If human subjects are part of the project, use the NIH Human Subjects Decision Tool to:
- Understand the NIH definition of human subjects
- Identify the correct funding opportunity, if you are applying for NIH Parent Announcements
Clinical Trial or Not?
Understanding whether a human subjects research study meets the NIH definition of a clinical trial helps you connect with the appropriate funding opportunities and complete submission forms correctly. Use NIH’s Clinical Trial Decision Tool to learn whether your study is a clinical trial, and consult COUHES for more information about clinical trials at MIT.
Human Subjects and Clinical Trial Information Form
The Human Subjects and Clinical Trials Information form includes a Study Record, which is intended to capture and consolidate the details of the planned use of human subjects. Unless the human subjects study has a delayed onset, complete the Study Record to the extent required:
- Not a clinical trial, no delayed onset: Complete the Study Record through sections 3.2.
- Clinical trial, no delayed onset: Complete sections 1-4 of the Study Record, as well as section 5 if specified in the solicitation.
- Delayed onset (clinical trial or not): Complete the Delayed Onset Study Record, listing the title of the study and the justification for the omission of the human subjects study information. Multiple delayed onset studies may be uploaded in a single record/justification attachment.
View detailed instructions [PDF] for completing the Human Subjects and Clinical Trial Information Form.
Updated November 4, 2025