Overcoming Language Barriers in the Informed Consent Process: Regulatory and Compliance Issues with the Use of the “Short Form”

TitleOvercoming Language Barriers in the Informed Consent Process: Regulatory and Compliance Issues with the Use of the “Short Form”
Publication TypeJournal Article
Year of Publication2014
AuthorsLad, PM, Dahl, R
JournalAccountability in Research: Policies & Quality Assurance
Volume21
Issue5
Pagination315-320
Date Published2014
Publication Languageeng
ISBN Number08989621
KeywordsAUDITING , Clinical , COMMUNICATION , Informed , IRB , Medical , NON-English , patient , quality , short
AbstractLanguage 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. 
NotesLad, Pramod M. 1; Dahl, Rebecca 1; Affiliations: 1: Children’s Hospital Los Angeles, Los Angeles, California, USA; Issue Info: Sep/Oct2014, Vol. 21 Issue 5, p315; Thesaurus Term: INFORMED consent (Law); Thesaurus Term: MEDICAL care; Thesaurus Term: QUALITY control; Thesaurus Term: AUDITING; Subject Term: COMMUNICATION barriers; Subject Term: NON-English speaking people; Subject Term: MEDICAL research; Subject Term: PATIENT compliance; Author-Supplied Keyword: auditing; Author-Supplied Keyword: clinical research; Author-Supplied Keyword: informed consent; Author-Supplied Keyword: IRB; Author-Supplied Keyword: quality assurance; Author-Supplied Keyword: short form; Number of Pages: 6p; Document Type: Article
URLhttps://ezproxy.gl.iit.edu/login?url=http://search.ebscohost.com/login.aspx?direct=true&db=buh&AN=94907570&site=ehost-livehttp://www.tandfonline.com/doi/abs/10.1080/08989621.2013.848801
DOI10.1080/08989621.2013.848801

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