"The Role of Community Consultation in Promoting Ethical Obtainment of Informed Consent in Clinical Trials in Developing Countries"
With funding provided in part by the UVA Center for Global Health, I worked with the Socio-Behavioral Working Group of the South African AIDS Vaccine Initiative (SAAVI) during the Summer of 2007. SAAVI provides funding for research and clinical trials of HIV/AIDS vaccines in South Africa. In order to facilitate the productive pursuit of their mission, SAAVI also finances several academic working groups to better understand contextual issues of HIV vaccines (i.e. ethical concerns, social aspects of research). The Socio-Behavioural working group, which facilitated my research, focuses on social aspects of vaccine research; addressing issues such as enablers and inhibitors to individual trial participation and concerns surrounding community consultation. The group works from the University of Stellenbosch and is primarily composed of psychologists from that institution. During my tenure in South Africa, I conducted a qualitative study about vaccine trial participation with the Desmond Tutu HIV Foundation of the University of Cape Town (a group which is funded, in part, by SAAVI).
Although the focus of my research originated in a fairly abstract, philosophical consideration, its ultimate realization produced concrete results regarding the role which other people play in influencing an individual's decision to participate in an HIV vaccine trial. The initial question asked whether individual informed consent, as defined in the most prominent codes of research ethics, necessarily conforms to purportedly different "African" conceptions of personhood. The obtainment of individual informed consent from clinical trial participants forms a core component of medical research ethics. Research guidelines such as the Council for International Organizations of Medical Sciences CIOMS regulations, Belmont Report, and the Declaration of Helsinki emphasize that consent should be produced free from "undue inducement" and outside influence. Constructing consent in this manner, as a necessarily individual decision, derives from the ethical tenet of autonomy, a central theme in the Western philosophical tradition of Liberalism. As such, defining informed consent for research conducted in cross-cultural, non-Western environments can be ethically problematic. For example, it has been suggested that traditionally, many African societies understand personhood as a communal phenomenon rather than as an individual one. Personhood then derives from and depends upon interpersonal relationships and the fulfillment of societal obligations. One outward manifestation of "communal personhood" is communitarian decision-making, wherein an individual's choice to participate in a clinical trial may be contingent upon the approval of a husband, elder, or other family member. The purpose of my study was to better elucidate the degree to which communitarian decision-making affects the decisions of participants to consent to HIV vaccine trials conducted at trial sites surrounding Cape Town.
In pursuing this question, I conducted semi-structured qualitative interviews with staff members at three trial sites in townships surrounding Cape Town. The research shed some light on the nature and relative importance of the opinions of other people on an individual's decision to participate in HIV vaccine research. I present my findings in a paper which is currently circulating for comments from the SAAVI Socio-Behavioral Working Group, and under consideration for publication. It will also be presented to the Desmond Tutu HIV Foundation for their own internal use.