title: Surgically implanted devices: ethical challenges in a very different kind of research.
abstract: Research on surgically implanted devices not only can raise issues familiar from drug studies, but also can raise special challenges. This article suggests some ways in which device trials can raise distinctive ethical issues. The AbioCor artificial heart trial is used as an example. Although this particular trial should not be deemed typical of surgically implanted device studies, it can highlight some particularly significant methodologic and ethical features.
authors.affiliation: College of Medicine, University of Tennessee Health Science Center, Memphis, TN 38163, USA. hmorreim@utmem.edu
authors.forename: E Haavi
authors.initials: EH
authors.lastname: Morreim
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics*; D018795:Device Approval; D017277:Drug Approval; D026690:Ethics, Clinical; D032984:Ethics, Research; D006353:Heart-Assist Devices / Q000941:ethics; D006801:Humans; D019736:Prostheses and Implants / Q000941:ethics*