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Guidance

Consent - an essential guide

Everything you need to know about consent in medical practice and patient care.

Introduction to decision making and consent

Patient autonomy and the right to make decisions about their care and treatment, if they are able to do so, is a fundamental legal and ethical principle in healthcare. Doctors and other healthcare providers must therefore be satisfied that they have a patient’s consent or other valid authority before providing care or treatment, including physical examination.

What is consent?

Medical authorities define consent in different ways. In this article, we address consent in healthcare under various circumstances, to give the broadest understanding of the term and its use in medical practice. In any discussion around consent, the best interest of the patient should be the priority.

The Medical Council of Hong Kong’s (MCHK) Code of Professional Conduct states that "In law, a doctor cannot perform diagnostic procedures and medical treatment on a patient who does not consent to the treatment.”

Key principles

According to the MCHK, consent is valid if:

  • It is given voluntarily
  • The doctor has provided proper explanation of the nature, effect and risks of the proposed treatment and other treatment options (including the option of no treatment)
  • The patient properly understands the nature and implications of the proposed treatment.

Capacity

The starting point with all adult patients is the presumption that the patient has the capacity to make decisions about their care and treatment. A patient’s capacity is assessed on their ability to understand, weigh up and communicate the information relevant to a specific decision at a particular point in time. 

Patients whose ability to consent is impeded should still be supported to make their own decision where that is possible

Mental capacity is therefore decision specific and time specific, and a patient can only be judged to lack capacity to make a decision after an appropriate assessment. Assessing capacity is a core clinical skill and doesn’t necessarily require specialist input. However, it may be advisable to seek input from healthcare providers familiar with the patient. In some cases additional assessment or support from a psychiatrist or other appropriate specialist such as a neurologist or speech and language therapist may be appropriate for facilitating and optimising a capacity assessment.

Patients whose ability to consent is impeded should still be supported to make their own decision where that is possible. The choice of treatment or care for patients who lack capacity must be of overall benefit to them - and the decision should be made in consultation with those who are close to the patient or advocating for them. Only those with legally appointed roles have the right to consent to treatment on behalf of a patient who lacks capacity. Where family are consulted and do not have legal powers it is important they understand that they are assisting with best interest decision making by providing information relating the patient’s values as opposed to their own views.

In an emergency, if a patient is unconscious or lacks capacity and it’s not possible to find out their wishes, treatment that is immediately necessary to save their life or to prevent a serious deterioration of their condition can be provided. If there is more than one option, the treatment provided should be the least restrictive of the patient’s rights and freedoms, including their future choices. Once the patient regains capacity and is sufficiently recovered to understand then they must be informed about what has been done and why.

Free will

It is essential that a patient gives their consent willingly and is not pressured into consenting by a member of the healthcare team or any other person such as a friend or member of their family. It is important to be alert to situations in which patients may be particularly vulnerable or susceptible to pressure, for example, if they are experiencing domestic or other forms of abuse. 

It is essential that a patient gives their consent willingly and is not pressured into consenting

A patient can be supported to make their own decision by giving them time and space to consider the options, by making sure they have the opportunity to discuss matters on their own, and signposting or providing specialist support services, when available.

Children under the age of 18 who are capable of understanding the nature and implications of a treatment are able to provide valid consent. The child should still be encouraged to involve the parents relating to important procedures. If the child is not competent to provide valid consent, then this should be sought from a parent or legal guardian.

Information

A patient must be provided with enough information to make a decision about their care, this requires a meaningful dialogue between the healthcare provider and the patient, involving an exchange of relevant information specific to the individual patient. 

It is important to try to find out what matters to the patient in terms of their health, their quality of life and their day-to-day activities

The patient should be given information in a way that they can understand it and be given the time and support they need to make their decision. Essential information will include information about the proposed treatment or care option, the benefits and harms and reasonable alternatives, including the option to take no action. Information provided should be up to date, evidence based and presented in an objective way. 

It is important to try to find out what matters to the patient in terms of their health, their quality of life and their day-to-day activities so that the patient can be better supported in the consent making process. It is also helpful to explore a patient’s needs, and values and the priorities that influence their decision making, their concerns and preferences about treatment options and their expectations about what treatment or care could achieve.

It wouldn’t be possible to share every possible risk of harm, potential complication or side effect with a patient and any discussion should be tailored to each individual patient, guided by what matters to them. It would usually be considered advisable to discuss with the patient recognised risks of harm and common side effects, risks of harm that the patient would consider significant for any reason, any risk of serious harm, however unlikely it is to occur. 

Information that is necessary to make a proper decision should not be withheld from a patient even if this is requested by the family. The only exception is if the information would cause serious harm to the patient, however the threshold for this is high, and if this is the case then it must be documented and the decision reviewed to establish if the information can be safely provided a later date. There may be situations whereby a patient refuses to listen to the relevant information but wishes to proceed with a treatment; great caution must be exercised by the doctor as the consent may be deemed not to be valid. It of course must be documented but it would be wise to explore the reasoning behind this and any concerns, so that a valid informed decision can be made by the patient.

