Consent for Dental Patiends

7/27/2019 Consent for Dental Patiends

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DENTAL PROTECTION LIMITED

DENTAL ADVICE SERIES

Consent

SUITABLE FOR UK EXCLUDING SCOTLAND

www.dentalprotection.org


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DENTAL ADVICE SERIES CONSENT|2

Dental Protection Limited

33 Cavendish Square, London W1G 0PS, UKGranary Whar House, Leeds LS11 5PY, UK39 George Street, Edinburgh EH2 2HN, UK

Telephone

0845 608 4000 (UK only)+44 (0)20 7399 1400

ConsentSUITABLE FOR UK EXCLUDING SCOTLAND

CONTENTS

www.dentalprotection.org Dental Protection Limited

1.00 Introduction

2.00 Aspects o autonomy2.01 Inuence2.02 Respect

3.00 Competence

4.00 Authority4.01 Competent adults4.02 Children4.03 The incompetent adult4.04 Assessing lack o capacity4.05 Best interests4.06 Record keeping4.07 Statutory deence4.08 Situations in which a designated decision-

maker can act on behal o someone wholacks capacity

4.09 Inormation given to a patient4.10 Material risks

4.11 Evidence base4.12 Inormed consent4.13 Communication

5.00 Aspects o consent5.01 Is consent given voluntarily5.02 General anaesthesia and sedation5.03 Private or NHS?5.04 Consent orms5.05 Warnings

6.00 Consent checklist

7.00 Summary


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IntroductionA patients inormed consent to investigations or treatment is a undamental aspect o the proper provision

o dental care. Without inormed consent to treatment, a dentist is vulnerable to criticism on a numbero counts, not least those o assault and/or negligence - which in turn could lead respectively to criminalcharges and/or civil claims against the dentist. Furthermore, the question o consent arises increasingly atthe heart o complaints made under the NHS Complaints Procedure, and complaints to the General DentalCouncil on matters on proessional ethics and conduct.

It is sel-evident, thereore, that every practising dentist, therapist and hygienist needs not only a thoroughunderstanding o the principles o consent, but also an awareness o how to apply these principles in thewide variety o circumstances that can arise in the practise o dentistry.

The law is continually changing and developing, as the courts interpret both the common law andlegislation. The doctrine o precedent means that judgements rom a higher court will bind a lower court.At the same time, clinical knowledge and ability have developed, and this makes the interpretation o whatconstitutes inormed consent and who can give it, a constantly changing perspective.

Clinicians have a responsibility to ensure that every eort is made to keep abreast o changing standards,to show not only that the optimum treatment is being given to their patients, but also that the patientsthemselves have had the best opportunity to be involved in decision making about the care o their bodies.

Nearly eighty years ago, Judge Cardozo in a case in America declared:

Every human being o adult years and sound mind has a right to determine what shall be done with his

own body1

The concept o patients rights, adult responsibility and a mind sound enough to understand, are embodiedin the principles o consent. In 1990 The Department o Health, in its advice booklet on obtaining consent,has defned consent as;

The voluntary and continuing permission o the patient to receive a particular treatment. It must be based

upon adequate knowledge o the purpose, nature and likely eects and risks o that treatment, including

the likelihood o its success and any alternative to it.2

The current version o the Department o Healths guide to consent was revised in July 20093

When considering consent, it is important to ask a number o questions.

What does the patient or the patients carer need to know and understand? Is the patient capable o understanding? Does the patient have capacity to give consent? I not, is the carer not only capable, but also qualifed to consider the best interests o the patient? Is consent given voluntarily? Does the law o the land give any guidance on the value o the opinion o dentists, patient or carer? Does the law resolve any conict between patient and carer?

The Human Rights Act 1998 came into orce in October 2000, putting into eect in English Law, theEuropean Convention o Human Rights. Courts are expected to take into account case law rom theEuropean Court o Human Rights in Strasbourg as well as English Law. An understanding o the lawconcerning consent must bear in mind the relevant articles which might be invoked in medical law cases,notably Article 2 (protection o right to lie); Article 3 (prohibition o torture, inhuman or degrading treatmentor punishment); Article 5 (right to liberty and security) Article 8 (right to respect or private and amily lie)and Article 9 (reedom o thought, conscience and religion)

These Articles may seem somewhat distant rom dental practice but a dispute about consent to treatmentor the right to withhold or withdraw consent, might involve consideration o a number o these Rights.

The subject o consent, then, can be rather more involved than it might frst appear although merciullywe in dentistry are spared many o the most complex and sensitive dilemmas that are aced by some o

our medical colleagues.1 Schloendor v Society o New York Hospital105 NE 92 [NY 1914]

2 A Guide to Consent or Examination or Treatment, Department o Health, 1990. acc HC(90)22

3 Reerence guide to consent or examination or treatment, second edition 2009 Department o Health London 2009

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Aspects o autonomyDepending on where one goes in the world, autonomy can mean dierent things. In most western

countries, the moral principle o consent is reected in a respect or personal autonomy as soon as aperson is able to make decisions or him/hersel. Here, the growing emphasis on patient autonomy inrecent years contrasts with the historical position sometimes described as the Doctor knows best erao medical paternalism.

In some countries, although certainly no longer in the UK, medical paternalism is alive and well andpatients may still be happy to deer to whatever their treating clinician is recommending or them, with littleor no questioning or challenge. In some cultures personal autonomy may not be regarded as being quiteso important and the roles o the amilies or elders within amilies may have a ar greater inuence.

These national and cultural dierences become all the more signifcant now that both patients andhealthcare proessionals have become more mobile, and dentists fnd themselves treating more and morepatients rom dierent cultures. The UK, in particular, has become highly multi-cultural at quite a rapidpace, and yet ew dentists have undertaken any specifc training to help them to understand and preparethemselves or the possible implications - this is another reason why consent has again become such a hottopic medico-legally.

