By Chidera Nwokeke

INTRODUCTION

An essential of good medical practice is the recognition by the attending physician of the inherent right of the patient to their own body and life. The healthcare provider has no right to examine or treat a patient without their consent. The consent that is in issue here is not the consent as a constitutive element for the conclusion of the contract with the medical practitioner, but consent as a condition precedent to and justification for the legality of the physician’s intervention. This rule is subject to the exception that in an emergency if it is impossible or impracticable to obtain the patient’s consent or the consent of anyone authorized to assume such responsibility, in which case, the law implies consent.

In Nigeria, when a healthcare provider recommends specific medical care, a patient can agree to all of it, or only some of it. Before the procedure, the patient will have to complete and sign a consent form. This form is a legal document that shows their participation in the decision and their agreement to have the procedure done. The right to informed consent of a patient in Nigeria has certain legal backups which has also received judicial imprimatur. However, it is pertinent to note that it is not all treatments that require the signing of forms especially when it does not involve any invasive procedure.

Prefatorily, the crux of this article is to ascertain whether a patient is waiving their right to sue upon signing a medical consent form.  It is a notorious fact that unfolding events shows that many healthcare providers are oblivious of what a proper consent should be. There are some forms of consent which are imperative to be obtained by a practitioner from the patient. The medical profession insists that certain interaction deserves specific and expressly defined and documented forms of consent. However, there are many barriers to enjoyment of this right to informed consent. Some patients see the signing of consent forms as relinquishing their rights, or as a procedure that is only there to protect the hospital and the doctors. Also some patients do not always allow healthcare providers to use different treatment options owing to their cultural or religious beliefs.

WHAT IS INFORMED CONSENT?

Informed consent means that the patient specifically consents to the proposed medical procedure. Informed consent is more than just consent. In order for a patient to give informed consent to a medical procedure, the health care provider must inform the patient of all of the risks and complications that may reasonably occur during that procedure, however minor they may be. Only after a patient is truly informed about the potential risks of a medical procedure can a patient give consent to the procedure.[1]

Patient consent is not an optional extra but a core part of examination and treatment. All adults are assumed to have mental capacity to consent to or refuse treatment, unless there is evidence to the contrary. Consent by a person with capacity is valid when it is adequately informed and voluntary. Consent merely means to agree or to permit someone to do something.[2] Consent need not be in writing. As long as patients understand what is proposed, a verbal indication of acceptance is sufficient, but written authorisation is advisable for higher risk or innovative treatments and is legally required for some procedures. [3]

The purpose of the form is to ensure that the patient gives their informed consent for the medical procedure before the procedure is performed. Current legal, moral, medical and philosophical thought lists five elements for a valid informed consent, comprising of: two preconditions – voluntarism and capacity; two information elements – disclosure and understanding, and; a decision element – consenting or refusing.[4]

LEGAL SUPPORT FOR INFORMED CONSENT

The Patients’ Bill of Right is an aggregation of patients’ rights that exist in other instruments including, The Constitution, Federal Competition and Consumer Protection Act, Child Rights Act, Freedom of Information Act, National Health Act, the Hippocratic Oath, other professional ethical codes and sundry regulations. The bill provides for the rights, responsibility of patients and healthcare obligations. The bill provides for the right of patients to have access to all relevant information in a language that the patient understands, including complete and accurate information about diagnosis, treatment, and prognosis, other procedures and possible outcomes. The patient is to fully participate in implementing the treatment plan and making decisions. [5]

The healthcare provider is to inform the patient about services that are available at the facility and eligibility based on health insurance or out-of pocket costs and responsibilities. Equally inform patient whether proposed treatment or procedure is experimental or part of ongoing research; answer questions about proposed treatment and/or procedures and provide information about potential risks, alternative treatment and/or procedures; provide the patient’s medical records on request by the patient or other authorized persons, in accordance with prevailing laws.

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.[6] Explanations to patient from whom consent is sought should be simple, concise and unambiguous about expectations. Proper counseling should precede the signing of the consent form. Discussion and explanation to the patient must be in the language in which the patient is fluent and when necessary through a competent interpreter.[7]

Where the patient is under age (below 18) or is unconscious or is in a state of mind constituting a mental impairment, a next of kin should stand in. In the absence of a next of kin, the most senior doctor in the institution can give appropriate directive to preserve life. In special situations, a court order may need to be procured to enable life saving procedure to be carried out. The attendant benefits and risks are to be clearly laid before the patient. Appropriate professional advice on options must be given. The preferred option is to be chosen by the patient who will then authorise the clinician by completing the form MDCN/COMEIN/R19. An essential element of good medical practice is the recognition by the attending physician of the inherent right of the patient to his own body and life.[8]

