As research designs change, so too do their ethical implications. In recent years pragmatic clinical trials use study designs intended to test real-world interventions on a large scale in health systems. These have emerged as one promising approach to balance rigor and relevance in practice-based research. As that science has developed a body of literature addressing the ethical implications of that research has also emerged, raising questions about several dimensions of that research including risk-benefit ratio, autonomous authorization, and scientific validity. Please join us for a Biomedical Ethics and Humanities Grand Rounds that will examine practical, regulatory, and ethical dimensions of pragmatic clinical trials in a panel conversation. 

We’ll be joined by a leading Mayo Clinic expert in pragmatic trials, Dr. Andrea Cheville, Professor of Physical Medicine and Rehabilitation and lead investigator of numerous NIH-funded pragmatic trials; the chair of the Mayo Clinic IRB, Dr. Scott Wright, Professor of Medicine, Consultant in Cardiology and the Director of the Mayo Clinic Human Research Protection Program and Senior Chair and Medical Director of the Mayo Clinic Institutional Review Board; and Dr. Jon Tilburt, Professor of Medicine and Biomedical Ethics. Together, the panel will share their practical experience in discerning the ethical implications of pragmatic trials, discuss the terminology surrounding those discussions, and discuss how to think about human subjects protection more broadly for research being conducted in the usual course of care. Dr. Richard Sharp, the  Lloyd A. and Barbara A. Amundson Professor of Biomedical Ethics will moderate the conversation. Please join us for an engaging conversation. 

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TRANSCRIPT
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