Surgical innovation as sui generis surgical research
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Surgical innovation as sui generis surgical research Mianna Lotz
Published online: 16 November 2013 Springer Science+Business Media Dordrecht 2013
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. Keywords Surgical research Research Surgical innovation Medical experimentation Ethics Ethics Review Knowledge transfer Innovation Surgery
Introduction Successful innovative ‘leaps’ in surgical technique can contribute exponentially to surgical advancement and, thereby, to improved health outcomes for patients. Such M. Lotz (&) Department of Philosophy, Building W6A, Macquarie University, Balaclava Road, North Ryde, Sydney, NSW 2109, Australia e-mail: [email protected]
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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 explorations. It is this feature that is generally thought to make early-stage surgical innovation resistant to classification as ‘research’, given the attendant methodological and ethical obligations—of planning, regulation, monitoring, reporting, and publication—associated with that classification. Yet, there are compelling grounds—both conceptual and ethical—for proposing that innovation in surgical technique might, in fact, be usefully classified as a form of surgical ‘research’, albeit of a sui generis kind. This paper considers the foundations and implications of adopting a ‘sui generis research’ classification for surgical innovation. While my initial goal is purely conceptual, the arguments in this paper provide the necessary foundation on which specific forms and mechanisms of ethical review and oversight can in future be developed, so as to be amenable to the complexities of innovation in surgi
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