|
|
Abstract
Reconceptualizing risk and benefit in North American HIV preventive vaccine trials: balancing fairness and vulnerability in female subject selection
Berkhout S.1, Anderson S.2, Tyndall M.3
Objectives: In Vancouver’s downtown eastside (DTES), women most at risk of HIV infection include those who are young, live in poverty, cope with violence and multiple addictions, and whose survival necessitates participation in commercial sex work. Although a modestly effective HIV vaccine could significantly reduce the risk of new infections in this population, controversy surrounds the testing of such a vaccine.
Methods: Situating contemporary philosophical theory and bioethics discourse on research involving vulnerable populations within a Foucauldian framework, this paper provides an analysis of the requirement for fair subject selection in clinical research, examining some potential harms of HIV vaccine research, and considering whether benefits exist that could surmount these harms.
Results: The nature of women’s vulnerabilities, and the potential for trial participation to magnify these, problematizes the requirement for fair subject selection in HIV vaccine research. This is confounded by the issue of whether risks to women participants should be considered “minimal.” This paper argues that the “minimal risk” label is inappropriate, and that the nature of the potential harms requires societal benefits alone not suffice to balance identified risks. Nevertheless, there is potential for clinical trials to mitigate some inequalities faced by eligible female participants. Meeting the demand for fair subject selection may require a reconceptualization of the “well-designed” vaccine trial, producing results are both scientifically and socially responsible.
Conclusions: The enrollment of the initial participants in Vancouver’s Phase IIb HIV vaccine trial highlights the need to attend to ethical issues related to justice and vulnerability. In the absence of effective public health strategies, adequate social services and economic opportunities, the goal of an effective, safe, and widely available HIV vaccine is unrealizable. This analysis of particular ethical concerns that exist outside of the issue of informed consent provides insight into how trials themselves might play a role in attaining these goals.
4th IAS Conference on HIV Pathogenesis, Treatment and Prevention
Abstract no.
CDC105
Suggested Citation
"BerkhoutS., et al.
Reconceptualizing risk and benefit in North American HIV preventive vaccine trials: balancing fairness and vulnerability in female subject selection.
:
4th IAS Conference on HIV Pathogenesis, Treatment and Prevention:
Abstract no.
CDC105"
|
|
|