New policies for studies involving human subjects and/or clinical trials:

• Carefully select the right NIH funding opportunity announcement, because most NIH funding either “requires”, “prohibits”, or allows “optional” clinical trials. Pay extra careful attention, so you apply to the correct opportunity.
• Familiarize yourself with the new required “Human Subject and Clinical Trial Information form” as part of NIH applications. Learn about the new form here.
• Know if you are conducting a clinical trial, based on the following:

1) Does the study involve human participants?

2) Are the participants prospectively assigned to an intervention?

3) Is the study designed to evaluate the effect of the intervention on the participants?

4) Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

If the answer to all four questions is yes, then your proposed research meets the NIH definition of a clinical trial. The definition encompasses a wide range of trial types: mechanistic, exploratory/developmental, pilot/feasibility, behavioral, and more. See the NIH webpage on the definition, case studies, FAQs and other resources that can help. Also see the new NIH webpage for Clinical Trial Requirements for NIH Grantees and Contractors.

For more information or to receive this notice through email, contact aubreyturner@uncg.edu.