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.
Highlights
Like a fox in a chicken coop, the Protection of Personal Information Act (POPIA)1 has caused consternation among some scientists, bioethicists, and biolawyers.2 Until recently the issue of acceptable modes of informed consent seemed to have been settled on a position that either specific, broad, or tiered consent is acceptable in South Africa
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
We propose that the health research sector, including both private and public research institutes that conduct health research, should take the following actions: 1) Apply to the Information Regulator for a sector-wide exemption of all health research projects from the requirement that research participant consent must be for a specific purpose – subject to the conditions that: Section 1 of POPIA. Section 57(1)(a) of POPIA. Section 57(3) of POPIA. see the supplementary page where a clearer picture is provided
Summary
Like a fox in a chicken coop, the Protection of Personal Information Act (POPIA) has caused consternation among some scientists, bioethicists, and biolawyers. Until recently the issue of acceptable modes of informed consent seemed to have been settled on a position that either specific, broad, or tiered consent is acceptable in South Africa. As we discuss below, POPIA requires consent to be specific, and for such specific consent to be obtained for various actions that are part of health research, such as the storage and sharing of research information. This has raised concerns that health research in South Africa and with South African collaborators abroad may be impeded.. We show that the possible solutions offered by POPIA can for the most part be embedded in South Africa's well-established and comprehensive regulatory framework for health research.
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