Role of Consent in Medical Practice
Written consent, apart from becoming documentary evidence in a judicial trial, is also a
confirmation of patient autonomy—the basis of modern bioethics.
Consent may be express or implied. Express consent is an oral or written authority by the
patient to render the proposed treatment. Consent may be implied from the conduct of the patient
in a particular case, or from the application of law, to certain factual situations. A patient who
voluntarily submits to treatment under circumstances which would indicate awareness of the
planned treatment impliedly authorizes the treatment, even without express consent. A patient
who presents himself or herself at the doctor’s office for a routine procedure implies his or her
consent to treatment.
There is a significant difference in the nature of express consent of the patient, known as ‘real
consent’ in the UK and as ‘informed consent’ in the USA. In the UK, the elements of consent are
defined with reference to the patient and a consent is considered to be valid and ‘real’ when (i)
the patient gives it voluntarily without any coercion; (ii) the patient has the capacity and
competence to give consent; and (iii) the patient has a minimum level of information about the
nature of the procedure to which she/he is consenting to. On the other hand, the concept of
‘informed consent’ developed by American courts, while retaining the basic requirements of
consent, shifts the emphasis to the doctor to disclose necessary information to the patient to
secure his/her consent
An invasive therapeutic or investigative procedure without consent is technically a battery
(Trespass” has been defined which generally means interfering with personal property or body
or liberty, which is considered as wrong in legal terminology. Where there is a consent there is
no trespass and if some medical practitioner examines the person other than that of emergency he
will be liable for the same, under the law of torts.) which can be tried either under criminal or
tort (civil) law. When it is a criminal offence, the indictments are framed under the penal code
and when compensation is involved, tort law is used. The Indian Penal Code (IPC) is not specific
about the age at which a person can give valid consent. At present, the minimum legal age to
give valid consent to undergo medical treatment is ambiguous.
Section 87 of the IPC says that a person above 18 years of age can give valid consent.
((volunti nonfit injuria ))Act not intended and not known to be likely to cause Death or
Grievous Hurt, done by consent Nothing which is not intended to cause death, or
grievous hurt, and which is not known by the doer to be likely to cause death or grievous
hurt, is an offence by reason of any harm which it may cause, or be intended by the doer
to cause, to any person, above eighteen years of age, who has given consent, whether
express or implied, to suffer that harm; or by reason of any harm which it may be known
by the doer to be likely to cause to any such person who has consented to take the risk of
that harm.
Section 89 Act done in Good Faith for Benefit of Child or Insane Person, by Consent of
Guardian. Section 89 of the IPC says that a child under 12 years of age cannot give a
valid consent.
Section92 of the IPC (Act done in Good Faith for Benefit of a Person without
Consent)offers legal immunity to a registered medical practitioner to proceed with
appropriate treatment even without the consent of the patient in an emergency when the
victim is incapable of understanding the nature of the treatment or when there are no
legal heirs to sign the consent.
The Medical Termination of Pregnancy Act, 1971
When Pregnancies may be terminated by registered medical practitioners: the continuance of
the pregnancy would involve a risk to the life of the pregnant woman or of grave injury
physical or mental health Ex: 1)Where any pregnancy is alleged by the pregnant woman to
have been caused by rape, the anguish caused by such pregnancy shall be presumed to
constitute a grave injury to the mental health of the pregnant woman. 2)No pregnancy of a
woman, who has not attained the age of eighteen years, or, who, having attained the age of
eighteen years, is a lunatic, shall be terminated except with the consent in writing of her
guardian
Section 5, PCPNDT Act, 1994: Written consent of pregnant woman and prohibition of
communicating the sex of foetus. 1. No person shall conduct the pre-natal diagnostic
procedures unless
(a) he has explained all known side and after effects of such procedures to the pregnant
woman concerned;
(b) he has obtained in the prescribed form her written consent to undergo such procedures
in the language which she understands; and
(c) a copy of her written consent obtained under clause (b) is given to the pregnant
woman.
CASES:
1) Schloendorff v Society of New York Hospitals,1914: Justice Cardozo in Schloendorff v
Society of New York Hospitals,1914 offered what has become perhaps the best-known
statement of the principle of consent: ‘Every human being of adult years and sound
mind has a right to determine what shall be done with his own body: and a surgeon
who performs an operation without his patient’s consent commits an assault...’
2) Canterbury v. Spence ,1972, Until the 1960s, it was conventional medical doctrine to
withhold significant information from patients, particularly potentially upsetting
information. Jerry Canterbury was an F.B.I. clerk who suffered a ruptured disk in 1958,
was operated on by Dr. Spence, a well-known Washington neurosurgeon, and as a result
of the surgery, and he ended up paralyzed below the waist and incontinent. Canterbury
sued for malpractice on the grounds of negligence. At the second trial, Dr. Spence
acknowledged that he had told Canterbury and his mother only that the surgery might
result in “weakness" without mentioning paralysis, and that he avoided a more specific
warning so as not to deter the patient from pursuing the operation. Nevertheless, the jury
ruled against Canterbury (the court rejected the professional practice standard of
disclosure, as general approach at that time the approaches were what a reasonable
practitioner would have done under the circumstances, what medical custom in the
community would demand.)
The major legal implication of the decision was that it largely shifted our culture from a
‘professional practice standard’ to a ‘reasonable person standard’ in malpractice cases
3) Border v Lewisham and Greenwich NHS Trust [2015] was a Court of Appeal decision
before Montgomery. It highlights the importance of considering not only whether a
treatment is acceptable but whether the patient has consented at all.
