Transcript Week 3. Lecture 1. Consent and the competent

Week 3. Consent & the
competent patient
Notion of individual autonomy
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Principle of consent is underpinned by the notion of
autonomy.
Liberal philosopher John Stuart Mill in his landmark essay
“On Liberty”:
“Over himself, over his own body and mind, the
individual is sovereign”
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(Mill 2003, in The classical utilitarians, Bentham and Mill, ed. J.
Troyer, 150–248. Cambridge: Hackett, at 158).
“[e]ach is the proper guardian of his own health,
whether bodily, or mental and spiritual” (Mill 2003, 160).
Problems in a clinical setting:
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“Autonomy and clinical intuition do not sit comfortably together”
(Davies)
Developing a culture of consent
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Buck v Bell (1927) – US Supreme Court.
Carrie Buck, whose mother was mentally disabled, was
committed to an institution in 1924 aged 17.
Prior to her committal, she had given birth to a baby girl.
Carrie had been described as being “feeble- minded”.
Her baby daughter was also deemed to be “of defective
mentality”.
The manager of the institution decided that Carrie ought
to be sterilized to prevent her from becoming pregnant
again.
Carrie was fully aware of what this meant and she
objected to the sterilization.
Buck v Bell (1927) 274 US 200
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Carrie brought her claim to the US Supreme
Court, which ruled that the sterilisation was
lawful.
Justice Oliver Wendall Holmes (at 207-208):
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“It is better for all the world, if instead of waiting to
execute degenerate offspring for crime, or to let them
starve for their imbecility, society can prevent those
who are manifestly unfit from continuing their kind.
The principle sustains compulsory vaccination is broad
enough to cover cutting the fallopian tubes… Three
generations of imbeciles is enough.”
Daniels v Heskin [1954] IR 73
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Mrs Daniels gave birth to a child at home on 17th June 1951. She
was attended by the local midwife during the birth.
The next day, she was attended by the defendant, a medical doctor,
who inserted stitches in her perineum.
When the stitches were being inserted the needle broke.
Dr Heskin was unable to find the final portion of the broken needle.
However he finished the stitching leaving the broken part of the
needle inside the patient.
He failed to inform the patient or her husband about this incident.
Dr Heskin had left instructions with the midwife that the patient
should be X-rayed if anything unusual happened to the patient and
if the needle was not found within a 6 week period.
Daniels v Heskin [1954] IR 73
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Six weeks later, the midwife arranged for the patient to be examined
and X-rayed by a different doctor who performed an operation to
remove the broken portion of the needle.
Plaintiffs initiated a legal action for damages.
Supreme Court dismissed the claim finding that there was no
evidence to suggest that the breaking of the needle was caused by
negligence.
Furthermore, the defendant’s actions in completing the stitching &
deferring the operation to remove the needle were reasonable and
not negligent.
The Supreme Court deemed the non-disclosure of the
incident to be reasonable and did not constitute negligence.
There is no consideration of patient having a right to know.
Daniels v Heskin [1954] IR 73
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Per Kingsmill Moore, J.:
“I cannot admit any abstract duty to tell patients
what is the matter with them or, in particular, to
say that a needle has been left in their tissues.
All depends on the circumstances —the
character of the patient, her health, her
social position, her intelligence, the nature
of the tissue in which the needle is
embedded, the possibility of subsequent
infection, the arrangements made for
future observation and care, and
innumerable other considerations.”
Consent, medical trials & research subjects
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Tuskagee Syphilis Study, United States Public
Health Service 1932-1972
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This study was carried out to examine the
pathological evolution of syphilis if left untreated.
399 black sharecroppers in Macon County, Alabama
were denied treatment and therapy for syphilis and
prevented from getting treatment elsewhere.
Subjected to invasive research procedures which they
were told were ‘special free treatment.’
Irish Vaccine Trials 1960s-1970s
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211 children who were in resident care were
vaccinated as part of medical trials on vaccines for
common childhood illnesses.
Developing a culture of consent
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World War II – Nazi physicians, medical
treatment and experimentation.
Nuremberg Code 1947, supplemented by
Helsinki Declaration of the World Medical
Organisation 1964.
