Between August 2004 and February 2005 the HIV prevention world was rocked by the suspension and cancellation of PrEP effectiveness trials in Cambodia and Cameroon. To the considerable surprise of researchers, advocates, and donors, the trials became embroiled in escalating controversies and sparked protests by advocates speaking on behalf of the communities where trial participants were being recruited. The activists not only raised questions about how the research was being conducted, but also challenged the fundamental ethics and underlying motives of the research. The Global Campaign for Microbicides is launching two in-depth case studies relating the events that led to these cancellations and extracting the lessons they provide for current and future research. Acknowledging that no single version of the events constitutes the “real story”, the case studies are built from extensive interviews with researchers, policymakers and other government officials, donors, NGO staff, and advocates to reconstruct often incompatible accounts of what eventually led to government intervention that halted the research. The case studies capture the political context and backdrop against which the controversies arose and the underlying and unaddressed conflicts that led to the costly collapse of two Phase 3 trials. These reports are important and exciting reading for anyone interested in sound science, human rights and communication across enormous cultural, social, and economic disparities. The HIV prevention field has made substantial progress since 2005 in forging mechanisms to be transparent and build trust between trial communities and researchers. But much remains to be done, and that the potential for conflict remains. As the first PrEP trials move toward completion this year, these case studies offer a timely look at what we have learned and what pressing challenges remain unaddressed.
The two case studies are available on-line at http://www.global-campaign.org/ethics-resources.htm