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Volume 340:804-807 March 11, 1999 Number 10
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Is Informed Consent Always Necessary for Randomized, Controlled Trials?

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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 . . . [Full Text of this Article]

Address reprint requests to Dr. Truog at the MICU, Children's Hospital FA-108, Boston, MA 02115.

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Related Letters:

Is Informed Consent Always Necessary for Randomized, Controlled Trials?
Carome M. A., Grodin M. A., Dresser R., Johnson J. R., Silverman H., King N. M.P., Churchill L. R., Tenery R. M., Truog R. D., Robinson W., Morris A. H.
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N Engl J Med 1999; 341:448-450, Aug 5, 1999. Correspondence

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