This document provides guidance on obtaining valid consent and assessing mental capacity. It discusses the importance of ensuring patients understand procedures and risks before obtaining consent. It outlines key principles from the Mental Health Act and Mental Capacity Act, such as assessing capacity and determining best interests. The document also describes types of consent forms, roles like IMCA advocates, and powers like LPAs. It includes examples of how to quantify and qualify risks to patients. Finally, it provides answers to sample cases related to valid consent and mental capacity.
4. Important!
• Consent forms are not always legal waivers
• If patients do not receive enough information on
which to base their decision, a signed consent
may not be valid. (Use interpreting service!)
• Patients also have every right to change their
minds after signing the form
5. Important!
Do not sub-delegate inappropriately
• Do not ask junior doctor/nursing or
midwifery staff to take consents for
surgery or procedures they do not
understand or trained to perform
Do not accept inappropriate delegation
• Are you the best person to consent the pt?
6. GMC on Appropriate Delegation
The practitioner must be:
• suitably trained and qualified
• have sufficient knowledge of the proposed
investigation or treatment; can discuss the
alternatives and risks involved
• understands, and agrees to act in
accordance with the GMC guidance
booklet
Source:
http://www.gmc-uk.org/static/documents/content/GMC_Consent_0513_Revised.pdf
7. Approaching Consents
Ensure that YOU understand the procedure and
complications & can describe them
Ensure that patient understands:
• Nature of the condition
• Benefits of receiving the treatment versus likely
consequences of no-treatment
• Reasonable or accepted alternative treatments
• Any uncertainties
8. Approaching Consents
• Empathise: procedure may be stressful
• Ensure dignity and respect
• Adequate privacy: Talk to patient alone, if
indicated
• Appropriate delegation
• Simplify and use leaflets to support
• Present risk in simple language
9. Approaching Consents
• If (patient, relative or carer) worried about
certain kinds of risk, make sure you
discuss these, even if minor or rare e.g.
– Sore throat, scar numbness,
– colostomy, death
• Always answer questions honestly
10. Can I talk it over with
my family before
deciding?
What are the
risks and
benefits of the
alternatives?
Are there any
alternatives?
What do they
think is wrong
with me?
What treatment
might help?
Will it cure me?
What will it
involve?
What about the
risks?
Will it hurt?
How long
before I drive/
work/ look after
my family?
Will I have to
stay in
hospital? How
long for?
What are the
long term
complications
Remember Patient’s Perspectives
11. Approaching Consents
• The courts states that patients be told about
‘significant’ risks which could affect the
judgement of a reasonable patient’
(Chester v Afshar [2004] UKHL 41 Pt 2; The duty to warn patients about risk)
• ‘Significant risk’ is not legally defined, GMC
requires doctors to tell patients about
– serious risks, even if uncommon
– frequently occurring’ risks, even if minor
13. The need to know: The Sidaway
point – 1980s
In mid-1980s, majority of the House of Lords
•decided that it was on the whole a matter for
doctors to decide how much to tell patients
about risks of treatments (The need to know)
•Patients could not sue their doctors for
negligence for failing to inform of a risk
– if other reasonable body of doctors would not
have informed of the risks
– An extension of “Bolam principle”
14. The right to know: Montgomery v.
Lanarkshire Health Board - March 2015
An important new Supreme Court decision:
•1999, Mrs Montgomery, small, diabetic
woman suffered shoulder dystocia
– 12 minutes to free he baby’s shoulder
– Resulting in brain damage and arm paralysis
– Application of Sidaway principle was rejected
•patients now regarded as persons holding
rights, rather than passive recipients of the
care of the medical profession (The right to
know)
