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

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID)

National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Neurological Disorders and Stroke ( NINDS)
National Center for Advancing Translational Sciences (NCATS)
National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Funding Opportunity Title

NIH Medical Scientist Partnership Program (FM1 Clinical Trial Not Allowed)

Activity Code

FM1 Fellowship for Intramural Dual-Degree Scientists

Announcement Type

New

Related Notices

See Notices of Special Interest associated with this funding opportunity

  • February 23, 2024 - Notice of Change to the Application and Submission Information in NIH Medical Scientist Partnership Program (FM1 Clinical Trial Not Allowed), PAR-23-109. See Notice NOT-AI-24-033.
  • January 4, 2024 - NIDCD Individual Fellowship Pre-Application Information Session. See Notice NOT-DC-24-013

    August 4, 2023 -Notice of NINDS Participation in PAR-23-109. See Notice NOT-NS-23-102

    August 1, 2023 - NIDCR Notice of Participation in PAR-23-109, NIH Medical Scientist Partnership Program (FM1 Clinical Trial Not Allowed). See Notice NOT-DE-23-014

    NOT-OD-22-195 New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023

    NOT-OD-22-189 Implementation Details for the NIH Data Management and Sharing Policy

    NOT-OD-22-198 Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023

    NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available

    Funding Opportunity Announcement (FOA) Number

    PAR-23-109

    Companion Funding Opportunity

    None

    Assistance Listing Number(s)

    93.855, 93.398, 93.867, 93.838, 93.837, 93.839, 93.840, 93.233, 93.172, 93.866, 93.173, 93.279, 93.113, 93.350, 93.121, 93.853, 93.846

    Funding Opportunity Purpose

    The purpose of the Medical Scientist Partnership Program (MSPP) is to develop a diverse pool of combined doctoral degree students (e.g., M.D./Ph.D., D.D.S./Ph.D., D.V.M./Ph.D.) who will conduct their Ph.D. dissertation research at research laboratories in the NIH Intramural Research Program. MSPP Scholars will gain experience in the basic, translational, and clinical biomedical sciences to prepare them for leadership positions in biomedical careers. The combined degree experience will provide the recipients with a strong understanding of the rigorous research study design, critical thinking, experimental methods and rigor, quantitative approaches, bioethics, and data analysis. MSPP Scholars will receive a mentored research experience, extensive career and professional development, mentoring, and networking opportunities. This program thus provides the knowledge, professional skills, and experiences required to identify and transition into careers in the biomedical research workforce that utilize the combined doctoral degree.

    Key Dates
    Posted Date

    March 10, 2023

    Open Date (Earliest Submission Date)

    July 8, 2023

    Letter of Intent Due Date(s)

    Not Applicable

    Application Due Date(s)

    August 8, 2023; August 8, 2024; August 8, 2025

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

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

    AIDS Application Due Date(s)

    August 8, 2023; August 8, 2024; August 8, 2025

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

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

    Scientific Merit Review

    November 2023; November 2024; November 2025

    Advisory Council Review

    Not Applicable for Fellowships

    Earliest Start Date

    July 2024; July 2025; July 2026

    Expiration Date

    August 9, 2025

    Due Dates for E.O. 12372

    Not Applicable

    Required Application Instructions

    It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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

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

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


    4. Table of Contents

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

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

      The National Institutes of Health (NIH) Medical Scientist Partnership Program's (MSPP) overarching goal is to support highly promising predoctoral students during their mentored dissertation research and clinical training who are matriculated in (a) a formal combined M.D./Ph.D. program or other combined-doctoral degree training program (e.g., D.O./Ph.D., D.N.P./Ph.D., D.D.S./Ph.D., Au.D./Ph.D., D.V.M./Ph.D.), or (b) a clinical doctoral degree program plus a separate accredited Ph.D. program at their clinical degree school or other university.

      MSPP Scholars will conduct their clinical degree education at their home institution and will conduct the Ph.D. portion of their education/experience in research laboratories in the NIH Intramural Research Program (IRP) through participation in the NIH Graduate Partnership Program (GPP). The students will receive their research degree from the home institution or one of the partnership institutions affiliated with the NIH. The IRP is the internal research program of the NIH, known for its synergistic approach to biomedical science. Its unique environment means the IRP can facilitate opportunities to conduct both long-term and high-impact research that would otherwise be difficult to undertake. With approximately 1,200 Principal Investigators and more than 4,000 Postdoctoral Fellows conducting basic, translational, and clinical research, the IRP is one of the largest biomedical research institutions in the world. Its unique funding environment means the IRP can facilitate opportunities to conduct both long-term and high-impact science that would otherwise be difficult to undertake.

