July 26, 2019
NIH: Basic Experimental Studies with Humans (BESH) ClinicalTrials.gov Reporting Requirement Delayed
With NIH Notice: NOT-OD-19-126, NIH has delayed the requirement for reporting results of basic research on human studies in ClinicalTrials.gov until Sept. 2021. This delay only applies to studies designated as “basic experimental studies with humans” (BESH) in the title of the funding opportunity.
NIH still expects registration and results reporting, but there is more flexibility to register and report results on other publicly available platforms. Applicants must describe plans for meeting the research results reporting requirement in the application’s Dissemination Plan attachment.
Funded awardees for applications submitted to BESH-specific FOAs who are not using ClinicalTrials.gov for results reporting should provide the alternative platform’s unique identifier assigned to their results report, if available, and a link to the report.
Review the more details in the full notice: NOT-OD-19-126.