With biobank research on the increase and the history of exploitation in Africa, it has become necessary to manage the transfer of human tissues across national boundaries. There are many accepted templates of Material Transfer Agreements that currently exist internationally. However, these templates do not address the specific concerns of South Africa and even of Africa as a continent. This article will examine three significantly important ethico-legal concepts that were deliberated and carefully adapted by a South African Institution to suit (...) the transfer of Human Biological Materials and associated data for biobank research, namely: informed consent; benefit sharing arrangements; and ownership together with intellectual property rights in human tissues. The discussion includes an analysis of current practice; the ethico-legal challenges in the South African/African context; the decisions made with regard to how the related ethico-legal challenges were addressed in the MTA; and justifications for implementing these decisions. The processes considered could be of benefit to other developing world countries who consider it necessary to manage the transfer of HBMs across national boundaries. (shrink)

Biobanks are repositories that store human biological materials and their associated data. They are rapidly becoming part of national and international networks and give rise to unique ethico-regulatory issues. Whether consent is informed and whether this term should be used when specimens are collected for biobank research is questionable. Where risks occur, they are usually social and relate to identifiability. Public trust and confidence are important for the success of this type of research. Consensus is growing that governance of biobanks (...) should be harmonised. Controlled specimen and data access agreements are essential. The South African National Health Act and its Regulations, that provide the foundation for the legal framework with regard to human tissue and research in South Africa, are silent on the issue of biobanks and the law lags behind while science and technology advance rapidly. The use of biobank assets will lead to significant benefits in human health and should be encouraged while taking account of the associated ethical, legal and social issues and working towards a balance between these two positions. (shrink)