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3
Consent
A basic principle of law is that a patient must give their consent to medical
treatment.
When it is alleged that there has been a failure to properly advise on risks or
reasonable alternative treatments, the cause of action is likely to be negligence. If
it is contended that there has been a failure to obtain consent at all, the cause of
action is assault/battery.
To give valid consent, a patient must have capacity, and consent must be
informed and given voluntarily.
DOES THE PATIENT HAVE CAPACITY TO GIVE CONSENT?
e Mental Capacity Act 2005 (MCA) sets out a statutory test for mental capacity
to be applied in England and Wales. In the context of medical care, to be able to
make a decision, the patient must be able to:
●
Understand the information relevant to the decision
●
Retain that information
●
Use or weigh it as part of a decision and
●
Communicate their decision eectively by any means
e MCA makes clear that patients should be presumed to have capacity unless
it can be established otherwise.
Capacity is both time- and decision-specic.
INFORMED CONSENT
In 1985, the House of Lords determined that the health care professional decides
what information to provide when warning patients of the risks inherent in the
treatment being proposed.
1
However, over the following years, the case law moved
away from paternalistic medicine towards patient autonomy and doctors work-
ing in partnership with patients to make decisions about their health care.
2
A ra
DOI: 10.1201/9781003179351-4
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Montgomery 11
of professional guidance has addressed the nature and extent of the information
that a patient should be given to ensure that they are giving informed consent.
In 2008, the General Medical Council (GMC) issued the guidance ‘Consent:
Patients and Doctors Making Decisions Together’,
3
and in 2013, the GMC guid-
ance ‘Good Medical Practice’
4
instructed doctors to:
●
Work in partnership with patients
●
Listen and respond to their concerns and preferences
●
Give patients the information they want or need in a way they can
understand
●
Respect patients’ rights to reach decisions with doctors about their treatment
and care
MONTGOMERY
In 2015, the Supreme Court reconsidered the duty of care a doctor owes a
patient when advising on medical treatment in the landmark case Montgomery v
Lanarkshire Health Board.
5
Known as the ‘Montgomery standard’, it is the legal
benchmark for informed consent in the United Kingdom (UK).
e case involved a pregnant woman, Nadine Montgomery. Ms Montgomery
was of slight build and had diabetes. Diabetes increases the risk of a large
baby and the risk of shoulder dystocia during a vaginal delivery by 9–10%. Ms
Montgomery was concerned about the risks associated with a vaginal delivery
and raised these with her obstetrician, McLellan. It was Dr McLellan’s policy
not routinely to advise diabetic women about shoulder dystocia as,
in her view, the risk of a grave problem for the baby was very small,
but if advised of the risks of shoulder dystocia women would opt
for a caesarean section, which was not in the maternal interest.
6
us, Ms Montgomery delivered vaginally. e baby was large, and he suered
from shoulder dystocia and oxygen deprivation during delivery, as well as conse-
quent serious disabilities.
It was alleged that Dr McLellan failed to properly inform Ms Montgomery of
the risks of giving birth to a large baby, given that she was a small woman with
diabetes, and that there was a failure to advise on the alternative to vaginal deliv-
ery, such as a caesarean section, which could have prevented the baby’s injuries.
Ruling in favour of Montgomery, the UK Supreme Court stated that doctors
have a duty to take reasonable care to ensure that patients are aware of any
material risks involved in any recommended treatment and of any reasonable
alternative or variant treatments. Such information must be given in terms the
patient can understand.
e Montgomery case is signicant because it shied the focus of informed
consent from a paternalistic doctor-centred model, where the doctor is the pri-
mary decision-maker who makes decisions on behalf of the patient, to a more
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12 Consent
patient-centred approach, where the patient has the right to be fully informed
of the material risks associated with their care and to make their own decisions
about their treatment (or refusing treatment). Patients should be actively involved
in the decision-making process and empowered to make decisions based on their
individual circumstances and preferences.
A ‘therapeutic exception’ provides that a doctor may withhold information if
they reasonably consider that its disclosure will cause the patient psychological
harm to a degree that outweighs the benets of informing them. However, the
Supreme Court made it very clear that this is not to be abused.
Nevertheless, the possibility of this exception presents signicant legal dif-
culties for health care professionals. Litigation is a likely consequence of the use
of the therapeutic exception, and health care professionals should ensure that, if
they use it at all, their reasons should be documented at the time. If contentious
issues are involved, legal advice should be sought.