A landmark legal case (3) involving a medical practitioner (a surgeon) broke new ground just a ew yearsago and demonstrated just how ar the UK courts would go in order to uphold patient autonomy, even inthe ace o well-established legal principles:

I start with the proposition that the law which imposed a duty to warn on a doctor has, at its heart, the right

o a patient to make an inormed choice as to whether, and i so when and by whom, to be operated on

Sir Denis Henry- Appeal Court Decision (UK) Chester v Afshar4, Paragraph 86

This decision was later supported by a majority decision in the House o Lords, even though (as stated inLord Binghams dissenting opinion)

The injury would have been just as likely to occur whenever the surgery was carried out, and whoeverperormed it.

Lord Hope, on the other hand, was clearly more anxious to fnd a basis upon which to support the plainti(patient) in her claim and fnd the surgeon (Mr Ashar) guilty o negligence on the consent issue. But thelaw relating to negligence requires there to be a direct causative link (causation) between the surgeonsomission in having ailed to warn the patient adequately, and the harm that resulted. In this case, there wasno disagreement that the surgery itsel had been provided to a perectly appropriate standard the casewas pleaded on the basis that but or the lack o adequate warnings, the patient would not have goneahead with the surgery that resulted in the adverse outcome.

In the House o Lords decision, Lord Hope explained:

It is plain that the but or test is not in itsel a sufcient test o causation. A solution to this problem which

is in Miss Chesters avour cannot be based on conventional causation principles. The issue o causation

cannot be separated rom issues about public policy. The law has as its heart the right o the patient to

make an inormed choice as to whether and i so, when and rom whom to be operated on. For many the

choice would be a difcult one, needing time to think, take advice and weigh up the alternatives.

Lord Steyn, also supporting the patients claim, expressed this view:

As a result o the surgeons negligent ailure to warn the patient, she cannot be said to have given her

consent to the surgery in the ull legal sense. Her right o autonomy and dignity can and ought to be

vindicated by a narrow and modest departure rom traditional causation principles.

This ground-breaking case happened to arise in the UK, and happened to involve a medical practitioner.But in country ater country around the world, the courts are stepping in to swing the pendulum very muchin avour o the patient when matters o consent are under discussion. In the above case, the Court o

Appeal and the House o Lords both concluded that the normal application o the law would result in the

4 Chester v Ashar [2004] UKHL 41

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clinician being ound not guilty o negligence so they departed rom traditional principles in order to fndhim guilty!

There are several aspects o autonomy which need to be considered, including

Choice

A centrally important eature o patient autonomy is the right o a patient to make a clear choice asillustrated in the Chester v Ashar decision above. That choice needs to be made according to the patientsown values and priorities.

A reasonable choice to one person may not be reasonable to another (including the treating practitioner)because this clinician may not hold the same personal values as the patient who is making the choice.

This conict in perspectives sometimes arises in dental practice when patients ask dentists or otherdental proessionals to proceed with treatment which is at odds with the dentists own values, ethics andproessional judgement. Here both parties have the right to hold their view, and sometimes the solution isor the clinician to withdraw rom treating the patient.

Free willA second eature o autonomy is the need to ensure that any decisions are taken reely, voluntarily andwithout coercion. This is easier to say than to achieve. Coercion can be overt or more commonly it maybe subtle. From an early age humans learn to adapt to situations and to make the best o situations totheir own advantage. Our codes o conduct and values inuence the way that we behave and react tosituations. Even with the best intentions we oten try to inuence how others might act around us.

An example in dentistry might be a teenage child who presents with his / her parents or orthodontictreatment. The parents clearly want the child to have orthodontic treatment or cosmetic reasons andthe orthodontic treatment may even be judged to be in the childs best interests by both parents and thetreating practitioner(s). The child may have a malocclusion that is severe and would greatly beneft romthe proposed treatment. But notwithstanding the best o intentions on the part o the parents, the childmay still eel coerced into having treatment which goes against his / her own wishes as regards theirown body. In many countries parents may even have a legal right to make a decision on behal o a child,notwithstanding a childs personal preerences.

I one examines consent purely rom the point o view o autonomy then any consent obtained in thatsituation may not be valid i the child has not made the decision with his / her own ree will. Even i the childagrees, a clinician may fnd it difcult to ensure that there is no undue inuence being placed upon the childin reaching that decision. We will discuss this urther at 3.00 and 4.02 below.

Infuence

We can inuence patients consciously or subconsciously by the way in which we communicate with them.For example

The words we use

Whether the words are written or spoken, a patients perception can easily be inuenced by the words thatwe choose to use. Some patients will be particularly reactive or sensitive to the use o certain words (eg.cut, drill, inject, bleeding, painul etc); when you are discussing a procedure ace to ace you canusually see this reaction, and deal with it there and then. But when you use the same words in a letter, youdont get this opportunity.

Our voice

The pace at which we speak, how loudly or sotly, and how clearly we articulate our words, the pitchand timbre o our voice, can all inuence how others might react to what we say. I we want to stress oremphasise something important, we should speak more slowly and clearly, and perhaps a little louder. Thishelps to dierentiate this inormation rom less critical discussions, during which we might speak a little

quicker and with less emphasis.

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In general, a higher pitch conveys nervousness or uncertainty, while a lower pitch particularly whenaccompanied by speaking more slowly tends to communicate calm, confdent authority and a eelingthat everything is under control.

Non verbal communication (body language)Our eyes, our ace, our posture, our gestures, will all orm part o the message that a patient receives whenwe are communicating with them. Sometimes deliberately, sometimes unconsciously, we send the patientnon-verbal signals that either accentuate, or detract rom the actual words we might have used. Good eyecontact communicates honesty and sincerity whereas avoidance o eye contact suggests the reverse.

Images

Many dentists use leaets, brochures and pictures, videos and commercial CD/DVD programmes,to complement any verbal explanations o procedures. These, too, can oten lead a patient to orm aparticular opinion. Some (especially those sold with the intention o promoting the uptake o a particularorm o treatment, rather than providing general inormation and patient education) are intended to makeone orm o treatment sound a lot more attractive than alternative options.

These visual aids can become pivotal evidence i and when a dispute arises over what a patient was and was

not told, and the extent to which they might have been misled or denied important inormation. All the more

reason, thereore, to reassess all the inormation material that you use, and to reect upon how air, balanced and

accurate it is. The risk o a one-sided picture being created in the patients mind is greater when using material

that has been created by manuacturers and suppliers. Not all such leaets all into this trap but unortunately

or the dentists concerned, many do, making it much easier or the patient to suggest that they were talked into

or sold some dentistry without having been made ully aware o its possible risks and limitations.

