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Update on Basic Science and Clinical Trials at NIH

The Federation of Associations in Behavioral & Brain Sciences (FABBS) has issued a new blog post discussing the recent updates on basic science and clinical trials at NIH.

Limping Toward the Goal Posts: Basic Science and Clinical Trials at NIH

January 23, 2018 by FABBS
Paula Skedsvold and Jeremy Wolfe*

In the summer of 2017, researchers in the mind, brain, and behavioral science communities became engaged in a dialogue of sorts with the National Institutes of Health about their plan to reclassify a great deal of basic science research as “clinical trials” and, as a result, subject that research to a number of policies specific to clinical trials. Our conversation with NIH has progressed, but it is not finished.

Progress

To be sure, there has been progress. Through interactions with NIH staff, the case studies that define whether a research project is or is not a clinical trial have been revised on multiple occasions, resulting in an apparent narrowing of the reach of the clinical trial definition to include less basic behavioral and brain science. The latest revision of the case studies can be found here.

Case 18 (in its many parts) has been central to the definition of clinical trials from the vantage point of basic behavioral and brain science. That case is revised in the newest list and it seems that much of our basic science (behavioral and fMRI) has been removed from the clinical trials framework. Cases 24 and 26 have also been of concern to our science community. In the latest revision, these case studies have been removed. It is unclear at this time whether the case studies are undergoing revision and will be posted later. Read more…

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