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Informed Consent Procedures in Persons with Mental Disorders: A
Juridical Review R. Windi Rachmawati Kusumah1*, Arrisman2,
Imam Haryanto3 Universitas Pembangunan Nasional
Veteran Jakarta, Indonesia Email: [email protected] |
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Keywords |
Abstract |
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Informed Consent, People With A Mental
Disorder; Juridical Review. |
No field escapes in the context of law, including,
in this case, health, so in the law itself, it is known as health law as a
branch of science. Health itself is not only in the physical context but also
mental, but what if the person with a mental disorder is physically ill? Of
course, it requires a doctor's action consent or informed consent from the
person with the mental disorder. In law, proficiency is known as a condition
for the validity of an agreement, and people with mental disorders are not
included in the clever person. So, in the research article, researchers are
interested in analysing and knowing how favourable laws that regulate are related to informed
consent in Indonesia and how legal procedures are related to informed consent
in laws and regulations in Indonesia for patients with mental disorders. The
method that researchers use is the normative method. In this article, it was
later found that first, informed consent itself is regulated in Law Number 17
of 2023 concerning Health, which was formed by the omnibus law method, and secondly
that the legal procedure of informed consent for patients with mental
disorders is regulated in Article 80 paragraphs (2) to paragraph (5), but
does not yet have an implementing regulation, so the government must
immediately form an implementing regulation.
© 2024 by the authors. Submitted for possible open-access publication under the terms and conditions of the Creative Commons
Attribution (CC BY SA) license (https://creativecommons.org/licenses/by-sa/4.0/). |
1. Introduction
Health law is a critical field or concentration
in legal science because it regulates the right to health as one of the human
rights guaranteed in the International Bill of Human Rights. In essence – not only health – many fields outside
of the law itself fall into the field of law because each field of science has
its own laws to regulate how a field can be in accordance with the procedures
and substances that should be. The feasibility in the health sector is in the
field of law, as mentioned in the previous paragraph, which is health law
(medical law). This health law does not have its codification in positive law
in Indonesia. Still, other fields of law, such as criminal, civil, and
administrative law, are closely intertwined with health science (Busro, 2018).
The basis of health law itself departs from the
conventional approach; the law regulating body intervention has considered the
body an object of analysis rather than a category of analysis. Legal analysis
can offer a richer understanding of legal involvement with the body and body
matter if it adopts a thicker embodiment conception. Such a conception would
seek to explain how we value the living physical body because it makes our
existence in the world and our interaction with others possible (Taylor, Dove, Laurie, & Townend, 2018). The
fields regulated by health law have a lot of substance, which essentially
regulates the human body and the human right to health. The presence can know
the legal relationship between doctors and patients in health law. Returning to the fields regulated in health
law, it regulated the rights and obligations of doctors and patients, ethics
and codes of ethics in the health profession, medical records, hospital
functions and responsibilities, medical malpractice, euthanasia, etc (Claessen, Lamkaddem, Oomen, & Eijkman, 2023).
The development of international health law can
be seen from the beginning of the World Congress on Medical Law in 1967 in
Belgium, which later in the congress formed the World Association on Medical
Law (WAML) to encourage the study and discussion of health law, medical law,
and ethics, for the benefit of society and the advancement of human rights (Jones, 2021). WAML aims to promote the study of
consequences in jurisprudence, legislation, and ethics of the development of
medicine, health and related sciences.
This right to health has become a constitutional right stipulated in
Article 28H paragraph (1):
"Everyone has the right
to live a prosperous life physically and mentally, to live in, and to get a
good and healthy living environment and the right to health services."
This confirms that the right to health is
inseparable from the health law, which is closely intertwined. This field,
which is also not spared in health law, is about informed consent as an
integral intertwining between the legal relationship of doctors and patients (Firdaus, 2023). Informed consent can be interpreted as
informed consent or consent to the doctor's actions towards patients, which is
one of the patient's rights and a form of special relationship between the
doctor and the patient. This form of relationship is one tool that allows
patients to determine their destiny in the doctor's practice (Wu et al., 2022).
