Informed Consent

Chapter 5
Informed Consent

Irehobhude O. Iyioha and Oluchi Aniaka

Introduction

Since its inception, the concept of informed consent has met with some resistance and controversy regarding its capacity to fulfil its objective. Some physicians have opposed the doctrine on the supposition that it is a ‘myth, a fiction, an unattainable goal, or a snare to entrap physicians’.¹ It is no surprise, therefore, that the concept has sometimes been treated as a mechanism for getting patients to agree to physicians’ notion of what is best for the patient, rather than as a method for affirming patients’ autonomous decision-making. In spite of the rise of patient rights in North America, the extent to which patients in different parts of the world, including in North American nations, are familiar with their rights and the evolution of those rights under the concept is uncertain. The idea of consent to treatment to a Nigerian patient is often vague, especially when the discourse is situated in the context of ‘informed consent’.

Except in serious cases involving major surgical operation or where the outcome of treatment is uncertain, the consent process is not always initiated in a manner that recognizes and respects patient autonomy. Where the consent process is initiated, emphasis is often placed on written authorization to proceed through what one author has described as a ‘lifeless piece of paper’² known as the ‘consent form’. In such instances, it is unclear whether the patient’s authorization is obtained following full and proper disclosure of information critical to the decision. In a 2004/2005 survey of the opinions and practice of surgeons in Nigeria in respect of informed consent, it was found that a majority of surgeons are of the opinion that enough information is not given to patients to enable them to make a medical decision.³ A majority of surgeons surveyed were of the view that informed consent is only a medico-legal ritual without a moral obligation, not a truly participatory process, alien to the African psyche, and cannot conceivably be sought for every procedure.⁴ On the nature and frequency of information disclosed to patients, it was found that the frequency of disclosure of risks, diagnosis, treatment options, alternative treatments, and such other information is less than 40 per cent.⁵ The results of this survey with respect to inadequacy of disclosure accord with other studies carried out to measure patients’ satisfaction with the consent process.⁶

Arguably, demographic factors in Nigeria such as illiteracy and poverty, including cultural and social dynamics, fuel medical paternalism and sustain a culture of submission to authority whether such authority is apparent or real. The consequences of such paternalism are incongruous with the concept of individual autonomy. ‘Paternalism’, according to Beauchamp and Childress, involves ‘the intentional overriding of one person’s preferences or actions by another person, where the person who overrides justifies this action by appeal to the goal of benefiting or of preventing or mitigating harm to the person whose preferences or actions are overridden’.7 In paternalistic medical practice, physicians act in accordance with their conceptions of the best interests of the patient and in many cases make decisions on behalf of the patient with little or no regard for the personal wishes of the patient.⁸ In Nigeria, justification of medical paternalism is often founded on the physician’s or healthcare practitioner’s specialized training, knowledge, and insight; and the practitioner is often deemed to be in the best position to determine what is in the patient’s best interests.

According to Beauchamp and Childress, paternalistic acts usually involve force or coercion on the one hand, or deception, lying, manipulation of information, or non-disclosure of information on the other, each of which places a limit on autonomous choice.⁹ Consequently, in order to foster the concept of patient autonomy in the Nigerian healthcare system, there is need for changes in the social and cultural factors that create the enabling environment for medical paternalism. However, such reforms, especially where they affect deep-rooted cultural values such as patriarchy, may be difficult. This is especially because reform would involve a de-socialization process to correct socio-cultural perceptions, such as the notion that women cannot make their own medical decisions. It might be easier to alter patients’ exaggerated perceptions about the authority of the healthcare provider, perceptions which sustain the exercise of extensive decision-making powers by healthcare authorities. Nevertheless, some success may be achieved through legal reform involving legislative recognition of the need for patient empowerment and the importance of curtailing the sometimes-extensive discretions of healthcare providers. A proper construction and delineation of the concept of informed consent plays a critical role in this objective.

