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Consent

Definition

Consent can be defined as permission for something to happen or agreement to do something. NHS Choices ([132]) states that ‘consent to treatment means a person must give permission before they receive any type of medical treatment, test or examination’.

Evidence‐based approaches

There are different types of consent in healthcare: written, verbal (explicit) and non‐verbal (implied or implicit). The requirement to gain consent has two purposes, one legal and the other clinical (Richardson [177]). Sufficient evidence‐based information must be provided to the patient to allow them to make a balanced and informed decision about their care and treatment (GMC [69], [70], RCN [172]).

Principles of care

It is important to recognize that seeking consent for a surgical intervention is not merely the signing of a form. It is the process of providing the information that enables the patient to make a decision to undergo a specific treatment. Consent should be a considered and informed decision‐making process. For major operations, it is good practice to gain a person's consent to the proposed procedure well in advance, ideally prior to pre‐assessment. This allows time to respond to the person's questions and provide adequate information so that the person has time to develop an understanding and thereby make an informed decision (Hughes [82]). For patients with learning disabilities or mental health problems, it is advisable that a relative or carer is present so that consent, capacity and any reasonable adjustments (e.g. to equipment or psychological support) can be discussed depending on the needs of the patient (RCN [172]). For consent to be valid, it must be given voluntarily and freely, without pressure or undue influence, by an appropriately informed person who has the capacity to consent to the intervention in question (NMC [152], RCN [172]). Informed consent is a legal requirement (Montgomery v Lanarkshire Health Board [127]).

While the validity of consent does not depend on the way in which it is given (RCN [172]), it is good practice to use forms for written consent where an intervention such as surgery is to be undertaken. Most hospitals’ local consent policies will require written consent to be obtained in these circumstances.

However, the procedure and risks must be written down for the patient to read and understand, before signing the form; their signature alone does not make the consent valid. For example, if a person's signature to confirm their consent is gained immediately before the surgical procedure is due to start, at a time when they may be feeling particularly vulnerable, this would raise concerns about its validity (GMC [70], RCN [172]). Furthermore, patients should not in any situation be given routine pre‐operative medication before being asked for their consent to proceed with the treatment (RCN [172]).

Clinical governance

It is accepted that when a patient gives valid consent, this is valid indefinitely unless it is withdrawn by the patient; therefore, no specific time limit is designated from signature to procedure (Hughes [82]). However, it is good practice to confirm the patient's wishes if significant time has elapsed since the initial process. The patient is entitled to withdraw consent at any time (Hughes [82]).

For consent to be valid, it must encompass several factors:

Consent must be given willingly: this means without pressure or undue influence to either undertake or not undertake treatment.
Consent must be informed: the person must have an understanding of the procedure and the purpose behind it, and have been given relevant information about the benefits and risks of the procedure as well as potential alternatives. This information needs to be explained or presented in a way that is meaningful and easy to understand by the person in a variety of formats (both verbal and written) to enable them to make an informed decision.
The person must have the capacity to consent to the procedure in question: that is, they must have the ability to understand and retain the information provided, especially around the consequences of having or not having the procedure (NMC [152], RCN [172]). An assessment of a person's capacity must be based on their ability to make a specific decision at the time it needs to be made, and not their ability to make a decision in general (DH [49]). Under the Mental Capacity Act ([122]), which became fully effective in England and Wales in 2007, a person must be presumed to have capacity unless it is established that they lack capacity. If there is any doubt, then the healthcare professional should assess the capacity of the patient to make a decision in general (see Chapter c05: Communication, psychological wellbeing and safeguarding).

During every discussion about consent, it is important to provide all relevant information about the procedure and its implications. In particular, discussions should include information on the following:

the patient's diagnosis and prognosis
options for treatment, including non‐operative care and the option of no treatment
the purpose and expected benefit of the treatment
the likelihood of success
the clinicians involved in the patient's treatment
the risks inherent with the procedure, however small the possibility of their occurrence
all potential side‐effects and complications
the consequences of non‐operative alternatives
potential follow‐up treatment (RCS [176]).

The patient and their family should also be provided with information on post‐operative care and expected recovery. This should include the following:

Explain what patients can expect to have in situ after surgery, such as intravenous lines or drains, and pumps that may sound alarms.
For patients who are expected to be transferred to the intensive care or high‐dependency unit after surgery, offer for them to visit the unit beforehand.
Explain that the patient's bed may be moved when they return to the ward so they can be observed more closely by nursing staff immediately after surgery.
Discuss analgesia.
Measure the patient for antiembolism stockings (see Procedure guideline 16.1: Measuring and applying antiembolic stockings), foot impulse devices and/or intermittent pneumatic compression devices (NICE [148]).
Explain the importance of deep breathing and coughing, regular gentle leg exercises and early mobilization to reduce the risk of complications such as chest infection, deep vein thrombosis and pulmonary embolism.
Explain the need for post‐operative physiotherapy.

Competencies

All healthcare professionals should be aware of the different types of consent and the importance of ensuring that patients understand what is going to happen to them and what is involved. Healthcare professionals should also be familiar with their local hospital consent policy and be aware of and understand what to do if people refuse care or treatment, or when consent is not valid or is no longer valid.

Current guidance states that the person obtaining consent must either be capable of performing the procedure themselves or have received specialist training in advising patients about the procedure (GMC [70]). The person who obtains the patient's consent for surgery should ideally be the surgeon performing the procedure. The anaesthetist should also discuss with the patient the risks related to the chosen method of anaesthesia and obtain consent from them (Hughes [82]).