Edwards S J L, Kirchin S, Huxtable R
Centre for Ethics in Medicine, University of Bristol, Bristol, UK.
J Med Ethics. 2004 Feb;30(1):88-91. doi: 10.1136/jme.2002.000166.
In this paper the authors argue that research ethics committees (RECs) should not be paternalistic by rejecting research that poses risk to people competent to decide for themselves. However it is important they help to ensure valid consent is sought from potential recruits and protect vulnerable people who cannot look after their own best interests. The authors first describe the tragic deaths of Jesse Gelsinger and Ellen Roche. They then discuss the following claims to support their case: (1) competent individuals are epistemologically and ethically in the best position to say which risks are reasonable for them, so RECs should be no more restrictive than the "normal" constraints on people taking risks with themselves; (2) RECs do not judge individual competence (that is for researchers and psychiatrists); (3) individual liberty is mostly limited by what serves the public interest, and RECs do not determine public interest; (4) RECs may have a paternalistic role in preventing exploitation of competent people vulnerable to the use of incentives, and in protecting the interests of incompetent people; however, (5) the moral and political authority of RECs has not been established in this respect.
在本文中,作者认为研究伦理委员会(RECs)不应采取家长式作风,拒绝那些对有能力自行做决定的人构成风险的研究。然而,重要的是,它们应有助于确保从潜在参与者那里获得有效的知情同意,并保护那些无法照顾自身最大利益的弱势群体。作者首先描述了杰西·格尔辛格(Jesse Gelsinger)和艾伦·罗氏(Ellen Roche)的悲惨死亡事件。然后,他们讨论了以下观点来支持自己的论点:(1)有行为能力的个体在认识论和伦理上最有资格判断哪些风险对他们来说是合理的,因此研究伦理委员会的限制不应超过人们自行承担风险时的“正常”约束;(2)研究伦理委员会不评判个体的行为能力(这是研究人员和精神科医生的职责);(3)个人自由大多受到服务于公共利益的因素的限制,而研究伦理委员会并不决定公共利益;(4)研究伦理委员会在防止对易受激励措施影响的有行为能力的人的剥削以及保护无行为能力的人的利益方面可能具有家长式的作用;然而,(5)研究伦理委员会在这方面的道德和政治权威尚未确立。