Medicolegal Aspects of Consent in Clinical Practice

Amit M. Patil*, Vyankatesh T. Anchinmane**

Abstract
Consent form is an integral part of patient treatment and management. The concept
of informed consent arises from the fundamental ethical principle of autonomy and
right of self-determination. The core idea of autonomy is one's action and decisions
are one's own. Therefore every patient has the right to know what happens to his
body. It is the moral and legal duty of a physician to inform the patient about all the
aspects of his illness and help him by advising so that he is able to make a logical and
intelligent decision about his treatment. Examining or treating a patient without his
consent amounts to battery and assault and may invite legal liabilities for a
physician. Also a well-taken and documented informed consent acts as a good
defence for a physician in matters of medical negligence. Any research involving
potential subjects, invasive procedures and examination of person for medicolegal
purpose, publication of patient's data in articles requires informed consent. This
article is an attempt to highlight the core issues related to consent.

Introduction The origin of the word consent is from the

E very 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 patient's consent commits an
assault for which he is liable in damages.' -
Judge Cardozo (1914)
With these words Judge Cardozo,
expressed patient's right to autonomy in
making informed decision pertaining to
his medical treatment.1 In other words it
means any examination or treatment done
by a doctor is unlawful unless done with
the consent of the patient.
The literature meaning of the word
consent is permission for something to
happen or agreement to do something or to
give permission for something to happen.
*Asst. Prof. in Forensic Medicine and Toxicology,
Padmashree Dr. D. Y. Patil Medical College Hospital
and Research Centre, Nerul - 400 706. **Asst. Prof. in
Pathology, Dept. of Pathology, Topiwala National
Medical College and B Y L Nair Ch Hospital, Mumbai
Central, Mumbai - 400 008.
French word 'consente' and the Latin word
'consentire', which means co 'together' +
sentire 'feel’.2
Sec 13 of the Indian Contract Act 1872
defines that, 'two or more persons are said
to consent when they agree upon the same
thing in the same sense’.3 As the physician
patient relationship is a contract, it is
essential to take consent before taking a
patient for treatment. Examining or
treating a patient without taking his
consent amounts to battery and assault.
Importance of consent
1. Consent represents the right of a
patient to make a decision regarding his
medical treatment.
2. C o n s e n t m e a n s v o l u n t a r y
participation of the patient in his own
treatment by a physician or any health
care institute.
3. Consent is mandatory for all
diagnostic and therapeutic procedures

