Kirstin Borgerson

When the editorial to the first philosophy thematic edition of this journal was published in 2010, critical questioning of underlying assumptions, regarding such crucial issues as clinical decision making, practical reasoning, and the nature of evidence in health care, was still derided by some prominent contributors to the literature on medical practice. Things have changed dramatically. Far from being derided or dismissed as a distraction from practical concerns, the discussion of such fundamental questions, and their implications for matters of practical import, is currently the preoccupation of some of the most influential and insightful contributors to the on‐going evidence‐based medicine debate. Discussions focus on practical wisdom, evidence, and value and the relationship between rationality and context. In the debate about clinical practice, we are going to have to be more explicit and rigorous in future in developing and defending our views about what is valuable in human life.

Most people working in bioethics will be familiar with Susan Sherwin's contributions to the field. There is much to be said about the value and importance of Sue's contributions to feminist theory and practice, but in this reflective piece I am going to focus on the experience of teaching Sue's work. This is for three reasons: the first is that I was hired into the Philosophy Department at Dalhousie just as Sue retired and I teach many of the courses she developed, so her philosophical legacy and teaching are intimately related for me. Second, in my observations of Sue's interactions with graduate students (she...

Arguments in favor of greater research-practice integration in medicine have tended to be ethical, political, or pragmatic. There are good epistemic reasons to pursue greater integration, and it is important to think through these reasons in order to avoid inadvertently designing new systems in ways that replicate the epistemic elitism common within current systems. Meaningful transformation within health care is possible with close attention to all reasons in favor of greater research-practice integration, including epistemic reasons.

Clinical research has at least three problematic features: it tends to be redundant, secretive, and isolated.1 Research with these features not only wastes resources and causes harm, it also fails to meet a basic ethical requirement of research: scientific validity. As bioethicists, we should be asking why, if research with these three features is ethically unjustified, it has been so routinely approved by research ethics committees over the past half century. In what follows, I provide one answer to this question. The first section of this paper outlines empirical evidence for the redundant, secretive, and isolated nature of much contemporary clinical research. Next, I argue that a lack of clarity..

The volume of clinical research is increasing exponentially—far beyond our ability to process and absorb the results. Given this situation, it may be beneficial to consider reducing the flow at its source. In what follows, I will motivate and critically evaluate the following proposal: researchers should conduct fewer clinical trials. More specifically, I c onsider whether researchers should be permitted to conduct only clinical research of very high quality and, in turn, whether research ethics committees should prohibit all other, lower-quality research, even when it might appear to meet some minimal ethical standard. Following a close analysis of the social-value requirement of ethical clinical research, I argue that this proposal is defensible. The problem identified in this paper has two parts, quantity and quality, and some clarification is needed about the latter because “quality” is a highly contested term in the medical literature. When some scholars advocate for high-quality trials, they mean large-scale, simple, explanatory randomized controlled trials. Others, including myself, have defended a different characterization of high-quality research that tends more toward pragmatic trial design and the use of methods other than RCTs. Pragmatic trials aim to provide evidence that directly supports clinical decision-making in “usual” care settings. Unlike explanatory trials, which aim to abstract away from particular settings and patients, in the hopes of creating ideal conditions for the success of an intervention, pragmatic trials deliberately pursue knowledge of high applicability, through the use of representative subjects, clinically important questions, flexible treatment protocols, patient-oriented outcome measures, and so on. I see applicability as a marker of high-quality research. The context in which research is meant to be applied should be the context in which new interventions are evaluated.

Most phase III clinical trials today are explanatory. Because explanatory, or efficacy, trials test hypotheses under “ideal” conditions, they are not well suited to providing guidance on decisions made in most clinical care contexts. Pragmatic trials, which test hypotheses under “usual” conditions, are often better suited to this task. Yet, pragmatic, or effectiveness, trials are infrequently carried out. This mismatch between the design of clinical trials and the needs of health care professionals is frustrating for everyone involved, and explains some of the challenges inherent in attempts to enhance knowledge translation and encourage evidence-based practice. The situation is more than simply frustrating, however; it is potentially unethical. Clinical trials must be socially valuable in order to (1) warrant the risks they impose on human research subjects and (2) fairly and efficiently assess new clinical interventions. Most bioethicists would agree that trials that have no social value, for instance, because their results do not have the potential to advance clinical care, should not be performed. What is less widely appreciated is that given limited research resources, trials that are more socially valuable should be preferred to trials that are less socially valuable when all else is equal. With respect to clinical trial design, I argue that while explanatory trials often have some social value, many have less social value than their pragmatic counterparts. On the basis of this general ethical assessment, I provide a preliminary defense of the position that clinical researchers should aim to conduct pragmatic trials, that is, that researchers face a burden of justification related to any idealizing elements added to trial designs.

