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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the end of January, FABBS started receiving emails from worried researchers saying their proposals to NIH had been withdrawn before review because they were not classified as clinical trials, and perception was that they should have been.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 grants.gov for BESH had been delayed, enforcement of the new definition for grant applications has gone into effect and our community has been experiencing the consequences.

FABBS has been working to gather information about the cases and details of these unintended consequences for our discussions with NIH. We are concerned that the definition of “clinical trial” remains unclear, the enforcement of the policy appears arbitrary, and the process of appeal seems ineffective and ad hoc. If you or a colleague have had a grant withdrawn as a result of confusion over the definition of a clinical trial, please contact Jeremy Wolfe (jwolfe@bwh.harvard.edu) or FABBS (info@fabbs.org). We can keep information confidential, if need be.

Some at NIH have recommended that all BESH grant proposals be submitted as clinical trials. This may be the best current advice but it is somewhat unsatisfying and may involve its own unintended consequence (e.g. some funding competitions do not accept clinical trial applications). If applying for NIH funding, we encourage you to seek advice from your program officer as to whether or not your research would be considered a clinical trial, though this is not a guarantee that your grant will proceed smoothly into review. FABBS is actively working on these problems together with the broad behavioral and brain science community and we will report back to our members.

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