Notice Number: NOT-OD-17-122
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.
National Institutes of Health (NIH)
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.
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.
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.
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.
The following questions are in addition to the standard individual fellowship review questions:
Sponsors, Collaborators, and Consultants
Research Training Plan
Institutional Environment & Commitment to Training
Please direct all inquiries to:
Division of Biomedical Research Workforce
Office of Extramural Programs
Office of Extramural Research