Continued Extension of Certain Flexibilities for Prospective Basic Experimental Studies With Human Participants

This notice replaces NOT-OD-19-126. The purpose of this notice is to extend interim policy flexibilities regarding registration and results reporting for a subset of NIH-funded research whose primary purpose is basic experimental studies with humans (BESH). These studies, referred to in NOT-OD-18-212 as “prospective basic science studies involving human participants,” meet both the NIH definition of a “clinical trial” and also the definition of basic research.

This additional extension will last through September 24, 2023. During this extension period, NIH will continue to work with the BESH community to explore solutions that allow for the dissemination of information in ways that are useful to other researchers and members of the public, while also maintaining the NIH commitment to stewardship and increasing transparency.

For more information, see the NIH Notice NOT-OD-21-088.

Last Updated on March 30, 2021