24 H A S T I N G S C E N T E R R E P O RT May-June 2007 T he reigning regulatory and ethical frame- works for human research emphasize the protection of research subjects. Although in- formed consent was given pride of place in the wake of the Nazi experiments and other infamous exam- ples of nonconsensual research, the current regulato- ry system���especially prospective risk-benefit assess- ment by independent ethics committees���focuses on protecting human subjects from undue risks of harm. The question arises, then, whether standard protections for research subjects are inherently pater- nalistic, and, if they are, then whether that paternal- ism is justified. A quick thought experiment will help. Imagine that a research study recruits a group of prospective participants who have expert scientific and clinical knowledge and exemplary skills of reasoning and judgment. In this case, we might be comfortable re- lying entirely on the subjects��� consent as the sole mechanism of subject protection, without any of the other standard safeguards. For these individuals are ideal subjects, fully competent to assess the value and the validity of the research and its risk-benefit ratio. By contrast, many prospective subjects are vulnera- ble to a range of decisional defects or impairments that render them unable to protect their own inter- ests, and thus we are right not to rely exclusively on informed consent. In this paper we defend a twofold thesis. First, the regulatory system for human research is justifiably paternalistic. Second, this form of paternalism is, nevertheless, compatible with the primacy of in- formed consent that, for example, is reflected in the Nuremberg Code. On our view, the values that un- derlie informed consent are indeed the cornerstone of research ethics. At the same time, research regula- tion does not rely exclusively on the mechanism of informed consent because many prospective subjects cannot give sufficiently robust or valid consent. Pa- ternalism in research is justifiable because it is neces- sary if we are to realize those values. Bioethicists have failed to understand the pervasively paternalistic character of research ethics. Not only is the overall structure of research review and regulation paternalistic in some sense even the way informed consent is sought may imply paternalism. Paternalism has limits, however. Getting clear on the paternalism of research ethics may mean some kinds of prohibited research should be reassessed. F A C I N G U P T O Paternalism IN RESEARCH ETHICS b y F R A N K L I N G . M I L L E R A N D A L A N W E R T H E I M E R Franklin G. Miller and Alan Wertheimer, ���Facing Up to Paternalism in Research Ethics,��� Hastings Center Report 37, no. 3 (2007): 24-34.

H A S T I N G S C E N T E R R E P O RT 25 May-June 2007 By itself, this thesis should not prove to be particularly controversial. We advance it here because bioethics has not come to terms with the deeply and pervasively paternalistic character of research ethics and thus has failed to adequately explore the soundness and limitations of its view. In one sense, it is surprising that bioethics has paid so little attention to paternalism in human subjects re- search. If we look at the literature on the ethics of medical care, we will en- counter vigorous and (almost) unani- mous arguments against paternalism. The dominant philosophical view has privileged respect for autonomy as a guiding principle over the ancient Hippocratic tradition that the doctor is entitled to decide what treatment is best for his patients. There is a near universal consensus that patients have the right to refuse treatment even if the physician (rightly) thinks that the patient is mistaken, and that physi- cians should not deceive or withhold information from patients, even when they think it is in the patient���s interests to do so. Antipaternalism ap- pears to reign. When it comes to research, how- ever, things are different. To be sure, paternalism is recognized with respect to research involving children, in- competent adults, and other arguably vulnerable populations such as pris- oners. These groups receive special��� paternalistic���treatment in the U.S. federal regulations on research sub- jects protection, which are known as the ���Common Rule.���1 What is not widely recognized is that the current system of regulating human subjects research with competent adults is also paternalistic at its core because it places a variety of restrictions on per- missible research, in addition to re- quiring that investigators obtain in- formed consent from subjects. We are not sure why the paternal- istic character of regulations to pro- tect research subjects has not been recognized. Perhaps ���paternalism��� has become so negatively valenced that bioethicists prefer to avoid the word, even if they understand that they are supporting paternalism. Or perhaps they simply do not understand the extent to which they actually support paternalism. Whatever the explana- tion, it is time to face up to paternal- ism in research ethics for both ex- planatory and normative reasons. First, it is necessary to face up to pa- ternalism simply to properly under- stand our practices. We think this is an important objective in its own right. We will argue that the existing regulatory system is best understood as resting on what we will call ���group soft paternalism.��� Second, we must face up to paternalism in order to thoughtfully consider when those practices are justifiable and when they are not. Contrary to the rhetoric of bioethics, paternalism can be justi- fied. The hard task is to determine when it is. To accomplish these aims, our analysis proceeds along the following steps. It begins with an overview of the conceptual geography of paternal- ism. Next, we examine the justificato- ry conditions for the type of paternal- ism that prevails in the current system of research regulation. In light of this conceptual framework, we illustrate the paternalistic character of the re- search regulation system. The limits of justifiable paternalism in research ethics are considered by examining an unsettled issue of research ethics: whether, on paternalistic grounds, there should be a cap on the level of net risks to which competent adult subjects are exposed, regardless of the potential social value of the research. Finally, we discuss the deeper theoret- ical connections between paternalism and the value of informed consent. A couple of caveats. First, our in- quiry focuses on the central core of research regulation and ethics���the protection of human subjects. It does not attend to other important dimen- sions of ethical research, such as allo- cation of research resources and issues of distributive justice, including ac- cess to the benefits of research and the usefulness of research to disadvan- taged populations. Second, we con- fine ourselves to the domestic con- text. Research in developing societies raises a host of unique ethical issues beyond the scope of this paper, al- though we think that our analysis may have some limited bearing on those issues as well. The Conceptual Geography of Paternalism Ageneral s a starting point, we adopt the liberal presumption that people should be free to do what they wish with their lives, including hav- ing the ability to enter into transac- tions or relationships to which they consent. Given this presumption, there are various possible justifica- tions for prohibiting or regulating be- havior. We may limit a person���s liber- ty on the ground that the behavior harms others (battery), or that it of- fends others (lewdness), or that it is intrinsically immoral (prostitution). We may also limit a person���s liberty on paternalistic grounds because the behavior is deemed harmful to the agent himself (seat belt laws). There are several ways in which one can re- strict an agent���s freedom for the agent���s own good. In some cases, we Contrary to the rhetoric of bioethics, paternalism can be justified. The hard task is to determine when it is.