Informed consent for functional MRI research on comatose patients following severe brain injury: balancing the social benefits of research against patient autonomy
Informed consent for functional MRI research on comatose patients following severe brain injury: balancing the social benefits of research against patient autonomy
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DOI：
10.1136/medethics-2018-104867
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发表时间：
2019-05-01
影响因子：
4.1
通讯作者：
Weijer, Charles
中科院分区：
文献类型：
--
作者：
Bruni, Tommaso;Graham, Mackenzie;Weijer, Charles
功能磁共振成像有望成为重型颅脑损伤后急性昏迷患者的一种候选预测方法。然而，在这项技术适合临床应用之前，还需要进一步的研究。根据一个临床案例，我们调查了为这类研究获得知情同意的过程，并确定了四个伦理问题。在描述了每个问题之后，我们提出了可能的解决方案，使患者参与研究符合她的权益。首先，我们为传统代理同意的必要性辩护，反对两种替代方法。其次，我们考察了重症监护病房环境对知情同意过程的影响。第三，我们讨论了治疗误区及其对知情同意的潜在影响。最后，我们讨论了招募参与者的时机问题以及可能影响参与风险的相关因素。
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.