Core concepts of consent in medical practice

Opening Vignette

Mr. Jay is a 50-year-old single man who lives with his elderly mother and works as a technician in a water treatment plant. He is a known schizophrenia sufferer whose illness is controlled with medication. He is also diagnosed by the cardiologist as having unstable angina with hypertension and mild diabetes mellitus. He has been referred to the cardiac surgery department for semi-urgent coronary artery bypass surgery. Mr. Jay is not keen to have the surgery and may consider it in 4 months’ time after the renovation of his apartment is completed. His uncle, a general practitioner in England, has strongly advised him to undergo the surgery. Mr. Jay has missed work several times this year due to complaints of fatigue, stress and insomnia, in addition to his symptoms of angina. The cardiac surgical team has several concerns regarding seeking consent for Mr. Jay: (a) whether the patient has the capacity in view of his psychiatric illness and (b) whether the patient understands the risks of delay of a beneficial medical procedure.

INTRODUCTION

Everything in the doctor–patient relationship is consensual. The process of consent starts the moment a patient seeks medical advice and continues throughout the relationship as a dialogue. Consent taking is a complex communicative, educational and trust building process where the doctor must balance his/her primary duty to promote the health and welfare of the patient while respecting the patient’s wishes and preferences. In this balancing of the two principles, the doctor must be mindful not to breach the professional and legal standard of care in medical advice.

There is no single formula or approach to consent taking in medical practice, treatment or care that will suit every patient or apply in all circumstances. Thus, developing a good knowledge and strong understanding of the core concepts, principles and elements of consent and acquiring proficiency in the process of consent are essential for every clinician.

WHAT IS INFORMED CONSENT?

Informed consent is voluntary authorisation by a competent patient based on the knowledge necessary to make an appropriate choice. Consent is a process by which a patient concurs with his/her doctor to undergo medical procedures, based upon an adequate disclosure of facts on the diagnosis, proposed procedure and risks, which are necessary for the patient to make the decision freely and without constraints.

ETHICAL BASIS FOR CONSENT

Consent in professional ethics is supported by the principles of respect for patient autonomy and beneficence. Consent is necessary, as patients have the right to choose the medical interventions according to their values and preferences. Patients are given the right to determine whether to accept or refuse any medical treatment, including beneficial therapy, the refusal of which may lead to deterioration of health, even death. Refusal of certain investigations and treatment can be overridden only by law in the public interest, such as in the case of certain infectious diseases.

Doctors as professionals and healers in medical practice find an inherent tension of striking the fine balance between respecting the principle of patient autonomy and voluntariness and upholding their professional responsibility of promoting medical beneficence. It is inevitable that in a doctor–patient relationship, there is an imbalance of power where the clinicians have more knowledge, experience and expertise. Exercising this power and skill in a compassionate and humane manner while preserving the patient’s dignity is crucial in developing a collaborative therapeutic doctor–patient relationship.

LEGAL BASIS OF CONSENT

Consent is a legal requirement before any medical intervention takes place. Every adult patient of sound mind has a legal and ethical right to determine what shall be done with his/her own body. Failure to get consent or performing surgery that exceeds the scope of the consent in medical practice is considered to be battery or assault. This could attract a criminal persecution. When death occurs in the absence of consent, it could amount to homicide and charge of serious negligence.

Failure to get informed consent breaches the professional or legal standard of care in medical advice and can attract medical litigation based on negligence in the duty to advise or disclose.

There is a professional requirement to get adequate consent before medical interventions. Intentional and deliberate departure from good professional practice could attract a professional censure. Where the conduct during consent seeking portrays an abuse of privileges of a medical practitioner or evidence of manipulation or misrepresentation, this could potentially amount to professional misconduct.

LEGAL STANDARD OF CARE IN MEDICAL ADVICE (DISCLOSURE IN CONSENT)

The current legal standard of care in medical advice in Singapore is embodied in section 37 of the Civil Law Act. The legal standard of care in medical advice is met when the advice provided by the doctor meets the standard of care that is accepted by a respectable body of medical opinion. This is called the ‘peer professional opinion’ of a reasonable doctor exercising his/her skill in similar circumstances. In addition, peer professional opinion must withstand the scrutiny of logic. A logical opinion should ensure that the relative risks and benefits have been considered, and that the opinion is internally consistent and does not contradict proven extrinsic facts. The fact that there are differing professional opinions held by other respected healthcare professionals does not, by itself, prevent the peer professional opinion from being relied on, provided that the opinion is logical.

To meet the legal standard of care, the doctor ought to have provided the patient with information (which the doctor knows or reasonably ought to know) that the patient would reasonably require to make an informed decision. This includes information that is material to the patient to reach an informed decision (that is, information important to the patient for idiosyncratic reasons).

The assessment of what constitutes ‘material’ is based on specific concerns or queries communicated by the patient to the doctor. Where concerns or queries are not expressed by the patient, the assessment is based on information that is apparent to the doctor from medical records that the doctor had reasonably accessed and reviewed. The doctor may decide to withhold information only where there is reasonable justification, such as in an emergency or where waiver is given by the patient, or when there is harm to the patient (therapeutic privilege). A healthcare professional is not entitled to withhold information on the risks of a procedure merely because he/she thinks the procedure is in the best interests of the patient and that hearing about the risks would dissuade the patient from undergoing it.

Where the patient is under a legal disability (e.g. minor, no mental capacity), information is to be provided to persons responsible for making decisions for the patient with regard to medical advice, such as the patient’s parents, court-appointed deputies, or donees under the lasting power of attorney.

ELEMENTS OF CONSENT

The three main elements of consent are capacity, disclosure and voluntariness.

Capacity in consent

All adults are presumed to have capacity to consent to medical therapy unless proven otherwise. Capacity is the mental status that is required to make self-determined choices regarding medical interventions and care. In medical practice, a person who can show all of the following is considered to have capacity to consent: able to understand the information presented, able to retain and remember the information, able to weigh the advantages and disadvantages or weigh the choices, and able to make and communicate the decision.

It is important in medical decision-making that a person is not to be treated as unable to make a decision unless all practicable steps to help him/her to do so have been taken without success. The threshold to capacity in medical practice is kept low so that everyone can participate in medical decision-making regarding their own health.

Disclosure in consent

Disclosure is the information that the treating clinician should provide before consent is taken. This involves the medical indications and nature of the procedure, benefits and expected outcomes, risk and how it could be mitigated, and alternatives including the choice of declining interventions. The patient should be given sufficient information on the medical condition and options for treatment, so that he/she is able to participate meaningfully in making decisions about his/her treatment.

The extent of disclosure will depend on the context and the needs of the patient. It is not necessary to disclose every conceivable risk, as this may inappropriately or disproportionately affect decision-making. The common and important risks and the ways of mitigating them should they arise are to be explained. The patient is also to be informed what to expect immediately after the procedure, so that he/she is forewarned.

Informed consent implies that the patient is informed of the various medically feasible options and given the choice of choosing the one that best fits his/her needs and preference. The option of watchful waiting or active surveillance should also be made available.

It is the doctor’s responsibility to initiate the discussion in consent and not depend only on the patient to ask questions. The lack of knowledge and experience often impedes patients from asking the relevant questions. However, when patients ask questions, doctors must make an effort to explain in a language that the patient can understand, even if they feel that the question is irrelevant or unimportant. The answers to questions and information must be relevant, comprehensive and communicated in a clear, simple and understandable language to the patient.

Voluntariness in consent

Consent is a voluntary process, and the patient should not be in any form of coercion. Sometimes, pressure may be put on patients by family members, employers, insurance companies or others to undergo particular tests or accept treatment. Patients may also be affected by their medical condition of pain, anxiety and fear, and have concerns of a financial nature. These factors may affect a patient’s ability to make a decision freely and without constraint. Physicians must be aware of these internal factors and help mitigate them.

Although force (physical restraints or sedation), coercion (implicit or explicit threats) and manipulation (misinformation) are unethical and illegal in obtaining consent, it does not imply that doctors should not use persuasion to appeal to reason, good judgement and understanding of the merits of their choices to help patients make medical decisions. Compassionate understanding of the difficulties that the persons experience in medical decision-making is an important maxim of the medical professional and the healer’s art. It is also important to ensure that patients have been given sufficient time, privacy to consider the options, and opportunity to confer with others and reach their own decision.

CONSENT IN PERSONS WITH DIMINISHED CAPACITY

When a patient is temporarily under reversible factors that could impede his/her capacity or voluntariness, it is the doctor’s duty to enhance the capacity by removing these impeding factors before seeking consent. This could include withdrawal of sedating medications, reversal of metabolic causes of drowsiness and pain relief. When patients lack decision-making capacity, it is generally expected of the physician to act by applying the ‘best interest’ principle. The doctor should first determine whether the patient is able to understand, retain, weigh the facts and make a decision.

In making a medical decision on behalf of persons lacking capacity, it is appropriate to apply the best interest principle. The discussion would involve persons who have legal authority to act on behalf of the patient and are able to consider the patient’s previously stated preferences and involve relevant healthcare professionals and significant other persons who are aware of the patient’s medical, social and other relevant factors. It is important to note that best interest does not merely include medical interest, but also encompasses relevant aspects of the patient’s psychological, social and cultural circumstances.

Under the Mental capacity Act (2008), persons holding the Lasting Power of Attorney (LPA) or a (court-appointed) deputy can make decisions on personal welfare, including treatment in conjunction with the medical practitioner caring for the person. The deputy or the person holding the LPA does not have the power to refuse life-sustaining treatment or treatment to prevent serious deterioration in the condition of donor [s13(8)].

CONSENT AND MINORS

Consent in minors and children should be a joint effort of both the parents/legal guardians and the physicians to decide on medical care that preserves the best interest of the child. Children and minors are at various stages of mental and emotional maturity. In Singapore, there is no statute law that defines the acceptable age for consent for medical procedures. The principles on consent for medical treatment for persons below the age of majority of 21 years is found in common law.

Doctors, on the other hand, have a duty to protect the health and well-being of children and young people, which includes treating them as individuals, respecting their views, and considering their physical, psychological and social welfare. It is important for doctors to assess the individual informational needs of each child. In the consent process, doctors and parents are to engage and communicate with the child in a manner that the child is informed of his/her medical condition and the proposed treatment, and they should answer all the child’s questions clearly.

At the same time, the doctor must assess a child’s capacity for medical decision-making on whether to consent to or refuse the proposed investigation or treatment. Where there is clear decisional capacity, a greater weightage is placed on the child’s preferences in determining the best interest of the child. At the same time, both parents and doctors should protect children from making decisions that could cause harm to themselves.

In medical practice, there could be situations where parents or guardians are not available or contactable. In such a situation, reasonable attempts should be made to inform and engage the parents. Where it is not possible to engage the parents and the child has clearly shown maturity to understand the purpose, benefits, risks and alternatives, and delay is unreasonable, the doctor could proceed with the minor’s consent. There should be clear documentation of the consent process in the medical records. For situations of emergency, where there is risk of death or irreversible disability, doctors should act out of necessity and in the best interest the child. In time-sensitive investigations or treatment where delay is likely to harm the child and if the minor has clear decisional capacity, the doctor may proceed with consent from the minor.

PROFESSIONAL PROCESS OF SEEKING CONSENT

It is difficult for physicians to predict patients’ preferences and tolerance of medical risk without obtaining the necessary information from the patient. This is best done in the form of dialogue in a shared medical decision-making process. During this process, the doctor explores the patient’s values, preferences, perspectives, issues, concerns and expectations. The clinician shares his/her knowledge, experience and recommendations on the diagnosis, prognosis and therapy of the patient’s medical condition. Shared decision-making is an interactive, communicative and educational process of information sharing, trust building and mutual respect.

Patients should be provided with appropriate and adequate information, so that they are enabled to participate meaningfully in medical decision-making. Informed consent implies that the patient is informed of the various medically feasible options and given the choice of choosing the one that best fits his/her needs and preference.

Patients may vary in their preferred mode of decision-making, from that of a benevolent paternalism mode (where the doctor processes the information and shares his/her decision for the patient to agree) to that of an independent client mode (where information processing and decision-making are done almost entirely by the patient). A skilful and well-implemented consent seeking process in medical practice is beneficial to both patients and physicians by developing a therapeutic and collaborative relationship based on mutual respect, trust and realistic expectations.

DOCUMENTATION OF CONSENT

Documentation of the consent process is essential for two main reasons: firstly, as a means of communication to all members of the healthcare team as to the exact procedure that has been consented for and secondly, as evidence for accountability and as the most critical component of a legal defence in the face of a claim or complaint.

Documentation should consist of an accurately filled consent form with the attested signature of the patient and the doctor. In filling the consent form, the writing should be legible and complete, and attempts should be made to avoid cancellations and to use only established abbreviations. The consent form should be accompanied with a risk acknowledgement form or an addendum containing the important and common risk, together with the material risk raised by the patient. The addendum to the consent form is to be duly signed by the patient and the doctor.

