Transcript Clinical Trials and the Laws in Hong Kong

Expensive Pearls:
Medicolegal Session
Consent
Chris Howse
15 May 2011
1.
Why is consent important?
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It is good practice and a legal requirement
in Hong Kong
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Patients are becoming better informed
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Good consent ensures that the relationship
between doctor and patient is based on
confidence and trust.
2. Consequences of a failure to obtain
consent:
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Criminal proceedings.
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Civil proceedings.
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Medical Council proceedings.
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Press.
What is meant by consent?
(1) The patient must be informed of the procedure.
(2) The patient should be competent.
(3) The patient must consent to the procedure.
(4) The consent must be informed.
Can you rely on a consent form?
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Undue emphasis or reliance can be placed on
the signing of a consent form.
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A consent form is not proof that the patient has
given an informed consent.
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A signature on a consent form is meaningless if
the patient is incapable of understanding what is
involved in the proposed treatment.
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Getting consent can be time consuming.
Common Myths
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A signed consent form counters any allegation
that the consent was invalid.
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Relatives can sign a consent form.
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The 1% rule.
Who should take consent?
- The medical practitioner giving the treatment.
- Can you delegate consent to a more junior
member of the team?
Who can give consent?
(1) Adults.
(2) Children.
(3) Patients under a mental disability.
How much information do patients need to
enable them to give a valid consent?
The patient needs to be made aware of the
procedure and of any potential risk or
complication, however rare that risk or
complication, which might influence their
decision as to whether to undergo the procedure.
Hong Kong Guidelines on the preanaesthetic consultation
"Consultation by an anaesthesiologist is essential
for the medical assessment of the patient prior to
anaesthesia for surgery or other procedures. The
main purpose of the consultation is to ensure that
the patient is in the optimal stage for anaesthesia
and surgery but will also include other aspects of
anaesthetic management listed under the
recommendations."
Patient's rights and patient's
responsibilities
- The right to be informed with a clear, concise and
understandable explanation of the proposed care
and procedures including alternatives and
common side effects and risks.
- The right to receive medical advice and treatment
which fully meets current accepted standards.
- The responsibility to inform the doctor fully of
all relevant medical history.
General principles
(1) The pre-anaesthetic consultation should
wherever possible be performed by the
anaesthetist who will administer the
anaesthetic.
(2) The consultation should take place at an
appropriate time before anaesthesia and
surgery to allow adequate consideration of the
factors involved.
Pre-anaesthetic consultation should
include:
(1)
Identification of the patient.
(2)
A concise medical history and clinical examination of
the patient.
(3)
Confirmation with the patient of the nature of the
procedure and their consent to anaesthesia.
(4)
A discussion with the patient of those details of the
anaesthetic management which are of significance to
the patient.
(5)
Consultation with colleagues in other disciplines,
where appropriate.
What information is important?
"A person is entitled to know the implications of
an anaesthetic before it is administered and to seek
clarification of any issues which may be of
concern. The person must be free to accept or
reject advice."
Important Principles
(1) Information about the proposed anaesthesia
should be provided in a way that the patient is
able to understand.
(2) Alternatives.
(3) Questions should be encouraged and answered
clearly.
(4) Where a patient does not wish further
information.
(5) Known risks should be disclosed.
Examples of risks which are given in
the guidelines include:
(1) Common adverse
anaesthesia.
effects
of
general
(2) Less common, but not rare, adverse effects.
(3) Rare adverse effects.
(4) Adverse effects which are related to preexisting disease.
How do you present the information
that the patient needs?
(1)
(2)
(3)
(4)
(5)
(6)
(7)
Consider whether an interpreter is necessary.
Use visual aids, leaflets and other publications.
If it helps, suggest that the patient brings a relative or
friend to the discussion.
Ensure that distressing information is given in a
sensitive way.
Involve other members of the healthcare team in the
discussion, where appropriate.
Answer any questions fully and honestly.
Give the patient plenty of time to understand the
information.
How do you know if the patient has
given a consent?
Implied consent
Express consent, especially where:
- The treatment or procedure is complex or
involves significant risks.
- There may be significant adverse consequences
for the patient's employment or personal life.
How long does consent last?
Refusing consent
Withdrawing consent