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

September 26, 2022
NIH Notice NOT-OD-22-205 replaces NOT-OD-21-088. It further extends 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) submitted in response to BESH Funding Opportunity Announcements (FOAs). 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.