Human Subjects and NIH Proposals

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 Decision Tool to learn whether your study is a clinical trial.  

Human Subjects and Clinical Trial Information Form

Detailed instructions for completing the Human Subjects and Clinical Trial Information Form [PDF]

Proposals with Human Subjects (non-clinical trial)

For all proposals with Human Subjects and that will not have a delayed onset, the applicant will need to include at least one New Study Record.

The New Study record is intended to capture and consolidate the details of the planned use of human subjects. Many sections will be familiar, such as the Inclusion of Women, Minorities, and Children, which was previously captured in the Research Plan form.

These proposals must complete sections through section 3.2 of the New Study form.

Proposals with Clinical Trials

Proposals that meet the NIH Definition of “Clinical Trials” (no delayed onset) must also include at least one New Study Record. In this case, Sections 1, 2, 3, 4 must be included and Section 5 may be required if specified in the solicitation.

Proposals with Delayed Onset of Human Subjects (either Clinical or not)

For Delayed Onset studies, a Delayed Onset Study Record must be uploaded 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.

Visit the MIT COUHES website for more information.