Rethinking the Research Ethics Regime: Historical Reflections on Scarcity, Precarity, and Inequity in Clinical Trials

abstract: This article examines the rise of the post–World War II regime for the bioethical management of research ethics. Following the Nazi crimes against humanity, a new set of regulations and expectations arose in the domain of research ethics, especially relating to the use of human subjects. These protocols centered on the invocation of informed consent, individual autonomy, and heightened peer and public review of proposed research. In the early 21st century, fundamental questions have been raised about the efficacy of this system and its "fit" with emerging new trends of precision therapeutics, complications of randomized protocols, and rising demands for the "right to try" experimental interventions. The authors assess current trends toward revision of the historical foundations of bioethics.