Gillett G R
Dunedin Hospital and Otago Bioethics Centre, University of Otago, Dunedin, New Zealand.
Anaesth Intensive Care. 2015 May;43(3):309-12. doi: 10.1177/0310057X1504300304.
There are widely acknowledged ethical issues in enrolling unconscious patients in research trials, particularly in intensive care unit (ICU) settings. An analysis of those issues shows that, by and large, patients are better served in units where research is actively taking place for several reasons: i) they do not fall prey to therapeutic prejudices without clear evidential support, ii) they get a chance of accessing new and potentially beneficial treatments, iii) a climate of careful monitoring of patients and their clinical progress is necessary for good clinical research and affects the care of all patients and iv) even those not in the treatment arm of a trial of a new intervention must receive best current standard care (according to international evidence-based treatment guidelines). Given that we have discovered a number of 'best practice' regimens of care that do not optimise outcomes in ICU settings, it is of great benefit to all patients (including those participating in research) that we are constantly updating and evaluating what we do. Therefore, the practice of ICU-based clinical research on patients, many of whom cannot give prospective informed consent, ticks all the ethical boxes and ought to be encouraged in our health system. It is very important that the evaluation of protocols for ICU research should not overlook obvious (albeit probabilistic) benefits to patients and the acceptability of responsible clinicians entering patients into well-designed trials, even though the ICU setting does not and cannot conform to typical informed consent procedures and requirements.
在研究试验中招募昏迷患者存在广泛公认的伦理问题，尤其是在重症监护病房（ICU）环境中。对这些问题的分析表明，总体而言，在积极开展研究的病房中，患者能得到更好的治疗，原因如下：i）他们不会成为没有明确证据支持的治疗偏见的受害者；ii）他们有机会获得新的、可能有益的治疗；iii）良好的临床研究需要对患者及其临床进展进行仔细监测的氛围，这也会影响所有患者的护理；iv）即使那些未参与新干预试验治疗组的患者也必须接受当前最佳标准护理（根据国际循证治疗指南）。鉴于我们已经发现一些“最佳实践”护理方案在ICU环境中并未优化治疗结果，不断更新和评估我们的做法对所有患者（包括参与研究的患者）都大有裨益。因此，对许多无法事先给予知情同意的患者开展基于ICU的临床研究的做法符合所有伦理标准，应该在我们的医疗系统中得到鼓励。非常重要的是，对ICU研究方案的评估不应忽视对患者明显（尽管是概率性的）益处以及负责的临床医生让患者参与精心设计试验的可接受性，尽管ICU环境不符合也无法符合典型的知情同意程序和要求。
