Exempting Health Research from the Consent Provisions of POPIA

Keywords: code of conduct, consent, exemption, POPIA, Protection of Personal Information Act, privacy

Abstract

The Protection of Personal Information Act 4 of 2013 (hereafter POPIA) has the potential to disrupt health research in South Africa. While the legal status quo is that broad consent by research participants is acceptable, POPIA requires specific consent for any processing of research participants' health and genetic information. However, POPIA offers mechanisms such as an exemption from specified measures which can potentially be used to ameliorate its impact. It is proposed that the health research sector should seek to utilise these mechanisms – in particular, a sector-wide exemption of all health research projects from the requirement of specific consent by research participants, subject to the conditions that: (a) a health research project must be approved by a health research ethics committee, and that (b) either specific, broad or tiered consent must be obtained for a health research project. Importantly, it would be counter-productive to approach such an application for exemption from the perspective of inconvenience for health researchers. Instead, an application for exemption must be approached from a human rights platform, and must be supported by solid evidence. Such evidence should include the results of empirical studies of South African research participants' preferences.

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Author Biographies

Donrich W Thaldar, University of KwaZulu-Natal, Durban

Associate Professor, School of Law, University of KwaZulu-Natal, Durban, South Africa

Beverley A Townsend, University of KwaZulu-Natal, Durban

Postdoctoral Research Fellow, School of Law, University of KwaZulu-Natal, Durban, South Africa

References

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Case law
Asko Beleggings v Voorsitter van die Drankraad 1997 2 SA 57 (NC)
Barkhuizen v Napier 2007 5 SA 323 (CC)
Bertie Van Zyl (Pty) Ltd v Minister for Safety and Security 2010 2 SA 181 (CC)
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Legislation
South Africa
Constitution of the Republic of South Africa, 1996
Liquor Act 27 of 1989
Liquor Act 59 of 2003
National Health Act 61 of 2003
Protection of Personal Information Act 4 of 2013
European Union
General Data Protection Regulation 679/2016
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GN R719 in GG 38000 of 19 September 2014
GN R719 in GG 41781 of 20 July 2018
Proc R21 in GG 43461 of 22 June 2020
International instruments
Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data (1981)
OECD Guidelines on the Protection of Privacy and Transborder Flows of Personal Data (1980)

Internet sources

Department of Health 2015 Ethics in Health Research: Principles, Processes and Structures http://nhrec.health.gov.za/index.php/grids-preview accessed 12 March 2021

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Human Heredity and Health in Africa 2017 H3Africa Guideline for Informed Consent https://h3africa.org/wp-content/uploads/2018/05/H3A%202017%20Revised%20IC%20guideline%20for%20SC%2020_10_2017.pdf accessed 20 August 2020

National Institutes of Health (United States of America) 2020 Human Heredity and Health in Africa (H3Africa) at NIH https://www.fic.nih.gov/Funding/Pages/collaborations-h3africa.aspx accessed 8 May 2021
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Published
2021-06-15
Section
Articles