Introduction

This article follows the guidance from the General Medical Council and relates to the medicolegal position in the United
Kingdom.

Consent to treatment is the agreement (usually by a patient) to a treatment, investigation or examination and is a key element
of care. It impacts the quality of shared decision-making, experiences of patient-centred care, and medico-legal risk.
Consent to treatment is one type of consent that may be discussed within a medical context. Others include research consent
and consent to data sharing.
In this article, we will discuss an adult giving consent for their treatment (i.e. consent form 1) and cover special circumstances
in the last section.

For consent to be valid, it must be informed and voluntary.
Informed consent
Informed consent is when the patient has received, or had the opportunity to receive, su
appropriate time to consider it. This should include an opportunity to discuss the decision, options, and any questions they
have (i.e. they have had a consent conversation with a clinician).
In the above paragraph, we said ‘or had the opportunity to receive’
. This is because a patient has the right to decline detailed
information and, in most cases, can still give informed consent. The way to understand this is that they are as informed as they
wish to be to make the decision.
Understanding why they do not wish to receive the information is important, as this will often reveal reasonable concerns.
Examples include previous experiences of consent conversations which led to signi
terms with a diagnosis. In these cases, empathetic exploration often leads to a valuable consent conversation and shared
decision-making process.
Otherwise, the patient should still be reassured that more information and a consent conversation with a clinician can be
provided if they change their mind, and you should explain that you need to convey basic information about the treatment.
This basic information includes whether it is an invasive treatment, the level of discomfort to expect, what to do to prepare, and
serious risks.
When a patient refuses to receive this basic information, seek advice from your medical defence union. They will support you
in considering whether consent is still valid, which will often be the case when the treatment is well-evidenced for the
diagnosis but may not be the case in other situations (e.g. an innovative treatment option is being proposed).
Mental capacity
In the context of an adult giving consent for their treatment, there must be no reason to doubt their mental capacity to
consent. Otherwise, a mental capacity assessment should be performed. It is important to remember that capacity is decision
speci
A patient with mental capacity can consent to, or refuse, any proposed treatment. This includes a refusal of treatment where a
clinician feels that doing so is not in the patient’s best interests.
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Clinicians are not required to agree to a patient's request for a treatment that the clinician does not feel would be in their best
interests. A second opinion can be o
Voluntary
Voluntary means that the decision is the individual’s own and is not in
If you believe a patient is being pressured, consult your safeguarding team.
Withholding information
Historically it was commonplace for clinicians to withhold information from patients with the rationale that knowing this
information would be psychologically harmful to the patient. This approach is not generally supported by now, except in rare
circumstances where sharing the information would convincingly cause serious harm to the individual.
This is termed a ‘limited exception’ in the GMC guidance and should be used only following legal advice and having followed
the required legal process.
The legal landscape
The consent process has sometimes been seen as paternalistic, with clinicians recommending their preferred option
and patients following this as instructed.
In 2015, a landmark decision by the UK Supreme Court in the Montgomery v Lanarkshire Health Board case prompted a
change in the law. The court ruled that doctors must now take “ r e a s o n a b l e c a r e t o e n s u r e t h a t t h e p a t i e n t i s a w a r e o f a n y
m a t e r i a l r i s k s i n v o l v e d i n a n y r e c o m m e n d e d t r e a t m e n t a n d o f a n y r e a s o n a b l e a l t e r n a t i v e o r v a r i a n t t r e a t m e n t s.
”
Previously, it was at the doctor’s discretion what to tell patients regarding the risks and bene
actions would have been judged only against other doctors’ opinions of what information should be shared with the
patient (known as 'The Bolam Test').
With the Montgomery ruling, the requirements regarding consent information changed to being what “ a r e a s o n a b l e
p e r s o n i n t h e p a t i e n t' s p o s i t i o n w o u l d b e l i k e l y t o a t t a c h s i g n i
. This includes a requirement for doctors not to
make assumptions about which risks are important to patients, and they must fully disclose any risks that may be of
particular importance or relevance to that patient (e.g. a professional pianist undergoing a hand operation).

