Consent
ED HOROWICZ
Ed is a 21 year old Olympic gold medal
winner (and part-time underwear model). He
has ruptured his ACL and surgery is offered
as treatment.
The surgeon Ms Hehir, explains to Ed that
the surgery can only proceed with his
consent.
What does this mean?
SESSION OBJECTIVES
 To review the bioethical principles that underpin
consent as a requirement in healthcare, within our
society.
 To understand the requirement of consent.
 To gain an understanding of the legal issues around
consent.
 To gain an understanding of the consent process.
AUTONOMY
 The most significant and fundamental bioethical principle in
relation to consent
 Everyone has the right to self determination for the decisions
they make, especially in respect of their own body.
What about healthcare professionals
knowing best?
Paternalism
 To not allow a person to exercise autonomy was an accepted
part of medical practice in society, through medical
paternalism.
 Paternalism is where the choices of an individual are
overridden by another person in authority, in order to benefit
or avoid harm to that individual.
 It is now considered by medicine as the most fundamental
patient right.
 There are circumstances when a patient is not deemed
competent to make an autonomous choice.
Beneficence & Non-maleficence
 Beneficence- The principle of a positive
obligation to do good for our patients.
 To be honest and act with integrity.
 To provide all of the information.
 To understand that we are concerned with
what is good for that patient and not what is
good for the healthcare professional/
organisation.
 To accept the decision!
 Non-maleficence- To do no harm! The oldest ethical
principle in healthcare.
 To not be dishonest.
 To not withhold information.
 To not coerce a patient’s into undergoing a treatment.
Coercion cannot allow a decision to be considered
autonomous.
 Carrying out treatment without the patient’s knowledge would
be considered harmful.
Justice
 Justice- That every person is entitled to the same rights to be
able to consent or refuse treatment.
 The duty to provide information is regulated and equitable.
 Is this always the case?
 Consider emergencies or those who lack capacity- We
will come back to this later in the course!
Consent
 Consent is a precondition of autonomous
decision making!
 “A patient who is sufficiently mature and intellectually
competent to understand what is entailed in treatment is
entitled to make up his or her own mind as to whether to
accept or reject proposed medical treatment. This right is
part and parcel of his or her autonomy, of sovereignty
over one’s own body.”
(Brazier, 1987, at p172)
TAKE HOME MESSAGE PLEA
Consent is a process!!!
NOT A FORM!!!!
Acting Without Consent
 Any healthcare professional who intentionally or
recklessly undertakes any form of medical
investigation or treatment without consent is acting
unlawfully.
 Such action could result in both or either a criminal or
civil action.
 Consent also applies to research participation and
other relevant data sharing.
Acting Without Consent
 Criminal charges could consist of Assault, Actual
Bodily Harm or even Grievous Bodily Harm.
 The difficulty with criminal prosecution is that often
actions are not done through malice and as such
criminal charges are rare.
 Civil actions are the more common in this area of tort
law, usually through Trespass Against the Person
(Battery) or Negligence.
 Civil actions are inter-part disputes; eg: Doctor V
Patient or Nurse V Patient. E.g. Ms B [2002]
What Constitutes Consent?
 Consent can be either verbal, given through gesture (e.g.
holding an arm out for a blood pressure measurement) or
written.
 Written consent is not a legal requirement per se but
serves as evidence that a person has consented and
documented evidence is legally required.. (Exceptions to
this include some provisions under the Mental Health Act
and the Human Fertilisation and Embryology Act 2008.)
 Written consent is best practice for invasive, complex or
lengthy treatment and almost entirely mandatory at
national and local policy level.
Informed Consent
In healthcare consent is not considered
valid unless the patient has made an
informed decision, this is known as
informed consent.
Informed Consent
 Faden and Beauchamp (1986, 274) identify 5 elements to
informed consent;
-The relevant information has been given (disclosure)
-The relevant information has been understood
(comprehension)
-The person is uncoerced (voluntariness)
-The person is capable of consenting (competence/capacity)
-The consent has been given (decision)
Informed Consent
 The onus is on the healthcare professional to take
into account the person’s ability to understand the
information given and present it in an appropriate
style.
