Institutional Officials and HRPP Leadership Track

2019 AER Conference

Advanced

C06 - Not Less Work, but Different—Re-Engineering for Single IRB (sIRB) Review

Speaker(s)

• 

  Megan Kasimatis Singleton, JD, MBE, CIP
  

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

  Kimberly K. Summers, PharmD
  

  Director, Research Protection Programs; Adjoint Assistant Professor, University of Texas Health San Antonio
  

As institutions adapt to the brave new world of sIRB review, HRPPs/IRBs face new challenges. The shift to sIRB review required by NIH policy and the revised Common Rule offers the opportunity to rethink and reconfigure approaches to research oversight. This session will tease apart institutional and IRB roles when using a sIRB, as well as highlight potential approaches to fulfilling the role of a relying organization. The potential pros/cons of various models will be discussed. Attendees are expected to have sufficient experience and understanding to actively contribute to the discussion. This session will not review basic concepts. Institutional officials and HRPP leaders responsible for establishing HRPP approaches to sIRB review requirements are encouraged to attend. During this session, speakers and attendees will:

Learning Objectives:

• Delineate the distinct roles for reviewing IRBs and relying institutions by identifying and separating appropriate (non-IRB) responsibilities of institutions from functions that are, by regulation, within the purview of the IRB
• Identify different models that may be adopted by institutions to effectively support single IRB review processes as a relying organization
• Use case examples to explore the pros/cons of various approaches to upholding the organizational responsibilities under a sIRB review model