      Potential areas of research within the IRP include, but are not limited to: biological chemistry, biophysics, bioinformatics, cellular and molecular biology, computational biosciences, epidemiology, developmental biology, genetics, immunology, neuroscience, oncology, biomedicine, pharmacology, physiology, bioethics, and technology development. MSPP Scholars will conduct their work with sponsors who have relevant experience in these areas of research in any of the participating NIH Institutes or Centers with an IRP.

      The objective of the MSPP is to develop a diverse pool of well-trained clinician scientists, who will have the following technical, operational, and professional skills:

      • The skills necessary to integrate research and clinical activities in support of a productive research career;
      • The ability to utilize clinical experience and observations to identify important biomedical research questions and develop impactful research programs;
      • A broad understanding across biomedical disciplines and the skills to independently acquire the knowledge needed to advance their chosen fields;
      • Expertise in a biomedical scientific discipline and the skills to think critically and independently, and to identify important biomedical research questions and approaches that push forward the boundaries of their areas of study and that enable the translation of basic research findings into clinical practice;
      • A strong foundation in scientific reasoning, rigorous research design, experimental methods, quantitative and computational approaches, and data analysis and interpretation;
      • The skills to conduct research in the safest manner possible, and a commitment to approaching and conducting biomedical research and clinical practice responsibly, ethically, and with integrity;
      • Experience initiating, conducting, interpreting, and presenting rigorous and reproducible biomedical research with increasing self-direction;
      • The ability to work effectively in teams with colleagues from a variety of cultural and scientific backgrounds, and to promote inclusive and supportive scientific research environments;
      • The skills to teach and communicate scientific research methodologies and findings to a wide variety of audiences (e.g., discipline-specific, across disciplines, and the public); and
      • The knowledge, professional skills and experiences required to identify and transition into careers in the biomedical research workforce (i.e., careers that utilize the dual degree).

      Nature of the research opportunity

      The MSPP award will provide up to four years of support during the extramural clinical degree training depending on how many years of clinical research education the applicant has completed prior to the award, as described below. NIH intramural funding will support the Scholar while they are engaged in their doctoral research at NIH. Scholars may combine clinical degree training with the MSPP via two academic tracks:

      For both Track 1 and Track 2 Scholars, the applicant does not need to identify the research project, clinical degree school, or dissertation mentor in their FM1 grant application. Some of this information will be required as just-in-time information prior to issuance of a Notice of Award. The NIH Institute or Center (IC) that will make the grant award will be based on the dissertation mentor's IC.

      Additional clarifying information can be found at the this resource page.

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

      Section II. Award Information
      Funding Instrument

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

      Application Types Allowed

      New

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

      Clinical Trial?

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

      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.

      Award Budget

      Award budgets are composed of stipends, tuition and fees, and institutional allowance, as described below.

      Award Project Period

      Individuals may receive up to 4 years of extramural support at the predoctoral level for clinical degree education as part of combined doctoral degree training (e.g., M.D./Ph.D.). Track 1 Scholars will receive 4 years of support, while Track 2 Scholars will receive 3 years of support for clinical degree education.

      Other Award Budget Information
      Stipends

      The stipend level for MSPP Scholars is the same as for the F30 Ruth L. Kirschstein National Research Service Award (NRSA) fellows. See https://researchtraining.nih.gov/resources/policy-notices

      Tuition and Fees

      Fellowship awards will contribute to the combined cost of tuition and fees at the rate in place at the time of award. See https://researchtraining.nih.gov/resources/policy-notices

      Institutional Allowance

      The applicant should request an institutional allowance to help defray the cost of fellowship expenses such as health insurance, research supplies, equipment, books, and travel to scientific meetings. The annual institutional allowance level for the FM1 is the same as that provided for the F30 Ruth L. Kirschstein National Research Service Award (NRSA) awards. See https://researchtraining.nih.gov/programs/fellowships

      Indirect Costs

      Fellowship awards do not include a separate reimbursement for indirect costs (also known as Facilities & Administrative [F&A] Costs). Instead of costs for administering fellowships are covered by the Institutional Allowance. See https://researchtraining.nih.gov/resources/policy-notices

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

      Section III. Eligibility Information
      1. Eligible Applicants
      Eligible Organizations

      Higher Education Institutions

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

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

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

      Governments

      • Eligible Agencies of the Federal Government
      Foreign Institutions

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

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

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

      Required Registrations

      Applicant Organizations

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

      • System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
        • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
        • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
      • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
      • Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

      All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.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.