Informed consent is a foundation in the legal
relationship between doctors and patients. It can even be understood that this
is by the conditions for the validity of an agreement stipulated in the Civil
Code, namely in Article 1320, where the conditions for the validity of an
agreement are an agreement between the parties that bind themselves to an
agreement; the competence of the parties; There is a sure thing that is agreed
and the causa is halal. Informed consent is closely related to the legal
conditions of an agreement, which, in essence, means that the patient trusts a
professional doctor (Scholten, Gather, & Vollmann, 2021). What is also important is the skills of the
parties, be they patients or a professional doctor. But what is discussed in this article is what
about informed consent to people with mental disabilities, which, in essence, is
not included in the legal capacity because, in essence, the right to health
does not look at whether the person has a mental disorder or not, the
application of human rights is egalitarian and mental or mental health is
included in the part of health and the right to health itself (Nurmardiansyah, 2022).
In positive law in Indonesia, health or mental
health is regulated by several laws and regulations. In the strata of law,
there is Law Number 23 of 1992 concerning Health, repealed by Law Number 9 of
1960 concerning Health Principles. Law 23/1992 was repealed by Law Number 36 of
2009 concerning Health, and the most recent is Law Number 17 of 2023 concerning
Health, which uses the method of forming omnibus law legislation. Some of the laws repealed by Law 17/2023 are
Law Number 4 of 2019 concerning Midwifery; Law Number 6 of 2018 concerning
Health Quarantine; Law Number 38 of 2014 concerning Nursing; Law Number 36 of
2014 concerning Health; Law Number 18 of 2014 concerning Mental Health; Law
Number 20 of 2013 concerning Medical Education; Law Number 44 of 2009
concerning Hospitals; Law Number 29 of 2004 concerning Medical Practice; Law
Number 419 of 1949 concerning the Hard Drugs Ordinance (Staatsblad
1949 Number 419).
As the researcher mentioned in the previous
paragraph, one of the laws that were repealed in Law 17/2023 with this omnibus
law method is Law 18/2014 on Mental Health, as will be the material for the
researcher's descriptive analysis in this research article where the scope or
scope in this study is about how favourable laws that
regulate are related to informed consent in Indonesia and how legal procedures
are related to informed consent in people with mental disorders in the laws and
regulations in Indonesia so that the existence of this research article will be
an additional treasure of scientific science about informed consent in people
with mental disorders.
2.
Materials and Methods
As the
researcher has described and explained comprehensively in the sub-background
section, the research method used is normative legal research, which the
researcher then uses to analyse favourable
laws, both material and formal, about informed consent in people with mental
disorders. The type of research that
researchers use is analytical descriptive research, and the author uses it to
describe how favourable laws are both material and
formal about informed consent in people with mental disorders. The researchers use both the statutory
approach and the conceptual approach.
3.
Results and Discussions
Ius Constitutum Informed Consent in the
Indonesian Legal System
As the author has quoted previously in the sub-background section, in
the legal system in Indonesia as a positive law or is constituted, there is a
development of regulatory law on health law, especially about informed consent.
In the current positive law, namely in Law 17/2023, there are 458 articles
which specifically discuss informed consent or action approval according to
legal jargon in Law 17/2023, regulated explicitly in Paragraph 5, namely about
approval of health service actions. The
obligation of informed consent is regulated in Article 293 paragraph (1):
"Every individual Health Service action taken
by Medical Personnel and Health Workers must be approved."
Article 293 paragraph (1) affirms the importance of this informed
consent and that the nature of informed consent is mandatory because the phrase
used is "shall" not "may", so based on grammatical
interpretation, it can be understood that this article expressly affirms that
this should not be an optional requirement only, but a mandatory requirement or
prerequisite for continuing further medical action. This article also regulates
all medical procedures and any patient condition, whether mentally normal or mentally
disordered (Ismaningrum & Sari, 2017).
This further emphasises the informed consent
of the doctor to the patient to emphasise the
importance of consent or permission from the patient for a doctor's action so
that it must meet adequate explanations, both related to diagnosis,
indications, health care measures, risks and complications that may occur,
risks if the action is not carried out and prognosis after obtaining action.
Based on this coverage, it can be understood that it describes all medical
actions given to patients and the effects that will occur if they are carried
out. If they are not done so that patients have unequivocal information, they
can consent (Mikhael, 2020).
One of the things that the author has mentioned before, informed
consent is closely related to the conditions for the validity of an agreement,
in this case, competence; this is further regulated in paragraph (7):
"If the patient concerned, as referred to in
paragraph (6), is incapable of giving consent, consent for action may be given
by the representative."