Every healthcare provider shall give patient relevant information pertaining to his state of health and necessary treatment except in circumstances where there is substantial evidence that the disclosure of the patient’s health status would be contrary to his best interest. The provider shall make known the range of diagnostic procedures and treatment options generally available to the patient. The provider shall also make known the benefits, risks, costs and consequences generally associated with each option and the user’s right to refuse health services and explain the implications, risks, obligations of such refusal. 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.[9]

In the case of Abi v Central Bank of Nigeria,[10] the trial court briefly mentioned the issue of informed consent. Nyako J observed simply: “The duty of a doctor includes warning the patient of any possible risk with any treatment.

BARRIERS TO INFORMED CONSENT IN NIGERIA

1. Gender: A prevalent practice in certain part of Nigeria is the refusal of healthcare providers in allowing female patients to sign their consent form.  Female patients in Nigeria face a certain amount of pressure from their families when making decisions regarding their personal healthcare. In fact, some women waive their right to make decisions, typically giving that responsibility to their husbands or fathers. In many places, consent for cesarean sections or assisted deliveries are obtained from the husband instead of the patient.

Research[11] carried out at the Federal Medical Centre, Azare, in Bauchi State found that the need to obtain the consent of the husbands[12] of patients facing an emergency during pregnancy resulted in delays, which significantly increased the risk of death. Notwithstanding the fact that the husband or father of a female patient can sign the consent form in times of emergency or when the patient is not mentally fit, it is a discriminatory practice and a breach of right to informed consent of the patient by healthcare providers.

1. Literacy: Basically, literacy is the ability to read and write.  With the high rate of illiteracy in Nigeria, its untold impact is seen in the inability of patients to understand the import of consent form. The level of education and sophistication of a culture affects the level of information disclosure that can be given to patients. Getting informed consent from uneducated people is a regular occurrence but is more difficult and time consuming. A patient who signed an informed consent form cannot be considered informed without comprehending the medical procedure as well as its associated risks and benefits.[13]

The patient’s level of education therefore seems to be an overriding factor in all the influences on informed consent in the country. It not only neutralizes the various cultural and social factors, it bridges the gap between the doctor and the patient, encourages discussion on medical matters, and also puts the physician on guard. Some patients see the signing of consent forms as relinquishing their rights, or as a procedure that is only there to protect the hospital and the doctors.[14]

1.  Religion: Section 38 of the 1999 constitution guarantees a patient’s right to any religion of his choice.  This right to religion encompasses what he believes in.  Religion has had a dominant influence on ethics and healthcare practice in Nigeria. In most parts of Nigeria, calamities, diseases, sicknesses and problems are claimed to be the direct influence of spiritual beings who may have been offended, especially if certain taboos were broken.[15]As a result, people in remote areas are reluctant to accept Western disease models and treatment strategies. Sickness is seen as the work of the devil and bad people. A strong belief in destiny makes people willing to accept good or bad medical results as the will of God, even when obvious mistakes have been made.

Patients consult their ministers and other spiritualists before surgery, not only for their prayers and blessings, but also to be sure it is in line with God’s will. Religious practices also influence the understanding and reception of consent information and may be used by patients to mask the reality of some information they would rather not know. It is usual during the disclosure of negative news or risks of a procedure to hear patients exclaim ‘I reject it’, ‘it is not my portion in Jesus’ name’, ‘I banish it in Jesus’ name. The rejection of blood transfusion by some patients on religious beliefs has been a long time dilemma for healthcare providers as to whether to save life and disregard the right of patient to religion or to respect the patient autonomy.[16]

In the Nigerian case of Medical and Dental Practitioners Disciplinary Tribunal v. Dr. John E. N. Okonkwo,[17] the Supreme Court recognized the right of a patient to self-determination in the context of freedom of thought, religion and conscience. In that case a patient who belonged to the Jehovah’s Witness faith refused blood transfusion as same was contrary to her religious faith. She died as a result of the refusal to accept blood transfusion. The respondent was charged before the Medical and Dental Practitioner Disciplinary Tribunal on two counts of negligence and acting contrary to his oath as a medical practitioner. On appeal at the Supreme Court, Ayoola JSC held:

The patient’s constitutional right to object to medical treatment or, particularly, as in this case, to blood transfusion on religious grounds is founded on fundamental rights protected by the 1979 Constitution as follows: (i) right to privacy: section 34; (ii) right to freedom of thought, conscience and religious: section 35. All these are preserved in section 37 and 38 of the 1999 Constitution respectively. The right to privacy implies a right to protect one’s thought conscience or religious belief and practice from coercive and unjustified intrusion; and, one’s body from unauthorized invasion. The right to freedom of thought, conscience and religion implies a right not to be prevented, without lawful justification, from choosing the course of one’s life, fashioned on what one believes in, and a right not to be coerced into acting contrary to one’s life, religious belief. The limits of these freedoms, as in all cases, are where they impinge on the rights of others or where they put the welfare of the society or public health in jeopardy. The sum total of the rights of privacy and of freedom of thought, conscience or religion which an individual has, put in a nutshell, is that an individual should be left alone to choose a course for his life, unless a clear and compelling overriding state interest justifies the contrary…

WHO CAN SIGN A CONSENT FORM?

It is a trite law that only a patient can give an informed consent thus only a patient can sign the consent form.  However, notwithstanding the general rule, in some cases, another person can sign a consent form for a patient. This is appropriate in the following scenarios:

1. Age: If a patient is a child or a young person that has not attained the legal age of making decisions, a parent or guardian will need to give consent on their behalf. The legal age of consent in Nigeria is 18.  However, despite the legal age, the healthcare providers can also consider the Gillick principle to ascertain the child’s competence. Gillick competence is a term originating in England and Wales and is used in medical law to decide whether a child under the age of 16 years is able to consent to their own medical treatment without the need for parental permission or knowledge.
2. Advance Directive: Just like letters, they are formally written instructions appointing and signed by a patient when still very conscious and have capacity to make decisions. The appointed person has the power to give consent or make future medical decisions for the patient if they are unable to make such decision or give consent.
3. Mental Capacity: The next of kin or the person who has been named under the advanced directive can make medical decisions if the patient can’t provide consent. This can happen if as at the time the consent is needed, the patient is of unsound mind or mentally unstable.
4.   Emergency: In an emergency situations like accident, coma etc, a close blood relatives can give the healthcare consent. But if the patient’s relatives aren’t available, a healthcare provider can perform the necessary life-saving procedures without consent.[18]

EFFECT OF SIGNING A CONSENT FORM

1. You received all the relevant information about your procedure from your healthcare provider.
2. You understand the information.
3. You used the information to determine whether or not you want the procedure.
4. You agree, or consent, to get some or all of the treatment options.
5.  A properly-executed consent form will generally bar a patient from suing a doctor for lack of informed consent.

Once you sign the form, your healthcare provider can move forward with the procedure and you are bound by the consent form. If you don’t want a procedure or treatment, you can choose to not sign the form. Your healthcare provider won’t be able to provide specific types of treatment if you don’t agree to it. [19]

CAN I STILL SUE?

It is rudimentary law that a person who signs a document is bound by it. In Enemchukwu v Okoye,[20] Ogunwumju JCA stated: In the absence of fraud, duress or plea of non est factum, the signature of a person on a document is evidence of the fact that he is either the author of the contents of the document that are above his signature or that the contents have been brought to his attention. Thus, he is bound by the contents of the document he has signed.

However, a medical consent form does not waive liability, and does not eliminate the option of pursuing damages for medical malpractice, assault and negligence. If a patient signs a consent form, proceeds with treatment, and then suffers some kind of ailment as a result, a medical malpractice suit can be maintained under such circumstance.

1. Lack of Informed Consent: A patient can sue the healthcare provider for not obtaining consent. The medical and Dental council of Nigeria is aware that there is no standard format for obtaining consent for procedures and surgical interventions on patients in Nigeria and as of now, there are indeed practitioners who do not insist on formal consent to intervene on the body of the patient, for adequate ethical protection. Whilst some consent may be concluded verbally, it is based on the necessity to correct this unwholesome situation that Council has approved a simple format for guidance and use in clinical management. The approved format, coded FORM MDCN/COMEIN/R19 is included here as a part of Rule 19 of the code of Medical Ethics in Nigeria for the purpose of universal application throughout Nigeria. This form is now the standard layout to be used by the registered practitioners in Nigeria to obtain appropriate consent to carry out procedure on patients. All other formats for obtaining consent for procedures on patients are hereby declared invalid.[21]

A patient can sue a healthcare provider for lack of consent where the provider uses any other format for obtaining consent for procedure other than Form MDCN/COMEIN/R19, because such other format is invalid and it is settled law that you cannot place something on nothing and expect it to stand. Furthermore, consent can be invalid if any of the five elements for a valid informed consent, comprising of: two preconditions – voluntarism and capacity; two information elements – disclosure and understanding, and; a decision element – consenting or refusing is missing.