These international documents sought to
safeguard the safety and consent of research
subjects in medical trials and experimentation.
Changing attitudes in the latter half of the 20th
century in respect of patients’ rights and
individual autonomy.
Paternalistic approach to
consent
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Paternalistic approach stems from the
Hippocratic Oath.
Paternalistic approach conflicts with:
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Respect for patient autonomy
Current rights based approach to health care
Hippocratic Oath
I swear by Apollo the physician, and Asclepius, and Hygieia and
Panacea and all the gods and goddesses as my witnesses, that,
according to my ability and judgement, I will keep this Oath and
this contract:
To hold him who taught me this art equally dear to me as my
parents, to be a partner in life with him, and to fulfill his needs
when required; to look upon his offspring as equals to my own
siblings, and to teach them this art, if they shall wish to learn it,
without fee or contract; and that by the set rules, lectures, and
every other mode of instruction, I will impart a knowledge of the
art to my own sons, and those of my teachers, and to students
bound by this contract and having sworn this Oath to the law of
medicine, but to no others.
I will use those dietary regimens which will benefit my patients
according to my greatest ability and judgement, and I will do no
harm or injustice to them.
I will not give a lethal drug to anyone if I am asked, nor will I
advise such a plan; and similarly I will not give a woman a
pessary to cause an abortion.
Hippocratic Oath
In purity and according to divine law will I carry out my life and my
art.
I will not use the knife, even upon those suffering from stones, but
I will leave this to those who are trained in this craft.
Into whatever homes I go, I will enter them for the benefit of the
sick, avoiding any voluntary act of impropriety or corruption,
including the seduction of women or men, whether they are free
men or slaves.
Whatever I see or hear in the lives of my patients, whether in
connection with my professional practice or not, which ought not
to be spoken of outside, I will keep secret, as considering all
such things to be private.
So long as I maintain this Oath faithfully and without corruption,
may it be granted to me to partake of life fully and the practice
of my art, gaining the respect of all men for all time. However,
should I transgress this Oath and violate it, may the opposite be
my fate.
Paternalistic approach to consent
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Buchanan (1979) argued against full disclosure
of risk for 3 reasons:
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Doctor has an overarching duty to do no harm
In the context of a therapeutic relationship, the
patient will defer to the doctor to reach the clinically
appropriate decision
Danger that full explanation would confuse the
decision-making process for the patient who would
not possess the same technical expertise as the
doctor
(Contrast this with the more recent patients’
rights based approach to healthcare.)
Legal Recognition of Consent
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Slater v Baker and Stapleton (1767) 2 Wils
K.B. 359 (English decision)
The plaintiff hired a surgeon and
apothecary to remove bandages from the
plaintiff’s fractured leg.
This case is recognised as the first time
that the courts acknowledged that there is
a need to acquire patient’s consent for
medical intervention or treatment.
Slater v Baker and Stapleton (1767) 2 Wils
K.B. 359
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“…indeed it is reasonable that a patient
should be told what is about to be done to
him, that he may take courage and put
himseif in such a situation as enable him
to undergo the operation.”
Basic requirement of consent
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Rationale for consent epitomised by Cardozo J in
Schloendorff v Society of New York Hospital 211
NY 124 (1914)
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Female patient consented to examination of a fibroid
tumour under ether anaesthesia to determine if the
tumour was malignant.
Doctor discovered that the tumour was malignant &
removed it despite this being against the patient’s
wishes.
Plaintiff claimed that the operation to remove the
tumour constituted medical battery.
Consent to Medical Treatment
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“Every human being of adult years and sound
mind has the right to determine what shall be
done with his own body; and a surgeon who
performs an operation without the patient’s
consent commits an assault for which he is liable
in damages. This is true except in cases of
emergency where the patient is unconscious and
where it is necessary to operate before consent
can be obtained.”
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Cardozo, J., Schloendorff v Society of New York
Hospital 211 NY 124 (1914)
USA - Canterbury v Spence 464 F2d
772 (DC Cir 1972)
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This decision provides the basis for the requirement for
informed consent.
