The South African Medico Legal Society

INFORMED CONSENT IN SOUTH AFRICAN MEDICAL LAW WITH REFERENCE TO LEGISLATIVE DEVELOPMENTS

PA Carstens

BLC LLB LLD (Pret)

Professor in Criminal and Medical Law, University of Pretoria

Associate member of the Pretoria Bar

Department of Public Law

University of Pretoria

Tel: (012) 420 4067

Fax: (012) 420 2991

e-mail: pieter.carstens@up.ac.za

1. INTRODUCTION

In this presentation the current positive law pertaining to informed consent in South African medical law is assesssed. The assessment is made with reference to the reason for the requirements for informed consent; the concept of patient autonomy; the purpose and function of informed consent as well as the nature and scope thereof; the issue of diagnosis disclosure; extensions and restrictions to the physician’s duty to inform; the required standard of disclosure in context of medical research; and the requirement for informed consent in new medico-legal legislation introduced in South Africa. It is submitted that the doctrine of informed consent in medical law (in terms of legislative developments), can only be understood against the backdrop of the above assessment.

2. REASON FOR REQUIREMENT OF INFORMED CONSENT

Ordinarily, lawful consent is out of the question unless the consenting party knows and appreciates what it is that he or she is consenting to. Since the patient is usually a layperson in medical matters, knowledge and appreciation on his or her part can only be effected by appropriate information. In this way, adequate information becomes a requisite of knowledge and appreciation and, therefore, also of lawful consent. In the absence of information, real consent will be lacking. In turn, this means that the doctor, as an expert, is saddled with a legal duty to provide the patient with the necessary information to ensure knowledge and appreciation and, hence, real consent on the patient's part. The doctor's duty of disclosure is not treated as one of negligence, arising from a breach of care, but as one of consent in the contractual setting (1).

3. PATIENT AUTONOMY

The requisite that consent in the medical context must be informed consent is usually associated with the so-called "doctrine of informed consent", which has in recent times received judicial recognition and acceptance. Accordingly, patient autonomy as a fundamental right has been endorsed and medical paternalism rejected. The ultimate decision to undergo (informed consent) or refuse (informed refusal) a medical intervention lies with the patient and not with the doctor. This applies even if, from the point of view of the medical profession, a refusal by the patient to undergo the proposed intervention would be grossly unreasonable and might result in his or her death, and even if the medical profession takes the view that the disclosure of the risks and dangers in such circumstances is unnecessary or undesirable. In the absence of other grounds of justification, medical interventions without the patient's consent on the basis of the "patient's-best-interest" and the "doctor-knows-best" criteria constitute a violation of the patient's autonomy (2).

4. PURPOSE AND FUNCTION

The purpose and function of the doctrine of informed consent are twofold:

· To ensure the patient's right to self-determination and freedom of choice; and

· to encourage rational decision-making by enabling the patient to weigh and balance the benefits and disadvantages of the proposed intervention in order to come to an enlightened choice either to undergo or refuse it (3).

5. HOW DETAILED MUST IT BE?

As regards the nature and scope of the information which must be disclosed, the doctor is obliged to:

· give the patient a general idea in broad terms and

· in a layperson's language

· of the nature, scope, consequences, risks, dangers, complications, benefits and

· disadvantages and prognosis of,

· as well as the alternatives to the proposed intervention (4).

More particularly, all serious and typical risks and dangers should be disclosed, but not unusual or remote risks and dangers, unless they are serious or typical, respectively, or the patient makes enquiries about them (5).

The test of disclosure is whether the risk or danger inherent in the intervention in question is material, a risk or danger being material if in particular circumstances:

· A reasonable patient, if warned of the risk or danger, would be likely to attach significance to it; or

· the doctor is or should reasonably be aware that the individual patient, if warned of the danger, would be likely to attach significance to it (6).

Expert evidence is relevant in determining what risks or dangers are inherent in or the result of a particular intervention and whether or not they are material, provided it is borne in mind that the matter will not be concluded on the basis of expert evidence alone, but will ultimately be decided upon by the court (7).

