Schmidt Terri A, Salo David, Hughes Jason A, Abbott Jean T, Geiderman Joel M, Johnson Catherine X, McClure Katie B, McKay Mary Pat, Razzak Junaid A, Schears Raquel M, Solomon Robert C
Department of Emergency Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97235, USA.
Acad Emerg Med. 2004 Oct;11(10):1082-9. doi: 10.1197/j.aem.2004.05.028.
The Society for Academic Emergency Medicine believes that protection of human subjects is vital in emergency medicine research and that, whenever feasible, informed consent is at the heart of that protection. At the same time, the emergency setting presents unique barriers to informed consent both because of the time frame in which the research is performed and because patients in the emergency department are a vulnerable population. This report reviews the concept of informed consent, empirical data on patients' cognitive abilities during an emergency, the federal rules allowing exemption from consent under certain circumstances, issues surrounding consent forms, and the new Health Insurance Portability and Accountability Act regulations as they relate to research. The authors conclude that, in many circumstances, informed consent is possible if the researcher is diligent and takes time to adequately explain the study to the potential subject. In cases in which it is possible to obtain consent, precautions must be taken to ensure that subjects have decision-making capacity and are offered time to have their questions answered and their needs met. Sometimes resuscitation and other emergency medicine research must be conducted without the ability to obtain consent. In these cases, special protections of subjects under the exception from consent guidelines must be followed. Protection of research subjects is the responsibility of every researcher in emergency medicine.
学术急诊医学协会认为，在急诊医学研究中保护人类受试者至关重要，并且只要可行，知情同意就是这种保护的核心。同时，急诊环境给知情同意带来了独特的障碍，这既是由于进行研究的时间框架，也是因为急诊科的患者是弱势群体。本报告回顾了知情同意的概念、关于患者在急诊期间认知能力的实证数据、允许在某些情况下豁免同意的联邦规则、围绕同意书的问题以及与研究相关的新的《健康保险流通与责任法案》规定。作者得出结论，在许多情况下，如果研究人员勤勉并花时间向潜在受试者充分解释研究，那么知情同意是可行的。在有可能获得同意的情况下，必须采取预防措施以确保受试者具备决策能力，并给予他们时间来解答疑问和满足需求。有时必须在无法获得同意的情况下进行复苏和其他急诊医学研究。在这些情况下，必须遵循同意豁免准则下对受试者的特殊保护。保护研究受试者是急诊医学领域每位研究人员的责任。
