Void for Vagueness

Abstract

“What would happen if the informed consent process were truly seen as an opportunity for optimizing decision making?” This excellent question appeared recently in this journal in an editorial by Rao and Kim,1 commenting on an article in which Arnold et al2 described a web-based tool for improving such decision making. Although there is certainly substantial room for improvement in obtaining informed consent in the face of complicated clinical decisions, those problems can be simple compared with the dilemma of doing a similarly good job in obtaining consent to participate in a clinical trial. Unlike a patient, who at least is under legal and ethical protections requiring the doctor to keep their well-being as the first priority, no such protection exists for the research subject. To the contrary, a research subject is under a watered-down set of protections. In research, to further the goal of answering a research question, the doctor is authorized to do a variety of things that may not advance the subject’s well-being and may in fact be substantially antithetical to that well-being. Article see p 151 It is for this reason that consent in the research setting bears such a great weight on its shoulders. Perhaps we should refer to it, in comparison to clinical consent, as a beefed-up consent, or consent on steroids. It is largely the fact that the subject has agreed to this weakened set of protections that makes research ethical. This key concept was recognized even in the early days of research ethics. In the landmark Nuremberg Code,3 more than half a century old, only 1 of its 10 paragraphs is more than a couple of sentences long. That single much longer paragraph, the very first, highlights the huge importance of informed consent in research. The very first words …