Notice Number: NOT-OD-18-109
Key Dates
Release Date: December 1, 2017
Issued by
National Institutes of Health (NIH)
Purpose
This notice revises and replaces the previous notice (NOT-OD-17-121) to inform the community of additional scored review criteria that NIH will apply to individual career development (K) award applications submitted for due dates on or after January 25, 2018.
Important Note: Review criteria will differ for specific career development (K) funding opportunity announcements (FOAs), depending on whether they are for mentored K awards or independent K awards.
In addition, review criteria will differ depending on whether the FOA requires an independent clinical trial or allows the applicant to gain research experience in a clinical trial led by a mentor or co-mentor.
Note that these additional review criteria will not be used for the evaluation of institutional career development applications (K12 or KL2).
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 submitted for funding consideration for due dates on or after January 25, 2018. 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 interventions 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:
Candidate
Career Development Plan/Career Goals and Objectives
Research Plan
Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)
Environment & Institutional Commitment to the Candidate
The following questions are in addition to the standard individual K award review questions:
Candidate
Career Development Plan/Career Goals and Objectives
Research Plan
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)
Inquiries
Please direct all inquiries to:
Division of Biomedical Research Workforce
Office of Extramural Programs
Office of Extramural Research
Email: [email protected]