Dickert Neal W, Kass Nancy E
Division of Cardiology, Emory University, EPICORE, Bldg A, Suite 1N, Mailstop 1256/001/1AR, Atlanta, GA 30322, USA.
Soc Sci Med. 2009 Jan;68(1):183-91. doi: 10.1016/j.socscimed.2008.10.001. Epub 2008 Nov 10.
Conditions such as stroke, sudden cardiac death, and major traumatic injury are major causes of morbidity and mortality, and there is a need for clinical research to improve treatment for these conditions. However, because informed consent is often impossible, research in these situations poses ethical concerns. Despite growing literature on the ethics of emergency research, little is known about the views of relevant patient populations regarding research in emergency settings conducted under an exception from informed consent (EFIC). In this qualitative study, survivors of sudden cardiac death (SCD)--recruited from an outpatient cardiology clinic in late 2005--were asked their views on scenarios representing different types of EFIC research. Patients were generally accepting of such research, more than previous studies would have predicted. Their concerns focused primarily on study risks and benefits and less on waiving consent or randomization. EFIC research is of international importance and ethical controversy. This study represents the first attempt to assess views of SCD survivors on this type of research and one of the first to assess patients' views in-depth. Findings indicate broad acceptance of EFIC research among this population and re-focus discussion on what risks are reasonable for non-autonomous subjects. The study also demonstrates potential for valuable input from patients regarding complicated and ethically challenging issues using a method that allows them to develop opinions on unfamiliar issues.
中风、心源性猝死和重大创伤性损伤等病症是发病和死亡的主要原因,因此需要开展临床研究以改善对这些病症的治疗。然而,由于通常无法获得知情同意,这类情况下的研究引发了伦理问题。尽管关于急诊研究伦理的文献越来越多,但对于相关患者群体对在免除知情同意(EFIC)情况下开展的急诊研究的看法却知之甚少。在这项定性研究中,我们询问了2005年末从一家门诊心脏病诊所招募的心源性猝死(SCD)幸存者对代表不同类型EFIC研究的情景的看法。患者总体上接受这类研究,这超出了以往研究的预期。他们主要关注研究的风险和益处,而较少关注放弃同意或随机分组。EFIC研究具有国际重要性且存在伦理争议。本研究首次尝试评估SCD幸存者对这类研究的看法,也是首批深入评估患者看法的研究之一。研究结果表明该群体广泛接受EFIC研究,并将讨论重新聚焦于对于无自主能力的受试者而言哪些风险是合理的。该研究还表明,使用一种能让患者就不熟悉的问题形成意见的方法,患者有可能就复杂且具有伦理挑战性的问题提供有价值的意见。