This paragraph confirms that informed consent to an incompetent person
is given by the person representing the person, be it a parent, sibling,
guardian or other person representing the incompetent patient. However, there
are exceptions, as provided for in paragraph (9):
"If the patient's condition as referred to in
paragraph (6) is incompetent and requires emergency action, but no party can be
asked for consent, no action approval is required."
This exception is emphasised in matters that
are indeed emergencies that require immediate health care and immediate action
so that it does not require informed consent from its representative. Still,
the health action information will then be shared with the patient after he has
been competent or there is a representative who has attended, so the term for
this is implied consent, which is often used in emergencies or implicit
approval of medical measures. This
incompetence can also occur in the context of the patient being a minor still
under his parents' care; this is known as parental consent or proxy for the
actions given to his child (Kumalasari & Ningsih, 2018).
In addition, informed consent is also related to health costs, as
stipulated in Article 294 by healthcare facilities. However, for certain other
matters, informed consent does not need to be given in the context of health
services organised as a form of health service
program from the government, but still needs to be informed to the patient;
this is regulated in Article 295. In theory, there must be certain conditions
worthy of being met in this informed consent, namely adequate information to
patients about the need for medical action and the risks it can cause. Based on
the information provided by the doctor, the patient gives his consent.
Furthermore, the patient must consent to every diagnostic and therapeutic
action (Aji, 2019).
Informed consent generally has another meaning with a complete intertwinedness: approval of medical actions related to
consent, permission that must be given from the patient or the patient's family
related to the doctor before operating, or other invasive actions that have
risks to patient health. Therefore, medical approval is often also mentioned
with surgical licenses and patient consents, letters of agreement – between
patients and doctors – and other terms known about this informed consent. Medical consent departs from 2 (two) fundamental
patient rights, namely the right to self-determination and the right to medical
information. These rights are closely
related to human rights principles in general.
Legal Procedure for Informed Consent in Patients
with Mental Disorders
In general, it is widely accepted that competence or professionalism is
a necessary condition for informed consent. In this viewpoint, if a person is
incompetent to make a particular treatment decision, the treatment decision
must be based on the prior direction or made by a substitute decision-maker
based on a surrogate assessment standard, the best interest standard, or what
can be called a competency model. On the scale of international law, there is a
convention concerning mental or mental health, namely the United Nations
Convention on the Rights of Persons with Disabilities (United Nations
Convention on the Rights of Persons with Disabilities), which explains that
persons with mental or mental disorders are included in the persons with
disabilities themselves, as in Article 1:
“The purpose of the present Convention is to
promote, protect and ensure the full and equal enjoyment of all human rights
and fundamental freedoms by all persons with disabilities and to promote
respect for their inherent dignity. Persons with disabilities include those who
have long-term physical, mental, intellectual or sensory impairments which, in
interaction with various barriers, may hinder their full and effective
participation in society on an equal basis with others.
This Convention aims to promote, protect, and ensure the full and equal
enjoyment of all human rights and fundamental freedoms by all persons with
disabilities and to promote respect for their inherent dignity. Persons with
disabilities include those with long-term physical, mental, intellectual or
sensory impairments that in interaction with various barriers may hinder their
full and effective participation in society on an equal basis with
others)."
This article in the UNCRPD confirms that persons with disabilities are
included in terms of physical, mental, intellectual and sensory impairments in
the long term, so in this case, it also confirms that this United Nations
Convention cannot be separated from discussion in this scientific journal
article that discusses health and informed consent.
The development of international health law itself underwent an
expansion of medical engineering, the possibility for modern medicine to
prevent rather than cure, and the fact that doctors are required to lead and
direct the physiological life of man, especially in terms of work and family
life. It is no longer a matter of healing arts but more and more of a privilege
to work on the human body. From the point of view of "pure" legal
theory, international health law is now a set of principles, standards and various
institutions designed to ensure unequivocally and effectively the protection of
human values that are symbols of human life and health. The intricate and
complex activities carried out in this new branch of the law will have the
objective of limiting the subject while at the same time harmoniously
distributing it but giving rise in particular to the human character,
impartial, universal and, as far as possible, independent of international
medical law in the system of humanitarian law.
