Hot Topics Track (SBER)

2019 SBER Conference

B06 - Reliance—SBER Specific Issues

Speaker(s)

• RD

  Robleinscky Isabel Dominguez, BS, CIP
  

  IRB Reliance Specialist, Boston Children's Hospital
  
• 

  Carissa Minder, RN, BSN, MS, CIP, CCRP
  

  Manager of Single IRB Services , Washington University in St. Louis
  
• AH

  Ashley D. Hicks, CIP
  

  Manager of Operations, Social, Behavioral, & Educational Research IRB , Tufts University
  

This session will review regulatory considerations, as well as the specific ethical issues that arise when negotiating and executing reliance agreements in SBER contexts between ceding institutions and central or single IRBs. During this session, speakers and attendees will:

Learning Objectives:

• Discuss issues of local context and institutional knowledge as it pertains to ceding review to another IRB in SBER studies
• Review what an institution is responsible for when it is not the IRB of record, but remains charged with ensuring proper conduct of the study at their site and without the benefits biomedical research boards often receive from other oversight bodies (e.g., Data and Safety Monitoring Boards, Contract Research Organizations, etc.)
• Outline the issues that arise when ancillary reviews are required outside of IRB review, and learn strategies for handling them
• Learn about the challenges that arise when SBER and biomedical institutions collaborate in a ceded review arrangement