Money for research participation: Does it jeopardize informed consent? Just compensation: Paying research subjects relative to the risks they bear
Money for research participation: Does it jeopardize informed consent? Just compensation: Paying research subjects relative to the risks they bear
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DOI：
10.1162/152651601300169121
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发表时间：
2001-03-01
影响因子：
13.4
通讯作者：
Menikoff, Jerry
中科院分区：
文献类型：
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作者：
Menikoff, Jerry
克里斯汀·格雷迪(2001)巧妙地组织了令人信服的论点，支持补偿研究对象。她用自己的论点支持了一个相对不具争议性的命题：允许以非熟练工人的时薪支付受试者的工资(例如，正如她在其他地方概述的那样，每小时10美元，外加一些小附加费；参见Dickert and Grady 1999)。然而，支持付钱给受试者的论点比她的结论更有说服力。格雷迪允许补偿的基本理论是“平等主义的立场，即执行类似功能的受试者应该得到同样的报酬”(Dickert和Grady 1999)。薪酬问题在一定程度上引发了最令人恼火的问题，我们谈论的是研究，在这些研究中，我们想要的不仅仅是受试者的时间和精力，而是他们承担健康风险的意愿。事实上，制定一项与受试者“不当引诱”有关的规则，主要是为了防止某人不适当地将自己置于此类健康风险之下。(我完全同意乔纳森·莫雷诺(Jonathan Moreno)(2001)的评论，即当关于进入的决定由代理决策者做出时，需要特别考虑；接下来的讨论假设，一名称职的成年人将自己做出关于参加审判的决定。)鉴于“风险承担”往往是受试者的真实贡献，格雷迪自己的理论和正义原则都表明，这一问题应该在确定什么构成对这类受试者的适当金钱诱因方面发挥重要作用。毕竟，在社会的其他领域，我们确实希望薪酬会根据某人承担的风险程度而有所不同。消防员和在仓库里堆放箱子的人可能会执行类似的体力工作，但由于工作风险，消防员的报酬要高得多。一项涉及给健康受试者服用新药的研究可能只涉及受试者两个小时的时间，但参与时间并不能很好地衡量受试者提供的服务。如果认为这相当于在麦当劳的收银台工作两个小时，这将是一个误导性的比较。同样具有误导性的是，说一名受试者吞下一种经过充分研究的药物，其功能类似于I期研究中吞下药片的受试者。
Christine Grady (2001) skillfully marshals compelling arguments in favor of compensating research subjects. She uses her arguments to support a relatively noncontroversial proposition: that it is permissible to pay subjects at essentially the hourly rate of an unskilled worker (eg, as she has outlined elsewhere, $10 an hour, with some small supplements; see Dickert and Grady 1999). The arguments in favor of paying subjects are more compelling than her conclusions suggest, however. Grady’s basic theory for permitting compensation is “the egalitarian position that subjects performing similar functions should be paid similarly”(Dickert and Grady 1999). To the extent the compensation issue raises the most vexing questions, we are talking about studies where it is not merely the subjects’ time and effort that we want; rather, it is their willingness to assume health risks. Indeed, the reasons for creating a rule relating to “undue inducement” of subjects are primarily related to preventing someone from inappropriately subjecting himself to such health risks.(I fully agree with Jonathan Moreno’s comment (2001) that special considerations apply when decisions about entry are made by surrogate decision makers; the discussion that follows assumes that a competent adult would be making his or her own decision regarding entry into a trial.)Given that “risk assumption” is often a subject’s true contribution, Grady’s own theory, and the principle of justice, both suggest that this issue should play a major role in determining what constitutes an appropriate monetary inducement for such subjects. After all, in other areas of society we do expect compensation to vary based on the amount of risk someone assumes. A fireman and a person who stacks boxes in a warehouse may perform similar physical tasks, yet the fireman gets paid far more due to the job risks. A research study involving administration of a new drug to a healthy subject may involve only two hours of a subject’s time, but the time involvement is a poor measure of the services provided by the subject. It would be a misleading comparison to suggest that this was the equivalent of working two hours behind the cash register at McDonald’s. It is equally misleading to say that a subject who swallows a well-studied medicine is performing a function similar to someone who swallows a pill in a Phase I study.