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2012 HSR&D/QUERI National Conference Abstract

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2012 National Meeting

3061 — Toward Ethical Oversight of Implementation Projects: The VAIL Model

Darling JESimon BF, and Stockdale SE, COE Sepulveda; Yano EM, COE Sepulveda, UCLA; Simon AR, COE Sepulveda; Rubenstein LV, COE Sepulveda, UCLA, RAND;

Objectives:
The VAIL PACT Demonstration Laboratory aims to develop a sustainable model that encompasses ethical oversight aligned with the aims and goals of QI innovation and implementation. As a QI Implementation project, VAIL faces a common ethical dilemma - the need to facilitate and support QI innovations while narrowing the ethical gap in QI oversight. VAIL employed a two-pronged approach: (1) determine when QI innovations overstep the border between operations and research; and (2) detect potential harm to patients, providers, and the delivery system.

Methods:
The VAIL approach involves obtaining IRB agreement for VAIL to operate as an administrative umbrella program, and establishing a structure for separate review of VAIL operations (VAIL QI) and research (VAIL Evaluation) under separate IRB protocols. VAIL obtains an IRB administrative determination of non-research that includes VAIL QI innovations. The VAIL determination creates a pathway for VAIL innovations needing rapid IRB administrative review to clarify QI status, satisfy publication requirements, access VA-sensitive data, or other administrative purposes. At the IRB’s request, VAIL developed a QI review form for these purposes. VAIL also facilitates the formation of a regional (VISN) level, multi-disciplinary deliberative body. This body reviews innovations and detects unintended harm and system impact, and provides guidance to innovation teams through local primary care leadership councils.

Results:
All VAIL innovations were covered under the VAIL QI determination of non-research without additional review. Several VAIL innovation leaders have requested rapid administrative IRB determination to confirm QI status, satisfy journal requirements, or access VA patient data. A deliberative body has been formed to discuss the potential impact of VAIL innovations, generate its charter and determine group composition and roles.

Implications:
The VAIL approach to oversight of QI implementation projects, through partnering with both the IRB and VISN leadership, provides an innovative model that encompassed the entire spectrum of oversight needed for the ethical conduct of implementation projects aligned, with quality improvement goals.

Impacts:
Creating a low-burden IRB review process for quality improvement projects reduces the potential for regulatory non-compliance while fostering rapid QI implementation. Establishing a deliberative body to detect unintended consequences may protect stakeholders at all levels from potential harm.


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