Medizinhistorisches Institut, Universitätsklinikum Bonn, Bonn, Germany.
Oxford Uehiro Centre for Practical Ethics, University of Oxford, Oxford, UK.
J Med Ethics. 2019 May;45(5):299-303. doi: 10.1136/medethics-2018-104867. Epub 2019 Feb 25.
Functional MRI shows promise as a candidate prognostication method in acutely comatose patients following severe brain injury. However, further research is needed before this technique becomes appropriate for clinical practice. Drawing on a clinical case, we investigate the process of obtaining informed consent for this kind of research and identify four ethical issues. After describing each issue, we propose potential solutions which would make a patient's participation in research compatible with her rights and interests. First, we defend the need for traditional proxy consent against two alternative approaches. Second, we examine the impact of the intensive care unit environment on the informed consent process. Third, we discuss the therapeutic misconception and its potential influence on informed consent. Finally, we deal with issues of timing in recruiting participants and related factors which may affect the risks of participation.
功能磁共振成像有望成为严重脑损伤后昏迷患者的候选预后方法。然而，在这项技术适合临床实践之前，还需要进一步的研究。通过一个临床案例，我们研究了获得这种研究知情同意的过程，并确定了四个伦理问题。在描述每个问题之后，我们提出了一些潜在的解决方案，以使患者参与研究符合她的权利和利益。首先，我们反对两种替代方法，为传统的代理同意辩护。其次，我们研究了重症监护病房环境对知情同意过程的影响。第三，我们讨论了治疗误解及其对知情同意的潜在影响。最后，我们处理了招募参与者的时间安排和可能影响参与风险的相关因素的问题。