What a careful and reasonable doctor would disclose would depend upon the circumstances, such as the nature of the matter to be disclosed, the nature of the medical intervention, the patient's desire to be informed, the patient's temperament and health and the patient's intelligence and understanding. However, the doctor should avoid causing the patient anxiety and distress by an unnecessary disclosure of an adverse diagnosis or the adverse consequences of the proposed intervention (8).

6. DIAGNOSIS DISCLOSURE

Whether disclosure of the diagnosis is obligatory, is a moot point, but it is conceivable that diagnosis disclosure is imperative where:

· It may affect the patient's decision whether or not to submit to the proposed intervention;

· it is an express or implied term of the contract between doctor and patient;

· it is essential for therapy (9).

7. EXTENSIONS OF DUTY

An extended duty of disclosure is commonly recognised and accepted where the patient asks questions, in which case there is a duty incumbent upon the doctor to respond both fully and truthfully to the patient's enquiries (l0).

8. RESTRICTIONS OF DUTY

No duty of disclosure exists where:

· The patient is already in possession of the requisite information;

· the patient expressedly or impliedly waives his/her right to information;

· the defence of so-called "therapeutic privilege" or "contra-indication", in terms of which the harm caused by disclosure would be greater than the harm caused by non-disclosure; or

· disclosure is, in the circumstances, physically impossible (11).

Consent must be freely and voluntarily given: that is not induced by force, fear or fraud. Consent must be clear and unequivocal - in this regard it is imperative that the surgeon should personally discuss the procedure and the complications with the patient with the aid of a comprehensive consent document. Consent must be comprehensive: that is extend to the entire transaction, inclusive of its consequences (12).

9. CASE LAW

The above principles pertaining to informed consent were accepted by the South African judiciary in the important case of Castell v De Greeff 1994 (4) SA 408(C). The impact or effect of this decision is of significance with regard to the doctrine of informed consent in South African medical law, for the following reasons:

a) Importing and accepting the doctrine of informed consent in South African medical law;

b) Ousting medical paternalism in favour of patient autonomy;

c) Treating lack of informed consent as an issue of assault and not negligence; and

d) Establishing the yardstick of the "reasonable patient" as the test for informed consent and not that of the "reasonable doctor".

10. ABSENCE OF INFORMED CONSENT INDICATIVE OF CIVIL ASSAULT?

The construction in our law that a doctor in civilly liable for assault if medical treatment is undertaken without informed consent has been questioned in Broude v McIntosh 1998 (3) SA 69 (SCA), but the decision in Castell v De Greeff was not overturned. It should be noted that the legal consequences of medical interventions without the patient's effective consent are that the doctor/hospital may incur liability for (a) breach of contract; (b) civil or criminal assault (a violation of bodily integrity); (c) civil or criminal iniuria (a violation of dignity/privacy), or (d) negligence, as the case may be.

11. STANDARD OF DISCLOSURE IN CONTEXT OF MEDICAL RESEARCH

It is submitted that within the context of medical research, however, that the minimum standard of disclosure in both therapeutic and non-therapeutic research should be so-called "full disclosure". The patient should be informed that the proposed medical intervention involves research and must be furnished with comprehensive and detailed information about (a) the precise nature, scope, purpose and duration of the proposed research project (that is whether it is therapeutic, non-therapeutic, invasive, non-invasive, a pilot study, controlled, randomised, single blind, double blind, triple blind or quadruple blind, and whether or not placebos are involved); (b) the nature, scope and consequences of the proposed research intervention; (c) the anticipated benefits and advantages, if any, of the proposed research intervention for the patient and society, and where the proposed research intervention is therapeutic, its benefits and disadvantages as compared to those of available standard therapy; and (d) the foreseeable prognosis and all foreseeable and additional risks, dangers and complications, as well as the possibility of unforeseen risks, dangers and complications, regardless of whether the proposed research is therapeutic or non therapeutic. In a different context, the research subject should also be informed that participation is voluntary and that he or she is under no obligation to consent to the research procedure and that a refusal will not adversely affect future treatment and he/she is free to withdraw his or her consent at any time. In addition, the research subject should be given sufficient time to contemplate and decide on participation in the research project (13).