Respect

This brings together the ethical and human dimensions o consent (see opening section 1.00), and can besummarised as dealing with patients as we would wish to be dealt with ourselves, or as we would hope

and expect that another health proessional might deal with us or a member o our amily.

It is not our right to carry out treatment on another person, without ully involving them in the decision-making process. It is not air, moral or decent to deprive another person o their right o autonomy andsel-determination. For a healthcare proessional to act in such a way in relation to someone under theircare is particularly unacceptable, given the special relationship o trust that exists (or should exist) betweena patient and that healthcare proessional.

Giving patients choices is one way o showing our respect or them, but a patient cannot exercise thatchoice unless they have sufcient, meaningul and balanced inormation to support that process.

In any relationship between a lay person and a proessional person there tends to be a wide gul betweenthe relative levels o knowledge and understanding. It is the proessional persons responsibility to closethat gap by being prepared to spend time and eort in sharing their special knowledge o the procedure(s)

in question, and their likely outcome, so that the patient is better placed to understand the optionsavailable to them.

Making this investment o time and eort helps to build a stronger relationship o trust and confdencebetween you and the patient, as well as laying the oundations or an eective, valid consent process.

CompetenceIn order both to understand the inormation provided, and to give the necessary authority or consent, apatient must be competent. Competence in this context means the patients ability to understand theexplanations given, about:

The nature and purpose o a particular procedure; Its likely eects and risks; and

Any alternative treatment and how these alternatives might compare.

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Only i a patient is competent to consent, can the patients consent be considered valid. The patient maylack competence or a number o reasons; they might be unconscious or suering some temporary orpermanent orm o mental impairment. On the other hand, a very young child will clearly not have thecompetence to consent to a dental procedure.

On the subject o children, many dentists mistakenly assume that because a child is allowed to sign aNHS orm at age 16 then he/she is thereore competent to consent (and indeed, is giving a valid consentin the very process o signing the NHS orm). Such assumptions are misplaced, and reect a lack ounderstanding o the underlying principles.

Firstly, a signature on a NHS orm is not consent at all, but merely a request to be treated within the NHS,rather than on a private basis.

Secondly, most children eventually reach an age where they can grasp relevant acts about their bodyand about proposed treatment to their body. A ew children are never, even when adulthood is reached,capable o properly understanding the inormation given to them and then must thereore be consideredincapable o giving consent.

In order to protect children, laws exist in many countries defning the age at which children can normallybe considered capable o making their own decisions in this respect. In England and Wales, the relevantlegislation is to be ound within the Family Law Reorm Act 1969. It permits an individual o 16 or over, ando sound mind, to give a legally valid consent to dental treatment; it does not preclude children under 16rom also giving consent.

Many members will be amiliar with the Gillick5 case, which related to the provision o contraceptive aids togirls under 16 years o age without parental consent. As a result o this case, the view is generally held thatchildren, i they can ully understand the proposed treatment, can give consent to that treatment. Dentistsshould always try to confrm that both the child and the parent understand the treatment to be given. Evenin cases where it is believed that the child may be capable o giving consent which (according to Gillick)would negate the need to obtain parental consent, it is still wise to try to seek the childs permission or adiscussion with the parent to confrm their agreement.

I a parent is not available when children under 16 years o age are examined, then extreme caution isadvised. A ew years ago, the Court o Appeal in the case Re-R6 decided that where a child under 16reuses consent to treatment, that consent could be obtained rom a parent.

The ailure or reusal o the Gillick Competent child is a very important actor in a doctors decision

whether or not to treat, but does not prevent the necessary consent being obtained rom another

competent source.

This decision could only lead to urther conusion and difculty. As a result, consideration should be givento reusing treatment (except in an emergency) i concern remains about the quality o the understandingand agreement o both child and parent.

Whilst a child o 16 or 17 can consent to treatment in accordance with the Family Law Reorm Act 1969 aperson with parental responsibility can also consent to the treatment o a child aged 16 or 17. I a child o16 or 17 consents to treatment, consent cannot be withdrawn by the person with parental responsibility.A person with parental responsibility can consent to the procedure where the 16 or 17 year old reusestreatment; however, in dentistry, in the majority o cases treatment is unlikely to be successully providedwhere the patient at age 16 or 17 reuses. Dental Protection would thus advise that it is appropriate to tryto encourage the patient and consenting adult to reach a consensus.

5 Gillick v West Norolk v Wisbeach Area Health Authority [1986] AC 112

6 Re-R(A Minor) 1991 4 ALL ER


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Authority

Competent adultsClearly, in the case o an adult aged 16 years or over who is o sound mind, he/she has the authority togive or withhold consent to any treatment proposed or himsel/hersel, and it could be held to be an act oassault to violate the patients autonomy and right o sel determination by providing treatment against his/her declared wishes.

Children

Most children eventually reach an age where they can grasp relevant acts about their body and aboutproposed treatment to it. They can give consent to treatment, but the degree o understanding can varyin relation to the complexity o the treatment envisaged. A ew children are never, even when adulthoodis reached, capable o properly understanding the inormation given to them and must thereore beconsidered incapable o giving consent.

In England and Wales the Children Act 1989 defnes who has parental responsibility and the consequentright to give consent to a childs treatment. Understanding who holds parental responsibility is not alwaysstraightorward and dierences in the childs date o birth may now mean that a ather may hold parentalresponsibility or one child but not or their older sibling.

All mothers have automatic parental responsibility. Parental responsibility rests with both parents, providedthey are named on the birth certifcate and regardless o whether they are married or not, or childrenwhose births were registered rom:

15 April 2002 in Northern Ireland 1 December 2003 in England and Wales 4 May 2006 in Scotland.

For children whose births are registered prior to these dates, the ather would only have parentalresponsibility in the ollowing circumstances:

I he and the mother were married at the time o the conception, birth or sometime ater; thisresponsibility is not lost i the mother and ather later divorce;

I he and the mother were never married, but he has a parental responsibility agreement with the motherthat is registered with the High Court, or a parental responsibility order rom the court.

Other people may gain parental responsibility by court order or by being appointed guardian upon the deatho the parents. I the child is the subject o a care order, the Local Authority has parental responsibility whichis shared with the parents. I the child is in care voluntarily, parental responsibility remains with the parents.

I two people have parental responsibility or a child, one can be given access without the other beinginormed. For example, i a child lives with its mother, the ather can obtain access without the mother

being inormed. There are a limited number o procedures where both individuals holding parentalresponsibility must give consent including vaccination and circumcision.

Difculties can arise with determining parental consent, and in these cases caution is advised andconsideration should be given to the merit o withholding treatment i doubt exists.

The incompetent adult

The Mental Capacity Act 2005 sets out in law many o the previous decisions relating to adults wholack capacity. The Act brought into orce a statutory scheme in England and Wales, which sets out thetests and steps that should be taken which treating an adult patient (and a 16 or 17 year old) who lackscapacity. There is a Code o Practice7

The Act sets out fve key principles, which underlie the treatment o patients who lack capacity.

7 Mental Capacity Act Code o Practice 2005. Code o Practice. Department o Constitutional Aairs 2007

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1. A person must be assumed to have capacity unless it is established that he lacks capacity;2. A person is not to be treated as unable to make a decision unless all practicable steps to help him to

do so have been taken without success;3. A person is not to be treated as unable to make a decision merely because he makes an unwise decision;

4. An act done, or decision made, under this Act or or on behal o a person who lacks capacity mustbe done, or made in his best interests;

5. Beore the act is done, or the decision made, regard must be had to whether the purpose or whichit is needed can be as eectively achieved in a way that is less restrictive o the persons rights andreedom o action.

These key principles can be summarised:

1. There is a presumption of capacity. Every adult has the right to make his or her own decisions andmust be assumed to have capacity to do so unless it is proved otherwise;

2. People should receive support to help them make their own decisions;3. Unwise decisions people have the right to make decisions that others might think unwise;4. Best interests an act done or, or a decision made on behal o, someone who lacks capacity must

be in their best interests;5. Least restrictive option anything done or or on behal o a person who lacks capacity should be

the least restrictive o their basic rights and reedoms.

Assessing lack o capacity

An individuals capacity must be assessed specifcally in terms o their capacity to make a particulardecision at the time it needs to be made.

This means that a person may lack capacity to make a decision about one issue but not about others.Care must be taken not to judge an individuals capacity merely by reerence to their age, appearance ormedical condition.

Supporting the person to make the decision or themselves

It is important to take all possible steps to try to help people make a decision or themselves beoredeciding that someone lacks capacity to make a particular decision.

In supporting someone to make the decision themselves it is important to provide all necessary relevant

inormation. The Code o Practice specifcally sets out that in relation to medical treatment the doctor must

explain the purpose and eect o the course o treatment and the likely consequences o accepting or reusing

treatment. The Code o Practice sets out guidance on supporting a person to make the decision themselves.

Two-stage test o capacity

Any practitioner assessing someones capacity to make a decision or themselves or the purposes o theAct should use the two-stage test o capacity.

Does the person have an impairment o the mind or brain, or is there some sort o disturbance aectingthe way their mind or brain works? I so, does that impairment mean that the person is unable to make the decision in question at the timeit needs to be made?

Assessing the ability to make the decision

A person is unable to make a decision or himsel i s/he is unable:

To understand the inormation relevant to the decision; To retain that inormation; To use or weigh that inormation as part o the process o making the decision; or To communicate his decision (whether by talking, using sign language or any other means).

The person must be able to hold the inormation in their mind long enough to use it to make an eectivedecision. However, people who can only retain inormation or a short while must not automatically beassumed to lack the capacity to decide.

In any proceedings under the Act any question as to whether a person lacks capacity must be decided onthe balance o probabilities.

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Statutory deence

The Act oers statutory protection rom liability where a person is perorming an act in connection with thecare or treatment o someone who lacks capacity. To receive protection rom liability under section 5 o the

Act, all actions must be related to the care and treatment o the person who lacks capacity to consent.

Beore taking action, the dentist must take reasonable steps to establish whether the patient lacks capacityin relation to the matter in question and reasonably believe that:

The patient lacks the capacity to make the decision at the time it needs to be made, and The action is in the patients best interests.

Section 5 does not provide a deence in cases o negligence.

Dentists also should be aware that section 5 does not authorise a person to carry out an act, whichconicts with a decision made by a donee o a lasting power o attorney or a deputy appointed by the court.

Situations in which a designated decision-maker can act on behal o

someone who lacks capacity

Lasting powers o attorney (LPAs)

A patients relative may explain that they have a power o attorney. Prior to the Mental Capacity Act 2005coming into orce, enduring powers o attorney could be created. An enduring power o attorney (EPA)enables a named person to make decisions on their behal in respect o property and fnancial aairs.A LPA, i so directed can also make decisions about an individuals personal welare, which includesdecisions in respect o treatment, when the individual lacks capacity.

I a dentist is advised by a relative or other individual that they have a power o attorney it will be necessaryto ascertain whether this in an EPA created prior to 30 September 2007 or a LPA. I it is a LPA this mayenable the individual to make decisions about the patients healthcare, i the patient lacks capacity.

A person must have capacity at the time the LPA is executed and be over 18. Beore the LPA can be usedit must be registered with Ofce o the Public Guardian.

For a decision to be made under the LPA about the patients personal welare the patient must lackcapacity or the donee must reasonably believe that the patient lacks capacity.

Where the LPA authorises the donee to make decisions about the patients personal welare, the authorityextends to giving or reusing consent to the carrying out or continuation o a treatment by a personproviding healthcare or the patient. The authority under a LPA may also be subject to an advance decision.

Court appointed deputies

The Act provides or a system o court appointed deputies. Deputies will be appointed to take decisions onhealthcare but will only be appointed when the Court cannot make a one-o decision to resolve the issue.

Each case needs to be assessed careully on its merits. I in doubt, deer treatment and seek advice eitherrom colleagues, or rom one o the dento-legal advisers at Dental Protection.

