Don’t Think Your Human Subjects Research Is a Clinical Trial?

Many investigators will be surprised to know that the mechanistic human studies they have been doing for years may now fall under the NIH definition of clinical trials. The NIH clinical trial definition is very broad and it may not be the same definition used by other organizations, including your own institution.

Why is this so important now?

After January 25, 2018, applications containing an NIH-defined clinical trial of any size or complexity can only be submitted through one of the new NIH funding opportunity announcements that require or allow clinical trials. Additional human subjects information will be required, and that information may be different from what you have submitted with earlier applications.

Reviewers need to be prepared for change, too. The new PHS Human Subjects and Clinical Trials Information form consolidates and extends the types of human subjects information that was collected in previous applications, so reviewers will receive guidance on where in the application to look for important information that they need to review. Additional review questions will be used to evaluate clinical trial applications, and reviewers will be trained on that, too.

Information about this change, and useful tools to help you successfully submit your clinical trial application can be found at: