Cargando…

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 monumen...

Descripción completa

Detalles Bibliográficos
Autores principales: Nagai, Hiroyuki, Nakazawa, Eisuke, Akabayashi, Akira
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9700634/
https://www.ncbi.nlm.nih.gov/pubmed/36357708
http://dx.doi.org/10.1007/s40592-022-00165-5
_version_ 1784839354270613504
author Nagai, Hiroyuki
Nakazawa, Eisuke
Akabayashi, Akira
author_facet Nagai, Hiroyuki
Nakazawa, Eisuke
Akabayashi, Akira
author_sort Nagai, Hiroyuki
collection PubMed
description 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.
format Online
Article
Text
id pubmed-9700634
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher Springer International Publishing
record_format MEDLINE/PubMed
spelling pubmed-97006342022-11-27 The creation of the Belmont Report and its effect on ethical principles: a historical study Nagai, Hiroyuki Nakazawa, Eisuke Akabayashi, Akira Monash Bioeth Rev Original Article 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. Springer International Publishing 2022-11-10 2022 /pmc/articles/PMC9700634/ /pubmed/36357708 http://dx.doi.org/10.1007/s40592-022-00165-5 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Original Article
Nagai, Hiroyuki
Nakazawa, Eisuke
Akabayashi, Akira
The creation of the Belmont Report and its effect on ethical principles: a historical study
title The creation of the Belmont Report and its effect on ethical principles: a historical study
title_full The creation of the Belmont Report and its effect on ethical principles: a historical study
title_fullStr The creation of the Belmont Report and its effect on ethical principles: a historical study
title_full_unstemmed The creation of the Belmont Report and its effect on ethical principles: a historical study
title_short The creation of the Belmont Report and its effect on ethical principles: a historical study
title_sort creation of the belmont report and its effect on ethical principles: a historical study
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9700634/
https://www.ncbi.nlm.nih.gov/pubmed/36357708
http://dx.doi.org/10.1007/s40592-022-00165-5
work_keys_str_mv AT nagaihiroyuki thecreationofthebelmontreportanditseffectonethicalprinciplesahistoricalstudy
AT nakazawaeisuke thecreationofthebelmontreportanditseffectonethicalprinciplesahistoricalstudy
AT akabayashiakira thecreationofthebelmontreportanditseffectonethicalprinciplesahistoricalstudy
AT nagaihiroyuki creationofthebelmontreportanditseffectonethicalprinciplesahistoricalstudy
AT nakazawaeisuke creationofthebelmontreportanditseffectonethicalprinciplesahistoricalstudy
AT akabayashiakira creationofthebelmontreportanditseffectonethicalprinciplesahistoricalstudy