Back to Annual Meeting Page		American Public Health Association 133rd Annual Meeting & Exposition December 10-14, 2005 Philadelphia, PA

Abstract #107753

Mary Ann Baily, PhD, The Hastings Center, 21 Malcolm Gordon Road, Garrison, NY 10524, 845-424-4040 Ext. 200, bailym@thehastingscenter.org

Quality improvement (QI) refers to a broad range of systematic, data-guided activities designed to improve clinical practice. Because QI activities may have elements in common with research, there is uncertainty about whether they require IRB review to ensure that they are conducted ethically and patients affected by them receive appropriate protection. To help resolve the uncertainty, the Hastings Center received AHRQ funding to develop a conceptual framework for the ethical conduct of QI. We convened an interdisciplinary group of experts, and began by comparing and contrasting three kinds of overlapping activities – clinical practice, QI, and research. We then looked at the accepted ethical requirements for research, asked to what extent they applied to QI, and from that analysis drew conclusions about the type of ethical review and oversight that made conceptual sense for QI. The final step was to develop practical strategies for implementing this kind of ethical oversight. The presentation will describe the conceptual framework and the practical recommendations that have resulted from the project, using case examples of QI activities to discuss the kind of review that is appropriate.

Learning Objectives:

• Explain the nature of the current uncertainty about the role of IRBs in the ethical review of QI activities.
• Describe the conceptual framework developed for the ethical conduct of QI and explain how it differs from the framework generally accepted for research.
• Summarize the practical recommendations for ethical oversight of QI derived from the conceptual framework for ethical conduct of QI.

Keywords: Quality Improvement, Research Ethics

Presenting author's disclosure statement:

I wish to disclose that I have NO financial interests or other relationship with the manufactures of commercial products, suppliers of commercial services or commercial supporters.

Recorded presentation