摘要
所有关于研究伦理的国际法典及实际中的关于人体受试者研究领域的各国立法及规则都表明了保护主义的姿态。他们的主旨是保护个人不受伤害和剥削。这种保护主义姿态有其重要的历史原因 ,起草这些文件具有这样的目的 :保证像被纳粹医生—研究者犯下的罪行。试验药物Thalidomide引发的灾难及Tuskegee梅毒研究对伦理道德的亵渎永远不会重演。近些年来社会对临床研究的理解已发生了戏剧性转变。如经AIDS积极分子努力的结果 ,人们已以宽容和有益的心态广泛接受临床试验。虽然这种姿态的转变已产生了在指导进行临床研究方面的政策及实践某些重要的改善 ,但人们必须认识到 ,这种新的接受正像先前的过度保护主义一样的错误 ,其应该维护一个平衡的比例。我们的政策应反映出鼓励符合伦理学的研究的要求 ,同时要保持必要的防范以保护受试者的权益。
All international codes of research ethics and virtually all national legislation and regulation in the field of research involving human subjects project an attitude of protectionism. Their dominant concerns are the protection of individuals from injury and from exploitation. There are important historical reasons for this protectionistic attitude. These documents were written with the aim of ensuring that there would never be a repetition of atrocities like those committed by the Nazi physician-researchers, calamities like the thalidomide experience or ethical violations like those of the Tuskegee syphilis study. In recent years society's perception of clinical research has shifted dramatically. Now, largely as a consequence of the efforts of the AIDS activists, clinical research is widely perceived as benign and beneficial. Although this shift in attitude has resulted in some important improvements in policies and practices regarding the conduct of clinical research, one must recognize that this new perception is just as wrong-headed as was the earlier excessive protectionism. It is necessary to maintain a balanced perspective. Our policies should reflect the need to encourage the conduct of ethical research while maintaining the necessary vigilance to safeguard the rights and welfare of the subjects.
出处
《医学与哲学》
2001年第12期1-5,共5页
Medicine and Philosophy
关键词
人体受试者
保护主义
伦理法典
立法
知情同意
药物试验
research involving humans as subjects
protectionism
ethical codes
regulations
informed consent
drug trials