Bombay Hospital Journal, Vol. 53 , No. 2 , 2011 203

that have risk/adverse effects or
complications.
4. Consent is very much essential in
all medicolegal cases.
Types of Consent
1. Implied Consent
In implied consent, the behaviour and
the conduct of a patient indicate his
consent. It implies consent to medical
examination in a general sense e.g. when a
patient put forth his arm for
intramuscular injection. Though it is not
expressed it is legally effective. This is the
most common form of consent seen in
medical practice. But such type of consent
is generally restricted to general and
common procedures of medical
examination. Beyond basic procedures it
is necessary to take a full expressed
informed consent.
2. Expressed consent
In expressed consent, a patient
specifically expresses his free consent to a
physician to undertake diagnostic or
therapeutic treatment. This may be
expressed either verbally or in writing after
having the patient informed about all the
aspects of the diagnostic and therapeutic
procedure.
When the patient conforms verbally to
a specific diagnostic or therapeutic
procedure it is called as oral or verbal
expressed consent and when he gives it in
writing it is called as written expressed
consent. Both the forms of expressed
consent are accepted in the court of law as
proof of consent, but it is the written
expressed consent, which has more value,
as it is a permanent record. But expressed
consent must conform to the doctrine of
informed consent to be legally acceptable.
3. Blanket Consent
It is a consent taken on a printed form
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that covers almost everything that a doctor
or hospital might do to a patient, without
mentioning specifically. Blanket consent
is legally inadequate for any procedure
that has risks and alternatives. 4
Doctrine of Informed Consent
Literally informed consent means
permission granted in the knowledge of
the possible consequences, typically that
which is given by a patient to a physician
for treatment or for any other procedure
with full knowledge of the possible risks
and benefits.2 The basic aim of informed
consent is to give sufficient information to
a patient so that he can take a
knowledgeable and informed decision
about the drug, device or procedure
proposed for him in the course of
treatment after having him explained
about all the known possible and
foreseeable risks associated with it. The
doctrine of informed consent also gives a
patient the right to refuse the proposed
treatment.
Physicians have a moral, ethical and
legal duty to provide all the necessary and
relevant information to a patient that
helps him to make a rational and
intelligent decision about the proposed
treatment, whether to accept or refuse the
treatment. Legally, treating a patient
without his valid informed consent may
entice action for negligence. Even if
implied consent is taken before treatment
of the patient and the treatment is
satisfactory, action for negligence can still
be initiated if the physician has not
adhered to all the components of doctrine
of informed consent. Depriving patient by
nondisclosure of relevant information that
would enable a patient to make a wise
choice, and which is the cause of alleged
injury, may form a prima facie case for
negligence.
Bombay Hospital Journal, Vol. 53 , No. 2 , 2011
Elements of informed consent
a) Disclosure of information
b) Free and voluntary decision
c) Capacity to decide
a) Disclosure of information
It includes the following :
1. A doctor should explain to his
patient the exact nature of the disease or
the ailment.
2. A patient must be explained the
need for the treatment and the nature of
the procedure along with the expectation
form the line of treatment recommended
along with the likely chances of success.
3. He should be made aware of the
alternative forms of treatment available
with benefits and reasonably foreseeable
adverse effects/risks and complications
involved in both the proposed and
alternative procedure.
4. The right to choose between
proposed and alternative procedure.
5. The right to refuse all of them and
the medicolegal consequences of such
refusal.
6. Informed consent is an ongoing
process rather than a mere signed form
which involves doctor's readiness to listen
and discuss patients problems especially
concerned with the proposed treatment.
b) Free and voluntary consent
The patient's consent must be
voluntary and free from coercion, force
and misrepresentation of facts. Consent to
be legally valid must be intelligent,
informed and voluntary and should be
taken freely and exclusively by the patient.
Nobody is authorized to give consent on
behalf of the patient (with few exception
discussed later).
Bombay Hospital Journal, Vol. 53 , No. 2 , 2011
c) Capacity to decide
This forms the most important aspect
of informed consent. A competent person
who is able to understand the nature of the
act and logical consequences of the act
should give consent. The person should be
mature enough to understand, analyse
and assess the risks and benefits
associated with such form of proposed
treatment and accept the responsibility for
the informed consent given to such
treatment. A competent person must fulfil
following criteria's,
1. He should be of sound disposing
mind.
2. He should be legally competent to
do so.
3. He should have proper reasoning
for his decision.
4. He should be able to understand
the implications of his consent.
5. He should be at least 12 years of
age.
6. The informed consent will be
legally valid when all the above-
mentioned components of
informed consent are met.
Disclosure
The word disclosure means the action
of making new or secret information
known or a fact, especially a secret that is
made known (The New Oxford Dictionary
of English).
The responsibility of disclosure of
information relevant to a case rests with
the treating physician. The physician
decides what and how much information
to be disclosed by taking the patient’s
psychological condition into
consideration. Once a physician patient
relationship is established then it is the
legal duty of the physician to explain him
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about the diagnosis, treatment,
alternative treatment available, their risks
and the benefits associated with it.
Sometimes the disclosure of information
may disturb the patient mentally and
psychologically, and he may refuse the
treatment that involves a minimal risk. In
such situation the treating physician may
discuss and seek consent from one of his
close relative (a condition called
therapeutic privilege).
A full written informed consent forms
the legal documentary proof of disclosure
of information. Verbal consent poses a
