The concept of shared healthcare decision-making

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REVIEW OF LITERATURE

Introduction

This chapter will discuss the literature review that was undertaken for this thesis. A review of the relevant literature will encompass an analysis of the doctrine of informed consent as applied in South Africa jurisprudence, followed by the socio-legal aspects of IC in South Africa and the potential impact of the cultural milieu and multiculturalism on IC practice in South Africa. This will be followed by an analysis of the Hippocratic tradition and the evolution of the IC doctrine, as well as a critical discussion of the philosophical concepts of autonomy from a Kantian (duty based),¹⁰¹⁰ and Millian or utilitarian¹⁰¹¹ perspectives.¹⁰¹² This is followed by analysis of the concept of patients’ rights, shared healthcare decision-making, and the rights of vulnerable population groups.
According to Polit and Beck,¹⁰¹³ a literature review is usually done to assist the researcher to comprehend and extend his or her knowledge regarding the phenomenon under study. It also helps the researcher to determine whether the phenomenon is worth studying and assists in determining the scope of the study, so that research can be limited to a needed area of inquiry.¹⁰¹⁴ A review of the literature may also help the researcher to determine the extent to which the topic under study is covered in the existing body of knowledge.¹⁰¹⁵ Moreover, the literature review shares with the reader the results of other studies that are closely related to the topic under study, it relates the current study to other larger and ongoing debates in the literature, in this case the medico-legal cases and analysis regarding the doctrine of IC, by filling in gaps and extending prior studies. Hence a literature review provides a framework for establishing the importance of the present study and a basis for comparison of the results of the present study to findings by other researchers working on the same phenomenon or in the same area of inquiry.^1016,1017

The legal doctrine of informed consent in South Africa Constitutional rights to informed consent

Informed consent before medical procedres is a constitutionally protected right in South Africa. These constitutionally protected rights to bodily integrity and security have been tested in South African courts in the cases of Minister of Safety and Security v Gaqa¹⁰¹⁸ and Minister of Safety and Security v Xaba (hereinafter the Xaba case).¹⁰¹⁹ In both cases, the police sought a court order to compel an accused person to undergo a surgical procedure in order to extract a bullet to be used as evidence in their prosecution. In the Xaba case,¹⁰²⁰ the court ruled that granting such an order would violate the defendant’s constitutional rights to a fair trial, bodily integrity and privacy.¹⁰²¹ By contrast, such an order was granted by a judge in the case of Minister of Safety v Gaqa (hereinafter the Gaqa case),¹⁰²² where the judge felt that there were grounds within the Criminal Procedure Act,¹⁰²³ which allowed use of reasonable force by the police in the public interest.¹⁰²⁴ In both cases, the defendants sought protection under the constitutionally protected rights to bodily and psychological integrity as enshrined in section 12(2) of the Constitution.¹⁰²⁵ In the Gaqa case, Desai J granted the order for the extraction of the bullets, basing his judgment on the fact that the rights enshrined in section12 were limited rights when read together with section 36 of the Constitution, which provides that rights in the constitution could be limited by a law of general application in a democratic society.¹⁰²⁶ The court further held that this limitation was supported by the Criminal Procedure Act,¹⁰²⁷ which stipulates that the police could use any reasonable force to procure evidence from suspected criminals.¹⁰²⁸ On the other hand, Southwood J denied the police the right in the Xaba case,¹⁰²⁹ basing his decision on the rights to bodily and psychological integrity enshrined within the Constitution, arguing that the judgment in the former case was wrong in terms of section 12 of the Constitution.¹⁰³⁰ Further, it was held that relief could not be provided by the Criminal Procedure Act since the Act did not allow forced surgical removal of an object from the body of a person.¹⁰³¹
Some commentators argued that the limitation of rights applied in Gaqa case by Desai J refers only to the limitation of rights in the Bill of Rights and specifies that those limitations apply “only in terms of law of a general application to the extent that the limitation is reasonable and justifiable in an open and democratic society based on human dignity, equality and freedom.”¹⁰³² The authors contend that court adjudication may not be considered a law of general application and such abrogation should probably be done via legislative mandate, as suggested by Southwood J in the Xaba case.¹⁰³³
One may conclude this section by noting what has been suggested by others, namely that: “The ease with which any jurisdiction is capable of upholding patient’s rights depends on its history and jurisprudence as it does on its willingness to make appropriate modifications or enthusiasm for change.”¹⁰³⁴ In South Africa, the constitutionally protected rights to bodily integrity and security as well as the right to IC have been codified in theNHA,¹⁰³⁵ and further enshrined in the Constitution and disseminated in the Patients Right Charter.¹⁰³⁶ These provisions and regulations are designed to assist in achieving the right of access to healthcare by all South African citizens. The Patients’ charter formally recognizes the patients’ right to IC during medical treatment. It has been advanced that the Charter provides an officially sanctioned baseline standard that can be referred to as tool for accountability to patients, HCPs and the broader civil society.¹⁰³⁷ Under South African law, health related autonomy rights are constitutionally protected as outlined in section 12 of the Constitution, with section 12(1) stating that “everyone has the right to freedom and security of the person,” whilst section12(2) stipulates that:
Everyone has the right to bodily and psychological integrity, which includes the right to:

To make decisions concerning reproduction
To security in control over their body; and
Not to be subjected to medical and scientific experiments without their informed consent.¹⁰³⁸

Historical origins of informed consent in South Africa

According to Van Oosten, patient consent, as a requirement for all lawful medical interventions, is a well-established principle in South African common law.¹⁰³⁹ The earliest leading cases in this area were the cases of Stoffberg v Elliot¹⁰⁴⁰ and the Esterhuizen case.¹⁰⁴¹ In the former case, a patient whose penis was wrongfully amputated without his consent sued his doctors for damages in action for assault. The court agreed that any treatment done without the necessary consent is and interference with and individuals bodily integrity and can lead to charges of assault and award of damages.¹⁰⁴² In the Esterhuizen case a 10-year-old child who was diagnosed with Kaposi’s sarcoma, a form of skin cancer was initially treated with superficial radiation for the condition with both parents’ consent. Later, however, because of recurrence of the tumour, she was subjected to extensive radiation therapy, which resulted in severe burns and tissue damage necessitating amputation of her limbs. This was done without the express consent of her guardians. In action for damages for assault against the treating physician, the court held that while the superficial radiation was duly performed with appropriate consent from the parents, the latter procedure was performed without full disclosure, knowledge and consent of the child’s mother although there was adequate time to obtain such consent. The court rejected the treating doctor and hospital’s argument that the fact that her grandfather and parents had brought the child to hospital and previously consented to a similar treatment implied consent for the more radical procedure. The court also rejected arguments that the treatment was in the best interests of the child. The court held rather, that because the radical treatment was vastly different from the former superficial radiation given to the child, it was necessary that the child’s mother should have been adequately informed of the dangers inherent in the radical treatment for such consent to be considered valid.¹⁰⁴³
More recently in the Castell case,¹⁰⁴⁴ it has been argued that the judgment of the court in this case seems to have introduced the prudent patient standard of information disclosure and IC into South African medical jurisprudence.¹⁰⁴⁵ Further, the SCA revisited this judgement in the case of Broude v McIntosh,¹⁰⁴⁶ but did not overrule this decision despite some technical reservations, thereby reaffirming the prudent patient and material risks standards as the required standard for information disclosure in South Africa.¹⁰⁴⁷ The consequences of the court’s decision in the Castell case¹⁰⁴⁸ on South African medical jurisprudence were that the following principles were generally accepted, according to Van Oosten: ¹⁰⁴⁹

a shift from medical paternalism to patient autonomy
A shift from the ‘reasonable doctor’ standard to the ‘prudent patient’ standard
A shift in disclosure to the ‘material risk’ standard, where the level of disclosure required is what a reasonable patient would consider pertinent before making a decision
The court appears to place the patients’ informed consent within the framework of volenti non fit injuria or voluntary assumption of risk rather than delict.
In 2004, enactment of the NHA¹⁰⁵⁰ codified the requirements for IC into South African healthcare law specifying the nature and aspects of information to be disclosed prior to IC as discussed in chapters 1 and 2 of this thesis. In terms of South African common law, the issue of how much information should be disclosed to a patient has been the subject of debate starting from the case of Lymberg v Jeffries 1925,¹⁰⁵¹ where the court was of the opinion that a “doctor is not obliged to disclose all the conceivable complications that may arise during a medical procedure.” However the judgment of Ackerman J in Castell v De Greef, ¹⁰⁵² suggested that a doctor is obliged to warn the patient of all the ‘material risks’ inherent in the treatment, where the material risks are based on a ‘prudent patient standard’.¹⁰⁵³ Therefore, the requirement for information disclosure in South Africa tends towards the practice in North America where libertarian rights-based autonomy is predominant. Furthermore, section 6 of the NHA requests that as part of IC, “every HCP should inform the user of the user’s health status except where it would be contrary to the user’s best interests,” which would include “the range of diagnostic procedures and treatment options available, the benefits, risks, costs and consequences generally associated with each option. The user’s right to refuse health services and the implications thereof”.¹⁰⁵⁴ It may be said that this appears to reaffirm the requirement for disclosure of all material risks with appropriate exceptions.

