{"title":"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。","authors":"Hiroyuki Nagai, Eisuke Nakazawa, Akira Akabayashi","doi":"10.1007/s40592-022-00165-5","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":43628,"journal":{"name":"Monash Bioethics Review","volume":null,"pages":null},"PeriodicalIF":1.6000,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9700634/pdf/","citationCount":"0","resultStr":"{\"title\":\"The creation of the Belmont Report and its effect on ethical principles: a historical study.\",\"authors\":\"Hiroyuki Nagai, Eisuke Nakazawa, Akira Akabayashi\",\"doi\":\"10.1007/s40592-022-00165-5\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":43628,\"journal\":{\"name\":\"Monash Bioethics Review\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.6000,\"publicationDate\":\"2022-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9700634/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Monash Bioethics Review\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1007/s40592-022-00165-5\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2022/11/10 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"ETHICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Monash Bioethics Review","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1007/s40592-022-00165-5","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2022/11/10 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"ETHICS","Score":null,"Total":0}
The creation of the Belmont Report and its effect on ethical principles: a historical study.
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.
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