title: Research subjects with limited English proficiency: ethical and legal issues.
abstract: In this article, we examine Institutional Review Board (IRB) policies, international guidelines, and federal regulations and guidance for dealing with Limited English Proficiency (LEP) research subjects. We show that federal and international guidance concerning this topic is insufficient, and there is considerable variation in IRB policies. While some IRBs have thorough and useful policies, others do not. Many IRBs do not provide researchers and IRB member with answers to several important questions relating to language barriers in research. We recommend that federal agencies, international organizations, IRBs, and researchers take steps to fill in the gaps in guidance and policy to help insure that LEP populations will receive equitable and ethical treatment in research.
authors.affiliation: National Institute of Environmental Studies, National Institutes of Health, P.O. Box 12233, Mail Drop NH 06, Research Triangle Park, NC 27709, USA. resnikd@niehs.nih.gov
authors.forename: David B
authors.initials: DB
authors.lastname: Resnik
authors.forename: Caitlin W
authors.initials: CW
authors.lastname: Jones
mesh_terms: D003144:Communication Barriers; D032962:Consent Forms / Q000331:legislation & jurisprudence / Q000592:standards*; D003625:Data Collection; D028744:Ethics Committees, Research / Q000458:organization & administration*; D005006:Ethnicity; D033161:Government Regulation; D017408:Guidelines as Topic; D006805:Human Experimentation / Q000331:legislation & jurisprudence / Q000592:standards; D006801:Humans; D038622:Internationality; D007802:Language; D016134:Organizational Policy; D018579:Patient Selection / Q000941:ethics; D035842:Research Subjects; D012935:Social Justice; D014177:Translations; D014481:United States; D014483:United States Dept. of Health and Human Services