12. CURRENT LEGISLATIVE MEASURES GOVERNING CONSENT

It is common cause that consent must be given by someone who is legally capable of consenting. Two broad categories of patients may be distinguished in this context:

12.1 Adults

Provided that they are of sane and sober mind, adults have the capacity to validly to consent to medical interventions. Patients in a state of unconsciousness, intoxication, delirium, trance, shock or coma, may be incapable of consenting in law.

Mentally ill patients are specifically catered for by the Mental Health Act, which provides that where a patient is on account of mental illness incapable of consenting to medical treatment of an operation upon himself or herself, the following persons, in order of precedence, may give written consent to the treatment or operation: A curator, the patient’s spouse, parent, major child or brother or sister (14). In the absence of such persons or where such persons cannot be found, the superintendent (CEO) of the mental institution where the patient finds himself or herself may give written consent to the required treatment or operation.

In the case of married couples, each spouse must consent to his or her own medical intervention, inclusive of medical interventions in the parties’ procreative functions by means of contraception, sterilization and abortion (15).

12.2 Minors

In the absence of specific legislative provisions to the contrary and provided they are sane and sober, minors who have attained the age of fourteen years are legally competent to consent to medical treatment of themselves and their children, and minors who have attained the age of eighteen years are legally competent to consent to medical operations upon themselves. Conversely, minors under the age of fourteen or eighteen years need the consent of their parents or guardians to medical treatment or operations respectively. In the event of a conflict between the child’s father and mother, the father’s views settle the matter unless they go manifestly against the child’s medical interests. Where the parents or guardians have delegated their power to consent to medical interventions upon their children to persons acting in loco parentis, such as relatives or teachers, the latter’s consent suffices. The supreme court is also vested, as the upper guardian of minors, with the power to authorize the intervention in question (16)

Moreover, to cater for contingencies, the Child Care Act (17) vests the authority to consent to necessary operations upon and medical treatment of children in persons other than the child’s parents or guardians:

(a) The minister concerned where the parent or guardian refuses consent to the operation or treatment, or cannot be found, or is by reason of mental illness unable to give such consent, or deceased; and

(b) the superintendent of a hospital, heads of institutions, such as reform schools, schools of industries and children’s homes, and persons in whose custody the child finds himself or herself, where the superintendent or head, as the case may be, is of the opinion that an operation or medical treatment is necessary to preserve the child’s life or to save him or her from serious and lasting physical injury or disability and so urgent that it ought not be deferred for the purpose of consulting the person who is legally competent to consent to the operation or treatment.

Whether or not a minor under the age of fourteen years has the right to refuse indicated medical treatment, or a minor under the age of eighteen years has the right to refuse a medically indicated operation, and whether or not such a minor may be compelled, by his or her parents or guardians or person acting in loco parentis, to undergo such an intervention, is an open question (18).

13. RECENT/NEW LEGISLATION INTRODUCED IN SOUTH AFRICA IMPACTING

ON INFORMED CONSENT IN MEDICAL LAW

13.1 General remarks:

In terms of the final Constitution of the Republic of South Africa (Act 108 of 1996 [which came into operation on 4 February 1997]), national legislation had to be enacted within three years after the Constitution came into operation, to give effect to certain rights in the Bill of Rights (contained in Chapter 2 of the Constitution), with specific reference to the right to equality, access to information and administrative justice. Specific legislation enacted to give effect to the right to equality is the Promotion of Equality and the Prevention of Unfair Discrimination Act 4 of 2000 (not yet in operation).

