Evidence map›Paper›PMID 36357708›Full record

ReviewMonash bioethics review2022

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

Hiroyuki Nagai, Eisuke Nakazawa, Akira Akabayashi

Open access · hybridAbstract readReview
In one paragraph

Review in Monash bioethics review, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
14.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 59 citations in OpenAlex.

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  10. Not whether but how: the ethics and Language of reporting back individual results.Environmental health : a global access science source · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 3 institutions in 2 countries.

Hiroyuki NagaiDepartment of Biomedical Ethics, University of Tokyo Faculty of Medicine, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan.ORCID http://orcid.org/0000-0003-3837-5492
Eisuke NakazawaDepartment of Biomedical Ethics, University of Tokyo Faculty of Medicine, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan.ORCID http://orcid.org/0000-0002-3320-3811
Akira AkabayashiDepartment of Biomedical Ethics, University of Tokyo Faculty of Medicine, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. akira.akabayashi@gmail.com.ORCID http://orcid.org/0000-0003-0811-1955
New York University · USThe University of Tokyo · JPToyobo (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Ethical ReviewSocial JusticeBeneficenceChildHumansUnited StatesBelmont ReportBeneficenceCommon RuleEthical principlesGene therapyJusticeRespect for PersonsUnited States

Identifiers

PMID36357708
PMCPMC9700634
OpenAlexW4308770204

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.