Patients have a fundamental legal and ethical right to determine what happens to their own bodies. Valid consent to treatment is therefore absolutely central in all forms of health care, from providing personal care to undertaking major surgery. Seeking consent is also a matter of common courtesy between health professionals and patients.
“Consent” is a patient’s agreement for a health professional to provide care. Patients may indicate consent non-verbally (for example by presenting their arm for their pulse to be taken), orally, or in writing. For the consent to be valid, the patient must:
• Be competent to take the particular decision.
• Have received sufficient information to take it; and
• Not be acting under duress.
The context of consent can take many different forms, ranging from the active request by a patient of a particular treatment (which may or may not be appropriate or available) to the passive acceptance of a health professional’s advice. In some cases, the health professional will suggest a particular form of treatment or investigation and after discussion the patient may agree to accept it. In others, there may be a number of ways of treating a condition, and the health professional will help the patient to decide between them. Some patients, especially those with chronic conditions, become very well informed about their illness and may actively request particular treatments. In many cases “seeking consent” is better described as “joint decision making”: the patient and health professional need to come to an agreement on the best way forward, based on the patient’s values and preferences and the health professional’s clinical knowledge.
Where an adult patient lacks the mental capacity (either temporarily or permanently) to give or withhold consent for themselves, no one else can give consent on their behalf. However, treatment may be given if it is in their best interests, as long as it has not been refused in advance in a valid and applicable advance directive.
For significant procedure, it is essential for health professionals to document clearly both a patient’s agreement to the intervention and the discussions which led up to that agreement through documenting it in the patient’s notes that they have given oral consent.
Consent is often wrongly equated with a patient’s signature on a consent form. A signature on a form is evidence that the patient has given consent, but is not proof of valid consent. If a patient is rushed into signing a form, on the basis of too little information, the consent may not be valid, despite the signature. Similarly, if a patient has given valid verbal consent, the fact that they are physically unable to sign the form is no bar to treatment. Patients may, if they wish, withdraw consent after they have signed a form: the signature is evidence of the process of consent giving, not a binding contract.
It is rarely a legal requirement to seek written consent, but it is good practice to do so if any of the following circumstances apply:
The treatment or procedure is complex, or involves significant risks (the term “risk” is used throughout to refer to any adverse outcome, including those, which some health professionals would describe as “side effects” or “complications”)
The procedure involves general/regional anaesthesia or sedation.
Providing clinical care is not the primary purpose of the procedure.
There may be significant consequences for the patient’s employment, social or personal life.
Completed forms should be scanned onto computer record. Any changes to a form, made after the patient has signed the form, should be initialled and dated by both the patient and health professional.
It will not usually be necessary to document a patient’s consent to routine and low-risk procedures, such as providing personal care or taking a blood sample. However, if you have any reason to believe that the consent may be disputed later or if the procedure is of particular concern to the patient (for example if they have declined, or become very distressed about similar care in the past) it would be helpful to do so.
Procedures to follow when patients lack capacity to give or withhold consent
Where an adult patient does not have the capacity to give or withhold consent to a significant intervention, this fact should be documented in Form 4 (form for adults who are unable to consent to investigation or treatment), along with the assessment of the patient’s capacity, why the health professional believes the treatment to be in the patient’s best interests, and the involvement of people close to the patient. The standard consent forms should never be used for adult patients unable to consent for themselves. For more minor interventions, this information should be entered in the patient’s notes.
An apparent lack of capacity to give or withhold consent may in fact be the result of communication difficulties rather than genuine incapacity. You should involve appropriate colleagues in making such assessments of incapacity, such as specialist learning disability teams and speech and language therapists, unless the urgency of the patient’s situation prevents this. If at all possible, the patient should be assisted to make and communicate their own decision, for example by providing information in non-verbal ways where appropriate.
Occasionally, there will not be a consensus on whether a particular treatment is in an incapacitated adult’s best interests. Where the consequences of having, or not having the treatment are potentially serious, a court declaration may be sought.
When should consent be sought?
When a patient formally gives their consent to a particular intervention, this is only the endpoint of the consent process. It is helpful to see the whole process of information provision, discussion and decision making as part of “seeking consent”. This process may take place at one time, or over a series of meetings and discussions, depending on the seriousness of what is proposed and the urgency of the patient’s condition.
