Bioethics has made a compelling case for the role of experience and empirical research in ethics. This may explain why the movement for empirical ethics has such a firm grounding in bioethics. However, the theoretical framework according to which empirical research contributes to ethics—and the specific role it can or should play—remains manifold and unclear. In this paper, we build from pragmatic theory stressing the importance of experience and outcomes in establishing the meaning of ethics concepts. We then propose three (...) methodological steps according to which the meaning of ethics concepts can be refined based on experience and empirical research: function identification, function enrichment, and function testing. These steps are explained and situated within the broader commitment of pragmatic ethics to a perspective of moral growth and human flourishing. We hope that this proposal will give specific direction to the bridging of theoretical and empirical research in ethics and thus support stronger actualization of ethics concepts. (shrink)

Pediatric participation in non-therapeutic research that poses greater than minimal risk has been the subject of considerable thought-provoking debate in the research ethics literature. While the need for more pediatric research has been called morally imperative, and concerted efforts have been made to increase pediatric medical research, the importance of protecting children from undue research risks remains paramount.United States research regulations are derived largely from the deliberations and report of the National Commission for the Protection of Human Subjects of Biomedical (...) and Behavioral Research. The authors of this report specifically designated children as a vulnerable population and suggested additional protections, most of which became U.S. law. One of the more contested sets of regulations surrounds non-therapeutic research, e.g., research that does not offer the potential for direct benefit to participants. Federal regulations allow local Institutional Review Boards to approve non-therapeutic research posing a minor increase above minimal risk when it involves children who have the disease or medical condition that the research addresses. (shrink)

Some public health behavioral intervention research studies involve deception. A methodological imperative to minimize bias can be in conflict with the ethical principle of informed consent. As a case study, we examine the specific forms of deception used in three online randomized controlled trials evaluating brief alcohol interventions. We elaborate our own decision making about the use of deception in these trials, and present our ongoing findings and uncertainties. We discuss the value of the approach of pragmatism for examining these (...) kinds of ethical issues that can arise in research on public health interventions. (shrink)

Institutional Review Board decisions hinge on the availability and interpretation of information. This is demonstrated by the following well-known historical example. In 2001, 24-year-old Ellen Roche died from respiratory distress and organ failure as a result of her participation in a study at Johns Hopkins Asthma and Allergy Center. The non-therapeutic physiological study, “Mechanisms of Deep Inspiration-Induced Airway Relaxation,” was designed to examine airway hyperresponsiveness in healthy individuals in order to better understand the pathophysiology of asthma. Participants inhaled hexamethonium, a (...) chemical ganglionic blocker that was not FDA-approved for use as specified in the experimental protocol. Risks of inhaling hexamethonium, including lung damage, had been reported in the 1950s and ‘60s. An investigation conducted after Roche's death determined that the study's principal investigator had failed to adequately search the medical literature; the protocol submitted for IRB review cited articles indexed in online literature databases that went back only as far as the 1970s. (shrink)

The impression one derives from the target article on “The Duty to Disclose Adverse Clinical Trials Results” is that Liao and colleagues (2009) envision a research platform consisting only of a tea...

Institutional Review Boards and their federal overseers protect human subjects, but this vital work is often dysfunctional despite their conscientious efforts. A cardinal, but unrecognized, explanation is that IRBs are performing a specific function – the management of risk – using a flawed theoretical and practical approach. At the time of the IRB system’s creation, risk management theory emphasized the suppression of risk. Since then, scholars of governance, studying the experience of business and government, have learned that we must distinguish (...) pure from opportunity risks. Pure risks should be suppressed. Some opportunity risks, in contrast, must be accepted if the institution is to meet its goals. Contemporary theory shows how institutions may make these decisions wisely. It also shows how a sound organizational understanding of risk, a proper locus of responsibility, and appropriate institutional oversight all contribute to effective risk management. We can apply this general theory, developed in other contexts, to the problems of the IRB system. Doing so provides a unifying explanation for IRBs’ disparate dysfunctions by spotlighting five related deficiencies in IRB theory and structure. These deficiencies are inability to focus on greater risks, loss of balanced theory, inaccessibility to guidance from senior leadership, unbalanced federal oversight, and inflexibility. These flaws are deeply rooted in the system, and superficial reform cannot resolve them. Congress should overhaul the system to meet contemporary standards of risk management; this would benefit subjects, scientists, and the public that needs the fruits of research. (shrink)

Brendel and Miller (2008) take the most distinctive commitment in their pragmatic approach to be treating ethical principles as having a hypothetical status. I am sympathetic to a pragmatic approac...

In the target article, Brendel and Miller (2008) attempt to bring pragmatic insights to bear on research ethics through the approach called freestanding pragmatism that John Arras (2001) brought sq...