跨国人体试验伦理挑战及我国伦理审查制度因应

Ethical Challenges of Transnational Human Trials and the Response of China’s Ethical Review System

跨国人体试验之设计初衷未必满足东道国公民需要,试验发起国可能涉嫌对东道国国民的剥削利用,需要关注跨国人体试验中的伦理倾销现象。我国伦理委员会制度在应对跨国人体试验特殊伦理诉求方面尚存在审查标准不一、审查内容不清晰、自身机制不完善等问题。伦理委员会在审查跨国人体试验时需关注其特殊性,避免我国受试者遭到别国可能的“剥削”;加强国际伦理审查互认程序,消解跨国人体试验双重甚至多重伦理审查标准困惑;承认伦理委员会的行政主体地位,确保审查意见的中立性。

Transnational human trials may not be intended to fulfill the needs of the citizens of the host country, and the initiating country may be suspected of exploiting the nationals of the host country, requiring attention to the phenomenon of ethical dumping in transnational human trials. The ethics committee system in China still suffers from inconsistent review standards, unclear review content, and insufficient mechanisms to address the specific ethical requirements of transnational human trials. When reviewing transnational human trials, ethics committees need to pay attention to their specificity to avoid possible "exploitation" of Chinese subjects by other countries;strengthen the mutual recognition process of international ethics review to dispel the confusion of double or even multiple ethics review standards for transnational human trials;and recognize the administrative subject status of ethics committees to ensure the neutrality of review opinions.