What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research
Abstract
In recent years, there has been substantial debate about the ethics of research in developing countries [1–5]. In general, the controversies have centered on 3 issues: first, the standard of care that should be used in research in developing countries[6–13]; second, the “reasonable availability” of interventions that are proven to be useful during the course of research trials [14–19]; and third, the quality of informed consent. The persistence of controversies on such issues reflects, in part, the fact that existing ethical guidelines can be interpreted in multiple ways, are sometimes contradictory, or rely on unstated, yet controversial, ethical principles [6, 7, 9–11, 13, 20–24]. To provide unified and consistent ethical guidance, we apply a previously proposed ethical framework for clinical research within developed countries to developing countries, explicating a previously implicit requirement for collaboration [25]. More importantly, we propose specific and practical benchmarks to guide researchers and research-ethics committees in assessing how well the enumerated ethical principles have been fulfilled in particular cases.
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The literature on conducting clinical trials in low resource countries mostly relates to ethical issues.
“Even within the paucity of literature on conducting clinical trials in low resource countries, the literature mostly relates to ethical issues [19, 26–28].”
From Barriers for conducting clinical trials in developing countries—A systematic review (2018) · cites this paper as [28]
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- Authors
- Emanuel, E. J., Wendler, D., Killen, J., & Grady, C.
- Affiliations
- National Institutes of Health (US)
- Corresponding author
- Emanuel, Ezekiel J.
- Venue
- The Journal of Infectious Diseases
- Publisher
- Oxford University Press (OUP)
- Published
- 2004-03
- Volume
- 189
- Issue
- 5
- Pages
- 930-937
- ISSN
- 0022-1899 (ISSN-L)
- 1537-6613
- OpenAlex
- W2165845288
- Cited by
- 966
- References
- 59
- Citations by year
- 2026: 31 · 2025: 39 · 2024: 62 · 2023: 47 · 2022: 45 · 2021: 50 · 2020: 52 · 2019: 53 · 2018: 50 · 2017: 54 · 2016: 59 · 2015: 59 · 2014: 73 · 2013: 66 · 2012: 30
- FWCI
- 19.01
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Infectious Diseases (publishedVersion)
- PubMed (publishedVersion)
- Funders
- International AIDS Society
- 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 › Medicine › Physiology › Biomedical Ethics and Regulation
- Keywords
- clinical research ethics, research ethics in developing countries, informed consent, standard of care, research ethics committees, research collaboration, ethical principles
- MeSH terms
- Developing Countries, Humans, Poverty, Social Values, Reproducibility of Results, Patient Selection, Ethics, Research, Biomedical Research
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