Ethical Considerations in Biomedical HIV Prevention Trials

Well into the third decade of the HIV epidemic, there remains no effective HIV preventive vaccine, microbicide, product or drug to reduce the risk of HIV acquisition.

As the numbers of those infected by HIV and dying from AIDS continue to increase, the need for such biomedical HIV preventive interventions becomes ever more urgent.

Several such products are at various stages of development, including some currently in phase III efficacy trials.

The successful development of effective HIV preventive interventions requires that many different candidates be studied simultaneously in different populations around the world.

This in turn will require a large international cooperative effort drawing on partners from various health sectors, inter-governmental organisations, government, research institutions, industry, and affected populations.It will require that these partners be able and willing to address the difficult ethical concerns that arise during the development of biomedical HIV prevention products.

This document does not aim to capture the extensive discussion, debate, consensus and disagreement which have taken place among stakeholders in HIV prevention research. Rather it highlights, from the perspective of UNAIDS and WHO, some of the critical ethical elements that must be considered during the development of safe and effective biomedical HIV prevention interventions.

It suggests standards, as well as processes for arriving at standards which can be used as a frame of reference from which to conduct further discussion at the local, national, and international levels and can inform the development of national guidelines for the conduct of biomedical HIV prevention trials.