Trials of Tenofovir: Mediating Ethics in Third-World Research

Abstract

A clash between a union of Cambodian sex workers and a team of international researchers funded by the Bill and Melinda Gates Foundation led to the cancellation of an important HIV/AIDS prevention study. The union was demanding better disclosure of information, insurance against the threat of long-term study-related side effects, and assurances of future access to the study drug (tenofovir) if it proved effective in preventing HIV transmission. The union was also demanding to be taken seriously as a stakeholder in the joint fight against HIV/AIDS. The Cambodian controversy highlights the inability of first world ethical standards to meet the needs of international medical research. A study protocol obtaining Institutional Review Board (IRB) approval in the U.S. or Australia cannot simply be exported to a country like Cambodia. This article details the science and politics of the tenofovir trials and explores how the tensions of third world research might be better mediated in light of emerging international standards