In Law 17/2023, informed consent for people with mental/mental
disorders is precisely regulated, which is regulated in the eleventh section on
mental health. The legal definition or meaning of mental health according to
Law 17/2023 is contained in Article 74 paragraph (1):
"Mental health is a condition in which an
individual can develop physically, mentally, spiritually, and socially so that
the individual realises his or her abilities, can
cope with pressure, can work productively, and can contribute to his
community."
Furthermore, it can then be understood that this Law and this article
that health itself is included in mental health and becomes unity with this
omnibus law method so that the emphasis on the importance of mental health for
a person can develop physically, mentally, spiritually and socially. The
purpose of this mental health arrangement is a form of guarantee of the right
to health as one of the undruggable human rights, worthy of achieving a good
quality of life, enjoying a healthy mental life, free from fear, pressure and
other disorders that tend to interfere with mental health and also as a form of
guarantee for everyone to get various intelligence and psychological
potentials. This is stipulated in paragraph (2) of it. Especially for informed
consent for people with mental/mental disorders, the legal procedure is
explicitly regulated in Article 80 paragraph (20:
"In the case of a person with a mental disorder
who is deemed incompetent in making decisions, consent to action may be given
by:
1. husband or wife;
2. parents;
3. children or
siblings who are at least 18 (eighteen) years old;
4. guardian or
custodian; or
5. the office by the
provisions of the law."
This confirms that there is a harmony between the positive law and
theory in general, which asserts that incompetence can be resolved with the
consent of the closest person to the incompetent patient – in this case, a
person with a mental disorder – so that in this context incompetence in
informed consent – as a form of engagement and agreement that is closely
related to the conditions of the validity of an agreement – for the closest
person can give people with mental disorders.
In the context of positive mental health law in Indonesia, initially
regulated for the first time in Law 18/2014, precisely and explicitly regulates
mental health – which will later be repealed by Law 17/2023 – but until now,
the implementing regulations from Law 18/2014 until it is repealed by Law
17/2023 do not have to implement regulations, even though legally it is essential
to support in the context of enforcement or implementation of the law
(upholding the law). However, by the
closing provisions of Law 17/2023, the implementing regulations of the law that
were repealed and no longer valid due to Law 17/2023 remain in effect provided
that they do not conflict with Law 17/2023, it is necessary to refer to the
Minister of Health Regulation Number 290/MENKES/PER/III/2009 concerning
Approval of Medical Actions which generally regulates the Approval of Medical
Actions, However, it only regulates in
general about informed consent, does not regulate informed consent for patients
with mental/mental disorders, so the legal vacuum that currently occurs in the
absence of further implementing regulations on mental health, especially the
implementation of informed consent for patients with mental disorders.
Before the enactment of Law 17/2023, when Law 18/2014 was still in
effect, there was no implementing regulation regulating informed consent for
patients with mental disorders until the repeal of Law 18/2014 with Law 17/2023
with the omnibus law method. The transitional provisions order the government
as an implementing agency to form and establish implementing regulations of Law
17/2023 within 1 (one) year, calculated from the promulgation of Law 17/2023;
this is regulated in Article 456. Law 17/2023 was passed on August 8, 2023, so
the government has until August 8, 2024, to form and establish implementing
regulations from Law 17/2023, especially in this case, the implementing
regulations of mental health, which then regulate informed consent for people
with mental disorders in more detail.
4. Conclusion
In
essence, informed consent to patients has explicitly been regulated in Law
Number 17 of 2023 concerning Health, namely in paragraph 5 concerning Approval
of Health Service Actions, regulated from Article 293 to Article 295, which is
regulated in the strata of the Law, of course, which emphasises
the importance of informed consent as one of the rights of patients to obtain
information and explanations from medical parties who Then it becomes his right
to self-determination and obtain medical information.
The legal procedure
for informed consent for patients with mental disorders is regulated in Law
Number 17 of 2023 concerning Health, in the eleventh part of Article 80,
paragraph (2) to paragraph (5). In general, this law regulates mental health
from Articles 74 to 85. What is currently lacking is informed consent in
patients with mental disorders and certainly does not have legal competence –
as one of the requirements for legal competence, but there are exceptions in
the name of health – there is no implementing regulation from Law Number 18 of
2014 concerning Mental Health until the repeal of this law with Law Number 17
of 2023 concerning Health, So it is
necessary for the government to immediately form implementing regulations or
derivative regulations, especially in this case is the implementing regulation
on informed consent for patients with mental disorders.
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