The limitations of "vulnerability" as a protection for human research participants

Carol Levine, Ruth Faden, Christine Grady, Dale E Hammerschmidt, Lisa Eckenwiler, Jeremy Sugarman

Research output: Contribution to journalReview articlepeer-review

293 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)44-49
Number of pages6
JournalAmerican Journal of Bioethics
Issue number3
StatePublished - 2004

Bibliographical note

Funding Information:
This paper is a project of the Consortium to Examine Clinical Research Ethics (CECRE), which is funded by the Doris Duke Charitable Foundation. Other members of CECRE who provided valuable contributions to this manuscript were Angela Bowen, M.D., Western IRB; Ezekiel Emanuel, M.D., Ph.D., National Institutes of Health; Alan Fleischman, M.D., New York Academy of Medicine; and Kenneth Getz, Cen-terWatch. Kenneth Kipnis, Ph.D., provided useful unpublished materials and suggested important references.


  • Decisional capacity
  • International research
  • Research ethics
  • Research involving children
  • Research involving prisoners
  • Vulnerability


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