At least since the seminal work of the (US) National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the 1970s, a fundamental distinction between research and practice has underwritten both conceptual work in research ethics and regulations governing research involving human subjects. Notwithstanding its undoubted historical importance, I believe the distinction is problematic because it misrepresents clinical inquiry. In this essay, I aim to clarify the character of clinical inquiry by identifying crucial contextual constraints on (...) justification constitutive of clinical science. This analysis shows that, from an epistemological point of view, clinical research and clinical practice are not sharply distinct but intimately intertwined. This result is important in its own right—an enriched understanding of the epistemology of clinical research is valuable in and of itself. But this result is also important because it has profound implications for the ethics of human subjects research. (shrink)

The UNESCO Universal Declaration on Bioethics and Human Rights of 2005 purports to articulate universal norms for bioethics. However, this document has met with mixed reviews. Some deny that the elaboration of universal bioethics norms is needed; some deny that UNESCO has the expertise or authority to articulate such norms; some regard the content of the UNESCO document as too vague or general to be useful; and some regard the document as a cog in the effort of like-minded cosmopolitans to (...) codify their particular moral intuitions in international law. This issue examines the potential merits and pitfalls of the Universal Declaration on Bioethics and Human Rights. (shrink)

A frequent feature of pharmaceutical research is the open label extension study, in which patients participating in double blind placebo controlled trials of new medications are invited, on completion of the initial trial, to take the study drug for some further period. Patients are openly given the active substance at this stage, regardless of their assignment in the initial trial. Investigators are typically reluctant to unblind the patients’ assignment at the point of entry into the open label phase, on the (...) grounds that this may introduce ascertainment bias in the main study.It is argued that patients invited to participate in open label extension studies cannot give a proper consent to such research unless they know to which arm of the main trial they were recruited. It is further argued that to recruit certain groups of patients from placebo controlled trials into open label extension studies may also be unethical for clinical reasons. (shrink)

The institutional review board Is charged with assessing the risks and benefits of research projects Involving human subjects. Ethical considerations and federal regulations require that an IRB, in part, must find that the potential risks of participation are proportional to the potential benefits and to the Importance of the knowledge that may be learned before the IRB can approve the voluntary assumption of risk by a research participant. Adequate assessment of the risks and benefits requires careful scrutiny of the study (...) design In relation to the study objectives. (shrink)

The United Nations Educational, Scientific, and Cultural Organization's (UNESCO) Universal Declaration on Bioethics and Human Rights announces a significant array of welfare entitlements—to personal health and health care, medicine, nutrition, water, improved living conditions, environmental protection, and so forth—as well as corresponding governmental duties to provide for such public health measures, though the simple expedient of announcing that such entitlements are “basic human rights.” The Universal Declaration provides no argument for the legitimacy of the sweeping governmental authority, taxation, and regulation (...) to create and impose such “rights.” As this paper explores that some action promotes a purported good, such as “health,” does not thereby make the action morally permissible. Just as there are moral limits on legitimate personal actions, there are also moral limits on legitimate governmental actions to promote purported goods, including health. A core question of any governmental regulation, therefore, is whether it is a legitimate application of moral political authority or an unauthorized act of state coercion. Pace UNESCO's wide-ranging assertions, this paper argues that promoting health only falls within the legitimate authority of governments in very narrowly defined circumstances. As the paper critically explores, at stake are foundational moral and political questions concerning the limits of governmental authority to intervene in the consensual interaction of persons. Imposing such duties on others, including citizens of a state through regulatory activity and taxation, must be justified, nonarbitrary, and demonstrably within the limits of moral political authority. UNESCO's assertions do not meet this burden of proof. (shrink)