BDA advice

Consent

Date: March 2016

 Contents
3 Competency
6 Types of consent
8 Material risks and benefits
8 Duress
8 Battery
8 Clinical trials, research and lectures

© BDA March 2016 Consent Page 2

 The need to obtain consent arises from the moral obligation and ethical principle
to respect a person’s autonomy and right to self-determination in all healthcare
matters. Any treatment or intentional physical contact with the patient
undertaken without valid consent may amount to assault and a breach of the
patient’s human rights and lead to a charge of serious professional misconduct
(see the GDC’s guidance Principles of patient consent). Assault may result in an
award for damages and criminal investigations.
In any healthcare situation, patients have a choice and must agree to and give
consent for any proposed examination or treatment. In reaching an agreement,
the patient must understand their clinical situation, the proposed procedure and
intended outcomes, and the possible associated risks and alternative options.
For consent to be valid, it must be given freely. The individual giving consent
must be competent to do so and adequately informed of the procedure that is
being agreed to. If the patient is under 16 years and unable to give informed
consent, a parent or guardian can give consent on their behalf.
Consent must be obtained by the clinician providing the treatment and is an
ongoing process, so effective communication with the patient is vital. Obtaining
consent must not be delegated to staff, although staff may be used to reinforce
the information provided by the clinician.
If you refer a patient for treatment by another clinician, including in-house
referrals to a hygienist or therapist, you must obtain the patient’s consent for
the referral and ensure that they understand why they are being referred and the
treatment or advice that they will receive as a result of the referral. The clinician
accepting a referred patient must confirm with the patient that they understand
why they have been referred and that they are still content for the treatment to
be carried out.
© BDA March 2016
Competency
You must assess whether a patient is competent to give consent before providing
any dental care or treatment. To be competent, the patient must be able to:
• Understand and retain the relevant information
• Use the information to arrive at a choice, and
• Communicate their decision.
The patient must be able to understand that there is a clinical problem, that it
requires treatment and the consequences of undergoing or declining treatment.
They do not have to make a ‘mature’ or ‘wise’ decision; the law does not impose
unreachable expectations about a patient’s reasoning powers and experiences.
A person who has reached the age of 18 (ie, an adult) and is competent to reach
decisions can give or withhold consent. No-one else can provide consent on their
behalf.
A young person who has reached age 16 and is of sound mind can consent to
any surgical, medical or dental treatment1. If a young person understands the
treatment proposed but refuses consent, a parent can consent to treatment
on their behalf although best practice would be for the parent to make an
application to the court to decide on the treatment. A parent cannot overrule
consent to treatment given by a competent 16 or 17 year old.
Children under age 16 who are of sufficient maturity and intelligence to
understand fully the nature of the treatment proposed and its ramifications are
regarded as Gillick competent2. In deciding whether a child is Gillick competent,
the Fraser Guidelines (set down by Lord Justice Fraser in the Gillick case) may
provide a useful reference:
• The clinician is satisfied that the young person will understand the
professional’s advice
• The young person cannot be persuaded to inform their parents
• Unless the young person receives treatment, their physical or mental health,
or both, are likely to suffer
• The young person’s best interests require them to receive advice or treatment with
or without parental consent.
Where the child is assessed as ‘Gillick competent’, a parent can give consent
and overrule a child’s refusal to receive treatment, but they cannot overrule the
child’s consent to treatment.
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 For younger children and those judged not to be Gillick competent, consent must
be obtained from a person with parental responsibility for the child:
• The child’s mother
• The child’s father, where they
- are married to the mother at the time of birth, or
- are not married but are listed on the child’s birth certificate, or
- have acquired parental responsibility via a parental responsibility
agreement with the mother or by a court order
• A person appointed as the child’s guardian
• A person in whose favour the court makes a residence order with respect to
the child.
Where more than one person has parental responsibility for the same child at
the same time, each may act alone. If they disagree about consent to treatment
for the child, the court can intervene and make a judgement. Where they refuse
treatment that is in the child’s best interests, a court can order the treatment to
be carried out.
Where a child who is unable to consent is accompanied by an adult relative
without parental responsibility (a grandparent, aunt or uncle, for example), the
relative cannot give consent on behalf of the child; consent must be obtained
from the parent. If the parent cannot be contacted, treatment should only
proceed in exceptional circumstances, for example where the child is in pain and
treatment will alleviate it.
Where a child is taken into local authority care, the local authority may acquire
parental responsibility in addition to the child’s natural parents. Consent can
be obtained from an authorised representative of the local authority. Where a
major surgical procedure is involved, the consent of the parents should also be
sought.
If a child under 18 is a ward of court, the court must provide consent for any
major intervention.
© BDA March 2016
Mental capacity
Patients who, for reasons of mental incapacity or illness, lack a full understanding
of the need for, the nature of or the consequences of treatment proposed,
cannot give informed consent to treatment. Incapacity may arise from a stroke,
head-injury, a mental health problem, dementia, a learning disability, confusion,
drowsiness, or unconsciousness because of an illness or its treatment or the long-
term effects of substance misuse (including drugs and alcohol).
Comprehensive legislation in England and Wales and in Scotland provides a
framework for making a decision about the capacity of a patient to consent
to dental treatment and to take decisions in relation to their dental care3. It
also enables others, in certain circumstances, to make decisions on behalf of
incapacitated adults. Although there is no legislation for Northern Ireland,
common law and general ethical rules mean that you should apply similar criteria
as in England, Wales and Scotland.
Codes of practice provide guidance for those working with incapacitated adults:
• Mental Capacity Act 2005 – Code of Practice (England and Wales)
• Adults with Incapacity (Scotland) Act 2000 – Code of Practice for practitioners
authorised to carry out medical treatment or research under part 5 of the Act
In England and Wales, there is a legal duty to abide by the code unless there is
a convincing reason for not doing so. Although not mandatory in Scotland, the
code is regarded as best practice so not following it could put you at risk legally.
Guiding principles
Each Act contains guiding principles for providing care or treatment to a patient
who lacks capacity. These principles differ between England and Wales and
Scotland but can be summarised as respecting the individual and acting in their
best interests.
In England and Wales the principles are:
• Every adult has the right to make his or her own decisions and must be
assumed to have capacity unless it is established that they lack it
• A person must be given all practicable assistance to make their own decision
before they are treated as being unable to do so
• Just because an individual makes what might be seen as an unwise decision,
they should not be treated as lacking capacity to make that decision
• Anything done or any decision made on behalf of a person who lacks capacity
must be done in their best interests
• Anything done for a patient who lacks capacity should restrict their basic
rights and freedoms as little as possible.
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 In Scotland the principles are:
• The decision must benefit the patient. Any intervention should only be made
if it will benefit the patient and if the benefit cannot reasonably be achieved
without the intervention
• The decision must restrict the patient’s freedom as little as possible while still
achieving the desired benefit
• The decision must take account of the patient’s past and present wishes and
feelings so far as they can be ascertained
• The decision must take into account the wishes and feelings of relevant
others, for example a relative, carer, or guardian – if it is reasonable and
practicable to do so
• You should encourage the patient to use their existing skills or develop new
skills to assist with decision making.
Assessment of capacity
You must assess a patient’s capacity before carrying out any dental care or
treatment, taking into account whether or not the patient is able to understand
the proposed care or treatment, its benefits and risks, and to communicate their
decision to accept or decline.
Capacity should be assessed for each proposed treatment; a person may be
legally capable of some decisions and actions but not others. Involving the
relevant family, friends or carer or an Independent Mental Capacity Advocate (if
one has been appointed) can allow those who know the patient to advise you on
the best methods of communication. Avoid expressing an opinion without first
conducting a proper assessment of the patient’s capacity to make the required
decision.
Always start with the assumption that the patient has the capacity to make the
required decision. A two-stage approach requires you to carry out a ‘diagnostic
test’ followed by, if necessary, a ‘functional test’:
• Does the patient have a mental impairment or disturbance?
• If yes, does the impairment or disturbance makes the patient unable to make
the required decision?
© BDA March 2016
A patient is unable to make the required decision if, after having been given the
necessary support, they are unable to:
• Understand the information relevant to the decision and the consequences
(risks and benefits) of making or not making the decision
• Understand that the information is of personal relevance
• Retain the information
• Consider the information as part of the decision making process
• Communicate their decision by talking, using sign language or other means.
The results of the assessment should be recorded in the patient’s clinical
record together with an explanation of how you reached your conclusion. This
explanation is important if your assessment of capacity is challenged by the
patient or someone acting for them. If you have doubts about our assessment,
you should seek help from the patient’s medical practitioner.
Best interests
If you assess a patient as lacking the mental capacity to make their own decision,
any decision or action that you take must be in their best interests and the first
question you should ask is whether treatment is necessary at all.
Consider all the relevant circumstances relating to the need to make a decision
and, as far as possible, encourage the patient to participate. Do not make
assumptions about the patient’s best interests based on their age, appearance,
condition, or any aspect of their behaviour. Where appropriate, consult with
others, including family, carers and close friends.
Your records should demonstrate how you arrived at your decision and that, in
the circumstances, it was reasonable to believe that it was in the best interests
of the patient.
The Adults with Incapacity (Scotland) Act 2000 allows patients who lack
capacity to be treated, provided a certificate of incapacity has been issued by an
authorised practitioner and the general principles of the Act are observed. The
certificate of incapacity, must use the prescribed form and specify the period
of valid authority. The period will depend on the condition or circumstances of
the patient and should not generally exceed one year. During the period of valid
authority, you have authority to do what is reasonable to safeguard or promote
the physical or mental health of the adult. If a patient requires multiple or
complex care, a treatment plan may be attached to the certificate.
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 Use of restraint
Restraint is defined as ‘using or threatening to use force to do an act which the
patient is resisting; or restricting the patient’s liberty of movement, whether or
not the patient resists’.
In the provision of dental care, restraint should only be used in exceptional
circumstances where it is necessary to provide the required treatment and
prevent harm to an incapacitated patient. It must be proportionate to likelihood
of the patient suffering harm and the seriousness of that harm. Where used, an
approved code of practice should be followed; excessive restraint may leave you
liable to a range of civil and criminal penalties.
Advance wishes
In England and Wales, people can plan ahead for a time when they may lack
capacity:
(i) Lasting Power of Attorney (LPA) allows a person over the age of 18 to
formally appoint one or more people (attorneys) to look after their health
decisions if they subsequently lack the capacity to make such decisions
themselves. Where appointed, the attorney will be the decision-maker on
all matters relating to the patient’s care and treatment and have a duty
of care to the adult on whose behalf they act and to abide by the general
principles of the Mental Capacity Act 2005. To be valid, an LPA must be
registered with the Public Guardian. You must check registration as an
unregistered LPA cannot be used.
(ii) Before losing capacity, people over 18 years can make advance decisions
to refuse particular medical treatments (including dental treatment) and
explain the circumstances when the refusal would apply. Advance decisions
cannot be made to request medical treatment. If you treat a patient who
is unable to consent, you must check for an advance decision that relates
to dentistry; generally it should be lodged with their clinical records or the
patient should carry a card clearly setting out their wishes.
(iii) Individuals can make a written or verbal statement about their preferences
for future care and treatment. If the individual subsequently loses capacity,
you must consider the statement when determining what care and
treatment is in the patient’s best interests. If your professional judgement
differs from the patient’s stated preferences, you should keep a written
record of this in the patient’s clinical records.
© BDA March 2016
In Scotland, a welfare power of attorney (WPA) allows a person over 18 to appoint
one or more people to look after their health decisions, if they subsequently lack
the capacity to make such decisions themselves. The WPA has a duty of care
to the adult on whose behalf they act, and to abide by the general principles of
the Adults with Incapacity (Scotland) Act 2000. To be effective, a WPA must be
registered with the Public Guardian.
Statutory bodies
In England and Wales, the following organisations may become involved in
cases of mentally incapacitated adults:
• The Court of Protection considers mental capacity issues and decisions about
healthcare and treatment. The Court can appoint deputies to have ongoing
authority to make decisions for those who lack capacity.
• The Office of the Public Guardian is an agency of the Ministry of Justice and
is responsible for maintaining a register of Lasting Powers of Attorney. It
protects people who lack capacity from abuse.
• Independent Mental Capacity Advocates (IMCA) assist those who lack
capacity and who do not have the support of close-family or friends to help
