Notice Number: NOT-OD-17-123
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) Institutional Research Training Grants if one or more appointed trainees will propose to gain research experience in an ongoing clinical trial led by a mentor or co-mentor, 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 Institutional applications when the program proposes to offer appointed trainees the opportunity to obtain clinical trial research experience in an ongoing clinical trial led by a mentor or co-mentor. 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 trainee(s) and the scope of proposal relative to the available resources, including the mentor's and/or co-mentor's research support.
Scored Review Criteria
The following questions are in addition to the standard training review questions:
Training Program and Environment
- No additional questions.
Training Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)
- No additional questions.
- If the program will support clinical trial research experience for the Trainees, do the mentor(s) who will supervise the Trainee(s) have the expertise, experience, resources and ability to provide appropriate guidance and help the Trainee(s) to meet the timelines?
Trainees
- No additional questions.
Training Record
- 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)
