|View Video Online Duration: 90 min|
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.