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ResourcesHuman Research EthicsSome scientists hate NIH’s new definition of a clinical trial. Here’s why – Nature (Jocelyn Kaiser | July 2017)

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Some scientists hate NIH’s new definition of a clinical trial. Here’s why – Nature (Jocelyn Kaiser | July 2017)

Published/Released on August 19, 2017 | Posted by Admin on August 3, 2017 / , , , , , ,
 


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Nancy Kanwisher, a cognitive neuroscientist, has spent her career pinning down how the human brain responds to visual inputs such as faces. As part of that work, Kanwisher asks volunteers—usually college students at the Massachusetts Institute of Technology (MIT) in Cambridge, where she works—to lie in an MRI machine that records their brain activity while they do a task, such as viewing a photo. Although such studies reveal information that can be relevant to diseases, and disorders such as autism, they do not test treatments.

But a few weeks ago, Kanwisher and colleagues in related behavioral research fields—from cognitive psychology to vision science—were dismayed to learn that the U.S. National Institutes of Health (NIH) in Bethesda, Maryland, could soon deem their studies to be clinical trials. That designation would impose a raft of new requirements on studies that have already passed ethics review, such as following different standards for funding applications, and reporting results on clinicaltrials.gov, a public database.

NIH officials say they simply want to ensure that all clinical trials—including those testing drugs, medical devices, and behavioral interventions—meet recently bolstered standards for rigor and transparency. But Kanwisher and others say that the agency’s widening definition of clinical trials could sweep up a broad array of basic science studies, resulting in wasted resources and public confusion. “The massive amount of dysfunction and paperwork that will result from this decision boggles the mind” and will hobble basic research, Kanwisher says. To prevent that outcome, she and dozens of other researchers, along with several scientific societies, have flooded NIH with letters and emails expressing concern about the policy, which the agency announced last September but is only now implementing.

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