The Limitations of “Vulnerability” as a Protection for Human Research Participants
Abstract
Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges.
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Bioethicists are highly critical of the vagueness of the label "vulnerable" and its propensity to stereotype groups of quite diverse patients.
“Bioethicists are highly critical of the vagueness of the label and its propensity to stereotype groups of quite diverse patients.37”
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- Authors
- Levine, C., Faden, R., Grady, C., Hammerschmidt, D., Eckenwiler, L., & Sugarman, J.
- Affiliations
- United Hospital Fund (US)
- Johns Hopkins University (US)
- National Institutes of Health (US)
- University of Minnesota (US)
- Old Dominion University (US)
- Venue
- The American Journal of Bioethics
- Publisher
- Informa UK Limited
- Published
- 2004-08
- Volume
- 4
- Issue
- 3
- Pages
- 44-49
- ISSN
- 1526-5161 (ISSN-L)
- 1536-0075
- OpenAlex
- W2085225076
- Cited by
- 438
- References
- 24
- Citations by year
- 2026: 20 · 2025: 18 · 2024: 27 · 2023: 31 · 2022: 33 · 2021: 27 · 2020: 23 · 2019: 23 · 2018: 25 · 2017: 29 · 2016: 19 · 2015: 19 · 2014: 19 · 2013: 12 · 2012: 22
- FWCI
- 12.56
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The American Journal of Bioethics (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
- Social Sciences › Sociology and Political Science › Qualitative Research Methods and Ethics
- Keywords
- research participant vulnerability, informed consent, Belmont Report, power imbalance in research, vulnerable populations, international research, stereotypes, research ethics regulation, protection from harm
- MeSH terms
- Child, Choice Behavior, Clinical Trials as Topic, Developing Countries, Humans, Human Experimentation, Informed Consent, Prisoners, Research Design, Socioeconomic Factors, United States, Mental Competency, Patient Selection, Developed Countries, Ethics, Clinical, Ethics Committees, Research, Codes of Ethics, Comprehension, Ethics, Research, Research Subjects, Vulnerable Populations
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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