 This may sound obvious but consider the use of
jargon, abbreviations and other everyday medical
terminology that we use but that importantly
patients do not understand!
Informed Consent
 Does informed consent really exist?
 To be truly informed the patient has to be given information
relating to all aspects of a proposed treatment and this
includes alternatives.
 There are obstacles to this and the courts have been reluctant
to recognise informed consent as a principle ;
 Firstly, can a person with no medical knowledge really
understand such information and can we truly make sure that
they do?
 Secondly, the information given is at the discretion of the
healthcare professional who can be influenced by their own
knowledge, speciality, personal ideology and even financial
restrictions.
 Ed has been told that the operation is minor and that he
will be up and about in no time.
 Is this adequate?
 What else might he need to know?
Tort of Battery
 A claimant can bring a claim of Battery against a healthcare
professional if they fail to comply with the consent of a patient
or act without that patient’s consent.
 Consider;
 A patient expresses a wish to be cannulated in her right arm
but is instead cannulated in her left arm.
 Wrong site surgery (also actionable in negligence)
 A doctor who discovered that his patient’s womb was ruptured
whilst performing minor gynaecological surgery performed a
sterilisation without her consent. Devi v West Midlands AHA
[1980]
 Ms B [2002].
Consent as Negligence
 How can consent be negligent?
 Inadequate Information
 Inaccurate Information
 Failure to discuss alternative treatments
 Failure to recognise that the patient does not
understand the information
How Much Information Is Enough?
 There is no legal framework that states exactly what facts and
specific information should be given.
 The starting point was in Chatterton v Green [1981]. The court
held that consent was valid if the patient had been told in
broad terms about the nature of the procedure.
 Traditionally and predominantly the law operated a
“professional standard” approach, i.e. the standard to which it
is the practice for the profession to offer. This approach was
very medically paternalistic- Doctor knows best!
Professional Standard Approach
 The Bolam test:
Bolam v Friern Hospital Management Committee
[1957]
“A doctor is not guilty of negligence if he has acted in
accordance with a practice accepted as proper by a
responsible body of medical men skilled in that
particular art.”
In other words a doctor of the same training can avoid
liability if another doctor stands up in court and states
that the actions of the defendant were reasonable.
-Modified in Bolitho v City and Hackney HA
[1997]
Where there is more than one opinion, the
court is entitled to take a logical analysis in
deciding the most appropriate.
What Was Insufficient?
 For a patient to be successful in a claim of
negligence or battery as a result of lack of
information, they have to demonstrate that they were
not given such information.
 In Chester v Afshar [2002] the Court of Appeal held
that the phrase;
“ I’ve done hundreds of these and I haven’t crippled
anyone yet” fell way beyond the legal and professional
standards.
However Until Now!
Montgomery v Lanarkshire HB
 In March 2015 the UK Supreme Court held that in cases of
negligence in relation to consent, the Bolam test was no
longer the correct approach. Doctors or other consenting
healthcare practitioners must take , as their Lordships stated ;
‘reasonable care to ensure that the patient is aware of any
material risk involved in any recommended treatment, and
of any reasonable alternative or variant treatments’.
The Law and Consent Now,
How to Legally Obtain Consent.
 Does the patient know about the material risks of the treatment proposed?
-What sort of risks would a reasonable person in the patient’s circumstances
want to know?
-What sorts of risks would this particular patient want to know?
 Does the patient know about reasonable alternatives?
 Has reasonable care been taken to ensure that the patient knows all this?
 Do any exceptions to my duty to disclose apply? (Necessity, likelihood of
causing harm and the patient not wanting to know.
 Documentation of the consent process properly as evidence.
Consent and the Human Rights Act
1998
 In 1998 the UK incorporated the European Convention of
Human Rights and Fundamental Freedoms (ECHR) into
domestic legislation.
