New process for NIH clinical trial submissions

Published November 27, 2017

The National Institutes for Health (NIH) is changing how they accept NIH-defined clinical trial applications.

Clinical trial submissions

Effective Jan. 25, 2018, the NIH is changing how they accept NIH-defined clinical trial applications, per NIH guide notice NOT-OD-17-043. All researchers with plans to conduct clinical trials must submit the grant applications in response to a Funding Opportunity Announcement (FOA) which specifically states that clinical trials are allowed.

After Jan. 25, 2018, if you submit a clinical trial application to a non-clinical trial FOA, your application will be returned without review.

NIH's definition of clinical trial now includes some research approaches not traditionally considered clinical trials. For example, many behavioral or biobehavioral studies that focus on underlying mechanisms of development may now be considered clinical trials. If you are conducting studies involving human subjects, it is very important that you understand the NIH definition of a clinical trial and determine whether it applies to your research.

Faculty wanting to submit an application for NIH-funded research involving human subjects, should familiarize themselves with the new PHS Human Subject and Clinical Trial Information Form to determine if their proposed research meets the NIH definition of a clinical trial. Faculty also should review NIH policy changes related to enhanced stewardship of clinical trials.

NIH developed this website to help guide you. Guidance on whether a faculty member's project should be defined as a clinical trial can use the NIH decision tree or reach out to the UB IRB office. NIH is encouraging faculty to connect with their NIH Program Officer for further clarification on this issue.