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

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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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Authors and Affiliations

  1. Human Subjects Protection Program, Children’s Hospital Los Angeles, 4650 Sunset Boulevard, Mailstop #23, Los Angeles, CA, 90027, USA

    Pramod M. Lad & Rebecca Dahl

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  1. Pramod M. Lad
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  2. Rebecca Dahl
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Correspondence to Pramod M. Lad.

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Lad, P.M., Dahl, R. Audit of the Informed Consent Process as a Part of a Clinical Research Quality Assurance Program. Sci Eng Ethics 20, 469–479 (2014). https://doi.org/10.1007/s11948-013-9461-4

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  • DOI: https://doi.org/10.1007/s11948-013-9461-4

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