Dresser Rebecca
Daniel Noyes Kirby Professor of Law and Professor of Ethics in Medicine at Washington University in St. Louis.
J Law Med Ethics. 2013 Winter;41(4):829-40, Table of Contents. doi: 10.1111/jlme.12093.
Research subjects do not always conform to research requirements. When their personal interests conflict with the demands of participation, some subjects surreptitiously break the rules. These subjects are subversive--they undermine the research endeavor. In rejecting the restrictions research imposes, subversive subjects diminish the value of research results. From one vantage point, subversive subjects engage in unethical behavior. They create risks to themselves and others; they also disregard ethical responsibilities to adhere to research agreements and tell the truth. At the same time, subversive subjects expose ethical problems in the design and conduct of clinical trials. Features of the research environment create fertile ground for subject subversion. Intensified policing and guidance are two common strategies for reducing subject subversion, but collaborative reforms are more consistent with the partnership model of clinical research.
研究对象并不总是符合研究要求。当他们的个人利益与参与要求相冲突时，一些研究对象会偷偷违反规定。这些研究对象具有颠覆性——他们破坏了研究工作。在拒绝研究施加的限制时，颠覆性研究对象降低了研究结果的价值。从一个角度来看，颠覆性研究对象的行为是不道德的。他们给自己和他人带来风险；他们也无视遵守研究协议和讲真话的道德责任。同时，颠覆性研究对象暴露了临床试验设计和实施中的伦理问题。研究环境的特点为研究对象的颠覆行为创造了滋生的土壤。加强监管和指导是减少研究对象颠覆行为的两种常见策略，但合作改革更符合临床研究的合作模式。
