Keywords

Direct-to-consumer genetic testing; saliva sample; removal; tissue; biological material; National Health Act; autonomy; privacy; human dignity; bodily integrity.

1 Introduction

Completion of the Human Genome Project1 and recent advances in science and technology have allowed genetic testing to be conducted inexpensively,2 expeditiously and directly by consumers. Individuals are thus able to access their genetic information without the intervention of a healthcare practitioner or genetic counsellor.3 Direct-to-consumer genetic testing refers to DNA tests for traits, medical or otherwise, that provide the communication and interpretation of results directly to consumers – thus bypassing healthcare professionals.4 However, recently the direct-to-consumer genetic testing model has changed, with more providers now requiring a physician’s involvement before and/or after testing.5

The internet has made the recent surge in direct-to-consumer genetic testing significantly easier by making such tests publicly accessible.6 Anyone with internet access and a credit card can purchase a test.7 Sample collection kits containing a buccal swab are mailed directly to consumers8 who then provide their saliva sample and return the sample via the post.9 Certain direct-to-consumer genetic testing providers offer a single test for one trait, others sell tests for a collection of traits, and some providers conduct genome-wide testing that analyses multiple genetic variants and provides results for numerous traits.10 Consumers can view the results of

the genetic tests through their online accounts or on mobile apps.11 These accounts and apps offer personalised details and risk estimates of their susceptibility to certain genetic conditions or traits.12

The proliferation of direct-to-consumer genetic testing has generated discussion of the ethical, legal and social issues involved,13 the potential harms to consumers, as well as concerns about the commercialisation of genetic testing.14 While direct-to-consumer genetic testing holds several advantages, including patient autonomy and empowerment,15 involvement in healthcare decisions,16 increased affordability and speed,17 greater privacy and convenience,18 and enhanced genetic literacy19 – the field remains contentious. The questionable validity, accuracy and utility of tests, the absence of healthcare professional involvement, the potential misinterpretation of results, privacy concerns about the use and confidentiality of the genetic data,20 follow-up costs which burden healthcare systems,21 genetic discrimination and exaggerated advertising and marketing claims have all been raised as legal and ethical concerns associated with direct-to-consumer genetic testing. Of further note, the business model of most direct-to-consumer genetic testing providers focusses on building large databases of genomes.22 The data generated are invaluable for research and serve to benefit population health through an understanding how genetic factors influence disease predisposition.23 Such research also has the potential to improve diagnostics,24 develop

sound prevention and treatment strategies25 and advance genetic discoveries and drug development.26

One of the most prominent controversies about direct-to-consumer genetic testing is the regulation of the field. Two central issues in regulating direct-to-consumer genetic testing are the need to protect consumers from harm and ensuring that tests are analytically and clinically valid.27 Many academics worldwide have claimed that direct-to-consumer genetic testing is unregulated in their jurisdictions and have advocated legal intervention.28 There is limited South African literature on direct-to-consumer genetic testing, and the little that exists asserts that direct-to-consumer genetic testing is unregulated.29 In this article we challenge this assertion. We focus

on the very first step in the direct-to-consumer genetic testing process, namely the collection of saliva samples by consumers themselves. We show that this is indeed regulated – even over-regulated – but in an unsatisfactory manner that calls for legal reform.

Here is a roadmap of our article: First, we examine the statutory scheme relevant to the collection of saliva samples by consumers as part of the direct-to-consumer genetic testing process. We review the legislation relevant to such a process and the kinds of objects regulated by the statutory scheme, namely saliva, and whether saliva falls within the statutory definitions of "tissue" and/or "biological material". This section concludes that on a plain reading of the statutory scheme, there is an apparent ban on individuals collecting their own saliva samples for direct-to-consumer genetic testing. Next, we consider three possible arguments against the apparent ban on persons collecting their own saliva samples: (1) the ban can be overlooked based on the de minimis principle; (2) the purpose of the legislation is not to regulate the collection of saliva; and (3) personal autonomy. We conclude that the apparent ban on individuals collecting their own saliva samples for direct-to-consumer genetic testing is both irreconcilable with a purposive interpretation of the statutory scheme and unconstitutional. We conclude with recommendations for statutory reform.

