title: 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.
authors.affiliation: United Hospital Fund.
authors.forename: Carol
authors.initials: C
authors.lastname: Levine
authors.forename: Ruth
authors.initials: R
authors.lastname: Faden
authors.forename: Christine
authors.initials: C
authors.lastname: Grady
authors.forename: Dale
authors.initials: D
authors.lastname: Hammerschmidt
authors.forename: Lisa
authors.initials: L
authors.lastname: Eckenwiler
authors.forename: Jeremy
authors.initials: J
authors.lastname: Sugarman
mesh_terms: D002648:Child; D002755:Choice Behavior; D002986:Clinical Trials as Topic / Q000941:ethics; D032781:Codes of Ethics; D032882:Comprehension; D019049:Developed Countries; D003906:Developing Countries; D028744:Ethics Committees, Research; D026690:Ethics, Clinical; D032984:Ethics, Research; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D007258:Informed Consent; D016743:Mental Competency; D018579:Patient Selection / Q000941:ethics*; D011329:Prisoners; D012107:Research Design / Q000592:standards; D035842:Research Subjects; D012959:Socioeconomic Factors; D014481:United States; D035862:Vulnerable Populations