      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)

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

      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).

      By the time of award, the applicant must have a baccalaureate degree or equivalent, show evidence of high academic performance in the sciences, and commitment to a career as an independent physician-scientist or other clinician-scientist. They must be matriculated into a combined degree program (e.g., M.D./Ph.D., D.O./Ph.D., D.D.S./Ph.D., or D.V.M./Ph.D.) or clinical doctoral program with the option to pursue a Ph.D. during their clinical degree training and must be accepted into a laboratory within the NIH IRP to conduct their research training. Clinical degree programs that are eligible for the MSPP include, but are not limited to, the M.D., D.O., D.D.S., D.M.D., O.D., D.N.P., D.C., or Pharm.D. Applicants pursuing clinical degrees not listed above are encouraged to reach out to the scientific contacts listed in the FOA to determine eligibility.

      2. Cost Sharing

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

      3. Additional Information on Eligibility
      Number of Applications

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

      • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
      • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
      • An application that has substantial overlap with another application pending appeal of initial peer review (2.3.9.4 Similar, Essentially Identical, or Identical Applications).
      Duration of Support

      Individuals may receive up to 4 years of extramural support for their clinical degree from the MSPP. Furthermore, individuals are expected to be supported by the IRP for the completion of their Ph.D. dissertation research at the NIH for no more than 5 years, except under extenuating circumstances.

      Level of Effort

      At the time of award, individuals are required to pursue their research training on a full-time basis, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies.

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

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

      2. Content and Form of Application Submission

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

      Page Limitations

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

      Instructions for Application Submission

      The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

      How to Apply

      For Track 1 applicants, the applicant organization will be the National Institute of Allergy and Infectious Diseases (NIAID), and the applicants should work directly with NIAID staff to submit the applications. Applications will initially be assigned to NIAID, but that assignment will be transferred to the appropriate IC after receipt of the just-in-time information. Track 1 applicants should contact NIAID staff at least 90 days before the submission deadline by sending an email to NIHMSPPQuestions@niaid.nih.gov to receive specific instructions on how to apply.

      Track 2 applicants will use their clinical degree school as the applicant organization and should contact that school's business or grants administration office (e.g., office of research administration, office of research administration services, office of financial and grants administration, office of sponsored programs) to receive specific instructions on how to apply. Track 2 applicants should contact their school's business or grants administration staff at least 90 days before the submission deadline.

      Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST, Grants.gov Workspace or an institutional system-to-system solution. 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.

      This grant application process does not include any of the steps needed for an applicant to apply to the NIH Graduate Partnership Program (GPP) and an accredited graduate department that can confer the Ph.D degree. Acceptance into the GPP and selection of an IRP mentor is not a prerequisite for applying for a FM1 grant, but is required before an award can be made. Therefore, for funding consideration, interested applicants should submit a FM1 application and a GPP application. GPP applications may be submitted via the NIH GPP Application Portal. Please note the following:

      • Interested applicants who are currently applying to U.S. clinical degree schools should submit an application for Track 1 of the NIH MD/PhD Program. MSPP applicants should note the difference between MSPP Track and NIH MD/PhD Program Track 1. To apply for the NIH MD/PhD Program Track 1, start the NIH GPP application, then under Partnership Selection, select University of Oxford(England)/University of Cambridge (England)/Consortia of Universities- NIH-MD/PhD- Track 1.
      • Interested applicants who are currently enrolled in U.S. clinical degree schools should submit an application for Track 2 of the NIH MD/PhD Program. To apply for Track 2, start the NIH GPP application, then under Partnership Selection, select University of Oxford(England)/University of Cambridge (England)/Consortia of Universities- NIH-MD/PhD- Track 2.

      For more information on how to apply to the GPP, visit https://mdphd.gpp.nih.gov/prospective-students. Questions related to the NIH MD/PhD Program application may be directed to the program administrators at mdphd@od.nih.gov.

      By submitting an application to NIAID, the expectation is that the applicants agree to allow NIAID to provide a copy of the peer review summary statement to the IRP GPP to be used as part of their evaluation and selection process.

