Scientists doing basic studies of human brain win longer reprieve from clinical trials reporting rule
U.S. scientists who challenged a new rule that would require them to register their basic studies of the human brain and behavior in a federal database of clinical trials have won another reprieve. The National Institutes of Health (NIH) in Bethesda, Maryland, says it now understands why some of that kind of research won’t easily fit the format of ClinicalTrials.gov, and the agency has delayed for the reporting requirements for another 2 years.
The agency has not backed down from classifying many basic research studies with humans as clinical trials. “But it seems to essentially be saying that NIH knows that relabeling basic research as clinical trials won’t work,” says Sarah Brookhart, executive director of the Association for Psychological Science in Washington, D.C. “My hope is they are now willing to work with the community to figure out the best ways to achieve our shared goal of providing access to the research in question,” she says.
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