RFA-HL-27-010-Revised-Full-Announcement.html

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

Check for any recent Notices of NIH Policy Changes that may impact application requirements.

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

November 09, 2026

November 09, 2026

Not Applicable

July 2027

June 11, 2027

June 11, 2027

Not Applicable

April 2028

October 13, 2027

October 13, 2027

Not Applicable

July 2028

October 13, 2028

October 13, 2028

Not Applicable

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.

Table of Contents

Part 1. Overview Information Key Dates Part 2. Full Text of Announcement Section I. Funding Opportunity Description Section II. Award Information Other Award Budget 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 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:

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:

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:

Applications that propose research objectives that are not aligned with the mission of the participating ICs

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.

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 $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.

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

Other Project Information

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

R&R Budget

PHS 398 Cover Page Supplement

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

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

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

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:

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)

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

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

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).

PHS Assignment Request Form

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…