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September 12, 1966


JAMA. 1966;197(11):25-27. doi:10.1001/jama.1966.03110110011003

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Consent For Drug Testing—  The Food and Drug Administration announced a policy of requiring physicians to obtain written consent from patients before giving them investigational drugs except for specified unusual circumstances.The Kefauver-Harris Drug Amendments of 1962 provided that physicians using investigational drugs on humans must "obtain the consent of such human beings or their representatives, except where they deem it not feasible or, in their professional judgment, contrary to the best interests of such human beings." In specific guidelines published in the Aug 30 Federal Register, the FDA, for the first time, spelled out that consent is to be obtained and indicated what exceptions are allowed.Investigational drugs are new pharmaceuticals that have not yet been demonstrated to be safe and effective and approved for general use by the FDA.In addition to requiring that the patient give his consent in writing, the guidelines provide that the patient must