Recommendations for Supporting Prospective Study Registration in the Basic Experimental Studies in Humans And Alternative Procedures for Results Dissemination

Recently, the NIH has modified the definition of clinical trial so that it applies to a much broader range of studies that previously were classified as clinical research but not specifically as trials. This definition, below, specifically includes research where behavioral outcomes are a focus of the study: “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.”With the addition of behavioral outcomes, many studies that previously would not have been “clinical trials” are now so classified. Research studies that meet both criteria for “clinical trial” and “basic research” are now referred to as basic experimental studies in humans (BESH). The purpose of this whitepaper is to analyze and investigate ways that existing infrastructure could be improved to support these new requirements in ways that benefit all stakeholders.