Surgical innovation as sui generis surgical research

Mianna Lotz*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

6 Citations (Scopus)

Abstract

Successful innovative 'leaps' in surgical technique have the potential to contribute exponentially to surgical advancement, and thereby to improved health outcomes for patients. Such innovative leaps often occur relatively spontaneously, without substantial forethought, planning, or preparation. This feature of surgical innovation raises special challenges for ensuring sufficient evaluation and regulatory oversight of new interventions that have not been the subject of controlled investigatory exploration and review. It is this feature in particular that makes earlystage surgical innovation especially resistant to classification as 'research', with all of the attendant methodological and ethical obligations - of planning, regulation, monitoring, reporting, and publication - associated with such a classification. This paper proposes conceptual and ethical grounds for a restricted definition according to which innovation in surgical technique is classified as a form of sui generis surgical 'research', where the explicit goal of adopting such a definition is to bring about needed improvements in knowledge transfer and thereby benefit current and future patients.

Original languageEnglish
Pages (from-to)447-459
Number of pages13
JournalTheoretical Medicine and Bioethics
Volume34
Issue number6
DOIs
Publication statusPublished - Dec 2013

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