15. Presenting Information on Risk
Term Equivalent
numerical ratio
Colloquial
equivalent
Very common 1/2 to 1/10 One in a family
Common 1/11 to 1/100 One in a street
Uncommon 1/101 to 1/1000 One in a village
Rare 1/1001 to 1/10,000 One in small town
Very rare Less than 1/10,000 One in large Town
16. Risks: Serious or Frequent?
Term Ratio Examples
Very
frequent
1/2 to 1/10 Tenderness around scar
Shoulder dystocia (If at risk)
Frequent
Potentially Serious
1/11 to
1/100
Wound infection, PPH
Infrequent; but
Serious
1/101 to
1/1000
Bowel, bladder, ureteric
injuries at TAH & Operative
Laparoscopy
Rare; but
Serious
1/1001 to
1/10,000
Bowel, bladder ureteric injuries
at Diagnostic Lap
Very rare; but
very serious
Less than
1/10,000
Death following Diagnostic Lap
(Depends on ASA score)
18. • In March 2015, the Supreme Court set aside the
Sidaway ruling
– In 1988, majority of the House of Lords decided that it
was on the whole a matter for doctors to decide how
much to tell patients about the risks of treatment
– (i.e. 1988-2015 the need to know rule applied)
• It ruled in favour of Montgomery, that:
– “patients are now widely regarded as persons holding
rights, rather than as the passive recipients of the
care of the medical profession” (
– (i.e. from 2015 – Patients have the right to know)
19. Example 1
Before: March 2015:
•if a woman was pregnant and had risk
factors, Most Doctors focused on:
– Birth traumas, particularly:
– Clavicular fracture & brachial plexus damage
After: 2015, also document discussions on:
– Perinatal asphyxia and cerebral palsy stillbirth
or neonatal death
– Pros and cons of alternative interventions
– Ensure patient has ALL relevant LEAFLETS
20. Example 2
Before: March 2015
•if a woman needed a hysterectomy, Most
Doctors focused mainly on:
– Infection, bleeding, transfusion, bowel, bladder,
ureteric injuries, VTE, anaesthesia,
After: 2015, also document discussions on
– Risk of colostomy, urinary diversion
– Risk of not leaving hospital (ASA score)
– Discuss pros and cons of alternative options
– Ensure patient has ALL relevant LEAFLETS
21. Predicting Risk of Dying
• Complex, depends on
– Primary diagnosis, planned operation
– Co-morbidity, age
– Centre expertise, MDTs, ITU support
– ASA score
• Best discussed in dedicated peri-op clinic
– Liaise with anaesthetists
– Liaise with other professionals
– Provide all clinical information
23. Types of Consent Forms
• Form 1. Patient agreement to investigation or
treatment
• Form 2 Parental agreement to investigation or
treatment for a child or young person
• Form 3 Patient/parental agreement to
investigation or treatment (procedures where
consciousness not impaired)
• Form 4 Healthcare professionals for adults who
are unable to consent to investigation or
treatment
24. Consent Forms 1 AND 2
• Suitable for all investigations / treatments
– Minor
– Intermediate
– Major
25. Consent Forms 3
• Investigations / treatments where
consciousness not impaired
– Diagnostics
– Minor treatment procedures
26. Consent Form 4:
When Patient Lacks Capacity
Life-saving, or best interest procedure
– Unable to comprehend and retain information material
to the decision and/or
– Unable to use and weigh this information in the
decision-making process; or
– Is unconscious
Make sure there are no standing arrangements
– Advance directive refusing that particular treatment
– Lasting Power of Attorney (LPA)
– Court Appointed Deputy (CAD)
– Independent Mental Capacity Advocates (IMCA)
27. Consent Form 4:
When Patient Lacks Capacity
• Relatives cannot be asked to sign this form in
lieu of an adult who is not legally competent
• Signature of health professional proposing
treatment, preferably with countersignature of
second professional giving opinion
• Discuss with close relatives, who may also wish
to countersign
29. Re T (Adult) [1992] 4 All ER 649
• T, a 20-year-old pregnant woman, injured
in a car accident, developed complications
needing blood transfusions. She did not
indicate on admission that she was
opposed to receiving blood
• After spending some time with her mother,
(a practising Jehovah's Witness) she
decided to refuse the treatment
What would you have done?
