Basic Experimental Studies in Humans (BESH) Will No Longer Be Considered Clinical Trials by the NIH
National Institutes of Health (NIH)
About this opportunity
NIH is notifying the community that Basic Experimental Studies Involving Humans (BESH) will no longer be subject to the requirements under the NIH Clinical Trial Definition. In 2014, the NIH revised its clinical trial definition to increase transparency, accountability, and precision in tracking research: 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. This new definition was part of a broader stewardship initiative to ensure all NIH-supported research involving human participants is subject to rigorous standards and that results are rapidly disseminated, even if not considered an Applic...