Barnbaum D R
Department of Philosophy, Kent State University, P.O. Box 5190, Kent, OH 44242-0001, USA.
Politics Life Sci. 2000 Sep;19(2):261-8. doi: 10.1017/s0730938400014866.
In January 2001, the Food and Drug Administration (FDA) proposed annual public disclosure of adverse events during gene therapy and xenotransplantation trials. The proposed policy raises the following questions: (1) Is the reformed policy in accord with the FDA's long-standing informed consent policies? (2) Why pair gene therapy trials and xenotransplantation trials in the revised guidelines? (3) Why single out these trials for public disclosure of adverse events? Each question is examined, and three conclusions are drawn. First, the FDA's own policies on informed consent require prompter public disclosure of adverse events. Second, the coupling of gene therapy and xenotransplantation trials entails a conceptual mistake in the types of communities that are harmed by each therapy's related adverse events. Third, all clinical trials merit such public disclosure of adverse events, not only gene therapy and xenotransplantation trials.
2001年1月，美国食品药品监督管理局（FDA）提议每年公开基因治疗和异种移植试验期间的不良事件。该提议的政策引发了以下问题：（1）改革后的政策是否符合FDA长期以来的知情同意政策？（2）为什么在修订后的指南中将基因治疗试验和异种移植试验配对？（3）为什么要特别挑选这些试验来公开不良事件？对每个问题进行了审视，并得出了三个结论。第一，FDA自身的知情同意政策要求更及时地公开不良事件。第二，基因治疗试验和异种移植试验的结合在因每种治疗相关不良事件而受影响的群体类型方面存在概念性错误。第三，所有临床试验都应如此公开不良事件，而不仅仅是基因治疗和异种移植试验。
