Lecouturier Jan, Rodgers Helen, Ford Gary A, Rapley Tim, Stobbart Lynne, Louw Stephen J, Murtagh Madeleine J
Institute of Health and Society, Newcastle University, The Medical School, Framlington Place, Newcastle upon Tyne, UK.
BMC Med Ethics. 2008 Apr 29;9:9. doi: 10.1186/1472-6939-9-9.
In emergency research, obtaining informed consent can be problematic. Research to develop and improve treatments for patients admitted to hospital with life-threatening and debilitating conditions is much needed yet the issue of research without consent (RWC) raises concerns about unethical practices and the loss of individual autonomy. Consistent with the policy and practice turn towards greater patient and public involvement in health care decisions, in the US, Canada and EU, guidelines and legislation implemented to protect patients and facilitate acute research with adults who are unable to give consent have been developed with little involvement of the lay public. This paper reviews research examining public opinion regarding RWC for research in emergency situations, and whether the rules and regulations permitting research of this kind are in accordance with the views of those who ultimately may be the most affected.
Seven electronic databases were searched: Medline, Embase, CINAHL, Cochrane Database of Systematic Reviews, Philosopher's Index, Age Info, PsychInfo, Sociological Abstracts and Web of Science. Only those articles pertaining to the views of the public in the US, Canada and EU member states were included. Opinion pieces and those not published in English were excluded.
Considering the wealth of literature on the perspectives of professionals, there was relatively little information about public attitudes. Twelve studies employing a range of research methods were identified. In five of the six questionnaire surveys around half the sample did not agree generally with RWC, though paradoxically, a higher percentage would personally take part in such a study. Unfortunately most of the studies were not designed to investigate individuals' views in any depth. There also appears to be a level of mistrust of medical research and some patients were more likely to accept an experimental treatment 'outside' of a research protocol.
There are too few data to evaluate whether the rules and regulations permitting RWC protects - or is acceptable to - the public. However, any attempts to engage the public should take place in the context of findings from further basic research to attend to the apparently paradoxical findings of some of the current surveys.
在急诊研究中，获得知情同意可能存在问题。迫切需要开展研究以开发和改进针对因危及生命和使人衰弱的病症而住院的患者的治疗方法，然而未经同意的研究（RWC）问题引发了对不道德行为以及个人自主权丧失的担忧。与让患者和公众更多地参与医疗保健决策的政策和实践转变相一致，在美国、加拿大和欧盟，为保护患者并促进对无法给出同意的成年人进行急性研究而实施的指南和立法，在制定过程中公众参与很少。本文回顾了关于急诊情况下RWC研究的公众意见调查，以及允许此类研究的规则和法规是否符合最终可能受影响最大的人群的观点。
检索了七个电子数据库：医学期刊数据库（Medline）、荷兰医学文摘数据库（Embase）、护理学与健康领域数据库（CINAHL）、Cochrane系统评价数据库、哲学家索引数据库、年龄信息数据库、心理学文摘数据库、社会学文摘数据库和科学引文索引数据库（Web of Science）。仅纳入了那些与美国、加拿大和欧盟成员国公众观点相关的文章。排除了评论文章和非英文发表的文章。
考虑到关于专业人员观点的大量文献，关于公众态度的信息相对较少。确定了12项采用一系列研究方法的研究。在六项问卷调查中的五项中，约一半的样本总体上不同意未经同意的研究，尽管自相矛盾的是，更高比例的人会亲自参与这样的研究。不幸的是，大多数研究并非旨在深入调查个人观点。对医学研究似乎也存在一定程度的不信任，一些患者更有可能接受研究方案“之外”的实验性治疗。
几乎没有数据可用于评估允许未经同意的研究的规则和法规是否保护了公众——或者是否为公众所接受。然而，任何让公众参与的尝试都应在进一步基础研究结果的背景下进行，以处理当前一些调查中明显自相矛盾的结果。
