Mueller Mary-Rose, Instone Susan
Hahn School of Nursing and Health Science, University of San Diego, San Diego, CA 92110, USA.
Cien Saude Colet. 2008 Mar-Apr;13(2):381-9. doi: 10.1590/s1413-81232008000200013.
An ethnographic field study about informed consent in hepatitis C clinical trials provides insight into how changes in protocol requirements and patient health status triggered the actions and decisions of researchers and human subjects during the conduct of these trials. U.S. federal guidelines recommend that informed consent should be conceptualized as more than a one-time event. Rather, a process of continuing consent should be the standard but little is understood about how exactly this process should unfold. We used a proposed typology of continuing consent to frame our analysis and were able to document that only some of the proposed types took place at the site of our study. The most frequent practice involved the researchers' re-consent of their subjects for major protocol revisions. Only one subject dissented and chose to withdraw even though he was technically eligible to continue in the study. Two other types of continuing consent were not observed. We discovered an additional type of continuing consent not described in the typology whereby subjects gave implied consent through their cooperation and adherence to the on-going requirements of the protocols. Implications for the informed consent process and the need for further research are presented.
一项关于丙型肝炎临床试验中知情同意的人种志实地研究，深入探讨了方案要求和患者健康状况的变化如何在这些试验开展过程中引发研究人员和受试者的行动与决策。美国联邦指南建议，知情同意不应被视为一次性事件。相反，持续同意过程应成为标准，但对于这个过程具体应如何展开，人们了解甚少。我们使用一种提议的持续同意类型学来构建分析框架，并且能够记录到在我们的研究地点仅发生了部分提议的类型。最常见的做法是研究人员就主要方案修订对其受试者重新进行同意程序。尽管从技术上讲他有资格继续参与研究，但只有一名受试者表示反对并选择退出。另外两种持续同意类型未被观察到。我们发现了一种类型学中未描述的额外持续同意类型，即受试者通过合作并遵守方案的持续要求给予默示同意。文中呈现了对知情同意过程的启示以及进一步研究的必要性。
