Informed Consent
Informed Consent
Consent to medical treatment is fundamental in the relationship between patients and healthcare providers, with a focus on patient-centered care and shared decision-making, underscoring the significance of informed consent To ensure equitable access to healthcare for individuals with learning disabilities (LD), they must be capable of providing informed consent for medical interventions or undergo assessment for competency to consent. While laws regarding consent may vary, there is a prevailing recognition that there should be a presumption of capacity to consent unless proven otherwise .This presumption may be rebutted if it can be demonstrated that the individual cannot comprehend or retain pertinent information related to the decision, including the potential consequences of accepting or refusing treatment, or if they are unable to utilize the information to make a reasoned decision.
Informed Consent For Medical Treatment
The legal concept of informed consent for medical treatment has developed primarily through case law. Courts have specifically addressed instances where patients claimed that physicians did not obtain proper authorization for the procedures they performed. Due to the retrospective and adversarial nature of the legal system, the idea of informed consent has taken on a defensive tone, particularly evident in increased emphasis on disclosing risks. Although the risk management aspect of informed consent is significant, it has also brought about fundamental and positive practical and moral implications for medical practice.
In contrast to the courts’ focus on retrospectively evaluating a physician’s actions, moral philosophy has centered on ensuring a patient’s right to make autonomous decisions. Ethicists perceive informed consent as the practical manifestation of respect for individuals and their autonomy. Autonomy encompasses concepts of self-governance, rights to liberty, and privacy.
The notion of independent approval for a medical procedure. This stance directly opposes the paternalistic view of the physician acting solely in the patient’s best interest, without regard for patient autonomy. In the case of Mohr v. Williams 104 N.W. 12, the doctor obtained the patient’s agreement to undergo surgery on her right ear. However, during the operation, the surgeon realized that it was actually the patient’s left ear requiring surgical intervention and proceeded accordingly. The court ruled that the surgeon breached the terms of informed consent, emphasizing that the patient “agrees to a contract allowing the physician to operate only to the extent of the given consent, and no further”. In this scenario, the patient consents when she deliberately permits a professional to carry out a procedure, demonstrating comprehension, and without interference from others.
Elements Of Informed Consent
i. Voluntarism
Patients should be liberated from “coercion and unfair persuasions and inducements.” Coercion denotes morally unjust pressures exerted by individuals or institutions, which limit patients’ ability to make choices; the presence of a serious illness alone does not diminish voluntarism. Furthermore, efforts by physicians to sway patients’ decisions do not necessarily compromise voluntarism. Instead, physicians should be prompted to elucidate patients’ objectives, offer suitable options aligned with these objectives, and provide recommendations within the framework of the “deliberative model” of the doctor-patient relationship.
ii. Capacity
Patients are usually assumed to be capable of making healthcare decisions unless there’s strong evidence to the contrary. Various criteria, like the ability to choose, understand relevant information, grasp the situation and its outcomes, and process information rationally, can be used to evaluate a person’s capacity. The standard for assessing capacity varies depending on the importance, complexity, and consequences of the decision. Competence, which is related, refers to the patient’s legal ability to make healthcare decisions. For instance, a 17-year-old might have the ability to make decisions for themselves, but may not be considered competent from a legal standpoint.
iii. Disclosure
It entails furnishing the patient with the necessary details to comprehend a procedure. Such information encompasses the essence and objective of the treatment, along with its risks, potential advantages, and alternative options. The disclosure of information should be done using straightforward explanations. This includes outlining common complications, regardless of severity, as well as less common but potentially significant or irreversible risks.
iv. Understanding
It is essential for the patient to grasp the information provided and recognize its significance in their particular circumstances. There is limited agreement, both in legal and ethical realms, on what level of understanding is deemed adequate. Courts typically do not rule that a lack of understanding nullifies informed consent. Instead, they often assess whether adequate disclosure was provided when determining if a patient was sufficiently informed.
v. Decision
This pertains to the patient granting permission for a physician to carry out the suggested treatment. Consent forms aid in both facilitating and recording this permission, but they should be considered as supplementary to the dialogue and negotiation between the patient and the physician regarding the proposed treatment.
Consent For Treatment Of Patients By Registered Medical Practitioners
Under the Malaysian Medical Council each patient holds the right to decide whether to undergo a recommended procedure, surgery, examination, or treatment. It is the responsibility of the medical practitioner to provide information and caution the patient about significant risks before seeking consent. Failure to obtain consent or disclose these risks may lead to disciplinary action by the Medical Council or legal repercussions for breaching the duty of care.