WHAT IS A MATERIAL RISK?
e test of materiality is based on what a reasonable person in the patient’s posi-
tion would consider signicant. Under this test, a risk is considered material if,
at the time in question:
●
e risk should reasonably have been known to the health care professional
7
●
e risk is one that a reasonable person in the patient’s position would
consider signicant or if the doctor is or should reasonably be aware that the
particular patient would attach signicance to it
8
and
●
e doctor knows or ought reasonably to know that the patient would be
likely to attach signicance to the risk
Materiality is fact- and case-sensitive. For example, an ophthalmic procedure
carrying a negligible risk of sight loss in one eye is likely to be material to a
patient who has already lost sight in the other eye. It may be less material to a
fully sighted patient.
GENERAL MEDICAL COUNCIL GUIDANCE
In 2020, the GMC issued the updated guidance ‘Decision Making and Consent’.
e guidance outlines seven core principles:
●
All patients have the right to be involved in decisions about their treatment
and care and be supported to make informed decisions if they are able.
●
Decision making is an ongoing process focused on meaningful dialogue: the
exchange of relevant information specic to the individual patient.
https://t.me/med1917
Who should consent the patient? 13
●
All patients have the right to be listened to and to be given the information
they need to make a decision and the time and support they need to under-
stand it.
●
Doctors must try to nd out what matters to patients so they can share
relevant information about the benets and harms of proposed options and
reasonable alternatives, including the option to take no action.
●
Doctors must start from the presumption that all adult patients have capac-
ity to make decisions about their treatment and care. A patient can only be
judged to lack capacity to make a specic decision at a specic time and only
aer assessment in line with legal requirements.
●
e choice of treatment or care for patients who lack capacity must be of
overall benet to them, and decisions should be made in consultation with
those who are close to them or advocating for them.
●
Patients whose right to consent is aected by law should be supported to be
involved in the decision-making process and to exercise choice if possible.
is guidance is intended to support doctors in their conversations with patients.
Following it will help doctors ensure that patients give informed consent to their
care. It provides advice on:
●
What to tell a patient when talking about risks
●
What to do if the patient refuses to hear information that is relevant
●
What to do if the patient may lack the capacity to make a decision
●
What to document
WHO SHOULD CONSENT THE PATIENT?
In the UK, typically, the health care professional who is responsible for the
patient’s care should lead the discussions. is may mean doctors, nurses, den-
tists or other health care professionals.
e 2020 GMC guidance allows for the delegation of part of the decision-
making process, but the guidance makes it clear that the doctor should carefully
consider whether it is appropriate to delegate. If the responsibility is delegated,
that person should be suitably trained and competent; should have sucient
knowledge of the proposed treatment plan and its benets and risks, as well as
alternative options; must have the skills to discuss consent with the patient; and
should feel competent to ensure that the patient gives informed consent. If part
of the decision-making process has been delegated, the doctor is still responsible
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14 Consent
for ensuring that the patient has been given the information they need to make
the decision, has had time and support to consider it and has given their consent
before treatment or care is provided.
WHEN IS THE RIGHT TIME TO CONSENT A PATIENT?
Consent is a continuum. It begins at the rst consultation.
If the decision is for an elective procedure, the patient should give consent
that is documented well in advance of any procedure. Furthermore, the patient
should be given a ‘cooling-o’ period to deliberate, consider their treatment
options and do their homework.
In the UK, there is no specic time limit for the validity of patient consent to
treatment. Patient consent is an ongoing process and can be withdrawn at any
time, even aer treatment has started.
In certain cases, such as for treatments that carry signicant risks, where a
patient’s capacity to consent is in question or where circumstances have changed
in a way that signicantly alters the patient’s condition, material risks or any
other aspect of treatment, renewed consent should be sought and appropriately
documented in the medical records.
GETTING INTO THE RIGHT MINDSET
Consent is a patient’s to give, not a doctor’s to take. ere is no routine consent.
A signature on a consent form does not equate to consent.
Facilitating a patient to give valid consent takes time.
Health care professionals should get to know their patients and nd out what
matters to them, personally and professionally, so that they can understand their
patients’ needs, values and priorities that inuence their decision making, as well
as their concerns and preferences about the options and their expectations about
what treatment or care may achieve.
