Brain researchers in uproar over NIH clinical trials policy –

Scientists studying human behaviour and cognitive brain function are up in arms over a plan by the US National Institutes of Health (NIH) to classify most studies involving human participants as clinical trials.

An open letter sent on 31 August to NIH director Francis Collins says that the policy could unnecessarily increase the administrative burden on investigators, slowing the pace of discovery in basic research. It asked the NIH to delay implementation of the policy until it consulted with the behavioural science community. As this article went to press, the letter had garnered 2,070 signatures.

Every scientist I have talked to who is doing basic research on the human mind and brain has been shocked by this policy, which makes no sense, says Nancy Kanwisher, a cognitive neuroscientist at the Massachusetts Institute of Technology in Cambridge, who co-wrote the letter with four other researchers.

The policy is part of an NIH clinical trial reform effort started in 2014 to ensure that all clinical results were publicly reported. The policy is scheduled to go into effect in January 2018. Its definition of a clinical trial included anything involving behavioural interventions, such as having participants perform a memory task or monitor their food intake. Such studies would need special evaluation by NIH review committees and institutional ethics review boards; and the experiments would need to be registered online in the database.

But many researchers believe that studies of normal human behaviour intended to discover new phenomena rather than alter them should not be classified in this way. Among other concerns, small institutions that do not normally perform clinical trials may not have the resources or knowledge to fully comply.

These concerns are overblown, said Michael Lauer, NIH deputy director for extramural research at a 1 September NIH advisory council meeting in Bethesda, Maryland. The only regulation were talking about is reporting that the trial exists and telling the world about the results. It is as simple as this and as profound as this. He said that his office would work with behavioural scientists to ensure their studies were getting the proper review and that their research could be properly registered.

But advisory council member Terry Jernigan, a cognitive scientist at the University of California San Diego, told Lauer that it was not as simple as that. She said the policy has already caused problems for a study shes leading that tracks normal brain development in adolescents. When her group had the parents sign the required clinical trial consent form, some expressed concerns that the language indicated that something was being done to their children, rather than just having researchers observe them.

The NIH, in response to some of those concerns, will release a list of study examples that qualify as clinical trials under the new policy next week. The NIH definition of a clinical trial may be broader than other clinical trial definitions because it reflects NIH's mission, encompassing biomedical and behavioral outcomes as they pertain to human health, said the NIH in a statement to Nature News. This definition does not encompass all psychological and cognitive research that is funded by NIH.

Jeremy Wolfe, a vision researcher at Brigham and Womens Hospital in Boston, says he is encouraged to hear Lauer say the NIH plans to work with researchers in his field, but says that the details of the policy will be key. Were worried about whether those details can be worked out by the January deadline, he says.

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