EXPIRED
September 9, 2019
September 17, 2019
Not Applicable
November 18, 2019; October 15, 2020; October 15, 2021, by 5:00 PM local time of applicant organization.
All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s). Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
January 14, 2020; January 14, 2021; January 14, 2022, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
April 2020, March 2021, March 2022
May 2020, May 2021, May 2022
July 2020, July 2021, July 2022
January 15, 2022
Not Applicable
It is critical that applicants follow the Career Development (K) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section
I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals.More information about Career programs may be found at the NIH Extramural Training Mechanisms website.
Purpose
The purpose of the Stimulating Access to Research in Residency Transition Scholar (StARRTS) K38 Career Development program is to retain and support clinician investigators who have successfully completed the Stimulating Access to Research in Residency (StARR) R38 Program (RFA-HL- 18-023) as resident-investigators. Individuals who are awarded K38 grants described in this FOA will be referred to as Transition Scholars. The intent of this FOA is to provide Transition Scholars with opportunities for additional research and career development during subsequent clinical fellowship or early career faculty appointments (as defined in Section III. 3. Additional Information on Eligibility). It is anticipated that the StARRTS K38 program will provide a pathway to retain the newly-created pool of clinician-investigators generated through the StARR R38 program. Transition Scholars grantees will receive support for continued research and career development opportunities in basic, clinical and/or translational research thereby providing enhanced potential to accelerate the transition to independent research careers.
This FOA is intended to support only individuals who have successfully participated in the StARR R38 program for at least 12, and up to 24 months.. The StARRTS K38 Transition Scholar applicant can propose a research and career development plan at the same, or different department or institution as the Institutional StARR R38 research program in which he or she successfully participated.At the K38 Transition Scholar career stage, participants typically have clinical responsibilities in addition to research activities; for this reason, the proposed research activities should fall within an overall program structure consistent with appropriate medical board, dental or veterinary specialty eligibility.
In general, research projects described in the StARRTS K38 application should fall within the mission of the NIH Institute/Center which supported the StARR R38 program in which the Transition Scholar applicant has successfully participated. In certain instances, with funds permitting, the programmatic management of the StARRTS K38 award may be transferred to another NIH Institute or Center (IC) participating in the StARR R38 program based on scientific content and according to established NIH referral guidelines.
Background
There is a critical workforce need for clinician-scientists/investigators, i.e., those with clinical experience who conduct research and offer skills and perspectives directly related to human health, disease conditions, clinical decision-making, diagnoses, prevention, and improving health outcomes. Despite existing opportunities, relatively few physicians and other health professionals are pursuing research careers, and current opportunities may not maintain adequate numbers or diversity of clinician-scientists (ACD Physician Scientist Workforce Report, 2014). The overall size of the current clinician-investigator workforce constitutes a small proportion of all NIH-funded research investigators, and this is particularly true for early-stage clinician-investigators.
Novel strategies are needed to recruit, prepare, and retain more clinician-investigators from the large pool of potential researchers with health professional doctorates. Among today’s NIH-funded clinician-investigators, about 60% hold a single health professional degree and 40% hold both health professional and research doctorate degrees. Women and individuals from underrepresented racial and ethnic groups represent a particularly low proportion of this workforce. Each year in the United States, some 18,000 individuals earn an MD, while 600 individuals earn MD/PhDs; these data suggest that recruitment of even a slightly greater proportion of MDs, and retention of more MDs and MD/PhDs in research careers, could significantly enhance the clinician-investigator workforce.
Providing significant research opportunities during post-doctoral clinical training periods may be one strategy to enhance the clinician-investigator workforce, yet the typical graduate medical education ( residency ) period offers limited opportunity to acquire the research skills and experience needed for a career as a clinician-investigator. To increase access to more in-depth research opportunities, several medical board-approved graduate medical residency programs have developed fast track, short track, accelerated, or research pathway approaches. These programs can support longer durations of protected research time, while meeting the residency clinical requirements approved by respective medical boards. Available outcomes indicate that the clinical competency of pathway graduates is comparable to those participating in traditional residency training programs. Many research pathway graduates subsequently hold positions in academic medicine, report research activity, and contribute substantial professional effort in research as clinician-investigators. However, most such programs do not offer substantive research opportunities during residency training.
For health professionals who recognize the critical need to develop new understanding and therapeutic modalities for diseases, performing research during residency training can provide valuable experience and an early on-ramp to a research career. It is also recognized that many MDs/health professionals as well as MD/PhDs have had previous research experience, and research during residency provides an opportunity to build upon prior research experiences. The NIH StARR R38 program is designed to support institutional programs in facilitating unique and fulfilling research opportunities during residency training. Building on successful completion of R38-supported research in residency, additional research and career development during fellowship or early-career faculty can offer StARRTS K38 Transition Scholars essential experience in experimental approaches and additional research experience needed to enhance retention in research and competitiveness for subsequent individual
career development and research awards.
