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Institutional Officials and HRPP Leadership Track
2019 AER Conference
Advanced
Megan Kasimatis Singleton, JD, MBE, CIP
Assistant Dean, Human Research Protection; Director, HRPP, Johns Hopkins University School of Medicine
Hallie Kassan, MS, CIP
Director, HRPP, Northwell Health
Greg E. Manship, DBe, MDiv, CIP, CIM
Manager, Human Subject Protection Program (HSPP), OSF HealthCare
The focus of this session is to address the regulatory, structural, and operational challenges facing organizations that have multiple facilities (e.g., a multi-hospital system, a multi-facility academic medical center, etc.) that are engaged in human subjects research. These challenges are exacerbated by simplification and centralization of organizational structures, such as a single, organization-wide Federalwide Assurance (FWA), no internal IRB, and a centralized HRPP. Such organizations have the added challenge of establishing and maintaining local research oversight programming in order to meet expectations of external IRBs and fulfill FWA responsibilities. This session will bring together experiences and resources from various institutions to provide information and materials that equip institutions to develop, implement, and assess local research oversight programming. Before attending this session, attendees should have proficiency with FWA responsibilities, requirements, and maintenance; working with external IRBs (e.g., reliance agreements, master service agreements, etc.); and at least two years working as HRPP staff/administration in a multi-facility organization. During this session, speakers and attendees will: