Institutional Officials and HRPP Leadership Track

2019 AER Conference

Advanced

E20 - Who's Minding the Store? Local Oversight of Research Without an IRB

Speaker(s)

• 

  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:

Learning Objectives:

• Identify the "pros" and "cons" of FWA and HRPP consolidation in multi-facility organizations
• Recognize policy, procedural, and structural challenges to providing local research oversight in facilities that do not have an IRB and/or HRPP presence
• Develop strategies for creating and implementing local research oversight programming