NIH National Research Service Award (NRSA) Fellowship for Students at Institutions Without NIH-Funded Institutional Predoctoral Dual-Degree Training Programs (Parent F30)

NIH National Research Service Award (NRSA) Fellowship for Students at Institutions Without NIH-Funded Institutional Predoctoral Dual-Degree Training Programs (Parent F30) is sponsored by National Institute of Allergy and Infectious Diseases (NIAID) - NIH. NIH awards NRSA individual fellowship grants to provide research experience to students and scientists. The Parent F30 is for students enrolled in formally combined M.

D. and Ph. D.

PA-25-425: Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship for Students at Institutions Without NIH-Funded Institutional Predoctoral Dual-Degree Training Programs (Parent F30) Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations NATIONAL INSTITUTES OF HEALTH ( NIH ) National Eye Institute ( NEI ) National Heart, Lung, and Blood Institute ( NHLBI ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Institute of Allergy and Infectious Diseases ( NIAID ) National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS ) National Institute of Biomedical Imaging and Bioengineering ( NIBIB ) Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Institute on Deafness and Other Communication Disorders ( NIDCD ) National Institute of Dental and Craniofacial Research ( NIDCR ) National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK ) National Institute on Drug Abuse ( NIDA ) National Institute of Environmental Health Sciences ( NIEHS ) National Institute of General Medical Sciences ( NIGMS ) National Institute of Mental Health ( NIMH ) National Institute of Neurological Disorders and National Institute of Nursing Research ( NINR ) National Institute on Minority Health and Health Disparities ( NIMHD ) National Center for Complementary and Integrative Health ( NCCIH ) National Cancer Institute ( NCI ) National Human Genome Research Institute ( NHGRI ), July 17, 2025 Participated added (NOT-HG-25-038) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.

The following NIH Offices may co-fund applications assigned to those Institutes/Centers. Office of Data Science Strategy ( ODSS ) Funding Opportunity Title Ruth L.

Kirschstein National Research Service Award (NRSA) Individual Fellowship for Students at Institutions Without NIH-Funded Institutional Predoctoral Dual-Degree Training Programs (Parent F30) F30 Individual Predoctoral NRSA for MD/PhD Fellowships Notices of Special Interest associated with this funding opportunity January 28, 2026 - NIH Removing AIDS Application Due Dates from NOFOs. See Notice NOT-OD-26-029 .

November 24, 2025 - Notice of Rescheduled NIDCR Pre-Application and Technical Assistance Webinars on Applying for Fellowship (F) Awards and Career Development (K) Awards. See Notice NOT-DE-26-013 . September 25, 2025 - Notice of NIDCR Pre-Application and Technical Assistance Webinars on Applying for Fellowship (F) Awards and Career Development (K) Awards.

See Notice NOT-DE-26-012 . July 17, 2025 - Notice of NHGRI's Participation in PA-25-425: Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship for Students at Institutions Without NIH-Funded Institutional Predoctoral Dual-Degree Training Programs (Parent F30).

See Notice NOT-HG-25-038 . June 17, 2025 - NOTICE OF CORRECTION: Eligible Individuals, Ruth L. Kirschstein Research Service Award (NRSA) Fellowships.

See Notice NOT-OD-25-126 . August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 .

August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Notice of Funding Opportunity See Section III.

3. Additional Information on Eligibility. Assistance Listing Number(s) 93.

242, 93. 398, 93. 273, 93.

855, 93. 307, 93. 233, 93.

837, 93. 838, 93. 839, 93.

840, 93. 173, 93. 286, 93.

865, 93. 847, 93. 867, 93.

866, 93. 279, 93. 113, 93.

310, 93. 859, 93. 361, 93.

846, 93. 121, 93. 853, 93.

213, 93. 172 Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO) will support students at institutions without NIH-funded institutional predoctoral dual-degree training programs.

The purpose of the Kirschstein-NRSA, dual-doctoral degree, predoctoral fellowship (F30) is to enhance the integrated research and clinical training of promising predoctoral students, who are matriculated in a combined MD/PhD or other dual-doctoral degree training program (e.g. DO/PhD, DDS/PhD, AuD/PhD, DVM/PhD, PharmD/PhD), and who intend careers as physician/clinician-scientists.

Candidates must propose an integrated research and clinical training plan and a research training project in scientific health-related fields relevant to the missions of the participating NIH Institutes and Centers. The fellowship experience is expected to clearly enhance the individual's potential to develop into a productive, independent physician/clinician-scientist.

This Notice of Funding Opportunity (NOFO) does not allow fellowship candidates to propose to lead an independent clinical trial, but does allow candidates to propose research experience in a clinical trial led by a sponsor or co-sponsor.

Funding Opportunity Goal(s) The goals of the NOFO are to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk.

Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization. Fellowship candidates 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.

Required Application Instructions It is critical that candidates follow the Fellowship (F) instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced.

Candidates must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the How to Apply - Application Guide , follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

Use the NIH ASSIST system to prepare, submit and track your application online. 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. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

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

Award Information Other Award Budget Information Section III. Eligibility Information Section IV. Application and Submission Information Section V.

Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII.

Other Information Part 2. Full Text of Announcement Section I. Funding Opportunity Description The overall goal of the NIH Ruth L.

Kirschstein National Research Service Award (NRSA) program is to help ensure a highly trained, heterogenous pool of scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. NRSA fellowships support the training of pre-and postdoctoral scientists, dual-degree investigators, and senior researchers.

More information about NRSA programs may be found at the NIH Research Training and Career Development website. Note : This Notice of Funding Opportunity (NOFO) does not allow candidate to propose to lead an independent clinical trial, but does allow applicants to propose research experience in a clinical trial led by a sponsor or co-sponsor.

The goal of the Kirschstein-NRSA Individual Predoctoral MD/PhD or Other Dual-Doctoral Degree Fellowship (F30) is to support promising predoctoral students, who are matriculated in a combined MD/PhD or other dual-doctoral degree training program (e.g. DO/PhD, DDS/PhD, AuD/PhD, DVM/PhD), during their mentored research training and clinical training under the guidance of appropriate faculty sponsors.

The research and training plans are expected to provide the candidate with a strong understanding of the rigorous research design, experimental methods, quantitative approaches, and data analysis. This program thus contributes to efforts to increase the pool of highly trained physician-scientists and other clinician-scientists in the biomedical research workforce.

This Notice of Funding Opportunity (NOFO) will support students at institutions without NIH-funded institutional predoctoral dual-degree training programs. In a companion NOFO, NIH is also seeking F30 applications from students at institutions with NIH-funded institutional predoctoral dual-degree training programs.

These programs include institutions with NIH-supported Medical Scientist Training Programs (MSTP), or Dental Scientist Training Programs (DSTP), or similar predoctoral dual-degree training programs.

The intent of this two-NOFO approach is to promote equitable review of applications from these two kinds of institutions, as well as better tracking of fellowship awardee candidate’s future progress in establishing independent careers as physician/clinician-scientists. There is a critical need for physician-scientists and other clinician-scientists to investigate human health and disease through rigorous research.

The complexity of biomedical, behavioral, and clinical science poses a challenge in the integration of research training into the standard course of study at most medical schools and other health professional schools.

To address this challenge, a variety of programs have been developed to combine training for the MD or other health professional degrees (e.g., DO, DDS, AuD, DVM) with extensive research experience leading to a second, advanced degree. It is expected that graduates of these dual-degree programs will play a vital role in advancing knowledge across the full spectrum of health-related research.

Candidates for the Kirschstein-NRSA F30 award are expected to propose an integrated research and clinical training plan and a research training project in scientific health-related fields relevant to the missions of the participating NIH Institutes and Centers. The integrated program of research and training should enhance the individual’s potential to transition into the next phase of their physician/ clinician-scientist career.

The training plan should document the need for, and the anticipated value of, the proposed mentored training in relationship to the individual’s career goals. The training plan should also facilitate transition to a residency or other postdoctoral program appropriate to the candidate’s career goals and particular clinical degree.

It is expected that the mentored training experience will provide: A strong foundation in rigorous research design, experimental methods, and analytic techniques appropriate to the proposed research; Enhanced ability to conceptualize and think through research problems with increasing independence; Experience conducting research using appropriate, state-of-the-art methods, as well as presenting and publishing the research findings as first author; The opportunity to interact with members of the scientific community at appropriate scientific meetings and workshops; Opportunities to integrate clinical experiences during the research training component; Clinical clerkship opportunities tailored to the candidate and his/her interests, as appropriate for the dual-degree program of study; and Skills needed to transition to the next stage of the candidate’s research career.

The Kirschstein-NRSA program may provide up to six years of support for research and clinical training that leads to the MD/PhD degree or another dual-doctoral degree. Because the F30 program is intended to support individuals matriculated in an integrated, dual-degree program during both their graduate research training and clinical training, the F30 cannot be used to support only the clinical training years.

Note : This Notice of Funding Opportunity (NOFO) is designed specifically for candidates proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial, but does allow candidates to propose research experience in a clinical trial led by a sponsor or co-sponsor.

Special Note: Because of the differences in individual Institute and Center (IC) program requirements for this announcement, prospective candidates are strongly encouraged to consult the Table of IC-Specific Information, Requirements and Staff Contacts , to make sure that their application is appropriate for the requirements of one of the participating NIH ICs. See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed Renewal - Individual fellowship awards are generally not renewable.

