Unpacking the New NIH Policies for Research with Human Participants

Scientific disciplines can differ on what elements of a study are necessary to meetthe definition of a “clinical trial.”Some investigators conducting human subjects research may not know that NIH considers their study to be a clinical trial - - a term defined broadly by NIH as “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 biom
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