The role of research ethics committees in South Africa when human biological materials are transferred between institutions

Abstract

The role of health research ethics committees (RECs) has evolved dramatically over the past few decades. Novel and specialised research, multicentre trials across borders and commercially sponsored research, coupled with a huge increase in the number and complexity of research protocols, and capacity and resource constraints on the part of RECs, have led to serious breaches regarding the protection of human participants. Research involving the exchange or cross-border transfer of human biological materials (HBMs) requires specialised legal and ethical knowledge relating to multiple governance frameworks. RECs may be required to monitor compliance not only with contractual requirements, but also the national laws and national ethical guidelines and standards of selected jurisdictions, not to mention adherence to international regulatory instruments governing biomedical research generally, and the conditions for the collection and use of HBMs specifically. The South African (SA) legislator’s decision to make RECs signatories to the prescribed material transfer agreement (MTA) template is a first step in the right direction, reinforcing the role and responsibilities of RECs, and their duty of care towards human participants in research. In addition, there has to be a transformation of the general mindset, towards accepting ethical principles within legal documents, particularly legal documents that involve the REC and create binding provisions that have a direct impact on participants. It is time that African views and participant protections are respected and accepted with the same vigour commanded by the Western world. In this article, the role of RECs in general is considered, prior to focusing on their responsibilities with respect to HBM transfer. The ethico-regulatory framework for REC functioning is discussed both from global and national perspectives. Also deliberated is the critical role that RECs play in reviewing health research proposals when HBMs are transferred between institutions, and the REC as a party to the SA national MTA template.