The StARRTS K38 program is a limited competition for individuals who have successfully completed the program described in RFA-HL-18-023 Stimulating Access to Research in Residency (StARR) R38 Program. The StARRTS K38 award is designed to sustain and support a path toward a research career . NIH anticipates that Transition Scholar StARRTS K38 awardees will continue research activity after the K38 project period ends. The future research activity may be supported by Institutional or Individual Mentored Career Development Awards (e.g., KL2, K12, K01, K08, K23, K76, K99) or independent research project grant awards (e.g., R01, R21), depending on research background and experience.
Program Components
Transition Scholar awards are intended to further research and career development by providing:
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
Specific Areas of Research Interest of Participating Institutes
The participating NIH Institutes have provided a brief outline of their interests as they relate to the goals of this FOA. These mission statements are intended to indicate the breadth of the biomedical areas of interest.
The National Institute on Aging supports research to advance our understanding of the nature of aging and the aging process, as well as diseases and conditions associated with growing older, in order to extend the healthy, active years of life. NIA s Division of Aging Biology supports molecular, cellular, and genetic research on the mechanisms of aging. The Division of Behavioral and Social Research supports social, behavioral, and economic research on the processes of aging at both the individual and societal level, including cross-disciplinary research, at multiple levels from genetics to cross-national comparative research, and at stages from basic through translational. The Division of Geriatrics and Clinical Gerontology supports clinical and translational research on health and disease in the aged, and research on aging over the human lifespan, including its relationships to health outcomes, with foci that include translational research for the development of new interventions for age-related conditions, prevention and treatment of multiple chronic conditions in the elderly, and studies that help to promote evidence-based geriatric care and inform policies affecting older adults. The Division of Neuroscience supports collaborative research to further the understanding of neural and behavioral processes associated with the aging brain. Research on dementias of old age in particular Alzheimer’s disease is one of the program’s highest priorities. Note: The NIA will support only investigators in clinical fellowship under this FOA. Investigators interested in research support as early career faculty are encouraged to consider NIA's GEMSSTAR program.
The National Heart, Lung, and Blood Institute (NHLBI) supports a broad research and training portfolio in the treatment and prevention of heart, lung, blood, and sleep diseases. The institute is tasked with combating not only the major causes of death and disability but also rare disorders such as congenital heart disease, sickle cell disease, thalassemia, and pulmonary fibrosis. The NHLBI’s research programs span the entire research spectrum comprising fundamental discovery science, early translational research, clinical investigations, population science research, and translational research that moves fundamental discoveries into clinical and public health practice in real world settings. Visit the NHLBI Strategic Vision for research priorities that will help accelerate research and scientific advances over the next decade. To achieve the goals related to this FOA, NHLBI is interested in applications from clinicians (with MD or equivalent degrees) who intend to pursue research in the investigation of heart, lung, blood or sleep diseases for careers as clinician-scientists.
The National Cancer Institute (NCI) supports and facilitates basic research in all areas of cancer biology and investigates the biological aspects of every form of cancer, carrying out studies that range from targeted, long-running projects that are revealing the microscopic details of cell processes to high-risk, innovative research that holds promise for providing key insights into tumor development; research in cancer surveillance, epidemiology, health services, behavioral science, and cancer survivorship; research to assess a person's risk of developing cancer and to find ways to reduce that risk; research focus across the continuum between the initiation of the cancer process and the occurrence of the invasive disease, with the goal of detecting changes and intervening early in the cancer process to prevent disease and death; research that facilitates the path to clinical application of promising cancer detection, diagnosis, and treatment methods; it also expedites the initial small-scale and subsequent large-scale testing of new anticancer agents, biomarkers, imaging tests, and other therapeutic interventions in patients; cancer health disparities and community-based participatory research; research in HIV/AIDS and HIV malignancies.
The National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. For more than 60 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions. Specifically, our areas of study are HIV/AIDS, infectious diseases, and allergy, immunology, and transplantation research. Applications for this program would be appropriate for NIAID if they propose to gain research experiences in the fields of biomedical research (including translational research) in these NIAID mission-relevant areas.
Note: This FOA is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants to this FOA are permitted to propose to gain research experience in a clinical trial led by a mentor or co-mentor.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
New
Resubmission
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
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?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
The following NIH components intend to commit the following amounts:
NHLBI intends to commit total costs of up to $1,367,280 in FY 2020, up to $2,962,440 in FY 2021, and up to $4,215,780 in FY 2022. NHLBI intends to support up to 12 new awards in FY 2020, up to 26 new awards in FY 2021, and up to 37 new awards in FY 2022.
