Levine R J
Yale University School of Medicine, New Haven, CT.
Kennedy Inst Ethics J. 1994 Jun;4(2):93-8. doi: 10.1353/ken.0.0054.
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. Written with the aim of avoiding 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, their dominant concerns are the protection of individuals from injury and from exploitation. In recent years, however, 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 research policies and practices, 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 encourage the conduct of ethical research while maintaining the vigilance necessary to safeguard the rights and welfare of the subjects.
所有国际研究伦理准则以及几乎所有涉及人类受试者研究领域的国家法律法规都体现出一种保护主义态度。这些准则和法规旨在避免纳粹医生研究者所犯下的暴行、沙利度胺事件那样的灾难,或是塔斯基吉梅毒研究那样的伦理违规行为再次发生,其主要关注点在于保护个人免受伤害和剥削。然而,近年来,社会对临床研究的认知发生了巨大转变。如今,很大程度上由于艾滋病活动家的努力,临床研究被广泛视为有益无害。尽管这种态度转变在研究政策和实践方面带来了一些重要改进,但这种新认知与早期过度保护主义一样错误。保持平衡的观点很有必要;我们的政策应鼓励开展符合伦理的研究,同时保持必要的警惕以保障受试者的权利和福祉。