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 Institute of Allergy and Infectious Diseases (NIAID)

National Cancer Institute (NCI)

Note: Not all NIH Institutes, Centers, and Offices (ICOs) participate in Announcements. Applicants should carefully note which ICOs participate in this announcement and view their respective areas of research interest at the ICO-Specific Scientific Interests website. ICOs that do not participate in this announcement will not consider applications for funding.

Funding Opportunity Title
Limited Competition: Stimulating Access to Research in Residency Transition Scholar (StARRTS) (K38 Clinical Trial Not Allowed)
Activity Code
K38 Early Stage Mentored Research and Career Development
Announcement Type
Reissue of RFA-HL-23-007
Related Notices
Funding Opportunity Number (FON)
RFA-HL-27-010
Companion Notice of Funding Opportunity
None
Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.837, 93.839, 93.840, 93.233, 93.838, 93.398, 93.855
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-26-012 and previous NOFOs) as resident-investigators. Individuals who receive K38 grants described in this Notice of Funding Opportunity (NOFO) will be referred to as Transition Scholars. The intent of this NOFO is to provide Transition Scholars with opportunities for additional research and career development during subsequent clinical fellowships 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 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 is a Notice of Funding Opportunity (NOFO) for a Limited Competition that will invite application(s) from eligible organization(s) to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding.

This Notice of Funding Opportunity (NOFO) 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. Under this NOFO applicants are permitted to propose a research experience in a clinical trial led by a mentor or co-mentor.

Funding Opportunity Announcement Goal(s)

The National Heart, Lung, and Blood Institute (NHLBI) provides global leadership for a research, training, and education program to promote the prevention and treatment of heart, lung, blood, and sleep conditions and enhance the health of all individuals so that they can live longer and more fulfilling lives.

Key Dates

Posted Date
October 09, 2026
Open Date (Earliest Submission Date)
October 09, 2026
Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
November 09, 2026 November 09, 2026 Not Applicable March 2027 May 2027 July 2027
June 11, 2027 June 11, 2027 Not Applicable November 2027 January 2028 April 2028
October 13, 2027 October 13, 2027 Not Applicable March 2028 May 2028 July 2028
October 13, 2028 October 13, 2028 Not Applicable March 2029 May 2029 July 2029

All applications are due by 5:00 PM local time of applicant organization.

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

Expiration Date
October 14, 2028
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The overall purpose of the NIH Research Career Development program is to help ensure that a 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 Research Training and Career Development website.

This is a Notice of Funding Opportunity (NOFO) for a Limited Competition that will invite application(s) from eligible organization(s) to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding.

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-26-012 and previous NOFOs) as resident-investigators. Individuals who are awarded K38 grants described in this NOFO will be referred to as Transition Scholars. The intent of this NOFO is to provide Transition Scholars with opportunities for additional research and career development during subsequent clinical fellowships 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 recipients 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.

The StARRTS K38 Transition Scholar candidate 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 candidate 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.

The StARRTS K38 program is a limited competition for individuals who have successfully completed the program described in RFA-HL-26-012 Stimulating Access to Research in Residency (StARR) R38 Program for at least 12, and up to 24, months. The StARRTS K38 award is designed to sustain and support a path toward a research career. NIH anticipates that Transition Scholar StARRTS K38 recipients will continue research activity after the K38 project period ends. The future research activity may be supported by I Career Development or independent research project grant awards, 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.

Applications Not Responsive to this NOFO

The following types of applications are not responsive to this NOFO and will not be reviewed:

Note: This Notice of Funding Opportunity (NOFO) is designed specifically for proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Under this NOFO, candidates are permitted to propose a 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 financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New
Resubmission

Only those application types listed here are allowed for this NOFO.

The OER Glossary and the How to Apply - Application Guide provides details on these application types.

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.

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 $6,444,000 in FY 2027-2029 to support up to 6 new K38 awards per fiscal year.