Explicit consent is when a person shows their agreement verbally or in writing.
For some treatments, consent can be implied non-verbally. Implied consent can be expressed by behaviour, such as
extending an arm for a blood test or opening the mouth to enable a throat examination.
In either case, the clinician should be con
treatment.

Consent forms are operationally required for most invasive treatments, and serve as a prompt to share key information,
including material risks, document the consent information shared, and record that written consent has been given. They
include consent statements from the patient and clinician to state that an appropriate process has been followed. Historically,
these have been completed on paper consent forms, but digital consent is being introduced in some areas.
Minor bedside procedures (e.g. intravenous cannulation and venepuncture) do not usually require a consent form to be
completed.
It is important to note that completing a consent form does not replace meaningful dialogue between the patient and the
clinician. A consent form in isolation does not demonstrate that an appropriate, medicolegally robust, consent process has
been followed.
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An e
A clinician who is an expert in the medicine, including what may be particularly relevant in the clinical context
A patient who is an expert in themselves and what matters to them
For this reason, you should ensure that you appropriately understand the individual clinical context before undertaking a
consent conversation (e.g. by reading the medical notes).
The consent conversation with the patient should usually involve a clinician trained to perform the procedure or prescribe the
treatment. However, the process may be delegated to another member of the team.
If you are obtaining consent for treatment on behalf of another clinician (i.e. delegated consent), you must be su
quali
consent conversation and should communicate this to the responsible clinician and/or person performing the procedure.
Ensure you have enough time for an e
preferences and priorities, and answer their questions. Try to minimise the risk that you will be disturbed during the
conversation.

Giving consent to treatment should be a process rather than a one-o
decision in their own time.
The initial consent conversation should occur well before treatment commences, be con
may involve further consent conversations in between.
There remains a challenge in the UK of consent conversations happening and consent being documented on the day of
treatment. In some cases, this is necessary (e.g. before emergency surgery). However, in most cases, it should be avoided as it
is not best practice, and new information shared on the day may be disregarded in terms of a medicolegal defence.

Opening the consultation

Wash your hands and don PPE if appropriate.
Introduce yourself to the patient including your name and role.
Con
Discuss the diagnosis and establish prior understanding\:
Check the patient’s understanding of their diagnosis, the
left untreated
Gauge what the patient already knows about their condition to clarify any misunderstandings
Explain the purpose of the conversation\:
“ I’ d l i k e t o d i s c u s s y o u r t r e a t m e n t , i s n o w a go o d t i m e ?”
Understand the patient’s wishes, needs, views and expectations\:
Ask the patient what matters to them, and do not make assumptions about what is a good outcome for them
Everyone has di

Discussing the options

Explain the indication for treatment, various treatment options and what they would involve (including anaesthetic options if
relevant), and the key risks and bene
Discuss any preparation needed before the procedure and the expected follow-up.

Explaining risks

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When discussing risks, you should establish the patient context and what matters to the patient to ensure that you cover all
material risks of the treatment for that individual and assess the signi
a patient might want to know, as evidence shows our assumptions are often incorrect.
Information should be presented in an understandable way to the patient, avoiding medical jargon (or, where not possible,
explaining terms in lay language). The use of diagrams is often helpful.
Explain the risks of treatment, ideally in the context of when they may occur and how likely they are for that individual.
Individual patient risk pro
veriSurgical Outcome Risk Tool (SORT) where available.
There is no simple explanation or rule as to what risks need to be discussed or how likely a risk needs to be to meet the
threshold of being discussed.
In general, common complications should always be discussed. As a risk becomes rarer, then the severity of the complication
and whether it may have particular relevance to an individual (i.e. it is a material risk) will determine whether it should be
discussed. Risks of serious harm should usually be discussed, however unlikely they are to occur.
Example
A 1 in 200 chance of death will usually be deemed signi
temporary nosebleed in a patient without any bleeding disorder may not.
Signi shows that the information traditionally discussed and documented during a paper-based consent
process is highly variable, with signi
alongside a consent conversation to minimise the risk of omitting key risks through human error.
You should be honest about any uncertainties (e.g. likely outcomes) and honest regarding the experience of the individual
performing a procedure, especially in the context of new or innovative treatments.

