Supplementary funding is requested to meet the costs of travel and accommodation for African and European experts attending a seminar on health research ethics to be held from 1-4 November 1999 in Arusha, Tanzania. The seminar will set out to establish common ethical criteria and standards for clinical trials of new medicines, in particular candidate malaria vaccines in Africa. The seminar will also seek to advance AMVTN efforts to establish local scientific and ethical review boards in Africa.
The objectives of the seminar are:
1) to set common ethical criteria and standards for clinical trials of new
medicines, in particular candidate malaria vaccines in Africa
2) to advance AMVTN efforts to establish local scientific and ethical review boards in Africa
3) to promote dialogue and debate between north and south on African health problems and potential solutions
4) to raise consciousness on ethical problems in health research in Africa.
The seminar will review and discuss recent developments and debates arising from the International Guidelines for Ethical Review of Epidemiological Studies (1991), the International Ethical Guidelines for Biomedical Research Involving Human Subjects (1993), and the continuing evolution of the World Medical Association Declaration of Helsinki (1996). It will also seek to address the role of regulatory authorities in an African context and the composition and responsibilities of ethics committees and investigators. Various issues concerning confidentiality and property rights, informed consent in medical research, ownership and use of data, culture collections, data banks and the human genome, and optimum ethical guidelines will be discussed and debated. Socio-ethical questions concerning traditional African health-seeking behaviour and the ethical context of traditional African rural societies will also be discussed. The overall context and evolution of ethical problems in current vaccine research in Africa will serve as a framework for the seminar discussions.
The seminar will lead to the setting of common criteria and ethical standards for trials of malaria and other new candidate vaccines in Africa. It will also accelerate the establishment and development of local scientific and ethical review boards in Africa. It will raise consciousness in Europe and Africa on ethical problems and solutions in health research. The process of standardising ethical criteria and standards for vaccine trials in Africa will be advanced and guidelines on these matters, based on the seminar's proceedings, will be written up and published.
Statens Serum Institut,
Office of International Health
Statens Serum Institut Artillerivej
Tel: +45 32 683188
Fax: +45 31 683228