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All applicants proposing clinical trials must submit applications through a notice of funding opportunity (NOFO) that is specifically designated for clinical trials.
Purpose
For due dates on or after January 25, 2018, NIH requires all applications involving one or more clinical trials to be submitted through a notice of funding opportunity specifically designated 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 and proposals involving clinical trials with due dates on or after January 25, 2018 must be submitted to a notice of funding opportunity (NOFO) or request for proposal (RFP) that explicitly states it will accept clinical trials. Since January 25, 2018, NIH no longer accepts clinical trial applications through previous parent announcements.
Remember that NIH supports many types of clinical trials (mechanistic, exploratory/developmental, pilot/feasibility, pragmatic, behavioral, and others), so be sure to read your funding opportunity carefully for specific instructions and considerations. It is also recommended that applicants check the online version of their funding opportunity within 8 weeks before the due date to ensure it is still appropriate for their application.
Check Which Opportunities Allow Clinical Trials
To confirm whether a NOFO allows clinical trials, check the opportunity notice's Title and Section II. Award Information for the following designations:
| Clinical Trial Not Allowed | Only accepts applications that do not propose clinical trial(s) |
| Clinical Trial Required | Only accepts applications that propose clinical trial(s) |
| Clinical Trial Optional | Accepts applications that either propose or do not propose clinical trial(s) |
| Basic Experimental Studies with Humans (BESH) Required | Only accepts applications that propose clinical trial(s) that also meet the definition of basic research |
Notices of funding opportunities that accept clinical trials have specific review criteria to ensure that reviewers appropriately consider clinical trial-related information.
Special Considerations
Basic Experimental Studies with Humans (BESH)
These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research.
- All notices of funding opportunities for Basic Experimental Studies with Humans (BESH) are designated as "Required -– Basic Experimental Studies with Humans: Only accepting applications that propose clinical trial(s) that also meet the definition of basic research" in Section II. Award Information.
- These notices of funding opportunities are designated as "Basic Experimental Studies with Humans Required" in the funding opportunity title.
- Participation in notices of funding opportunities for Basic Experimental Studies with Humans will vary by NIH Institute and Center (IC). Many ICs will continue to accept Basic Experimental Studies with Humans through existing notices of funding opportunities that accept clinical trials. However, BESH studies responsive to NOFOs other than designated BESH NOFOs will not have registration and results reporting flexibilities temporarily afforded to those responsive to the designated BESH NOFOs. It is important to check with a Program Officer to determine the most appropriate notice of funding opportunity for your application.
- BESH Resources:
Career Development (K) Awards
Career Development awards may support either independent clinical trials or a mentored research training experience, depending on the funding opportunity.
- Notices of funding opportunities that indicate "Independent Clinical Trial Required” in the title and in Section II. Award Information support independent clinical trials conducted by the applicant.
- Notices of funding opportunities that indicate “Independent Clinical Trial Not Allowed” 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 are 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.
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) notices of funding opportunities are designated as "Clinical Trial Not Allowed" in Section II. Award Information, but the notices indicate that applicants are permitted to propose research experience in a clinical trial led by a sponsor or co-sponsor.
- Fellowship (F) notices of funding opportunities do not include this designation in the funding opportunity title.
- Fellowship applicants proposing to gain mentored training in a clinical trial are 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.
Training (T) Awards
Institutional Training awards do not support clinical trials (with the exception of some D43 and K12 awards).
- All Training (T) notices of funding opportunities are designated as “Clinical Trial Not Allowed” in Section II. Award Information, but the notices indicate that appointed trainees are permitted to obtain research experience in a clinical trial led by a mentor or co-mentor.
- Training (T) notices of funding opportunities do not include this designation in the funding opportunity title.
- D43 and K12 notices of funding opportunities are designated as "Clinical Trial Not Allowed" or “Clinical Trial Optional” in the funding opportunity title and Section II. Award Information. These applicants will only be permitted to complete fields for Delayed Onset Studies in the PHS Human Subjects and Clinical Trials Information form.
Notices
- Updates to Funding Opportunity Terminology
- Continued Extension of Certain Flexibilities for Prospective Basic Experimental Studies with Human Participants
- Notice of Intent to Publish Parent Funding Opportunities for Basic Experimental Studies with Humans
- Delayed Enforcement and Short-Term Flexibilities for Some Requirements Affecting Prospective Basic Science Studies Involving Human Participants
- Reminder: Policy on Funding Opportunities for Clinical Trials Takes Effect January 25, 2018
- Guide Notice on Clinical Trial Funding Opportunity Policy
- NIH Plans for Clinical Trial Specific Parent R01 and Parent R21 Funding Opportunities