Africa needs its own regional guidelines for ethics, good clinical practice (GCP), good laboratory practice (GLP) and other key facets of health research, concluded a recent roundtable in Addis Ababa, Ethiopia.
A model bioethics law should also be considered by the Africa Union
(AU), the intergovernmental organisation that represents 53 African nations, as well as the national parliaments and governments of the region, the roundtable participants recommended.
The clinical trials roundtable was part of the Science with Africa conference, organised by the Africa Unio
n and the United Nations Economic Commission for Africa (UNECA) earlier this month. It was based on a proposal for Developing Guidelines for Health Research in Africa formulated by Francis Crawley, executive director of the Good Practice Alliance – Europe (GCPA), which arranged the roundtab
le in collaboration with the AU and UNECA.
Among the speakers were representatives of the Pan-African Bioethics Initiative, the Association for Good Clinical Practice in Nigeria, the Forum for Research Ethics in Uganda, the Kenya Medical Research Institute and Pfizer.
As the roundtable
heard, a number of initiatives have already been taken at national level to formalise research ethics and good clinical/laboratory practice. For example, South Africa first introduced GCP guidelines in 2000, subsequently revising them in 2006.
The guidelines are very similar to those of the
International Conference on Harmonisation (ICH) and the World Health Organization (WHO), but with provisions specific to the local context – such as insisting that the principal investigator of a clinical trial must be resident in South Africa, to emphasise the importance of research ownership an
d capacity-building.
The Uganda National Council for Science and Technology published National Guidelines for Research Involving Humans as Research Participants in March 2007. This document addresses issues around the rights and welfare of research participants; regulatory oversight of
research projects; the establishment, function and procedures of Institutional Review Boards; ethical considerations in the review of research protocols; informed consent; standards of care during research; the responsibilities of investigators, sponsors and host institutions; monitoring and report
ing; and the publication and dissemination of clinical trial results.
There are also further moves underway to harmonise guidelines and practices across the continent. The Cameroon Bioethics Society (CBS) is organising the first Panafrican Bioethics Congress, provisionally scheduled for the l
ast week of May 2008 in Yaoundé, Cameroon. This will draw together stakeholders from the south and north who are interested in developing health research and bioethics in Africa.
Both CBS and GCPA are planning a number of workshops with a view to developing resolutions on guidelines for health research ethics in Africa that can be presented at the next United Nations assembly.
The roundtable participants stressed that pan-African guidelines for health research and a model bioethics law should be formulated by experts working in close co-operation with national, African and international policymakers, so as to ensure their implementation (as appropriate) into local law, regulations, education and practices.
To these ends, the roundtable has established an African and international co-operative group, with an African Project Secretariat at the CBS in Douala, Cameroon and an International Project Secretariat at the GCPA in Brussels, Belgium.
Specific working groups will be set up for health research guidelines and a model bioethics law. A series of meetings and workshops will be held over the next 24 months to complete the standards and begin the process of implementation.
