Nigerian laws on informed consent before a surgical procedure

Introduction

Informed consent is a process of communication between a clinician and a patient that results in the patient's authorisation or agreement to undergo a specific medical intervention.

It spells out the procedure that the clinician plans to achieve that specific medical intervention. In addition, it clearly states the benefits and risks associated with the procedure.

A patient is given the informed consent form to read and to append his/her signature to show that he/she understands what the medical intervention is for and consents to it.

This is a mandatory part of medical practice which when found wanting can result in litigation. Informed consent is part of the preoperative routine as a matter of hospital policy, legal requirement and ethical obligation. In surgical practice, the principle behind consent for surgery is essentially the same everywhere, but the emphasis placed on it and the process of obtaining it vary from place to place. ¹

Informed consent is an established ethical and legal requirement for surgical treatment. It has important roots in Anglo-American political theory and has been articulated in the law in a series of judicial decisions. ²

There is a marked disparity between patients and their medical practitioners with regard to enlightenment and education in Nigeria.

There are scant studies on informed consent before a surgical procedure. Medico-legal issues rarely make it to the courts, and the few that eventually do are on medical negligence resulting in death or grievous bodily harm stricto sensu.

The very few studies mostly emanate from empirical studies of medical researchers. Why are the courts not pushing this all important medico-legal issue?

Medical practitioners in a fiduciary relationship with their patients

A fiduciary relationship in law comes under the ambit of the law of torts. According to Black’s Law Dictionary, ³ fiduciary relation is a relation subsisting between two persons in regard to a business, contract, or piece of property, or in regard to the general business of estate of one of them, of such a character that each must repose trust and confidence in the other and must exercise a corresponding degree of fairness and good faith.

Medical practitioners stand in a fiduciary relationship with their patients. In Witherell v Weimer, ⁴ it was stated that the physician–patient relationship has its foundation on the theory that the former is learned, skilled and experienced in those subjects about which the latter ordinarily knows little or nothing but which are of the most vital importance and interest to him, since upon them may depend the health or even life of himself or his family. Therefore, the patient must necessarily place great reliance, faith and confidence in the professional word, advice and acts of the physician.

According to the World Medical Association Declaration of Lisbon on the Rights of the Patient ⁵ and of which the Nigerian Medical Association is a member, a mentally competent adult patient has the right to give or withhold consent to any diagnostic procedure or therapy. The patient has the right to the information necessary to make her/his decisions. The patient should understand clearly what the purpose of any test, treatment or results would imply and what the implications of withholding consent will be. ⁶

Sections 17(c) and (d) of the Nigerian Constitution ⁷ guarantee the right to health.

The State shall direct its policy towards ensuring that:

(c) the health, safety and welfare of all persons in employment are safeguarded and not endangered or abused.

Medical ethics on informed consent

One of the statutory functions of the Medical and Dental Council of Nigeria, as contained in Section 1(2)(c) of the Medical and Dental Practitioners Act [CAP 221], Laws of the Federal Republic of Nigeria 1990 is: ‘Reviewing and preparing from time to time a statement as to the code of conduct which the council considers desirable for the practice of the professions in Nigeria’.

It is the Council’s desire that every medical and dental practitioner is familiar with the provisions of this Code. This is to ensure that practitioners practice the profession with conscience and dignity within the limits of the provisions of the code, thus bringing the incidence of ethical violations to the barest minimum, as ignorance of the law will not be an excuse for any ethical violations. The Code aims to enhance the image of the profession, increase the confidence of the public in the practitioners and offer protection to the conscientious practitioner.

Rule 19 Part A: Code of Medical Ethics of Nigeria on informed consent.

Practitioners involved in procedures requiring the consent of the patient, his relation or appropriate public authority must ensure that the appropriate consent is obtained before such procedures, either for surgery or diagnostic purposes, are done, be they in invasive or non invasive. Consent forms should be in printed or in written form either as a part of case notes or in separate sheets with the institutions name boldly indicated.

Section 23: National Health Act 2004.

1. Every healthcare provider shall give a user relevant information pertaining to his state of health and necessary treatment relating thereto including: (a) the user’s health status except in circumstances where there is substantial evidence that the disclosure of the users health status would be contrary to the best interest 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 associated with each option; and (d) the user’s right to refuse health services and explain the implications, risks, obligations of such refusal. 2. The healthcare provider concerned shall, where possible, inform the user in a language that the user understands and in a manner which takes into account the user’s level of literacy.

The locus classicus on informed consent in Nigeria is the case of Medical and Dental Practitioner Disciplinary Tribunal v Okonkwo, ⁸ where it was held that the patient’s consent is paramount. In that case, the patient was a pregnant Jehovah's Witness who declined blood transfusion and was discharged against medical advice. She was later admitted for treatment in another hospital of Dr Okonkwo, also a Jehovah's Witness, who treated her without blood based on the refusal of the patient to be treated with blood. She died as a result. Her relatives filed a complaint to the medical tribunal; he was found guilty of breach of the ethics of his profession and was suspended from practising for six months. He appealed, and at the Supreme Court the tribunal decision was overruled. It held as follows: ‘The patient was free to decide whether or not to submit to a treatment by a doctor…, the patient is entitled to reject the advice for reasons which are rational or irrational or for no reason’.

Medical negligence presupposes that harm is caused to a patient by the negligent act of a medical practitioner. Section 303 of the criminal code ⁹ states that it is the duty of every person who, except in a case of necessity, undertakes to administer surgical or medical treatment to any person, or any other lawful act which is or may be dangerous to human life or health, to have reasonable skill and to use reasonable care in doing such act, and such a person by reason of any omission to observe or perform that duty.

For the medical practitioner to be held liable under criminal law, the degree of negligence required is that it should be gross and not mere negligence. ¹⁰

It is also a stated law ¹¹ that the standard to be used to judge a medical professional is that of a reasonable, skilful medical professional.

It is more common to seek civil relief in cases of medical negligence. Where a healthcare provider administers treatment to a patient negligently and injury is caused to the patient, he may sue for negligence against the provider for the injury suffered. The rationale for liability for negligence of a healthcare provider is that someone harmed by the actions of such a provider deserves to be compensated by him.

In law, a plaintiff must establish three elements ¹² to succeed in an action in medical negligence. These include:

the healthcare provider owed the plaintiff a legal duty of care;

Conclusion

There are laws on informed consent before a surgical intervention. Most medical practitioners fail to follow all the procedures prescribed in the Code of Medical Ethics. There is a call on the Nigerian Medical and Dental Council to review its Code of Medical Ethics with regard to informed consent; it should expressly spell out the sanctions on erring medical practitioners and state what amounts to an offence. The same goes for Section 23 of the National Health Act 2004.