IRB Operations Advanced Track

2019 AER Conference

Advanced

D09 - Ensuring IRB Compliance in a Hybrid World—Strategies for Operating in a World Where Multiple Regulatory Frameworks Apply

Speaker(s)

• 

  Martha Jones, MA, CIP
  

  Vice President, Human Research Affairs, Partners HealthCare System, Inc.
  
• 

  Megan Kasimatis Singleton, JD, MBE, CIP
  

  Assistant Dean, Human Research Protection; Director, HRPP, Johns Hopkins University School of Medicine
  

While the revised Common Rule permits organizations to transition their entire research portfolio to the revised Rule, many organizations have found this type of transition impractical and burdensome to researchers. Organizations that do not make a complete transition are now required to implement strategies for operating their IRBs in a world where two sets of regulatory criteria apply. Moreover, for organizations that must also comply with FDA regulations, a third set of regulatory criterion may apply. Challenges include appropriate identification and application of the correct regulatory framework to existing and new studies, ensuring IRB members and staff are aware of and appropriately apply the applicable criteria, and effectively communicating applicable requirements to study teams. This session will explore these challenges, identify potential compliance risks and offer solutions developed by two IRBs to address this hybrid world. Before attending this session, attendees should have an understanding of the requirements of the revised common rule and of the requirements for IRB record keeping including meeting minutes. During this session, speakers and attendees will:

Learning Objectives:

• Identify the challenges faced by IRBs operating under varied regulatory frameworks
• Understand how these challenges can create potential compliance risks for IRBs in performing and documenting their key responsibilities
• Consider examples of potential operational solutions and how to adapt them for their own HRPP