All information given should be tailored to the patient, and discussions should
take place in terms the patient can understand. Visual or other aids may be help-
ful, for example, to put a patient-specic risk in the context of general population
risk.
e language used should be objective, clear and unbiased, and the health
care professional should be truthful, open and honest during the discussion. e
health care professional should ensure that the patient understands the informa-
tion provided and has the opportunity to ask questions.
WHAT INFORMATION SHOULD BE GIVEN TO THE
PATIENT?
e health care professional should explain several key pieces of information to
the patient to help them give informed consent, including:
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Documenting consent 15
●
Diagnosis: e diagnosis and the condition being treated
●
Treatment options: e various treatment options available, including their
risks and benets
●
Prognosis: e likely outcome of the condition without treatment
●
Risks and benets: e risks and benets of the proposed treatment, includ-
ing the likelihood and severity of potential side eects
●
Alternative treatments:
(a) Any alternative treatments available that are within the knowledge of a
reasonably competent clinician at the time and are an accepted practice
and an appropriate treatment, not just a ‘possible’ treatment
9
(b) eir risks and benets
●
Recovery time: How long it will take the patient to recover from the
treatment
●
Cost: Any costs associated with the treatment
●
Consent: e consent process and ensuring that the patient understands that
they have the right to refuse treatment
More detail is provided in paragraphs 10 and 13 of the GMC guidance ‘Decision
Making and Consent’.
DOCUMENTING CONSENT
Documenting the consent process in the patient’s medical records is important
to ensure that there is a clear record of the discussions conducted and decisions
made. is helps ensure that the patient’s wishes are respected and that health
care professionals have a clear understanding of the patient’s medical history and
treatment preferences.
Health care professionals should record:
●
e capacity assessment, if the patient’s capacity to consent was assessed
●
e decision-making process, including the discussions conducted with the
patient, the information provided, any questions asked and any concerns or
preferences expressed by the patient
●
e patient’s decision, including the date and time of the decision
●
e risks and benets of the proposed procedure that were discussed, includ-
ing any potential complications and their likelihood and severity
●
Any alternative treatments discussed, including their risks and benets
●
Concerns or objections, if the patient expressed any
●
e identity of the person who provided the information
It is good practice not only to document these in a written clinical note but also in
correspondence to the patient’s GP, and the patient should receive a copy.
In the case of Malik,
10
the clinician concerned did not keep handwritten notes
or typed notes of the consent consultation. HHJ Blair QC commented:
https://t.me/med1917
16 Consent
I was taken aback by his practice of simply dictating a letter to
his patient’s GP after an outpatient clinic appointment to relay
the details of his patient’s current symptoms, recording his clini-
cal assessment, giving his opinion as to appropriate treatment(s)
but omitting to state what advice has been given about the risks
and benefits of the avenue(s) open to the patient. This is a practice
which it seems to me is fraught with risks of being unable con-
fidently to answer important questions many years later without
having the benefit of a contemporaneous set of detailed notes.
CONSENT IN SPECIAL CIRCUMSTANCES
In certain circumstances, it may be dicult for a health care professional to
obtain consent to be able to treat the patient. For example:
●
Children: Children under the age of 16 are generally not considered legally
competent to make their own decisions about medical treatment. In these
circumstances, consent must be obtained from a parent or legal guardian.
However, if the child is deemed to be competent to make their own decision,
their consent can be obtained instead.
11
●
Adults lacking capacity: If the patient lacks the capacity to make decisions
about their medical treatment, the health care professional must seek con-
sent from someone who has the legal authority to make decisions on their
behalf. is may be a family member, an appointed representative or the
Court of Protection.
●
Emergencies: In emergency situations where the patient is unable to provide
consent, treatment may be given without consent if it is in the patient’s best
interests.
●
Mental health conditions: If the patient has a mental health condition that
aects their decision-making capacity, the health care professional must
determine whether the patient has the capacity to give consent to treatment.
If the patient lacks capacity, consent must be sought from someone who has
the legal authority to make decisions on their behalf.
In all special circumstances, the health care professional should ensure that they
obtain valid consent or authority to treat the patient. is may involve following
specic legal and ethical guidelines and consulting with other health care profes-
sionals and legal experts when necessary.
https://t.me/med1917
Consent in special circumstances 17
NOTES
1. Sidaway v Board of Governors of the Bethlem Royal Hospital [1985] AC
871.
2. Rogers v Whitaker [1992] HCA 58; 175 CLR 479; Pearce v United Bristol
Healthcare NHS Trust [1999] ECC 167; Chester v Afshar [2004] UK HL 41.
