Perspect Biol Med. 2020;63(2):220-239. doi: 10.1353/pbm.2020.0028.
Given its outsized influence as a core document in bioethics, it is worth reminding ourselves of the historical context in which the Belmont Report came to be. This article examines the societal forces that helped bring about the Belmont Report and that shaped its conception of ethical research. A product of a public investigation that included many nonscientists and espoused philosophical principles, the Report internalized a growing call in the late 1960s for oversight over the research enterprise, which had long been the private realm of physician-investigators. Belmont helped bring about a regulatory and oversight apparatus to the research enterprise, as well as a language and discipline of bioethics that added a multidisciplinary set of voices and decision-makers to discussions of what constitutes ethical research. Because it reflected the spirit of protectionism engendered by events of the 1960s and 1970s, Belmont also helped emphasize the importance of informed consent and the protection of vulnerable populations. But because the Report was a product of its time, contingent on historical developments and highly publicized events, it is not necessarily responsive to new factors that now condition the research enterprise.
鉴于《贝尔蒙报告》作为生物伦理学核心文件的巨大影响力，值得提醒我们注意其产生的历史背景。本文考察了促成《贝尔蒙报告》出台并塑造其伦理研究理念的社会力量。这是一项公众调查的成果，其中包括许多非科学家，并拥护哲学原则，报告内化了 20 世纪 60 年代末对研究事业监管的强烈呼吁，而长期以来，研究事业一直是医师研究者的私人领域。《贝尔蒙报告》为研究事业带来了监管和监督机构，以及生物伦理学的语言和学科，为研究伦理的构成增添了一套多学科的声音和决策者。由于它反映了 20 世纪 60 年代和 70 年代事件引发的保护主义精神，《贝尔蒙报告》还强调了知情同意和保护弱势群体的重要性。但由于报告是其时代的产物，取决于历史发展和备受关注的事件，因此不一定能应对现在影响研究事业的新因素。