30. St George's Healthcare NHS Trust v S; R v
Collins and others, ex parte S [1998]
• S, diagnosed with pre-eclampsia was admitted
to hospital for induction of labour, but refused as
she did not agree with medical intervention in
pregnancy.
• Although competent and not suffering from
mental illness, S was detained for assessment
under the Mental Health Act. A judge made a
declaration overriding the need for her consent
to treatment, and her baby was delivered by
caesarean section.
What do you think of this civil “sectioning”?
Did the Judge act correctly?
Was the judgement right or wrong?
31. Re MB [1997] 38 BMLR 175 CA
• MB needed a caesarean section, but panicked
and withdrew consent at the last moment
because of needle phobia. The hospital obtained
a judicial declaration that it would be lawful to
carry out the procedure, a decision that MB
appealed
• Did MB lack capacity or not?
• What do you think of the judicial declaration?
33. Mental Capacity Act 2005
Framework to empower / protect those lacking
capacity to make decisions for themselves
• Applies in England and Wales
• Defines “Persons Who Lack Capacity”
• Defines how to gauge “Best Interest”
• A person does not lack capacity merely because
she makes an unwise decision
• Replaces Part 7 of the Mental Health Act 1983
(for mentally disordered persons)
34. Mental Capacity Act 2005
• Rules about advance decisions to refuse
medical treatment
• Safeguards for research involving people who
lack capacity
• Creates a new offence of wilful neglect or ill-
treatment
• New roles for the courts
– Independent mental capacity advocates (IMCA) for
vulnerable people
– Lasting Power of Attorney (LPA)
– Court Appointed Deputy (CAD)
35. Mental Capacity Act (2005)
Mental Health Act (2007) Amendments
Are in response to the 2004 European Court of
Human Rights (‘the Bournewood’) judgement
• involved an autistic man (HL) kept at
Bournewood Hospital by doctors against the
wishes of his carers
• The ECHR found that admission & retention in
hospital (under the common law of necessity)
was a breach:
– of Article 5(1) ECHR (deprivation of liberty) and
– Article 5(4) (right to have lawfulness of detention
reviewed by a court)
36. Mental Capacity Act (2005)
2007 - Amendments
The main purpose was to:
• Amend the Mental Health Act 1983 (the
legislation governing the compulsory admission
• detention and treatment of certain people who
may have a mental disorder)
• Introduce ‘deprivation of liberty safeguards’
37. Determining Mental Capacity:
5 Key Principles
1. Every adult has the right; and must be
assumed to have capacity to make his or her
own decisions unless proved otherwise.
2. A person must be given all practicable help
before anyone treats them as not being able to
make their own decisions.
– Always take reasonable steps (more specialist colleagues) to support
a patient in making her own decision
– Document details of how judgements of “lack of capacity” reached
– Seek High Court approval if doubts
38. Determining Mental Capacity:
5 Key Principles
3. Just because an individual makes “an unwise
decision”, does not imply lacking capacity to
make that decision.
4. Anything done or decision made on behalf of a
person who lacks capacity must be in their
best interests.
5. Anything done for or on behalf of such a
person should be the least restrictive of their
basic rights and freedoms.
