Walker Rebecca L, Cottingham Marci D, Fisher Jill A
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
University of Amsterdam, Amsterdam, The Netherlands.
J Med Philos. 2018 Jan 12;43(1):83-114. doi: 10.1093/jmp/jhx033.
Phase 1 healthy volunteer clinical trials-which financially compensate subjects in tests of drug toxicity levels and side effects-appear to place pressure on each joint of the moral framework justifying research. In this article, we review concerns about phase 1 trials as they have been framed in the bioethics literature, including undue inducement and coercion, unjust exploitation, and worries about compromised data validity. We then revisit these concerns in light of the lived experiences of serial participants who are income-dependent on phase 1 trials. We show how participant experiences shift attention from discrete exchanges, behaviors, and events in the research enterprise to the ongoing and dynamic patterns of serial participation in which individual decision-making is embedded in collective social and economic conditions and shaped by institutional policies. We argue in particular for the ethical significance of structurally diminished voluntariness, routine powerlessness in setting the terms of exchange, and incentive structures that may promote pharmaceutical interests but encourage phase 1 healthy volunteers to skirt important rules.
一期健康志愿者临床试验——在药物毒性水平和副作用测试中对受试者给予经济补偿——似乎对支持研究的道德框架的每个关节都施加了压力。在本文中，我们审视了生物伦理学文献中对一期试验的担忧，包括不当诱导和胁迫、不公正的剥削，以及对数据有效性受损的担忧。然后，我们根据依赖一期试验收入的连续参与者的实际经历重新审视这些担忧。我们展示了参与者的经历如何将注意力从研究企业中的离散交换、行为和事件转移到连续参与的持续动态模式上，在这种模式中，个体决策嵌入集体社会和经济条件并受机构政策塑造。我们特别强调结构上自愿性降低、在设定交换条件方面常规的无力感以及可能促进制药利益但鼓励一期健康志愿者规避重要规则的激励结构的伦理意义。