It will amount to lack of consent where the patient or anyone giving consent to sign the form whereas he did not understand the language used.  Thus, it is fundamental for the healthcare providers to explain to the patient or anyone signing on their behalf the procedure, benefits, risk, consequences involved in the treatment procedure in a language he/she can understand and if possible, make the consent form available in a language he understands.  The burden of proving want of consent is on the plaintiff.

Just as the doctor’s failure to fill out the consent form properly can give rise to a medical malpractice claim, a properly executed consent form will generally bar a patient from suing a doctor for lack of informed consent. As long as:

1. The consent form identifies the medical procedure and its reasonably known risks with reasonable adequacy
2. The patient was not pressured to sign the form
3. The patient was mentally competent to sign the form[22]

1. Medical Negligence: No medical consent form can bar a patient from bringing a legal claim if negligent treatment did occur in course of treatment despite signing the form. If a doctor or hospital made errors that amounted to negligence, it can’t hide from a medical malpractice claim behind a legal form. Medical negligence is the failure of the medical practitioner to exercise a reasonable duty of care in the course of his duty as a professional in the field. A registered medical practitioner is liable for professional negligence when he fails to exercise the skill or act with the degree of care expected of his experience and status in the process of attending to a patient. For the patient (Claimant) to succeed, he needs to prove the following[23]:
2. That the defendant (doctor) owed him a duty to exercise due care. Before the accrual of liability, however, the basic requirement of the law is that the defendant must owe a duty of care to the plaintiff. Where there is no such notional duty to exercise, negligence will have no legs to stand and any claim premised thereon will fail.[24]
3. The doctor breached his duty of care. The position of the law in the case of negligence is that the claimant must be able to link the breach of duty of care which occasioned the injury to the defendant. This to my mind is to say that the cause of the injury has to be traced to the act or omission of the defendant.[25]
4. That the breach resulted in damage to the patient. It is a basic principle of law that there can be no action in negligence unless there is damage.[26]

The courts have long recognised that there is no negligence if a doctor exercises the ordinary skill of an ordinary competent man professing to have that special skill.[27] Where the extent of the negligence had been such that it resulted in permanent disability or death of the patient, then the practitioner will be held liable for gross negligence.[28] Once a doctor undertakes to treat a patient, a duty of care arises. It doesn’t matter whether or not such care is rendered for a fee or ex gratia. He must conform to the reasonable standard of an ordinary doctor of his training and skill.[29]

1. Your Doctor Didn’t Follow Medical Protocol: Healthcare professionals are guided by what’s considered the standard of care. Basically, there are guidelines that the medical profession deems reasonable for certain medical conditions and diseases. For instance, the standard of care for a cancer patient may involve surgery, chemotherapy, or radiation. Now, let’s assume that during surgery, your doctor strays from normal practices and opts to try out a new technique he heard about. And unfortunately for you, it makes things worse.  In cases like this, the surgery consent form holds no weight. You are entitled to sue the doctor for turning you into a guinea pig without your consent.[30]

It is rudimentary law that in order to find a medical professional guilty of negligence, the situation has to be such that what he did is what professional colleagues would say that he really made a mistake and that he ought not to have made it. Put differently, the action would be such that falls short of the standard of a reasonably skillful medical professional.[31]

CONCLUSION

Generally, professional medical negligence or malpractice has been on the increase and needs to be addressed in terms of the attitude of law towards medical practice for the protection of the patient to make the physician liable as well as to secure punitive punishment for any medical practitioner who through carelessness causes harm to a patient.

Moreover there is the need to caution medical practitioners who have sent many patients to their untimely graves in the course of their professional duties. It would in addition aid to restore people’s confidence in the medical profession. There is need to increase the awareness that patients can seek compensation for things such as medical expenses, lack of informed consent, medical negligence and pain and suffering. While money will not get the patient back all of what they may have lost, it can certainly help on the road to recovery.

Increasingly, there is the need for patients to be protected from medical practitioners who no longer see their professional calling principally as that of saving lives but as that of making money. The need for the protection of patients is not new. In advanced countries, precaution has been taken through legislation and through increased reliance on court action both of which ensure that negligent medical practitioners are made to pay damages to affected patients.

It is our hope that a time will come and now is the time for the courts in this country to rise up in one accord and with one voice clearly and in unmistaken terms in all appropriate cases to not only condemn and deprecate abuses of infringement of patient’s rights to informed consent, ineptitude of healthcare providers but also to make abuse of these rights and negligence by doctors and healthcare providers very unattractive by rewarding exemplary damages in deserving cases.