NIAID intends to commit up to $2,180,000 in total costs in FY 2027-2029 to support up to 2 new K38 awards per fiscal year.

NCI intends to commit up to $2,180,000 in total costs in FY 2027-2029 to support up to 2 new K38 awards 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 $100,000 per year toward the salary of the career award recipient plus fringe benefits. 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 $90,000, with a monthly salary of $7,500; 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 $67,500 ($7,500 x 9.0 or 75% of $90,000).

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 $100,000. The award will support 50% effort over 12 months, which equates to 6.0 person-months.

For example, a scholar engages in research for a year at a faculty salary of $150,000, with a monthly salary of $12,500; the K38 award will support 50% effort over 12 months, which equates to 6.0 person-months; the budgeted salary for this participant would be $75,000 ($12,500 x 6.0 or 50% of $150,000).

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible 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 Organizations/International Collaborations

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

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

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

NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement 2.3.9.2 Electronically Submitted Applications for additional information.

  • 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. Foreign organizations must obtain a NATO Commercial and Government Entity (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. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; 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.  Obtaining an eRA Commons account can take up to 2 weeks.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Eligible Individuals (Program Director/Principal Investigator)

Transition Scholar Program Director/Principal Investigator (PD/PI). Health professionals who have successfully completed the Stimulating Access to Research in Residency (StARR) Program (RFA-HL-26-012 and previous NOFOs) 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 candidates 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. 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 candidate has been appointed as a 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 NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

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.

NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

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 Institute or Center prior to preparing an application to discuss their eligibility.

After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances. See NOT-OD-18-156 and NIH Grants Policy Statement, Section 12.3.6.4 Temporary Adjustments to the Percent Effort Requirement for more details.

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

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Career Development (K) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

Project Summary/Abstract

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

Other Attachments: All candidates must include the Nomination Letters; the "Clinical Fellowship Program Director Letter" must be provided only for clinical fellowship K38 candidates.

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 candidate 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 candidate'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 candidates still in the R38 program. Nomination letters are required whether the K38 Transition Scholar candidate stays at the NIH StARR R38-funded Institution or moves to a new institution.

2. Clinical Fellowship Program Director Letter

For clinical fellowship K38 candidates, 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 candidate'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 candidate to achieve eligibility for subspecialty board certification and for general board certification (ABIM, ABP, ABS, etc.) for candidates not yet general board certified.

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

All instructions in the How to Apply - Application Guide must be followed.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - 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 How to Apply - Application Guide must be followed.

Candidate Section

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

Candidate Information and Goals for Career Development

Candidate's Background

  • 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.
  • Describe the candidate's professional responsibilities at the R38 grantee institution and their relationship to the proposed activities of this career development award.

Career Goals and Objectives

  • Describe a systematic plan: (1) that shows a logical progression from prior research and training experiences to the research and career development experiences that will occur during the career award period and then to independent investigator status; and (2) that justifies the need for further career development to become an independent investigator. 

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

  • The candidate and the mentor(s) are jointly responsible for the preparation of the career development plan. A career development timeline is often helpful.  
  • The didactic (if any) and the research aspects of the plan must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the candidate's career goals. 
  • Describe the professional responsibilities/activities including other research projects beyond the minimum required 9 person months (75% full-time professional effort) commitment to the career award.  Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator.

Research Plan Section

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Research Strategy

The suggested length for the Research Strategy 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:

  • A sound research project that is consistent with the candidate's level of research development and objectives of their career development plan must be provided. The research description should demonstrate the quality of the candidate's research thus far and also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the research.
  • The application must also describe the relationship between the mentor's research and the candidate's proposed research plan.
  • 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.
  • 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 candidate 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.
  • If proposing a feasibility study, to begin to address a clinical question, provide justification why this is warranted and how it will contribute to the overall goals of the research project including planning and preliminary data for future, larger scale clinical trials.

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 How to Apply - Application Guide for instructions.

