Notice Number: NOT-OD-17-122
Key Dates
Release Date: October 6, 2017
September 29, 2023 - Notice of Information: Recruitment and Retention Monitoring and Reporting of Clinical Research Awards Supported by the National Institute on Drug Abuse. See Notice NOT-DA-23-033.
Issued by
National Institutes of Health (NIH)
Purpose
This notice informs the community of additional review criteria that NIH will apply to Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowships if the applicant fellow is proposing to gain research experience in an ongoing clinical trial led by a sponsor or co-sponsor, submitted to due dates on or after January 25, 2018.
Background
NIH is utilizing a multi-faceted approach to strengthen policies across the life cycle of a clinical trial, from development of the funding opportunity announcement (FOA), to the information collected in a grant application or contract proposal, to peer review of the application/proposal, and through to monitoring of the award. These actions include the implementation of new and more rigorous review criteria for evaluating clinical trial applications. Addressing these challenges will ensure the highest likelihood of translating research results into knowledge that will improve human health.
Implementation
The review criteria questions below will be effective for the evaluation of Kirschstein-NRSA Individual Fellowship applications when the applicant fellow is proposing to gain research experience in an ongoing clinical trial led by a sponsor or co-sponsor. The questions below will be added to the existing review questions (see https://grants.nih.gov/grants/policy/review_templates.htm), which will not change for projects that do not involve clinical trials. Some Program Announcements and Requests for Applications may include additional, FOA-specific questions.
Criteria
In addition, for applications involving clinical trials:
Reviewers will consider the nature of the research experience proposed by the applicant fellow and the scope of proposal relative to the available resources, including the sponsor's and/or co-sponsor's research support.
Scored Review Criteria
The following questions are in addition to the standard individual fellowship review questions:
Fellowship Applicant
- No additional questions.
Sponsors, Collaborators, and Consultants
- 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?
Research Training Plan
- If proposed, will the clinical trial experience contribute to the proposed project and/or the applicant’s research training?
Training Potential
- No additional questions.
Institutional Environment & Commitment to Training
- No additional questions.
Inquiries
Please direct all inquiries to:
Division of Biomedical Research Workforce
Office of Extramural Programs
Office of Extramural Research
Email: NIHTrain@mail.nih.gov
and Human Services (HHS)
