Audit of the Informed Consent Process as a Part of a Clinical Research Quality Assurance Program

Science and Engineering Ethics 20 (2):469-479 (2014)

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
Keywords IRB  Good clinical practice  Auditing  Clinical research  Quality assurance  Monitoring  Informed consent
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DOI 10.1007/s11948-013-9461-4
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References found in this work BETA

Responsible Conduct of Research.Adil E. Shamoo - 2009 - Oxford University Press.
Is Patients' Time Too Valuable for Informed Consent?Arthur R. Derse - 2007 - American Journal of Bioethics 7 (12):45 – 46.

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