By Mustapha Moyosore

INTRODUCTION

The right to life is sacrosanct to the bearer and nobody has the authority to deprive them of this natural gift which the creator has gifted them. Just as this right is intrinsic and fundamental, so is the right to decide what happens to one’s state of health which ultimately has a far-reaching effect on the person’s life.

This is the reason for obtaining the consent of a patient before the conduct of any medical process or treatment on them is paramount. Failure to do so will render the medical practitioner liable for breach of the Medical Code and for assault on the patient or research subject. This work will discuss the key concepts around Informed Consent, the components that underlines this practice and the exceptional cases where it may be legally foregone.

AUTONOMY

Autonomy is a Latin word for “self-rule”. Every human has an obligation to respect the autonomy of other persons, which is to respect the decisions made by other people concerning their own lives. This is in accordance with the fundamental right to human dignity. In medical practice, autonomy is usually expressed as the right of competent adults to make informed decisions about their own medical care. The principle underlies the requirement for a medical practitioner to seek the consent or informed agreement of the patient before any investigation or treatment takes place. The principle of patience autonomy mandates the health care providers to educate the patients about the treatment options available to the patient; it prohibits the health care provider making the decision for the patient. It is an absolute, inalienable right of the concerned patient.

INFORMED CONSENT

Informed consent forms the basis of the fiducial relationship existing between the patient and the health worker and it is essential to the health worker’s ability to diagnose and treat patients as well as the patient’s right to accept or reject clinical evaluation, treatment, or both.

According to the provision of Part A section 19 of the Code of Medical Ethics in Nigeria[1], informed consent is:

“The permission granted in full knowledge of the possible consequences, typically that which is given by a patient to a doctor for treatment with knowledge of the possible risks and benefits”.

Informed consent means that patients or research subjects understand their health condition after much explanation by their health care provider; the options available to them, and the attendant benefits and risks of each option.

It is important that the person undergoing the treatment has sufficient time to weigh his or her option before making the decision. In fact, according to the code of medical practice, the main purpose of informed consent process is to protect the patient.

A consent form is a legal document that ensures an ongoing communication process between the patient and health care provider. It enables the patient decide which treatment they want to receive and whether they even want it or not.

Additionally, informed consent allows the patient to make decisions with the close assistance of their healthcare provider. This collaborative decision-making process is an ethical and legal obligation of healthcare providers and a fundamental right of the patient[2].

Informed consent generally requires the patient or responsible party to sign a statement confirming that they understand the risks and benefits of the procedure or treatment and are willing to proceed and receive it.

The concept of Informed consent is not an alien practice in Nigeria, its operation, as in other societies, is influenced by relationships within the culture of the people and the ethos of the Medical profession. It is modulated by extended family relationships, the high level of religious expression, the multiplicity of religions and ethnic groupings, and defined gender and age relationships within the society. These influences, however, seem vitiated in the educated patient.

Societies and cultures are neither homogenous nor static. Therefore, variations in the practice of informed consent exist not just in comparison with the Western world but also between and within the different subcultures in the country.

The Nigerian medical community should improve the ethical conduct of her healthcare workers through better education and additional research on the consent needs of the Nigerian public.

ELEMENTS OF INFORMED CONSENT

The key components of informed consent are the ethical issues of research involving human subjects. The principles of autonomy, beneficence, and justice are basic to these ethical issues and merit your consideration. Obtaining informed consent in medicine is a process that should include:

Describing the proposed intervention to the patient,
Emphasizing the patient’s role in decision-making,
Discussing alternatives to the proposed intervention,
Discussing the risks of the proposed intervention
Making sure the patient has the capacity (or ability) to make the decision.
The healthcare worker must disclose information on the treatment, test, or procedure in question,
The expected benefits and risks, and the likelihood (or probability) that the benefits and risks will occur must be fully explained.
The patient must comprehend the relevant information.
The patient must voluntarily grant consent, without coercion or duress.
BASIS OF LIABLILIY

The basis of liability on the part of a healthcare provider or researcher for not seeking the informed consent of the patient or research subject is that; a person has the right to determine what is done with his or her body. Failure to secure the consent in circumstances not exempted by law, attracts liability on the part of the healthcare provider or researcher. It is the informed consent that distinguishes medical procedures from assault. Explaining the basis of liability, JUSTICE CARDOZO stated in the landmark decision of Schloendorff v. Society of New York Hospital, 105 N.E. 92 (N.Y. 1914) that:

“Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault, for which he is liable in damages.” (Underlined is mine for emphasis).

It is important to note that informed consent does not only apply to surgery. It applies to therapeutic and non-therapeutic procedures, invasive and non-invasive treatment.