In rare cases in which fellowship awardees require further fellowship support, they should consult with NIH staff to obtain advice regarding submission of a renewal application. The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Not Allowed: Only accepting applications that do not propose independent clinical trials. Note: Candidates may propose to gain experience in a clinical trial led by a sponsor/co-sponsor as part of their research training. Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Award budgets are composed of stipends, tuition and fees, and institutional allowance, as described below.

Individuals may receive up to 5 years of aggregate Kirschstein-NRSA support at the predoctoral level (up to 6 years for dual degree training, e.g., MD/PhD), and up to 3 years of aggregate Kirschstein-NRSA support at the postdoctoral level, including any combination of support from institutional training grants (e.g., T32) and an individual fellowship award.

Other Award Budget Information Kirschstein-NRSA awards provide stipends as a subsistence allowance to help defray living expenses during the research and clinical training experiences. See https://researchtraining. nih.

gov/resources/policy-notices . Award recipients in the NIH intramural program will be supported by intramural funds provided by the NIH Institute/Center intramural laboratory in which they are conducting their research. 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 .

The application should request a Kirschstein-NRSA institutional allowance to help defray the cost of fellowship expenses such as health insurance, research supplies, equipment, books, and travel to scientific meetings. See https://researchtraining. nih.

gov/resources/policy-notices . 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 .

Stipend levels, as well as funding amounts for tuition and fees and the institutional allowance are announced annually in the NIH Guide for Grants and Contracts, and are also posted on the Ruth L. Kirschstein National Research Service Award (NRSA) webpage . NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III.

Eligibility Information Higher Education Institutions - Includes all types Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) Eligible Agencies of the Federal Government Eligibility is limited to applicant organizations without NIH-funded institutional predoctoral dual-degree training programs, including NIH-supported Medical Scientist Training Programs (MSTP), or Dental Scientist Training Programs (DSTP), or similar predoctoral dual-degree training programs.

This eligibility criterion applies to applicant organizations without currently active institutional training programs supporting the same dual degree, at the time the F30 fellowship application is submitted for review. Before submitting a fellowship application, the candidate must identify a sponsoring organization.

The sponsoring organization must have staff and facilities available on site to provide a suitable environment for performing the research training described within the application. The training should occur in an environment that has appropriate human and technical resources and is demonstrably committed to training in the field(s) proposed by the candidate.

The sponsoring organization may be private (profit or nonprofit) or public, including the NIH Intramural Programs and other Federal laboratories. All organizations with the appropriate resources and commitment are encouraged to apply. An individual may request support for training abroad.

In such cases, the candidate is required to provide detailed justification for the foreign training, including the reasons why the facilities, the sponsor, or other aspects of the proposed experience are more appropriate than training in a domestic setting. The justification is evaluated in terms of the scientific advantages of the foreign training as compared to the training available domestically.

Foreign training will be considered for funding only when the scientific advantages are clear. Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted.

Registration can take 6 weeks or more, so applicant organizations should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2. 3.

9. 2 Electronically Submitted Applications for additional information. System for Award Management (SAM) Applicant organizations 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 Applicant organizations 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 candidate(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with their sponsor and organization to develop an application for support. Multiple PDs/PIs are not allowed.

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).

A Kirschstein-NRSA F30 award does not support studies leading to the MD, DO, DDS, AuD or similar professional degrees, or studies that are part of residency training leading to a medical specialty alone.

The F30 program is specifically designed to support combined, dual-degree training leading to award of both a health professional doctoral degree (e.g., MD, DO, DDS, AuD, DVM, PharmD) and a research doctoral degree (e.g., PhD, DrPH) from an accredited program. The candidate must have a baccalaureate degree or equivalent and show commitment to a career as an independent physician-scientist or other clinician-scientist.

For all MD/PhD and DO/PhD degree candidates: To be eligible, a candidate 1) Must have matriculated (be enrolled) into a formal dual-degree program. 2) Must have identified a dissertation research training project and sponsor(s) - Candidates are strongly encouraged to submit as soon as a dissertation research project and training program can be fully developed in collaboration with the sponsor.

Most candidates are expected to apply within 48 months of matriculating into the dual degree program but no later than 24 months into their dissertation research training. Over the total duration of F30 support, at least 50% of the award period must be devoted to full-time graduate research training leading to the doctoral research degree.

Exceptions to the eligibility criteria will be considered for dual-degree programs with non-standard formats or for candidates who have taken an official leave of absence from the dual-degree program. Requests for exceptions should be submitted to NIH Program Staff or the designated Scientific/Research Contact.

Because dentist-scientist, audiologist-scientist, and veterinarian-scientist dual-degree programs are highly variable in their phasing and integration, the eligibility parameters for these dual-degree candidates are different, as follows: For all AuD-PhD, DVM-PhD, and VMD-PhD degree candidates: To be eligible, a candidate 1) must have matriculated into a dual-degree program; and 2) must have identified a research training project and sponsor(s).

