Specialty postgraduate programs, only dental specialties approved by the Council on Dental Education and Licensure of the American Dental Association may be included in the proposed program. For veterinary specialties, only veterinary specialties approved by the American Veterinary Medical Association may be included in the proposed program.

    Evidence is required that the overall structure of research and clinical activities outlined in the application is consistent with 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).

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

    Required Registrations

    Applicant Organizations

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

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • o   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. 
    • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

    Eligible Individuals (Program Director/Principal Investigator)

    Transition Scholar Program Director/Principal Investigator (PD/PI). Health professionals who will have successfully completed the Stimulating Access to Research in Residency (StARR) Program (RFA-HL-18-023) and started a clinical fellowship or early career faculty position (as instructor or assistant professor for less than 40 months at the time of submission or resubmission) by the time of the K38 award are eligible and encouraged to apply. While the structure of clinical fellowship training may vary among subspecialties, most include at least one year of clinical training and one year of research training. For applicants in clinical fellowship, the StARRTS K38 program is intended to support the Transition Scholar during their research training year(s). The PD/PI is invited to work with his/her mentor and organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Multiple PDs/PIs are not allowed.

    Transition Scholar K38-supported research and career development may occur at the same or a different institution as that of the NIH StARR R38 funded Institution where the Transition Scholar's research in residency occurred. In most instances, the K38 application should be submitted by the Institution where the Transition Scholar applicant has been appointed as clinical fellow or early career faculty. For other scenarios, applicants are encouraged to contact the appropriate NIH program staff.

    By the time of award, 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 Card USCIS Form I-551, or other legal verification of such status).

    Clinicians (including those with M.D., D.D.S, D.V.M. and other licensed professionals) in positions not designated as postdoctoral (clinical fellowship) positions: Following clinical residency training, some clinicians directly transition to a faculty position that denotes independence in clinical responsibilities but not in research. Clinicians in such positions who have participated in the NIH R38 StARR program are strongly encouraged to obtain confirmation of their eligibility with NIH Institute or Center staff before they begin to prepare their K38 applications. Such individuals may also wish to consider other career awards (see K Kiosk, for example) available for junior faculty development.

    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, and each is from a different candidate.

    The NIH will not accept duplicate or highly overlapping applications under review at the same time. An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, NIH will not accept:

    • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
    • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
    • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
    Level of Effort

    This award is intended to support Transition Scholars research and career development activities during the research training phase of fellowship. During a K38-supported research year, Transition Scholars in fellowship are expected to commit at least 75% professional effort (e.g., 9 person months per year). Recognizing that some R38 StARR resident investigators may directly transition to faculty positions, early career faculty (as defined in Section III: Eligibility Information) are expected to commit at least 50% professional effort. In addition, this K38 award is intended to support Transition Scholars who can document  that sufficient institutional support is available to allow for sufficient protected time to dedicate to K38 mentored research effort. Transition Scholar awardees may concurrently engage in other duties (such as clinical and teaching activities) as part of the remaining effort not covered by the award, as long as such duties do not interfere with or detract from the proposed research and career development activities.

    Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full-time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant participating Institute or Center prior to preparing an application to discuss their eligibility.

    Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in minimum required percent effort, which will be considered on a case-by-case basis. Details on this policy are provided in NOT-OD-09-036.

    The overall structure of research and clinical activities outlined in the application should 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, specialties approved by the Council on Dental Education and Licensure of the American Dental Association, or for veterinarians, specialties approved by the American Veterinary Medical Association.

    Mentor(s), Co-Mentor, Career Support

    Before submitting the application, the candidate must identify a primary mentor who will supervise the proposed career development and research activities. This individual should have both research expertise and a successful track record of mentoring clinician-investigators at the candidate's career stage. Where possible, clinician-investigator co-mentor(s) or career mentor(s) with different professional and research degree backgrounds should have opportunities to meet with both Transition Scholars and primary mentor(s) to discuss effective research career strategies.

    The primary mentor should be an active investigator in the area of the proposed research, and should demonstrate commitment both to the career development of the candidate and to the direct supervision of the candidate’s research. This mentor should document the availability of sufficient research support and facilities for high-quality research. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team (and/or an advisory committee), if this is deemed advantageous for providing expert advice in all aspects of the research and career development program. In such cases of multiple mentors, the application must identify the primary mentor who will coordinate the candidate’s research activities, and include a mentoring plan. The candidate is encouraged to work with the mentor(s) in preparing the application.

