Proxy Consent?

Abstract

Sponsors of phase III HIV vaccine trials in developing nations may ask to be excused from the requirement to fully inform each individual prospective subject and to obtain each individual prospective subject’s free and uncoerced consent. They could base their request on the difficulty (or impossibility) of explaining such complex material to persons in communities with less than optimum literacy, and/or on the length of time it would take to so educate each individual subject. They might also base their request on the perceived difficulty of finding large numbers of persons who are “so situated as to be able to exercise free power of choice,” i.e., who are completely free of any possibility of coercion, constraint, duress, or intimidation. That is, they could ask instead to invoke the principle of proxy consent.