NIAID intends to commit up to $1,125,000 in annual total costs in FY 2020, FY 2021, and FY 2022 to support up to 9 new K38 awards per fiscal year.
NCI intends to commit total costs of up to $213,300 in FY 2020, up to $955,800 in FY 2021, and up to $1,595,500 in FY 2022. The NCI intends to support up to 2 new awards in FY 2020, up to 4 new awards in FY 2021, and up to 6 new awards in FY 2022.
NIA intends to commit total costs of up to $120,000 per year in FY 2020, FY 2021, and FY 2022 to support up to one new award per fiscal year.
Award budgets are composed of salary and other program-related expenses, as described below..
The total project period may not exceed 2 years.
NIH will contribute up to $60,000 per year toward the salary of the career award recipient. Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide (see also NOT-OD-17-094).
Transition Scholar Compensation: The total salary requested must be based on a full-time appointment and be consistent with the postgraduate year (PGY) salary structure at the applicant institution. During a research year, Transition Scholars in clinical fellowships will be paid 75% of their base PGY salary level set by the institution.
Transition Scholar salary should be calculated for the months of full-time research engagement over a year:
For example, a scholar engages in research for a year at a PGY salary of $75,000, with a monthly salary of $6,250; the K38 award will support 75% effort over 12 months, which equates to 9.0 person-months; the budgeted salary for this participant would be $56,250 ($6,250 x 9.0 or 75% of $75,000).
Transition Scholars who are early career faculty applicants (as defined in Section III: eligibility information), total salary requested must be based on a full-time appointment. During a research year, Transition Scholar faculty will be paid 50% of their base salary up to a maximum of $60,000. The award will support 50% effort over 12 months, which equates to 6.0 person-months.
Further guidance on budgeting for career development salaries is provided in the SF 424 (R&R) Application Guide. The total salary may not exceed the legislatively mandated salary cap. See: http://grants.nih.gov/grants/policy/salcap_summary.htm.
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 (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.
NIH grant policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
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).
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to
apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Transition Scholar Program Director/Principal Investigator (PD/PI). Health professionals who will have successfully completed the Stimulating Access to Research in Residency (StARR) Program (RFA-HL-18-023) and started a clinical fellowship or early career faculty position (as instructor or assistant professor for less than 40 months at the time of submission or resubmission) by the time of the K38 award are eligible and encouraged to apply. While the structure of clinical fellowship training may vary among subspecialties, most include at least one year of clinical training and one year of research training. For applicants in clinical fellowship, the StARRTS K38 program is intended to support the Transition Scholar during their research training year(s). The PD/PI is invited to work with his/her mentor and organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Multiple PDs/PIs are not allowed.
Transition Scholar K38-supported research and career development may occur at the same or a different institution as that of the NIH StARR R38 funded Institution where the Transition Scholar's research in residency occurred. In most instances, the K38 application should be submitted by the Institution where the Transition Scholar applicant has been appointed as clinical fellow or early career faculty. For other scenarios, applicants are encouraged to contact the appropriate NIH program staff.
By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).
Clinicians (including those with M.D., D.D.S, D.V.M. and other licensed professionals) in positions not designated as postdoctoral (clinical fellowship) positions: Following clinical residency training, some clinicians directly transition to a faculty position that denotes independence in clinical responsibilities but not in research. Clinicians in such positions who have participated in the NIH R38 StARR program are strongly encouraged to obtain confirmation of their eligibility with NIH Institute or Center staff before they begin to prepare their K38 applications. Such individuals may also wish to consider other career awards (see K Kiosk, for example) available for junior faculty development.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, NIH will not accept:
This award is intended to support Transition Scholars research and career development activities during the research training phase of fellowship. During a K38-supported research year, Transition Scholars in fellowship are expected to commit at least 75% professional effort (e.g., 9 person months per year). Recognizing that some R38 StARR resident investigators may directly transition to faculty positions, early career faculty (as defined in Section III: Eligibility Information) are expected to commit at least 50% professional effort. In addition, this K38 award is intended to support Transition Scholars who can document that sufficient institutional support is available to allow for sufficient protected time to dedicate to K38 mentored research effort. Transition Scholar awardees may concurrently engage in other duties (such as clinical and teaching activities) as part of the remaining effort not covered by the award, as long as such duties do not interfere with or detract from the proposed research and career development activities.
Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full-time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant participating Institute or Center prior to preparing an application to discuss their eligibility.
Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in minimum required percent effort, which will be considered on a case-by-case basis. Details on this policy are provided in NOT-OD-09-036.
The overall structure of research and clinical activities outlined in the application should lead to participant eligibility for certification or endorsement and oversight by a Board recognized by the American Board of Medical Specialties (ABMS), or for dentists, specialties approved by the Council on Dental Education and Licensure of the American Dental Association, or for veterinarians, specialties approved by the American Veterinary Medical Association.
