title: Overcoming language barriers in the informed consent process: regulatory and compliance issues with the use of the "short form".
abstract: Language barriers in the informed consent process can be a significant impediment when recruiting non-English speaking subjects into clinical research studies. Regulatory guidelines indicate that the short form procedure be utilized in such circumstances. In this paper, we examine some of the ambiguities in the regulatory framework, the resulting need for institutional policy guidelines, and compliance issues with the short form process.
authors.affiliation: a Children's Hospital Los Angeles , Los Angeles , California , USA.
authors.forename: Pramod M
authors.initials: PM
authors.lastname: Lad
authors.forename: Rebecca
authors.initials: R
authors.lastname: Dahl
mesh_terms: D035843:Biomedical Research / Q000592:standards*; D003144:Communication Barriers; D005260:Female; D005568:Forms and Records Control; D017408:Guidelines as Topic; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence*; D007802:Language; D008297:Male; D011785:Quality Assurance, Health Care; D035842:Research Subjects; D035844:Researcher-Subject Relations; D014481:United States