Informed consent to medical treatment is fundamental in both medical ethics and law. It requires that patients fully understand the nature of their medical treatment, including risks, benefits, and alternatives, before agreeing to proceed. Once fully informed, patients can voluntarily decide whether to proceed with the treatment. This process is crucial for safeguarding patients' autonomy and ensuring that they play an active role in making decisions about their healthcare.
Procedure Prior to Obtaining Consent
There are several essential prerequisites for a medical practitioner to obtain informed consent from a patient (or their spouse, next of kin or legal guardian, as the case may be):
1.Established Doctor-Patient Relationship:
The practitioner must have previously met or interacted with the patient in the context of a professional doctor-patient relationship.
2.Personal Contact Before Procedure:
The practitioner intending to perform a surgical or invasive procedure must personally meet with the patient before the procedure. This ensures that the patient is aware of the identity of the practitioner who will be conducting the procedure.
3. Explanation of Procedure:
The practitioner is responsible for explaining the nature and objective of the procedure to the patient including any alternative procedures that may be available.
4. Disclosure of Risks and Complications:
The practitioner must also inform the patient of the potential risks and complications that could arise, which may impact the outcome of the procedure or affect the duration of the patient’s stay in the ward or intensive care unit.
These prerequisites are most effectively met when the practitioner who will perform the procedure personally and directly obtains consent from the patient. This approach not only adheres to the principles of good medical practice but also ensures the standard of care provided.
Regulations Governing Valid Written Consent for Private Hospitals
Regulation 47(1) of the Private Healthcare Facilities and Services (Private Hospitals and Other Private Healthcare Facilities) Regulations 2006 provides that the person holding a license to establish or maintain a private healthcare facility (or “licensee”), or a person in charge of a private healthcare facility, must obtain valid consent from a patient before any procedure or surgery is carried out.
Regulation 47(2) of the Regulations provides that consent must be obtained from:
(a) The patient;
(b) If the patient is mentally or physically disabled, the spouse, parent or next of kin; or
(c) If the patient is unmarried and below eighteen years of age, the parent or guardian.
Regulation 47(3) of the Regulations provides that such consent obtained or caused to be obtained under this regulation must be in writing.
The exceptions to this rule are in the following circumstances:
1.Emergency Situations:
The consent of a patient may be dispensed with if a surgeon believes that any delay caused in obtaining the consent would endanger the life of a patient (Regulation 48(1) of the Regulations).
However, to dispense with a patient’s consent, a consensus of the surgeon and another registered medical practitioner must be obtained and the surgeon must sign a statement stating that the delay would endanger the life of the patient.
2.Court Order:
If the treatment is ordered by a court of law, the consent of a patient may not be required.
Medical practitioners and healthcare providers must be cognisant that any person who contravenes Regulation 47 or 48 may, upon conviction, be subject to a fine not exceeding RM 10,000.00, or to imprisonment for a term not exceeding three months, or to both.
Consent For Treatment Of A Minor
Patients under the age of 18 years old do not have the capacity to give valid consent. The Law Reform (Marriage & Divorce) Act 1976 makes it clear that each parent has full responsibility for each of his/her children who is under 18 years of age.
The determination of whether a young individual possesses the capacity to provide valid consent for medical treatment hinges both on their age and their maturity and intellectual ability to comprehend the nature and consequences of the proposed procedure, surgery, examination or treatment. This assessment must be made on a case-by-case basis, with decisions guided by the principle of acting “in the best interest of the patient”.
The Malaysian Medical Council Guideline: Consent for Treatment of Patients by Registered Medical Practitioners (MMC Guideline) provides that the “best interest of the patient or child” refers to a decision made by the medical practitioner(s) for the management of a patient in a vulnerable position, ensuring that the decision is the most appropriate and equitable under the circumstances.
In situations where the patient is an "infant" as defined under the Guardianship of Infants Act 1961, it is advisable for the medical practitioner to consult/obtain consent from the infant’s legal guardian. The Act stipulates that the guardian of an infant has custody and is responsible for the child’s support, health, and education.
Consent For Patients Who Are Incapable Of Or Impaired With Decision-Making Abilities
Patients who lack the capacity for decision-making due to impairments in reasoning and judgment may be unable to provide informed or valid consent. In an emergency to save life, the procedure as outlined for emergency treatment or management pursuant to Regulation 48(1) should be followed.
When a relative, next-of-kin or legal guardian is available and their relationship with the patient is well-established or confirmed, consent for an elective or non-emergency procedure may be obtained from that person, based on the medical practitioner's professional judgment.
Pursuant to Section 77 of the Mental Health Act 2001, consent is generally not required for conventional treatment, unless the patient is required to undergo surgery, electroconvulsive therapy or clinical trials.
In situations where consent is necessary, it must be obtained as follows:
From the patient himself if he is capable of giving consent, as assessed by a psychiatrist;
If the patient is incapable of giving consent, from his legal guardian in the case of a minor or a relative in the case of an adult, as defined by the Mental Health Act; or
From two psychiatrists, one of whom must be the primary or attending psychiatrist, if the guardian or relative is unavailable or untraceable, and the patient is incapable of giving consent.
Consent Forms
The MMC Guideline states that a standard consent form should contain:
Patient’s data (Name, IC number, address, gender)
Name of medical procedure/treatment/surgery
Type of anesthesia
Name of registered medical practitioner performing the medical procedure/treatment/surgery
Permission to proceed with any additional procedure that may become necessary during the surgery
A statement which states that the medical practitioner has explained to the patient the nature of the procedure/treatment/surgery and potential material risks
Signature of patient/next of kin, IC number and date
Signature of a medical practitioner, name stamp, and date
Signature and name of witness and date
Nevertheless, when consent is not taken in a standard consent form, a medical practitioner should record in the patient’s case notes/ medical records that the patient has been informed and has consented to the particular procedure.
Conclusion
Informed consent is not only a legal obligation but a critical ethical practice that upholds patient autonomy and fosters trust in the healthcare system. The thorough procedures outlined above, from establishing a doctor-patient relationship to the meticulous documentation of consent, are designed to ensure that patients are fully informed and voluntarily consenting to their medical treatment. By adhering to these principles and legal requirements, medical practitioners not only protect themselves from legal liability but also affirm their commitment to providing patient-centered care of the highest standard.
20 August 2024