Patient had undergone elective thoracic spine surgery for
a herniated disc.
Surgeon failed to inform the patient of the risk of
paralysis.
In court, the surgeon claimed that the reasons for not
providing the patient with this information was that the
risk of paralysis was small and that disclosure of the risk
may have caused the patient unnecessary anxiety that
could have resulted in the patient postponing a medical
procedure that was essential.
Canterbury v Spence 464 F2d 772 (DC
Cir 1972)
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“true consent to what happens to one’s self is
the informed exercise of a choice, and that
entails an opportunity to evaluate
knowledgeably the options available and the
risks attendant upon each… it is the prerogative
of the patient, not the physician, to determine
for himself the direction in which his interests
seem to lie.”
The principle that a doctor has a duty to disclose
information about medical procedures has been
widely accepted.
USA: Canterbury v Spence 464 F2d
772 (DC Cir 1972)
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“demand for the patient’s right to selfdetermination on particular therapy
demands a standard set by law for
physicians rather than one which
physicians may or may not impose upon
themselves”
Therapeutic privilege still exists to
withhold certain information.
Consent for Medical
Intervention
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Who is a competent patient?
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Person who has reached the age of majority
What about mentally ill patients?
Children?
Consent is necessary for:
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Examination
Diagnosis
Treatment
Consent
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Fundamental prerequisite for medical treatment.
Sufficient information.
Exceptions to the principle of consent:
- emergency situation;
- therapeutic privilege;
- patient lacks capacity to understand the
information involved.
Criteria necessary for genuine consent
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Information
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Capacity
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Voluntariness
Problems with professional standard of
disclosure
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Fails to protect patient autonomy.
Patients only told what medical
professionals, as a group, want them to be
told.
Imbalance in professional relationship
(doctor knows best) means many patients
do not ask questions.
Information needs vary among patients.
Consent & Irish Law
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No specific reference to consent to medical
treatment in the Irish Constitution (Bunreacht na
hÉireann).
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Both the High Court and Supreme Court have
developed the legal principles of the right to
consent and to refuse to medical treatment in
Ireland as a Constitutional right.
Section 23, Non-Fatal Offences Against the
Person Act 1997
Mental Health Act 2001
The Irish Constitution & the right to
consent
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Ryan v Attorney General [1965] IR 294
Supreme Court established that a competent
adult has a Constitutional right to bodily integrity
Justice Kenny explains that this means that:
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“…no mutilation of the body of any of its members
may be carried out on any citizen under authority of
the law.”
Every person has the right object to any form of
bodily interference or restraint.
Every patient must consent to medical
intervention.
Competence & Consent in Irish
Law
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Competent adult patient must consent to
treatment
In re a Ward of Court (withholding medical
treatment) (No.2) [1996] 2 IR 79
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“There is an absolute right in a competent person to
refuse medical treatment even if it leads to death.”
(Justice O’Flaherty)
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Right to bodily integrity; right to privacy and
right to self-determination.
Competent adult patient must consent to
treatment.
Consent
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“Medical treatment may not be given to an adult person
of full capacity without his or her consent. There are a
few rare exceptions to this e.g., in regard to
contagious diseases or in a medical emergency
where the patient is unable to communicate. This
right arises out of civil, criminal and constitutional law. If
medical treatment is given without consent it may be
trespass against the person in civil law, a battery in
criminal law, and a breach of the individual's
constitutional rights. The consent which is given by an
adult of full capacity is a matter of choice. It is not
necessarily a decision based on medical considerations.
Thus, medical treatment may be refused for other than
medical reasons, or reasons most citizens would regard
as rational, but the person of full age and capacity may
make the decision for their own reasons.”
In Re a Ward of Court (withholding medical treatment) (No. 2)
[1996] 2 IR 79, 156 (Denham J.).
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Consent
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Ward [1996] 2 IR 79, at 156.
“The requirement of consent to medical
treatment is an aspect of a person's right
to bodily integrity under Article 40, s.3 of
the Constitution”
Who can give consent?