3. https://www .gmc -uk .org/- /media /documents /GMC -guidance -for -doc-
tors-- -Consent-- -English -2008---2020_pdf-48903482.
4. https://www .gmc -uk .org/- /media /documents /good -medical -practice--
-english -20200128 _pdf -51527435 .pdf.
5. Montgomery v Lanarkshire Health Board [2015] UKSC 11.
6. https://www .supremecourt .uk /cases /docs /uksc -2013 -0136 -press -sum-
mary .pdf.
7. Duce v Worcestershire Acute Hospitals NHS Trust [2018] EWCA Civ 1307
(7 June 2018).
8. A v East Kent Hospitals University NHS Foundation Trust [2015] EWHC
1038 (QB) (31 March 2015); Tasmin v Barts Health NHS Trust [2015] EWHC
3135 (QB) (30 October 2015); Spencer v Hillingdon Hospital NHS Trust
[2015] EWHC 1058 (QB).
9. Bayley v George Elliot Hospital [2017] EWHC 3398.
10. Malik v St George’s University Hospital NHS Foundation Trust [2021]
EWHC 1913 (QB).
11. Gillick v West Norfolk and Wisbech AHA 1986 provided that children
under the age of 16 can consent to their own treatment if they fully
appreciate what is involved.
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18
4
Criminally negligent
manslaughter
Criminally negligent manslaughter (or gross negligence manslaughter, as it is
mostly referred to in English law) is a form of involuntary manslaughter. is
crime is dierent from murder, where there is intent to kill or cause grievous
bodily harm.
In the context of health care, it is exceptionally rare for a health care profes-
sional’s behaviour to be deemed criminal. e crime of gross negligence (medi-
cal) manslaughter arises when death occurs as the result of truly, exceptionally
bad health care.
THE LEGAL TESTS
Gross negligence manslaughter is when a death occurs as a result of a grossly
negligent but otherwise lawful act or omission by a health care professional.
In 1994, an anaesthetist called Adomako was convicted of gross negligence
manslaughter. Dr Adomako did not notice that a patient’s oxygen pipe had
become disconnected during an operation. Consequently, the patient died. e
judge stated the test for gross negligence manslaughter,
1
which includes the
following:
●
ere must be a duty of care.
A health care professional always owes a duty of care to their patients.
●
e health care professional must have breached that duty of care.
Per the (civil) law of negligence, in a clinical context, breach of duty means
a failure to act in accordance with the standard of a reasonably competent
practitioner,
2
in the applicable eld of expertise,
3
at the time of the incident
in question.
DOI: 10.1201/9781003179351-5
https://t.me/med1917
The legal tests 19
●
at breach must have caused the death of the patient.
is element of the oence requires that the breach of duty caused the death of
the patient, but it does not have to be the sole or even principal cause. It merely
must have more than minimally caused the death.
In cases of omission potentially leading to death, as opposed to an act, the
prosecution must prove that the negligent failure to act was a substantial cause
of death.
●
A serious and obvious risk of death was foreseeable.
e jury must nd that a reasonable person in the health care professional’s
position at the time would have foreseen a serious and obvious risk of death,
not merely a risk of injury or even serious injury.
While a health care professional’s subjective awareness may be relevant
when assessing the obviousness of the risk of death, this test remains objective
in nature.
●
e breach of duty was so serious in all the circumstances that it should be
judged criminal.
e prosecution must prove that the circumstances were such that a reason-
able person in the health care professional’s position would have foreseen a
serious and obvious risk of death arising from their act or omission and that
the breach of duty was reprehensible and so far below the expected standard
of someone in their position (with the same qualications, experience and
responsibilities) that it amounted to a crime.
e denition of gross negligence in R v Adomako is as much maligned as it is
seemingly circular because it seeks to dene criminal conduct by asking the jury
to determine whether the conduct is criminal without dening what constitutes
criminal conduct. us, it can be hard for a health care professional to know
whether their conduct will be deemed criminal or not.
e judge did provide some examples of what might constitute a criminally
serious breach, such as:
●
Indierence to an obvious risk of injury to health
●
Knowledge of the risk of injury to health at the outset but a determination to
run the risk nevertheless
●
Knowledge of the risk of injury to health and an intention to avoid it but
coupled with such a high degree of negligence in attempting to avoid that
injury that a jury deems it a charge of criminally serious breach, as necessary
https://t.me/med1917
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