title: Vulnerability as a regulatory category in human subject research.
abstract: This article examines and critiques the use of the term "vulnerability" in U.S. and international regulations and guidelines on research ethics. After concluding that the term is currently used in multiple, often inconsistent, senses, it calls on regulators to differentiate between three distinct types of vulnerability: "consent-based vulnerability,""risk-based vulnerability," and "justice-based vulnerability."
authors.affiliation: Seton Hall University School of Law, USA.
authors.forename: Carl H
authors.initials: CH
authors.lastname: Coleman
mesh_terms: D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence; D033161:Government Regulation; D006805:Human Experimentation / Q000941:ethics* / Q000331:legislation & jurisprudence*; D006801:Humans; D017410:Practice Guidelines as Topic; D035842:Research Subjects; D009626:Terminology as Topic; D014481:United States; D035862:Vulnerable Populations