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ResourcesHuman Research Ethics(US) NIH delays controversial clinical trials policy for some studies – Science (Jocelyn Kaiser | July 2018)

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

(US) NIH delays controversial clinical trials policy for some studies – Science (Jocelyn Kaiser | July 2018)

 


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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.

Although research groups had hoped NIH would drop its plans to tag basic studies with humans as trials, they say they’re relieved they get more time to prepare and give the agency input. “It’s a positive step forward,” says Paula Skedsvold, executive director of the Federation of Associations in Behavioral & Brain Sciences in Washington, D.C.
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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.
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