Of particular importance to the doctrine of informed consent in medical law was the promulgation of the Promotion of Access to Information Act 2 of 2000 which came into operation on 9 March 2001. The purpose of this Act is to give effect to the constitutional rights to access of any information held by the state and any information held by anther person that are required for the exercise or protection of any rights. Part of the objects of the Act, in giving effect to this right, was to make provision for the reasonable protection of privacy, commercial confidentiality and effective, efficient governance, in a manner which balances this right with any other right, including the other rights in the Bill of Rights. The Act establishes voluntary and mandatory mechanisms or procedures to give effect to the right to information, with the purpose to ensure that it will enable persons to obtain access to records of a public or private body swiftly, inexpensively and effortlessly, as far as is reasonably possible. Generally the Act aims at the promotion of transparency, accountability and the effective governance of all private and public bodies, and to ensure that everyone will be empowered and educated to understand their rights in terms of the Act. Of particular significance, in context of the obtaining of informed consent, is section 34 of the Act where provision is made for the mandatory protection of the privacy of a third person who is a natural person. Specifically the said section states that the information officer of a public body must refuse a request for access to a record of a body if its disclosure would involve the unreasonable disclosure of personal information about a third party, including a deceased individual; and that a record may only released with the consent of the individual concerned (19).

Emanating from a similar constitutional vein is the introduction of the National Health Bill (22 October 2001) which will be enacted towards the end of 2003 and the Mental Health Care Bill (Act 17 of 2002), to be enacted during the course of 2004. Both Bills, when eventually enacted, will repeal existing Acts on Health and Mental Health, and will restructure the national health and mental health care systems in South Africa dramatically. Both Bills, in structure and purpose, take cognisanse of the spirit of the Constitution of the Republic of South Africa and provide for the right of everyone of access to health services, including mental health care and reproductive health care. Both Bills provide extensively for the requirement of informed consent in effecting access to health care. The Mental Health Care Bill (section 9(1)(a)) provides that subject to this Act and any other law, a person or health establishment may provide care, treatment and rehabilitation service to or admit a mental care user only if the user has consented to the care, treatment and rehabilitation service or to being admitted (20).

Informed consent in medical law is thus entrenched not only in the South African common law and case law, but fulfils a pivotal role in newly introduced and enacted legislation in which effect is given to the fundamental provisions of the Constitution of the Republic of South Africa (the supreme law of the land). As such, the judicial and ethical recognition and protection of informed consent undoubtedly will have a significant influence on the very nature of the physician-patient relationship and medical practice in all its spheres.

13.2 Informed Consent in terms of the National Health Bill of 2003:

It should be noted that the doctrine of “informed consent” is firmly entrenched in the proposed National Health Bill in terms of its definition, nature, scope and requirements. Because of the significant influence of this doctrine on the very nature of the physician-patient relationship and medical practice in all its spheres the relevant sections of the said Bill are stated comprehensively here.

13.2.1 Chapter 2 of the Bill:

Chapter 2 of the Bill contains the rights and duties of users and health care providers. Section 6 of the Bill provides for the nature/scope and requirements for informed consent and reads as follows:

Every health care provider must inform a user of –

(a) the user’s health status except in circumstances where there is substantial evidence that the disclosure of the user’s health status would be contrary to the best interests of the user;

(b) the range of diagnostic procedures and treatment options generally available to the user;

(c) the benefits, risks, costs and consequences generally associate with each option; and

(d) the user’s right to refuse health services.

Section 7 of the Bill provides for the specific consent of a user in the following terms:

(1) Subject to section 8, a health service may not be provided to a user without the user’s informed consent, unless -

(a) the user is unable to give informed consent and such consent is given by a person –

(i) mandated by the user in writing to grant consent on his or her behalf; or

(ii) authorised to give such consent in terms of any law or court order;

(b) the user is unable to give informed consent and no person is mandate or authorised to give such consent, and the consent is given by the spouse or partner of the user or, in the absence of such spouse or partner, a parent, an adult child or a brother or a sister of the user, in the specific order as listed;

(c) the provision of a health service without informed consent is authorised in terms of any law or a court order;

(d) failure to treat the user, or group of people which includes the user, will result in a serious risk to public health; or

(e) any delay in the provision of the health service to the user might result in his or her death or irreversible damage to his or her health and the user has not expressly, impliedly or by conduct refused that service.

