Veatch Robert M
Perspect Biol Med. 2016;59(1):3-17. doi: 10.1353/pbm.2016.0018.
In the 1950s and '60s, Henry Beecher pioneered the discussion of the ethics of clinical research, leading eventually to the publication of the famous New England Journal of Medicine article summarizing 22 research studies that Beecher suggests were unethical. Those studies generally showed a pattern of posing serious risks to subjects without anticipated proportional benefit. Beecher famously claimed that the problem was not that researchers were malicious or evil; rather, he claimed the problem was they manifested thoughtlessness or carelessness. He called for more rigorous self-scrutiny rather than public review.This article argues that Beecher's reliance on conscientious investigators is problematic. In particular, it focuses on benefits and harms to the exclusion of other moral criteria. However, both research subjects and public regulators are also concerned about autonomy and the consent requirement, confidentiality, and fairness in subject selection and research design. The movement in the 1970s toward more public scrutiny was critical, even though Beecher was right in holding that it was not "vicious disregard for subject welfare" that explained unethical protocols.
在20世纪50年代和60年代，亨利·比彻开创了临床研究伦理的讨论，最终促成了发表在《新英格兰医学杂志》上的那篇著名文章，该文章总结了比彻认为不道德的22项研究。这些研究总体上呈现出一种模式，即给受试者带来严重风险，却没有预期的相称益处。比彻著名的论断是，问题不在于研究人员怀有恶意或邪恶；相反，他认为问题在于他们表现出轻率或粗心。他呼吁进行更严格的自我审查，而非公开审查。本文认为，比彻对尽责研究者的依赖存在问题。特别是，它只关注益处和危害，而忽略了其他道德标准。然而，研究受试者和公共监管机构也关注自主性和同意要求、保密性以及受试者选择和研究设计中的公平性。20世纪70年代朝着更多公开审查的转变至关重要，尽管比彻认为不道德的实验方案并非“对受试者福利的恶意漠视”这一点是正确的。