      SF424(R&R) Cover

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

      Complete the Estimated Project Funding section as follows:

      Total Federal Funds Requested: Enter applicable stipend amount, the estimated tuition and fees, and the standard institutional allowance
      Total Non-Federal Funds: Enter $0.
      Total Federal & Non-Federal Funds: Enter applicable stipend amount, the estimated tuition and fees, and the standard institutional allowance
      Estimated Program Income: Enter $0.

      Note: Only the total should be entered in the fields for "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds." Enter the total amount requested for the entire period of support. This amount should include the applicable stipend amount, the estimated tuition and fees, and the standard institutional allowance. Applicants should refer to the NIH Research Training and Career Development website for current stipend and other budgetary levels. A detailed budget and budget forms are not required and will not be accepted. If the application is under consideration for funding, detailed budget information will be requested with the 'Just in Time' request.

      SF424(R&R) Project/Performance Site Locations

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

      DO NOT USE this form.

      Other Project Information

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

      Are Human Subjects Involved? Check 'NO'.

      Are Vertebrate Animals Used? Check 'NO'.

      Project Summary/Abstract: Upload attachment that indicates "Not Applicable".

      Project Narrative: Upload attachment that indicates "Not Applicable".

      Bibliography & References Cited: DO NOT PROVIDE ATTACHMENT.

      Facilities & Other Resources: DO NOT PROVIDE ATTACHMENT.

      Equipment: DO NOT PROVIDE ATTACHMENT.

      Other Attachments: Applicants must provide the following, each as a separate PDF attachment. If the application is missing any of the attachments it will be considered incomplete and will be withdrawn.

      Applicant s Background and Goals for Fellowship Training

      3 page limit

      The applicant's academic record should be provided including their most recent transcripts from prior baccalaureate, master's education, or other course work, and a description of their academic accomplishments and accolades. Accomplishments can include any honors, awards, internships, prizes, or other activities related to their academic or research work. The filename "Applicants_Background.pdf" must be used.

      Research Experience and Accomplishments

      3 page limit

      Describe the applicant's prior research experience(s). The description should include information about where, when, duration of the research experience, and identity of primary and secondary research mentor(s). It should provide information about the projects that the applicant participated in and their specific role. Outputs such as publications, patents, abstracts, and presentations at scientific conferences, and awards or recognition resulting from the research should be described. The filename "Research_Experience.pdf" must be used.

      Personal Statement

      2 page limit

      The applicant should provide a personal statement describing their interest and commitment to a career as a clinician scientist. The applicant should describe their research aspirations and goals and should describe how their current career trajectory will allow them to achieve those goals. The applicant should discuss their specific interest in, and motivation for, pursuing a combined degree that involves conducting their research training in the NIH IRP as well as the intended general or specific area(s) of research interest with a statement about whether basic, clinical, or a combination of these types of research is intended. The applicant should address the unique nature of a combined degree program and the synergistic benefits of integrating research and clinical training. The applicant should also provide a self-assessment of their scientific and academic strengths and any area of growth necessary to advance the applicant's career in biomedical research. The filename "Personal_Statement.pdf" must be used.2 page limit.

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

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

      IMPORTANT REMINDER: The personal profile associated with the eRA Commons username entered in the Credential field for the PD/PI (fellowship applicant) must include an 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.

      Profile Project Director/Principal Investigator Field-

      Biographical sketch: Use Non-Fellowship Biographical Sketch format page.

      Profile Senior Key Person 1: DO NOT USE. Only the PD/PI may serve as senior/key personnel.

      Research and Related Senior/Key Person Profile (Expanded) - Additional Senior/Key Person Profiles(s): DO NOT USE. Only the PD/PI may serve as senior/key personnel.

      Research and Related Senior/Key Person Profile (Expanded) - Additional Biographical Sketch(es): DO NOT USE. Only the PD/PI may submit a Biographical Sketch.

      R&R or Modular Budget

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

      A detailed budget, budget forms and budget justification are not required at the time of submission. If the application is under consideration for funding, detailed budget information will be requested with the 'Just in Time' request.

      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.

      Reference Letters

      Applicants must carefully follow the SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. Reference letters should describe their relationship with the applicant, their own experience as a research trainee mentor, their assessment of the applicant's academic qualifications, and their assessment of the applicant's commitment and to, and potential as, a future biomedical scientist that utilizes the combined degree. Reference letters should provide examples of personal and professional growth as a consequence of the applicant's research experience and accomplishments, in addition to any areas of growth necessary to advance the applicant's career in biomedical research. Reference letters should also describe any area of growth necessary to advance the applicant's career in biomedical research. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Reference Letter link and not through Grants.gov.