    In addition, prior to award, applicants are encouraged to identify a separate career mentor who will serve as a clinician investigator career role model and help broaden the candidate's professional network by providing additional career guidance, advice about research directions and other potential funded research opportunities, and promoting the applicant for national presentations.  The career mentor may be affiliated with the K38 candidate's institution or another institution and is expected to be involved with one or more professional societies important for the Transition Scholar's career as a clinician investigator (e.g. American Thoracic Society, American Heart Association, Society of Black Surgeons, American Hematological Society, Association for Women Radiologists, American Society for Clinical Investigation).

    Institutional Environment

    The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors for clinician investigators.

    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 Career Development (K) 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 may be delayed or not accepted for review.

    Page Limitations

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

    Instructions for Application Submission

    The following section supplements the instructions found in the SF 424 (R&R) Application Guide and should be used for preparing an application to this FOA.

    SF424(R&R) Cover

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

    SF424(R&R) Project/Performance Site Locations

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

    Other Project Information

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

    Project Summary/Abstract

    Include a description of your current research and the research you propose to continue in the independent phase.

    Other Attachments: The attachments listed below must be attached or the application will not be peer reviewed, with the exception of the "Clinical Fellowship Program Director Letter", which must be provided only for clinical fellowship K38 applicants.

    1. Nomination Letters

    Two nomination letters must be provided as an attachment using the filename "Nomination Letters.pdf" and may not exceed 4 pages. The two required nomination letters include: (1) a nomination letter from the PD/PI of the NIH StARR R38 Institutional Research Program in which the K38 applicant is/was an active participant as a Resident-Investigator and (2) a nomination letter from the primary research preceptor who oversaw/is overseeing the R38 mentored research. The nomination letters should provide an assessment of the applicant’s qualifications and potential for investigative research and for a career as a clinician-investigator. Nomination letters should indicate either the dates of participation and the completion date of the R38 program along with achieved milestones, or provide the anticipated R38 completion date and milestones achieved to-date for applicants still in the R38 program. Nomination letters are required whether the K38 Transition Scholar applicant stays at the NIH StARR R38-funded Institution or moves to a new institution.

    2. Clinical Fellowship Program Director Letter

    For clinical fellowship K38 applicants, a letter from the clinical fellowship program director must be provided as an attachment using the filename "Clinical Fellowship Letter.pdf". The letter must affirm the fellowship director's support for the applicant's participation in research and career development activities through the K38 StARRTS program and that the proposed structure and timeline of research and clinical activities is appropriate for the applicant to achieve eligibility for subspecialty board certification and for general board certification (ABIM, ABP, ABS, etc.) for applicants not yet general board certified.

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

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

    R&R Budget

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Career Development Award Supplemental Form

    The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:

    •         Candidate
    •         Research Plan
    •         Other Candidate Information
    •         Mentor, Co-Mentor, Consultant, Collaborators
    •         Environment & Institutional Commitment to the Candidate
    •         Other Research Plan Sections
    •         Appendix

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

    Candidate Section

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

    The Candidate Section should include the following two sections and the suggested length is three pages.

    Candidate’s Background 

    • Previous Research Experience: Briefly describe the overall rationale, hypotheses, and approaches of any research completed before residency leading to an interest in a career as a clinician investigator.
    • Research in Residency: Describe research experience and research skill-building that occurred in the NIH StARR R38 Institutional Research in Residency Program, including a brief rationale for hypotheses and approaches proposed, and a perspective on the work’s significance. Highlight any significant research outcomes, and/or skills and techniques mastered in the R38 program that may contribute to a career as a clinician-investigator.
    • Include a description of the candidate’s professional responsibilities at the R38 grantee institution and their relationship to the proposed activities of this career development award.
    • Describe the candidate’s commitment to a career in biomedical, behavioral or clinical research.

