Flexibilities for Registration and Results Reporting of Prospective Basic Experimental Studies with Human Participants

July 24, 2025

NIH is indefinitely extending the period of delayed enforcement for registration and results reporting, originally announced in NOT-OD-18-212 for basic experimental studies involving humans (BESH) responsive to designated BESH notices of funding opportunities (NOFOs), including those with application due dates on or after September 25, 2025. During the period of delayed enforcement, NIH continues to expect registration and results reporting for these BESH but with the continued flexibility to register and report results on alternative publicly available platforms, although use of ClinicalTrials.gov is encouraged. 

For more information, please see the full guide notice and visit the BESH resources webpage, and the Special Considerations for BESH webpage. 

Categories: Top Stories

Related News

What Study Information Should Be Included on a ClinicalTrials.gov Entry?

A ClinicalTrials.gov study record is intended to summarize key information from a study’s protocol and the study’s findings. The study sponsor or investigator is responsible for ensuring that their studies follow all applicable laws and regulations and for submitting complete, accurate, and up-to-date information about their study.

You Ask, We Answer

Reminder of Requirement for Certification of IRB Approval

NIH would like to remind the extramural research community that NIH requires recipients to submit a certification to NIH that all nonexempt research involving human subjects has been reviewed and approved by an appropriate Institutional Review Board (IRB).

Tips Before You Submit
For technical issues E-mail OER Webmaster