Ethics committee experience with emergency exception from informed consent protocols
Ethics committee experience with emergency exception from informed consent protocols
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DOI：
10.1525/jer.2007.2.3.23
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发表时间：
2007-09-01
影响因子：
1.3
通讯作者：
Schmidt, Terri A.
中科院分区：
文献类型：
--
作者：
DeIorio, Nicole M.;McClure, Katie B.;Schmidt, Terri A.
自 1996 年以来，美国联邦法规允许在没有知情同意的情况下对紧急情况进行研究，如果目前没有令人满意的治疗方法，没有时间获得患者或代表的事先同意，并且通过公开披露和社区咨询过程有社区参与。 REB 此后的经历无人知晓。我们对 126 所美国医学院的 REB 主席进行了调查，以量化审查的协议并确定对该规则的态度，从而更好地了解该规则对 REB 的影响。返回 69 份调查（55%）。五十二名审查人类研究的受访者听说过该规则。百分之四十八 (25/52) 的人审查过此类研究；其中 40% 的人至少拒绝了一项。 78% 的人认为该规则可以保护人类受试者，88% 的人感到准备实施这些规则。对于如何最好地进行通知和咨询，REB 的观点与公众意见不同。
SINCE 1996, U. S. FEDERAL REGULATIONS allow research without informed consent to study emergency conditions, if there is currently no satisfactory treatment for the condition, no time to obtain advance consent from the patient or representative, and if there is community involvement through a public disclosure and community consultation process. REB experiences since then are unknown. We surveyed REB chairpersons at the 126 United States medical schools to quantify reviewed protocols and identify attitudes about the rule, to better understand the rule's impact on REBs. Sixty-nine surveys were returned (55%). Fifty-two respondents reviewing human research had heard of the Rule. Forty-eight percent (25/52) had reviewed such a study; 40% of those had rejected at least one. Seventy-eight percent believe the rule protects human subjects, and 88% feel prepared to implement them. REB views differed from public opinion on how best to enact notification and consultation.