Is Informed Consent Always Necessary for Randomized, Controlled Trials?

Abstract

Consider this paradox: if a physician reads a case report about a novel method of ventilation for critically ill patients and wants to try it in the next several patients with respiratory failure he or she treats, the physician may do so provided the patients have given general consent for treatment. On the other hand, if a physician is interested in performing a randomized, controlled trial to determine rigorously which of two widely used antibiotics is more effective at treating bronchitis, he or she must prepare a formal protocol, obtain approval from the institutional review board, and seek written informed . . .