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Issued by
NATIONAL INSTITUTES OF HEALTH (NIH)
Purpose
NIH is issuing this Request for Information (RFI) to seek public input on potential funding models that would allow recipients of mentored K awards to serve as principal investigators (PIs) of clinical trials while receiving support for the clinical trial through a funding mechanism separate from the K award.
BACKGROUND
NIH career development ("K") awards provide intensive, supervised research and career development experiences that prepare investigators to transition to research independence. These awards provide protected time, mentorship, and structured research and professional development opportunities that enable investigators to acquire the knowledge, skills, and experience needed for successful independent research careers.
To strengthen the future clinical trial workforce, NIH is revising its mentored career development award policies to better distinguish career development support from support for the conduct of clinical trials. Under the revised policy:
- NIH will no longer support "Independent Clinical Trial Required" K award Notices of Funding Opportunities (NOFOs).
- K award funds may not be used to support or offset the costs of conducting a clinical trial, clinical feasibility study, or a separate ancillary study to an existing clinical trial.
- K award recipients who wish to lead a clinical trial as PI must secure separate funding (e.g., institutional, philanthropic, or other research grant support) to support those activities.
Under this policy, K awards will continue to support activities that prepare investigators for independent clinical trial research careers, including additional coursework, participation in a clinical trial led by a mentor or co-mentor, research that builds skills relevant to clinical trial leadership (e.g., qualitative research, observational studies, or secondary data analyses), and development of a clinical trial protocol.
NIH recognizes that serving as the PI of a clinical trial can be an important step toward research independence for many clinician-scientists by providing experience designing, leading, and managing complex clinical research and generating preliminary data to support future studies. Accordingly, NIH is exploring funding models that would allow mentored K award recipients to lead clinical trials while maintaining the K award's primary focus on career development. Under these models, support for the clinical trial would be provided through a funding mechanism separate from the K award, either during the mentored K award period (Approach 1) or during the subsequent Research Project Grant (RPG) stage of a K/R transition award (Approach 2).
NIH seeks public input on the advantages, challenges, and implementation considerations associated with these potential funding models.
Approach 1 | Approach 2 | |
| Best suited for | K award recipients leading their first clinical trial | Investigators with substantial prior clinical trial experience who are nearing independence |
| Career stage | Overlapping with a mentored K award | Transition from mentored development to independent research |
| Clinical trial application | Submitted after obtaining a K award | Submitted as part of the initial application |
| Goal | Add separate trial funding while remaining on a K award | Transition to an independent RPG to lead a clinical trial |
POTENTIAL NEW FUNDING MODELS
Approach 1 – Mentored K Award + Limited-Competition Clinical Trial Research Project Grant (RPG)
NIH is considering a limited-competition Research Project Grant (RPG) available only to recipients of mentored K awards. Under this approach, eligible investigators could apply for a separate RPG to support the costs of conducting their first clinical trial as PI. The RPG would support clinical trial-related expenses, while the investigator's salary would continue to be supported through the K award.
Applications would undergo NIH peer review and would include standard information required for review of clinical trial applications. The scope and budget of the proposed clinical trial would be expected to be appropriate for an investigator at the mentored career development stage.
This approach is intended for investigators who require separate support to conduct their first clinical trial while continuing to receive the protected time and career development provided through the K award. It would replace the current approach where recipients of "Independent Clinical Trial Required" K award NOFOs may use K award funds, with or without supplemental research support, to conduct clinical trials.
Approach 2 – Phased Transitional Award (Mentored Phase Followed by an Independent Research Project Grant Phase)
NIH is considering a phased transitional award consisting of a mentored K phase followed by an independent Research Project Grant (RPG) phase. Applicants would submit all information required for peer review of the proposed clinical trial as part of the initial application.
During the mentored phase, recipients could participate in a clinical trial led by a mentor or co-mentor, conduct research that prepares them for independent clinical trial leadership (e.g., qualitative research, observational studies, or secondary data analyses), and further refine plans for the proposed clinical trial.
Transition from the mentored phase to the independent RPG phase would be contingent upon successful completion of predefined programmatic milestones and NIH approval. The independent phase would provide funding to support the recipient as PI of the proposed clinical trial, including the resources needed to conduct the trial.
INFORMATION REQUESTED
NIH invites comments from the public on the topics below. Respondents are encouraged to address any or all areas and provide examples, evidence, or other information that may inform NIH's consideration of these potential funding models.
Clinical Trial Training and Career Development
NIH seeks input on considerations for supporting the development of independent clinical trial investigators under these funding models. Responses may address training, mentorship, transition to research independence, or other factors relevant to preparing investigators to lead clinical trials.
Proposed Funding Approaches
NIH seeks input on the design of the two proposed funding models. Responses may address the suitability of each model for its intended investigator population, eligibility criteria, timing of support, peer review considerations, transition between phases, budgetary or administrative features, and other recommendations to improve the proposed models. NIH also welcomes suggestions for alternative funding models.
Other Suggestions for Optimizing the Development of Clinical Trialists
NIH seeks any other relevant input related to how best to support the development of researchers who will lead or participate in running well-designed, efficient clinical trials that produce important information for improving clinical practice and human health.
HOW TO SUBMIT A RESPONSE
All comments must be submitted electronically at this website. Responses must be received by 11:59:59 PM (ET) on September 30, 2026.
Responses may be submitted by any interested stakeholder, including investigators, academic institutions, professional societies, patient advocacy organizations, industry, scientific organizations, and members of the public. NIH encourages organizations to submit a single coordinated response when appropriate.
This RFI is for planning purposes only and should not be construed as a funding opportunity announcement or solicitation for proposals. Responses are voluntary and may be submitted anonymously. Please do not include personally identifiable information or any information you do not wish to make public. NIH will not provide individual feedback on submissions; information received may be used for planning purposes and summarized in publicly available materials.
Inquiries
Please direct all inquiries to:
Email: [email protected]
and Human Services (HHS)