In addition, over the total duration of F30 support, at least 50% of the award period must be devoted to full-time graduate research training leading to the doctoral research degree. For DDS/DMD-PhD degree candidates: To be eligible, a candidate 1) must have matriculated into a dual-degree program; and 2) must have identified a research training project and sponsor(s).

In addition, over the total duration of the dual degree training program, at least 50% of the program must be devoted to full-time graduate research training leading to the doctoral research degree.

Although a Kirschstein-NRSA award is not usually made for study leading to the MD, DO, DDS, AuD or similar professional degrees, the F30 program is specifically designed to support combined, dual-degree training leading to award of both a health professional doctoral degree (e.g., MD, DO, DDS, AuD, DVM, PharmD) and a research doctoral degree (e.g., PhD, DrPH) from an accredited program.

The candidate 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. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

3. Additional Information on Eligibility NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2. 3.

7. 4 Submission of Resubmission Application . 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 (see NIH Grants Policy Statement 2. 3.

9. 4 Similar, Essentially Identical, or Identical Applications ). Individuals may not exceed the aggregate limit of NRSA support shown above in the Award Project Period (see Section II.

Award Information). Candidates must consider any prior NRSA research training in determining the duration of support requested. Information regarding previous Kirschstein-NRSA support must be included in the application and will be considered at the time of award.

The F30 fellowship is generally not intended to support dual-degree students after year 8 of dual-degree training. Over the total duration of F30 support, at least 50% of the award period must generally be devoted to research training leading to the doctoral research degree (see exceptions under Eligible Individuals, above); award durations may be adjusted accordingly.

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 organization in accordance with its own policies. Before submitting the application, the candidate must identify a sponsor(s) who will supervise the proposed mentored training experience.

Candidates are encouraged to identify more than one sponsor, i.e., a sponsor team, if this is deemed advantageous for their training program. When there is a sponsor team, one individual must be identified as the primary sponsor, and will be expected to coordinate the candidate's overall training.

The primary sponsor should be committed both to the candidate's research training plan and to the direct supervision of their research training project. The candidate must work with the primary sponsor(s) in preparing the application. 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 NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicant organizations and fellowship candidates follow the Fellowship (F) instructions in the How to Apply - Application Guide , except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. All page limitations described in the How to Apply - Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the How to Apply - Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile Expanded All instructions in the How to Apply - 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 candidate) 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 PHS Fellowship Supplemental Form The PHS Fellowship Supplemental Form is comprised of the following sections: Commitment to Candidate, Mentoring, and Training Environment Other Research Training Plan Sections All instructions in the How to Apply - Application Guide must be followed.

Goals, Preparedness, and Potential All instructions in the How to Apply-Application Guide must be followed. Research Training Project Specific Aims and Strategy All instructions in the How to Apply - Application Guide must be followed.

Commitment to Candidate, Mentoring and Training Environment All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: If the candidate is proposing to gain experience in a clinical trial as part of their research training, the sponsor or co-sponsor must include a statement to document leadership of the clinical trial including source of funding, NCT# and appropriate expertise to guide the candidate in any proposed clinical trials research experience.

The individual receiving support for the clinical trial (i.e., the sponsor/primary mentor or a co-sponsor) is the responsible individual of record for oversight of the trial though fellows can take part in all components of a clinical trial.

Oversight includes (but is not limited to): interacting with relevant Institutional Review Board (IRB) staff; reviewing all informed consent documents; reporting potential serious adverse events; and maintaining responsibility for patient safety. However, the fellow can gain experience in all these components in conjunction with the mentor or individual leading the trial. Limited items are allowed in the Appendix.

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

PHS Human Subjects and Clinical Trials Information When involving 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 How to Apply - Application Guide , with the following additional instructions: If you answered “yes” to the question “Are Human Subjects Involved?

” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply - Application Guide must be followed. Do not provide an NCT# in Section 1, item 1.

5. See instruction for Sponsor(s), Collaborator(s), and Consultant(s) above. Do not complete Section 4 - Protocol Synopsis information or Section 5 - Other Clinical Trial-related Attachments.

Note: Delayed onset does NOT apply to a study that can be described, but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed. PHS Assignment Request Form All instructions in the How to Apply - Application Guide must be followed.

Applicant organizations must carefully follow the How to Apply - Application Guide , including the time period for when reference letters will be accepted . 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. Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement , and procedures for foreign organizations described throughout the How to Apply - Application Guide . 3.

Unique Entity Identifier and System for Award Management (SAM) See Part 2. Section III. 1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.

gov 4. Submission Dates and Times Part I. contains information about