Research involving human subjects is much more stringently regulated than many other nonresearch activities that appear to be at least as risky. A number of prominent figures now argue that research is overregulated. We argue that the reasons typically offered to justify the present system of research regulation fail to show that research should be subject to more stringent regulation than other equally risky activities. However, there are three often overlooked reasons for thinking that research should be treated as a (...) special case. First, research typically involves the imposition of risk on people who do not benefit from this risk imposition. Second, research depends on public trust. Third, the complexity of the moral decision making required favors ethics committees as a regulative solution for research. (shrink)

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. (shrink)

In this chapter, our focus is the role played by notions of rationality in the diagnosis of mental disorders, and in the practice of overriding patient autonomy in psychiatry. We describe and evaluate different hypotheses concerning the relationship between rationality and diagnosis, raising questions about what features underpin psychiatric categories. These questions reinforce widely held concerns about the use of diagnosis as a justification for overriding autonomy, which have motivated a shift to mental incapacity as an alternative justification. However, this (...) approach too has recently been criticized from a mental disability rights perspective. Our analysis of the relationship between mental capacity and rationality is used to illuminate these concerns, and to investigate further the relationship between rationality and psychiatric diagnosis. (shrink)