2 The statutory scheme

2.1 Overview

The topics of health, genetic testing, and genetic research are regulated by the National Health Act 61 of 2003 (hereafter the NHA) and its relevant regulations, including the Regulations Relating to the Use of Human Biological Material (hereafter the Human Biological Material Regulations),30 and the Regulations Relating to the Taking of Buccal Sample or Withdrawal of Blood from a Living Person for Testing (Amendment) (hereafter the

Buccal Sample and Blood Withdrawal Regulations).31 We refer to these statutes collectively as the "statutory scheme".

2.2 The kinds of objects that are regulated by the statutory scheme

To determine whether a specific act performed in the context of genetic testing and/or genetic research is regulated by the statutory scheme depends on whether the object of the act – in this case saliva – falls within the definitional scope of the kinds of objects that are regulated by the statutory scheme (we refer to objects of this kind as "regulated objects"). This is not always a straightforward exercise, given the bifurcated nature of the lexicons used by the statutory scheme.32 While the NHA itself and some of its regulations use terms such as "tissue", "gametes", "blood", and "blood products" to denote the kinds of objects that are regulated, one of the most consequential sets of regulations made in terms of the NHA – the Human Biological Material Regulations – introduces a shift away from these terms and instead uses the term "biological material". Importantly, as we discuss in more detail below, although there is an overlap in meaning between some of the terms of the two lexicons, the terms and their meanings in the NHA and the Human Biological Material Regulations are not the same. Accordingly, in order to determine whether saliva falls within the definitional scope of the kinds of objects that are regulated by the statutory scheme, it is necessary to consider the relevant terms in each of these lexicons. First, consider the NHA's term "tissue". The NHA defines "tissue" as:

[H]uman tissue, and includes flesh, bone, a gland, an organ, skin, bone marrow or body fluid, but excludes blood or a gamete.33

Although human tissue in its common meaning does not include saliva, the fact that the NHA's definition includes "body fluid" expands "tissue" beyond its normal meaning to include saliva.34

Second, "biological material" in the Human Biological Material Regulations is defined as follows:

[M]aterial from a human being including DNA, RNA, blastomeres, polar bodies, cultured cells, embryos, gametes, progenitor stem cells, small tissue biopsies and growth factors from the same.35

The use of the word "including" indicates that this definition is not a closed list and may incorporate other types of material from a human being.36 Since saliva is "material from a human being", saliva is included in the definition of "biological material". Accordingly, irrespective of the lexicon, saliva falls within the definitional scope of the regulated objects.

In the following section we analyse the way in which the statutory scheme regulates acts with regulated objects in the context of genetic testing and/or genetic research.

2.3 The apparent ban on persons who collect buccal swabs themselves

Generally when dealing with regulated objects there are defined categories of persons (usually qualified professionals) who are legally permitted to perform certain acts with these objects. The most apparent reason is that regulated objects are typically used in the clinical healthcare and health research contexts. Direct-to-consumer genetic testing differs in this regard as consumers (usually individual laypersons) are responsible for collecting their own saliva samples, typically with no professional oversight.37 Ostensibly to minimise potential harm to individuals due to the erroneous handling of samples, South Africa's extant law appears to place the duties

relating to samples on those with some sort of professional qualification. For example, the NHA requires a registered medical practitioner or dentist to remove, use or transplant tissue from a living person.38 The Human Biological Material Regulations permit only "competent persons" – a term that is defined to include only certain types of healthcare professionals – to undertake activities relating to biological material.39 But what is the position in the context of direct-to-consumer genetic testing, where it is not a professional but rather an "unqualified" consumer without specialist training who is responsible for collecting a saliva sample? Are these consumers legally permitted to collect their own saliva samples, where they are to be used in direct-to-consumer genetic testing and possibly for subsequent genetic research?

Section 59(1) of the NHA provides that only registered medical practitioners or dentists are permitted inter alia to "remove any tissue from a living person".40 This clearly exclude laypersons. Similarly the Human Biological Material Regulations provide that only a "competent person" may remove biological material for "genetic testing, genetic health research or therapeutic purposes",41 and that this must be undertaken at an authorised and prescribed institution.42 The definition of "competent person" in the Human Biological Material Regulations provides various categories under which a competent person may fall, depending on the circumstance, the activity and the purpose for which the biological material will be used.43 For example, a person registered as a medical practitioner or a health professional trained as a phlebotomist and registered in terms of the Health Professions Act 56 of 1974 (hereafter the Health Professions Act) or as a nurse in terms of the Nursing Act 33 of 2005 (hereafter the Nursing Act) is required for intravenous blood withdrawal,44 a medical practitioner registered under the Health Professions Act as a specialist in the procedure is required for the intra-arterial withdrawal of blood,45 and a urologist registered in terms of the Health Professions Act or a male reproductive health expert is required for the withdrawal of sperm.46 However, prior to

listing these categories the definition states that "'competent person' means trained…".47 This implies that a "competent person" requires some type of professional training in a particular area and thus appears to exclude laypersons, who generally lack medical or scientific expertise.

The Buccal Sample and Blood Withdrawal Regulations provide that a healthcare provider or a person considered in section 56 of the NHA who is not a healthcare provider but who has undergone specified training may take a buccal sample or remove blood from another living person.48 As such, the Buccal Sample and Blood Withdrawal Regulations are not applicable to taking a buccal sample from oneself.

A brief excursus on regulation 2 of the Buccal Sample and Blood Withdrawal Regulations is necessary to point out a legal anomaly. It refers to a person considered in section 56 of the NHA as possibly not a healthcare provider. However, this can never be the case. Section 56 of the NHA provides inter alia that a "person" may use tissue removed from a living person only for such medical or dental purposes as may be prescribed through regulation. This section in isolation does not seem to limit the kind of person that may use tissue as prescribed. However, section 59(1) of the NHA, referred to above, makes it clear that for the purposes of Chapter 8 of the NHA, which includes section 56, only a registered medical practitioner or dentist may remove any tissue from a living person. Accordingly, the "person" referred to in section 56 of the NHA must be a registered medical practitioner or dentist. This considered, the reference in the Buccal Sample and Blood Withdrawal Regulations to a person considered in section 56 of the NHA who is not a healthcare provider is anomalous. The NHA defines a "health care provider" as "a person providing health services in terms of any law", including inter alia the Health Professions Act.49 Since a registered medical practitioner or dentist is a healthcare provider, the person referred to in section 56 of the NHA can only be a healthcare provider.

To conclude our analysis of how the statutory scheme regulates the collection of saliva for direct-to-consumer genetic testing: Both the NHA and the Human Biological Material Regulations render it unlawful for persons to

collect a buccal sample themselves. Is this the writing on the wall for direct-to-consumer genetic testing?

In the following section, we analyse three possible arguments against the conclusion that persons are legally banned from collecting their own saliva samples for direct-to-consumer genetic testing.

3 Arguments against the apparent ban on persons collecting buccal swabs themselves

3.1 The ban can be ignored based on the de minimis principle

The first possible argument would be that the ban on individuals collecting their own saliva samples can be ignored based on the maxim de minimis non curat lex (the law does not concern itself with trifles) – also known as the de minimis principle.50 Is a seemingly harmless buccal swab something that the law should concern itself with? The problem with reliance on the de minimis principle is the subjectivity involved in deciding whether an issue is actually trifling or not. Those who oppose direct-to-consumer genetic testing because of ethical concerns such as whether test results are useful and whether consumers can understand the genetic information that is provided to them without professional assistance would argue that the statutory ban on collecting one's own saliva sample plays an important role in protecting persons from unscrupulous direct-to-consumer genetic testing providers that function outside of the traditional healthcare system. We do not suggest that such an argument will necessarily have force in a court of law – but it could. Accordingly, it would be cavalier of direct-to-consumer genetic testing providers that consider entering the market and offering their products and services in South Africa to assume that this issue is unimportant. Therefore, the argument based on the de minimis principle does not contribute much to legal certainty.

3.2 The purpose of the legislation is not to regulate saliva

Although a plain reading of the statutory scheme renders it unlawful to collect one's own saliva for a direct-to-consumer genetic test, in the light of South Africa's commitment to purposive interpretation the question must be asked: Is this truly the purpose of the statutory scheme? We suggest that there are a number of indicia that point to a negative answer. First, while

blood, gametes, ova, and sperm are specifically catered for in the definition of "competent person" in the Human Biological Material Regulations, saliva is not mentioned.51 One can argue that this omission indicates that the purpose of the Human Biological Material Regulations is not to regulate the collection of saliva. It can be countered that the Human Biological Material Regulations do contain a general provision that "[n]o person, except a competent person, may remove biological material".52 However, lacking any provision about who would be a "competent person" in the case of saliva, this general provision does not seem to compensate for the omission in the definition of "competent person" in the Human Biological Material Regulations.

Second, the ostensible purpose of the provisions in the statutory scheme that only certain healthcare professionals may remove regulated objects from living persons is to protect the health and bodily integrity of persons from whom biological material is removed. But clearly there is a difference in the risk involved in the withdrawing a vial of blood for genetic testing or research and collecting a saliva sample. While using a blood sample is common in genetic testing in the clinical context, direct-to-consumer genetic testing uses less invasive saliva samples, which consumers can easily collect at home. Although there are risks involved in collecting saliva samples, such as the contamination of the saliva sample53 or the compromising of DNA quality and yield54 leading to inaccurate results, these are not risks to the health and bodily integrity of the person providing the saliva sample for direct-to-consumer genetic testing. Collecting a saliva sample for a direct-to-consumer genetic test merely entails spitting into a tube or swabbing the inside of one's cheek to obtain the necessary cells from which DNA can be extracted, sequenced, and analysed.55 By contrast, blood withdrawal involves inserting a needle into a vein, which requires precision and some medical knowledge. This poses a risk to one's health and bodily integrity. It is evident that professional training and skill are necessary for genetic testing using blood, while collecting a saliva sample

is a relatively straightforward process. In addition, direct-to-consumer genetic testing providers typically provide step-by-step instructions on how to collect a saliva sample which, if followed, should mean that there are no complications.

The third indicium that the purpose of the statutory scheme cannot be to regulate the self-collection of saliva is the practical reality that thousands of diabetics regularly prick their own fingers to check and manage their blood sugar levels – in apparent disregard of the statutory scheme. The Human Biological Material Regulations specifically provide for situations where a finger prick to obtain a drop of blood is sufficient for testing and, in such a case, define a "competent person" as someone registered in terms of the Health Professions Act.56 Such a "competent person" may obtain a drop of blood for "therapeutic purposes",57 which would include managing a diabetic's blood sugar levels. Does this mean that all diabetic individuals who are pricking their own fingers are contravening the Human Biological Material Regulations? On a plain reading of the Human Biological Material Regulations, the answer must be affirmative, constituting a mass-scale, ongoing contravention. However, it would be absurd to criminally prosecute all of these diabetics.58 Accordingly, a reading of the statutory scheme that excludes pricking one's own finger to obtain a blood sample for therapeutic purposes is necessary. If this conclusion is accepted, then consistency would demand that the same applies to collecting one's own saliva sample. This is amplified by considering that in the case of diabetics, a finger prick can be painful and may cause bleeding or bruising, and yet individuals do this themselves at home. By contrast, collecting a saliva sample involves no pain and should not have any side effects. In comparison to other procedures, such as blood withdrawal, the risks associated with the collection of a saliva sample are minimal and thus it can be done without professional oversight.

Given the three indicia analysed above, we suggest that a purposive interpretation of the statutory scheme points away from a prohibition on persons collecting their own saliva samples for direct-to-consumer genetic testing.

3.3 Personal autonomy

A value that is relevant to the current analysis is autonomy. Autonomy refers to individual freedom or self-determination.59 The Stanford Encyclopedia of Philosophy defines autonomy as:

[A]n idea that is generally understood to refer to the capacity to be one's own person, to live one's life according to reasons and motives that are taken as one's own and not the product of manipulative or distorting external forces.60

The Constitutional Court in Barkhuizen v Napier (hereafter Barkhuizen) described "self-autonomy"61 as "the ability to regulate one's own affairs, even to one's own detriment". In South African case law, autonomy has been recognised as a constitutional value that underlies various rights such as human dignity, freedom and privacy. In NM v Smith (hereafter NM)62 O'Regan J in her dissenting judgment held as follows:

Recognising the role of freedom of expression in asserting the moral autonomy of individuals demonstrates the close links between freedom of expression and other constitutional rights such as human dignity, privacy and freedom. Underlying all these constitutional rights is the constitutional celebration of the possibility of morally autonomous human beings independently able to form opinions and act on them … Our Constitution seeks to assert and promote the autonomy of individuals …63

From an individual's perspective, the purpose of participating in direct-to-consumer genetic testing is to obtain information on and insight into one's own genetic make-up. The self-collection of a saliva sample by an individual is the first step toward this purpose, and is done of the individual's own free will.64 We therefore suggest that collecting one's own saliva sample for direct-to-consumer genetic testing is an expression of autonomy.

The value of autonomy as well as the constitutional rights linked thereto are relevant to direct-to-consumer genetic testing in several ways. Below we analyse the constitutional rights of human dignity, privacy, and bodily integrity and show how – because each of these rights is infused by the value of autonomy – prohibiting individuals from collecting their own saliva samples for direct-to-consumer genetic testing infringes on autonomy and is thereby a violation of these constitutional rights.

First, dignity is explicitly recognised as a right in the Constitution of the Republic of South Africa, 1996 (hereafter the Constitution).65 In National Coalition for Gay and Lesbian Equality v Minister of Justice (hereafter National Coalition),66 it was held that at a minimum dignity necessitates acknowledging "the value and worth of all individuals as members of our society."67 In Teddy Bear Clinic for Abused Children v Minister of Justice

and Constitutional Development (hereafter Teddy Bear Clinic),68 the Constitutional Court linked this recognition of individual worth with respecting individual choices. The Court held that:

[D]ignity recognises the inherent worth of all individuals (including children) as members of our society, as well as the value of the choices that they make.69

In Barkhuizen the Constitutional Court held that autonomy is "the very essence of freedom and a vital part of dignity".70 This is elaborated on by the Constitutional Court in MEC for Education: KwaZulu-Natal v Pillay (hereafter Pillay)71 as follows:

A necessary element of freedom and of dignity of any individual is an 'entitlement to respect for the unique set of ends that the individual pursues' … That we choose voluntarily rather than through a feeling of obligation only enhances the significance of a practice to our autonomy, our identity and our dignity.72

Accordingly, dignity demands that individuals' autonomy be respected. We have already established that collecting one's own saliva sample for direct-to-consumer genetic testing is an expression of autonomy. Therefore, it follows that collecting one's own saliva sample for direct-to-consumer genetic testing is protected by the right to dignity. The apparent ban in the statutory scheme on individuals collecting their own saliva samples therefore infringes on the right to dignity.

Second, the constitutional right to privacy73 also shares links with autonomy and dignity. The right to privacy entails that individuals "have a right to a sphere of intimacy and autonomy that should be protected from invasion."74 In Bernstein v Bester (hereafter Bernstein)75 Ackermann J referred to privacy as the "inner sanctum of a person".76 The right to privacy includes

the right to live life, within a personal realm, as one pleases,77 and free from interference.78 We suggest that an individual's choice to participate in direct-to-consumer genetic testing and to self-collect saliva for this purpose falls within this "inner sanctum" and personal realm – and is thus protected by the right to privacy. The apparent ban on individuals collecting their own saliva sample therefore not only infringes on the right to dignity but also on the right to privacy.

Third, individuals enjoy the right to bodily integrity,79 which consists of two elements: "security in" and "control over" one's body.80 The former represents protecting bodily integrity against external intrusions, while the latter indicates the protection of "bodily autonomy or self-determination against interference".81 We suggest that the act of collecting one's own saliva from one's own body for direct-to-consumer genetic testing is protected by the right to bodily integrity. This adds a third rights infringement to the apparent ban on individuals collecting their own saliva sample.

In order to promote autonomy, individuals should have the freedom and the privacy to do as they wish with their own bodies, free from governmental control, and where the risk of harm to themselves and others is minimal. In line with this, prohibiting individuals from collecting their own saliva samples for direct-to-consumer genetic testing violates their autonomy. Can there be a legitimate government purpose that is served by outlawing individuals from collecting their own saliva samples? The ostensible purpose of the provisions in the statutory scheme that only certain healthcare professionals may remove regulated objects from living persons is to protect the health and bodily integrity of persons from whom biological material is removed. This is indeed a legitimate government purpose. But, as we have already argued, it is certainly not applicable to the self-collection of a saliva sample. While there are several concerns pertaining to direct-to-consumer genetic testing in the absence of a healthcare professional, we suggest that there is simply no conceivable legitimate government purpose that is served by

prohibiting individuals from collecting their own saliva samples. Accordingly the relevant provisions of the statutory scheme that purport to ban individuals from collecting their own saliva samples for direct-to-consumer genetic testing are unconstitutional and hence invalid.

4 Conclusion

Although a plain reading of the statutory scheme prohibits individuals from collecting their own saliva samples for direct-to-consumer genetic testing, we suggest that a plain reading is evidently untenable. Not only is a plain reading incompatible with a purposive interpretation of the statutory scheme, but it is also unconstitutional. What is the impact of this conclusion on the practice of direct-to-consumer genetic testing? Simply that the first step in the process – collecting saliva samples by the consumers themselves – is lawful.

It is interesting to note that the Draft Regulations Regarding the Use of Human DNA, RNA Cultured Cells, Stem Cells, Blastomeres, Polar Bodies, Embryos, Embryonic Tissue and Small Tissue Biopsies for Diagnostic Testing, Health Research and Therapeutics (hereafter the Draft Testing and Research Regulations)82 – although never made into law in its draft form – explicitly provides for individuals to collect their own saliva samples. The Draft Testing and Research Regulations states that a "competent person" in the case of collecting cells from the inside of the cheek (buccal swab) is:

[A]ny person who has been trained to perform such a procedure or the person himself/herself who provides the sample for genetic testing.83

However, even if this definition of "competent person" in the Draft Testing and Research Regulations had become law, it would have been in ostensible conflict with a plain reading of the NHA and the Human Biological Material Regulations. As such, we recommend that the relevant provisions of the NHA and the Human Biological Material Regulations be amended to accommodate situations wherein individuals collect their own saliva (and blood by finger pricking) – aligned with the Draft Testing and Research Regulations.

Although the analysis in this article was limited to only the first step of the process of direct-to-consumer genetic testing, it is already evident that the assertion in the literature that direct-to-consumer genetic testing is "unregulated" in South Africa is mistaken. The first step in the process of direct-to-consumer genetic testing is regulated, but poorly so, and is in dire need of reform. The subsequent steps in the direct-to-consumer genetic testing process remain a greenfield – awaiting legal analysis.

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Tamir S "Direct-to-Consumer Genetic Testing: Ethical-Legal Perspectives and Practical Considerations" 2010 Med Law Rev 213-238

Thaldar and Shozi forthcoming SALJ

Thaldar DW and Shozi B "The Legal Status of Human Biological Material Used for Research" forthcoming SALJ

Thaldar and Steytler 2021 SALJ

Thaldar DW and Steytler MR "Time for Cinderella to Go to the Ball: Reflections on the Right to Freedom of Scientific Research" 2021 SALJ 260-288

Thrush and McCaffrey 2010 J Nurse Pract

Thrush SA and McCaffrey R "Direct-to-Consumer Genetic Testing: What the Nurse Practitioner Should Know" 2010 J Nurse Pract 269-273

Tiller and Lacaze 2018 Front Public Health

Tiller J and Lacaze P "Regulation of Internet-Based Genetic Testing: Challenges for Australia and Other jurisdictions" 2018 Front Public Health 1-6

Varga 2012 J Genet Counsel

Varga EA "You Want to Do What? My Mother's Choice to have Direct-to-Consumer Genetic Testing" 2012 J Genet Counsel 382-385

