Title

Operationalizing Research Compliance in the Healthcare Setting

Date of Award

3-18-2011

Document Type

Capstone Project

Disciplines

Healthcare Leadership

Degree Name

Master of Professional Studies

Department

Healthcare Leadership

Advisor

Michael Campo

Keywords

compliance; human subjects; research

Abstract

Healthcare organizations that engage in research or host research activities in their premises can be exposed to great risks and liabilities. In the higher- education academic setting, Research Compliance has been well established due to academe commitment to research. However, in healthcare organizations, Research Compliance oversight is fundamentally different, and often, not as coordinated as other operations within the system. Research Compliance must be operationalized upon development of the research program to protect healthcare organizations from non-compliance with regulatory requirements. In addition, a well-established structure promotes ethical research and enhances the organization's vision and mission. The following project looks at healthcare systems and proposes nine recommendations for an operational framework similar to a higher-education academic model of research integrity and compliance.

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