Yap Tsiao Yi, Kassimatis Kathleen A, Kodish Eric
Dr. Yap was a third-year Pediatric Hematology Oncology Fellow, Children's Hospital, Cleveland Clinic, Cleveland Ohio.
Ethics Behav. 2010;20(5):380-386. doi: 10.1080/10508422.2010.491764.
Randomization is the "gold standard" design for clinical research trials, and is accepted as the best way to reduce bias. Although some controversy remains over this matter, we believe equipoise is the fundamental ethical requirement for conducting a randomized clinical trial. Despite much attention to the ethics of randomization, the moral psychology of this study design has not been explored. This paper analyzes the ethical tensions that arise from conducting these studies, and examines the moral psychology of this design from the perspectives of physician-investigators and patient-subjects. We conclude with a discussion of the practical implications of this analysis.
随机化是临床研究试验的“金标准”设计，并且被公认为是减少偏差的最佳方法。尽管在这个问题上仍存在一些争议，但我们认为均衡是进行随机临床试验的基本伦理要求。尽管人们对随机化的伦理问题给予了很多关注，但这种研究设计的道德心理尚未得到探讨。本文分析了进行这些研究时出现的伦理紧张关系，并从医生研究者和患者受试者的角度审视了这种设计的道德心理。我们最后讨论了这一分析的实际意义。
