Clinical research plays a vital role in producing knowledge valuable for understanding human disease and improving healthcare quality. Human subject protection is an obligation essential to the clinical research endeavor, much of which is governed by federal regulations and rules. Institutional Review Boards (IRBs) are responsible for overseeing…

Throughout history human subject research has been plagued by researchers whose studies were riddled with danger and/or risk to their subjects. Indeed, one may cite numerous situations where human subjects were injured and/or killed in experiments that were designed with no thought or anticipation of risk to the subjects. As a result, the federal…