IRB Operations Advanced Track

2019 AER Conference

A9 - The Etiquette and Necessity of Communication in the Single IRB World

Speaker(s)

• 

  John Heldens, CIP, CCRP
  

  IRB Director, University of Colorado Denver, Anschutz Medical Campus
  
• 

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

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

George Bernard Shaw stated, “the biggest problem in communication is the illusion that it has taken place,” which presaged one of the key challenges for single IRB review: how reviewing IRBs can effectively work with relying institutions and study teams to obtain and share the information necessary to ensure adequate oversight of a multi-site research study. When communication does not occur or go well, frustration, potential increase in research risks, and failure to provide new information to subjects can occur. Before attending this session, attendees should have some experience working with IRB reliance arrangements, either as a reviewing IRB or a relying institution. This session will use case studies to explore how institutions can work together proactively and collegially under the single IRB model by addressing critical components of communication. During this session, speakers and attendees will:

Learning Objectives:

• Review what local context information a reviewing IRB should collect, both about relying institutions and study implementation, how to tailor it for the study type, and mechanisms for retaining that information to reduce burdens on the rely
• Explore how to engage relying institutions so they address noncompliance and unanticipated problems (e.g., in the development of corrective action plans and reports to federal agencies and authorities)
• Determine when to reach out to relying institutions to obtain input on amendments
• Identify what information to include in approval notices or other documents to assist the relying institution with their oversight responsibilities
• Share writing policies that are accessible to and take into account the perspectives of relying institutions and relying site study teams
• Note: this session will be repeated on November 20, 10:00-11:15 AM.