them make important decisions. The IMCA will only be involved in certain
circumstances, for example if the decision is about serious medical treatment
provided by the NHS or moving to a hospital or care home.
In Scotland:
• The Office of the Public Guardian (Scotland) is an agency of the Scottish
government and fulfils the same role as in England and Wales.
• The Mental Welfare Commission (MWC) has protective functions for adults
whose incapacity stems from mental disorder and maintains a list of medical
practitioners to provide an additional opinion in disputes about treatment.
Local authorities have a wide range of functions, including investigating
circumstances where the personal welfare of an adult is at risk and providing
information and advice to those exercising welfare powers.
In Northern Ireland the care of incapacitated adults is governed by common law
so disputes are referred to the High Court.
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 Types of consent
Express consent
Express consent to undergo examination or treatment can be given orally or in
writing.
Best practice is to obtain written consent, although oral consent is generally
adequate for routine treatments, provided full records are maintained. Written
consent is necessary where treatment involves extensive intervention and is
essential for certain situations – for example, where conscious sedation is used.
Implied consent
In limited circumstances consent may be implied – for example, a patient indicates
agreement to an examination by sitting in the dental chair and opening their mouth.
Consent to other types of dental procedures cannot normally be implied from
compliant actions; an open mouth does not mean that the patient has understood
what the treatment will involve or the reasons for it.
Informed consent
The principle of informed consent is to acknowledge individual autonomy and
avoid making assumptions about a patient’s views, values or code of conduct.
Informed consent requires the patient to have sufficient information about the
proposed treatment to allow them to make a balanced judgement on whether to
proceed. You must ensure that the patient understands the reason for treatment,
the treatment options available, the risks that each option presents, methods of
pain control and the consequences of no treatment. The patient should have
the opportunity to consider the information and ask questions to help them to
arrive at a decision. The onus is on you, as the treating clinician, to ensure that
the patient understands.
Treatment plans and estimates can provide a useful record of the information
given to patients about their dental care needs and treatment options. If you use
treatment plans in this way they must accurately reflect the discussion held and
explanations given to the patient.
Specific consent
Specific consent means that the patient gives express consent to each procedure
to be undertaken. An agreement to undertake a course of treatment without
knowing what is to be done is not specific consent – for example, giving
informed consent to sedation does not mean that the patient has consented to
the treatment that is to be provided. The patient must understand the precise
nature of the treatment that is to be undertaken.
© BDA March 2016
Exceeding consent
Consent obtained for one procedure is not transferable for alternative or
subsequent treatment that may become necessary. Consent is specific and any
change in treatment plans must be explained to the patient and further consent
sought.
The best interests of the patient are paramount. If the patient is unable to consent to further
necessary treatment – for example, if they have had a general anaesthetic or sedation –
it may be reasonable to proceed but you must be willing to account for your actions. If
this scenario is likely, prior consent should be obtained. The patient should receive a full
explanation of the treatment provided and the reasons for it at the earliest opportunity
(when the patient is sufficiently recovered to understand).
Restricted consent
A patient can consent to only part of a treatment plan and withhold consent
for any treatment that may later become necessary to ensure that the reasons
for it and any options are considered fully. Restricted consent must be properly
recorded and followed.
Material risks and benefits
The patient must be warned of any substantial or unusual risks involved with their
treatment and of any consequences that commonly occur – for example, the
possibility of nerve damage in oral surgery procedures, perforation or instrument
breakage in endodontics, and crown and bridge failures. You must decide which
risks are material and require explanation.
Case law from medical negligence and consent claims provides guidance on the
approach to take:
The Bolam v Friern Hospital Management Committee (1957) established the
Bolam test. It was held that a doctor is not negligent if they act in a way that
a competent doctor would act and their actions are supported by a responsible
body of medical opinion. This rule applies to all clinicians, including dentists.
Sidaway v Board of Governors of Bethlem Royal and the Maudsley Hospital
(1985) affirmed the Bolam test and extended it to require that a patient should
receive sufficient information about the risks to allow them to reach a balanced
judgement. The health professional must take all relevant factors into account
