Basic brain and behavioral researchers will get more than a year to comply with a new U.S. policy that will treat many of their studies as clinical trials. The announcement from the National Institutes of Health (NIH) appears to defuse, for now, a yearlong controversy over whether basic research on humans should follow the same rules as studies testing drugs.
Update on an unpopular US plan to radically expand the definition of a clinical trial. While limited to the States at the moment, the change might ripple out to the rest of us.
.
At issue is a recently revised definition of a clinical trial along with a set of rules in effect since January that are meant to increase the rigor and transparency of NIH-funded clinical trials. About a year ago, basic scientists who study human cognition—for example, using brain imaging with healthy volunteers—were alarmed to realize many of these studies fit the new clinical trial definition.
.