Supporting patients

In order to help a patient to make a better and more informed decision there are a number of steps that can be taken, for example having a dialogue with the patient in a place and at a time when they are most likely to understand and retain the information shared. 

A patient should be given time to think about and process information, particularly when complex treatments or procedures are proposed or where there is a risk of significant side effects or harm

Where possible a patient’s wishes to record a discussion should be accommodated, some healthcare providers are proactive in this approach and find it helpful to suggest this to the patient. A patient may also like a relative, partner, friend, carer or advocate to be involved in discussions and/or help them to make decisions. If there is a language barrier, then an interpreter or translation service should be used. Sharing information in a way that a patient prefers or will better understand for example in written, audio, picture or other media format is useful.

It is important to check a patient’s understanding of the information given and any questions must be answered honestly, accurately, and as fully as possible. A patient should be given time to think about and process information, particularly when complex treatments or procedures are proposed or where there is a risk of significant side effects or harm.

Obtaining consent

Consent may be implied or express. The Medical Council of Hong Kong (MCHK) states that in respect of minor and non-invasive treatments, consent can usually be implied from a patient’s conduct in consulting the doctor for his or her illness, though not in a situation where the consultation was only for the purpose of seeking an opinion. Oral consent is acceptable for minor invasive procedures. Documenting oral consent in the patient’s medical records offers protection to doctors, in case of subsequent dispute as to whether consent has been given.

Express and specific consent is required for major treatments, invasive procedures, and any treatment which may have significant risks. S. 2.5 of the Code of Professional Conduct specifically says:

“(a) Consent for surgical procedures involving general/regional anaesthesia and parenteral sedation must be given in writing.

(b) For written consent, a reasonably clear and succinct record of the explanation given should be made in the consent form. The patient, the doctor and the witness (if any) should sign the consent form at the same time. Each signatory must specify his name and the date of signing next to his signature.”

Patients have the right to withhold their consent, provided they are competent to do so. 

All discussions around consent should be clearly documented, including the options available (including the option of taking no action), associated risks and benefits, any concerns or queries raised by the patient, and decisions reached.

Explaining the treatment

MCHK’s Code of Professional Conduct says that it is the doctor’s duty to ensure that the patient truly understands the doctor’s explanation about the proposed treatment and the related risks and benefits. Therefore, an explanation should be given in clear, simple and consistent language, and in terms that the patient can understand.

According to the Code, the explanation should cover not only significant risks, but also risks of serious consequence even though the probability is low (i.e. low probability serious consequence risks).

The Code also provides that a doctor should not withhold information necessary for making a proper decision for any reason, even if the patient’s family members ask for the information to be withheld from the patient, unless in the doctor’s judgment the information will cause serious harm to the patient (such as where the information may have a serious effect on the patient’s mental health). However the threshold for withholding information is high, and upsetting the patient or causing him to refuse treatment will not be proper justification for withholding information. Any decision to withhold information must be recorded in the patient’s records.

Documenting decisions

Keeping good records about a decision made by a patient regarding their care or treatment is important for continuity of care and it is also important from a medicolegal perspective, particularly if the patient or someone on their behalf later wishes to ask questions or has concerns about the decision made or the decision-making process. 

Filling in a consent form isn't a substitute for a meaningful dialogue tailored to the individual patient's needs

The information recorded should include details of the dialogue that took place, including the information provided to the patient and any questions asked or concerns expressed by the patient. If information documents or aids were provided then these should be retained with the notes where possible or clearly referenced. If the patient was supported by a relative and or another healthcare worker at the discussion or in reaching their decision then this should be documented.

Consent forms are a standard way of recording a decision and a useful way of documenting essential elements of the care or treatment provided. However, filling in a consent form isn’t a substitute for a meaningful dialogue tailored to the individual patient’s needs and shouldn’t be relied on alone as evidence that the patient made an informed decision specific to their individual circumstances. 

If there is any dispute over whether informed consent was provided: the key issue will not be whether the patient signed a form or not, but whether they were given all the information they needed in a way that they could understand it to make a considered decision.

Scope of decisions and reviewing decisions

It is important that patients understand exactly what they are consenting to and that the scope of a patient’s consent is not exceeded, except in an emergency.

If the treatment is ongoing there should be regular opportunities to review care.

Consent is an ongoing process - and so it is essential to ensure that a patient’s consent is reviewed at appropriate times. This includes immediately before a procedure or treatment, if some time has passed between the initial decision-making process, and the treatment itself.

If treatment is ongoing, there should be regular opportunities to review care and treatment. Reviewing a decision to consent to treatment is especially important if the patient’s condition or situation changes or care and treatment options alter. Patients have the right to change their minds at any point and to withdraw consent given previously.

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