Isabella Carnovale

Spontaneous surgical innovation (SSI) is surgical innovation that occurs in response to an intraoperative emergency, where standard approaches are either unknown to the surgeon or not available. But whereas the ethics and appropriate oversight of planned surgical innovation have been discussed in some detail in the literature, SSI has been neglected. There are various reasons for this, mainly that questions concerning the ethics and oversight of surgical innovation tend to focus on the period preceding the performance of a surgical innovation (eg, questions about informed consent for an innovative procedure). Because SSI happens without any prior planning and cannot be anticipated, these preoperative steps or oversight measures cannot be applied. As such, SSI poses a unique challenge both to the ethics and epistemology of surgical innovation. There are many questions that are raised by SSI. These might include how surgeons make decisions to pursue it, when/how it is justified, what kinds of ethical obligations the surgeon might have when they engage in SSI and when/where these obligations might end. SSI can provide surgeons with significant epistemic gains and has the potential to contribute to important advancements in surgery. In this paper, I will provide a more detailed account of what SSI is and discuss some of the ethical and epistemic implications of SSI.

Health technology assessments (HTA) and related decision making by regulators, payers and clinical policymakers (henceforth HTA-DM) are not simply technical processes, but normative ones, shaped by economic, moral, and scientific values. Since these value-laden decisions affect consumers, it is broadly accepted that their values need to be taken into consideration in HTA-DM and that they should be actively engaged in some aspects of these processes. This paper begins by examining current approaches to consumer engagement in HTA-DM. We then identify key challenges inherent in meaningful consumer participation, including procedural obstacles, representation issues, and difficulties in values interpretation. After briefly reviewing existing responses to these challenges, we demonstrate how insights from the philosophy of science—particularly scholarship on values in scientific inquiry—can provide new insights into the challenges of integrating consumers’ values into HTA-DM and offer some strategies for more targeted and effective consumer involvement.