Mentor, Co-Mentor, Consultant, Collaborators Section

All instructions in the How to Apply - 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. The candidate may also nominate co-mentors as appropriate to the goals of the program.   
  • The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award. 
  • Include a statement that the candidate will commit at least 9 person months (75% of full-time professional effort) to the career development program and related career development activities. 
  • The application must include a statement from the mentor providing: 1) information on their research qualifications and previous experience as a research supervisor; 2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period; 3) a plan for career progression for the candidate to move from the mentored stage of their career to independent research investigator status during the project period of the award; and 4) a plan for monitoring the candidate's research, publications, and progression towards independence. 
  • Similar information must be provided by any co-mentor. If more than one co-mentor is proposed, the respective areas of expertise and responsibility of each should be described. Co-mentors should clearly describe how they will coordinate the mentoring of the candidate. If any co-mentor is not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of face-to-face meetings. 
  • The mentor must agree to provide annual evaluations of the candidate's progress as required in the annual progress report.
  • If the candidate 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 candidate in any proposed clinical trials research experience.

Environmental and Institutional Commitment to the Candidate

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

Description of Institutional Environment

  • The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate. 
  • Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.

Institutional Commitment to the Candidate’s Research Career Development

  • The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award. 
  • Provide assurances that the candidate will be able to devote the required effort to activities under this award. The remaining effort should be devoted to activities related to the development of the candidate's career as an independent scientist. 
  • Provide assurances that the candidate will have access to appropriate office and laboratory space, equipment, and other resources and facilities (including access to clinical and/or other research populations, as applicable) to carry out the proposed research plan. 
  • Provide assurance that appropriate time and support will be available for any proposed mentor(s) and/or other staff consistent with the career development plan.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

  • A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format . Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. 

Appendix:

Limited items are allowed in the Appendix.  Follow all instructions for the Appendix as described in the How to Apply - Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - 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 How to Apply - Application Guide must be followed.

The following additional instructions apply:

  • For NOFOs that do not allow independent clinical trials, 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 How to Apply - Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

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

See Part 2. 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. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply – 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 Section 7.9.1 Selected Items of Cost .

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 How to Apply - 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. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - 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. 

Mandatory Disclosure

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov. 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described 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.

 

Specific to this NOFO:

  • To what extent will the award contribute to the academic and research career development of the candidate in his/her chosen field?

 

Specific to this NOFO:

  • 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 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?

 

Specific to this NOFO:

  • How 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?

 

Specific to this NOFO:

  • Do the mentor(s) adequately address the candidate's potential and his/her strengths and areas needing improvement?

 

Specific to this NOFO:

  • To what extent 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)?
  • 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?
  • 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)?

Additional Review Criteria

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

 

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

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

This NOFO only accepts applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.


 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research. 


 

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.


 

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


 

For Resubmissions (as applicable), 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.


 

For Renewals (as applicable), the committee will consider the progress made in the last funding period.


 

For Revisions (as applicable), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.


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.

 

All applications for support under this NOFO 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 candidate, including any prior instruction or participation in RCR as appropriate for the candidate'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 and NOT-OD-22-055.


 

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).


 

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.


 

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.


 

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 policies and practices, 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.

Requests for reconsideration of initial peer review will not be accepted for applications submitted in response to this NOFO.

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 Announcement. Following initial peer review, recommended applications will receive a second level of review by the National Heart, Lung, and Blood Advisory Council.

The following will be considered in making funding decisions:
  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant's federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant's integrity, business ethics, and performance record of managing Federal awards per 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. 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 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient's business official.