Inormation given to a patient

There are diering views held throughout the English speaking world on what constitutes the answer tothe question What does the patient need to know? In England and Wales, the best known interpretationo English law on the subject is to be ound in the case oSidaway8. In this case, fve Law Lords had todecide whether or not Mrs Sidaway had the prognosis and the sequelae o a difcult operation on her backproperly explained to her prior to the operation. She had suered permanent nerve damage as a result othe operation.

The attitude o the law to a doctor or dentists duty is measured in courts in England and Wales by the

application o what is known as The Bolam Test.

8 Sidaway v Board o Governors o the Bethlehem Royal Hospital[1985] 1 ALL ER 643 HL

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This is a standard that arose rom a speech given by McNair J in Bolam v Friern Barnet HospitalManagement Committee9, which was a major landmark in defning the duty o care that a doctor owed to apatient. McNair J stated,

The test (whether there has been negligence) is the standard o the ordinary skilled man exercising andproessing to have that special skill.

The best summary o this case came rom Lord Diplock who elt that the Bolam Test was,

Applicable to every aspect o the duty o care owed by the doctor to his patient, in the exercise o his

healing unctions, as respects that patient.

The case oSidawayshowed that the degree o probability o a risk arising, and the seriousness opossible injury are two important acts that a patient needs to know beore being able to consent totreatment. Not only does a dentist have a duty to explain relevant acts to the patient, but the languageused should assist the patient to understand, and any additional points raised by the patient should alsobe properly addressed.

How much advice should be given and how consent should be recorded will depend upon the meritso the individual case. When a patient sits in the dental chair, it can be assumed that implied consent toa non-invasive examination only has been given. Any invasive technique that might include periodontalprobing, radiographs, blood tests and diagnostic cavities would require urther consent rom the patientand it is dangerous to rely upon the assumption o implied consent to these urther procedures.

Consent would normally be obtained verbally ater explaining the need or the investigation and anypossible sequelae.

Once the investigations are complete, the patient is entitled to advice on diagnosis and treatment planning.Where a number o alternative treatment plans are available, the choice should be explained, together withthe merits and disadvantages o each plan. I a preerence or one particular plan is oered, it is helpul tothe patient in making a choice, i the reason or the preerence is given.

Patients cannot properly consider treatment options i they are not given inormation on sequelae andprognosis, i either o these is pertinent. For example, where the extraction o a third molar tooth is tobe undertaken a possible sequel (eg. a risk o one in ten o transient lingual paraesthesia) occurring,would certainly merit a warning to the patient10. Patients have a right to know i their liestyles may becompromised by a side eect o treatment. When the incidence o a possible complication is very slight,it is oten considered to be in the best interests o the patient not to warn and thus risk rightening thepatient, but the signifcance o the above possibility is very real to a proessional singer, or example anda ailure to elicit any relevant inormation about a patient and to warn them accordingly could be legallydisastrous.

The concept in England and Wales has thereore been that o the prudent dentist. What would a prudentdentist explain to a patient? The answer to be ound in Bolam is the inormation which a dentist in thatsituation would normally be expected to explain to a patient who needs that inormation.

However, there is no doubt that the situation is changing, and that the Bolam test is now considered insome quarters a rather too paternalistic, rom a doctor (dentist) knows best perspective.

Material risks

In an Australian case (Rogers v. Whitaker)11, the High Court o Australia ruled that a 1 in 14,000 risk oblindness associated with a procedure, should have been disclosed to a patient. In this example, thepatient was already almost blind in one eye and the doctor should have warned o the possible risk oblindness to the other eye no matter how slight in these circumstances, regardless o whether the patienthad expressly asked the question or not.

9 Bolam v Friern Barnet Hospital Management Committee [1957] 1WLR 582

10 Blackburn C.W., Bramley P. lingual nerve damage associated with removal o third molars, Br. Dent J. (1989) 167: 103-107

11 Roger v Whitaker (1992) 109 ALR 625-631 [1993] 4 med LR 79-82 (High Court o Australia)

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The High Court said,

A risk is material i in the circumstances o the particular case, a reasonable person in the patients

position - i warned o the risk - would be likely to attach signifcance to it, or where the medical practitioner

is (or should reasonably be) aware that the particular patient - i warned o the risk - would be likely toattach signifcance to it.

Consequently, the perspective o the prudent dentist needs to be balanced frst against that o theprudent patient i.e. what would a normal patient o sound mind, reasonably expect to know beore beingin a position to make a decision as to whether or not to proceed with the treatment?

Even this, however, might not be enough i the Australian precedent were to be applied more widely. Whatmatters more, arguably, is what this specifc and individual patient would wish (or need) to know beoredeciding whether or not to proceed with treatment. No treatment should ever be undertaken without givingthe patient the opportunity to ask questions and/or raise any concerns or ears.

Where there is a high risk o ailure or post-operative complication, not only should the patient be warnedbut a specifc entry naming the complication should be made on the record card.

Many claims involving paraesthesia and also immediate dentures are successul simply because it cannotbe shown later that the patient was specifcally warned o the possible post-operative complications.

While on the subject o inormation, cost (in some branches o dentistry at least) becomes an importantacet o consent. Without the knowledge o the fnancial and social implications o treatment, a patientcannot give a proper commitment. Where treatment is to be protracted, involved or expensive, it isworthwhile writing to the patient with an explanation o the treatment, the time it will take, prognosis,sequelae and costs. The patient can then have the opportunity to raise any enquiries beore agreeing thetreatment and making an appointment. The GDCs Standards or Dental Proessionals: Principles o PatientConsent12 also requires that a patient returning or treatment should be given a written treatment plan:

Whenever a patient is returning or treatment ollowing an examination or assessment, give them a written

treatment plan and cost estimate.

Language is also an important element in obtaining consent. I the patient speaks a dierent language romthe dentist an interpreter may be indicated. Whenever the common language is not the frst language oeither patient or dentist, then care should be taken to ensure that the points have been properly explainedand understood. All specialities tend to have their own shorthand and nomenclature, and care should betaken to avoid dental jargon, which can also be a barrier to eective communication.

An explanation should be simple and clear. The patients ailure to grasp inormation would be the dentistsresponsibility, i it can be shown that the language o the explanation was simply not understood by thepatient. Special care should be taken with dea, partially sighted or blind patients.