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

      See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

      4. Submission Dates and Times

      Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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

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

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

      5. Intergovernmental Review (E.O. 12372)

      This initiative is not subject to intergovernmental review.

      6. Funding Restrictions

      All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The National Research Service Award (NRSA) policies apply to this program. A Kirschstein-NRSA fellowship may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of this award.

      Pre-award costs are generally not allowable for Fellowships.

      7. Other Submission Requirements and Information

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

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

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

      Important reminders:
      All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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


      See more tips for avoiding common errors.

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

      Post Submission Materials

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

      Section V. Application Review Information
      1. Criteria

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

      Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review, and a Data Management and Sharing Plan is not applicable for this FOA.

      Overall Impact

      Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the fellowship will enhance the applicant’s potential for, and commitment to, a productive independent scientific research career in a health-related field as a combined degree scientist, in consideration of the scored and additional review criteria.

      Scored Review Criteria

      Reviewers will consider each of the review criteria below in the determination of merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to transition to a biomedical career in that utilizes the combined degree.

      Applicant s Background and Goals for Fellowship Training

      Does the applicant have a solid academic record that supports their potential to successfully complete a combined degree training program?

      Based on their academic accomplishments, does the applicant have the potential to develop into an independent and productive researcher?

      Based on their course of study, does the applicant have the potential to successfully complete a combined degree training program?

      Research Experience and Accomplishments

      Does the applicant have sufficient familiarity and experience in conducting biomedical research?

      How extensive is the applicant's prior biomedical research experience?

      Are the gaps in the applicant's prior research experience well described and are the plans to address these gaps adequate?

      When provided the opportunity, has the applicant contributed to any scientific papers or abstracts?

      Has the applicant given an oral presentation at a national or international scientific conference?

      If applicable, does the applicant's record of publication and conference presentation suggest future success as a productive biomedical researcher?

      Personal Statement

      Does the applicant's personal statement reveal realistic and strong motivation for pursuing a combined degree and a commitment to a future career as a clinician scientist?

      Are the applicant's scientific and academic strengths appropriate and areas of growth achievable in order to advance their career in biomedical research based on their self-assessment?

      Does the applicant understand the unique nature of a combined degree program and the synergistic benefits of integrating research and clinical training?

      Does the applicant provide a sound rationale for why they are interested in becoming a clinician scientist?

      Has the applicant provided a sound rationale for why they are interested in a combined degree program that involves conducting their dissertation research in an NIH IRP laboratory?

      Reference Letters

      Did the letters cite any strengths or weaknesses of the applicant that have the potential to impact their development into an independent and productive researcher?

      If applicable, are the areas of growth necessary to advance the applicant's career in biomedical research achievable and appropriate?

      Do the letters support the applicant's potential in completing a combined degree program?

      Do the letters support the applicant's commitment to a career in biomedical research?

      Additional Review Criteria

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

      Protections for Human Subjects

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

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

      Inclusion of Women, Minorities, and Individuals Across the Lifespan

      When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

      Vertebrate Animals

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

      Biohazards

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

      Resubmissions

      Not Applicable

      Renewals

      Not Applicable

      Revisions

      Not Applicable

      Additional Review Considerations

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

      Applications from Foreign Organizations

      Not Applicable

      Select Agent Research

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

      Resource Sharing Plans

      Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review, and a Data Management and Sharing Plan is not applicable for this FOA.

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

      Authentication of Key Biological and/or Chemical Resources

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

      Budget and Period of Support

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

      2. Review and Selection Process

      Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the Center for Scientific Review 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:

      • Will receive a written critique.

      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 . Following initial peer review, recommended applications will receive a second level of review by the appropriate NIH Institute or Center. The following will be considered in making funding decisions:

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

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

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

      Section VI. Award Administration Information
      1. Award Notices

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

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

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

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

      Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

      2. Administrative and National Policy Requirements

      All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

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

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

      Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

      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.

      Activation of the MSPP Award

      The activation of the MSPP award is not automatic. If the applicant receives a meritorious overall impact score after the review of the MSPP application, s/he/they will be notified in writing by receiving an Approval Letter that will include the terms and conditions to activate the FM1 award. The applicant will then have a period of up to 6 months to be accepted into both a clinical degree school and the NIH IRP.

