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IRB Operations Advanced Track
2019 AER Conference
Advanced
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: