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Ethical considerations in HIV preventive vaccine research

This guidance was formulated following recognition that many candidate vaccines for HIV/AIDS would be studied simultaneously in different populations around the world, requiring a large international co-operative effort. Meetings were convened by UNAIDS secretariats in Geneva, Brazil, Thailand and Washington to identify and discuss ethical issues specific to the development of HIV preventive vaccines.

The resulting guidance includes consideration of vaccine availability, capacity building, the design of research protocols and selection of study populations, community participation, scientific and ethical review, vulnerable populations, potential harms and benefits, consent, and care and treatment.

One area that was subject to extensive debate concerned the standard of care that should be provided to research participants who went on to develop HIV/AIDS. Guidance point 16 states that in such circumstances the minimum that should be provided is the highest level of care attainable in the host country, and sets out a number of factors to be taken into account when determining what that standard is.

Usefully, throughout the guidance, in addition to recommending specific standards, points from debates about the standards are set out to inform further discussion. The document is also available in FrenchSpanish and Russian.

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