Petrini C
Bioethics Unit, Office of the President, Istituto Superiore di Sanità, Rome, Italy.
Transplant Proc. 2010 May;42(4):1040-2. doi: 10.1016/j.transproceed.2010.03.075.
Living organ donation and participation in clinical research trials have several features in common from an ethical perspective. The primary similarity is risk justification: the risk of harm to living organ donors and clinical research participants is justified by a resulting benefit to one or more other individuals. Some authors hold that organ donation and clinical trial participation are full-fledged duties. Such an implicit likening of the two leads to several considerations regarding informed consent in each situation. Informed consent raises ethical concerns in every medical context, and some of those concerns, such as competence, understanding, autonomy, and free or voluntary choice, are uniquely relevant to living organ donation and clinical trial participation. Most countries regulate informed consent procedures for living organ donation in great detail, and although informed consent procedures for clinical trial participation are somewhat less detailed, their rules are subject to review by ethics committees. It would be constructive for research participation informed consent procedures and living organ donation informed consent procedures to learn from one another.
从伦理角度来看,活体器官捐赠和参与临床研究试验有几个共同特点。主要的相似之处在于风险合理性:对活体器官捐赠者和临床研究参与者造成伤害的风险,因给一个或多个其他个体带来的益处而具有合理性。一些作者认为器官捐赠和参与临床试验是完全成熟的义务。这种对两者的隐含类比引发了在每种情况下关于知情同意的若干考量。知情同意在每个医疗背景下都会引发伦理问题,其中一些问题,如行为能力、理解、自主性以及自由或自愿选择,与活体器官捐赠和参与临床试验具有独特的相关性。大多数国家对活体器官捐赠的知情同意程序进行了非常详细的规范,尽管临床试验参与的知情同意程序细节稍少,但其规则需接受伦理委员会审查。研究参与知情同意程序和活体器官捐赠知情同意程序相互借鉴会具有建设性意义。