精神类药物临床试验中受试者权益保障的伦理思考

Ethical Thinking on Subjects' Rights and Interests Protection in Psychiatric Drug Clinical Trials

由于精神病人和精神类药物的特殊性,在精神类药物临床试验中,必须选择精神病人作为受试者。在试验过程中,存在着生命健康权受到威胁、知情同意瑕疵、精神病受试者隐私权得不到保护等伦理问题。通过对上述伦理问题进行关于生命健康权、知情同意权以及隐私权的伦理分析,并就此探索伦理原则,为伦理问题的解决提出了客观可行的对策,以实现在推动医药卫生事业发展的同时,保障精神病人在精神类药物临床试验中的权益。

Due to the speci as subjects in psychiatric drug al nature of mental patients and psychiatric drugs, we have to recruit mental patients clinical trials. In the process of the experiments, there exist ethical problems. For example, the right of life and health is threatened, the informed consent is insufficient, and the privacy of the sub- jects cannot be protected. This paper ethically analyzed them, explored the ethical principles, and proposed some objective and feasible countermeasures, in order to promote the development of medicine and health care and pro- tect the rights of mental patients in psychotropic drug clinical trials.