Advarra IRB, Columbia, MD, USA.
Multi-Regional Clinical Trials Center, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Clin Trials. 2020 Jun;17(3):264-272. doi: 10.1177/1740774520905596. Epub 2020 Feb 17.
There has been significant analysis of the ethical and regulatory issues involved with paying research participants, but less attention has been focused specifically on paying individuals and the unique challenges it may present. This is important, as individuals of lower socio-economic standing are present in all disease groups and study populations. Moreover, clinical research is often conducted in economically under-developed locales, such as lower- or middle-income countries as well as impoverished locales of otherwise wealthy nations (such as, for example, rural Appalachia in the United States). Is it ethical to offer payment in such contexts? What are the ethical considerations relevant for determining payment rates and practices to individuals who are economically vulnerable? We offer an analysis of these issues, focusing on four unique areas of concern: (1) whether the risk of undue influence is greater for economically vulnerable individuals than for wealthier ones; (2) whether payment unacceptably raises the risk of 'unjust influence' or disproportionate representation of poor people in clinical research; (3) the positive reasons in favor of paying economically vulnerable people that stem from the ethical value of fairness; and (4) appropriate compensation rates for economically vulnerable populations. Our analysis supports the position that payment to economically vulnerable populations is ethically justified and indeed desirable when certain conditions are met.
对于支付研究参与者的费用，已经进行了大量的伦理和监管问题分析，但对于向个人支付费用以及它可能带来的独特挑战，关注较少。这很重要，因为社会经济地位较低的个人存在于所有疾病群体和研究人群中。此外，临床研究通常在经济欠发达地区进行，如低收入或中等收入国家以及富裕国家贫困地区（例如，美国的阿巴拉契亚农村地区）。在这种情况下提供报酬是否合乎道德？对于经济上脆弱的个人，确定报酬率和实践的伦理考虑因素是什么？我们对这些问题进行了分析，重点关注四个独特的关注领域：（1）经济脆弱的个人面临的不当影响风险是否大于富裕的个人；（2）支付是否不可接受地增加了“不公正影响”或贫困人群在临床研究中不成比例的代表的风险；（3）出于公平的伦理价值，向经济脆弱人群支付报酬的积极理由；以及（4）经济脆弱人群的适当补偿率。我们的分析支持这样的立场，即向经济脆弱人群支付报酬在符合某些条件时是合乎道德的，实际上也是可取的。