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CHAPTER 1- ORIENTATION TO THE STUDY
1.1 INTRODUCTION
1.2 RECENT DEVELOPMENTS IN SOUTH AFRICAN CASE LAW SINCE THE CASTELL CASE AND ENACTMENT OF THE NATIONAL HEALTH ACT 2003.
1.3 INFORMED CONSENT, THE SOCIO-CULTURAL MILIEU AND PATIENT RIGHTS’ IN SOUTH AFRICA
1.4 JUSTIFICATIONS FOR USING EMPIRICAL METHODS TO STUDY INFORMED CONSENT
1.5 RATIONALE FOR THE STUDY
1.6 SIGNIFICANCE OF THE STUDY
1.7 RESEARCH DESIGN AND METHODOLOGY
1.8 STUDY POPULATIONS AND SOURCES OF DATA
1.9 RESEARCH SETTING
1.10 RESEARCH INSTRUMENTS
1.11 SAMPLING PROCEDURES
1.13 ETHICAL CONSIDERATIONS
1.14 SCOPE AND LIMITATIONS OF THE STUDY
1.15 ASSUMPTIONS OF THE STUDY
1.16 DEFINITION OF KEY CONCEPTS AND TERMS
1.17 SUMMARY OF CHAPTER 1 AND CONCEPTUAL OUTLINE OF THE STUDY
CHAPTER 2 – BACKGROUND
2.1 INTRODUCTION
2.2 CONSENT TO TREATMENT
2.3 WHAT MAKES CONSENT VALID?
2.4 ELEMENTS OF A TRUE, REAL OR VALID CONSENT
2.5 VOLUNTARINESS
2.6 INFORMATION DISCLOSURE
2.7 SOME DIFFERENCES BETWEEN CONSENT TO MEDICAL TREATMENT VERSUS BIOMEDICAL RESEARCH
2.8 WHAT SHOULD GENERALLY BE DISCLOSED TO A PATIENT BY HEALTHCARE PROFESSIONALS?
2.9 EXCEPTIONS TO FULL INFORMATION DISCLOSURE DURING INFORMED CONSENT
2.10 UNDERSTANDING OR COMPREHENSION OF INFORMATION DISCLOSED
2.11 CONSENT, AGREEMENT OR AUTHORIZATION OF TREATMENT
2.12 SO, WHAT IS VALID OR TRUE CONSENT?
2.13 TYPES OF CONSENT AND THE VALIDITY OF CONSENT FORMS
2.14 LIMITS, DURATION, WITHDRAWALS, AND REFUSAL OF CONSENT
2.15 SUMMARY OF CHAPTER 2
CHAPTER 3 – REVIEW OF LITERATURE
3.1 INTRODUCTION
3.2 THE LEGAL DOCTRINE OF INFORMED CONSENT IN SOUTH AFRICA
3.3 DEVELOPMENTS IN SOUTH AFRICAN COMMON LAW ON INFORMED CONSENT SINCE THE JUDGMENT IN THE CASTELL V DE GREEF AND ENACTMENT OF THE NATIONAL HEALTH ACT 2003
3.4 OTHER LEGAL ISSUES PERTAINING TO THE DOCTRINE OF INFORMED CONSENT IN THE CONTEXT OF COMPARATIVE INTERNATIONAL LAWS
3.5 INFORMED CONSENT, THE SOCIO-CULTURAL MILIEU AND PATIENTS’ RIGHTS IN SOUTH AFRICA
3.6 THE RELATIONSHIP BETWEEN MULTICULTURALISM, RIGHT TO HEALTH, AND INDIVIDUAL AUTONOMY
3.7 THE HIPPOCRATIC TRADITION AND THE HISTORICAL ORIGINS OF IC IN MEDICAL PRACTICE
3.8 SOCIOHISTORICAL PHASES OF INFORMED CONSENT BASED ON STRUCTURATIONAL ANALYSIS
3.9 SOME PHILOSOPHICAL ARGUMENTS RELATED TO AUTONOMY AND THE INFORMED CONSENT DOCTRINE
3.10 PATIENTS’ RIGHTS
3.11 THE CONCEPT OF SHARED HEALTHCARE DECISION-MAKING
3.12 SUMMARY OF CHAPTER 3
CHAPTER 4: RESEARCH DESIGN AND METHODOLOGY
4.1 INTRODUCTION
4.2 Methodological considerations
4.3 RESEARCH DESIGN