 The decision in Montgomery appears to promote, in
conjunction with GMC guidance and existing law, the
following rights;
 Article 2: The right to life
 Article 3: the right not to be subjected to inhuman or
degrading treatment
 Article 8: The right to private and family life
 Article 9: The right to freedom of thought and religion
Consent Guidance for Professionals
 Both the DoH and the GMC have issued professional
guidelines prior to this.
 There are two key documents that provide this.
 Department of Health – ‘Reference Guide to Consent
for Examination or Treatment’.
https://www.gov.uk/government/uploads/system/uplo
ads/attachment_data/file/138296/dh_103653__1_.pd
f
 General Medical Council – ‘Consent: patients and
doctors making decisions together’. Importantly
Montgomery is in support of these!
www.gmc-uk.org/guidance/ethical_guidance.asp
 Ed comes into the anaesthetic room for his
surgery.
 You check with him the procedure and that he
has signed his consent form, which he has.
Happy?
 Ed then says “ This op is only minor isn’t it? I
have a modelling job the day after tomorrow so I
will be fine by then won’t I?
Still happy?
Questions?
ed.horowicz@edgehill.ac.uk
References
 Beauchamp.T and Childress.J, 2009. Principles of Biomedical Ethics, 6th Edition,
Oxford: Oxford University Press.
 Brazier.M. and Cave.E, 2011. Medicine, Patients and the Law. 5th Edition, London:
LexisNexis / Penguin.
 Faden, R. and Beauchamp, T. 1986 A History and Theory of Informed Consent Oxford:
Oxford University Press
 Fletcher.N, Holt.J, Brazier.M and Harris.J, 1995, Ethics, Law and Nursing. Manchester:
Manchester University Press.
 Harris.J. (Ed), 2001. Bioethics. Oxford: Oxford University Press.
 Herring.J, 2012. Medical Law and Ethics. 5th Edition, Oxford: Oxford University Press.
 Mason.J and Laurie.G, 2013. Law and Medical Ethics. 12th Edition Oxford: Oxford
University Press.
 Pattinson.S, 2011. Medical Law and Ethics. 3rd Edition, London: Sweet and Maxwell.

Autonomy and Consent

  • 1.
  • 2.
    Ed is a21 year old Olympic gold medal winner (and part-time underwear model). He has ruptured his ACL and surgery is offered as treatment. The surgeon Ms Hehir, explains to Ed that the surgery can only proceed with his consent. What does this mean?
  • 3.
    SESSION OBJECTIVES  Toreview the bioethical principles that underpin consent as a requirement in healthcare, within our society.  To understand the requirement of consent.  To gain an understanding of the legal issues around consent.  To gain an understanding of the consent process.
  • 4.
    AUTONOMY  The mostsignificant and fundamental bioethical principle in relation to consent  Everyone has the right to self determination for the decisions they make, especially in respect of their own body. What about healthcare professionals knowing best?
  • 5.
    Paternalism  To notallow a person to exercise autonomy was an accepted part of medical practice in society, through medical paternalism.  Paternalism is where the choices of an individual are overridden by another person in authority, in order to benefit or avoid harm to that individual.  It is now considered by medicine as the most fundamental patient right.  There are circumstances when a patient is not deemed competent to make an autonomous choice.
  • 6.
    Beneficence & Non-maleficence Beneficence- The principle of a positive obligation to do good for our patients.  To be honest and act with integrity.  To provide all of the information.  To understand that we are concerned with what is good for that patient and not what is good for the healthcare professional/ organisation.  To accept the decision!
  • 7.
     Non-maleficence- Todo no harm! The oldest ethical principle in healthcare.  To not be dishonest.  To not withhold information.  To not coerce a patient’s into undergoing a treatment. Coercion cannot allow a decision to be considered autonomous.  Carrying out treatment without the patient’s knowledge would be considered harmful.
  • 8.
    Justice  Justice- Thatevery person is entitled to the same rights to be able to consent or refuse treatment.  The duty to provide information is regulated and equitable.  Is this always the case?  Consider emergencies or those who lack capacity- We will come back to this later in the course!
