Background: HIV prevention trials conducted among disadvantaged vulnerable at-risk populations in developing countries present unique ethical dilemmas. A key concern in bioethics is the validity of informed consent for trial participation obtained from research subjects in such settings. The purpose of this study was to investigate the effectiveness of a continuous informed consent process adopted during the MDP301 phase III vaginal microbicide trial in Mwanza, Tanzania. Methods: A total of 1146 women at increased risk of HIV acquisition working as alcohol (...) and food vendors or in bars, restaurants, hotels and guesthouses have been recruited into the MDP301 phase III efficacy and safety trial in Mwanza. During preparations for the trial, participatory community research methods were used to develop a locally-appropriate pictorial flipchart in order to convey key messages about the trial to potential participants. Pre-recorded audio tapes were also developed to facilitate understanding and compliance with gel-use instructions. A comprehension checklist is administered by clinical staff to all participants at screening, enrolment, 12, 24, 40 and 50 week follow-up visits during the trial. To investigate women's perceptions and experiences of the trial, including how well participants internalize and retain key messages provided through a continuous informed consent process, a random sub-sample of 102 women were invited to participate in in-depth interviews (IDIs) conducted immediately after their 4, 24 and 52 week follow-up visits. Results: 99 women completed interviews at 4-weeks, 83 at 24-weeks, and 74 at 52 weeks (a total of 256 interviews). In all interviews there was evidence of good comprehension and retention of key trial messages including that the gel is not currently know to be effective against HIV; that this is the key reason for conducting the trial; and that women should stop using gel in the event of pregnancy. Conclusions: Providing information to trial participants in a focussed, locally-appropriate manner, using methods developed in consultation with the community, and within a continuous informed-consent framework resulted in high levels of comprehension and message retention in this setting. This approach may represent a model for researchers conducting HIV prevention trials among other vulnerable populations in resource-poor settings.Trial registrationCurrent Controlled Trials ISRCTN64716212. (shrink)
BackgroundHIV prevention research in resource-limited countries is associated with a variety of ethical dilemmas. Key amongst these is the question of what constitutes an appropriate standard of health care (SoC) for participants in HIV prevention trials. This paper describes a community-focused approach to develop a locally-appropriate SoC in the context of a phase III vaginal microbicide trial in Mwanza City, northwest Tanzania.MethodsA mobile community-based sexual and reproductive health service for women working as informal food vendors or in traditional and modern (...) bars, restaurants, hotels and guesthouses has been established in 10 city wards. Wards were divided into geographical clusters and community representatives elected at cluster and ward level. A city-level Community Advisory Committee (CAC) with representatives from each ward has been established. Workshops and community meetings at ward and city-level have explored project-related concerns using tools adapted from participatory learning and action techniques e.g. chapati diagrams, pair-wise ranking. Secondary stakeholders representing local public-sector and non-governmental health and social care providers have formed a trial Stakeholders' Advisory Group (SAG), which includes two CAC representatives.ResultsKey recommendations from participatory community workshops, CAC and SAG meetings conducted in the first year of the trial relate to the quality and range of clinic services provided at study clinics as well as broader standard of care issues. Recommendations have included streamlining clinic services to reduce waiting times, expanding services to include the children and spouses of participants and providing care for common local conditions such as malaria. Participants, community representatives and stakeholders felt there was an ethical obligation to ensure effective access to antiretroviral drugs and to provide supportive community-based care for women identified as HIV positive during the trial. This obligation includes ensuring sustainable, post-trial access to these services. Post-trial access to an effective vaginal microbicide was also felt to be a moral imperative.ConclusionParticipatory methodologies enabled effective partnerships between researchers, participant representatives and community stakeholders to be developed and facilitated local dialogue and consensus on what constitutes a locally-appropriate standard of care in the context of a vaginal microbicide trial in this setting.Trial registrationCurrent Controlled Trials ISRCTN64716212. (shrink)
: Catholic teaching has no moral difficulties with research on stem cells derived from adult stem cells or fetal cord blood. The ethical problem comes with embryonic stem cells since their genesis involves the destruction of a human embryo. However, there seems to be significant promise of health benefits from such research. Although Catholic teaching does not permit any destruction of human embryos, the question remains whether researchers in a Catholic institution, or any researchers opposed to destruction of human embryos, (...) could participate in research on cultured embryonic stem cells, or whether a Catholic institution could use any therapy that ultimately results from such research. This position paper examines how such research could be conducted legitimately in a Catholic institution by using an ethical analysis involving a narrative context, the nature of the moral act, and the principle of material cooperation, along with references to significant ethical assessments. It also offers tentative guidelines that could be used by a Catholic institution in implementing such research. (shrink)
