This article argues that environmental considerations fall within the scope of medical bioethics, and there are implications specific to medical education. It endorses the need to expand the scope and epistemology of contemporary medical bioethics discourse by including themes related to environmental considerations. Our discussion begins by providing a brief history of environmental bioethics. It then offers a critique of three specific health and environmental issues, namely technology, toxics, and consumption, and discusses how these issues are key to articulating moral (...) considerations of human health and subsequently medicine and its teaching. Lastly, it explores criticisms of including environmental issues into the bioethical debate before providing suggestions of how environmental ethics can be included into the medical curriculum. This article concludes by suggesting theoretical possibilities for environmentally inclusive bioethics, such as reorienting bioethical discussions to its original environmental advocacy and supporting environmental bioethics as a competency in medical education. (shrink)

This thesis is a contribution to the ethical justification for clinical research with children. A research subject’s participation in a trial is usually justified, in part, by informed consent. Informed consent helps to uphold the moral principle of respect for persons. But children’s limited ability to make informed choices gives rise to a problem. It is unclear what, if anything, justifies their participation in research. Some research ethicists propose to resolve this problem by appealing to social utility, proxy consent, arguments (...) explaining why it is permissible to expose children to some harm, and an argument concerning the appropriate balance between research harms and benefits. I argue that each of these is a necessary part of the justification for research with children, but that the argument concerning harms and benefits is under-developed. It relies on the concept of minimal risk, but minimal risk is inadequately justified. I propose an interpretation of minimal risk. I defend the idea that minimal risk should be interpreted according to the risks of daily life. I reject the most prominent defense of daily life, which claims that daily risks are morally relevant because they replace, rather than add to, the risks a child would ordinarily face. Instead, I propose that these risks are part of a reasonable trade-off between personal safety and our ability to pursue meaningful lives. I then examine whose daily life should be captured in the concept of minimal risk. I reject arguments that minimal risk should refer to healthy children or the subjects of the research and propose instead that the referent should be children who are not unduly burdened by their lives. I argue that children are not unduly burdened when they fare well and defend the idea that children fare well when they possess sufficiently high degrees of the substantive goods of childhood. I conclude by analyzing a controversial case study using my interpretation of minimal risk. I draw on this case to argue that my interpretation offers clear guidance for research ethics review and contributes to a determination that is more plausible than its rivals. (shrink)

The American Journal of Bioethics, Volume 12, Issue 1, Page 44-46, January 2012.

Minimal risk is a central concept in the ethical analysis of research with children. It is defined as the risks “. . . ordinarily encountered in daily life . . . .” But the question arises: who is the referent for minimal risk? Commentators in the research ethics literature often answer this question by endorsing one of two possible interpretations: the uniform interpretation or the relative interpretation of minimal risk. We argue that describing the debate over minimal risk as a (...) disagreement between the uniform and the relative interpretation impedes progress on the identification of a justifiable referent for minimal risk. There are two main problems with this approach: constructing the debate over minimal risk as a disagreement between a uniform and a relative interpretation misconstrues the main difference between competing interpretations and neither the uniform nor the relative interpretation identifies one unique and consistent group of children as the referent for minimal risk. We conclude that progress on the debate over minimal risk requires that we abandon the uniform and relative interpretations and address the main moral problem at stake: whether healthy children or the subjects of the research should be the referent for minimal risk. (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...

Uncertainty is a necessary condition for the sound moral and scientific conduct of research involving human subjects. If the expert scientific communities, medical or otherwise, lacked uncertainty about the interventions under investigation, it would be unethical to knowingly subject individuals to inferior or harmful treatment. Moreover, if the relative merits of the interventions were previously established, as indicated by the lack of uncertainty within the relevant expert community, the results of the trial would be of little, if any, scientific value. (...) Despite the important role that uncertainty plays in the formulation and conduct of research involving human subjects, the concept has received inadequate treatment in the research ethics literature. To the limited extent that uncertainty is addressed, much of the emphasis remains on the ethical, not epistemic, aspects of uncertainty. What is left insufficiently examined is the nature and scope of the uncertainty. Often, uncertainty is glossed as agnosticism, indifference, and conflict. Yet these terms represent distinct types of uncertainty, and the type that obtains impacts the epistemic and ethical justifications for a proposed trial. A failure to recognize and clearly articulate the parameters of uncertainty in particular situations compromises our ability to respond to important moral and scientific concerns in the development and conduct of research. This problem is particularly pronounced in public health research that investigates problems resulting not only from uncertainties in scientific knowledge but from institutional failures, economic and social constraints, and lack of political will. Indeed, the role of research in public health is tied to its capacities to successfully navigate such complex questions. The way in which a study is designed and carried out, as well as ethically and scientifically justified, must reflect a robust and systematic characterization of the uncertainties present. Using an example from a study examining the efficacy of using treated sewage sludgeto remediate lead-contaminated soil, I explore and analyze the aforementioned deficiencies in understanding uncertainty among researchers and ethicists. The case study serves as a vehicle through which to illustrate (1) important considerations in characterizing and addressing uncertainty; (2) the influence of the uncertainty characterization on the formulation of parameters used to evaluate the ethical permissibility of the research; and (3) ways in which these parameters might be operationalized in the context of a particular study. (shrink)

The American Journal of Bioethics, Volume 12, Issue 1, Page 42-44, January 2012.

In connection with research on humans, the term “vulnerability” is only appropriate to identify the special need for protection of certain sections of the population and individuals, if this term refers to the additional risk of certain groups of subjects. Authors who focus on the additional risk suffering of a subject group when defining vulnerability succeed in considering the specific worthiness of protection in a context-sensitive way. The attempt to define the risk–benefit assessment for vulnerable subject groups on a binding (...) basis faces considerable difficulties. This assessment depends both on the research situation and on the test subject. The normative aspect of this decision could be solved by referring to Rawl’s decision model of an original position. In cases where there is no benefit for the subject, arguments in the discussion of the risks and benefits that are based on a “group or overall benefit” and an “objective interest,” cannot be fully sustained. (shrink)

The Kennedy Krieger lead paint study is a landmark case in human experimentation and a classic case in research ethics. In this paper I use the lead paint study to assist in the analysis of the ethics of research on less expensive, less effective interventions. I critically evaluate an argument by Buchanan and Miller who defend both the Kennedy Krieger lead paint study and public health research on less expensive, less effective interventions. I conclude that Buchanan and Miller’s argument is (...) flawed but that does not mean that research designed to find less effective interventions cannot be justified in some situations. Based on my analysis, I suggest questions to ask when considering such research and I offer some principles to guide us. In the process, light is shed on the various debates and issues raised by the lead paint study; e.g. standards of care, researchers’ responsibilities to research subjects, the distinction between treatment and research and the question of what it is that legitimizes public health research. (shrink)