Richardson Lynne D
Emergency Medicine, Box 1620, Mount Sinai School of Medicine, One East 100th Street, New York, NY 10029, USA.
Mt Sinai J Med. 2005 Jul;72(4):242-9.
In 1996, the federal government published regulations that allow investigators to obtain a waiver of informed consent for emergency research when certain very specific criteria are met. The participants must be unable to give consent as a result of their medical condition, and the intervention involved in the research must be administered before consent from the participants' legally authorized representative is feasible. These regulations require that a number of special protections be provided whenever such a waiver is obtained. Before the study is performed, there must be "community consultation" and "public disclosure." The regulations leave the specific form and extent of these activities to the discretion of the Institutional Review Board granting the waiver of informed consent and the investigator conducting the study. The author reviews the development of these regulations, often referred to as "The Final Rule," the ethical basis for the waiver, and the specific provisions of the federal regulations that govern research without consent in emergency situations. Reactions of proponents, critics and the lay public are discussed.
1996年，联邦政府发布了相关规定，允许研究人员在满足某些非常具体的标准时，获得紧急研究的知情同意豁免。由于参与者的病情，他们必须无法给出同意，并且研究中涉及的干预措施必须在获得参与者法定授权代表的同意之前实施。这些规定要求，每当获得这种豁免时，必须提供一些特殊保护。在进行研究之前，必须进行“社区咨询”和“公开披露”。这些规定将这些活动的具体形式和范围留给给予知情同意豁免的机构审查委员会以及进行该研究的研究人员自行决定。作者回顾了这些规定（通常称为“最终规则”）的发展、豁免的伦理基础以及联邦法规中关于紧急情况下未经同意进行研究的具体条款。还讨论了支持者、批评者和普通公众的反应。