For a patient’s consent to be meaningful, they must receive relevant information and advice about a procedure. This includes understanding the nature of the condition, available investigations and treatments, potential benefits, significant risks, possible adverse effects, residual effects, and likely outcomes if treatment is refused. The medical practitioner is obligated to present this information in a way that the patient can comprehend, allowing them to make an informed decision about undergoing the proposed procedure, examination, surgery, or treatment.
Types Of Consent
i. Implied Consent
Implied consent is derived from a person’s conduct, surrounding facts, and circumstances, or sometimes from their silence or lack of action, rather than being explicitly given. This could pose a problem if there are disagreements or misunderstandings regarding the patient’s understanding of the practitioner’s actions or the resulting outcomes.
ii. Expressed Consent
Consent can be communicated orally, nonverbally, or in writing and should be clearly and unambiguously expressed. Challenges may arise when consent is conveyed verbally, as described in the concept of “implied consent.”
iii. Informed Consent
Informed consent can be understood as consent given with a clear understanding of the facts, implications, and future outcomes of an action. To provide informed consent, an individual must possess adequate reasoning capacity and be fully informed of all relevant details at the time of giving consent. Coined in a 1957 medical malpractice case by Paul G. Gebhard in the USA, informed consent serves as a medico-legal requirement to ensure that patients are aware of all risks and costs associated with a treatment. Its components include informing the patient about the nature of the proposed procedure, surgery, treatment, or examination, presenting possible alternative treatments, and outlining the potential risks and benefits of the treatment.
iv. Valid Consent
Consent can be described as the voluntary agreement of an individual to undergo a proposed procedure, provided that they have been adequately informed about the procedure, including its potential risks and benefits.
For consent to be considered “valid,” it must meet several requirements:
Consent to medical treatment is fundamental in the relationship between patients and healthcare providers, with a focus on patient-centered care and shared decision-making, underscoring the significance of informed consent To ensure equitable access to healthcare for individuals with learning disabilities (LD), they must be capable of providing informed consent for medical interventions or undergo assessment for competency to consent. While laws regarding consent may vary, there is a prevailing recognition that there should be a presumption of capacity to consent unless proven otherwise .This presumption may be rebutted if it can be demonstrated that the individual cannot comprehend or retain pertinent information related to the decision, including the potential consequences of accepting or refusing treatment, or if they are unable to utilize the information to make a reasoned decision.
Informed Consent For Medical Treatment
The legal concept of informed consent for medical treatment has developed primarily through case law. Courts have specifically addressed instances where patients claimed that physicians did not obtain proper authorization for the procedures they performed. Due to the retrospective and adversarial nature of the legal system, the idea of informed consent has taken on a defensive tone, particularly evident in increased emphasis on disclosing risks. Although the risk management aspect of informed consent is significant, it has also brought about fundamental and positive practical and moral implications for medical practice.
In contrast to the courts’ focus on retrospectively evaluating a physician’s actions, moral philosophy has centered on ensuring a patient’s right to make autonomous decisions. Ethicists perceive informed consent as the practical manifestation of respect for individuals and their autonomy. Autonomy encompasses concepts of self-governance, rights to liberty, and privacy.
The notion of independent approval for a medical procedure. This stance directly opposes the paternalistic view of the physician acting solely in the patient’s best interest, without regard for patient autonomy. In the case of Mohr v. Williams 104 N.W. 12, the doctor obtained the patient’s agreement to undergo surgery on her right ear. However, during the operation, the surgeon realized that it was actually the patient’s left ear requiring surgical intervention and proceeded accordingly. The court ruled that the surgeon breached the terms of informed consent, emphasizing that the patient “agrees to a contract allowing the physician to operate only to the extent of the given consent, and no further”. In this scenario, the patient consents when she deliberately permits a professional to carry out a procedure, demonstrating comprehension, and without interference from others.
