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Tytuł:
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Informed consent and compulsory medical device registries: ethics and opportunities.
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Autorzy:
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Kramer DB; Harvard Medical School, Boston, Massachusetts, USA .; Richard A. and Susan F. Smith Center in Outcomes Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
Parasidis E; The Ohio State University Moritz College of Law, Columbus, Ohio, USA.
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Źródło:
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Journal of medical ethics [J Med Ethics] 2022 Feb; Vol. 48 (2), pp. 79-82. Date of Electronic Publication: 2021 Feb 19.
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Typ publikacji:
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Journal Article; Research Support, Non-U.S. Gov't
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Język:
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English
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Imprint Name(s):
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Publication: <2004->: London : BMJ Publishing Group
Original Publication: London, Society for the Study of Medical Ethics.
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MeSH Terms:
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Ethics, Medical*
Informed Consent*
Humans ; Registries
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Contributed Indexing:
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Keywords: clinical ethics; ethics
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Entry Date(s):
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Date Created: 20210220 Date Completed: 20220202 Latest Revision: 20220202
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Update Code:
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20240105
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DOI:
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10.1136/medethics-2020-107031
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PMID:
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33608445
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Many high-risk medical devices earn US marketing approval based on limited premarket clinical evaluation that leaves important questions unanswered. Rigorous postmarket surveillance includes registries that actively collect and maintain information defined by individual patient exposures to particular devices. Several prominent registries for cardiovascular devices require enrolment as a condition of reimbursement for the implant procedure, without informed consent. In this article, we focus on whether these registries, separate from their legal requirements, have an ethical obligation to obtain informed consent from enrolees, what is lost in not doing so, and the ways in which seeking and obtaining consent might strengthen postmarket surveillance in the USA.
Competing Interests: Competing interests: This work was supported by the Greenwall Foundation.
(© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)
