So You Think You Know Who's the "Legally Authorized Representative": Clinical Research Hits a Snag

When a prospective participant in clinical research appears perhaps to lack decision-making capacity, many investigators do a capacity evaluation themselves, and if the person lacks capacity, reach out to the next of kin, presuming them to be the legally authorized representative (LAR) to consent (or not) on that person's behalf. However, that approach often does not actually comport with applicable law. This article begins with some history, explaining how, if there is no state law specifically governing clinical research, Institutional Review Boards have been instructed to base their policies concerning capacity determination and surrogacy selection on that jurisdiction's laws governing ordinary healthcare. A deep dive into many states' statutes reveals a remarkable, hitherto largely unrecognized diversity of provisions that, in turn, create unexpected legal and ethical hazards for investigators whose research participants may lack capacity. Several potential resolutions are suggested.