IRB Operations Advanced Track

2019 AER Conference

Advanced

E09 - How IRBs Identify Research vs. Non-Research Risks—The Impact of the “Standard of Care” Concept

Speaker(s)

• 

  Sharon Ellison, PharmD
  

  Lead IRB Chair, Duke University Health System, Inc.
  Duke University
• 

  Anthony E. Magit, MD, MPH
  

  Medical Director, HRPP, University of California, San Diego
  Clinical Professor of Surgery, UC San Diego

The FDA and revised Common Rule regulations require IRBs to ensure research risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In addition, in evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). For both single site or multi-site research, identifying what research risks are can be challenging because the therapies a subject could receive may vary based on the standard of care within that institution or across organizations. In other words, the risks, benefits, and alternatives of research participation could be different for each subject. This variability in standard of care, especially under the single IRB model or for the review of comparative effectiveness research, can have significant pragmatic consequences, such as consent form content and risk level determination. Before attending this session attendees should have an understanding of the criteria for approval related to risks in research and be familiar with the concept of standard of care as it relates to research. During this session, speakers and attendees will:

Learning Objectives:

• Discuss the potential impact of the intersection between research and clinical care on the assessment of risks, benefits, and alternatives
• Debate whether "standard of care" is the appropriate standard to use for assessing research vs. non-research risks, or if other standards, such as usual practice or standard practice, are more appropriate
• Share strategies for addressing variability in standard of care under the single IRB model, such as at the protocol writing stage, and how to identify the variability for IRB assessment