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 General Medical Sciences (NIGMS)

Funding Opportunity Title
Postdoctoral Research Associate Training (PRAT) Program (Fi2)
Activity Code

FI2 Intramural Postdoctoral Research Associate

Announcement Type
Reissue of PAR-19-286
Related Notices
  • NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
  • August 9, 2022 - Notice of Correction to Eligibility-Related Dates Table in PAR-22-191 "Postdoctoral Research Associate Training (PRAT) Program (Fi2)". See Notice NOT-GM-22-043
Funding Opportunity Announcement (FOA) Number
PAR-22-191
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.859
Funding Opportunity Purpose

The NIGMS Postdoctoral Research Associate Training (PRAT) Program’s overarching goal is to provide high quality postdoctoral research training in the basic biomedical sciences to a diverse group of postdoctoral fellows in NIH intramural research laboratories, and to prepare them for leadership positions in careers in the biomedical research workforce. Research projects proposed should fall within basic biomedical fields relevant to the NIGMS mission. In addition to the laboratory experience, the PRAT program provides a structured training environment with extensive career and professional development, mentoring, and networking opportunities planned and supported by the program.

This Funding Opportunity Announcement (FOA) does not allow applicants 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.

Key Dates

Posted Date
July 13, 2022
Open Date (Earliest Submission Date)
September 03, 2022
Letter of Intent Due Date(s)

Not Applicable

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
October 03, 2022 October 03, 2022 Not Applicable March 2023 May 2023 July 2023
October 03, 2023 October 03, 2023 Not Applicable March 2024 May 2024 July 2024
October 03, 2024 October 03, 2024 Not Applicable March 2025 May 2025 July 2025

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

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.

Expiration Date
October 04, 2024
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Fellowship (F) 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 2. Full Text of Announcement

Section I. Funding Opportunity Description

Note: This Funding Opportunity Announcement (FOA) does not allow applicants 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 NIGMS Postdoctoral Research Associate Training (PRAT) Program’s overarching goal is to provide high quality postdoctoral research training in the basic biomedical sciences to a diverse group of postdoctoral fellows in NIH intramural research laboratories, and to prepare them for leadership positions in careers in the biomedical research workforce.  Training includes a mentored research experience, and extensive career and professional development, mentoring, and networking opportunities planned and supported by the program.  Fellows selected for the PRAT program receive three years of stipend support, benefits, and an annual travel and training allowance.  More information on the PRAT program can be found on the program website.

PRAT fellows conduct research in laboratories in the NIH Intramural Research Program in basic biomedical research areas that are within the NIGMS mission. NIGMS research areas include fundamental biomedical research as well as research in certain clinical areas, primarily those that affect multiple organ systems.Fellows conduct their work with sponsors who have relevant experience in these areas of research in any of the NIH Institutes or Centers with an Intramural Research Program.  The PRAT program regularly brings fellows together to participate in seminars, workshops and other activities, which allows fellows from a diverse array of scientific disciplines to interact on a regular basis and to exchange ideas with the potential of inspiring creativity, driving innovation, and enhancing problem solving.

The PRAT program distinguishes itself from other postdoctoral training opportunities on the NIH campus through its approach to cultivating the next generation of leaders in the basic biomedical sciences. The following principles guide the PRAT program and its structured professional development curriculum:

  • Leadership - As part of a bimonthly seminar series, PRAT fellows regularly meet with and learn from leaders in the biomedical research community and develop professional skills that will help them transition into leadership roles (e.g., emotional intelligence, conflict resolution, negotiation). PRAT fellows plan a scientific symposium during their final year in the program.
  • Communication - The PRAT program offers regular opportunities to enhance oral and written communication skills through activities such as a seminar series in which fellows present their research, oral presentation trainings, grant writing workshops, and communications coaching sessions. 
  • Networking - The fellows interact on a regular basis to present their research and exchange ideas during a seminar series, combining a research presentation from a current PRAT fellow with a presentation from an outside speaker invited by the fellow.  PRAT fellows receive an annual travel and training allowance which can be used to support travel to scientific meetings that broaden their networks.  The fellows also engage with PRAT alumni through program events.
  • Mentorship - In addition to mentored research laboratory experience, PRAT fellows receive mentorship from the PRAT program director(s) and have the opportunity for additional mentorship from NIGMS scientific staff.
  • Knowledge of Biomedical Research Enterprise - As part of the seminar series, fellows are exposed to the NIH grants process through workshops on K-awards, peer review, and the various funding mechanisms available to support a biomedical research career. 
  • Diversity - Diversity at all levels is integral to research and training excellence (see NIH's Interest in Diversity). PRAT fellows come from a diverse variety of backgrounds (e.g., personal, cultural, and scientific).  Professional development focuses on developing skills to work effectively in teams with colleagues from a variety of cultural and scientific backgrounds, promoting inclusive and supportive scientific research environments, and communicating scientific research methodologies and findings to a wide variety of audiences (e.g., discipline-specific, across disciplines, and the public).
  • Service - PRAT fellows are expected to participate in service and outreach activities to the NIH (e.g., serving as the PRAT representative on the NIH Fellows Committee) or broader community (e.g., participate in NIGMS activities at the biennial USA Science and Engineering Festival, engaging with undergraduates who visit NIH as part of the annual NIGMS Director's Early-Career Investigator Lecture, etc.).

Fellows selected for the PRAT program are required to participate in PRAT-sponsored training activities which are overseen by NIGMS Program Officers.

PRAT fellows are encouraged to broaden their training by attending scientific seminars on the NIH campus, traveling to scientific meetings, participating actively in lab meetings, making scientific presentations, and publishing the results of their research. Fellows receive formal training in the ethical conduct of research and scientific methods, including a focus on the reproducibility of data. Fellows are encouraged to take courses in quantitative biology and statistics if they have not already done so.  Fellows are exposed broadly to the cutting-edge technologies for which the Intramural Research Program is noted.  Fellows also have access to and are encouraged to utilize the resources of the NIH Office of Intramural Training and Education (OITE).

Each training plan should be explicitly designed to facilitate the transition to the next career stage and should explain how, in combination with the candidate's prior training and experience, the plan will contribute to the individuals' career goals.  It is expected that the mentored training experience will provide:

  • A strong foundation in research design, methods, and analytic techniques appropriate to the proposed research;
  • An enhanced ability to conceptualize and think through research problems with increasing independence;
  • Experience conducting research using appropriate, state-of-the-art methods;
  • The opportunity to present and publish research findings (including first authorship as appropriate) and to interact with members of the scientific community at scientific meetings and workshops; and
  • Professional and scientific skills needed to transition to the next stage of the applicant's career in the biomedical research workforce.

NIGMS encourages applications from individuals sufficiently early in their postdoctoral training period that they can benefit from the mentored research and training opportunities provided by the PRAT program.  This includes doctoral students who will complete their degree by the time of entrance into the program.

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

Section II. Award Information

Funding Instrument

Other: A mechanism that is not a grant or cooperative agreement.

Application Types Allowed
New
Resubmission

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

Clinical Trial?

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

 

Note: Applicants 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 Budget

Fellowship budgets are composed of stipends and travel and training allowance, as described below.

Award Project Period

Postdoctoral fellows may receive up to 3 years of support from the PRAT fellowship.

Other Award Budget Information

Stipends
PRAT fellows are supported by the NIH Intramural Research and Training Award (IRTA) mechanism and are provided stipends as a subsistence allowance to help defray living expenses during the research and clinical training experiences.
Tuition and Fees

Not Applicable

Institutional Allowance
Indirect Costs

Not Applicable

Travel and Training Allowance

PRAT fellows receive a travel and training allowance of $3000 each year to attend scientific meetings or participate in courses to enhance their research training and professional development. Activities must be approved by the PRAT Director(s).

