国际合作中知情同意面临的难题及思考

目前在医学研究的国际合作中,知情同意原则在实施中出现了许多争议和难题.结合一些典型案例,对知情同意的跨文化研究、知情同意表格的误解以及保护受试者与自由研究之间的权衡等问题进行了深入地分析.指出:加强交流、相互尊重、求同存异是解决跨文化研究的必由之路;严格审查、加强监管是避免知情同意流于形式的重要手段;鼓励与防范并举才能达到双赢的局面.

Problems and Thinking on Informed Consent in International Cooperation

Presently, there are lots of controversies and problems of informed consent during international cooperation of medical research. Through some typical examples,to analyse and think profoundly these issues, which are trans-culture study of informed consent, misunderstanding to informed consent form and the balance between protection of human subjects and free research.And then to point out that it is the only way to solve trans-culture study for strengthening exchange, respecting each other and seeking common ground while reserving differences, it is an important means to avoid informed consent as a matter of form for examining strictly and enhancing supervision and administration and we can gain benefit both sides only by encouraging and precaution.