Flexibility and Innovation in IRB Processes Track

2019 AER Conference

B01 - Standard of Care, Medical Innovation, or Research—How Should We Decide?

Speaker(s)

• 

  Alexander M. Capron, LLB, MA (Hon).
  

  University Professor; Scott H. Bice Chair in Healthcare Law, Policy and Ethics, Gould School of Law; Professor of Medicine and Law, Keck School of Medicine; Co-Director, Pacific Center for Health Policy and Ethics, University of Southern California
  Scott H. Bice Chair in Healthcare Law, Policy and Ethics, Gould School of Law; Professor of Medicine and Law, Keck School of Medicine; , University of Southern California
• 

  Robert W. Frenck, Jr., MD
  

  Executive Chair IRB and Professor Division of Infectious Diseases, Cincinnati Children’s Medical Center
  Professor, Department of Pediatrics, University of Cincinnati
• 

  Michele Russell-Einhorn, JD
  

  Chief Compliance Officer and Institutional Official, Advarra
  

A frequent regulatory issue is whether a practice conducted by a physician or an institution, when consistently practiced in that institution, but novel and not yet adopted by the community, counts as medical innovation or research. For example: when a physician or group of physicians want to collect data on their consistently provided, but unique/novel practice (i.e., this practice "would be provided anyway" to their patients), is this standard of care, medical innovation, or research? If it is research, how should it be reviewed? This issue is important as it comes up frequently in IRB review, although it may be addressed differently by IRBs. This session will present the issue, discuss potential ways of addressing it, and attempt to problem solve the best treatment of these common situations. This session will make heavy use of active learning techniques, such as small group work, case studies, hands-on activities, and interactive discussion, and presumes sufficient experience and understanding to actively contribute to the discussion of and solution to these problems. This session will not review basic concepts. During this session, speakers and attendees will:

Learning Objectives:

• Recognize how standard of care, medical innovation, and research are highly intertwined in medical contexts
• Analyze a case(s) where an IRB is faced with the decision of how to regulate a particular study, and the strengths and weaknesses of different approaches
• Suggest best practices when faced with this type of situation