Professor of social medicine and of philosophy at the University of North Carolina at Chapel Hill.
Associate professor of public policy at the University of North Carolina at Chapel Hill.
Ethics Hum Res. 2022 Sep;44(5):2-21. doi: 10.1002/eahr.500139.
Phase I healthy volunteer trials test the safety and tolerability of investigational pharmaceuticals. In them, participants are exposed to study-drug risks without the possibility of direct medical benefit and typically must spend days or weeks in a residential research facility. Monetary payments are used to incentivize enrollment and compensate participants for their time. Together, these features of phase I healthy volunteer trials create a research context that differs markedly from most other clinical research, including by enrolling disproportionate numbers of economically disadvantaged people of color as participants. Due to these unique trial features and participation patterns, traditional biomedical research oversight offers inadequate ethical and policy guidance for phase I healthy volunteer research. This article details five ethical criteria crafted to be responsive to the particularities of this type of research: translational science value, fair opportunity and burden sharing, fair compensation for service, experiential welfare, and enhanced voice and recourse.
I 期健康志愿者试验旨在测试研究性药物的安全性和耐受性。在此过程中，参与者要承受研究药物的风险，但没有直接的医疗获益，通常需要在研究机构中待几天或几周。试验会提供经济报酬来鼓励参与者参与试验，并补偿他们的时间。I 期健康志愿者试验的这些特点创造了一个与大多数其他临床研究明显不同的研究环境，包括不成比例地招募经济困难的少数族裔人群作为参与者。由于这些独特的试验特点和参与模式，传统的生物医学研究监管在伦理和政策方面无法为 I 期健康志愿者研究提供充分的指导。本文详细介绍了五项旨在回应此类研究特殊性的伦理标准：转化科学价值、公平的机会和负担分担、服务公平补偿、体验式福利以及增强发言权和追索权。
