Unintended consequences: What is a "clinical trial"?
More than 2,400 researchers have now signed an "Open Letter to NIH Director Francis Collins" that starts like this:
We are writing to request that NIH delay implementation of its policy that sweeps basic science into a clinical trials framework until adequate feedback about its impact is obtained from the affected scientific community. We wholeheartedly agree with NIH’s goals of increasing scientific transparency and rigor, but we ask that you consider alternative mechanisms to accomplish those goals that would have fewer adverse effects on basic research.
The background is a new definition of what counts as a "clinical trial", to be enforced starting 1/1/2018 ("NIH's Definition of a Clinical Trial"):
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
Interpreted literally, this means that a study of priming effects on speech perception in healthy undergraduate students might count as a "clinical trial", since "human subjects are prospectively assigned to one or more interventions" (the priming part), and speech perception is a "health-related biomedical or behavioral outcome". Or maybe not. NIH has given some bizarrely irregular examples of how to interpret this rather general definition — thus vision and memory in adults are apparently "health-related outcomes" but learning in children is not.
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