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.
“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 reform effort started in 2014, which aims to ensure that all clinical results are publicly reported. The policy is scheduled to go into effect in January 2018; it defines a clinical trial as anything involving behavioural ‘interventions’, such as asking participants to perform a memory task or monitor their food intake. Under the policy, such studies would need special evaluation by NIH committees and institutional ethics-review boards.
[M]any researchers think that studies of normal human behaviour — intended to discover 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 comply fully with the policy.
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