Empirical Research Ethics Track

2019 AER Conference

Advanced

A03 - Ethics and Governance in Learning Healthcare Systems

Speaker(s)

• 

  Paul C. McLean

  Writing Faculty, Center for Bioethics, Harvard Medical School
  
• 

  Nancy E. Kass, ScD
  

  Phoebe R. Berman Prof. of Bioethics & Public Health, Berman Inst. of Bioethics; Prof., Dept. of Health Policy & Mgmt., Bloomberg School of PH, The Johns Hopkins University
  
• 

  Steven Joffe, MD, MPH
  

  Interim Chair, Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine
  Founders Professor of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine

The National Academy of Medicine defines learning healthcare systems as those in which "knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care." Learning healthcare systems bridge traditional boundaries between quality improvement and research, and so pose challenges for conventional regulatory frameworks. Based on the presenters' empirical work, this session will address the ethical challenges that such systems face, the governance mechanisms they have put in place, and the ways in which they might engage patients and families in governance and oversight. Before attending this session, attendees should be familiar with the regulations governing biomedical research in the United States in order to understand the challenges that learning healthcare systems pose. During this session, speakers and attendees will:

Learning Objectives:

• Describe the governance mechanisms that learning healthcare systems can use to ensure safe, high-quality, respectful learning
• Share how patients and families can contribute to governance of learning healthcare systems