Consent is oten given by a patient because o the apparent advantages or benefts o a particular line otreatment. Care should be taken to ensure that the inormation given is balanced and accurate, and can besubstantiated. Statements such as your crown will last or lie, or your molar root treatment will be 100%

successul or I guarantee you will have no problem may dramatically weaken the value o the consentcontained. It can also enable a patient to bring a successul claim or breach o contract at a later stage,even when no negligence is present.

Where treatment is unusual or experimental, it is important that the patient should ully understand thesituation and it is worthwhile to get the patient to sign a Statement to the eect that they recognise thecontroversial or relatively untried nature o the treatment and accept that the risks are greater and perhapseven unknown.

Even when all the relevant acts and explanations are given to a patient, confrmation must still be obtainedthat the patient can understand them. This raises the question o competence or the patients capacity orability to understand, which will now be considered.

12 Standards or Dental Proessionals: Principles o Patient Consent, General Dental Council, (May 2005)


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Evidence base

Some clinicians believe that patients must be provided with every last detail o the evidence base, in orderto enable them to assess the inormation objectively and to compare alternative treatment options. Not

only is this another onerous prospect or the clinician, it also ails to recognise two important aspects o theconsent process.

Firstly, it is not sufcient or the clinician to present the patient with inormation in terms that would bemeaningul to another clinician; the evidence base is useul to inorm a clinician, but this is usually verydierent rom what the patient needs to know, and how this inormation needs to be presented.

Secondly, while the evidence base provides inormation regarding what treatment is most likely to succeed,or ail, it takes no account o the particular situation and circumstances o an individual patient. Take, orexample, an oral surgeon who gives a standard warning to every patient that (or example) the incidence oinerior dental nerve damage associated with the surgical removal o lower third molars, is less than one ina thousand (10).

Patient (A) has a ully erupted lower third molar, with the pre-operative radiographs showing a separation

o at least 8mm between the inerior dental nerve bundle, and the roots o the tooth. Patient (B), on theother hand, has a deeply impacted third molar, where the radiographs suggest a very close or intimaterelationship between the roots and the inerior dental nerve. The clinicians standard warning is clearlyirrelevant and inappropriate to both o these patients.

This illustrates the danger o giving the same inormation to every patient, and the importance opersonalising any inormation provided, or each individual patient. It is in this context that the Rogers vWhitaker judgment (see above) is helpul to us in our understanding o the patients perspective, eventhough the judgment itsel has application only in Australia.

In some situations, it is clear rom the clinical records that there has been at least some discussion o aparticular risk, or a range o risks, in advance o treatment. But when bringing a subsequent complaint orclaim, a patient will oten maintain that these risks, while mentioned in passing, had been discussed in a

dismissive way, as i to suggest that the risk was so small or so remote as to be almost hypothetical ortheoretical, rather than a real and immediate possibility to be considered.

Clinicians will oten do their very best to be reassuring particularly when dealing with nervous patients but one must guard against doing this in a way which leads a patient to attach little or no signifcance tothe warning or inormation in question. Patients, however apprehensive, must be let in no doubt as to thenature and extent o any risks o care and treatment that they are contemplating.

Inormed consent

For as long as healthcare proessionals are encouraged to believe that providing inormation to a patientis alone sufcient or the purposes o obtaining a valid consent, we will continue to do our patients adisservice. The continued use o the term inormed consent, used without qualifcation and without ully

understanding the pitalls o this perspective o consent, is certainly not helpul.

It perpetuates an outdated and paternalistic approach to patient care and those who continue to usethis term do need to appreciate that the ocus should be on understanding, rather than the provision oinormation alone. It is or precisely this reason that Dental Protection stresses that consent orms serveonly to confrm some o the details o the inormation provided; they tell us little or nothing about thecommunication process, the questions asked, the replies given and the level o understanding achieved bythe time the consent was eventually given. Nor do they provide any insight into whether or not any undueinuence was exerted upon the patient when reaching a decision. This is why a detailed contemporaneousrecord will oten be ar preerable to a signed consent orm alone.

Perhaps the most convenient and concise confrmation o the prevalent abuse o the term inormed consent

comes rom one o the most highly respected and widely acknowledged authorities in the feld o Medical

Law, Sir Ian Kennedy and Pro Andrew Grubb. In their defnitive textbook, Medical Law13 they write:

13 Kennedy I, Grubb A; Medical Law; Butterworths, London 2000

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The aphorisminformedconsent has entered the language as being synonymous with valid

consent. This, of course, not so and is in fact unhelpful. It gives only a partial view. The requirement

that consent be informed is only one, albeit a very important ingredient of valid consent.

Furthermore, the expression informed consent begs all the necessary questions (which are the

subject of the following section); for example, how informed is informed?

Judges in certain other jurisdictions have ound more helpul ways to encapsulate the essential principleso consent. Amongst the best o these is the term enlightened consent, which captures very nicely theidea that a patient needs to be put into a position rom which they can understand the key issues whichwill inuence their willingness (or otherwise) to undergo a particular procedure.

A patient sometimes consents to a particular line o treatment because o the apparent advantages orbenefts as described by the dentist. Care should be taken to ensure that the inormation given is balancedand accurate, and that any claims (as to likely success) can be substantiated. Statements such as yourcrown will last or lie, or your molar root treatment will be 100% successul or I guarantee you will haveno problem may dramatically weaken the value and validity o the consent contained.

Where treatment is unusual or experimental, it is important that the patient should ully understand thesituation and it is worthwhile to get the patient to sign a statement to the eect that they recognise thecontroversial or relatively untried nature o the treatment, and accept that the risks are greater and perhapseven unknown.

For a clinician to say I obtained inormed consent rom the patient, or (worse still, as oten heard in ahospital setting) I consented the patient rather implies that this clinician is in a position to determine thepoint at which the patient has been given sufcient inormation in order to make a rational choice. Thisis almost as paternalistic as giving the patient no inormation at all, on the time-honoured doctor knowsbest principle. But a patient who is given only some o the relevant acts and considerations regarding aspecifc procedure, may well be very happy to proceed, while the same patient, i given some additionalinormation, may not. Inormed consent will always be a misnomer i the patient remains unaware o aurther relevant act that could have inuenced their decision.

