Cited by 204Ethics in Clinical ResearchEthics and bioethics in healthcareBiomedical Ethics and Regulation

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Ethical Issues in the Design and Conduct of Clinical Trials in Developing Countries

Shapiro, Harold T., Meslin, Eric M.·2001·New England Journal of Medicine

DOI 10.1056/nejm200107123450212

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Abstract

There has been considerable controversy about the ethics of clinical trials that are sponsored or conducted by groups in industrialized countries but carried out in developing countries.18 The National Bioethics Advisory Commission, of which we serve as chairman and executive director, respectively, has recently addressed these and related issues.9 International collaborative research covers a broad spectrum of methods, topics, and research strategies. In this essay, we discuss ethical issues in the design and conduct of clinical trials in developing countries. In particular, we focus on phase 3 and other drug trials that, if successful, can lead to the use . . .

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Authors: Shapiro, H. T., & Meslin, E. M.
Affiliations: National Institutes of Health (US)
ORCID: Meslin, Eric M.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2001-07-12
Volume: 345
Issue: 2
Pages: 139-142
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejm200107123450212
OpenAlex: W2065625460
Cited by: 204
References: 13
Citations by year: 2026: 1 · 2025: 2 · 2023: 2 · 2022: 2 · 2021: 3 · 2020: 8 · 2019: 4 · 2018: 5 · 2017: 9 · 2016: 7 · 2015: 6 · 2014: 6 · 2013: 13 · 2012: 8
FWCI: 15.50
Type: journal article
Language: en
Open access: closed
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
DigitalGeorgetown (Georgetown University Library) (submittedVersion)
Topics: Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
Health Sciences › Nursing › Issues, ethics and legal aspects › Biomedical Ethics and Regulation
Keywords: clinical trial ethics, developing countries, international collaborative research, research ethics oversight, National Bioethics Advisory Commission
MeSH terms: Clinical Trials as Topic, Developing Countries, Ethics, Medical, Helsinki Declaration, Humans, Research Design, United States, Ethical Review, Vulnerable Populations, Internationality

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Ethical Issues in the Design and Conduct of Clinical Trials in Developing Countries

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