Exempting Health Research from the Consent Provisions of POPIA
Exempting Health Research from the Consent Provisions of POPIA
复制标题
健康研究不受 POPIA 同意条款的约束
DOI：
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发表时间：
2021
期刊：
影响因子：
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通讯作者：
B. Townsend
中科院分区：
文献类型：
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作者：
D. Thaldar;B. Townsend
2013年第4号个人信息保护法（以下简称POPIA）有可能破坏南非的健康研究。虽然法律的现状是研究参与者的广泛同意是可以接受的，但POPIA要求对研究参与者的健康和遗传信息进行任何处理都要获得具体同意。然而，《持久性有机污染物法》提供了一些机制，如免除可能用于减轻其影响的具体措施。建议卫生研究部门应设法利用这些机制-特别是在整个部门范围内豁免所有卫生研究项目，使其不需要研究参与者的具体同意，但须符合下列条件：（a）健康研究项目必须得到健康研究伦理委员会的批准，并且（B）具体，卫生研究项目必须获得广泛或多层次的同意。重要的是，从给卫生研究人员带来不便的角度来处理这种豁免申请将适得其反。相反，豁免申请必须从人权平台提出，并且必须有确凿的证据支持。这种证据应包括对南非研究参与者的偏好进行实证研究的结果。
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.