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101120122
30452
Dev World Bioeth
Dev World Bioeth
Developing world bioethics
1471-8731
1471-8847

37192424
10.1111/dewb.12403
nihpa1908953
Article
Children as participants in health research in South Africa: A response to Labuschaigne, Mahomed and Dhai
http://orcid.org/0000-0002-5574-7481
Donnelly Dusty-Lee PhD School of Law, University of KwaZulu-Natal in South Africa.

http://orcid.org/0000-0002-7346-3490
Thaldar Donrich W PhD School of Law, University of KwaZulu-Natal, South Africa
Petrie-Flom Center at Harvard Law School in Cambridge, Massachusetts, USA.

Correspondence: Dusty-Lee Donnelly, PhD, School of Law, Howard College, University of KwaZulu-Natal, Durban, South Africa. donnellyd@ukzn.ac.za
15 6 2023
9 2024
16 5 2023
04 9 2024
24 3 167171
https://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
A complex network of ethico-legal rules makes it difficult for health researchers in South Africa to lawfully recruit adolescents to the kinds of sensitive studies where it may be ethically appropriate to proceed without notifying parents or obtaining parental consent. This article responds to a recent proposal to amend the blanket requirement for mandatory parental consent presently contained in section 71 the South African National Health Act 61 of 2003 [NHA]. The proposed amendment is intended to bring the NHA into alignment with South Africa’s 2015 Department of Health Guidelines on Ethics in Health Research by permitting greater flexibility for a health research ethics committee to waive parental consent, and permit adolescents to consent independently. A lacuna in this proposal is highlighted with reference to the requirements of South Africa’s Protection of Personal Information Act 4 of 2013 [POPIA]: Even if the NHA is amended as proposed, the goal of aligning South African law with prevailing ethics norms in South Africa would not necessarily be attained, as parental consent may still be required by POPIA. This article investigates whether this goal (of aligning the law with ethics) can be attained in a way that is compliant with POPIA. It is concluded that this is indeed possible in a number of ways, and that the best way to attain this goal is by requesting the South African Information Regulator to issue a guidance note to the effect that all health research projects that are approved by institutional health research ethics committees are to be regarded as being in the public interest, which would qualify such health research projects to be exempted from POPIA’s consent requirements.

capacity to consent
children’s consent
children’s personal information
health research participation
Protection of Personal Information Act 4 of 2013
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pmc1 | INTRODUCTION

Children are a vulnerable group within society deserving of special protection. That the best interests of the child are not always served by subjecting them to absolute parental control is trite and has been recognised in scholarship, case law and legislative prescript for some time. This is particularly true in the case of adolescents, who are in the process of developing levels of adult maturity.

In a recent article in this journal, Labuschaigne, Mahomed and Dhai1 present an analysis of the legal and ethical requirements for health research involving adolescents in South African law and highlight the problem that section 71 of the National Health Act [NHA]2 requires mandatory parental consent for all research involving children, while the 2015 Department of Health Guidelines on Ethics in Health Research3 permit greater flexibility for a health research ethics committee (HREC) to waive parental consent, and permit adolescents to consent independently. As a solution, they suggest an amendment to the NHA that would entail, in brief, that research can be conducted with the consent of the minor, provided the minor has sufficient maturity and mental capacity to be able to consent independently, failing which a parent’s consent would be required. Labuschaigne et al.s’ work builds on an article by Strode, Grant and Slack4 which presented a legal and ethical scoping review of provisions for independent consent by minors in South Africa.

However, a lacuna in the analyses of Labuschaigne et al. is their omission of the requirements of the Protection of Personal Information Act 4 of 2013 [POPIA]. POPIA is highly relevant to health research in South Africa, as it deals explicitly with health information and with information in respect of children. In this response article, we do not engage in the merits of the normative argument presented by Labuschaigne et al. (and before them Strode et al.) that the legal requirement of parental consent for children to participate in research should in certain circumstances be waived in favour of consent by children themselves. Instead, we accept arguendo their normative position and focus purely on a positivist analysis of POPIA. We analyse the question: How, if at all, can the normative outcome envisioned by Labuschaigne et al. be attained in a way that is compliant with POPIA? In this way, this response article effectively supplements the article by Labuschaigne et al. to present a more comprehensive analysis of relevant South African law.

2 | WHO IS A CHILD?

The answer is more complex than it might first appear. The legal starting point is that under South African law a minor (i.e., a child) is any person under the age of 18. A person automatically becomes a major (the legal term for an adult) on their eighteenth birthday. The age of majority is determined by statute, most importantly the Constitution of the Republic of South Africa, and section 17 of the Children’s Act 38 of 2005. This is also the position adopted in POPIA, where ‘child’ means ‘a natural person under the age of 18 years who is not legally competent, without the assistance of a competent person, to take any action or decision in respect of any matter concerning him- or herself.’

The term adolescent, on the other hand, is not defined by statute in South Africa. As the term adolescent is used to include persons roughly between the ages of 10−19, it follows that legally there are two categories of adolescent: the adolescent child and the adolescent adult. As far as the law is concerned an adolescent is a child if they are under the age of 18, regardless of their levels of psychological maturity and understanding. An adolescent child (10–17) is thus not legally competent to give informed consent.

There are limited exceptions to this clear legal position. Under the common law, a person under the age of 18 will attain majority status if they marry, or if they become financially independent of their parents. In both circumstances that person would be legally competent to consent to participate in a research project.

In addition, a minor (child) can legally consent to certain medical procedures in terms of statutory exceptions created under the Children’s Act and the Choice on Termination of Pregnancy Act 92 of 1996. These statutory exceptions only apply to consent to the medical procedure. They do not apply to health research concerning the procedure, or the circumstances that led to the child seeking the procedure. Moreover, even if a statute were to relax the provisions for research participation by minors, when the research involves processing personal data, POPIA will override the less stringent provisions. This follows in terms of Section 3(2) (a) of POPIA, which reads:

‘This Act applies, subject to paragraph (b), to the exclusion of any provision of any other legislation that regulates the processing of personal information and that is materially inconsistent with an object, or a specific provision, of this Act.’

As such, health researchers seeking to recruit an adolescent child as a study participant without parental consent will face a legal conundrum in relation to the collection of the child’s personal information. This is the problem that our article seeks to address.

3 | THE PROTECTION OF PERSONAL INFORMATION ACT

POPIA prohibits the processing of special personal information (part B) and all personal information (including special personal information) of children (part C) unless stringent criteria are met. Both parts of POPIA must be read together in the context of health research involving adolescents, who are defined as children (under the age of 18) in POPIA. An HREC cannot lawfully grant a consent waiver that exceeds the bounds of what is permitted under POPIA. There are provisions that might offer a legal pathway that would allow the outcome envisioned by Labuschaigne et al. However, opening up these pathways will require much pioneering effort.

We first analyse the general requirement for parental consent, followed by possible instances in which this general requirement would not apply.

3.1 | The general requirement of parental consent

No collection or other processing of the child’s personal information (including special personal information) may be carried out with the prior consent of a competent person (section 35(1)(a)). A competent person, as defined in Section 1, ‘means any person who is legally competent to consent to any action or decision being taken in respect of any matter concerning a child.’ In other words a parent or legal guardian’s consent is required for all processing of the personal information of a child, including in the context of health research.

In the context of health research the information being collected in the study will include special personal information. Special personal information is defined as:

he religious or philosophical beliefs, race or ethnic origin, trade union membership, political persuasion, health or sex life or biometric information of a data subject; or

the criminal behaviour of a data subject to the extent that such information relates to— the alleged commission by a data subject of any offence; or

any proceedings in respect of any offence allegedly committed by a data subject or the disposal of such proceedings. (own emphasis).

Such information may be processed with the consent of the data subject in terms of section 27(1)(a), but where the data subject is a child, section 11 and section 35 make it clear that lawful consent can only be given by a parent or other competent person. Importantly, POPIA contains no provision in terms of which it is lawful to rely on consent given by a child. The definition of child in POPIA approximates to the common law term minor, which is also the term used in the relevant provisions of the NHA.