      The following information for the Just In Time materials must include:

      • A new face page signed by the sponsoring institutional representative
      • A revised budget
      • A list of any other support, such as scholarships, grants, and fellowships. Applicants must use the Other Support format page to submit information.
      • Copy of the acceptance letter to the applicant's clinical degree school
      • Copy of the acceptance letter to the NIH GPP
      • A letter of commitment from the NIH IRP mentor who will support the applicant during their dissertation research training at the NIH.
      • In addition, a letter from the Dean, Department, or Division Chair(s) from the institution(s) conferring both degrees describing the sponsoring institution’s commitment to the applicant's dual degree training at the NIH IRP. If an organized combined degree program exists, then an assurance letter from the Director of such program that indicates the students will have the same educational pathway, opportunities, and support by inclusion in the organized program as student supported by other mechanisms should be included.

      Transition after completion of Ph.D. dissertation research at the NIH IRP

      While the MSPP Scholar is working at the NIH IRP conducting their Ph.D. dissertation research project, they will be supported by the NIH Intramural Research and Training Award. As such, the MSPP award will be paused and will need to be reactivated once the dissertation research has been completed in order to support the last 2 years of clinical degree training.

      To avoid potential problems in reactivating the MSPP, applicants are strongly encouraged to submit their reactivation package no later than 2 months prior to the proposed return date to their clinical degree school.

      The clinical degree school will submit an application on behalf of the applicant that must include:

      • A new face page signed by the sponsoring institutional representative
      • A summary of the completed dissertation research
      • A letter from the school confirming approval of the dissertation and completion of all requirements for the school to confer the Ph.D. degree
      • An updated budget

      These materials should be sent directly to the appropriate extramural office of the awarding NIH Institute or Center (IC). The original application plus one copy (preferably in PDF format) are to be e-mailed to the Financial or Grants Management contact person of the awarding NIH Institute or Center listed in the Notice of Award. The reactivation package will be evaluated by extramural program staff of the awarding component for completeness and appropriateness to the program.

      Although the financial plans of the NIH Institute or Center provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

      The taxability of stipends is described in the NIH Grants Policy Statement.

      Inventions and Copyrights

      Fellowships funded primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required. More details, including exceptions for fellows training at NIH are provided in the NIH Grants Policy Statement.

      3. Data Management and Sharing

      Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

      Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement.

      Not applicable for fellowship awards .

      4. Reporting

      When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually. The report is due two months before the beginning date of the next budget period and must include information describing the current year's progress as well as the research and training plans for the coming year. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR 200.301.

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

      Other Fellowship Reporting Requirements:
      • Individuals admitted to the United States as Permanent Residents must submit notarized evidence of legal admission prior to the award.
      5. Evaluation

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

      The overall evaluation of the program will be based on metrics that will include, but are not limited to, the following:

      For programs involving graduate students:

      • Successful completion of a STEM graduate program
      • Subsequent participation in a formal research training or career development program in a STEM field
      • Subsequent participation in research or employment in a STEM field
      • Authorship of scientific publications in a STEM field
      • Subsequent independent research grant support from NIH or another source
      Section VII. Agency Contacts

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

      Application Submission Contacts

      eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

      Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
      Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

      General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
      Email: GrantsInfo@nih.gov (preferred method of contact)
      Telephone: 301-480-7075

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

      Scientific/Research Contact(s)

      Marie Mancini, Ph.D.
      National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
      Telephone: 301-594-5032
      Email: mancinim2@mail.nih.gov

      Anissa Brown, PhD
      National Institute of Dental and Craniofacial Research (NIDCR)
      Research Training and Career Development Branch
      Telephone: 301-594-4805
      Email: anissa.brown@nih.gov

      NIAID Training Help Desk
      National Institute of Allergy and Infectious Diseases (NIAID)
      Telephone: 301-761-6203
      Email: NIHMSPPQuestions@niaid.nih.gov

      Peer Review Contact(s)

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

      Financial/Grants Management Contact(s)

      Erik Edgerton
      National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
      Tel: (301) 594-7760
      Email: edgertont@mail.nih.gov

      Samuel Ashe
      National Institute of Allergy and Infectious Diseases (NIAID)
      Telephone: 301-435-4799
      Email: samuel.ashe@nih.gov

      Section VIII. Other Information

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

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

      Authority and Regulations

      Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 63A and 45 CFR Part 75 and 2 CFR Part 200.

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