Similarly, consent cannot be said to be inormed i the patient misunderstands the inormation, perhapsbecause o the words used, or the way in which the inormation is imparted. At the beginning o theconsent process the clinician has the advantage o knowing much more than the patient, about what theprocedure involves, about its risks, benefts, limitations, about alternatives and how they compare in each othese respects and also in terms o relative costs. On the other hand, the clinician may also be at a similardisadvantage in knowing relatively little about the patient, and his/her lie and personal circumstances.

The clinician must thereore ask the patient the right questions in the right way, at the right time, and needsto listen careully to the patients responses, in order to gain an insight into any additional inormation thatthis particular, individual patient might require in order to decide whether or not to proceed. Any ailure toelicit this inormation, i it might be material to the patients decision, is more likely to be used to criticise theclinician, than to criticise the patient or not having volunteered the inormation without prompting. Patients,ater all, may not understand why the inormation is even relevant, let alone important.

Choosing to withhold certain inormation or example, the risks or limitations o procedure A or decliningto mention the option o procedure B at all, is always raught with dento-legal risks. It will be argued thatthe resulting consent cannot be valid because it was based on only a selected sample o the inormationthat could and should have been provided to the patient.

Taken to an extreme, one might reach a position where the clinician is placed in a situation where every detailo every procedure, and every possible adverse outcome (however minor or rare) would need to be explainedto the patient beore starting any treatment. Clearly this would place an impossible burden on the clinician.

In non-emergency cases the emphasis should be on ensuring that a patient has sufcient knowledge, inadvance o treatment, o:

The purpose The nature o the treatment (what it involves) The likely eects and consequences Risks, limitations and possible side eects


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Alternatives and how they compare Costs.

When patients believe that they have been denied sufcient inormation they oten eel angry, misled

or indeed violated or assaulted. These are powerul, destructive eelings that are likely to destroy anyrelationship o trust upon which consent is ounded.

Communication

There is in reality the inter-dependence between the patient and dentist that requires both parties tocommunicate eectively so that a decision can be made that respects patient autonomy. It is obviouslyimportant that the dentist also eels comortable with proceeding. Eective two-way communication isthereore a corner stone o the consent process.

Consent is all about communication and a relationship o trust between a patient and a healthcareproessional. It relies on a total respect or patient autonomy as ar as the patients capacity will allow. Thebest interest principle, whilst having a valuable role in special needs and emergency situations, needs to

be cautiously applied because o the risk o paternalism. These dilemmas are not unusual in dentistry andhelpul advice is always at hand rom Dental Protection.

Aspects o consentThe General Dental Council is involved in various matters o consent, as ethical issues which reect uponthe proessional conduct o a dentist. The General Dental Council identifes the main ethical principles ogetting consent as:

Inormed consent Voluntary decision making Ability.

The Guidance puts esh on the bones o these basic principles and all dental registrants are advised toamiliarise themselves with the Guidance.14

Is consent given voluntarily?

In order or consent to be valid, it must be given reely and voluntarily, without any pressure or inuencebeing brought to bear on the patient. This pressure might be rom a amily member, parent or a health careproessional. It is important when seeking to obtain consent that you satisy yoursel that consent has beenreely given.

These types o situation will rarely arise in dental practice but when issues o authority and competenceconuse the picture, or example in decisions concerning orthodontic treatment o teenagers, you shouldbe considering who is driving the decision to accept treatment. Equally undue pressure should never be

exerted on a patient who is unsure about whether to accept a complex, expensive treatment plan. Theyshould be given all the alternatives, and plenty o time to think about their choice prior to starting treatment.

General anaesthesia and sedation

The General Dental Council (GDC) takes an active interest in matters relating to consent, as an ethical issuewhich reects upon the proessional conduct o a dentist.

When receiving treatment under general anaesthesia or sedation, the patient is temporarily deprived o theircapacity (see above) to give a valid consent to treatment. This makes it all the more important that theyunderstand what is proposed in advance o the treatment because it will not be possible to reer to themonce treatment is under way. It is also undesirable or the consent process to be carried out immediatelyprior to the administration o the anaesthesia or sedation, because patients are likely to be preoccupiedwith or anxious about what lies ahead. Ideally, the consent process should take place at a prior visit, giving

14 Standards or Dental Proessionals: Principles o Patient Consent, General Dental Council, (May 2005)

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the patient time to reect upon the inormation provided, and to raise any urther questions when theyarrive or the procedure to be carried out.

The General Dental Council requires that a valid consent to treatment under general anaesthetic or

sedation must be obtained, and confrmed in writing(11) by the patient (or parent) prior to carrying outthe treatment. The dentist must himsel (or hersel) have explained to the patient the treatment proposed,the risks involved in the treatment, and any alternative treatments. All the procedures involved in theanaesthesia/sedation, and in the dental treatment itsel, must be explained to the patient. The Councilmakes it clear that the onus is on the dentist to ensure that all necessary inormation and explanationshave been given to the patient or parent / guardian, either by the dentist or by the anaesthetist. It is notacceptable or these explanations to be given by a member o the practice sta.

But providing treatment or a sedated or anaesthetised patient can raise other complications whereconsent is concerned. In the middle o treatment you notice that there is a cavity on an adjacent tooth tothe one that you are treating. Do you fll it to avoid the need or urther sedation or leave it and run the risko the patient being inconvenienced? Does it make a dierence i the patient has travelled a great distanceor treatment? These are questions that are difcult to answer other than by saying that it depends upon

the patient. The best interests consideration needs to be weighed careully against the question o patientautonomy and choice, bearing in mind the act that some patients might be more than happy or a clinicianto proceed whilst others would want the opportunity to inuence and to take a specifc decision in relationto a specifc urther item o treatment.

In some cases one could pre-empt this by discussing such possibilities with a patient in advance otreatment but unoreseen circumstances can always arise. It is the classic dilemma o paternalism againstautonomy and there is no one size fts all answer.

Private or NHS?

The General Dental Council considers that it is the responsibility o the dentist to explain the nature o thecontract clearly to the patient, i.e. whether the patient is being accepted or treatment under the NHS, or

under private contract.

