The creation of the Belmont Report and its effect on ethical principles: a historical study.

IF 1.6 Q2 ETHICS Monash Bioethics Review Pub Date : 2022-12-01 Epub Date: 2022-11-10 DOI:10.1007/s40592-022-00165-5
Hiroyuki Nagai, Eisuke Nakazawa, Akira Akabayashi
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Abstract

The Belmont Report continues to be held in high regard, and most bioethical analyses conducted in recent years have presumed that it affects United States federal regulations. However, the assessments of the report's creators are sharply divided. Understanding the historic reputation of this monumental report is thus crucial. We first recount the historical context surrounding the creation of this report. Subsequently, we review the process involved in developing ethical guidelines and describe the report's features. Additionally, we analyze the effect of unfolding events on the subsequent creation of federal regulations, especially on gene therapy clinical trials. Moreover, throughout this paper we evaluate the ethical principles outlined in this report and describe how they overlap with the issue of protecting socially vulnerable groups. Based on the analysis, we conclude that the features of the Belmont Report cannot be considered as having affected the basic sections of the federal regulations for ethical reviews that were made uniform in 1981. Nevertheless, regarding the regulations on gene therapy clinical trials-which were at first expected to be applicable to research involving children-in addition to implementing policies regarding the public review of protocols that passed ethical review, this report's principles are clearly reflected in the key notes that should have been referred to when the report was created.

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贝尔蒙特报告》的创作及其对伦理原则的影响:一项历史研究。
贝尔蒙特报告》继续受到高度评价,近年来进行的大多数生物伦理分析都假定该报 告影响了美国联邦法规。然而,对该报告创作者的评价却众说纷纭。因此,了解这份不朽报告的历史声誉至关重要。我们首先回顾了该报告产生的历史背景。随后,我们回顾了制定伦理指南的过程,并介绍了报告的特点。此外,我们还分析了事件发展对随后制定联邦法规的影响,尤其是对基因治疗临床试验的影响。此外,在本文中,我们还对报告中概述的伦理原则进行了评估,并阐述了这些原则与保护社会弱势群体问题的重叠之处。根据分析,我们得出结论,《贝尔蒙特报告》的特点不能被视为影响了 1981 年统一制定的联邦伦理审查法规的基本部分。尽管如此,关于基因治疗临床试验的规定--起初预计将适用于涉及儿童的研究--除了实施有关对通过伦理审查的方案进行公开审查的政策外,该报告的原则在关键说明中得到了明确的体现,而这些关键说明本应在该报告制定时得到参考。
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来源期刊
CiteScore
2.70
自引率
6.20%
发文量
16
期刊介绍: Monash Bioethics Review provides comprehensive coverage of traditional topics and emerging issues in bioethics. The Journal is especially concerned with empirically-informed philosophical bioethical analysis with policy relevance. Monash Bioethics Review also regularly publishes empirical studies providing explicit ethical analysis and/or with significant ethical or policy implications. Produced by the Monash University Centre for Human Bioethics since 1981 (originally as Bioethics News), Monash Bioethics Review is the oldest peer reviewed bioethics journal based in Australia–and one of the oldest bioethics journals in the world. An international forum for empirically-informed philosophical bioethical analysis with policy relevance. Includes empirical studies providing explicit ethical analysis and/or with significant ethical or policy implications. One of the oldest bioethics journals, produced by a world-leading bioethics centre. Publishes papers up to 13,000 words in length. Unique New Feature: All Articles Open for Commentary
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