NIH policies as described in the Office of Intramural Research Sourcebook and the NIH Policy Manual will apply to the applications submitted and awards made from this FOA.

 

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Governments

Intramural Research Program of the NIH

Before submitting a fellowship application, the applicant must identify a sponsoring NIH Institute or Center. The application will be submitted by the sponsoring IC’s Authorized Organizational Representative (AOR) on behalf of the fellow. Fellows should plan for sufficient lead time in preparing the application to ensure the appropriate individual(s) for submitting the application is identified.

  • None
Other
  • None
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 not 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.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); 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 full SAM and Grants.gov registrations; 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)

Students/postdoctoral scientists applying for this fellowship will apply as the PD/PI - multiple PDs/PIs are not allowed. Applicants should work with the sponsor(s) and Institutes or Centers to develop an application for support of the proposed research training plan. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities 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).

As this is a postdoctoral fellowship, eligible individuals must have completed their degree by the time of entrance into the program (students who will complete their degree by the time of entrance into the program are strongly encouraged to apply). In accordance with the policy of NIH Office of Intramural Research, individuals appointed to postdoctoral training positions using the Intramural Research Training Award (IRTA) must have no more than five years of relevant research experience since receipt of their most recent doctoral degree.

Additionally, individuals may only be supported on the IRTA mechanism for a maximum of 5 years, only 3 of which can be via the PRAT fellowship. Individuals currently in postdoctoral IRTA appointments in the NIH Intramural Research Program should plan to submit their applications early in their appointment so that they have accumulated no more than 24 months of training on the IRTA mechanism before entrance into the PRAT program. Below is a table of application due dates and the earliest date of entrance into the Intramural Research Program for which applicants are eligible to apply for the PRAT fellowship:

Application Due Date

Earliest IRTA start date eligible to apply

October 3, 2022

July 1, 2021 or after

October 3, 2023

July 1, 2022 or after

October 3, 2024

July 1, 2023 or after

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.
Duration of Support

Individuals may receive up to 3 years of support from the PRAT fellowship. Additional options are available to extend one's time in training in the NIH Intramural Research Program should this be needed at the completion of the PRAT program.

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.

Sponsor

Before submitting the application, the applicant must identify an NIH intramural investigator who will serve as the primary sponsor and play an active role in the proposed mentored research training experience. Applicants are encouraged to identify more than one sponsor, i.e., a sponsor team, if this is deemed advantageous for the research training and career development plan. When there is a sponsor team, one individual must be identified as the primary sponsor. An NIH intramural investigator is only allowed to serve as the primary sponsor on one PRAT application per review cycle but may co-sponsor additional applicants. If multiple applications with the same primary sponsor are received in a single review cycle, they will all be withdrawn. The primary sponsor should be a scientist in the area of the proposed research training and demonstrate a commitment to be an active mentor in the applicant's research training and career development. For example, the primary sponsors are expected to participate in a training and mentoring plan appropriately tailored to the needs of the applicant that will facilitate skills development and career advancement.

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 Fellowship (F) 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 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.

Instructions for Application Submission
SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

Other Project Information

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

Other Attachments: The application must include the following attachment.

Leadership Statement (1-page maximum)

The application must include a leadership statement from the PD/PI applying for a PRAT award (i.e., the postdoctoral fellow).  Include a description of past leadership and service activities in the scientific community, or to enhance public engagement/understanding of scientific research. Include a description of commitment to diversity in the biomedical sciences, and your leadership, mentoring and outreach activities to enhance diversity – especially involving groups underrepresented in the biomedical research enterprise.  Describe planned activities during the fellowship to develop or enhance leadership skills (e.g., leading teams, skills to work effectively with scientists from a wide variety of backgrounds and promote inclusive and equitable scientific biomedical research environments). Please name this file: Leadership Statement.

The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

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.

