There is near universal agreement within the scientiﬁc and ethics communities that a necessary condition for the moral permissibility of cross-national, collaborative research is that it be responsive to the health needs of the host community. It has proven difﬁcult, however, to leverage or capitalize on this consensus in order to resolve lingering disputes about the ethics of international medical research. This is largely because different sides in these debates have sometimes provided different interpretations of what this requirement amounts (...) to in actual practice. The goal of the discussion that follows is to clarify the nature of this important moral requirement. The ﬁrst section explains the requirement for responsiveness to host community health needs in the context of international medical research. The second section examines various formulations of this requirement as they are enunciated in some of the core consensus documents in research ethics. The third section then defends a particular interpretation of this requirement, and the ﬁnal sections examine more liberal alternatives with the aim of highlighting points of agreement and assessing the signiﬁcance of areas of disagreement. (shrink)
To cite this Article: , 'Two Dogmas of Research Ethics and the Integrative Approach to Human-Subjects Research', Journal of Medicine and Philosophy, 32:2, 99 - 116 To link to this article: DOI: 10.1080/03605310701255727 URL: http://dx.doi.org/10.1080/03605310701255727..
An Aristotelian conception of practical ethics can be derived from the account of practical reasoning that Aristotle articulates in his Rhetoric and this has important implications for the way we understand the nature and limits of practical ethics. An important feature of this conception of practical ethics is its responsiveness to the complex ways in which agents form and maintain moral commitments, and this has important implications for the debate concerning methods of ethics in applied ethics. In particular, this feature (...) enables us to understand casuistry, narrative, and principlism as mutually supportive modes of moral inquiry, rather than divergent and mutually exclusive methods of ethics. As a result, an Aristotelian conception of practical ethics clears the conceptual common ground upon which practical ethicists can forge a stable and realistic self-understanding. (shrink)
Recent debates over the use of sham surgery as a control for studies of fetal tissue transplantation for Parkinson’s disease have focused primarily on rival interpretations of the US federal regulations governing human-subjects research. Using the core ethical and methodological considerations that underwrite the equipoise requirement, we nd strong prima facie reasons against using sham surgery as a control in studies of cellular-based therapies for Parkinson’s disease and more broadly in clinical research. Additionally, we believe that these reasons can be (...) generalized to apply to the use of other placebo controls that carry signi cant risks of positive harms in and of themselves. As a result, our arguments are centrally relevant to the emerging drive to subject therapies with a surgical component to the same rigorous standards of evaluation as those governing the approval of new pharmaceuticals. (shrink)
The use of charged-particle radiation therapy (CPRT) is an increasingly important development in the treatment of cancer. One of the most pressing controversies about the use of this technology is whether randomised controlled trials are required before this form of treatment can be considered to be the treatment of choice for a wide range of indications. Equipoise is the key ethical concept in determining which research studies are justified. However, there is a good deal of disagreement about how this concept (...) is best understood and applied in the specific case of CPRT. This report is a position statement on these controversies that arises out of a workshop held at Wolfson College, Oxford in August 2011. The workshop brought together international leaders in the relevant fields (radiation oncology, medical physics, radiobiology, research ethics and methodology), including proponents on both sides of the debate, in order to make significant progress on the ethical issues associated with CPRT research. This position statement provides an ethical platform for future research and should enable further work to be done in developing international coordinated programmes of research. (shrink)
This paper offers a non-paternalistic justification for prospective research review as providing a credible social assurance that the institutions of scientific advancement respect and affirm the moral equality of all community members and as creating a “market” in which stakeholders working to advance diverse ends also advance the common good.
This article argues that lingering uncertainty about the normative foundations of research ethics is perpetuated by two unfounded dogmas of research ethics. The first dogma is that clinical research, as a social activity, is an inherently utilitarian endeavor. The second dogma is that an acceptable framework for research ethics must impose constraints on this endeavor whose moral force is grounded in role-related obligations of either physicians or researchers. This article argues that these dogmas are common to traditional articulations (...) of the equipoise requirement and to recently articulated alternatives, such as the non-exploitation approach. Moreover, important shortcomings of these approaches can be traced to their acceptance of these dogmas. After highlighting these shortcomings, this article illustrates the benefits of rejecting these dogmas by sketching the broad outlines of an alternative called the "integrative approach" to clinical research. (shrink)
: The debate over when medical research may be performed in developing countries has steered clear of the broad issues of social justice in favor of what seem more tractable, practical issues. A better approach will reframe the question of justice in international research in a way that makes explicit the links between medical research, the social determinants of health, and global justice.
This paper examines the role of equipoise in evaluating international research. It distinguishes two possible formulations of the equipoise requirement that license very different evaluations of international research proposals. The interpretation that adopts a narrow criterion of similarity between clinical contexts has played an important role in one recent controversy, but it suffers from a number of problems. An alternative interpretation that adopts a broader criterion of similarity does a better job of avoiding both exploitation of the brute fact of (...) social deprivation and the exploitation of needy populations for the benefit of more well-off populations. It also holds out the promise of reconciling the need to find interventions that can be employed in developing world contexts with the cluster of moral values that must constrain the way such research is carried out. (shrink)
After criticizing three common conceptions of therelationship between practical ethics and ethical theory, analternative modeled on Aristotle's conception of the relationshipbetween rhetoric and philosophical ethics is explored. Thisaccount is unique in that it neither denigrates the project ofsearching for an adequate comprehensive ethical theory norsubordinates practical ethics to that project. Because the purpose of practical ethics, on this view, is tosecure the cooperation of other persons in a way that respectstheir status as free and equal, it seeks to influence thejudgments (...) of others by providing them with reasons that areaccessible to their own understanding. On this account, theindependence of practical ethics is rooted in an appreciation ofthe constraints that non-ideal circumstances place on the rolethat the philosophically refined premises of moral theory canplay in such public deliberations. Practical and philosophicalethics are united, not by shared theoretical frameworks orprinciples, but by the need to exercise intelligently the sameintellectual and affective capacities. They are separated, notby the particularity or generality of their starting points, butby their responsiveness to the practical problem of facilitatingsound normative deliberations among persons as we find them,under non-ideal circumstances. (shrink)
: An Aristotelian conception of practical ethics can be derived from the account of practical reasoning that Aristotle articulates in his Rhetoric and this has important implications for the way we understand the nature and limits of practical ethics. An important feature of this conception of practical ethics is its responsiveness to the complex ways in which agents form and maintain moral commitments, and this has important implications for the debate concerning methods of ethics in applied ethics. In particular, this (...) feature enables us to understand casuistry, narrative, and principlism as mutually supportive modes of moral inquiry, rather than divergent and mutually exclusive methods of ethics. As a result, an Aristotelian conception of practical ethics clears the conceptual common ground upon which practical ethicists can forge a stable and realistic self-understanding. (shrink)
This paper examines the concept of a 'standard of care' as it has been used in recent arguments over the ethics of international human-subjects research. It argues that this concept is ambiguous along two different axes, with the result that there are at least four possible standard of care arguments that have not always been clearly distinguished. As a result, it has been difficult to assess the implications of opposing standard of care arguments, to recognize important differences in their supporting (...) rationales, and even to locate the crux of the disagreement in some instances. The goal of the present discussion, therefore, is to disambiguate the concept of a 'standard of care' and to highlight the areas of genuine disagreement among different standards. In the end it is argued that one standard of care argument in particular is more complex than either its proponents or its critics may have recognized and that understanding this possibility opens up a potentially promising avenue of inquiry that remains to be carefully explored. (shrink)