Watters Drew, Sayre Michael R, Silbergleit Robert
Department of Emergency Medicine, University of Arizona, Tucson, AZ 85724, USA.
Acad Emerg Med. 2005 Nov;12(11):1040-4. doi: 10.1197/j.aem.2005.06.022.
Medical research involving critically ill and injured subjects unable to provide informed consent can only be conducted under federal regulations that attempt to balance the need to develop lifesaving treatments with protection of research subjects' rights. Regulators, researchers, and medical ethicists have all struggled to define the conditions under which an emergency exception from informed consent is appropriate. Although research has been successfully conducted under the current regulations, confusion remains regarding the meaning of the regulations, the applicable conditions, and the best ways to balance the needs of future patients and the rights of research subjects. In May 2005, at the Academic Emergency Medicine Consensus Conference "Ethical Conduct of Resuscitation Research," a breakout session was held on the research conditions that qualify for the emergency exception from informed consent process. Several recommendations emerged: 1) The definition of "life-threatening condition" should be broadly interpreted to include serious disability as well as death. 2) Existing therapies should be considered "unsatisfactory," even if partially effective, when serious risk of morbidity or mortality remains even with the best available treatment or when the adverse effects of the best available treatment are serious. 3) Research with the emergency exception should be performed only if sufficient evidence exists that the proposed intervention has a reasonable chance of benefit. 4) More evaluation is needed to determine the degree to which the current rules impede research. 5) Application of the current regulatory framework for abbreviated or waived consent in emergency research should be encouraged. 6) Further study should also address variability among institutional review boards, the goals of community involvement, and how best to engage and educate the public in research efforts using emergency exception from informed consent.
涉及无法提供知情同意的重症和受伤受试者的医学研究，只能在联邦法规下进行，这些法规试图在开发救生治疗方法的需求与保护研究受试者权利之间取得平衡。监管机构、研究人员和医学伦理学家都在努力界定在何种情况下适用知情同意的紧急例外情况。尽管根据现行法规研究已成功开展，但对于法规的含义、适用条件以及平衡未来患者需求和研究受试者权利的最佳方式仍存在困惑。2005年5月，在学术急诊医学共识会议“复苏研究的伦理行为”上，就符合知情同意程序紧急例外情况的研究条件举行了一次分组会议。会议提出了几项建议：1）“危及生命的状况”的定义应作广义解释，包括严重残疾以及死亡。2）即使现有疗法部分有效，但如果即使采用最佳可用治疗仍存在严重发病或死亡风险，或者最佳可用治疗的不良反应严重，那么现有疗法应被视为“不令人满意”。3）仅当有充分证据表明拟议的干预措施有合理的获益机会时，才可进行有紧急例外情况的研究。4）需要进行更多评估，以确定现行规则对研究的阻碍程度。5）应鼓励在紧急研究中应用现行的简化或豁免同意的监管框架。6）进一步的研究还应解决机构审查委员会之间的差异、社区参与的目标，以及如何最好地让公众参与并了解利用知情同意紧急例外情况开展的研究工作。
