title: Audit of the informed consent process as a part of a clinical research quality assurance program.
abstract: Audits of the informed consent process are a key element of a clinical research quality assurance program. A systematic approach to such audits has not been described in the literature. In this paper we describe two components of the audit. The first is the audit of the informed consent document to verify adherence with federal regulations. The second component is comprised of the audit of the informed consent conference, with emphasis on a real time review of the appropriate communication of the key elements of the informed consent. Quality measures may include preparation of an informed consent history log, notes to accompany the informed consent, the use of an informed consent feedback tool, and the use of institutional surveys to assess comprehension of the informed consent process.
authors: Human Subjects Protection Program, Children's Hospital Los Angeles, 4650 Sunset Boulevard, Mailstop #23, Los Angeles, CA, 90027, USA, plad@chla.usc.edu.
authors: Pramod M
authors: PM
authors: Lad
authors: Rebecca
authors: R
authors: Dahl
mesh_terms: D035843:Biomedical Research / Q000941:ethics* / Q000592:standards; D003142:Communication; D032882:Comprehension; D026724:Ethical Review; D035082:Federal Government; D033161:Government Regulation; D006801:Humans; D007258:Informed Consent / Q000941:ethics* / Q000592:standards; D011786:Quality Control
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