Levine R J
Yale University School of Medicine, New Haven, Connecticut 06510.
Ann N Y Acad Sci. 1988;530:133-43. doi: 10.1111/j.1749-6632.1988.tb35305.x.
In the U.S., the development of extensive regulations for the protection of human subjects of research began in the 1960s and continued through the 1970s. The substance of these regulations reflects the American social and political climate of the time. There is a focus on rights--e.g., to be left alone, to be self-determining--reflected in elaborate requirements to assure the validity and documentation of informed consent. There is also a focus on systems of disinterested review and monitoring procedures to assure uniform adherence to the requirements of the regulations. To the extent that the U.S. has developed extensive regulations in this field, it may be viewed as more advanced than the U.K. And yet, it is apparent that there remain on both sides of the Atlantic very difficult and similar problems regarding the definition of responsible research. Such problems are illustrated by consideration of current controversies about the ethical justification of RCTs. There are some features of the U.S. regulatory system that I can commend to the attention of other nations as they develop policies for the protection of human research subjects. For example, a uniform requirement for informed consent and committee review appears to be responsive to some problems currently encountered in the conduct of RCTs in the U.K. A note of caution is in order, however. Some features of our regulatory policy and practices are excessively inflexible, wasteful of human resources, and occasionally counterproductive.
在美国，针对保护研究中的人类受试者制定广泛法规始于20世纪60年代，并一直持续到70年代。这些法规的实质反映了当时美国的社会和政治氛围。法规注重权利，比如不受打扰、自我决定的权利，这体现在为确保知情同意的有效性和文件记录而制定的详尽要求中。同时也注重公正审查和监督程序体系，以确保统一遵守法规要求。就美国在该领域制定了广泛法规而言，它可能被视为比英国更先进。然而，很明显，在大西洋两岸，关于负责任研究的定义仍存在非常棘手且类似的问题。当前关于随机对照试验伦理合理性的争议就说明了这类问题。美国监管体系的一些特点值得其他国家在制定保护人类研究受试者政策时予以关注。例如，对知情同意和委员会审查的统一要求似乎能应对英国目前在进行随机对照试验时遇到的一些问题。然而，需要提醒的是。我们监管政策和做法的一些特点过于僵化，浪费人力资源，有时甚至适得其反。