In subsection 7(2) a specific definition of “informed consent” is contained:

(2) For the purposes of this section “informed consent” means consent for the provision of a specified health service given by a person with legal capacity to do so and who has been informed as contemplated in section 6.

Section 8 of the Bill provides for participation in decisions and effectively recognises a user’s

Right to self determination in the following terms:

(1) A user has the right to participate in any decision affecting his or her personal health and treatment.

(2)(a) If the informed consent required by section 7 is given by a person other than the user, such person must, if possible, consult the user before giving the required consent.

(b) A user who is capable of understanding must be informed as contemplated in section 6 even if he or she lacks the legal capacity to give the informed consent required by section 7.

(3) If a user is unable to participate in a decision affecting his or her personal health and treatment, he or she must be informed as contemplated in section 6 after the provision of the health service in question unless the disclosure of such information would be contrary to the user’s best interest.

Section 9 of the Bill provides for health service without consent in the following terms:

(1) Where a user is admitted to a health establishment without his or her consent, the health establishment must notify the head of the provincial department in the province in which that health establishment is situated within 48 hours after the user was admitted of the user’s admission and must submit such other information as may be prescribed.

(2) If the 48-hour-period contemplated in subsection (1) expires on a Saturday, Sunday or public holiday, the health establishment must notify the head of the provincial department of the user’s admission and must submit the other information contemplated in subsection (1) at any time before noon of the next day that is not a Saturday, Sunday or public holiday.

(3) Subsection (1) does not apply if the user consents to the provision of any health service in that health establishment within 24 hours of admission.

13.2.2 Chapter 9 of the Bill:

An important provision is section 76 of the Bill pertaining to informed consent for research on

or experimentation with human subjects. The provision reads as follows:

(1) Notwithstanding anything to the contrary in any other law, research or experimentation on a living person may only be conducted -

(a) in the prescribed manner; and

(b) with the written consent of the person after he or she has been informed of the objects of the research or experimentation and any possible positive or negative consequences on his or her health.

(2) Where research or experimentation is to be conduct on a minor for a therapeutic purpose, the research or experimentation may only be conducted -

(a) if it is in the best interests of the minor;

(b) in such manner and on such conditions as may be prescribed;

(c) with the consent of the parent or guardian of the child; and

(d) if the minor is capable of understanding, with the consent of the minor.

(3)(a) Where research or experimentation is to be conducted on a minor for a non-therapeutic purpose the research or experimentation may only be conducted –

(i) in such manner and on such conditions as may be prescribed;

(ii) with the consent of the Minister;

(iii) with the consent of the parent or guardian of the minor; and

(iv) if the minor is capable of understanding the consent of the minor.

(b) The Minister may not give consent in circumstances where -

(i) the objects of the research or experimentation can also be achieved if it is conducted on an adult;

(ii) the research or experimentation is not likely to significantly improve scientific understanding of the minor’s condition, disease or disorder to such an extent that it will result in significant benefit to the minor or other minors;

(iii) the reasons for the consent to the research or experimentation by the parent or guardian and, if applicable, the minor are contrary to public policy;

(iv) the research or experimentation poses a significant risk to the health of the minor; or

(v) there is some risk to the health or well-being of the minor and the potential benefit of the research or experimentation does not significantly outweigh that risk.

13.2.2 Provisions in Bill subject to regulations to be made by the Minister:

An assessment of the impact of the National Health Bill on the practice and application of informed consent in South African Medical Law can only be assessed in full when the Regulations to the National Health Bill in terms of section 95 are made within the near future. Many prescriptive issues that are currently not stated or vague in the Bill will then be hopefully addressed.

END NOTES

(1) Veatch RM Medical Ethics, Jones & Bartlett (1989) 175; Beauchamp TL & Childress JF Principles of Biomedical Ethics, Oxford University Press (1994) 120.

(2) Veatch 175; It must also be noted that the advent of the Constitution of the Republic of South Africa, Act 108 of 1996, (specifically the Bill of Rights in Chapter 2 thereof), contributed to this increased demand - the right to bodily integrity; selfdetermination; privacy; equality; information; administrative justice etc; subject to the limitation clause in section 36.

