Safeguarding the future of genomic research in South Africa: Broad consent and the Protection of Personal Information Act No. 4 of 2013

Staunton, Ciara; Adams, Rachel; Botes, Marietjie; Horn, Lyn; Labuschaigne, Melodie; Loots, Glaudina; Mahomed, S; Makuba, J.; Olckers, Antonel; Pepper, Michael Sean; Pope, Anne; Ramsay, Michael A. E.; Loideáin, Nóra Ní; Vries, Jantina de

doi:10.7196/samj.2019.v109i7.14148

Cited by 26 publications

(23 citation statements)

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“…Privacy and confidentiality are defined by the U.S. Department of Health and Human Services (2009) in the U.S. and by the National Department of Health (DoH) Ethics in Health Research Guidelines in South Africa (Staunton et al, 2019). Privacy is the right of an individual (e.g., the PLWH) to keep his / her information private from others, and not unlawfully collected or disseminated (U.S. Department of Health and Human Services, 2009;Staunton et al, 2019) and confidentiality is the protection of health information, which is entrusted to another entity (e.g., the owner of the mHealth SMS/texting system), is kept private (U.S. Department of Health and Human Services, 2009;Staunton et al, 2019). Another aspect of privacy is data privacy-the ability to guarantee that information and data about a person will be protected against both intentional and unintentional exposure (World Health Organization, 2015).…”

Section: Privacy and Confidentialitymentioning

confidence: 99%

“…Privacy is the right of an individual to keep his or her information from unlawful and improper collection and disclosure (U.S. Department of Health and Human Services, 2009;Staunton et al, 2019). For the purposes of this review, personal privacy, the protection of personal information-e.g., HIV status, legal name, drivers' license number, and other identifying informationis distinguished from data privacy.…”

Section: Personal Privacymentioning

confidence: 99%

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Digitized HIV/AIDS Treatment Adherence Interventions: A Review of Recent SMS/Texting Mobile Health Applications and Implications for Theory and Practice

Duthely

Sanchez‐Covarrubias

2020

Front. Commun.

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Section: Privacy and Confidentialitymentioning

confidence: 99%

Section: Personal Privacymentioning

confidence: 99%

Digitized HIV/AIDS Treatment Adherence Interventions: A Review of Recent SMS/Texting Mobile Health Applications and Implications for Theory and Practice

Duthely

Sanchez‐Covarrubias

2020

Front. Commun.

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“…Despite the clear and unambiguous definition of consent as a specific expression of will, some have argued that POPIA may be interpreted as allowing broad consent, based on the legal doctrine of purposive interpretation [24]. We have reservations about the legal merits of such an argument.…”

Section: Legal Environment In South Africamentioning

confidence: 99%

South Africa’s new standard material transfer agreement: proposals for improvement and pointers for implementation

2020

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Background Whenever South African (SA) research institutions share human biological material and associated data for health research or clinical trials they are legally compelled to have a material transfer agreement (MTA) in place that uses as framework the standard MTA newly gazetted by the South African Minister of Health (SA MTA). Main body The article offers a legal analysis of the SA MTA and focuses on its substantive fit with the broader legal environment in South Africa, and the clarity and practicality of its terms. The following problematic aspects of the SA MTA are highlighted: (a) Where only data and no human biological material are transferred, the SA MTA does not apply, leaving a lacuna; (b) Health Research Ethics Committees are required to be parties to a MTA despite it being outside their legal mandate and undermining their oversight function; (c) the SA MTA’s consent provisions are not aligned with extant law; and, similarly, (d) its provision on donor ownership is misaligned with extant law; (e) its creation of fictitious performance can only cause frustration on the part of an injured party; (f) its benefit-sharing provision is vague and will have little practical effect; (g) its dispute-resolution provisions fail to adequately protect South African research institutions and research participants; (h) it fails to provide substantive guidance regarding intellectual property as its provisions relating to intellectual property may cause practical problems; and, finally, (i) its data privacy provision is insufficiently specific, is overbroad, and fails to provide terms that in general would facilitate the international sharing of human biological material and associated data in terms of existing privacy law. Conclusions While some of the problematic aspects of the SA MTA are intricate and require consultative processes with stakeholders and others, to develop comprehensive solutions, most of the problematic aspects can be resolved immediately through amendments by the South African Minister of Health. The formulation of such amendments is proposed and, where possible, interim measures are suggested that may ameliorate the problems presented by the SA MTA.

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“…In South Africa, for instance, the Protection of Personal Information Act No. 4 of 2013 (POPIA) was introduced (Staunton et al, 2019). While these regulations have boosted public trust, there are loopholes that still need to be addressed especially when dealing with international collaborations sharing personal genomic data.…”

Section: Analytical Ethical and Regulatory Challenges In Analysis Omentioning

confidence: 99%

Next Generation Sequencing and Bioinformatics Analysis of Family Genetic Inheritance

et al. 2020

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Mendelian and complex genetic trait diseases continue to burden and affect society both socially and economically. The lack of effective tests has hampered diagnosis thus, the affected lack proper prognosis. Mendelian diseases are caused by genetic mutations in a singular gene while complex trait diseases are caused by the accumulation of mutations in either linked or unlinked genomic regions. Significant advances have been made in identifying novel diseases associated mutations especially with the introduction of next generation and third generation sequencing. Regardless, some diseases are still without diagnosis as most tests rely on SNP genotyping panels developed from population based genetic analyses. Analysis of family genetic inheritance using whole genomes, whole exomes or a panel of genes has been shown to be effective in identifying disease-causing mutations. In this review, we discuss next generation and third generation sequencing platforms, bioinformatic tools and genetic resources commonly used to analyze family based genomic data with a focus on identifying inherited or novel disease-causing mutations. Additionally, we also highlight the analytical, ethical and regulatory challenges associated with analyzing personal genomes which constitute the data used for family genetic inheritance.

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Safeguarding the future of genomic research in South Africa: Broad consent and the Protection of Personal Information Act No. 4 of 2013

Abstract: This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

Cited by 26 publications

References 1 publication

Digitized HIV/AIDS Treatment Adherence Interventions: A Review of Recent SMS/Texting Mobile Health Applications and Implications for Theory and Practice

Digitized HIV/AIDS Treatment Adherence Interventions: A Review of Recent SMS/Texting Mobile Health Applications and Implications for Theory and Practice

South Africa’s new standard material transfer agreement: proposals for improvement and pointers for implementation

Next Generation Sequencing and Bioinformatics Analysis of Family Genetic Inheritance

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