Moral problems in the research-practice distinction and in oversight systems to protect patients (The Daniel W. Foster, M.D., Visiting Lectureship in Medical Ethics)

Abstract

This presentation concerns whether we have good reasons for our sharp division of the biomedical world into research and practice, while requiring ethical oversight systems only for research. The first consideration is backward looking in history: how and why required institutional ethics review committees emerged in the 1970s with a burdensome network of rules and oversight systems for clinical research, while creating nothing truly comparable for clinical medicine. The second consideration is future-regarding: how and why we need to change the current oversight system to protect patients to include clinical medicine, not merely clinical research. The third consideration is how a healthcare system ideally should be constructed to integrate health care with rapid input of research information, while also creating better systems of ethics review and ones that do not under-regulate but also do not over-regulate. Extensive adjustments in the current system of review will be needed to meet these goals.