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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.

 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 vSociety 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:

·       
Emergencies.

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.