Biographical Sketch: Do not complete Section D "Scholastic Performance."    

PHS Fellowship Supplemental Form

The PHS Fellowship Supplemental Form is comprised of the following sections:

  • Fellowship Applicant
  • Research Training Plan
  • Sponsor(s), Collaborator(s), and Consultant(s);
  • Institutional Environment & Commitment to Training
  • Other Research Training Plan Sections
  • Additional Information
  • Budget
  • Appendix

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

Sponsor(s), Collaborator(s), and Consultant(s) Section

All instructions in the SF424 (R&R) Application Guide must be followed with the exception of the "Sponsor and Co-Sponsor Statements" section.

Sponsor and Co-Sponsor Statements

For this section, follow “Who must complete the “Sponsor and Co-Sponsor Statement” and the “Format” sections as indicated in the SF424 (R&R) application guide.

DO NOT follow the "Content" instructions for this section. Instead, follow the instructions below.

Content

Complete these items as comprehensively as possible so that the reviewers can make a meaningful evaluation of the training environment .

Create a heading at the top of the first page titled “Sponsor and Co-Sponsor Statements.” Organize each statement in the specified order and use the instructions below. Start each section with the appropriate section heading – Research Training Plan, Environment, Facilities; Number of Fellows/Trainees to be Supervised During the Fellowship; Applicant's Readiness and Capacity to Benefit from the Research Training Plan; and Clinical Trial (if applicable).

Each sponsor and co-sponsor statement must address all of the following sections.

A. Research Training Plan, Environment, Facilities

The applicant’s Research Training Plan should be individualized for the applicant, keeping in mind the candidate’s strengths and any gaps in needed skills. The Research Training Plan should be designed to enhance both research and clinical training (if applicable). The information contained in the “Research Training Plan, Environment, Facilities” section of the Sponsor’s and Co-sponsors’ Statements should augment, but not duplicate, information provided in the “Description of Institutional Environment” and “Commitment to Training” sections. This section should address the following:

    • How the Research Training Plan has been individualized and optimized for the fellowship applicant's career goals. Specifically, describe the skills and techniques that the applicant will learn. Relate these to the applicant's career goals.
    • The sponsor's strategy to participate in and monitor the progress of the Research Training Plan. Address how the sponsor will engage in or support activities that promote the development of the skills, credentials, and experiences needed for the trainee to transition into the next phase of a career in the biomedical research workforce;
    • Whether the sponsor has sufficient time to commit to the individualized Research Training Plan given their other professional obligations;
    • The sponsor's commitment to mentoring and promoting inclusive, safe, and supportive research training environments. The application should describe how the sponsor uses evidence-informed training and mentoring practices that promote the development of trainees from all backgrounds e.g., from groups underrepresented in the biomedical sciences (see Notice of NIH's Interest in Diversity);
    • How the research environment and available research facilities and equipment are adequate to complete the research component of the Research Training Plan;
    • How the sponsor promotes the use of highest standards of practice to ensure the safety of all individuals in the research environment;
    • How the sponsor employs the highest standards of scientific rigor and impart those standards to their trainees; and
    • How the sponsor reinforces and augment the curricular material on responsible conduct of research, and methods for enhancing reproducibility.

B. Number of Fellows/Trainees to be Supervised During the Fellowship

Indicate how many pre- and/or post- doctoral fellows/trainees the Sponsor/Co-sponsor is expected to supervise during the award period.

C. Applicant's Readiness and Capacity to Benefit from the Research Training Plan

Evaluate and describe the readiness of the applicant to undertake the proposed research training and their capacity to benefit from the fellowship. Sponsors are encouraged to comment on qualities that go beyond academic and institutional backgrounds, such as determination, persistence, integrity, and creativity. Explain how the fellowship applicant has the potential to strongly benefit from, and with proper training and support, succeed in the research training environment and reach the proposed goals.

