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Military "anticipatory consent" for unapproved agents suggested by FDA in Federal Register notice.

Executive Summary

MILITARY RECRUIT "ANTICIPATORY CONSENT" TO RECEIVE UNAPPROVED AGENTS is one possibility raised by FDA in a July 31 request for comments on military exemptions to informed consent procedures. "Instead of waiving the requirement for informed consent, is it feasible to obtain anticipatory consent from military recruits (prior to their recruitment into the military) for the future use of investigational products during a military conflict?" the agency asked. Alternatively, FDA suggested, "anticipatory consent" could be given during peace time. In either case, "would such consent be valid as `informed consent'? What would be the needed consent algorithm to make it valid and feasible?"

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