Documentation of the consent process in a contemporaneous manner in the clinical case notes is an incredibly important risk management strategy in defending a claim of medical negligence in failure to advice. The case notes should include discussion of the material risk, questions raised by the patient and their responses. In addition, there should be documentation of the review of medical records of previously expressed concerns and queries by the patient on the procedure. It is important to list the alternatives to the procedure and the patient’s reasons for the preferred choice of medical intervention in the medical records. Documentation of a request for waiver or withholding of relevant information from the patient must be comprehensive with the reasons for doing so documented in the patient’s medical records. The doctor must be prepared to explain and justify such a decision.

CONCLUSION

Valid consent is a legal requirement before any medical intervention is initiated on the patient. Every mentally competent adult has the right to accept or refuse to consent to any medical treatment, regardless of the reasons and potential outcomes. Doctors have a legal and ethical duty of care to provide sufficient information to enable the patient to make an appropriate medical decision for his/her present and future medical care. Doctors must be aware and capable of meeting the current legal standard of care for medical advice. There is strong professional ethical basis to obtaining informed consent through a process of shared decision-making that results in building trust and confidence for a therapeutic doctor–patient relationship.

KEY LEARNING POINTS

1. Informed consent is voluntary authorisation by a competent patient based on the knowledge necessary to make an appropriate choice. The three elements of consent are capacity, disclosure and voluntariness.

2. Valid consent is a legal requirement before any medical intervention is applied to the patient. Doctors have a legal and ethical duty of care to provide sufficient information for the patient to make an appropriate medical decision. Failure to reach the legal standard of care in consent-taking can lead to legal risk of a claim in negligence.

3. Appropriate documentation of the consent process in a contemporaneous manner in the clinical case notes is important in defending a claim of medical negligence in failure to advice.

4. Medical decision taken on behalf of a person who lacks capacity or a minor must be made in a way that upholds the patient’s best interests.

5. A skilful and well-implemented consent seeking process in medical practice is beneficial to both patients and physicians by developing a therapeutic and collaborative relationship based on mutual respect, trust and realistic expectations.

Closing Vignette

The presence of a psychiatric illness is the first step in assessing capacity. The second step is to determine if the psychiatric illness is impeding the patient’s capacity to consent. It is reasonable to request the treating psychiatrist to review Mr. Jay and optimise his therapy and management of his psychiatric condition. This is to ensure that he is cognitively and emotionally competent to participate in medical decision-making. As Mr. Jay’s preference is for a nonsurgical approach, a joint consultation with the cardiologist to optimise his medical therapy and management for hypertension, diabetes mellitus and ischaemic heart disease would be prudent. In addition, the medical team should engage Mr. Jay with appropriate psycho-social support, health literacy and follow-up to ensure that timely and appropriate treatment is provided. In this way, the medical team can uphold the primacy of the patient’s welfare (medical beneficence) and, at the same time, respect the patient’s wishes, preferences and values in upholding the principle of respect for patient autonomy.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

SMC CATEGORY 3B CME PROGRAMME

Online quiz: https://www.sma.org.sg/cme-programme

Deadline for submission: 6 pm, 12 July 2023

Question	True	False
1. Taking of informed consent involves:
(a) Convincing the patient to accept the medically most appropriate treatment.
(b) Engaged communication through dialogue.
(c) Building of trust.
(d) Educating the patients about the nature and prognosis of their illness.
2. Elements of informed consent include:
(a) Voluntariness.
(b) Decision-making capacity.
(c) Disclosure of material medical advice.
(d) Authorisation that can be verbal or in writing.
3. Failure to obtain valid consent before a medical intervention is:
(a) Negligence with civil liability.
(b) Battery and assault with criminal liability.
(c) Professional misconduct with professional liability.
(d) Not necessary for patients with impaired decision-making capacity.
4. To have decision-making capacity, the patient must be able to:
(a) Understand the information presented.
(b) Retain and remember medical advice.
(c) Weigh the advantages and disadvantages or assess the choices.
(d) Make and communicate a decision.
5. Disclosure of material medical information includes:
(a) Medical indications and nature of the procedure.
(b) Benefits and the expected outcomes.
(c) Risks and how they can be mitigated.
(d) Alternatives, including the choice of having no intervention.