The claimant was a 64 year old woman who had fractured her right humerus. She was
taken to the Emergency Department of Queen Elizabeth Hospital in Woolwich where the
duty SHO wanted to put an IV line into her arm. This was standard procedure. There was
no immediate need to do so but it ensured that staff would be ready should an emergency
arise.
He was unable to use her injured right arm and normal practice would have been to use
the left. However, as she told the doctor, she had recently undergone a left mammectomy
and axillary node clearance in the left arm. As a result there was a risk of oedema if he
used the left arm. The options were either to go ahead using the left arm or to wait and
see whether a cannula would actually be needed at a later stage. There was a conflict of
evidence as to exactly what happened. However the judge accepted the claimant’s
account that the doctor in effect made a ‘quick and silent calculation’ and only
communicated with the claimant to the extent of saying something like, ‘I’m sorry, but
we really need to put it in the left arm’. She hardly realised what was happening until it
was done.
She went on to develop a permanent and serious case of oedema in the left arm which
caused significant disability.
At first instance the judge found that the decision to insert a line in the left arm rather
than adopting a ‘wait and see’ approach accorded with accepted practice. On appeal, the
claimant raised a case which had not been argued at trial. She argued (and this was
contested by the Defendant) that there had been a finding of fact that the doctor had not
obtained her consent before inserting the cannula. On that ground there was a breach of
duty in failing and she was entitled to judgment. The fact that the doctor acted in
accordance with accepted practice did not mean he was entitled to do so without consent.
The Court of Appeal granted a declaration that the doctor was in breach of his duty in
inserting the cannula without the claimant’s consent and remitted that claim to the judge
to determine causation.
4) Montgomery v Lanarkshire Health Board: Ms Montgomery was admitted to hospital in
Lanarkshire for the delivery of her baby. There was a relatively high risk of shoulder
dystocia of 9-10% because of the mother’s diabetes and her small size. There was a
relatively low risk of prolonged hypoxia from shoulder dystocia of around 0.1%. She was
not advised of the risks of vaginal delivery as opposed to Caesarean section.
Unfortunately the risk materialised and her baby was born severely disabled.
The obstetrician’s evidence was that she did not advise Ms Montgomery of the increased
possibility of shoulder dystocia because the risk of a grave problem for the baby was so small. If
the condition had been mentioned, most women would elect for a Caesarean section although
this would not be in their interests.
The Supreme Court therefore rejected application of the Bolam test to a doctor’s duty to advise.
The test was not whether a doctor acted in accordance with a practice accepted as proper by a
responsible body of medical practitioners but was based instead on what a particular patient
would expect to know.
‘An adult person of sound mind is entitled to decide which, if any, of the available forms of
treatment to undergo, and her consent must be obtained before treatment interfering with her
bodily integrity is undertaken. The doctor is therefore under a duty to take reasonable care to
ensure that the patient is aware of any material risks involved in any recommended treatment,
and of any reasonable alternative or variant treatments. The test of materiality is whether, in the
circumstances of the particular case, a reasonable person in the patient’s position would be
likely to attach significance to the risk, or the doctor is or should reasonably be aware that the
particular patient would be likely to attach significance to it.’
There are 3 exceptions but not to be abused:
1. Where a patient tells a doctor that she does not want to know the risks.
2. The ‘therapeutic exception’: ie if disclosure of the risk would be seriously detrimental to a
patient’s health; and
3. Necessity: for instance an unconscious patient requiring urgent treatment.
5) Thefaut v Johnson [2017]: Mrs Thefaut was found not to have given valid consent to
spinal surgery because the advice her surgeon gave was inaccurate. Experts gave
evidence at trial as to the percentage risks and benefits of surgery as opposed to
conservative treatment. He had under-estimated the risks of surgery, over-estimated its
benefits and failed to advise on the benefits of conservative management as an alternative
to surgery.
6) In Samira Kohli vs Dr Prabha Manchanda,(2008) the Supreme Court of India states
that consent in the context of a doctor–patient relationship is defined as grant of
permission by the patient for an act to be carried out by the doctor, such as a diagnostic,
surgical or therapeutic procedure. Consent can be implied in some circumstances from
the action of the patient. This order gives the principles of consent with regard to medical
treatment and therapeutic investigations and not for medical research/clinical trials as
follows:
A doctor has to seek and secure the consent of the patient before commencing a
‘treatment’. The consent so obtained should be real and valid; the consent should
be voluntary; and the consent should be on the basis of adequate information
concerning the nature of the treatment procedure, so that she/he knows what
she/he is consenting to.
A balance should be maintained between the need for disclosing necessary and
adequate information and at the same time avoid the possibility of the patient
being deterred from agreeing to a necessary treatment or offering to undergo an
unnecessary treatment.
Consent given only for a diagnostic procedure cannot be considered as consent
for treatment. Consent given for a specific treatment procedure is not valid for
some other treatment or procedure.
There can be a common consent for diagnostic and operative procedures where
they are contemplated. There can also be a common consent for a particular
surgical procedure and an additional or further procedure that may become
necessary during the course of surgery.
7) Dr. T.T. Thomas vs. Elisa (1987): ……This doesn’t mean that if the patient is in critical
condition(appendicitis) the doctor will not operate him by saying I was not having
consent the High Court stated in Dr. T.T. Thomas vs. Elisa [10]that” the consent factor
may be important very often in cases of elective operations which may not be imminently
necessary to save the patient’s life. But there can be instances where a surgeon is not
expected to say that “I did not operate him because I did not get his consent.” Such cases
also include emergency operations where a doctor cannot wait for the consent of his
patient or where the patient is not in a fit state of mind to give or not to give a conscious
answer regarding consent. So, the doctor must perform his duty if it’s an emergency he
cannot refuse that I am not having any consent regarding it.