University of Iowa

NIH Forms-E: Human Subjects and Clinical Trials Information Form

Effective for applications due on or after January 25, 2018, the required new NIH Forms-E packet will include a new Human Subjects and Clinical Trials Information form. This new form is intended to aid investigators in determining whether the proposed project involves non-exempt human subjects research; to confirm whether the proposed project meets the NIH definition of a “clinical trial”; and to consolidate and extend the HS/CT information formerly scattered throughout the application.

The NIH-annotated HS & CT Info Form offers field-specific guidance. This can be a very helpful tool for becoming familiar with this new form, and a very useful reference when completing the form.

The annotated Human Subjects and Clinical Trials Information form was excerpted from the full Annotated Form Set for NIH Grant Applications - FORMS-E Series, which can also serve as a most useful reference as we transition to the new Forms-E packet.