    Candidate's Plan for Career Development/Training Activities During Award Period

    • Provide a description of the career development plan, incorporating the candidate's goals and prior experience, and a career development timeline. The candidate and the mentor are jointly responsible for the preparation of the career development plan. 
    • Describe the professional responsibilities/activities, including periods of clinical activity and any other research projects beyond the minimum required time commitment to this career award (75% full-time professional effort, 9 person-months for fellows; 50% full-time professional effort, 6 person-months for early career faculty). Explain how these responsibilities/activities will lead to research competency, will not interfere with medical board eligibility, and a career as a clinician-investigator.
    • Describe how the proposed activities, e.g., those that may enhance research skills and knowledge, as well as related skills such as grant-writing, communication, leadership, and laboratory management, will lead to the goal of achieving independence as a clinician-investigator.

    Research Plan Section

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

    Research Strategy

    • Research Plan (suggested length is three pages).  It is not expected that the description of the research would be as detailed as an application for individual research award (R01, R21, etc.) or career development awards (e.g., K08 or K23), however sufficient information should be provided to permit a thorough evaluation of the scientific merit of the candidate's proposed K38 research activities and mentored research education program.

    Address the following items: 

    o   Identify the research direction to be pursued in the K38 application and explain the rationale for pursuing this direction. Describe the scientific question to be addressed, the approach(es) to be taken, and the scientific goals to be achieved.

    o   Describe how the proposed research is consistent with the candidate’s level of research development and objectives of his/her career development. Describe how the proposed research and career development plan will enhance the candidate's knowledge, technical expertise, and professional skills, keeping in mind existing strengths as well as any gaps in existing skills.

    • If the applicant is proposing to gain experience in a clinical trial, ancillary clinical trial or a clinical trial feasibility study as part of his or her research career development, describe the relationship of the proposed research project to the clinical trial.

    Training 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). See SF424 (R&R) Application Guide for instructions.

    Mentor, Co-Mentor, Consultant, Collaborators Section

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

    Plans and Statements of Mentor and Co-mentor(s)

    • The candidate must name a primary mentor who, together with the candidate, is responsible for the planning, directing, monitoring, and executing the proposed program. A research preceptor from the StARR R38 institutional research in residency program may continue as mentor, or the applicant may identify a new research mentor. The candidate may also nominate co-mentors as appropriate to the goals of the research project.
    • The research mentor should document the availability of sufficient research funds and facilities for high-quality research.
    • The research mentor should provide a plan describing the nature of the supervision and mentoring that will occur, including how the candidate’s scientific and professional career development will be promoted; and a description of the elements individualized for the applicant, keeping in mind the applicant’s strengths and any gaps in needed skills that are designed to enhance ability to pursue future research. The plan should describe how the mentor will facilitate the applicant’s transition to the next stage of his/her career.
    • Describe the mentor's experience training clinician-investigators. Provide the number of years of mentoring experience, mentoring role (i.e., research advisor, clinical mentor, etc.), the number of clinicians mentored, the specialties of the individual mentees and the current stage in their professional career. In addition, describe the types of research that were conducted by the individuals mentored and the proportion of mentored individuals currently in academic medicine and/or directly participating in biomedical research.
    • If the applicant is proposing to gain experience in a clinical trial as part of his or her research career development, the mentor or a member of the mentoring team must include a statement to document leadership of the clinical trial, and appropriate expertise to guide the applicant in any proposed clinical trials research experience.
    • Applicants whose projects will depend on access to an existing resource, such as an on-going clinical trial, longitudinal study, dataset, biospecimen repository, or equipment, should include a letter of support from the investigator who controls access to the resource committing to making the resource available to applicant.

    Letters of Support from Collaborators, Contributors and Consultants

    Applicants are expected to leave this requirement out of the StARRTS K38 application.

    Environmental and Institutional Commitment to the Candidate

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

    Description of Institutional Environment

    • Describe the sponsoring institution’s scientific environment including the resources and facilities that will be available to the candidate. Describe how the institutional research environment is particularly suited for the candidate’s mentored research and career development during the Transition Scholar phase.
    • Describe the institutional resources and environment for clinician-investigator research and career development. Include a description of the facilities, 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 research project.
    • 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 candidate will benefit from any existing NIH research, training and career development programs, affiliations with other institutions, and academic or non-profit partnerships where Transition Scholars might engage in research.