– such as the severity and likelihood of the risk to the particular patient and the
patient’s need for the procedure. The patient must be informed if there is a risk
of grave and adverse consequences.
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 Bolitho v City and Hackney Health Authority (1997) refined the Bolam test,
giving more authority to the courts to adjudicate on whether the body of medical
opinion is logically defensible or not. The logic of common clinical practices
should always be considered.
Pearce v United Bristol Healthcare NHS Trust (1999) held that a doctor must take
account of all relevant circumstances when deciding how much information to
give. If there is a significant risk that would affect the judgement of a reasonable
patient, the patient should be informed and be allowed to decide what to do.
Chester v Afshar (2004) found that the failure to warn about a risk itself can be a
breach of the clinician’s duty of care; the autonomy and dignity of each patient
must be respected.
Montgomery v Lanarkshire Health Board (2014) developed the clinician’s duty to
seek informed consent and recognise each patient as an individual. Be aware of
each patient’s situation and medical history and find out what they may want to
know or consider significant or important (rather than merely going through the
issues that are felt, by the profession, to be statistically significant).
When explaining the benefits of the various treatment options, take care not
to overstate or exaggerate the outcomes for a particular treatment. You must
be able to substantiate any claims about benefits and avoid raising patients’
expectations of the benefits or results of particular treatments.
Duress
Consent must be given voluntarily and freely; if obtained under duress, consent
is not valid. In addition to obvious force, duress includes other forms of undue
influence, including for example, emotional or financial pressure. When obtaining
consent in the presence of third parties, especially family members, ensure that
the third party does not unduly influence the patient to give consent.
© BDA March 2016
Battery
Undertaking treatment without the patient’s consent constitutes assault and
could render you liable to an action in battery even if the treatment were not
performed negligently. Liability can arise by:
• Failing to obtain consent at all
• Failing to ensure that the patient understood even in broad terms the nature
of what was proposed
• Failing to give adequate information about this risks involved or the possible
alternatives.
The fact that the patient, if asked, would probably have consented to the
procedure is no defence.
Unnecessary treatment at the patient’s request
If you are asked by a patient to undertake treatment that you believe is
unnecessary, you must act in the patient’s best interest and will be responsible
for any treatment provided.
Do not undertake treatment that will cause permanent damage to the dentition
or will be of no clinical or cosmetic benefit. If the treatment fails, the patient
may seek damages for negligence or a refund of treatment costs. You may find
it difficult to establish that treatment was undertaken with the required skill
and care. A signed statement from the patient instructing you to carry out the
treatment and absolving you from any of the stated adverse consequences, may
not provide a valid defence in court or before the GDC.
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 Clinical trials, research and lectures
A patent’s participation in research must be voluntary. Research should only be
carried out on patients with their specific consent following a full explanation
of the research and its possible effects and a check to ensure the patient’s full
understanding.

Research protocols should always be submitted to your local Research Ethics

Committee. Applications must be made through the online gateway. Further
information on ethical approval for research within the NHS can be found on the
National Research Ethics Committees’ website.

If you wish to use photographs or other images of patients in clinical lectures,

papers, videos or presentations, you must obtain consent from the individual
patients.

Where research uses data from patients’ records, the patient’s explicit consent
must be obtained or the data must be encoded or anonymised.
Consent forms
A signed consent form is best practice and can demonstrate patient consent
but does not, by itself, prove that the patient has understood and agreed to
what is being proposed. It is, therefore, no substitute for discussing treatment
needs and options with the patient in a way that ensures they understand what
is being proposed and allows them to make a choice freely. For some procedures
(conscious sedation, for example), written consent is a professional requirement.

Generally a practice consent form should include:

• The name and address of the patient (and, if applicable, their parent or
guardian)
• Details of the treatment and the costs
• A declaration that the patient understands the nature of the treatment and
gives their consent, with a space for them to sign and date the statement
• A declaration by the clinician that they have an up-to-date medical history for
the patient, have explained the treatment and are satisfied that the patient
understands

Template consent forms are available in Expert Solutions.

© BDA March 2016 Consent Page 9