The common rule's 'reasonable person' standard for informed consent

Abstract

Laura Odwazny and Benjamin Berkman have raised several challenges regarding the new reasonable person standard in the revised Common Rule, which states that informed consent requires potential research subjects be provided with information a reasonable person would want to know to make an informed decision on whether to participate in a study. Our aim is to offer a response to the challenges Odwazny and Berkman raise, which include the need for a reasonable person standard that can be applied consistently across institutional review boards and that does not stigmatize marginal groups. In response, we argue that the standard ought to be based in an ordinary rather than ideal person conception of reasonable person and that the standard ought to employ what we call a liberal constraint: the reasonability standard must be malleable enough such that a wide variety of individuals with different, unique value systems would endorse it. We conclude by suggesting some of the likely consequences our view would have, if adopted.

Keywords: Common Rule; bioethics; informed consent; institutional review board; reasonable person; research subjects.