In this paper, we defend the ethics of clinical research against the charge of paternalism. We do so not by denying that the ethics of clinical research is paternalistic, but rather by defending the legitimacy of paternalism in this context. Our aim is not to defend any particular set of paternalistic restrictions, but rather to make a general case for the permissibility of paternalistic restrictions in this context. Specifically, we argue that there is no basic liberty-right to participate in clinical (...) research and that considerations of distributive fairness justify some paternalistic protections of research subjects. (shrink)

Temkin presents a new way of thinking about equality and inequality that challenges the assumptions of philosophers, welfare economists, and others, and has significant implications on both a practical and theoretical level.

In her recent, provocative essay “What Is the Point of Equality?”, Elizabeth Anderson argues against a common ideal of egalitarian justice that she calls “ luck egalitarianism” and in favor of an approach she calls “democratic equality.”1 According to the luck egalitarian, the aim of justice as equality is to eliminate so far as is possible the impact on people’s lives of bad luck that falls on them through no fault or choice of their own. In the ideal luck egalitarian (...) society, there are no inequalities in people’s life prospects except those that arise through processes of voluntary choice or faulty conduct, for which the agents involved can reasonably be held responsible. Anderson asserts that the adherents of luck egalitarianism, which can be elaborated in many different ways, include John Roemer, Erik Rakowski, Thomas Nagel, Ronald Dworkin, Gerald Cohen, Richard Arneson, and Philippe Van Parijs.2 In contrast, according to the democratic equality conception, justice as equality requires an end to oppressive social relationships. In the ideal society of democratic equality, the social conditions of everyone’s freedom are secured, each stands to every other in a relationship of fundamental equality, including equal respect, and all have real freedom to participate in democratic self-government. (shrink)

"Cluster randomized trials," in which groups of patients are randomly assigned to different therapeutic interventions, provide a powerful way of evaluating drugs. CRTs have not been widely used, in good part because of concerns about whether patients must give informed consent to participate in them. A better understanding of how CRTs fit into clinical practice resolves the concerns.

Jansen and Wall suggest a new way of defending hard paternalism in clinical research. They argue that non-therapeutic research exposing people to more than minimal risk should be banned on egalitarian grounds: in preventing poor decision-makers from making bad decisions, we will promote equality of welfare. We argue that their proposal is flawed for four reasons.First, the idea of poor decision-makers is much more problematic than Jansen and Wall allow. Second, pace Jansen and Wall, it may be practicable for regulators (...) to uncover the values that a potential research participant holds when agreeing to enter a research project, so their claim that we must ban such research projects for all if we are to ban them for poor decision-makers looks to be unmotivated. Third, there seem to be cases where the liberty to enter the sort of research project Jansen and Wall discuss is morally weighty, and arguably should outweigh concerns of egalitarian distribution. Fourth, banning certain types of research, which seem on the face of it to offer an unfavourable risk-benefit ratio, would have unwelcome consequences for all clinical research, which Jansen and Wall do not recognize. (shrink)

It is commonly believed in research ethics that some form of equipoise is a necessary condition for justifying randomized clinical trials, that without it clinicians are violating the moral duty to do what is best for the patient. Recent criticisms have shown how complex the concept of equipoise is, but often retain the commitment to some form of equipoise for randomization to be justified. This article rejects that claim. It first asks for what one should be equally poised (scientific or (...) clinical equipoise), then asks who should be equally poised (scientist, clinician, or subject), and finally asks why any of these players need be equally poised between treatment options. The article argues that only the subject's evaluation of the options is morally relevant and that even the subject need not be equally poised or indifferent between the options in order to volunteer for randomization. All that is needed is adequately informed, free, and unexploited consent. It concludes equipoise is irrelevant. (shrink)