Medical Devices: A Different Twist on the Ethics and Law of Research Protections

Wednesday, December 3, 2003 - 12:30pm to 2:00pm

Mississippi Room, Coffman Memorial Union

Most of the discussion on research ethics focuses on drug trials. Medical devices raise rather different issues. Using the AbioCor artificial heart as an example, this presentation explored how device trials can blur the lines between research, innovation, and treatment. They also can challenge accepted approaches to ethics and accountability in clinical research. Devices usually require surgical implantation, for example, which may add unpredictable elements of innovation and risk, posing special challenges for informed consent. And once the device is implanted, it is difficult for a subject to withdraw from a study. These and other factors raise distinctive problems in research with medical devices.


Ken Liebman, Esq.
Faegre & Benson


Prof. Susan Foote, JD
Division of Health Services Research & Policy, University of Minnesota 

E. Haavi Morreim, JD, PhD, is a Professor of Bioethics in the College of Medicine, University of Tennessee. She also has a joint appointment as Professor in the Division of Health Services and Policy Research, Department of Preventive Medicine. For 23 years, initially at the University of Virginia School of Medicine and thereafter at the University of Tennessee, she has done clinical teaching and consulting in medical ethics. She also chairs the Independent Patient Advocacy Council created to serve patients enrolled in the AbioCor artificial heart trial. She is on the editorial board of several journals, including IRB: Ethics and Human Research. Dr. Morreim is author of two books and over 100 publications in journals of law, medicine, and ethics, including the Journal of the American Medical AssociationArchives of Internal MedicineCalifornia Law ReviewHastings Center Report, and Wall Street Journal. Her first book, Balancing Act: the New Medical Ethics of Medicine's New Economics, first appeared in 1991 and was republished in paperback by Georgetown University Press in 1995. Her new book, Holding Health Care Accountable: Law and the New Medical Marketplace, was published by Oxford in 2001. 

December 3, 2003