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Cited by 438Ethics in Clinical ResearchEthics and bioethics in healthcareQualitative Research Methods and Ethics

The DOI matches its Crossref record; 24 of the 24 references it cites were found in a registry or an index.

The Limitations of “Vulnerability” as a Protection for Human Research Participants

Levine, Carol, Faden, Ruth, Grady, Christine, Hammerschmidt, Dale, Eckenwiler, Lisa, Sugarman, Jeremy·2004·The American Journal of Bioethics
DOI 10.1080/15265160490497083
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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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Crossref · 10.1080/15265160490497083

Cites

24 of 24 references verified0 citation errors · 0 not checkable

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Citations

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Show all 24 references

Research works printed but not linked: 7

  1. 2002, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Commentary on Guideline 13
  2. DeBruin D., 2001, Bioethics Examiner, 1, 4
  3. Hawana J. S., 2003, Vulnerable research subjects may exceed definition in clinical research
  4. Kipnis K., 2001, Ethical and policy issues in research involving human research participants, G-1
  5. Code of Federal Regulations, Title 45, Part 46, Protection of Human Subjects
  6. 2001, NIH policy and guidelines on the inclusion of women and minorities as subjects in clinical research—Amended October 2001
  7. 2001, Institutional Review Board Guidebook

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Metadata

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)
ORCID
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
DOI
10.1080/15265160490497083
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

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