From: Nature
Brain researchers in uproar over NIH clinical-trials policy
An open letter to the US National Institutes of Health says that classifying human-behaviour studies as clinical trials creates unnecessary red tape.
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An open letter posted to an online petition site on 31 August and addressed to NIH director Francis Collins on 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 has consulted with the behavioural-science and neuroscience communities. The letter has so far garnered more than 2,700 signatures.
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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. The experiments would also need to be registered in the ClinicalTrials.gov database.