Center for Healthcare Ethics, Saint Louis University, 3545 Lafayette Ave., Suite 505, Saint Louis, MO 63104, USA.
Theor Med Bioeth. 2013 Feb;34(1):17-28. doi: 10.1007/s11017-013-9242-8.
Scholars and policymakers continue to struggle over the meaning of the word "vulnerable" in the context of research ethics. One major reason for the stymied discussions regarding vulnerable populations is that there is no clear distinction between accounts of research vulnerabilities that exist for certain populations and discussions of research vulnerabilities that require special regulations in the context of research ethics policies. I suggest an analytic process by which to ascertain whether particular vulnerable populations should be contenders for additional regulatory protections. I apply this process to two vulnerable populations: the cognitively vulnerable and the economically vulnerable. I conclude that a subset of the cognitively vulnerable require extra protections while the economically vulnerable should be protected by implementing existing regulations more appropriately and rigorously. Unless or until the informed consent process is more adequately implemented and the distributive justice requirement of the Belmont Report is emphasized and operationalized, the economically disadvantaged will remain particularly vulnerable to the harm of exploitation in research.
学者和政策制定者在研究伦理的背景下，一直在努力理解“脆弱”一词的含义。关于弱势群体的讨论之所以陷入僵局，一个主要原因是，在研究伦理政策的背景下，对于某些人群中存在的研究脆弱性的描述，以及对于需要特殊监管的研究脆弱性的讨论，并没有明确的区分。我提出了一种分析方法，以确定特定的弱势群体是否应该获得额外的监管保护。我将这一方法应用于两个弱势群体：认知弱势群体和经济弱势群体。我的结论是，认知弱势群体中的一部分需要额外的保护，而经济弱势群体则应该通过更恰当地执行现有法规和更严格地执行法规来得到保护。除非知情同意过程得到更充分的实施，并且《贝尔蒙报告》的分配正义要求得到强调和实施，否则经济上处于不利地位的人在研究中仍然容易受到剥削的伤害。
