Hemminki Elina
Health and Social Services, National Research and Development Centre for Welfare and Health STAKES, PO Box 220, 00531 Helsinki, Finland.
Health Res Policy Syst. 2005 Oct 4;3:6. doi: 10.1186/1478-4505-3-6.
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.
The 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.
The aims and the quality of the work of ethics committees should be evaluated, and a reformulation of the EU directive on good clinical trials is needed. Ethical judgement should consider the specific circumstance of each trial, and ethics committees should not foster poor research for legal reasons.
本评论的目的是描述伦理委员会可能对研究产生的意外影响，并分析临床试验的监管和行政问题。
芬兰法律对医学研究和其他健康研究进行了任意区分，欧盟关于良好临床试验的指令进一步区分了药物试验。现行规则的出发点是，临床试验对患者和社会的利益低于常规医疗保健。然而，商业利益并不被视为不道德。研究和正常医疗保健中相互矛盾的程序可能会诱使医生继续通过依靠非系统和无对照的观察将创新引入实践。繁琐和官僚主义的规则可能导致研究人员发起的试验消失。试图将新药试验的特殊立法要求适用于更复杂的干预措施可能会导致设计不佳、结果不可靠且成本增加。与此同时，现行法律要求可能会削弱伦理委员会成员的士气。
应评估伦理委员会工作的目标和质量，并且需要重新制定欧盟关于良好临床试验的指令。伦理判断应考虑每项试验的具体情况，伦理委员会不应出于法律原因助长劣质研究。