Lisa Hill’s response to my critique of compulsory voting, like similar responses in print or in discussion, remind me how much a child of the ‘70s I am, and how far my beliefs and intuitions about politics have been shaped by the electoral conflicts, social movements and violence of that period. -/- But my perceptions of politics have also been profoundly shaped by my teachers, and fellow graduate students, at MIT. Theda Skocpol famously urged political scientists to ‘bring the (...) state back in’ to their analyses, and to recognise that political identities, interests and coalitions cannot be read off straightforwardly from people’s socio-economic position. In their different ways, this was the lesson that Suzanne Berger, Charles Sabel and Joshua Cohen tried to teach us, emphasising the ways that political participation and conflict, themselves, can change people’s identities, their sense of what it is desirable and possible, and their ability to recognise, or oppose, the freedom and equality of others. -/- I do not therefore take it as self-evident that the poor and seemingly powerless should be politically apathetic, unwilling to vote, or incapable of imagining a political solution to at least some of the problems confronting them. Nor do I suppose that non-voters are all-of-a-piece, and that their shared interests are, inevitably, more significant, morally or politically, than those which divide them. Such assumptions seem mistaken in the case of voters, and I see no reason why they should be true of non-voters. The people we find in these categories are not predestined to be in one rather than the other; they do not always stay where they start off; and at an individual level, the reasons why people fall into one group, rather than another, are likely to be complex and sometimes unpredictable. -/- Above all I see nothing in a commitment to democratic government, understood realistically or in more idealistic terms, that requires us to treat raising turnout at national elections (once every four years or so) as of such moral or political importance that we should make it legally mandatory. Realistically, it is an open question how far the ballot box is, for most people, the path to empowerment – important though it is that people should have an equal right to vote and to stand as candidates at national elections. On a more idealistic view of democratic politics it is hard to avoid the thought that the importance of national elections to self-government, posited by proponents of compulsory voting, reflects an alienated and alienating view of democracy, in which the choice of our leaders becomes more important than the development and exercise of our own capacities to lead; and in which our awe at the power our leaders might wield is matched only by our inability to imagine less intimidating, distant and centralised forms of politics. -/- But before saying a little more about these points, and their significance for compulsory voting, I would like to dispel some misunderstandings or misrepresentations of my views in Hill’s essay. I do not believe socio-economic disparities in turnout are not worrying for democratic politics, nor do I believe that abstention is generally synonymous with consent. I do not assume that people have a right not to vote, but try to explain why moral and legal rights to abstain are an important part of democratic politics, including electoral politics. (shrink)
In Moral Failure, Lisa Tessman argues against two principles of moral theory, that ought implies can and that normative theory must be action-guiding. Although Tessman provides a trenchant account of how we are thrust into the misfortune of moral failure, often by our very efforts to act morally, and although she shows, through a discussion well-informed by the latest theorizing in ethics, neuroethics, and psychology, how much more moral theory can do than provide action-guiding principles, I argue that the (...) two theses of moral theory that she disputes remain indispensable for ethical theory. (shrink)
This is my response to the papers by Chris Pincock, Lisa Warenski and Jonathan Weinberg, which were presented at the Book Symposium on my Essays on A Priori Knowledge and Justification, American Philosophical Association Pacific Division Meetings, March 16–19, 2014.
In this interesting and engaging book, Shabel offers an interpretation of Kant's philosophy of mathematics as expressed in his critical writings. Shabel's analysis is based on the insight that Kant's philosophical standpoint on mathematics cannot be understood without an investigation into his perception of mathematical practice in the seventeenth and eighteenth centuries. She aims to illuminate Kant's theory of the construction of concepts in pure intuition—the basis for his conclusion that mathematical knowledge is synthetic a priori. She does this through (...) a contextualized interpretation of his notion of mathematical construction, which she argues can be approached by looking at Euclid's Elements and Christian Wolff's mathematical textbooks. The importance of the former for her interpretation is justified by the fact that nearly all of Kant's mathematical examples in the Critique are Euclidean propositions. The importance of the latter is revealed through the fact that Wolff's textbooks were not only widely read and representative of the state of elementary mathematics during Kant's time; Kant was also intimately familiar with them. During the thirty years prior to the publication of the Critique, he used the textbooks in the college-level introductory courses in mathematics and physics that he taught.In the introduction to her book, Shabel helpfully distinguishes her approach to Kant's philosophy of mathematics from that of previous commentators. She points out that most commentators assessed Kant's thoughts on mathematics in terms of the ‘supposedly devastating effects of the discovery of non-Euclidean geometry on his theory of space’ .1 Bertrand Russell, for example, criticized Kant for his lack of a proper …. (shrink)