    Institutional Commitment to the Candidate’s Research Career Development

    • Statement from Departmental Chair:
    • Provide assurance that K38 applicants in clinical fellowship will be able to devote a minimum of 9.0 person months (75%) of full-time professional effort to the proposed Transition Scholar research project.
    • If instead, the K38 applicant is an early career faculty (as defined in Section III: Eligibility Information), the statement should discuss how the applicant will receive protected time to dedicate towards research activities such that it adds up to 50% effort (6 person months), and describe the institutional commitment to enhancing the applicant's ability to be a productive, independent investigator.

    Appendix

    Limited items are allowed in the Appendix.  Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

    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 a 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 with the following additional instructions:

    • Do not complete Section 4 – Protocol Synopsis information or Section 5 - Other Clinical Trial-related Attachments.

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

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

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

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

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

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

    7. Other Submission Requirements and Information

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

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

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

    Important reminders:

    All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

    See more tips for avoiding common errors.

    Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by 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.

    Overall Impact

    Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate’s potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.

    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.

    Candidate

    • How do the candidate's prior experiences/accomplishments/environment suggest that she/he has the potential to develop as a productive clinician-researcher?
    • How strongly does the application demonstrate that the proposed research and career development plan and protected time will relieve the candidate from non-research institutional service and administrative duties and allow him/her to devote sufficient time and augment his/her capabilities in research?
    • To what extent will the award contribute to the academic and research career development of the candidate in his/her chosen field?
    • Based on the letter of nomination from the PD/PI of the Transition Scholar applicant's previous StARR R38 Institutional Research in Residency Program, what is the candidate's potential for productivity in research and as a clinician-investigator?
    • How strongly supportive is the letter from the applicant's primary preceptor overseeing R38 mentored research in assessing the applicant’s qualifications and potential for investigative research, and for a career as a clinician-investigator?
    • What is the likelihood that the candidate will become a successful independent investigator who will contribute significantly to a chosen health-related research field?

    Career Development Plan

    • How appropriate are the candidate's prior training and research experiences for this award?
    • How relevant and appropriate are the content, scope, phasing, and duration of the career development plan for achieving research independence when considered within the context of prior training/research experience and the stated training and research objectives?
    • Are there adequate plans for monitoring and evaluating the candidate’s research and career development progress?
    • If applicable, do the structured activities such as workshops, seminars or technical workshops, etc., meet the career goals of the candidate?
    • How appropriate are the planned timelines for the candidate’s progress?
    • How strong is the evidence that the candidate will be able to dedicate the required minimum (75% of full-time effort for clinical fellows or 50% effort for early career faculty) to research and related duties by limiting other responsibilities (e.g, teaching, administration, and/or clinical work)?
    • How feasible are the proposed research and career development plans for providing appropriate time to perform required clinical activities?
    • If proposed, how will the clinical trial experience contribute to the applicant's research career development?
    • Research PlanHow rigorous is the prior research that serves as the key support for the proposed project?
    • How strong are the candidate's  plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project?
    • To what extent has the candidate presented strategies that will ensure a robust and unbiased approach, as appropriate for the proposed work?
    • How adequate are the plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
    • Are the proposed research question, design, and methodology of significant scientific and technical merit?
    • How relevant is the research plan to the candidate’s stage of research development and career objectives? To what extent will the research plan facilitate development of the research skills described in the career development plan?
    • If proposed, how will the clinical trial experience contribute to the proposed research project?

    Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

    • Are the qualifications of the mentor(s) including current and pending research support, prior research experience, and mentoring track record appropriate and adequate for guiding the candidate in meeting the goals of the award?
    • Is the collective expertise, roles and responsibilities of any co-mentors, consultants, and/or collaborators likely to enhance the candidate’s career development?
    • Do the mentor(s) adequately address the candidate’s potential and his/her strengths and areas needing improvement?
    • Are there adequate plans for monitoring and evaluating the career development awardee’s progress toward independence?
    • If the applicant is proposing to gain experience in a clinical trial as part of his or her research career development, is there evidence of the appropriate expertise, experience, and ability on the part of the mentor(s) to guide the applicant during participation in the clinical trial?