Amending and Defending Critical Contextual Empiricism: Lessons from Medical Research In Science as Social Knowledge (1990) and The Fate of Knowledge (2002), Helen Longino develops a social epistemological theory known as Critical Contextual Empiricism (CCE). While Longino’s work has been generally well-received, there have been a number of criticisms of CCE raised in the philosophical literature in recent years. In this paper I outline the key elements of Longino’s theory and propose several modifications to the four norms offered by the account. The revisions I propose are shaped by a number of developments in the medical context in recent years. The modified norms, which determined whether a particular community produces objective knowledge, are thus: 1. Avenues for Criticism – there must be recognized avenues for criticism, and these avenues must be publicly accessible and require transparent disclosure of all relevant information (including competing interests) from those who present their ideas. It must also be a community requirement that all members present their ideas for critical scrutiny if they wish them to be recognized as knowledge. 2. Responsiveness to Criticism – the community must be responsive to criticism. 3. Shared Public Standards – there must be some shared standards that determine community membership. Outsiders to a particular community are welcome to engage in critical debates as long as they share at least one of the community standards with the target community. 4. Cultivation of Diverse Perspectives – communities must cultivate diverse perspectives, that is, the perspectives of those who express strong dissent. The version of CCE I defend gives the principle of diversity a more central role than the original and provides greater specification of two of the other norms in light of challenges faced by medical researchers in recent years. The medical context provides us with a number of cautionary tales in which knowledge production that appears to meet the original four norms has been seriously compromised by particular social interests. The proposed modifications attempt to address these ‘loopholes’ in a way that is not ad hoc. I argue that the modifications I suggest are in line with the underlying assumptions and goals of CCE. The modified version of CCE also offers resources for defending CCE against the criticisms leveled against it by Miriam Solomon & Alan Richardson, Alvin Goldman and Philip Kitcher as well as one general concern arising out of a recent work by David Michaels. I provide responses to these criticisms in the final section of the paper. Throughout the paper I connect the theoretical work done in social epistemology to the real practice of knowledge-production as is occurs in the medical context. In light of the variety of social pressures influencing contemporary scientific research, and the role of science in shaping public policy, I argue that a rigorous social epistemology such as CCE is indispensable for understanding and assessing contemporary scientific practice.

Proponents of evidence-based medicine have recently suggested a “4S” approach to clinical decision making in which physicians are advised to rely on increasingly abstract summaries of the available research evidence. This retreat from the original data of medical research is ill-advised: it extends an unjustified evidence hierarchy, overestimates the role of computer systems, divides communities, discards evidence, ignores contexts, and devalues broad critical evaluation. I draw upon feminist social epistemology to evaluate the 4S approach to EBM and to suggest means for improving the evidence base of medical research and practice.

In Science as Social Knowledge in 1990 and The Fate of Knowledge in 2002, Helen Longino develops an epistemological theory known as Critical Contextual Empiricism (CCE). Knowledge production, she argues, is an active, value-laden practice, evidence is context dependent and relies on background assumptions, and science is a social inquiry that, under certain conditions, produces social knowledge with contextual objectivity. While Longino’s work has been generally well-received, there have been a number of criticisms of CCE raised in the philosophical literature in recent years. In this paper I outline the key elements of Longino’s theory and propose modifications to the four norms offered by the account. The version of CCE I defend, which draws on lessons learned by medical researchers in recent years, gives principles of epistemic diversity a central role and also provides greater specification of three of the four norms. Further, it offers additional resources for defending CCE against Alvin Goldman’s suggestion that there is a need for a “healthy dogmatism” in science, as well as a concern about “manufactured uncertainty” arising out of recent work by David Michaels. Finally, the modified version proposed here is also well positioned to respond (negatively) to a suggestion from Kristen Intemann that CCE needs to be adapted to incorporate a central insight from feminist standpoint theory. In light of the variety of social pressures influencing contemporary scientific research, and the role of science in shaping public policy, I argue that a rigorous social epistemology such as CCE is indispensable for understanding and assessing contemporary scientific practice.