  • 9.
    Consent  Consent isa precondition of autonomous decision making!  “A patient who is sufficiently mature and intellectually competent to understand what is entailed in treatment is entitled to make up his or her own mind as to whether to accept or reject proposed medical treatment. This right is part and parcel of his or her autonomy, of sovereignty over one’s own body.” (Brazier, 1987, at p172)
  • 10.
    TAKE HOME MESSAGEPLEA Consent is a process!!! NOT A FORM!!!!
  • 11.
    Acting Without Consent Any healthcare professional who intentionally or recklessly undertakes any form of medical investigation or treatment without consent is acting unlawfully.  Such action could result in both or either a criminal or civil action.  Consent also applies to research participation and other relevant data sharing.
  • 12.
    Acting Without Consent Criminal charges could consist of Assault, Actual Bodily Harm or even Grievous Bodily Harm.  The difficulty with criminal prosecution is that often actions are not done through malice and as such criminal charges are rare.  Civil actions are the more common in this area of tort law, usually through Trespass Against the Person (Battery) or Negligence.  Civil actions are inter-part disputes; eg: Doctor V Patient or Nurse V Patient. E.g. Ms B [2002]
  • 13.
    What Constitutes Consent? Consent can be either verbal, given through gesture (e.g. holding an arm out for a blood pressure measurement) or written.  Written consent is not a legal requirement per se but serves as evidence that a person has consented and documented evidence is legally required.. (Exceptions to this include some provisions under the Mental Health Act and the Human Fertilisation and Embryology Act 2008.)  Written consent is best practice for invasive, complex or lengthy treatment and almost entirely mandatory at national and local policy level.
  • 14.
    Informed Consent In healthcareconsent is not considered valid unless the patient has made an informed decision, this is known as informed consent.
  • 15.
    Informed Consent  Fadenand Beauchamp (1986, 274) identify 5 elements to informed consent; -The relevant information has been given (disclosure) -The relevant information has been understood (comprehension) -The person is uncoerced (voluntariness) -The person is capable of consenting (competence/capacity) -The consent has been given (decision)
  • 16.
    Informed Consent  Theonus is on the healthcare professional to take into account the person’s ability to understand the information given and present it in an appropriate style.  This may sound obvious but consider the use of jargon, abbreviations and other everyday medical terminology that we use but that importantly patients do not understand!
  • 17.
    Informed Consent  Doesinformed consent really exist?  To be truly informed the patient has to be given information relating to all aspects of a proposed treatment and this includes alternatives.  There are obstacles to this and the courts have been reluctant to recognise informed consent as a principle ;  Firstly, can a person with no medical knowledge really understand such information and can we truly make sure that they do?  Secondly, the information given is at the discretion of the healthcare professional who can be influenced by their own knowledge, speciality, personal ideology and even financial restrictions.
  • 18.
     Ed hasbeen told that the operation is minor and that he will be up and about in no time.  Is this adequate?  What else might he need to know?
  • 19.
    Tort of Battery A claimant can bring a claim of Battery against a healthcare professional if they fail to comply with the consent of a patient or act without that patient’s consent.  Consider;  A patient expresses a wish to be cannulated in her right arm but is instead cannulated in her left arm.  Wrong site surgery (also actionable in negligence)  A doctor who discovered that his patient’s womb was ruptured whilst performing minor gynaecological surgery performed a sterilisation without her consent. Devi v West Midlands AHA [1980]  Ms B [2002].
  • 20.
    Consent as Negligence How can consent be negligent?  Inadequate Information  Inaccurate Information  Failure to discuss alternative treatments  Failure to recognise that the patient does not understand the information
  • 21.
    How Much InformationIs Enough?  There is no legal framework that states exactly what facts and specific information should be given.  The starting point was in Chatterton v Green [1981]. The court held that consent was valid if the patient had been told in broad terms about the nature of the procedure.  Traditionally and predominantly the law operated a “professional standard” approach, i.e. the standard to which it is the practice for the profession to offer. This approach was very medically paternalistic- Doctor knows best!