Single stage process
In many cases it will be appropriate for a health professional to initiate a procedure immediately after discussing it with the patient.
While administrative arrangements will vary, it should always be remembered that for consent to be valid the patient must feel that it would have been possible for them to refuse, or change their mind. It will rarely be appropriate to ask a patient to sign a consent form after they have begun to be prepared for treatment (for example, by changing into a hospital gown), unless this is unavoidable because of the urgency of the patient’s condition.
Treatment of young children
Only people with “parental responsibility” are entitled to give consent on behalf of their children. You must be aware that not all parents have parental responsibility for their children (for example, unmarried fathers do not automatically have such responsibility although they may acquire it). If you are in any doubt about whether the person with the child has parental responsibility for that child, you must check.
Provision of Information
The provision of information is central to the consent process. Before patients can come to a decision about treatment, they need comprehensible information about their condition and about possible treatments/investigations and their risks and benefits (including the risks/benefits of doing nothing).
Patients and those close to them will vary in how much information they want: from those who want as much detail as possible, including details of rare risks, to those who ask health professionals to make decisions for them. There will always be an element of clinical judgement in determining what information should be given. However, the presumption must be that the patient wishes to be well informed about the risks and benefits of the various options. Where the patient makes clear (verbally or non-verbally) that they do not wish to be given this level of information, this should be documented.
Provision for patients whose first language is not English
This practice is committed to ensuring that patients whose first language is not English receive the information they need and are able to communicate appropriately with health care staff. It is not appropriate to use children to interpret for family members who do not speak English.
Access to health professionals between formal appointments
After an appointment with a health professional patients will often think of further questions which they would like answered before they take their decision.
Who is responsible for seeking consent?
The health professional carrying out the procedure is ultimately responsible for ensuring that the patient is genuinely consenting to what is being done. It is they who will be held responsible in law if this is challenged later.
Where oral or non-verbal consent is being sought at the point the procedure will be carried out, this will naturally be done by the health professional responsible. However, team work is a crucial part of the way the NHS operates, and where written consent is being sought it may be appropriate for other members of the team to participate in the process of seeking consent.
Completing consent forms
The standard consent form provides space for a health professional to provide information to patients and to sign confirming that they have done so. The health professional providing the information must be competent to do so: either because they themselves carry out the procedure, or because they have received specialist training in advising patients about this procedure, have been assessed, are aware of their own knowledge limitations and are subject to audit.
If the patient signs the form in advance of the procedure (for example in out-patients or at a pre-assessment clinic), a health professional involved in their care on the day should sign the form to confirm that the patient still wishes to go ahead and has had any further questions answered. It will be appropriate for any member of the health care team (for example a nurse admitting the patient for elective procedure) to provide the second signature, as long as they have access to appropriate colleagues to answer questions they cannot handle themselves.
Insert local details, where appropriate at Directorate level covering:
what training is available for health professionals who do not themselves carry out specific procedures, but could potentially provide the information patients need in coming to a decision.
what procedures are in place to ensure that the health professionals “confirming” the patient’s consent have genuine access to appropriate colleagues where they are personally not able to answer any remaining questions.
Responsibility of health professionals
It is a health professional’s own responsibility:
to ensure that when they require colleagues to seek consent on their behalf they are confident that the colleague is competent to do so; and
to work within their own competence and not to agree to perform tasks which exceed that competence.
If you feel you are being pressurised to seek consent when you do not feel competent to do so (insert local details of whom to contact, such as clinical governance lead).
Refusal of treatment
If the process of seeking consent is to be a meaningful one, refusal must be one of the patient’s options. A competent adult patient is entitled to refuse any treatment, except in circumstances governed by the Mental Health Act 1983. The situation for children is more complex: see the Department of Health’s Seeking Consent: working with children for more detail. The following paragraphs apply primarily to adults.
If, after discussion of possible treatment options, a patient refuses all treatment, this fact should be clearly documented in their notes. If the patient has already signed a consent form, but then changes their mind, you (and where possible the patient) should note this on the form.