Elements Of Informed Consent
i. Voluntarism
Patients should be liberated from “coercion and unfair persuasions and inducements.” Coercion denotes morally unjust pressures exerted by individuals or institutions, which limit patients’ ability to make choices; the presence of a serious illness alone does not diminish voluntarism. Furthermore, efforts by physicians to sway patients’ decisions do not necessarily compromise voluntarism. Instead, physicians should be prompted to elucidate patients’ objectives, offer suitable options aligned with these objectives, and provide recommendations within the framework of the “deliberative model” of the doctor-patient relationship.
ii. Capacity
Patients are usually assumed to be capable of making healthcare decisions unless there’s strong evidence to the contrary. Various criteria, like the ability to choose, understand relevant information, grasp the situation and its outcomes, and process information rationally, can be used to evaluate a person’s capacity. The standard for assessing capacity varies depending on the importance, complexity, and consequences of the decision. Competence, which is related, refers to the patient’s legal ability to make healthcare decisions. For instance, a 17-year-old might have the ability to make decisions for themselves, but may not be considered competent from a legal standpoint.
iii. Disclosure
It entails furnishing the patient with the necessary details to comprehend a procedure. Such information encompasses the essence and objective of the treatment, along with its risks, potential advantages, and alternative options. The disclosure of information should be done using straightforward explanations. This includes outlining common complications, regardless of severity, as well as less common but potentially significant or irreversible risks.
iv. Understanding
It is essential for the patient to grasp the information provided and recognize its significance in their particular circumstances. There is limited agreement, both in legal and ethical realms, on what level of understanding is deemed adequate. Courts typically do not rule that a lack of understanding nullifies informed consent. Instead, they often assess whether adequate disclosure was provided when determining if a patient was sufficiently informed.
v. Decision
This pertains to the patient granting permission for a physician to carry out the suggested treatment. Consent forms aid in both facilitating and recording this permission, but they should be considered as supplementary to the dialogue and negotiation between the patient and the physician regarding the proposed treatment.
Consent For Treatment Of Patients By Registered Medical Practitioners
Under the Malaysian Medical Council each patient holds the right to decide whether to undergo a recommended procedure, surgery, examination, or treatment. It is the responsibility of the medical practitioner to provide information and caution the patient about significant risks before seeking consent. Failure to obtain consent or disclose these risks may lead to disciplinary action by the Medical Council or legal repercussions for breaching the duty of care.
For a patient’s consent to be meaningful, they must receive relevant information and advice about a procedure. This includes understanding the nature of the condition, available investigations and treatments, potential benefits, significant risks, possible adverse effects, residual effects, and likely outcomes if treatment is refused. The medical practitioner is obligated to present this information in a way that the patient can comprehend, allowing them to make an informed decision about undergoing the proposed procedure, examination, surgery, or treatment.
Types Of Consent
i. Implied Consent
Implied consent is derived from a person’s conduct, surrounding facts, and circumstances, or sometimes from their silence or lack of action, rather than being explicitly given. This could pose a problem if there are disagreements or misunderstandings regarding the patient’s understanding of the practitioner’s actions or the resulting outcomes.
ii. Expressed Consent
Consent can be communicated orally, nonverbally, or in writing and should be clearly and unambiguously expressed. Challenges may arise when consent is conveyed verbally, as described in the concept of “implied consent.”
iii. Informed Consent
Informed consent can be understood as consent given with a clear understanding of the facts, implications, and future outcomes of an action. To provide informed consent, an individual must possess adequate reasoning capacity and be fully informed of all relevant details at the time of giving consent. Coined in a 1957 medical malpractice case by Paul G. Gebhard in the USA, informed consent serves as a medico-legal requirement to ensure that patients are aware of all risks and costs associated with a treatment. Its components include informing the patient about the nature of the proposed procedure, surgery, treatment, or examination, presenting possible alternative treatments, and outlining the potential risks and benefits of the treatment.
iv. Valid Consent
Consent can be described as the voluntary agreement of an individual to undergo a proposed procedure, provided that they have been adequately informed about the procedure, including its potential risks and benefits.
For consent to be considered “valid,” it must meet several requirements:
- It must be given by a person who has legal capacity and sufficient intellectual capacity to understand the implications of the procedure.
- It should be communicated in a language that the person understands.
- It must be given freely and without coercion, fraud, or deceit.
- It should specifically cover the procedure being proposed.
- The individual must have awareness and understanding of the proposed procedure and its potential risks.
- Alternatives to the proposed treatment or procedure should be presented.
- The individual should have ample opportunity to seek further information or clarification about the proposed treatment.
- The consent process should be witnessed or interpreted by a neutral party, such as another registered medical practitioner or nurse, who is not directly involved in the patient’s care or related to the patient or medical practitioner and can attest to the process.
v. Verbal Consent
Consent is typically communicated verbally, but this method may lead to disputes and should be minimized whenever feasible.
vi. Non-verbal Consent
Consent can also be conveyed through non-verbal cues, such as nodding or extending the arm for a procedure, which can also be subject to interpretation. In such cases, it may be wise to document in the patient’s records that consent was provided in this manner.
17 May 2024