In this respect POPIA is therefore aligned with the current position in the NHA—with the difference that parental consent is sufficient in terms of POPIA, while subsections 71(2) and (3) of the NHA additionally require consent by the child where the child ‘is capable of understanding’.

To sum up the position thus far, failure to obtain parental consent for a child’s personal information to be collected and processed for a research project means, as a general rule under POPIA, that the research would be unlawful, and the responsible party (which may include both the research institution and the individual researcher) could be subject to civil damages suits or to criminal sanctions including imprisonment or a fine. However, there are exceptions to this general rule, which we discuss next.

3.2 | The research exemptions

Section 27(1)(d) and section 35(1)(d) permit processing of special personal information and children’s personal information for research without consent in only two scenarios:

it appears to be impossible or would involve a disproportionate effort to ask for consent; or

the purpose serves a public interest and the processing is necessary for the purpose concerned.

3.2.1 | The impossible or disproportionate effort scenario

This scenario is possible in theory, but, we suggest, more difficult to prove in most cases. If it is a matter of the children not having parents, it will clearly be impossible to get those parents’ consent. However, this would need to be proven on a case-by-case basis. Moreover, this is not the only reason why Strode et al. and Labuschaigne et al. are in favour of allowing, under certain circumstances, children to consent without involving their parents. The other main reason proffered by these authors is that parents may be entirely reachable, but may because of the nature of the research not want to consent to their children’s involvement – despite the fact that the research would benefit children generally. Examples are situations where children are engaged in sexual activity or substance abuse. The authors point out that informing the parents of the research without the child’s permission would breach the child’s right to privacy, and informing parents may place the child at risk of intimidation, questioning or harm. In such cases, asking for parents’ consent is evidently possible and does not entail disproportionate effort.

Accordingly, we suggest that this scenario offers a doubtful legal solution—if any. It might be applicable to some children, but not to all children, and will be difficult to prove. With this in mind, we now turn to the second scenario in search of a solution.

3.2.2 | The public interest scenario

The public interest scenario admits of two sub-scenarios:

All health research is in the public interest

Thaldar and Townsend5 suggested that all health research by its nature is in the public interest—subject to being approved by an HREC. If this position is accepted, there is a clear, general legal pathway through POPIA to accomplish Labuschaigne et al.s’ goal. The exemption from having to obtain consent is contained in POPIA itself, and thus requires neither an application to the Information Regulator for prior authorisation of the study (under section 35(2)) nor a specific exemption granted by the Information Regulator (under section 37). However, what remains unsatisfactory is the uncertainty introduced by the existing guidance notes published by the Information Regulator on the processing of special personal information6 and the processing of children’s personal information.7 These fail to address health research at all, and they contain an unduly restrictive interpretation of the concept of ‘public interest’ that has been trenchantly critiqued by Thaldar.8 What is required is thus a once-off request to the Information Regulator to issue a guidance note that all HREC-approved health research projects are regarded to be in the public interest.

In this regard, POPIA provides in sections 27(1)(d) and 35(1)(d) that the general consent exemption for public interest research may only be utilised if sufficient guarantees are provided for to ensure that the processing does not adversely affect the individual privacy of the child to a disproportionate extent. Thus, the onus will be on the researchers and HRECs involved to ensure that the processing of the children’s personal information is done strictly according to POPIA’s other conditions for processing. In other words, POPIA only exempts researchers from the requirement for consent by a parent or other competent person. Importantly, while this exemption means that no consent is required in terms of POPIA, consent may still be required by other sources of the law or ethics, including where appropriate, informed consent by the adolescent participating in the study. It would also, we suggest, be necessary to show that the study’s objectives can only be achieved by recruiting children, and that ethical safeguards are in place. The public interest ground would not be carte blanche to include children in studies that could be successfully conducted with adult participants, or where the children would be subjected to unreasonable harm.

Not all health research is necessarily in the public interest

The second sub-scenario is where Thaldar and Townsend’s position is not accepted, which still offers a pathway through POPIA, but significantly more cumbersome. It would entail that each health research project that seeks to process the personal information of children without their parents’ consent would need to apply on a case-by-case basis to the Information Regulator for prior authorisation of the study in terms of section 35(2) of POPIA and show why it serves the public interest.