D. Clinical Trial (indicate if not applicable)

If the applicant is proposing to gain experience in a clinical trial as part of the research training, the sponsor or co-sponsor should include information in the statement to document leadership of the clinical trial. Include the following:

    • Source(s) of funding;
    • ClinicalTrials.gov Identifier (e.g., NCT87654321), if applicable;
    • A description of how your expertise is appropriate to guide the applicant in any proposed clinical trials research experience; and
    • A statement/attestation that the sponsor will be responsible for the clinical trial. The sponsor must have primary responsibility for leading and overseeing the trial and must describe how he/she will provide this oversight (be careful to not overstate the fellow’s responsibilities). Outline the specific roles/responsibilities of the fellow and sponsor, keeping in mind that the terms of a fellowship award do not permit the fellow to lead a clinical trial.

Institutional Environment and Commitment to Training Section

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

Description of Institutional Environment and Commitment to Training

Describe how the institutional environment is well-suited to the candidate’s Research Training Plan. Detail the institutional commitment to promoting the following:

  • A culture in which the highest standards of safety, scientific rigor, reproducibility, and responsible conduct of research are advanced;
  • Inclusive, safe, supportive, equitable, and accessible research training environments; and
  • Research training environments that value diversity, equity, and inclusion at all levels (trainees, staff, leadership).

 

Budget Section

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

Tuition and Fees:  Select the box labeled "None Requested".

AppendixLimited 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.

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 SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. 

Study Record: PHS Human Subjects and Clinical Trials Information

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

  • 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.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described, but will not start immediately (i.e., delayed start). 

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

PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.
Reference Letters

Applicants must carefully follow the SF424 (R&R) 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.

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 PRAT fellowship awards are subject to the terms and conditions, and other considerations described in the Office of Intramural Research Sourcebook and the NIH Policy Manual.

A PRAT 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 fellowship.

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) and sponsor(s) must include their eRA Commons ID in the Credential fieldof 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 (DUNS number or UEI as required) provided on the application is the same number 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.

For this particular announcement, note the following:

  • A fellowship application has a research project that is integrated with the training plan. The review will emphasize the applicant’s potential for a productive biomedical research career, the applicant’s need for the proposed training, and the degree to which the research project and training plan, the sponsor(s), and the environment will satisfy those needs.
Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the fellowship will enhance the candidate’s potential for, and commitment to, a productive independent scientific research career in a health-related field, 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 scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

 
  • Is the applicant appropriately prepared for the proposed Research Training Plan?
  • With proper guidance and support, does the applicant have the potential to reach the career goals outlined in the Research Training Plan?
  • Does the candidate show the potential to develop into a leader in the biomedical research community? Does the candidate describe a compelling commitment to diversity in the biomedical sciences, and robust plans to develop or enhance their leadership skills?
 

 

  • Is there evidence of a match between the research and clinical interests (if applicable) of the candidate and the sponsor(s)? Do(es) the sponsor(s) demonstrate an understanding of the candidate’s training needs as well as the ability and commitment to assist in meeting these needs?
  • If a team of sponsors is proposed, is the team structure well justified for the mentored training plan, and are the roles of the individual members appropriate and clearly defined?
  • Do(es) the sponsor(s) have sufficient time to commit to the proposed Research Training Plan given their other professional obligations?
  • Is/Are the sponsor(s) committed to mentoring and promoting inclusive, safe, and supportive research training environments? Do(es) the sponsor(s) use evidence-informed training and mentoring practices that promote the development of trainees from all backgrounds?
  • If applicable, are the collaborator(s) and/or consultant(s) appropriate for the proposed Research Training Plan?
  • Do(es) the sponsor(s) promote the use of the highest standards of practice for safety, scientific rigor, and the responsible conduct of research?
  • If the applicant is proposing to gain experience in a clinical trial as part of his or her research training, is there evidence of the appropriate expertise, experience, resources, and ability on the part of the sponsor(s) to guide the applicant during the clinical trial research experience?
 

