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The recently updated NIH clinical trials policies will apply broadly to studies involving experimental manipulations of humans. These studies will require registration and reporting in ClinicalTrials.gov, grant application submission under a clinical trials funding opportunity announcement, and Good Clinical Practice training for investigators.
Last year, the NIH issued its clinical trials policies to enhance the accountability and transparency of clinical research. These policies, which become effective on January 25, 2018, apply to all NIH-supported research that meets the 2014 NIH revised definition of a clinical trial: “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” The NIH sought and received input on these clinical trials policies and definition. Here we describe these policies and their rationale, and address concerns including the breadth of studies subject to these policies, the additional effort required to adhere to the policies, and how the implementation of these policies may affect basic brain and behavioral research studies included under these policies.