This chapter contributes to achieving this task in the context of the formulation of the principle of informed consent in the Nigerian National Health Act (NHA)¹⁰ and the Code of Medical Ethics (CME). The chapter examines whether the NHA offers a rule of informed consent built around the foundational principle of patient autonomy, which both empowers patients to be the decision-makers in matters concerning their healthcare and treatment, and invests them with the right to demand information relevant to their medical care. This latter component of the informed consent doctrine is akin to the Canadian law on the subject, outlined by the Supreme Court of Canada, which sets the standard of information to be disclosed at the level of the objective patient, and therefore endows the patient with the right to seek further information beyond those volunteered by the physician.11

Alongside a review of this rule denoted in our analysis as the ‘standard of disclosure’ or the ‘materiality standard’¹² under Canada’s informed consent law, the chapter briefly highlights the dual standards of disclosure operative in the United States as well as the applicable standards in the United Kingdom – a country whose legal system has been influential in shaping aspects of Nigerian law. As part of the question on whether the NHA reflects the concept of patient autonomy, we examine whether there is a duty to disclose diagnostic information under Nigerian law on informed consent. Our examination of this issue as part of physicians’ therapeutic privilege of non-disclosure highlights broader debates on whether the principle of therapeutic privilege extends to diagnostic information.

This chapter further examines the classes of information that may be subsumed under the informed consent rule. Given that the doctrine inherently reflects the principles and practice of biomedicine, we examine the range of information that the patient needs to know, including details of alternative therapeutic options, and contend that the informed consent rule under Nigerian law does not expressly include non-biomedical forms of healthcare such as complementary and alternative therapies or indigenous Nigerian medicine among the alternative healthcare options to which patients are entitled. Contending that this is a defect in the law, we suggest that the number of Nigerian policies and legislation (including the NHA) which recognize that Nigeria operates dual systems of medical care makes it imperative that the informed consent provision – specifically as it relates to the patient’s right to be informed of alternative healthcare options – be interpreted to include validated non-biomedical and indigenous therapies. This proposal is fundamental as legal trends on the subject of patients’ right to autonomy, at least in the United States, reveal incremental judicial imposition of liability on physicians for non-disclosure of non-conventional alternative healthcare options.

What is Informed Consent?

Informed consent in healthcare law is a doctrine that requires healthcare practitioners to obtain the consent of their patients upon whom treatment is to be administered or surgery performed before embarking on the treatment or surgical procedure.¹³ It is an ethical and legal doctrine that is founded on the principles of patient autonomy.¹⁴ Patient autonomy captures the patient’s right to decide what is to be done with his/her body. The doctrine also reflects the law’s recognition of the right of every individual to bodily integrity. According to the Supreme Court of Canada in Ciarlariello v Schacter,¹⁵ bodily integrity embodies a patient’s right to decide the types of medical procedures that the individual will accept and the extent to which they will be accepted.¹⁶ Essentially, the doctrine of informed consent recognizes the patient’s right ‘to be free from medical treatment to which the individual does not consent’.17

Since the Nuremberg trials in 1946 and the horrifying accounts of inhuman experimentation carried out by medical physicians sworn under the Hippocratic Oath to do no harm, informed consent has formed part of biomedical ethics. Principle 1 of the Nuremberg Code articulated following the trial states: ‘the voluntary consent of a human subject is absolutely essential’ and the person involved ‘should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision’.¹⁸ These elements include ‘the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiments’.¹⁹

Prior to the articulation of the Nuremberg Code, liability of physicians for failure to secure consent was treated under the common law writ of trespass to the person. Modern informed consent was first invoked in non-experimental healthcare in the 1957 US case of Salgo v Leland Stanford Jr, University Board of Trustees²⁰ and was further expounded by the Kansas Supreme Court in Nathanson v Kline.²¹ Consent is required for all types of treatment whether invasive or diagnostic and whether major or routine.²² It may be express or inferred from conduct such as rolling up a sleeve for a blood pressure test in a clinic. Along with the invocation of the concept in non-experimental treatment came the requirement to define the applicable standard of care as cases alleging non-disclosure of risks and other relevant information came to be treated as negligence rather than assault.²³