 

  • Is the proposed research project well integrated with the proposed Research Training Plan?
  • Is the prior research that serves as the key support for the proposed project rigorous? Has the applicant included plans to address potential weaknesses in the rigor of the prior research?
  • Has the applicant presented strategies to ensure a robust and unbiased approach, as appropriate for the research project proposed?
  • Has the applicant presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
  • Is the proposed time frame feasible to accomplish the proposed research training?
  • Does the Research Training Plan provide adequate opportunities for career development and networking?
  • Will the Research Training Plan provide the skills needed for the candidate to transition and succeed in the proposed career?
 

 

  • Does the training plan take advantage of the candidate’s strengths, address gaps in needed skills, and align with the candidate's scientific interests and values? Does the training plan document a clear need for, and value of, the proposed training? Will the applicant benefit significantly from the Research Training Plan?
  • Will the proposed Research Training Plan provide the candidate with the requisite individualized and mentored experiences in order to obtain the appropriate skills for a career in the biomedical research workforce?
 

 

  • Will the institutional environment promote the success of the candidate? Are the institutional commitment and resources likely to fostering the candidate’s mentored training and career development?
  • Will the research environment, research facilities, and equipment allow for the completion of the research component of the Research Training Plan?
  • Is there a clear institutional commitment to develop and promote a culture in which the highest standards of safety, scientific rigor, reproducibility, and responsible conduct of research are advanced?
  • Is there evidence that there is a strong institutional commitment to mentoring and promoting inclusive, safe, supportive, and accessible research training environments?
  • Are diversity, equity, and inclusion promoted at all levels of the research training environment (trainees, staff, and leadership)?
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.

 

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.

 

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.

 

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.

 

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

 

Not Allowed

 

 

Not Allowed

 

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.

Additional Review Considerations

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

 

 

All applications for support under this FOA must include a plan to fulfill NIH requirements for Instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the candidate, including any prior instruction or participation in RCR as appropriate for the candidate’s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter -the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation -the role of the sponsor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction -the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction –instruction must occur during each career stage and at least once every four years. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019.

 

Not Applicable

 

 

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

 

 

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan.

 

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIGMS Scientific Review Branch, 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 may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will be assigned on the basis of established PHS referral guidelines to NIGMS. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by NIGMS. 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.
  • Contributions to portfolio breadth and diversity as outlined in the NIGMS Strategic Plan.

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

Selected applicants will be notified by the PRAT program Director(s) and will receive a formal offer of a fellowship position sponsored by NIGMS for research to be conducted within the Intramural Research Program of the NIH. NIGMS PRAT Fellows are appointed using the Intramural Research Training Award (IRTA) mechanism. NIH policies as described in the Office of Intramural Research Sourcebook and the NIH Policy Manual will apply to all fellowships funded through this FOA

2. Administrative and National Policy Requirements

Selected applicants will be appointed as NIGMS PRAT postdoctoral fellows in the NIH Intramural Research Program. PRAT fellows receive mentoring from the PRAT Director(s), and from Lab and Branch Chiefs in the Intramural Research Program. Additional information about the policies governing Intramural fellowship positions can be found in the NIH Policy Manual and Office of Intramural Research Sourcebook. More information about the design and purpose of the PRAT program can be found on the PRAT website.

Should the applicant organization successfully 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.

Terms and Conditions of Award

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. 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.

4. 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 postdoctorates and early career investigators:

  • 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 candidates.

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: http://grants.nih.gov/support/ (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: 301-637-3015

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)

Edgardo Falcon-Morales, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: edgardo.falcon@nih.gov

Peer Review Contact(s)

Stephanie Constant, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: stephanie.constant@nih.gov

Financial/Grants Management Contact(s)

Tony Moore
National Institute of General Medical Sciences (NIGMS) 
Email: tonym@mail.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 45 CFR Part 75 and 2 CFR Part 200.

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