Kim Scott Y H, Holloway Robert G, Frank Samuel, Wilson Renee, Kieburtz Karl
Department of Psychiatry, The Bioethics Program, The Center for Behavioral and Decision Sciences in Medicine, University of Michigan, 300 North Ingalls Street, 7C27, Ann Arbor, MI, 48109, USA.
Med Health Care Philos. 2008 Dec;11(4):393-401. doi: 10.1007/s11019-008-9153-z. Epub 2008 Jul 16.
Bioethicists have long been concerned that seriously ill patients entering early phase ('phase I') treatment trials are motivated by therapeutic benefit even though the likelihood of benefit is low. In spite of these concerns, consent forms for phase I studies involving seriously ill patients generally employ indeterminate benefit statements rather than unambiguous statements of unlikely benefit. This seeming mismatch between attitudes and actions suggests a need to better understand research ethics committee members' attitudes toward communication of potential benefits and risks of early phase studies to potential subjects. We surveyed the members of two U.S. research ethics committees using a phase I gene transfer study scenario, and compared the results to a previous survey of potential subjects' perceptions and attitudes toward benefit and risk for the same protocol. The results show that there is indeed a gap between the subjects' perceptions and the committee members' views on what is appropriate to be communicated to research subjects. This discrepancy is the product of both the commonly assumed optimism of the subjects and to a "protective pessimism" of the research ethics committee members. We discuss this discrepancy using "frameworks of trust" and demonstrate the need to incorporate these frameworks into the existing model of informed consent.
长期以来，生物伦理学家一直担心，进入早期（“I期”）治疗试验的重症患者即便获益可能性很低，仍会受治疗益处的驱使。尽管存在这些担忧，但涉及重症患者的I期研究的知情同意书通常采用不确定的益处声明，而非明确表明获益可能性不大的声明。这种态度与行动之间看似不匹配的情况表明，有必要更好地了解研究伦理委员会成员对于向潜在受试者传达早期研究潜在益处和风险的态度。我们利用一个I期基因转移研究场景对两个美国研究伦理委员会的成员进行了调查，并将结果与之前针对同一方案对潜在受试者的认知以及对益处和风险的态度所做的调查进行了比较。结果显示，在向研究受试者传达何种内容合适这一问题上，受试者的认知与委员会成员的观点之间确实存在差距。这种差异是受试者普遍被认为的乐观态度以及研究伦理委员会成员的“保护性悲观主义”共同作用的结果。我们使用“信任框架”来讨论这种差异，并证明有必要将这些框架纳入现有的知情同意模式。
