Human Subjects and NIH Proposals

Clinical Trial or not?

Effective January 25, 2018, NIH has changed their definition of Clinical Trials. Please visit this NIH page to determine if your human subject research study meets the NIH Definition of a Clinical Trial.

Parent Announcements

NIH has released a new set of Parent Announcements  which delineate between (1) Clinical Trial Required; (2) Clinical Trial Not Allowed or (3) Clinical Trial Optional. Not all NIH Institutes and Centers participate on all parent announcements. Before submitting an application, make sure the NIH Institute or Center that might be interested in this research is listed as a participating organization in the announcement.

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.