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 early-stage 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.
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Notes
Buxton is also cited with addition in Barkun et al. [3, p. 1092]. Buxton was referring to the transition from an initial point in the life of a technology (when adoption by surgeons is low, and formalized assessment is possible but innovation might not yet have been perfected) to the subsequent point at which uptake into society suddenly increases and involves an irrevocably large number of adopters. At this point, proper evaluation will rarely be successful or even feasible.
An important question exists as to whether the concept ‘innovation’ should be understood as a neutral concept or whether success is a necessary and, therefore, intrinsic property of any surgical intervention able to be classified as ‘innovative’. That is, is it appropriate to classify failed attempts at innovation as examples of ‘innovation’ at all? The definition of innovation is, in fact, a complex matter. Most centrally, any intervention classifiable as ‘innovative’ must be, in some sense, new; but even determining what counts as ‘new’ is not straightforward (e.g., does ‘new’ require that an intervention be performed for the first time in the world? Or is ‘new to country’ or ‘new to institution’ or even ‘new to surgeon’ sufficient to qualify an intervention as innovative?). In addition, to count as an innovation, an intervention would need to constitute a significant departure from existing standard practice. Again, however, determining what counts as a sufficiently ‘significant’ departure proves to be challenging. As important as the task of defining innovation is, however, this paper does not seek to address the challenges associated with providing such a definition. That task is the subject of other research; see, e.g., Wendy Rogers et al. [5], which provides a more detailed discussion of the definition of innovation, on which my comments here draw. For my purposes in this paper, I adopt a neutral definition, according to which the concept ‘innovation’ encompasses both those departures from standard practice that are ultimately successful and those that are not. But to defend that adoption requires arguments that lie beyond the scope of the present paper. I wish to thank an anonymous reviewer of this journal for pointing out the need for this clarification.
I here set aside the use of animal models (Stage 0), as these will typically be subject to review by an animal ethics review board or committee.
Bortolotti and Heinrichs adopt an approach that differs from mine; they propose that for an activity to count as a research activity, it must be mainly aimed at extending a body of knowledge. Thus, they argue that ‘the class of activities raising ethical issues and needing ethical regulation does not coincide with the class of activities that count as research’, emphasizing that any activity that puts patients at risk is as ethically problematic as a research activity, and hence is properly subject to ethical review [11, p. 173]. They themselves complicate this picture, however, in their discussion of activities that combine research and therapeutic goals, of which I would nominate surgical innovation to be a paradigmatic example.
A more detailed analysis is required of how such an online registry would be structured, how it would function and be implemented and accessed. It is also worth noting that it might be impractical to propose such a registry before one has been implemented to report the results of surgical innovations that have been formally designated as ‘research’ by the surgeons who conduct them, and that have even undergone research ethics review by an appropriate body but are not designed as randomized clinical trials and, therefore, are not subject to the general reporting requirements for such trials. However, these are applied rather than conceptual questions, and as such, they are beyond the scope of my purely conceptual aims in this paper. (I wish to thank an anonymous reviewer and this journal’s editor(s) for highlighting the importance of these practical questions.)
In particular, anonymous incident reporting mechanisms, such as are implemented worldwide within the aviation industry, provide useful models. See, for example, the online Australian Aerosafe Anonymous Report system used by members of the Aviation Safety Network [17].
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Lotz, M. Surgical innovation as sui generis surgical research. Theor Med Bioeth 34, 447–459 (2013). https://doi.org/10.1007/s11017-013-9272-2
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DOI: https://doi.org/10.1007/s11017-013-9272-2