Department of Biostatistics Seminar/Workshop Series

QA or Research? Which is which, and why involve the IRB?

Christopher J. Lindsell, PhD

Research Assistant Professor
Research Director, Department of Emergency Medicine
University of Cincinnati

Wednesday, September 24, 2008; 1:45-2:55pm, MRBIII 1220

Intended Audience: Persons interested in applied statistics, statistical theory, epidemiology, health services research, clinical trials methodology, statistical computing, statistical graphics, R users or potential users

In many respects, the methods used for quality assessment and implementation of best practice initiatives are similar to research methods; it is clear that dissemination of best practice efforts in the peer-reviewed literature is imperative. Despite this growing focus to disseminate findings from quality initiatives, there is little clarity or guidance about how the regulatory requirements for human subjects research apply to quality improvement. The result is a confusing and controversial framework in which those responsible for quality initiatives must attempt to advance these critical efforts while remaining compliant with existing research regulations. Until there is additional guidance from regulatory authorities, we have no choice but to work closely with our Institutional Review Boards (IRB) to find solutions to complex oversight and consent requirements. This talk provides practical guidance about navigating the ethical regulatory environment of medical research as it pertains to quality improvement, with case studies illustrating solutions found at our institution.
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Topic revision: r1 - 09 Sep 2008, DianeKolb

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