Misdirections in Informed Consent — Impediments to Health Care Innovation

N Engl J Med 2017; 377:1412-1414
Authors: David A. Asch, Tracy A. Ziolek, Shivan J. Mehta
“A large literature on research consent aims to prevent these problems, offering ethical analyses that are more forgiving of waivers of consent than what many investigators hear from their IRBs. Indeed, so many ethicists may have weighed in on this issue not because the ethics are disputed, but because overgeneralizations of research conventions persist despite the published literature. The QRS plan is instructive in part because it seems so obviously acceptable; yet IRBs are left to define “practicability” and “adverse effects on rights and welfare.” In doing so, they are susceptible to predictable sources of misdirection. Trials of substantially greater consequence — for example, those focused on critically ill patients — face greater obstacles.”
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