Contemporary research ethics policies started with reflection on the atrocities perpetrated upoconcentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of (...) this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upon concentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim (...) of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

1. The opinions expressed are the author's own. They do not reflect any position or policy of the National Institutes of Health, Public Health Service, Department of Health and Human Services, or any of the authors affiliated organizations.

Federal policies on human subjects research have performed a near‐about face. In the 1970s, policies were motivated chiefly by a belief that subjects needed protection from the harms and risks of research. Now the driving concern is that patients, and the populations they represent, need access to the benefits of research.

A predominant ethical view holds that physician‐investigators should conduct their research with therapeutic intent. And since a physician offering a therapy wouldn't prescribe second‐rate treatments, the experimental intervention and the best proven therapy should appear equally effective. "Clinical equipoise" is necessary. But this perspective is flawed. The ethics of research and of therapy are fundamentally different, and clinical equipoise should be abandoned.

Despite its title, Alan Wertheimer’s new book is not another tiresome exploration of Marxist economic theories. Indeed, there is virtually no extended discussion of Marxism at all, since Wertheimer believes that what is unique to that perspective is highly problematic, given that when Marxists simply assert that capitalists do exploit wage laborers they are appealing to “the ordinary notion that one party exploits another when it gets unfair and undeserved benefits from its transactions or relationships with others”. His goal is (...) to analyze this ordinary sense of exploitation, to explore in detail some of the many forms it can take, and to begin some serious thinking about what he terms its moral weight and its moral force. This groundbreaking work, the first book-length treatment of its subject from a broadly analytic standpoint, should do much to disabuse non-Marxist philosophers of the notion that exploitation is largely peripheral to the central questions of moral and political philosophy. (shrink)

Recent proposals to punish athletes for taking drugs or to impose mandatory drug testing cannot be defended in ethical terms. Nor is it possible to distinguish consistently between ethical and unethical uses of restorative drugs, additive drugs, painkillers, and recreational drugs. We oppose drugs in sports because they violate the majority notion of acceptable behavior. But such opposition has more to do with defending the ideals of the community than with creating policies that are ethically sound.