关键词: 医学人体试验, 行政许可, 伦理审查

Abstract:

Clinical trial is a high-risk behavior, and it involves not only the basic rights of natural persons - the right to life and health, but also the public interest. The consequences of these dangers are systemic in terms of public safety and cannot be remedied afterwards from the perspective of natural person’s rights relief. Therefore, administrative licenses should be applied to clinical trials from the perspective of controlling hazards and from the nature of the rights involved. A Two-tiered Review System shall be established, including the ethical review of the ethics committee and the administrative license of the competent authority.

Key words: clinical trial, administrative licensing, ethical review