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk. For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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 recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director's Statement of Priorities, entitled "Advancing NIH's Mission Through a Unified Strategy." 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

  • ongoing and consistent access to HHS owned or operated information or operational technology systems; and
  • receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Cybersecurity plans and procedures must at minimum include the following:

  • Develop cybersecurity plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data:
    • Identify:
      • Develop an inventory of all assets and accounts with access to HHS owned and operated information or operational technology systems or which obtain PII or PHI for the purposes of the award.
    • Protect:
      • Limit access to HHS owned and operated systems to only those in need of access to complete reward activities.
      • Require all staff to complete annual cybersecurity and privacy awareness training. Visit 405(d): Knowledge on Demand (hhs.gov) to obtain free trainings, if needed.
      • Enable multifactor authentication for all employees, subrecipients, and third-party entities to access HHS owned and operated information or operational technology systems.
      • Regularly backup sensitive data and test backups.
    • Detect:
      • Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.
    • Respond:
      • Develop an incident response plan. See Incident-Response-Plan-Basics_508c.pdf (cisa.gov) to learn about developing incident response plans.
      • Have cybersecurity incident reporting procedures that ensure the relevant HHS awarding agencies are notified of a cybersecurity incident within 48 hours of discovery. A cybersecurity incident is defined as an unplanned interruption to a technology service or reduction in the quality of a technology service, or an occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
    • Recover:
      • Investigate incidents and plug any security gaps identified. 

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings.  Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety.  If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.

For applications involving funding Medication-Assisted Treatment (MAT) or medications for opioid use disorder (MOUD), this funding should be used to provide comprehensive treatment and recovery support services rather than medication-only models for opioid use disorder. Services should include medications, where clinically indicated, in conjunction with psychosocial and other treatment and recovery support services. Funding can also be used to support individualized tapering and discontinuation of medications when clinically indicated. Please see Updated Funding Guidance for Recipients on  MAT/MOUD.

As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.

In administering programs under this and all funding announcements, NIH prioritizes: 

  • Research involving rigorous scientific methods, including for studies related to children and adolescents, where NIH is committed to approaches that reflect the highest standards of clinical care and child safety. 
  • Biological and physiological integrity: Recognizing the relevance of biological sex to health outcomes, NIH encourages applicants to account for sex-based health factors in program design, data collection, and service delivery where scientifically appropriate.
  • NIH will implement these priorities consistent with applicable laws, regulations, court orders, and all required administrative procedures. Applicants are encouraged to describe how their proposed programs align with these priorities in their project narratives. Funded activities must advance NIH's vision of protecting and improving the health and well-being of Americans. The particular focus is on those who are medically vulnerable, or live in areas with limited access to care. NIH's duty is to serve wisely, effectively, and with measurable results that justify every taxpayer dollar invested. 

3. Data Management and Sharing

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page . The DMS Plan must address the elements in the structured format . Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. 

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. For mentored awards, the Mentor's Report must include an annual evaluation statement of the candidate's progress. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. NIH NOFOs 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 2 CFR 200.301.

5. Evaluation

In carrying out its stewardship of human resource-related programs, 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

.

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.

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

Scientific/Research Contact(s)

StARRTS Program
National Heart, Lung, and Blood Institute (NHLBI)
Email: NHLBI_K38@nhlbi.nih.gov
Subject: RFA-HL-27-010

Center for Cancer Training
National Cancer Institute (NCI)
Telephone: 240-276-5630
Email: NCIK38@nih.gov

National Institute of Allergy and Infectious Diseases (NIAID)
Email: AITrainingHelpDesk@niaid.nih.gov
 

Peer Review Contact(s)

Center for Scientific Review (CSR)
Email: NOFOReviewContact@csr.nih.gov

Financial/Grants Management Contact(s)

Office of Grants Management
National Heart, Lung, and Blood Institute (NHLBI)
Email: NHLBIOGMInbox@nhlbi.nih.gov
Subject: RFA-HL-27-010

NIAIDFinancial-GrantsContact@mail.nih.gov 

Office of Grants Administration
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: NCIFinancialContact@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.

Please note that the NIH Loan Repayment Programs (LRPs) are a set of programs to attract and retain promising early-stage investigators in research careers by helping them to repay their student loans. Recipients of career development awards are encouraged to consider applying for an extramural LRP award.

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.