London Alex John, Kadane Joseph B
Department of Philosophy and Centre for the Advancement of Applied Ethics, Carnegie Mellon University, 135 Bakes Hall, Pittsburgh, PA 15213, USA.
Stat Methods Med Res. 2002 Oct;11(5):413-27. doi: 10.1191/0962280202sm300ra.
Recent debates over the use of sham surgery as a control for studies of fetal tissue transplantation for Parkinson's disease have focused primarily on rival interpretations of the US federal regulations governing human-subjects research. Using the core ethical and methodological considerations that underwrite the equipoise requirement, we find strong prima facie reasons against using sham surgery as a control in studies of cellular-based therapies for Parkinson's disease and more broadly in clinical research. Additionally, we believe that these reasons can be generalized to apply to the use of other placebo controls that carry significant risks of positive harms in and of themselves. As a result, our arguments are centrally relevant to the emerging drive to subject therapies with a surgical component to the same rigorous standards of evaluation as those governing the approval of new pharmaceuticals.
最近关于将假手术用作帕金森病胎儿组织移植研究对照的争论，主要集中在美国联邦关于人体研究的法规的不同解释上。运用支撑均衡要求的核心伦理和方法考量，我们发现有强有力的初步理由反对在帕金森病细胞疗法研究以及更广泛的临床研究中使用假手术作为对照。此外，我们认为这些理由可以推广适用于其他本身就带有显著积极伤害风险的安慰剂对照的使用。因此，我们的论点与当前将具有手术成分的疗法置于与新药物审批相同严格评估标准之下的新趋势密切相关。