4.4 TRIANGULATION
4.5 THE VALUE OF USING EMPIRICAL RESEARCH METHODS TO STUDY INFORMED CONSENT
4.6 STATEMENT OF THE PROBLEM
4.7 SIGNIFICANCE OF ANTICIPATED OUTPUTS .
4.8 VALIDITY AND RELIABILITY OF THE STUDY
4.9 MATERIALS AND METHODS
4.12 RESEARCH INSTRUMENTS
4.13 DATA COLLECTION
4.14 STATISTICAL METHODS
4.15 ETHICAL CONSIDERATIONS AND APPROVALS
4.16 SUMMARY OF CHAPTER 4
RESULTS AND FINDINGS FROM THE EMPIRICAL RESEARCH STUDY AND THE IMPLICATIONS 262
CHAPTER 5: FINDINGS ON QUALITY OF INFORMED CONSENT AS PRACTISED BY MEDICAL DOCTORS IN SOUTH AFRICA
5.2 RESEARCH DESIGN AND METHODOLOGY
5.3 ETHICAL CONSIDERATIONS
5.4 RESULTS: FINDINGS FROM THE DOCTORS’ STUDY
5.5 DISCUSSION
5.6 CONCLUSIONS
5.7 SUMMARY OF CHAPTER 5
CHAPTER 6: FINDINGS ON THE KNOWLEDGE AND PRACTICE OF INFORMED CONSENT BY
PROFESSIONAL NURSES IN SOUTH AFRICA
6.1 INTRODUCTION
6.2 KNOWLEDGE OF ETHICS, HUMAN RIGHTS AND MEDICAL LAW AMONG SOUTH AFRICAN NURSES
6.3 THE DOCTRINE OF INFORMED CONSENT AND RESPECT FOR AUTONOMY .
6.4 THE LEGAL DOCTRINE OF IC IN SOUTH AFRICA AND OTHER COMMON LAW JURISDICTIONS
6.5 IC REGULATIONS IN SOUTH AFRICA SINCE ENACTMENT OF THE NATIONAL HEALTH ACT
6.6 SOCIO-CULTURAL FACTORS POTENTIALLY INFLUENCING NURSING PRACTICE IN SOUTH AFRICA
6.7 RESEARCH DESIGN AND METHODOLOGY
6.8 ETHICAL CONSIDERATIONS
6.9 RESULTS
6.10 DISCUSSION
6.11 LIMITATIONS OF THIS STUDY
6.12 CONCLUSIONS
6.13 SUMMARY OF CHAPTER 6
CHAPTER 7: PATIENTS’ PERCEPTIONS ON INFORMED CONSENT PRACTICES BY HEALTHCAREPROFESSIONALS IN SOUTH AFRICA
7.1 A BRIEF OVERVIEW OF THIS STUDY
7.2 INTRODUCTION
7.3 MATERIALS AND METHODS
7.4 RESULTS
7.5 DISCUSSION
7.6 LIMITATIONS OF THIS STUDY
7.7 CONCLUSIONS
7.8 SUMMARY OF CHAPTER 7
CHAPTER 8: SYNTHESIS AND DISCUSSION
8.1 INTRODUCTION
8.2 RECENT DEVELOPMENTS IN SOUTH AFRICAN JURISPRUDENCE ON INFORMED CONSENT SINCE ENACTMENT OF THE NATIONAL HEALTH ACT 2003
8.3 THE IMPORTANCE OF USING EMPIRICAL METHODS TO STUDY INFORMED CONSENT
8.4 THE MEANING OF CONSENT TO TREATMENT
8.5 THE VALIDITY OF INFORMED CONSENT
8.6 STANDARDS OF INFORMATION DISCLOSURE
8.7 COMPREHENSION OF INFORMATION DISCLOSED
8.8 SOCIO-CULTURAL FACTORS IMPACTING ON INFORMED CONSENT IN SOUTH AFRICA
8.9 FINDINGS AND IMPLICATIONS OF THE EMPIRICAL STUDY
8.10 SUMMARY OF CHAPTER 8
CHAPTER 9: CONCLUSIONS AND RECOMMENDATIONS
9.1 INTRODUCTION
9.2 CONCLUSIONS DRAWN FROM ANALYSIS OF CASE LAW AND CURRENT SOUTH AFRICAN LEGISLATION
9.3 CONCLUSIONS TO BE DRAWN FROM THE EMPIRICAL RESEARCH STUDY
9.4 LIMITATIONS OF THIS STUDY
9.5 CENTRAL CONCLUSIONS
9.6 RECOMMENDATIONS