Czarny M J, Kass N E, Flexner C, Carson K A, Myers R K, Fuchs E J
School of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
Clin Pharmacol Ther. 2010 Mar;87(3):286-93. doi: 10.1038/clpt.2009.222. Epub 2010 Jan 20.
Although there is much discussion regarding the ethics of making payments to healthy volunteers for participating in clinical research, little data are available from the point of view of the volunteers as to what they would consider to be fair payment. The objectives of this study were to determine healthy volunteers' estimates of appropriate payments for participation in hypothetical clinical trials in order to explore the reasoning behind these estimates and to examine the association between volunteer demographics and payment expectations. Sixty participants with previous experience as healthy volunteers in research studies were presented with four hypothetical studies and interviewed about their impressions of burden and risks involved in the studies. They were also asked to estimate an appropriate payment to the volunteers for each of the studies. For each of the studies, the payment estimates made by the participants varied over a wide range. However, each individual tended to be consistent in estimate placement within this range. No demographic factor was significantly associated with the estimated study payment. Subjects frequently mentioned risk and logistical burden as factors that should determine payment levels. Healthy volunteer subjects appear to have individualized yet consistent methods of arriving at estimates of payments for participating in clinical studies. These estimates are based on each subject's perception of study burden and associated risk.
尽管对于向参与临床研究的健康志愿者支付报酬的伦理问题存在诸多讨论,但从志愿者的角度来看,关于他们认为何种报酬才算公平的可用数据却很少。本研究的目的是确定健康志愿者对参与假设性临床试验的适当报酬的估计,以探究这些估计背后的推理,并检验志愿者人口统计学特征与报酬期望之间的关联。60名曾有过作为健康志愿者参与研究经历的参与者被展示了四项假设性研究,并就他们对这些研究中所涉及的负担和风险的印象接受了访谈。他们还被要求估计每项研究应向志愿者支付的适当报酬。对于每项研究,参与者给出的报酬估计值差异很大。然而,每个人在这个范围内的估计位置往往是一致的。没有任何人口统计学因素与估计的研究报酬有显著关联。受试者经常提到风险和后勤负担是应决定报酬水平的因素。健康志愿者受试者似乎有个性化但一致的方法来得出参与临床研究的报酬估计值。这些估计是基于每个受试者对研究负担和相关风险的认知。