  • 22.
    Professional Standard Approach The Bolam test: Bolam v Friern Hospital Management Committee [1957] “A doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art.” In other words a doctor of the same training can avoid liability if another doctor stands up in court and states that the actions of the defendant were reasonable.
  • 23.
    -Modified in Bolithov City and Hackney HA [1997] Where there is more than one opinion, the court is entitled to take a logical analysis in deciding the most appropriate.
  • 24.
    What Was Insufficient? For a patient to be successful in a claim of negligence or battery as a result of lack of information, they have to demonstrate that they were not given such information.  In Chester v Afshar [2002] the Court of Appeal held that the phrase; “ I’ve done hundreds of these and I haven’t crippled anyone yet” fell way beyond the legal and professional standards.
  • 25.
    However Until Now! Montgomeryv Lanarkshire HB  In March 2015 the UK Supreme Court held that in cases of negligence in relation to consent, the Bolam test was no longer the correct approach. Doctors or other consenting healthcare practitioners must take , as their Lordships stated ; ‘reasonable care to ensure that the patient is aware of any material risk involved in any recommended treatment, and of any reasonable alternative or variant treatments’.
  • 26.
    The Law andConsent Now, How to Legally Obtain Consent.  Does the patient know about the material risks of the treatment proposed? -What sort of risks would a reasonable person in the patient’s circumstances want to know? -What sorts of risks would this particular patient want to know?  Does the patient know about reasonable alternatives?  Has reasonable care been taken to ensure that the patient knows all this?  Do any exceptions to my duty to disclose apply? (Necessity, likelihood of causing harm and the patient not wanting to know.  Documentation of the consent process properly as evidence.
  • 27.
    Consent and theHuman Rights Act 1998  In 1998 the UK incorporated the European Convention of Human Rights and Fundamental Freedoms (ECHR) into domestic legislation.  The decision in Montgomery appears to promote, in conjunction with GMC guidance and existing law, the following rights;  Article 2: The right to life  Article 3: the right not to be subjected to inhuman or degrading treatment  Article 8: The right to private and family life  Article 9: The right to freedom of thought and religion
  • 28.
    Consent Guidance forProfessionals  Both the DoH and the GMC have issued professional guidelines prior to this.  There are two key documents that provide this.  Department of Health – ‘Reference Guide to Consent for Examination or Treatment’. https://www.gov.uk/government/uploads/system/uplo ads/attachment_data/file/138296/dh_103653__1_.pd f  General Medical Council – ‘Consent: patients and doctors making decisions together’. Importantly Montgomery is in support of these! www.gmc-uk.org/guidance/ethical_guidance.asp
  • 29.
     Ed comesinto the anaesthetic room for his surgery.  You check with him the procedure and that he has signed his consent form, which he has. Happy?  Ed then says “ This op is only minor isn’t it? I have a modelling job the day after tomorrow so I will be fine by then won’t I? Still happy?
  • 30.
  • 31.
    References  Beauchamp.T andChildress.J, 2009. Principles of Biomedical Ethics, 6th Edition, Oxford: Oxford University Press.  Brazier.M. and Cave.E, 2011. Medicine, Patients and the Law. 5th Edition, London: LexisNexis / Penguin.  Faden, R. and Beauchamp, T. 1986 A History and Theory of Informed Consent Oxford: Oxford University Press  Fletcher.N, Holt.J, Brazier.M and Harris.J, 1995, Ethics, Law and Nursing. Manchester: Manchester University Press.  Harris.J. (Ed), 2001. Bioethics. Oxford: Oxford University Press.  Herring.J, 2012. Medical Law and Ethics. 5th Edition, Oxford: Oxford University Press.  Mason.J and Laurie.G, 2013. Law and Medical Ethics. 12th Edition Oxford: Oxford University Press.  Pattinson.S, 2011. Medical Law and Ethics. 3rd Edition, London: Sweet and Maxwell.