Patients must never be misled into accepting private treatment. The dentist is encouraged to avoidmisunderstandings by giving the patient a written treatment plan and estimate, and to obtain the patientsagreement to these terms in writing. The Council states that written treatment plans and estimates shouldalways be provided or extensive or expensive courses o treatment although the term is not defned. TheCouncil makes it clear that any acts or omissions by dentists, in connection with their practices which areliable to mislead the public, may be held to constitute serious proessional misconduct.

In this context, NHS practitioners are reminded that they are obliged, under the NHS (General DentalServices Contracts) Regulations 2005, Part 2, to complete a orm FP17DC or any private treatmentcarried out or a patient who has also been oered NHS treatment.

The patient should sign (and ideally, should also date) the completed top copy o the orm, the bottom

(sel-carbonating) copy o the orm being retained saely in the patients notes.

There can be no better deence against a subsequent allegation that the patient was not aware that thetreatment was being provided on a private basis - an allegation which could well be the subject o a PCT/LHB investigation and/or a complaint to the General Dental Council

Consent orms

Many dentists hold the frm, but mistaken, belie that they have secured proper consent to dental treatmentby obtaining the patients signature on a consent orm. The act that a patient has signed a orm does notmean that the treatment proposed has been understood or accepted, and the quality o consent can neverbe determined solely by a signature which may truly not be worth the paper it is written on. What mattersmore is obviously whether or not the consent has been properly obtained, by understanding and applyingthe principles o competence, inormation and authority as outlined above.

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Written consent orms, especially those o the I give my consent to any treatment variety, are otenworthless, i insufcient consideration has been given to the above actors. More important than a signatureon a consent orm is a properly documented patients record, which show clearly that all the necessarypre-treatment steps have been taken, including explanations and agreements.

Warnings

A prerequisite o obtaining consent rom a patient is a ull exchange o inormation regarding any risks,drawbacks and limitations o the proposed treatment. It is important to be able to demonstrate that anyappropriate warnings were given, and here the most valuable inormation would be a careully made entryin the patients record and/or a warning/advice sheet. I the latter is an integral part o a written consentorm signed by the patient (with a copy retained by the patient), then so much the better.

Dental Protection is oten asked by members why we do not publish approved consent orms thatinclude suitable or use in various situations and circumstances. Such requests ail to recognise thebroader issues raised throughout this document. For us to provide such consent orms would imply that to

obtain the patients signature on such a orm would be a valid consent; a misapprehension which we arekeen to avoid. We are keen to emphasise that consent is essentially a process o communication, and o atranser o knowledge and understanding rom dentist to patient. The value o clinical records and consentorms is dependent upon the extent to which they document and detail that exchange o inormation.

We have, however, contributed to the creation o consent protocols (checklists) which are available rom acommercial source (Admor) and we would be happy, in any event, to oer any member our views on anyproposed inormation/advice sheets and/or proposed consent orms which a dentist was planning to use.

Consent checklistThe patient should be aware o the purpose, nature, likely eects, risks, and chances o success o a

proposed procedure, and o any alternatives to it. The act that a patient has consented to a procedure onone occasion, does not create an open-ended consent which can be extended to subsequent occasions.Consent must be obtained or specifc procedures, on specifc occasions. Ask yoursel:

Is the patient capable o making a decision? Is that decision voluntary and without coercion in terms othe balance/bias o the inormation given, or the timing or context o its provision?

Does the patient actually need the treatment, or is it an elective procedure? I an elective procedure, theonus upon a clinician to communicate inormation and warnings becomes much greater.

What do I think will happen in the circumstances o this particular case, i I proceed with the treatment?Have I communicated this assessment to the patient in clear terms? Can I give an accurate prediction?I not, is the patient aware o the area(s) o doubt?

What would a reasonable person expect to be told about the proposed treatment? What acts are important and relevant to this specifc patient? (I I dont know, then I am probably not

ready to go ahead with the procedure anyway). Do I need to provide any inormation or the patient in writing? Has the patient expressed a wish to havewritten inormation? (Am I relying upon commercial marketing material produced by manuacturers and/or suppliers? I so, is this inormation sufciently balanced in the way it is presented?)

Do my records accurately and sufciently reect the details o the communication process? Will theyallow me to demonstrate perhaps many months or years rom now what inormation was given tothe patient, on what terms, and what was said at the time?

Does the patient understand what treatment they have agreed to, and why? Have they been given anopportunity to have any concerns discussed, and/or have their questions answered?

Does the patient understand the costs involved, including the potential uture costs, in the event o anypossible complications?

Does the patient want or need time to consider these options, or to discuss your proposals withsomeone else? Can you/should you oer to assist in arranging a second opinion?

I you are relatively inexperienced in carrying out the procedure in question, is the patient aware o thisact? Are they aware, (i relevant) that they could improve their prospects o a successul outcome, or

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reduce any associated risks, i they elect to have the procedure carried out by a specialist or a moreexperienced colleague?

I the technique is relatively untried or o an experimental nature, has the patient been made aware othis? Included here are any procedures or which the evidence base is limited or absent.

Summary1. First and oremost, respect any patients undamental right to decide whether or not they wish to

proceed with any dental treatment.2. Assess the patients competence to consent, bearing in mind their age and their ability to understand

a) the nature o the proposed treatmentb) its purposec) any risks and limitationsd) comparisons with any alternative treatment options which are available (including that o doing no

treatment at all)

3. Satisy yoursel regarding the authority o the patient (or that o anyone else acting on the patientsbehal) to give consent to the proposed treatment.4. Provide the patient with as much inormation as is appropriate and relevant (and as is required by

the patient) regarding the points raised at 2 (a) (b) (c) (d) above. Invite questions rom the patient, andanswer any such questions ully, truthully and airly, trying to avoid making any dismissive commentsabout any possible risks.

5. Satisy yoursel that consent has been given voluntarily.6. Bear in mind (see appendix) the situations where it might be sensible to give written inormation/

warnings as part o the process o obtaining a valid consent rom the patient, and where writtenconsent is a requirement o the General Dental Council.

7. Keep good and careul records o all matters concerning the question o consent.

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Documents

Consent for Dental Patiends