It is not certain that, except in cases of emergency, informed consent is required for every medical intervention. The language of the Code of Medical Ethics in Nigeria suggests that some medical procedures do not require consent while others require informed consent.²⁴ These two terms, though similar, are different in consequences. Mere consent operates to validate what may otherwise be battery. It requires particularly general disclosure of the nature of the intervention that is to be carried out.²⁵ On the other hand, the analytical components of informed consent include competence, disclosure, understanding, voluntariness, and consent.²⁶

Consent is said to be informed when it proceeds voluntarily, without fraud, duress, or misrepresentation, from a person who has the capacity to understand and appreciate the nature and consequences of the decision to be made as well as the implications of making no decision. For consent to be informed, an individual must receive all information necessary to make the relevant decision to accept or reject a course of action. Because this information is reposed in the physician, informed consent has been translated to a physician’s duty to disclose and a patient’s right to know information that is material to his/her decision-making.27 Consequently, while matters of competence, understanding, and voluntariness are important, discussions about informed consent often turn on the duty of physicians to disclose.

A competent patient in Nigeria is one who has attained the age of 18 and is not mentally impaired or unconscious.²⁸ On a literal interpretation of the above, once a patient is below the age of 18 or is diagnosed with a mental impairment however mild, he/she is automatically disabled from making a treatment-related decision. This is notwithstanding that the patient, though a minor or mentally impaired, understands and appreciates the decision to be made. This implies – unlike the ‘mature minor rule’ in Canada, which presumes older minors have capacity to make treatment decisions and holds that a minor who fully comprehends the nature and consequences of the proposed treatment can legally consent to treatment²⁹ – that competence to consent to medical treatment in Nigeria is based on status rather than a functional assessment of the patient’s capacity to understand the nature of the decision to be made. A finding of incompetence requires that a next-of-kin should decide on behalf of the patient. This general rule of law has somewhat been amended by the Nigerian Supreme Court decision in Dr Rom Okekearu v. Danjuma Tanko.³⁰ In that case, a physician was held liable in battery for failing to obtain the consent of a fourteen-year-old boy before amputating his injured finger. The physician argued that the patient’s aunt had asked him to ‘carry on with whatever treatment was necessary’. Observing that the boy’s consent should have been sought in the absence of any incapacitating factors, Tobi, J.S.C. held that the supposed authorization provided by the patient’s aunt did not constitute valid consent. There was no assessment of the minor’s capacity to understand the nature of the treatment to be applied and thereby give valid consent. There was also no evidence, as the court observed, why there was no attempt to obtain the consent of the fourteen-year-old whom the court described as ‘a rational human being’. Therefore, while the age of majority remains the general rule with respect to minors’ consent to treatment, the courts may invoke reasoning akin to the mature minor rule to support a treatment decision by a minor who understands the nature and consequences of the proposed treatment.

With respect to disclosure, informed consent reflects the fact that although there is generally a prior consent by the patient to proposed surgery or therapy, that consent does not immunize physicians or surgeons from liability for negligence if they have failed in their duty to disclose risks of the treatment known, or which ought to be known to them, and which are unknown to the patient.³¹ The underlying principle is the right of a patient to decide what, if anything, should be done with his/her body.³² As held in Hopp v Lepp, the issue of informed consent is at the core a question whether there is a duty of disclosure, and if so, the extent or scope of the duty. However, while there appears to be a consensus that a duty to disclose exists, the extent of that duty has been analysed through various standards. The standards which have been used by the courts to measure the physician’s duty to disclose are discussed next.

