On July 24th, NIH published a Guide Notice (NOT-OD-19-126) announcing the extension of delayed enforcement of registering and results reporting of Basic Experimental Studies involving Humans (BESH trials) on ClinicalTrials.gov through September 24, 2021. BESH trials are basic research projects exploring fundamental aspects of phenomena that involve human participants.
In a previous RFI (NOT-OD-18-217), NIH solicited feedback from the scientific community about challenges in reporting BESH trials on the ClinicalTrials.gov platform and several primary challenges were identified. Therefore, NIH has determined that more time is needed to address these challenges. In the interim, to meet NIH’s registration and results reporting requirement, alternative publicly available platforms should be used as described at the time of application in the Dissemination Plan attachment.
Please note this extension does not change the requirement for clinical trials to be registered on ClinicalTrials.gov.
For questions about this notice or your ClinicalTrials.gov requirement, please contact Ellen Ciesielski, 860.679.6004.