Consent - An essential guide

Introduction

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. The law relating to decision making and consent varies across the UK but this essential guidance is consistent with the law in all four countries.

What is consent?

“Consent to treatment means a person must give permission before they receive any type of medical treatment, test or examination.” - NHS

Key Principles of Decision Making and Consent

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, retain and weigh in the balance information relevant to a specific decision at a particular point in time. The patient must also be able to communicate their decision.

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 an assessment by a psychiatrist or other appropriate specialist such as a neurologist or speech and language therapist may be appropriate.

If a patient appears to lack the capacity to make a decision, their capacity must be assessed formally. Each jurisdiction of the UK has its own mental capacity legislation, which, together with accompanying codes of practice, provides a framework for making decisions when a patient lacks the capacity to decide for themselves.

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 them or advocating for them.

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 experiencing domestic or other forms of abuse.

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

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.

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. All 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, and any risk of serious harm, however unlikely it is to occur.

Supporting Patients

There are a number of steps that can be taken to help a patient make a better and more informed decision, such as 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.

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 the patient has difficulty understanding spoken English, 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 formats 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 given verbally, in writing, or non-verbally - often referred to as “implied” consent. The nature of the consent provided will very much depend on the complexity of the procedure performed, treatment or care provided. With complex procedures, typically surgery, written consent is usually provided by way of a signed consent form. There are, in fact, very few situations where there is a legal requirement for a patient’s consent in writing; an example includes the storage and use of gametes and embryos in fertility treatment. -

Verbal consent is usually considered appropriate for less complex procedures or less invasive types of care and treatment. Implied consent where a patient - for example holds their arm out to have a blood sample taken - is common. The most important factors in all of these scenarios remain:

• the patient’s understanding of the procedure or treatment
• their right to choose based on an opportunity to consider relevant information.

Ideally, the healthcare provider performing the procedure or providing the care or treatment should obtain consent from the patient. It is possible to delegate part of the decision-making process, such as sharing detailed information with a patient about a specific intervention. This type of delegation is routinely used in multidisciplinary teams.

When deciding whether it is appropriate to delegate, it is important to consider the nature of the intervention and the complexity of the information about it. The person to whom the consenting process has been delegated to must be trained and competent to have a dialogue with the patient in line with the law and professional guidelines such as those issued by the GMC.

If part of the decision-making process has been delegated, it is still the responsibility of the individual delegating that role to make sure that the patient has been given the information they need to make the decision, has had time and support to consider it, and has given appropriately informed consent before the treatment or care is provided.

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.

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. 

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.

Future Decisions

Sometimes and for some patients there are foreseeable circumstances when the patient will have a choice of options at a time when they might find it more difficult to make decisions or they may have a condition that over time will impair their capacity to make decisions.

If this circumstance is likely to arise then it is advisable to discuss this with the patient in advance, so that when a decision needs to be made the patient has already had time and opportunity to consider the relevant information. The patient may wish to take steps to make arrangements for some-one else to be involved in decisions about their care by nominating or appointing an advocate or they may want to make an advance statement about refusing or requesting a particular treatment. There are ways to formalise patient’s wishes in this respect and further advice is provided in our guidance on Advanced Decisions and Treatment at the End of Life

Special Circumstances

As highlighted above there are some situations where special considerations apply, for example:

• Adult patients that lack capacity to make decisions.
• Children and young adults under the age of 18 years.
• Advanced Decisions and Treatment at the end of life.
• Consent for organ donation
• Audiovisual Recordings and Consent

Additional guidance is provided for all of these situations.

Useful Resources

Decision making and consent - professional standards - GMC (gmc-uk.org).

Consent & refusal toolkit (bma.org.uk)