Conducting research using the emergency exception from informed consent: the Public Access Defibrillation (PAD) Trial experience.

Abstract

BACKGROUND The Public Access Defibrillation (PAD) Trial, a prospective, multicenter, randomized clinical trial comparing two prehospital resuscitation strategies, was conducted under the regulations for exception from informed consent (21CFR50.24) in 24 communities in North America. These regulations place additional requirements for human subject… (More)

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