    Environment & Institutional Commitment to the Candidate

    • Are the quality of the scientific environment and relevance to the candidate’s professional academic and scientific development, including any unique features of the scientific environment beneficial to the candidate, adequate and appropriate?
    • Are there unique features of the scientific environment of the institution(s) that will benefit the proposed research and career development plan (e.g., useful collaborative arrangements, special equipment or analytic methods, unique subject populations)?
    • Is there clear commitment of the sponsoring institution to ensure that the required minimum of the candidate’s effort will be devoted directly to the research and career development described in the application, with the remaining percent effort being devoted to an appropriate balance of clinical, teaching, and/or administrative responsibilities?
    • For clinical fellow candidates, is there adequate assurance that the required minimum of 9.0 person-months (75% of the candidate’s full-time professional effort) will be devoted directly to the research skills development, career development, and research activities proposed for the K38?
    • For early career faculty candidates, is there adequate assurance that the required minimum of 6.0 person-months (50% of the candidate’s full-time professional effort) will be devoted to research skills development, career development, and research activities proposed for the K38 or other related research activities?
    Additional Review Criteria

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

    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 across the lifespan (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

    Vertebrate Animals

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

    Biohazards

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

    Resubmissions

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

    Renewals

    Not Allowed

    Revisions

    Not Allowed

    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.

    Training in the Responsible Conduct of Research

    All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR).  Taking into account the level of experience of the applicant, including any prior instruction or participation in RCR as appropriate for the applicant’s career stage, 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 mentor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction –instruction must occur during each career stage and at least once every four years.  Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019.

    Select Agent Research

    Reviewers will assess the information provided in this section of the application, including (1) the Select Agent(s) to be used in the proposed research, (2) the registration status of all entities where Select Agent(s) will be used, (3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and (4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

    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 (GDS).

    Authentication of Key Biological and/or Chemical Resources

    For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

    Budget and Period of Support

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

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s),convened by participating Institutes/Centers, 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 for 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 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 grantee’s business official.

    Awardees 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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants. More specifically, for K Awards, visit the Research Career Development (“K”) Awardees section of the NIH Grants Policy Statement.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. 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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

    3. Reporting

    When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. The Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

    A final RPPR, invention statement, 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.

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

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

    4. Evaluation

    In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

    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 Transition Scholar program, the participating NIH Institutes/Centers expect to use the following evaluation measures:

    • Aggregate number and demographic characteristics of participants
    • Subsequent educational/career progress, including:
    • Subsequent presentations of research completed in this program
    • Subsequent authorship of scientific publications
    • Subsequent participation in research
    • Subsequent employment in a research or research-related field
    • Subsequent research grant support including other individual K awards or independent research awards from NIH or another source
    Section VII. Agency Contacts

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

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post submission issues)
    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)

    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    GrantsInfo (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)

    Telephone: 301-945-7573

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

    Scientific/Research Contact(s)

    Neil Aggarwal, M.D.
    National Heart Lung and Blood Institute (NHLBI)
    Telephone: 301-827-7820
    Email: neil.aggarwal@nih.gov

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


    Shawn Gaillard, Ph.D.
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-627-3857
    Email: shawn.gaillard@nih.gov

    Basil Eldadah, M.D., Ph.D.
    National Institute on Aging (NIA)
    Telephone: 301-496-6761
    Email: basil.eldadah@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

    Priti Mehrotra, M.Sc., Ph.D.
    National institute on Allergy and Infectious Diseases (NIAID)
    Telephone: 240-669-5375
    Email: pmehrotra@niaid.nih.gov

    Ramesh Vemuri, Ph.D.
    National Institute on Aging (NIA)
    Telephone: 301-496-9666
    Email: ramesh.vemuri@nih.gov

    Financial/Grants Management Contact(s)

    Reggie Brown
    National Heart, Lung, and Blood Institute (NHLBI)
    Telephone: 301-435-0166
    Email: brownreg@nhlbi.nih.go

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

    Mable Nee
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 301-761-7593
    Email: mable.nee@nih.gov


    John Bladen
    National Institute on Aging (NIA)
    Telephone: 301-402-7730
    Email: jbladen@mail.nih.gov


    Section VIII. Other Information

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

    Authority and Regulations

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

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