Standards of Disclosure

The standard or materiality of disclosure is determined through one of two tests or standards. There is the traditional professional standard by which the materiality of disclosure is left to the discretion of the physician whose duty of disclosure is circumscribed by the accepted practice of the medical profession. Consequently, only medical expert testimony counts as evidence of whether there has been (in)adequate disclosure.33 From the point of view of physicians, this standard is less demanding in the sense that it emphasizes the practice of the profession and as such, reduces speculation. However, this inherent advantage of the professional standard also represents its major shortcoming and that is the difficulty of stating with certainty what the medical custom is in particular cases even amongst practitioners in the same sub-field.

Further, if deference to professional custom is upheld in cases where there has been inadequate disclosure, it may lead to pervasive negligence where physicians disclose insufficient information or rely on an unbridled discretion to disclose only that which they deem part of established medical custom. And it is such a result that the Supreme Court of Canada in Reibl v Hughes³⁴ and Hopp v Lepp³⁵ attempts to avoid when it prioritizes the expectations or wishes of the patient as to the content or materiality of medical information above what the medical professional thinks should be disclosed. In expressing this sentiment, the Canadian Supreme Court states:

… [S]ince a particular patient is involved upon whom surgery is to be performed or particular therapy administered, and it is a duty of disclosure to him that affects the validity of his consent, evidence of medical experts of custom or general practice as to the scope of disclosure cannot be decisive, but at most a factor to be considered.³⁶

Importantly, the medical professional standard negates autonomous decision-making.³⁷ Beauchamp and Childress argue that where the decision to be made is medical in nature, physicians may be well suited to make such decisions. However, where the decision to be made is non-medical, such as the decision whether or not to accept treatment, the decision should be made by the patient.³⁸ According to the authors, the weighing of risks based on one’s subjective values does not require expert skill. As such, it is important that the person upon whom treatment is to be administered determine the information required to effectively decide on the treatment which accords with his/her values. Whether or not physicians have the skill to determine what information would advance or affect a patient’s best interest is uncertain. This is especially in view of studies that demonstrate that most patients want to be told about their diagnosis and prognosis however grim, while physicians in the same study were found to have reservation about delivering ‘bad news’ to the patient.³⁹

The second test, which is encapsulated in the Canadian Supreme Court’s decision in Reibl and Hopp reproduced above is the patient standard (or the patient-oriented standard) which requires that the information to be disclosed must be that which the patient deems material. In Reibl, the court articulated the standard of disclosure to be ‘what the average prudent person, the reasonable person in the patient’s particular position, would agree to or not agree to, if all material and special risks of going ahead with the surgery or foregoing it were made known to him’.40 According to the patient standard, valid consent is premised on the physician providing the patient with information about specific matters ‘that a reasonable person in the same circumstances’ as the patient ‘would require in order to make a decision’ about the medical procedure or treatment and the patient received answers to his or her inquiries about the outlined matters.⁴¹

The Ontario Health Care Consent Act – which defines valid consent as that which is voluntary, specific to the treatment, free from fraud or misrepresentation, and informed⁴² – outlines the matters a patient must be informed about as the nature of the treatment, the expected benefits of the treatment, the material risks and side effects of the treatment, alternative courses of action, the likely consequences of not having the treatment, and the answers to any additional questions that the patient may have about any of the foregoing.⁴³ Risks and side effects to be disclosed include ‘those that are probable or more likely to occur, those that are mere possibilities but can have serious consequences, and any risk that would be considered relevant by a reasonable person in the circumstances of the patient’.⁴⁴

This law has been described as ‘the most advanced legislation in protecting the rights of both the capable or competent patient as well as the incapable or incompetent patient in the health care field’.⁴⁵ Enacted to, among other objectives, enhance the autonomy of patients and promote communication and understanding between physicians and their patients,⁴⁶ it ‘reflects the need to shift the power balance from the knowledge’, expertise and ‘authority’ of the physician ‘to the wishes and autonomy of the patient’.⁴⁷