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
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Keywords | IRB Good clinical practice Auditing Clinical research Quality assurance Monitoring Informed consent |
Categories | (categorize this paper) |
ISBN(s) | |
DOI | 10.1007/s11948-013-9461-4 |
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References found in this work BETA
Beyond Informed Consent: The Therapeutic Misconception and Trust.Inmaculada de Melo-Martin & A. Ho - 2008 - Journal of Medical Ethics 34 (3):202-205.
Is Patients' Time Too Valuable for Informed Consent?Arthur R. Derse - 2007 - American Journal of Bioethics 7 (12):45 – 46.
Citations of this work BETA
Application of the Rapid Ethical Assessment Approach to Enhance the Ethical Conduct of Longitudinal Population Based Female Cancer Research in an Urban Setting in Ethiopia.Alem Gebremariam, Alemayehu Worku Yalew, Selamawit Hirpa, Abigiya Wondimagegnehu, Mirgissa Kaba, Mathewos Assefa, Israel Mitiku, Eva Johanna Kantelhardt, Ahmedin Jemal & Adamu Addissie - 2018 - BMC Medical Ethics 19 (1):87.
Why ‘Understanding’ of Research May Not Be Necessary for Ethical Emergency Research.Dan Kabonge Kaye - 2020 - Philosophy, Ethics, and Humanities in Medicine 15 (1):1-8.
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