Disclosure, consent, and the exercise of patient autonomy in surgical innovation: a systematic content analysis of the conceptual literature.
The classification of surgical innovation as clinical care, research, or as third distinct type of activity creates ambiguity which impacts standards for disclosure and informed consent. We conducted a systematic review of the conceptual literature to identify positions expressed about consent and disclosure, as well as major tension points associated with this issue. Literature overwhelmingly favors special consent and disclosure. Four major tension points were identified: the use of biasing/biased terminology to characterize innovation; patient vulnerability; the relationship between surgeon-innovator and patient; and practices and associated gaps related to consent and disclosure. Recommendations often focused on the informed consent process.
a Neuroethics Research Unit , Institut de recherches cliniques de Montréal (IRCM) , Montreal , Quebec , Canada.
Dearbhail
D
Bracken-Roche
Emily
E
Bell
Lila
L
Karpowicz
Eric
E
Racine
D003657:Decision Making; D030881:Disclosure; D006801:Humans; D007258:Informed Consent; D062069:Inventions / Q000941:ethics; D010361:Patients / Q000523:psychology; D013514:Surgical Procedures, Operative / Q000941:ethics*
autonomy; neuroethics; neurosurgery; surgical innovation