Chidera Nwokeke is a student of the Nigerian Law School, Lagos campus. He is committed in employing the tools of litigation, ADR, legal advocacy, research writing and policy dialogues in creating  a dependable framework for the advancement of Dispute Resolution, Medical Law, Consumers Right and Human Rights development in Nigeria and African he can be reached at [email protected] or +2348120945787

[1]Do release or consent forms preclude you from suing for medical malpractice? Available at http://www.alllaw.com/articles/nolo/medical-malpractice/release-consent-forms-preclude-suing.html accessed 12th January, 2021

[2] Ogundipe v. Oduwaiye & Anor (2013) LPELR-CA/I/108/04

[3] E.R. Ezeome, and P.A. Marshall, ‘Informed consent practices in Nigeria’ Dev World Bioeth 2009 Dec; 9 (3): 138-48, doi: 10.1111/j.1471-8847.2008.00234.x.Epub 2008 Apr 29, PMID: 18452553

[4] T.L. Beauchamp & J.F. Childress, eds. 2001, Principles of Biomedical Ethics,  New York, NY: Oxford University Press

[5] www.cpc.gov.ng

[6] Medical and Dental Council of Nigeria, 2004, Codes of Medical Ethics in Nigeria. Surulere: Petruvanni Co. Ltd: 26–31

[7] Ibid n5

[8] Ibid

[9] Section 23 National Health Act, 2004

[10] Abi v Central Bank of Nigeria (20 March 2007), Federal High Court, Abuja

[11] Bako, Umar, Garba & Khan, Informed Consent Practices and its Implication for Emergency Obstetrics Care in Azare, North-Eastern Nigeria (2011) 1 Ann Med Health Sc Res 149.

[12] It was not always a matter of obtaining the husband’s consent. The study reports (at 155), that: “[u]nfortunately, even the husbands are sometimes not empowered to give consent in the society especially if [they] cannot bear the financial burden of the treatment. In this situation, the consent will be given by the parent, in-laws or other relatives… These people often do not accompany the patient to the hospital and reside in remote areas. The logistics in reaching out to them often leads to the delay in obtaining consent.”

[13] A. Sherlock, and S. Brownie, ‘Patients’ recollection and understanding of informed consent: A literature review. ANZ J Surg. 2014; 84:207–10, doi: 10.1111/ans.12555.

[14] Atanda, Owonikoko & Adeniji, Pre-operative written consent in Nigeria: How informed are our patients? (2013) 4 J of Med & Med Sciences 307

[15] P.A. Marshall, Relevance of Culture for Informed Consent in U.S.-Funded International Health Research. In Ethical and Policy issues in International Research: Clinical Trials in Developing Countries. 2001 Vol. II. Bethesda, MD: National Bioethics Advisory Commission: C1–C38

[16] Ezeome & Marshall, Informed Consent Practices in Nigeria (2009) 9 Developing World Bioethics 138, at 141-142;

[17] (2001) LPELR-SC.213/1999

[18] Section 20(1) National Health Act, 2004

[19] K. Nunez, “What You Need to Know About Informed Consent’’ available at  https://www.healthline.com/health/informed-consent accessed on 9th January, 2021

[20] (2016) LPELR-(40027) 1 at 16

[21]Rules of Professional Conduct for Medical & Dental Practitioners: Codes on Medical Ethics in Nigeria, Rule 19

[22] Supra

[23] Otti v Excel-C Medical Centre Ltd & Anor (2019) LPELR-CA/L/755/2012

[24] Hamza v. Kure (2010) LPELR-SC.227/2001

[25] 7up Bottling Company Plc V. Emmanuel (2013) LPELR-CA/I/74/2009; Ogbiri vs. N.A.O.C. Ltd (2010) 14 NWLR (Pt. 1213) 208; Anyah vs. Imo Concorde Hotels Ltd (2002) 12 SC. (Pt. 11) 77

[26] Makwe v. Nwukor & Anor (2001) LPELR-SC.100/1996;

[27] Abi v CBN & Ors (2011) LPELR-CA/A/262/2007

[28] Rules of Professional Conduct for Medical & Dental Practitioners: Codes on Medical Ethics in Nigeria, Rule 30

[29] D. MOMODU and T. I. A. OSENI, American International Journal of Contemporary Research Vol. 9, No. 1, March 2019 doi:10.30845/aijcr.v9n1p7 Available at https://www.researchgate.net/publication/332947280 accessed 20 January, 2021

[30] I Signed A Medical Consent Form. Can I Still Sue? Available at https://www.hamptonking.com/blog/i-signed-a-medical-consent-form-can-i-still-sue/  accessed on 8^th January, 2021

[31] Ojo v Gharoro (2006) 10 NWLR (Pt. 978) 173