Informed consent to participation in interventional studies: second-order in a different sense

A peer commentary on Alan Wertheimer’s (Why) should we require consent to participation in research?—Journal of Law and the Biosciences Alan Wertheimer’s important article shows that while ‘the balance of [first-order] moral reasons might well tell against the use of coercion in most cases’ of interventional biomedical research, it does not tell against its use in all those cases.1 Wertheimer is right, for example, that coercive research does not always treat subjects as mere means or disrespect their autonomy rights. His article then adds that a broad consent requirement (CR) remains justifiable as a matter of ‘second-order’ morality. By thatWertheimermeans, ‘moral decisions that take into account the fact that first-order moral reasoners are not omniscient or are perceived to be so by others’.2 Wertheimer does not lay out in detail the determinate non-omniscience-related reasons for CR in intervention studies (except for suggestive analogies from other areas where non-omniscience supports strict rules).3 Whichever the exact reasons, his suggestion is that our non-omniscience is—somehow—why CR obtains so broadly in intervention studies, far more broadly than first-order reasoning can explain. I shall try to show that there must be more to the justification of CR than nonomniscience, and to characterize the remaining justification. Let me start by indicating that Wertheimer’s is not a full account of the CR in interventional biomedical research. I shall then suggest a key additional part of the account.