Clinical Trial-Specific Funding Opportunities

All applicants proposing clinical trials can learn about the requirement for submitting applications through a funding opportunity announcement (FOA) designated specifically for clinical trials.

Purpose

For due dates on or after January 25, 2018, NIH will require that all applications involving one or more clinical trials be submitted through a Funding Opportunity Announcement (FOA) specifically designed for clinical trials. The purpose of this policy is to improve our ability to identify proposed clinical trials, ensure that key pieces of trial-specific information are submitted with each application, and uniformly apply trial-specific review criteria.

Policy Implementation

Applications/proposals involving clinical trials with due dates on or after January 25, 2018 must be submitted to an FOA or request for proposal (RFP) that explicitly states it will accept clinical trials. After January 25, 2018, NIH will no longer accept clinical trial applications through existing parent announcements.

All existing FOAs will be updated in Fall 2017 with the following changes:

  • All FOAs will specify the allowability of clinical trials in Section II. Award Information
  • All clinical trial FOAs will specify allowability of clinical trials in the FOA title
  • FOAs that accept clinical trials will incorporate specific review criteria to ensure that reviewers appropriately consider clinical trial-related information 

Applicants should check the online version of the FOA within 8 weeks of the due date to ensure it is still appropriate for their application. 

Note that NIH supports all types of clinical trials (mechanistic, exploratory/developmental, pilot/feasibility, pragmatic, behavioral, and others), so be sure to read your FOA carefully for specific instructions and considerations. 

Special Considerations for Training, Fellowship, and Career Development Awards

Training (T) awards
Institutional Training awards do not support clinical trials (with the exception of some D43 and K12 awards).

  • All Training (T) FOAs will be designated as “Clinical Trial Not Allowed” in Section II. Award Information,  but will indicate that appointed trainees are permitted to obtain research experience in a clinical trial led by a mentor or co-mentor. 
  • Some D43 and K12 FOAs will be designated as “Clinical Trial Optional” in Section II. Award Information

Fellowships (F) awards
The NIH encourages fellows to receive training in clinical research, however, NIH supported fellows are not permitted to conduct a clinical trial independently.

  • All Fellowship (F) FOAs will be designated as ‘No Independent Clinical Trials’ in Section II. Award Information, but will indicate that applicants are permitted to propose research experience in a clinical trial led by a sponsor or co-sponsor
  • Fellowship applicants proposing to gain mentored training in a clinical trial will be instructed to provide details of their contribution to the study in the Research Strategy rather than in the clinical trial specific fields on the PHS Human Subjects and Clinical Trials Information form.
  • NIH expects the mentor or individual receiving support for the clinical trial to assume overall responsibility of the trial.

Career Development (K) awards
Career Development awards may support either independent clinical trials or a mentored research training experience, depending on the FOA.

  • FOAs that indicate ‘Clinical Trial Required” in the title and in Section II. Award Information will support independent clinical trials conducted by the applicant
  • FOAs that indicate “No Independent Clinical Trials” in the title and in Section II. Award Information permit the applicant to propose research experience in a clinical trial led by a sponsor or co-sponsor
    • Career Development applicants proposing to gain mentored training in a clinical trial will be instructed to provide details of their contribution to the study in the Research Strategy rather than in the clinical trial specific fields on the PHS Human Subjects and Clinical Trials Information form.
    • NIH expects the mentor or individual receiving support for the larger trial to have the overall responsibility of the trial.

Notices