Edgar H, Rothman D J
Center for the Study of Society and Medicine, Columbia College of Physicians and Surgeons, New York, NY 10032, USA.
Milbank Q. 1995;73(4):489-506.
Over the past two decades, institutional review boards (IRBs) have transformed the conduct of clinical research, in the process protecting human subjects and setting an admirable standard for monitoring the ethics of science. Nevertheless, the very proliferation of these committees, in addition to changing the character and sponsorship of new research, suggests that a ¿one size fits all¿ approach to the governance of human experimentation may have outlived its usefulness. It may be time to remove the ¿I¿ from the IRB and create a system with greater national oversight. Whether such a change can be accomplished within the current political climate is debatable. But the need for such a shift is becoming increasingly apparent.
在过去二十年里，机构审查委员会（IRB）改变了临床研究的实施方式，在此过程中保护了人类受试者，并为监督科学伦理树立了令人钦佩的标准。然而，这些委员会的大量增加，除了改变新研究的性质和赞助情况外，表明“一刀切”的人类实验治理方法可能已经过时。也许是时候去掉IRB中的“I”（个体性），创建一个有更强国家监督的体系了。这样的变革能否在当前政治环境中实现尚有争议。但这种转变的必要性正变得越来越明显。
