从北京艾滋病药物试验案谈弱势受试人群的特殊保护

Beijing anti-AIDS drug clinical trial case and particular protection to vulnerable persons as subjects

北京艾滋病药物试验案,揭示出药物临床试验中弱势受试人群权利保护特殊问题。弱势人群是指不具备自我保护能力的人,包括儿童、孕妇、精神病人、囚犯、绝症患者、文盲等等。临床试验伦理审查中,应重点关注他们特殊的知情能力、自我保护能力、个体健康特质。

Case of Beijing Anti-AIDS drug clinical trial has reveal problems about the protection to vulnerable persons as subjects in drug clinical trials. Vulnerable persons are those who are incapable of protecting their owninterests, including children, Pregnant women, mental disorders, prisoners, patients with incurable disease, illiteracies, etc. In ethical review of clinical trial, it should appraise their ability to understand the information, to protect own interests and their particular healthy situation.