(3) Van Oosten FFW International Encyclopeadia of Laws (ed Blanpain) Kluwer Law International (1996) 67 et seq; See also Van Oosten FFW "Castell v De Greeff and the Doctrine of Informed Consent" 1995 De Jure 164; Van Oosten FFW The Doctrine of Informed Consent in Medical Law (unpublished LLD thesis - UNISA [1989]) 33 et seq; Strauss SA Doctor Patient and the Law, Van Schaik (1991) 267; Claassen NJ & Verschoor T Medical Negligence in South Africa, Digma (1992) 57; Carstens PA Die Strafregtelike en Deliktuele Aanspreeklikheid van die Geneesheer op grond van Nalatigheid (unpublished LLD thesis UP 1996) 430 - 457.

(4) Van Oosten Encyclopeadia 68; Compare Castell v De Greeff 1994 (4) SA

408 (C); Phillips v De Klerk unreported 1983 TPD; Stoffberg v Elliot 1923 CPD 148.

(5) Van Oosten Encyclopeadia 69: "The form of disclosure known as

'self-determination disclosure' must be distinguished from so-called 'therapeutic disclosure', which serves the purpose not of ensuring patient autinomy, but of protecting the patient's health; Claassen & Verschoor 62-63; Castell v De Greeff supra 420-421, 426.

(6) There being no obligation to disclose in detail all the complications that may arise - Van Oosten Encyclopeadia 69; See also Lymbery v Jefferies 1925 AD 236;

Rompel v Botha unreported 1953 TPD.

(7) Van Oosten Encyclopeadia 69 et seq; Lymberry v Jefferies supra; Richter v Estate Hammann 1976 (3) SA 226 (C).

(8) Van Oosten Encyclopeadia 69; Castell v De Greeff supra 426.

(9) Van Oosten Encyclopeadia 70; Castell v De Greeff supra 426; Richter v

Estate Hammann supra 232.

(10) Van Oosten Encyclopeadia 70; Strauss 19 et seq; Claassen & Verschoor 63;

Skegg PDG Law Ethics and Medicine, Clarendon Press (1988) 88:"Generally speaking, the greater the patient's capacity to comprehend the issues involved and come to a decision about them, the greater will be the extent of the duty to disclose relevant information. Conversely the more restricted his capacity - whether by reason of his current medical condition, limited intelligence or education, or the complexity of the issues involved - the less may be the extent of the duty to inform; Also see SA Medical and Dental Council v McLoughlin 1948 (2) SA 355 (A). It should also be noted that in terms of the Constitution of the Republic of South Africa (section 12 (1) and (2)) everyone has the right to freedom and security of person and bodily and psychological integrity inclusive of the right not to be subjected to medical and scientific experiments without their informed consent.

(11) Van Oosten Encyclopeadia 71; Strauss 8, 15; Claassen & Verschoor 36; 116-117.

(12) Van Oosten Encyclopeadia 71; Compare Van Oosten Thesis 397; 409-41 0. 441.

(13) Van Oosten FFW “Law and ethics of information and consent in medical research” 2000 THRHR 6; See also section 12(2) of the Constitution of the Republic of South Africa with reference to the right not to be subjected to medical and scientific experiments without informed consent; See also international human rights instruments for the specific requirement of informed consent in medical experimentation : The Declaration of Helsinki (1964 as revised); The Universal Declaration on the Human Genome (UNESCO 1997).

(14) Van Oosten Encyclopeadia 65.

(15) Van Oosten Encyclopeadia 66; Strauss 169.

(16) Superintendent Groote Schuur Hospital 1993 (2) SA 255 (C ).

(17) Act 74 of 1983.

(18) Strauss 6-7 ; 211-212; Van Oosten Encyclopaedia 67.

(19) See full discussion of section 34 of the Act.

(20) It should be noted that section 9(1)(b)(c) of the Mental Health Care Bill make provision

for treatment without the user’s consent..