Additionally, where prior authorisation is applied for, section 35(3) requires the Information Regulator to determine if any reasonable conditions are to be imposed on the study. The section permits the Information Regulator to require a responsible party to put in place mechanisms by which a parent (or other competent person) is notified of the processing, can request to review the personal information the child has provided, and can refuse to permit further processing (section 35(3)(1)(a) and (b)). Additionally, a condition of authorisation can be that the project will not ‘encourage or persuade’ a child to disclose personal information that is not reasonably necessary for the project purposes, and will put in place reasonable measures to protect both the integrity and confidentiality of the child’s personal information (section 35(3)(1)(c) and (d)).

These conditions are discretionary, and thus the Information Regulator could be asked to waive the review and notice requirements in section 35(1)(a) and (b) which would be highly problematic in the kinds of studies where a parental consent waiver is being considered. However, in our view this creates undesirable (and unnecessary) overlap with the research ethics oversight role that is more appropriately exercised by HRECs who have been mandated under national health legislation to perform this function. As such, we prefer the route of regarding health research as falling under the general consent exemption for public interest research, and leaving the imposition of conditions appropriate to the ethical conduct of the particular study to the oversight of an HREC.

4 | CONCLUSION

Labuschaigne et al. suggest that the NHA be amended, in brief, to allow that research can be conducted with the consent of the minor, provided the minor has sufficient maturity and mental capacity to be able to consent independently, failing which a parent’s consent would be required. POPIA does not allow for such a test of sufficient maturity and mental capacity. As we have shown, the situation in POPIA is that either parental consent is required, or a research exemption applies, and no consent is required. Importantly, in the event that a research exemption applies and no consent is required in terms of POPIA, consent may still be required by other sources of the law or ethics. Equally, in the event that the amendment suggested by Labuschaigne et al. is indeed enacted by parliament, but the research project in question does not qualify for a research exemption in terms of POPIA, involving children in such a research project without their parents’ consent would remain unlawful—and criminal.

Clearly, it is essential to include POPIA in the discourse on child participation in health research in South Africa. For the practical outcome envisioned by Labuschaigne et al. to materialise, we suggest that attention should be given to clarifying when, and if, POPIA’s research exemptions apply. Ideally this should be done through a coordinated effort between the office of the Information Regulator— which can issue a guidance note in this regard—and the National Health Ethics Council—which is currently revising the national ethics guidelines. Our proposal is that the Information Regulator should clarify, by way of a guidance note, that health research falls under the general consent exemption for public interest research. This would mean that researchers do not legally require parental consent to process the adolescent child’s personal information. This would leave the imposition of conditions appropriate to the ethical conduct of the particular study to the proper oversight of an HREC. Without a solution regarding POPIA, the proposed amendment to the NHA will not attain the practical outcome for which Labuschaigne et al. are hoping.

ACKNOWLEDGEMENTS

We acknowledge the support by the US National Institute of Mental Health and the US National Institutes of Health (award number U01MH127690). The content of this article is solely our responsibility and does not necessarily represent the official views of the US National Institute of Mental Health or the US National Institutes of Health.

Dusty-Lee Donnelly, PhD, is an admitted advocate of the High Court of South Africa and a senior lecturer in the School of Law, University of KwaZulu-Natal in South Africa. Her current research interests centre around the impact of data protection laws and the regulation of artificial intelligence.

Donrich W Thaldar, PhD, is a professor in the School of Law, University of KwaZulu-Natal, South Africa; and a visiting scholar at the Petrie-Flom Center at Harvard Law School in Cambridge, Massachusetts, USA. His research interests are biolaw and bioethics. He also has a law practice, where he focuses on strategic litigation in biolaw. He served as legal counsel in several landmark cases in the field of biolaw in South Africa, including South Africa’s first physician-assisted dying test case, and South Africa’s first case of posthumous conception.

CONFLICT OF INTEREST STATEMENT

None to declare.
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