The complexity of microbicide research in developing countries is augmented by a host of unique ethical concerns. In the haste to develop an urgently needed microbicide (which in itself is an ethical imperative), some of these concerns, especially those related to safety have either not been anticipated or fully explored. The development of guidelines pertaining to the ethics of microbicide research is important to investigators and ethics committees alike internationally. Both formative and empirical research is required to resolve these dilemmas to ensure participant protection without obstructing the conduct of urgent and important HIV preventive research. Reaching consensus on ethical oversight at an international level is crucial.
Competing interests
The author(s) declare that they have no competing interests.
Acknowledgements
I would like to thank Dr Landon Myer for reviewing earlier drafts of the manuscript. This article has drawn significantly from insights gained during the HIV Prevention Trial Network (HPTN) Microbicide Safety Consensus Meeting in Bethesda March 1–3, 2006. Finally I am grateful to Debra Birnkrant from the FDA for her contribution to safety from the FDA perspective.