IMPORTANCE OF INFORMED CONSENT

Consent to treatment is among the most complex ethical issues healthcare workers face. Therefore, it is important to understand what is involved.

No one can guarantee positive outcomes in healthcare settings, but informed consent at least ensures that patients understand the risks they undertake with treatment. It is also the law, when patients agree to a treatment, they must sign paperwork indicating they understand the risks and agreeing that doctors can take specific life-saving measures if needed.

Informed consent creates trust between doctor and patient by ensuring good understanding. It also reduces the risk for both patient and doctor. With excellent communication about risks and options, patients can make choices which are best for them and physicians face less risk of legal action.

Informed consent allows patients to make their own decisions, instead of the traditional approach where the doctor decides what is best for them. This means medical professionals must offer enough information to patients to enable them make a choice and provide enough time to exercise this all too important right, where possible, so patients do not feel pressured.

Pain medication and some medical conditions can affect judgment and understanding, so doctors must consider these factors when seeking consent from a patient.

EXCEPTIONS TO INFORMED CONSENT

There are several exceptions to informed consent acknowledged by the legal system in most countries. The generally accepted exceptions to the requirement for informed consent include:

In an emergency, a doctor must act quickly to save lives. If stopping life-saving efforts and describing the risks of a procedure will cause a delay that puts the patient’s life further at risk, then the doctor does not need to obtain informed consent.
Voluntarily waived consent
This is when the patient has voluntarily disclaimed that he/ she needs not to be sought before any treatment is carried out on him/her. In this case, the patient has given the healthcare worker the sole responsibility to deal with his/ her condition according to their best practice and knowledge. This must be reduced to writing and signed by parties, to nip in the bud any chance of liability that may arise, should the patient subsequently deny consent.

Where the patient is incapacitated
If the patient’s ability to make decisions is questioned or unclear, an evaluation by a psychiatrist to determine competency may be requested.

A situation may arise in which a patient cannot make decisions independently but has not designated a decision-maker. In this instance, the hierarchy of decision-makers, which is determined by each state’s laws, must be sought to determine the next legal surrogate decision-maker. If this is unsuccessful, a legal guardian may need to be appointed by the court.

Prior patient knowledge
The patient is already aware of the risks involved in his or her treatment and has come to a conclusion which he/ she has disclosed to the healthcare provider prior to the treatment.

Therapeutic privilege
This is when a patient can be expected to become so emotionally distraught upon disclosure that he/she will not be able to make a rational decision, and this may hinder his/her own treatment. It acknowledges that in some situations the disclosure of certain risks would not be in the patient’s best medical interest. This exception does not imply that the health worker may withhold information simply because the patient will not agree with the preferred treatment (and later claim it was for the patient’s benefit). It should be exercised with great care and discretion and should not be used as an excuse to withhold the truth, it is the patient’s entitlement.

Patients lacking capacity
Legally, capacity refers to a person’s ability to understand the nature and quality of a transaction and to take actions or make decisions that influence his/her life. A decision that a patient lacks capacity is a significant one, as it strips them of their right to control their life in relation to the decision in question.

Where patients lack capacity, other people will have to make the decision for them. The health worker must consider the views of anyone the patient asks the health worker to consult, or who has legal authority to decide on their behalf or has been appointed to represent them. Otherwise, the views of people close to the patient, who know the patient’s preferences, feelings, beliefs, and values should be consulted to try to decide whether the proposed treatment would be in the patient’s best interests. If the patient regains capacity, they must be promptly informed what treatment has been administered to them and why it was opted for.

CONCLUSION

A healthcare provider or researcher should obtain the written, informed consent of the Patient or research subject; failing which the healthcare provider or researcher will be liable. However, the healthcare provide will escape liability if it comes under the exception provided by law.

There are adequate laws regulating Informed Consent in Nigeria. The problem is with the compliance. The mechanism to ensure compliance can be improved. Two great factors affecting the issue of informed consent are; awareness and finance. On one hand, most people are not aware that their healthcare providers are obligated to get their consents before carrying out treatment or medical examination. On the other hand, they are also ignorant of the fact that they are entitled to redress. Some healthcare providers are also ignorant of the law on informed consent. Those who are aware of the necessity for informed consent, do not seek redress because of the cost.

Written By MUSTAPHA MOYOSORE. is with Messrs O. M. Atoyebi, SAN & Partners (OMAPLEX LAW FIRM) where she works in the Corporate and Commercial Department of the Firm. She has an in-depth understanding of Medical Law and Minin Sector and has worked with various key industry stakeholders and facilitated several transactions.

[1] Issued by the Medical and Dental Council of Nigeria in consonance with the provision of the Medical and Dental Practitioners Act, Cap.221 Laws of the Federal Republic of Nigeria 1990, on 1st January, 2004.

[2] Section 19 ibid.