Updates on BESH Registration and Summary Results Reporting 


For a subset of NIH-funded basic experimental studies with humans (BESH) research, NIH has announced that we are further extending certain interim policy flexibilities for registration and results reporting. NIH is also developing an optional alternative approach for summary results reporting for these studies. BESH research meets both the NIH definition of a clinical trial and the federal definition of basic research.  

In summary: 

  • NIH is extending the period of delayed enforcement for registration and results reporting for BESH responsive to designated BESH notices of funding opportunity (NOFOs) with application due dates through September 24, 2025. The new notice replaces NOT-OD-22-205
  • NIH expects BESH responsive to designated BESH NOFOs with application due dates on or after September 25, 2025 to register in ClinicalTrials.gov and report summary results in accordance with the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
  • NIH is developing an optional alternate approach, expected in 2026, for awarded BESH responsive to a designated BESH NOFO that will allow linking from ClinicalTrials.gov study records to corresponding summary results information posted on Regulations.gov. 
    • This approach will be an optional alternative to summary results reporting for those rare BESH whose design precludes tabular results reporting in ClinicalTrials.gov.
    • While NIH encourages BESH summary results reporting in ClinicalTrials.gov, the alternative approach will meet the expectations of results reporting under the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information. 

Additional details are available in NOT-OD-24-118.  

Around late spring of 2025, NIH plans to share more information on the optional alternative approach, including guidance and resources to support the processes for BESH registration and submission of summary results information.  

Learn about Basic Experimental Studies Involving Humans (BESH), check the Frequently Asked Questions on BESH NOFOs, and read the Special Considerations for BESH section of the Clinical Trial-Specific Funding Opportunities webpage. 

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