Exempting Health Research from the Consent Provisions of POPIA

Authors

DOI:

https://doi.org/10.17159/1727-3781/2021/v24i0a10420

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.

GS96.png

Downloads

Download data is not yet available.

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

Bibliography

Literature

Budin-Ljøsne I et al "Dynamic Consent: A Potential Solution to Some of the Challenges of Modern Biomedical

Kaye J "The Tension between Data Sharing and the Protection of Privacy in Genomics Research" 2012 Annu Rev Genomics Hum Genet 415-431

Kaye J et al "Dynamic Consent: A Patient Interface for Twenty-First Century Research Networks" 2015 Eur J Hum Genet 141-146

Manson NC "The Biobank Consent Debate: Why 'Meta-Consent' is not the Solution?" 2019 Journal of Medical Ethics 291-294

Nembaware V et al "A Framework for Tiered Informed Consent for Health Genomic Research in Africa" 2019 Nature Genetics 1566-1571

Nordling L "South African Law may Impede Human Health Research" 2019 Science 802

Ram N "Tiered Consent and the Tyranny of Choice" 2007 Jurimetrics 253-284

South African Law Reform Commission Project 124: Report on Privacy and Data Protection (The Commission Pretoria 2009)

Shabani M and Borry P "Challenges of Web-Based Personal Genomic Data Sharing" 2015 Life Science, Society and Policy 1-13

Shabani M and Marelliv L "Re-identifiability of Genomic Data and the GDPR" 2019 EMBO Reports 1-5

Sheehan M et al "Authority and the Future of Consent in Population-Level Biomedical Research" 2019 Public Health Ethics 225-236

Staunton C et al "Protection of Personal Information Act 2013 and Data Protection for Health Research in South Africa" 2020 IDPL 160-179

Staunton C et al "Safeguarding the Future of Genomic Research in South Africa: Broad Consent and the Protection of Personal Information Act No 4 of 2013" 2019 SAMJ 468-470

Staunton C et al "Correspondence" 2020 SAMJ 175-176

Teare HJA et al "Reflections on Dynamic Consent in Biomedical Research: The Story so Far" 2021 Eur J Hum Genet 649-656

Thaldar DW and Townsend BA "Genomic Research and Privacy: A Response to Staunton et al" 2020 SAMJ 172-174

Thaldar DW et al "South Africa's New Standard Material Transfer Agreement: Proposals for Improvement and Pointers for Implementation" 2020 BMC Medical Ethics 1-13

Townsend BA "The Lawful Sharing of Health Research Data in South Africa and Beyond" 2021 Information and Communications Technology Law 1-18

Townsend BA and Thaldar DW "Navigating Uncharted Waters: Biobanks and Informational Privacy in South Africa" 2019 SAJHR 329-350

Vayena E et al "Caught in the Web: Informed Consent for Online Health Research" 2013 Science Translational Medicine 1-3

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)

British American Tobacco South Africa (Pty) Ltd v Minister of Health 2012 3 All SA 593 (SCA)

CJW Marketing CC v Limpopo Provincial Liquor Board 2008 ZAGPHC 403 (12 December 2008)

Hartswater Hotels BK v Drankraad van die Noord-Kaap 2003 ZANCHC 30 (28 March 2003)

Maharaj v Chairman, Liquor Board 1997 1 SA 273 (N)

New Modderfontein Gold Mining Company v Transvaal Provincial Administration 1919 AD 367

S v Zuma 1995 2 SA 642 (CC)

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

Government publications

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

European Commission Date Unknown Standard Contractual Clauses https://ec.europa.eu/info/law/law-topic/data-protection/international-dimension-data-protection/standard-contractual-clauses-scc_en accessed 20 August 2020

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

Additional Files

Published

15-06-2021

Issue

Section

Articles

How to Cite

Thaldar, D. W., & Townsend, B. A. (2021). Exempting Health Research from the Consent Provisions of POPIA. Potchefstroom Electronic Law Journal, 24, 1-32. https://doi.org/10.17159/1727-3781/2021/v24i0a10420

Similar Articles

101-110 of 1152

You may also start an advanced similarity search for this article.