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.
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the Career Development (K) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF 424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Project Summary/Abstract
Include a description of your current research and the research you propose to continue in the independent phase.
Other Attachments: The attachments listed below must be attached or the application will not be peer reviewed, with the exception of the "Clinical Fellowship Program Director Letter", which must be provided only for clinical fellowship K38 applicants.
Two nomination letters must be provided as an attachment using the filename "Nomination Letters.pdf" and may not exceed 4 pages. The two required nomination letters include: (1) a nomination letter from the PD/PI of the NIH StARR R38 Institutional Research Program in which the K38 applicant is/was an active participant as a Resident-Investigator and (2) a nomination letter from the primary research preceptor who oversaw/is overseeing the R38 mentored research. The nomination letters should provide an assessment of the applicant’s qualifications and potential for investigative research and for a career as a clinician-investigator. Nomination letters should indicate either the dates of participation and the completion date of the R38 program along with achieved milestones, or provide the anticipated R38 completion date and milestones achieved to-date for applicants still in the R38 program. Nomination letters are required whether the K38 Transition Scholar applicant stays at the NIH StARR R38-funded Institution or moves to a new institution.
2. Clinical Fellowship Program Director Letter
For clinical fellowship K38 applicants, a letter from the clinical fellowship program director must be provided as an attachment using the filename "Clinical Fellowship Letter.pdf". The letter must affirm the fellowship director's support for the applicant's participation in research and career development activities through the K38 StARRTS program and that the proposed structure and timeline of research and clinical activities is appropriate for the applicant to achieve eligibility for subspecialty board certification and for general board certification (ABIM, ABP, ABS, etc.) for applicants not yet general board certified.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
The Candidate Section should include the following two sections and the suggested length is three pages.
Candidate’s Background
Candidate's Plan for Career Development/Training Activities During Award Period
Research Plan Section
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy
Address the following items:
o Identify the research direction to be pursued in the K38 application and explain the rationale for pursuing this direction. Describe the scientific question to be addressed, the approach(es) to be taken, and the scientific goals to be achieved.
o Describe how the proposed research is consistent with the candidate’s level of research development and objectives of his/her career development. Describe how the proposed research and career development plan will enhance the candidate's knowledge, technical expertise, and professional skills, keeping in mind existing strengths as well as any gaps in existing skills.
Training in the Responsible Conduct of Research
Mentor, Co-Mentor, Consultant, Collaborators Section
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Plans and Statements of Mentor and Co-mentor(s)
Letters of Support from Collaborators, Contributors and Consultants
Applicants are expected to leave this requirement out of the StARRTS K38 application.
Environmental and Institutional Commitment to the Candidate
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Description of Institutional Environment
Institutional Commitment to the Candidate’s Research Career Development
Appendix
Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.
Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.
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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.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
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.
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.
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.
Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)
Environment & Institutional Commitment to the Candidate
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.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals across the lifespan (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
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, 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.
Not Allowed
Not Allowed
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 FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the applicant, including any prior instruction or participation in RCR as appropriate for the applicant’s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019.
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 following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s),convened by participating Institutes/Centers, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Appeals for initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the Advisory Council of the participating Institutes/Centers. The following will be considered in making funding decisions:
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.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants. More specifically, for K Awards, visit the Research Career Development ( K ) Awardees section of the NIH Grants Policy Statement.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. The Mentor’s Report must include an annual evaluation statement of the candidate’s progress.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.
Upon the completion of a program evaluation, NIH and its ICs will determine whether to (a) continue a program as currently configured, (b) continue a program with modifications, or (c) discontinue a program.
In evaluating this Transition Scholar program, the participating NIH Institutes/Centers expect to use the following evaluation measures:
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application
errors and warnings, documenting system problems that threaten submission by
the due date, and post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
GrantsInfo (Questions regarding application instructions,
application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov
registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
David Schopfer, M.D.
National Heart Lung and Blood Institute (NHLBI)
Telephone: 301-402-3833
Email: [email protected]
Mark Damico, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5630
Email: [email protected]
Roya Kalantari, PhD.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-480-9158
Email: [email protected]
Basil Eldadah, M.D., Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-6761
Email: [email protected]
Director, Office of Scientific Review
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0270
Email: [email protected]
Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]
Ann-Marie Brighenti, Ph.D.
National institute on Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-3100
Email: [email protected]
Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9666
Email: [email protected]
Reggie Brown
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0166
Email: [email protected]
Sean Hine
National Cancer Institute (NCI)
Telephone: 240-276-6291
Email: [email protected]
Kalaya M. Goffigan
Nation Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-7159
Email: [email protected]
John Bladen
National Institute on Aging (NIA)
Telephone: 301-402-7730
Email: [email protected]
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.
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.