The HIV pandemic is characterized by unique biological, social and geographical factors that affect the balance of risks and benefits for individuals and communities who participate in HIV vaccine development activities. These factors may require that additional efforts are needed to address the protection and welfare of participating individuals and communities in order to fulfil their rights as full and equal participants.

The need for an HIV vaccine is becoming more urgent, and over twenty vaccine candidates are at various stages of development. The successful development of effective HIV preventive vaccines is likely to require studies in different populations around the world involving the collaboration of various partners in government, agencies, research institutions and industry.

The UNAIDS secretariat has developed a guidance document on the ethical considerations in HIV preventive vaccine research which is directed to use by research participants, investigators, community members, governments, pharmaceutical companies, and ethical and scientific review committees. It suggests standards, but can equally be used as a frame of reference from which to conduct discussion and reach decisions. Consultation has taken place among lawyers, activists, social scientists, ethicists, research scientists, epidemiologists, nongovernmental organizations and public health officials and has included people from 33 countries.

The guidance document sets out to highlight some of the critical elements to be considered in ensuring availability, capacity building, development of research protocols, identification of study populations, community participation, ethical review and monitoring.

Ethical Considerations in HIV Preventive Vaccine Research. UNAIDS Guidance Document 00/07E/2000. UNAIDS, Geneva, Switzerland, http://www.unaids.org