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In Re a Ward of Court (withholding medical
treatment) (No 2), [1996] 2 IR 79, Denham J.:
“Medical treatment may not be given to an
adult person of full capacity without his or
her consent…If the patient is a minor then
consent may be given on their behalf by
parents or guardians. If the person is
incapacitated by reason other than age,
then the issue of capacity to consent
arises… where the patient is a ward of
court, the court makes the decision.”
When is consent valid?
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In order for consent to be valid it must
be given:
(i) by a person who has capacity;
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(ii) voluntarily, without duress;
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(iii) with the knowledge of the side
effects,
potential
risks
and
the
alternative treatments
which
are
available to the patient
How can consent be given?
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Express – In writing, orally
Implied – the patients behaviour indicates
that they are consenting to the treatment
Notwithstanding that there may be
express or implied consent, the consent
must be valid i.e. the person must be
aware of all of the consequences of the
procedure.
Trespass to the Person
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Section 23 of the Non-Fatal Offences against the
Person Act, 1997
23.—(1) The consent of a minor who has attained the age
of 16 years to any surgical, medical or dental treatment
which, in the absence of consent, would constitute a
trespass to his or her person, shall be as effective as it
would be if he or she were of full age; and where a
minor has by virtue of this section given an effective
consent to any treatment it shall not be necessary to
obtain any consent for it from his or her parent or
guardian.
(2) In this section “surgical, medical or dental treatment”
includes any procedure undertaken for the purposes of
diagnosis, and this section applies to any procedure
(including, in particular, the administration of an anaesthetic)
which is ancillary to any treatment as it applies to that
treatment.
The Irish Patients Charter 1992
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8 CONSENT TO TREATMENT
Generally, treatment should only be given to a patient
with his or her informed consent or, in the case of a
child, the consent of a parent or guardian. You may
request the presence of a person or persons of your
choosing during the procedure for granting consent. The
consent form you are asked to sign should clearly
state the nature of the procedure to be
undertaken.
Only in cases where a patient lacks the capacity to
give or withhold consent, and where a qualified
medical doctor determines that treatment is urgently
necessary in order to prevent immediate or imminent
harm, may treatment be given without informed
consent
European Charter of Patients
Rights 2002
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4-Right to Consent
Every individual has the right of access to
all information that might enable him or
her to actively participate in the decisions
regarding his or her health; this
information is a prerequisite for an
procedure and treatment, including the
participation in scientific research.
Article 8 of the European
Convention on Human Rights
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Right to consent to medical treatment
Junke v Turkey, 2008
Gynaecological examination was forced
upon the applicant when in custody was
held to be ‘imposed on the applicant
without her free and informed consent’
and therefore it was not ‘in accordance
with the law’ or ‘necessary in a democratic
society’
Article 8 ECHR - Junke v
Turkey
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‘Under Article 8 of the Convention and in
the light of the Court’s settled case-law,
according to which any medical
intervention against the subject’s will, or
without the free, informed and express
consent of the subject, constitutes an
interference with his or her private life’
[Junke v Turkey, 13th May 2008,
Application no. 52515/99, ECtHR]
Irish Medical Council’s Guide to
Ethical Conduct and Behaviour 7th Ed
[2009]
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Section D – Consent to Medical Treatment
33.1 You should ensure that informed
consent has been given by a patient before
any medical treatment is carried out. The
ethical and legal rationale behind this is to
respect the patient’s autonomy and their right to
control their own life. The basic idea of personal
autonomy is that everyone’s actions and
decisions are their own. Therefore, the patient
has the right to decide what happens to their
own body.
Irish Medical Council’s Guide to
Ethical Conduct and Behaviour 7th Ed
[2009]
35 Informed consent to medical treatment
 35.1 Consent given by the patient is the exercise of a
voluntary choice; it is the giving of permission for the
intervention to be carried out by competent
professionals, where possible in an appropriate
environment. You should explain the process in such a
way as to ensure that patients do not feel that their
consent is simply a formality or a signature on a page.
 35.2 As part of the informed consent process,
patients must receive sufficient information, in a
way that they can understand, to enable them to
exercise their right to make informed decisions
about their care. This refers to the disclosure of
all significant risks or substantial risks of grave
adverse consequences.