Managing Human Tissue Transfer Across National Boundaries – An Approach from an Institution in S outh A frica

With biobank research on the increase and the history of exploitation in A frica, it has become necessary to manage the transfer of human tissues across national boundaries. There are many accepted templates of M aterial T ransfer A greements ( MTA s) that currently exist internationally. However, these templates do not address the specific concerns of S outh A frica and even of A frica as a continent. This article will examine three significantly important ethico‐legal concepts that were deliberated and carefully adapted by a S outh A frican I nstitution to suit the transfer of H uman B iological M aterials ( HBM s) 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 S outh A frican/ A frican 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 HBM s across national boundaries.