Checking patient understanding

During the conversation, it is a good idea to summarise what has been discussed so far and check the patient's
understanding.
‘Teach-back’ is a mechanism that has been shown to improve the quality of a consent conversation, including
supporting patient understanding and retention of information. It involves a patient summarising the information in their own
words and adding their own context to the information.

Questions and subsequent support

Allow time for questions. In many cases, this can be the most rewarding part of a consent conversation, where your clinical
experience can be used to answer patient questions and concerns.
As discussed, in most cases, it is best practice that consent is a process rather than a one-o
time to consider their decision and discuss it with people who are important to them.
Provide personalised written information, including signposting to reputable resources and support from other
multidisciplinary team members.
If the patient has understood all of the information and is happy to do so, it may be appropriate for them to sign their consent
form during the consultation, or if possible, it may be shared with them to do so remotely once they have had time to consider
the information. Depending on local policy, this may be via a digital consent application or paper consent form.
If the patient decides during the consultation that they will not give their consent to proceed with the treatment, they do not
need to justify this, but you should ensure that this is not based on patient misunderstanding.

Closing the consultation

Document your assessment clearly in the medical notes, including\:
The indication for assessment
The decision this relates to
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Date and time
Who was present during the assessment
As capacity can
should be informed.
Complex cases, or inconclusive assessments, should be discussed with senior clinicians who may recommend specialist
assessment by liaison psychiatry.

Following the consultation

If a digital consent application has been used, the consent documentation will be automatically stored and should
subsequently be viewed digitally to con
If a paper consent form has been used, ensure the consent form is stored correctly. Depending on local policy, this may be
within the patient’s paper notes, sent for scanning, or sent to the department responsible for the treatment.
If the initial consent conversation occurs before the day of treatment (often considered more than 24 hours before treatment),
then a further con
This should explore any new information or changes in the clinical context or risks, and answer any additional questions the
patient may have. The conversation should be documented but does not require a further signature from the patient unless
there are changes to the details on the consent form.

Special circumstances

These special circumstances have nuances we will not cover in this article, but the same high-level principles apply.

The default position is that an individual with parental responsibility should give consent to treatment for a child aged 0 - 15.
The person(s) with parental responsibility will usually, but not invariably, be the child’s birth parents.
The principles of consent remain the same as in an adult giving consent for their treatment, only that consent is given by the
adult on behalf of the child. There are circumstances where the child may be able to give consent to treatment themselves,
where they are deemed Gillick competent.
Young people aged 16 or 17 are, like adults, presumed to have the capacity to decide on their medical treatment unless there
is signi
to doubt capacity, a mental capacity assessment should be completed, and if it is deemed that they do not have the mental
capacity to make the decision, then an individual with parental responsibility becomes the decision maker.

If an adult patient is demonstrated to lack the mental capacity to decide to proceed with treatment, then a decision in their
best interests is made.
Several possible scenarios exist, such as whether an advance directive exists and whether a health and welfare lasting power
of attorney or personal welfare duty has been appointed.
This will be documented in the best interests documentation alongside the Mental Capacity Assessment form and consent
form 4 regarding whether to proceed with treatment.
Depending on the circumstances, this may consider any known and relevant patient preferences or wishes, consultation with
those close to the patient or an Independent Mental Capacity Advocate (IMCA), and consideration of less restrictive
alternatives.

Reviewers

Dr Dafydd Loughran
Urology Registrar & CEO | Concentric Health
Dr Patrick Hart
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Founders Associate | Concentric Health

References

General Medical Council. 2020. D e c i s i o n m a k i n g a n d c o n s e n t . Available from\: [LINK]
Source\: geekymedics.com
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Obtaining consent

Introduction

What is consent?

Consent validity

Demonstrating consent

Consent forms

Preparing for the consent discussion

Timing of a consent conversation