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 controversy dates back to 2017, when behavioral and cognitive researchers realized that new requirements for registering and reporting results from NIH-funded clinical studies would also cover even basic studies of human subjects, experiments that did not test drugs or other potential treatments. The scientists protested that including such studies would confuse the public and create burdensome, unnecessary paperwork. A year ago, NIH announced it would delay the requirement until September and seek further input.

The responses prompted NIH staff to examine published papers from scientists conducting basic research. They agreed it would be hard to include some of these studies into the rigid informational format used by ClinicalTrials.gov—for example, because the authors didn’t specify the outcome they expected before the study began, or they reported results for individuals and not the whole group. In other cases, the authors did several preliminary studies to help them design their experiment.

…continue reading ‘Scientists Doing Basic Studies of Human Brain Win Longer Reprieve from Clinical Trials Reporting Rule’

Image: By Antoine Lutz – Barry Kerzin, Public Domain, https://commons.wikimedia.org/w/index.php?curid=56906405

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