基于案例探讨临床研究中的伦理难题

Considerations on Ethical Issues of Clinical Research Based on Case Study

近年来随着临床研究数量的大幅提升,有关受试者保护的新问题不断挑战着研究者和伦理委员会的伦理智慧。基于既往伦理审查的经验,总结梳理几个典型的临床研究案例,涉及研究目的、知情同意、研究损害赔偿等实践伦理内容,分析其伦理问题,并提出相应的对策,供临床研究者、机构伦理委员会及决策部门参考。

In recent years, with dramatic increase of the number of clinical studies, researchers and ethical committees face with the new challenge of ethical issues about protection of subjects. Based on the experience of previous ethical review, this article summed up a few typical eases of clinical research, involving the practical ethi- cal issues, such as the goal of research, informed consent, and compensation for damage caused by research. And then it analyzed the ethical issues in these cases, and proposed some suggestions for the reference of clinical re- searchers, ethical committees and policy makers.