Wright, Hall and Zimmern 2011 Genet Med

Wright CF, Hall A and Zimmern RL "Regulating Direct-to-Consumer Genetic Tests: What is All the Fuss About?" 2011 Genet Med 295-300

Case law

AB v Minister of Social Development 2016 2 SA 27 (GP)

Barkhuizen v Napier 2007 5 SA 323 (CC)

Bernstein v Bester 1996 2 SA 751 (CC)

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

Khumalo v Holomisa 2002 5 SA 401 (CC)

MEC for Education: Kwazulu-Natal v Pillay 2008 1 SA 474 (CC)

Minister of Safety and Security v Xaba 2003 2 SA 703 (D & CLD)

National Coalition for Gay and Lesbian Equality v Minister of Justice 1999 1 SA 6 (CC)

NM v Smith 2007 5 SA 250 (CC)

Teddy Bear Clinic for Abused Children v Minister of Justice and Constitutional Development 2014 2 SA 168 (CC)

Legislation

Constitution of the Republic of South Africa, 1996

Consumer Protection Act 68 of 2008

Health Professions Act 56 of 1974

National Health Act 61 of 2003

Nursing Act 33 of 2005

Government publications

Draft Regulations Regarding the Use of Human DNA, RNA Cultured Cells, Stem Cells, Blastomeres, Polar Bodies, Embryos, Embryonic Tissue and Small Tissue Biopsies for Diagnostic Testing, Health Research and Therapeutics (GN R7 in GG 29526 of 5 January 2007)

Regulations Regarding the General Control of Human Bodies, Tissue, Blood, Blood Products and Gametes (GN R180 in GG 35099 of 2 March 2012)

Regulations Relating to the Taking of Buccal Sample or Withdrawal of Blood from a Living Person for Testing (Amendment) (GN R944 in GG 34750 of 11 November 2011)

Regulations Relating to the Use of Human Biological Material (GN R177 in GG 35099 of 2 March 2012)

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23andMe date unknown Difference Between DNA Genotyping and Sequencing https://customercare.23andme.com/hc/en-us/articles/

202904600-Difference-Between-DNA-Genotyping-Sequencing accessed 17 January 2021

23andMe date unknown https://customercare.23andme.com/hc/en-us/articles/202904530-Providing-Saliva-Sample-for-DNA-Test-Kit

23andMe date unknown Providing Saliva Sample for DNA Test Kit https://customercare.23andme.com/hc/en-us/articles/202904530-Providing-Saliva-Sample-for-DNA-Test-Kit accessed 9 January 2021

23andMe date unknown https://www.23andme.com/howitworks/

23andMe date unknown How it Works https://www.23andme.com/ howitworks/ accessed 20 November 2020

Christman 2020 https://plato.stanford.edu/entries/autonomy-moral/

Christman J 2020 Autonomy in Moral and Political Philosophy https://plato.stanford.edu/entries/autonomy-moral/ accessed 20 June 2021

CRIN 2018 https://archive.crin.org/en/home/what-we-do/policy/bodily-integrity.html

Children Rights International Network 2018 Bodily Integrity https://archive.crin.org/en/home/what-we-do/policy/bodily-integrity.html accessed 14 April 2021

LexisNexis date unknown https://www.lexisnexis.co.uk/legal/glossary/de-minimis

LexisNexis date unknown De Minimis Definition https://www.lexisnexis.co.uk/legal/glossary/de-minimis accessed 10 May 2021

Merriam-Webster date unknown https://www.merriam-webster.com/medical/body%20fluid

Merriam-Webster Online Dictionary date unknown Body Fluid https://www.merriam-webster.com/medical/body%20fluid accessed 3 August 2020

National Human Genome Research Institute 2020 https://www.genome.gov/about-genomics/fact-sheets/A-Brief-Guide-to-Genomics

National Human Genome Research Institute 2020 A Brief Guide to Genomics https://www.genome.gov/about-genomics/fact-sheets/A-Brief-Guide-to-Genomics accessed 2 May 2022

List of Abbreviations