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Protecting participants in health research: The South African Material Transfer Agreement

M Labuschaigne, A Dhai, S Mahomed, K Behrens, A Nienaber, K Moodley, P Cleaton-Jones, A Olckers, N Maepa, C Penny

Abstract


The need to transfer human biological materials (HBMs) across national boundaries has become increasingly important in view of increased biobank and commercial activities globally. In light of South Africa (SA)’s history of colonisation and racial discrimination, coupled with well-known instances of exploitation of research participants in the developing world, it is critical that the management of HBMs from and to other jurisdictions is explored and regulated. Material transfer agreements (MTAs) represent an important point of departure in such a process. This article explores the need for a uniform MTA in SA and discusses some aspects of the recently gazetted national MTA, which provides a framework that can serve as a safeguard for cross-border transfer of HBMs in the absence of the National Health Act’s chapter 8 regulations in this regard.


Authors' affiliations

M Labuschaigne, Department of Jurisprudence, School of Law, University of South Africa, Pretoria, South Africa

A Dhai, Steve Biko Centre for Bioethics, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

S Mahomed, Department of Jurisprudence, School of Law, University of South Africa, Pretoria, South Africa

K Behrens, Steve Biko Centre for Bioethics, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

A Nienaber, Department of Public Law, Faculty of Law, University of Pretoria, South Africa; and Faculty of Health Sciences Research Ethics Committee, University of Pretoria, South Africa

K Moodley, Centre for Medical Ethics and Law, Department of Medicine, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa

P Cleaton-Jones, Steve Biko Centre for Bioethics, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

A Olckers, DNAbiotec (Pty) Ltd, Pretoria, South Africa

N Maepa, Legal Office, University of the Witwatersrand, Johannesburg, South Africa

C Penny, Human Research Ethics Committee (Medical), University of the Witwatersrand, Johannesburg, South Africa; and Department of Internal Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

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Keywords

Material transfer agreement; Human biological material; Need; Research participants; Cross-border transfer; Exploitation; Uniform national material transfer agreement; South Africa

Cite this article

South African Medical Journal 2019;109(5):353-356. DOI:10.7196/SAMJ.2019.v109i5.13803

Article History

Date submitted: 2019-04-29
Date published: 2019-04-29

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