Where a patient has refused a particular intervention, you must ensure that you continue to provide any other appropriate care to which they have consented. You should also ensure that the patient realises they are free to change their mind and accept treatment if they later wish to do so. Where delay may affect their treatment choices, they should be advised accordingly.
If a patient consents to a particular procedure but refuses certain aspect of the intervention, you must explain to the patient the possible consequences of their partial refusal. If you genuinely believe that the procedure cannot be safely carried out under the patient’s stipulated conditions, you are not obliged to perform it. You must, however, continue to provide any other appropriate care. Where another health professional believes that the treatment can be safely carried out under the conditions specified by the patient you must on request be prepared to transfer the patient’s care to that health professional.
Clinical photography and conventional or digital video recording
Photographic and video recordings made for clinical purposes form part of a patient’s record.
If you wish to make a photographic or video recording of a patient specifically for education, publication or research purposes, you must first seek their written consent (or where appropriate that of a person with parental responsibility) to make the recording, and then seek their consent to use it. Patients must know that they are free to stop the recording at any time and that they are entitled to view it if they wish, before deciding whether to give consent to its use. If the patient decides that they are not happy for any recording to be used, it must be destroyed. As with recordings made with therapeutic intent, patients must receive full information on the possible future uses of the recording, including the fact that it may not be possible to withdraw it once it is in the public domain.
ENGLISH LAW – 12 KEY POINTS
When do health professionals need consent from patients?
Before you examine, treat or care for competent adult patients you must obtain their consent. Adults are always assumed to be competent unless demonstrated otherwise. If you have doubts about their competence, the question to ask is “Can this patient understand and weigh up the information needed to make this decision?” Unexpected decisions do not prove the patient is incompetent, but may indicate a need for further information or explanation.
Patients may be competent to make some health care decisions, even if they are not competent to make others. Giving and obtaining consent is usually a process, not a one-off event. Patients can change their minds and withdraw consent at any time. If there is any doubt, you should always check that the patient still consents to your caring for or treating them.
Can children give consent for themselves?
Before examining, treating or caring for a child you must also seek consent. Young people aged 16 and 17 are presumed to have the competence to give consent for themselves. Younger children who understand fully what is involved in the proposed procedure can also give consent (although their parents will ideally be involved). In other cases, some-one with parental responsibility must give consent on the child’s behalf, unless they cannot be reached in an emergency. If a competent child consents to treatment, a parent cannot over-ride that consent. Legally, a parent can consent if a competent child refuses, but it is likely that taking such a serious step will be rare.
Who is the right person to seek consent?
It is always best for the person actually treating the patient to seek the patient’s consent. However, you may seek consent on behalf of colleagues if you are capable of performing the procedure in question, or if you have been specially trained to seek consent for that procedure.
What information should be provided?
Patients need sufficient information before they can decide whether to give their consent: for example information about the benefits and risks of the proposed treatment, and alternative treatments. If the patient is not offered as much information as they reasonably need to make their decision, and in a form they can understand, their consent may not be valid. Consent must be given voluntarily: not under any form of duress or undue influence from health professionals, family or friends.
Does it matter how the patient gives consent?
No: consent can be written, oral or non-verbal. A signature on a consent form does not itself prove the consent is valid – the point of the form is to record the patient’s decision, and also increasingly the discussions that have taken place. Your Trust or organisation may have a policy setting out when you need to obtain written consent.
Refusal of treatment
Competent adult patients are entitled to refuse treatment, even when it would clearly benefit their health. The only exception to this rule is where the treatment is for a mental disorder and the patient is detained under the Mental Health Act 1983. A competent pregnant woman may refuse any treatment, even if this would be detrimental to the fetus.
Adults who are not competent to give consent.
No-one can give consent on behalf of an incompetent adult. However, you may still treat such a patient if the treatment would be in their best interests. “Best interests” go wider than best medical interests, to include factors such as the wishes and beliefs of the patient when competent, their current wishes, their general well being and their spiritual and religious welfare. People close to the patient may be able to give you information on some of these factors. Where the patient has never been competent, relatives, carers and friends may be best placed to advise on their patient’s needs and preferences.
If an incompetent patient has clearly indicated in the past, while competent, that they would refuse treatment in certain circumstances (an “advance refusal”), and those circumstances arise, you must abide by that refusal.