NIH Extends Registration Flexibility for Clinical Trials
Following consideration by National Library of Medicine (NLM), the unit at the National Institutes of Health (NIH) that oversees the ClinicalTrials.gov database, NIH has extended flexibilities for registration and results reporting for studies submitted to Basic Experimental Studies Involving Humans (BESH) funding opportunities. This policy flexibility has been extended through September 24, 2023, it was slated to expire on September 24, 2021. Refer to NOT-OD-21-088 for more details.
NIH strongly encourages BESH investigators to register their studies and report summary results to ClinicalTrials.gov, despite the flexibility for investigators to register and report results on alternative publicly available platforms.
In December 2020, NLM together with the Office of Behavioral and Social Science Research (OBSSR), hosted a webinar on December 7th to update the research community. During the webinar, NLM staff thanked FABBS for helping to identify case studies for an analysis of the challenges of registration and results reporting for BESH sciences.
Watch the webinar on the NIH website.
“It has been an extremely interesting and educational process providing input to our NLM colleagues about how to best accommodate BESH sciences within a modified ClinicalTrials.gov. Speaking from my role as past president of FABBS, I am grateful for the hard work and careful consideration that they have committed to figuring it out, and the opportunity to be helpful.”Jeremy M. Wolfe, Ph.D.
See FABBS’ overview of NIH communications and responses from scientists, scientific societies, and university representatives
February 26, 2020
FABBS conducted an interview with William T. Riley, Ph.D., director of the Office of Behavioral and Social Sciences Research (OBSSR) at the National Institutes of Health (NIH).
December 15, 2020
Staff at the National Library of Medicine (NLM), the unit at the National Institutes of Health (NIH) that oversees the ClinicalTrials.gov database, conducted an analysis of the challenges of registration and results reporting of Basic Experimental Studies with Humans (BESH) in ClinicalTrials.gov.