The recently updated US National Institutes of Health 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.
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Acknowledgements
We thank our NIH Office of Science Policy colleagues, particularly K. Elzarrad and V. Gordon, for their efforts to turn principles into policies.
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Riley, W.T., Riddle, M. & Lauer, M. NIH policies on experimental studies with humans. Nat Hum Behav 2, 103–106 (2018). https://doi.org/10.1038/s41562-017-0265-4
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DOI: https://doi.org/10.1038/s41562-017-0265-4
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