NIH rolls back red tape on some experiments - spurring excitement and concern

"Many researchers are surprised and relieved over an unusual step taken by the US National Institutes of Health (NIH): the agency is rolling back the red tape on a host of basic-science experiments that involved human participants and had been classified as clinical trials. The decision, which was announced on 29 January and is part of a broader NIH effort to reduce administrative burden, should free such research from the heavy bureaucratic requirements that are designed for clinical trials but are sometimes ill-suited to other fields, such as basic psychology and behavioural studies."

"In 2014, the NIH expanded its definition of 'clinical trial' to include some studies of foundational biology in order to increase the transparency of research on human participants, says Deborah Zarin, a former director of the NIH database ClinicalTrials.gov. The clinical-trial designation usually comes with an obligation to preregister experiments and publish results on ClinicalTrials.gov. This was intended, in part, to address the fact that many studies on human participants are never published in academic journals: negative results, in particular, often remained locked away in laboratory notebooks. That made it difficult for researchers to learn from each other's failed experiments and replicate results, and for participants and ethics committees to fully evaluate a proposed study."

The NIH announced on 29 January a rollback of the clinical-trial classification for many basic-science experiments involving human participants to reduce administrative burden. The change should relieve basic psychology and behavioural studies from requirements designed for clinical trials that can be ill-suited to foundational research. Some researchers welcomed the move as a removal of unnecessary nuisance, while others urged refining implementation rather than eliminating the requirements entirely. The 2014 expansion of the clinical-trial definition had aimed to increase transparency by requiring preregistration and results reporting on ClinicalTrials.gov. The policy change reflects a tension between transparency goals and administrative feasibility.

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