39. Gauging Patient’s Best Interests
Not limited to their best medical interests;
other factors include:
• The wishes and beliefs of the patient when
competent (Jehovah’s Witness)
• Their current wishes
• Their general well-being
• Their cultural, spiritual and religious
welfare
40. Independent Mental Capacity
Advocates (IMCA)
New role created with the MCA 2005 to help make
decisions for people who lack capacity and no family
or friends appropriate to make important decisions
regarding:
• serious medical treatment, and / or
• changes of accommodation
– Admissions for >28 days in hospital
– Moves to care homes >8 weeks)
• in care reviews
• where an allegation of abuse has been made
Only exception is emergency, life-saving treatment
41. Lasting Power of Attorney (LPA)
A Lasting Power of Attorney allows a patient (plan
ahead) by appointing someone to make certain
decisions on his/her behalf after he/she loses
capacity
There are 2 types:
• LPA for health and welfare
• LPA for property and financial affairs
One can choose to make one type of Lasting
Power of Attorney or both
42. Health and Welfare LPA
This allows choice of one or more people to
make decisions about things like:
• Daily routine (e.g. food and clothes)
• Medical care
• Moving into a care home
• Refusing life-sustaining treatment
43. Property and Financial Affairs LPA
This allows choice of one or more people to
make decisions about money and property
e.g:
• paying bills
• collecting benefits
• selling your home
44. Court Appointed Deputy (CAD)
The MCA 2005 establishes a specialised
Court of Protection to deal with issues
arising from disputes about mental
capacity
• Under section 16(2) the CoP can appoint
a CAD if it believes that a patient may lack
capacity in:
– Managing of his/her property and affiars
– His/her personal welfare or healthcare
46. Re T (Adult) [1992] 4 All ER 649
• T, a 20-year-old pregnant woman, injured
in a car accident, developed complications
needing blood transfusions. She did not
indicate on admission that she was
opposed to receiving blood
• After spending some time with her mother,
(a practising Jehovah's Witness) she
decided to refuse the treatment
• What would you have done?
47. Court of Appeal’s Decision
Coercion/pressure on consent
The Court of Appeal considered that T had
been pressurised by her mother and that
her ability to decide about the transfusions
was further impaired by the drugs with
which she was being treated. The Court
allowed the blood transfusions to proceed.
– A patient’s consent to a particular treatment
may not be valid if given under pressure or
duress exerted by another person
48. St George's Healthcare NHS Trust v S; R v
Collins and others, ex parte S [1998]
• S, diagnosed with pre-eclampsia was admitted
to hospital for induction of labour, but refused as
she did not agree with medical intervention in
pregnancy.
• Although competent and not suffering from
mental illness, S was detained for assessment
under the Mental Health Act. A judge made a
declaration overriding the need for her consent
to treatment, and her baby was delivered by
caesarean section.
What do you think of this civil “sectioning”?
Did the Judge act correctly?
Was the judgement right or wrong?
49. Court of Appeal’s Decision:
-False and incomplete information
The Appeal Court held that:
• S’s right to autonomy had been violated, her
detention had been unlawful & motivated by the
need to treat pre-eclampsia
• That the judicial authority for the caesarean had
been based on false and incomplete information
– A competent woman can refuse treatment even if it
may result in harm to self or unborn child
– Patients cannot lawfully be detained and compulsorily
treated for a physical condition under the terms of the
Mental Health Act
50. Re MB [1997] 38 BMLR 175 CA –
Capacity to refuse Adult treatment
• MB needed a caesarean section, but panicked
and withdrew consent at the last moment
because of needle phobia. The hospital obtained
a judicial declaration that it would be lawful to
carry out the procedure, a decision that MB
appealed
• However, she subsequently agreed to induction
of GA and her baby was born by caesarean
section
• Did MB lack capacity or not?
• What do you think of the judicial declaration?
51. Court of Appeal’s Decision:
- Temporary Impairment of Capacity
• The Court of Appeal upheld the judges' view that MB had
not, at the time, been competent to refuse treatment,
taking the view that her fear and panic had impaired her
capacity to take in the information given and the
proposed treatment
An individual’s capacity to make particular decisions:
• May fluctuate or
• Be temporarily affected by factors such as pain, fear,
confusion or the effects of medication.
• Assessment of capacity must be time and decision-
specific.
52. Summary
We have covered:
• Principles of obtaining valid consents
• Lack of capacity, mental disorder; and
what constitutes best interest
• Common limitations and some medico-
legal aspects of consenting