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Research ethics committees: agents of research policy?

机译:研究伦理委员会:研究政策的代理人?

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摘要

The purpose of this commentary is to describe the unintended effects ethics committees may have on research and to analyse the regulatory and administrative problems of clinical trials.DiscussionThe Finnish law makes an arbitrary distinction between medical research and other health research, and the European Union's directive for good clinical trials further differentiates drug trials. The starting point of current rules is that clinical trials are lesser in the interest of patients and society than routine health care. However, commercial interests are not considered unethical. The contrasting procedures in research and normal health care may tempt physicians to continue introducing innovations into practice by relying on unsystematic and uncontrolled observations. Tedious and bureaucratic rules may lead to the disappearance of trials initiated by researchers. Trying to accommodate the special legislative requirements for new drug trials into more complex interventions may result in poor designs with unreliable results and increased costs. Meanwhile, current legal requirements may undermine the morale of ethics committee members.
机译:本评论的目的是描述伦理委员会可能会对研究产生意想不到的影响,并分析临床试验的监管和行政问题。讨论芬兰法律对医学研究和其他健康研究进行了任意区分,同时欧盟的指令良好的临床试验进一步区分了药物试验。当前规则的出发点是,与常规卫生保健相比,临床试验对患者和社会的利益较小。但是,商业利益并不被认为是不道德的。在研究和正常医疗保健中相反的程序可能会诱使医生依靠非系统化且不受控制的观察继续将创新引入实践。繁琐和官僚的规则可能导致研究人员发起的审判消失。试图将新药试验的特殊立法要求纳入更复杂的干预措施中,可能会导致设计不佳,结果不可靠并增加成本。同时,当前的法律要求可能会损害道德委员会成员的士气。

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