Notice Number: NOT-OD-17-121
Release Date: October 6, 2017
National Institutes of Health (NIH)
This notice informs the community of additional review criteria that NIH will apply to individual career development (K) award applications submitted to due dates on or after January 25, 2018.
Important Note: Review criteria will differ for individual mentored and independent K award applications, and for K award applications where the PD/PI will lead an independent clinical trial compared with individual K award applications where the PD/PI will undertake clinical trials research experience under the guidance of the mentor or co-mentor.
Note that these additional questions will not be used for the evaluation of institutional K12 or KL2 applications.
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 individual career development award (K) applications that involve independent clinical trials led by the PD/PI of the K award application or K award applications where the PD/PI will undertake clinical trials research experience under the guidance of the mentor or co-mentor, and are submitted for funding consideration for due dates on or after January 25, 2018. The questions below will be added to the existing review questions (see https://grants.nih.gov/grants/peer/critiques/k.htm). Some Program Announcements and Requests for Applications may include additional, FOA-specific questions.
In addition, for applications involving clinical trials:
The reviewers will consider that the clinical trial may include study design, methods, and intervention that are not by themselves innovative, but address important questions or unmet needs. Reviewers should also consider the scope of the clinical trial relative to the available resources, including the
possibility that research support provided through K awards may be sufficient to support only small feasibility studies.
The following questions are in addition to the standard individual K award review questions:
Career Development Plan/Career Goals and Objectives
Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)
Environment & Institutional Commitment to the Candidate
Study Timeline for Clinical Trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
Please direct all inquiries to:
Division of Biomedical Research Workforce
Office of Extramural Programs
Office of Extramural Research