News from FABBS

Clinical Trial Definition Continues to Cause Confusion

February 12, 2020

Towards the end of January, FABBS started receiving emails from worried researchers saying their proposals to NIH had been withdrawn before review because they were not classified as clinical trials, and perception was that they should have been. As readers may recall, in October 2014, NIH expanded their definition of clinical trials to include Basic Experimental Studies involving Humans (BESH). While the enforcement of registration in for BESH had been

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Struggles with NIH Clinical Trial Policies Continue For Basic Scientists

January 9, 2018

For at least six months now, NIH and segments of the basic science community have been engaged in a dialogue around the agency’s operationalization of the clinical trials definition to include much basic science involving humans. Through petitions, open letters (see NIH Director Awardee letter and Study Section Chairs letter), emails, responses to NIH blog posts, Advisory Council discussions, and more, the back-and-forth has led to some improvements in the process (e.g.,

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