Achmad Shiva’ul Haq Asjach
Scholar ID, Sinta ID, Scopus ID, WoS ID
The concepts of
patient rights and informed consent are fundamental elements of modern
healthcare services, which are oriented toward respect for human dignity and
patients’ human rights. In the therapeutic relationship between medical
personnel and patients, patients are no longer regarded merely as objects of
healthcare services, but as legal subjects who possess the right to determine
medical actions performed on their own bodies. Therefore, in principle, every
medical procedure must be carried out based on the patient’s consent after
obtaining complete, honest, and comprehensible information regarding the
intended medical intervention. This principle is known as informed consent or
consent for medical treatment.
From a health
law perspective, informed consent constitutes a form of protection for the
patient’s autonomy, namely the right of patients to freely determine their
choice regarding medical treatment. This concept has evolved alongside a shift
in the healthcare paradigm from a paternalistic model to a patient-centered
care approach. In the paternalistic model, physicians hold dominant authority
in determining medical treatment, whereas in the modern concept, patients have
the right to know, understand, and consciously agree to medical procedures
(Komalawati, 2002).
In Indonesia,
the regulation of informed consent is provided under Law of the Republic of
Indonesia Number 17 of 2023 concerning Health, as well as Minister of Health
Regulation Number 290/Menkes/Per/III/2008 concerning Consent for Medical
Procedures. These regulations affirm that any medical procedure involving risk
must obtain consent from the patient or their family after a full explanation
has been provided regarding the intended medical intervention. Accordingly,
informed consent has not only an ethical dimension but also legal consequences
in protecting patient rights and establishing medical personnel liability.
In principle,
informed consent contains several essential elements that must be fulfilled for
the patient’s consent to be considered legally valid. First is the disclosure
of information, which must be complete and clear to the patient. Such
information includes the diagnosis of the illness, the purpose of the medical
procedure, the procedure itself, possible risks and complications, alternative
treatments, and the prognosis of the patient’s condition if the procedure is
performed or not performed. The information must be delivered in language that
is easily understood and appropriate to the patient’s condition so that the
patient can truly comprehend the medical intervention to be undertaken
(Nasution, 2013).
Second, there
must be patient capacity to make decisions (competence or capacity). Consent
can only be given by patients who are legally and mentally capable of
understanding information and making decisions consciously. Patients who are
minors, have mental disorders, or are in an unconscious state are considered
not to have full capacity to provide consent; therefore, consent may be given
by their legally authorized family members or guardians.
Third, there
must be voluntariness. Consent must be given without any form of coercion,
pressure, threats, or manipulation from any party. Consent obtained under
pressure cannot be considered valid informed consent under the law.
Fourth, there
must be actual consent. Consent may be given either in written or oral form
depending on the type of medical procedure performed. For high-risk medical
procedures, consent is generally provided in written form as a form of legal
protection for both patients and medical personnel.
In healthcare
practice, the implementation of informed consent continues to face various
challenges. One of the main challenges is the low level of patient
understanding of the medical information provided by healthcare professionals.
Not all patients possess adequate education levels or health literacy to
comprehend complex medical terminology. As a result, patients sometimes merely
sign consent forms without truly understanding the substance of the medical
procedures to be performed.
In addition, a
paternalistic culture still exists in medical practice in Indonesia, where
medical decisions are often made entirely by physicians without active
involvement of the patient. Under such conditions, informed consent is
frequently treated merely as an administrative formality rather than as a
genuine expression of respect for patient rights. This condition contradicts
modern bioethical principles, which position the patient as the party who has
the right to determine what is done to their own body.
Challenges in
the implementation of informed consent are also particularly evident in
emergency medical situations. In emergencies, medical personnel are often
required to act immediately to save a patient’s life without having sufficient
time to obtain prior consent. In such circumstances, the law provides an
exception to the requirement of informed consent based on the principle of salus
aegroti suprema lex, meaning that the patient’s safety is the highest law.
Therefore, emergency medical interventions may still be performed as long as
they are intended to save the patient’s life and are carried out in accordance
with professional standards and standard operating procedures.
Nevertheless,
emergency medical interventions must still be conducted in a proportionate
manner and based on urgent medical necessity. Once the patient’s condition has
stabilized, medical personnel remain obliged to provide explanations to the
patient or their family regarding the procedures that have been performed.
Thus, the exception to informed consent in emergency situations does not
eliminate the obligation of medical personnel to respect patient rights.
Another issue
arises in patients with limited decision-making capacity, such as children,
patients with mental disorders, patients with dementia, or those in an
unconscious state. In such circumstances, medical consent is provided by the
patient’s closest family members, legal guardians, or other legally authorized
representatives. However, in practice, conflicts of interest often occur
between patients’ families and medical personnel regarding the appropriate
medical interventions to be undertaken.
For example,
there are cases in which a patient’s family refuses certain medical procedures
due to religious, cultural, or economic considerations, even though such
procedures are medically necessary to save the patient’s life. In such
situations, medical personnel face an ethical and legal dilemma between
respecting the family’s decision and fulfilling their professional obligation
to preserve the patient’s life. Therefore, effective communication approaches,
along with proportionate ethical and legal considerations, are required to
resolve such conflicts.
Indonesian law
has fundamentally provided protection for patient rights in the context of
informed consent. Law of the Republic of Indonesia Number 17 of 2023 concerning
Health affirms that patients have the right to obtain information regarding
their health condition and the medical procedures to be performed. In addition,
patients also have the right to give consent or refuse medical treatment after
receiving adequate explanations.
On the other
hand, the law also provides protection for medical personnel as long as their
actions are carried out in accordance with professional standards, service
standards, and applicable medical procedures. Thus, informed consent functions
as a legal protection instrument for both parties, namely patients and medical
personnel. For patients, informed consent safeguards the right to autonomy and
the right to information. Meanwhile, for medical personnel, informed consent
serves as evidence that medical procedures were performed with the patient’s
consent and in accordance with legal procedures.
From a critical
perspective, the implementation of informed consent in Indonesia still requires
strengthening, both in terms of regulation and healthcare practice. There is a
need to improve legal education and medical communication skills among healthcare
professionals to ensure that the provision of information to patients is
carried out more effectively and humanely. In addition, hospitals and
healthcare facilities must ensure that the informed consent process is not
merely understood as an administrative formality, but as an essential component
of respect for patient rights and medical ethical principles.
Thus, it can be
understood that informed consent is a fundamental pillar of modern healthcare
services that positions patients as legal subjects who have the right to
determine medical actions performed on their own bodies. The proper
implementation of informed consent not only provides legal protection for
patients but also enhances public trust in the healthcare system and fosters a
therapeutic relationship that is more ethical, transparent, and just.
References
Komalawati, V.
(2002). Peranan informed consent dalam transaksi terapeutik. Citra
Aditya Bakti.
Nasution, B. J.
(2013). Hukum kesehatan: Pertanggungjawaban dokter. Rineka Cipta.
Minister of
Health Regulation Number 290/Menkes/Per/III/2008 concerning Consent for Medical
Procedures.
Law of the
Republic of Indonesia Number 17 of 2023 concerning Health.
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