difficult challenge for the physician
regarding adequate disclosure of
information. To overcome this issue, it is
necessary that the treating physician
mention and record the material
information pertaining to the case in
clinical indoor papers. Any
communication problems like illiteracy,
language need to be addressed properly.
But there are certain exceptions to
material disclosure :
Firstly, the disclosure of information
may pose a psychological threat to the
patient (therapeutic privilege or
professional discretion).
Secondly, the patient may waive his
right to make an informed consent and
may remain ignorant, as he is already
aware of the risks or had undergone
similar procedure in the past.
Thirdly, doctor need not explain or
advise the patient what he already knows.
Fourthly, in cases of emergencies
where the patient is unconscious or
incapable to give valid consent.
Ingredients of a legally valid informed
consent
For consent to be legally valid it must
fulfil following criteria :
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1. A person of sound disposing mind
should give the consent.
2. The consent should be given
voluntarily, without any fear,
force, fraud, undue duress,
coercion, misrepresentation of
facts and threats of physical
violence, death etc.
3. The consent needs to be free, fair,
uninhibited, clear, direct and
personal.
4. The consent should be well
informed.
5. The consent should be taken prior
to the procedure (therapeutic or
diagnostic).
6. The consent should be complete
and specific.
7. The consent should be given by a
competent person means by a
person who is of sufficient
maturity to understand the
nature and consequence of the act
to which he has given consent.
8. A third uninterested party must
witness the consent.
Consent for medical examination and
care
Consent is essential in all cases where
a patient comes or is brought for
examination or treatment. The type of
consent varies from case to case pertaining
to the proposed treatment. If a patient
refuses to give consent then he cannot be
examined nor can be treated. Informed
consent is necessary where the
examination and treatment involves
beyond routine medical examination.
Consent is obligatory for blood
transfusion, organ transplantation,
artificial insemination, sterilization,
medical termination of pregnancy and all
Bombay Hospital Journal, Vol. 53 , No. 2 , 2011
other forms of invasive diagnostic and
therapeutic procedures.
In case of emergency consent is taken
from the patient if he is conscious,
oriented, competent and able to freely
express his willingness to accept the
treatment. In emergency situation
involving unconscious person and there is
no one who can give consent on his/her
behalf, consent can be taken from the
Assistant Medical Officer (AMO) on duty or
rather the situation gives consent for
treatment (Emergency Doctrine)
immunity from prosecution by sec 93 of
IPC (Act done in good faith for benefit of a
person without his consent).
The victim and the accused in all
medicolegal cases can be examined only
after they have given full written expressed
informed consent. If he/she refuses,
nobody can force them for examination.
Procedure for examination and an accused
and victim is done as per sec 53 and sec 54
of CrPC (Criminal Procedure Code).
Sections of IPC and CrPC related to
consent 5
Sec 87 IPC - A person above 18 years of
age can give valid consent to suffer any
harm, which may result from an act not
intended or not known to cause death or
grievous hurt.
Sec 88 IPC - A person can give valid
consent to suffer any harm that may result
from an act, not intended or not known to
cause death, done in good faith and for its
benefit.
Sec 89 IPC - Act done in good faith for
benefit of child or insane person, by or by
consent of guardian.
Sec 90 IPC - Consent to be given under
fear or misconception.
Sec 92 IPC - Act done in good faith for
benefit of a person without consent.
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Sec 53 CrPC - Examination of accused
by medical practitioner at the request of
police officer.
Sec 54 CrPC - Examination of arrested
person be medical practitioner at the
request of the arrested person.
Consent in special circumstances
1. If the patient happens to be a child
below 12 years of age, consent from the
parent or guardian is taken.
2. In emergency, involving child
when parents and guardians are not
available consent can be taken from the
person who is in charge of the child (Loco
Parentis).
3. Consent given for an illegal act is
not valid.
4. In case of emergency where the
patient is unconscious and incapable to
give consent, emergency doctrine is
applicable.
5. Consent of spouse for operation
and treatment in the routine course is not
necessary. But consent is required if the
operation or instrument involves danger to
the life or impairment of sexual functions.
6. Consent of both the spouses is
essential for an operation which involves
reproductive and sexual organs e.g.
sterilization. For artificial insemination
donor the consent of both the recipient
husband and wife and that of the donor
and his wife is obligatory.
7. Under Medical Termination of
Pregnancy Act 1972, for MTP the consent
of pregnant woman is sufficient if she is
above 18 year of age and has sound
disposing mind. In case, if she is below 18
years of age, unconscious or insane
consent of parent or legal guardian is
essential.
8. As per Sec 375 IPC, a female of
207
more than 16 years of age can give valid
consent for sexual intercourse. Therefore
sexual intercourse by a man with a woman
of less than 16 yrs even with her consent
amounts to rape.6
9. P r o f e s s i o n a l S e c r e c y A n y
information regarding the nature of illness
of the patient should not be disclosed to a
third party without his consent except in
i) Privileged communication.
ii) In case of negligence against the
doctor where he can reveal the
secrets in his defence.
iii) When asked by the honorable
court or judge.
10. It is mandatory to take consent
from the next of kin of a deceased person
for performing clinico pathological
autopsy. No consent required for
medicolegal autopsy as the law of the land
gives the consent.
11. Under The Transplantation of
Human Organs Act 2000, a donor means a
person who is above 18 years of age and
voluntarily authorizes the removal of any
of his organ for therapeutic
transplantation. For cadaveric
transplantation, consent form the next of
kin, who is in possession of the dead body,
is taken.
12. For publication of patient's record
or data or photographs, in articles or
journals, it is necessary to take consent
from them with the assurance of
protection of their identity.
13. Mandatory to take written
informed consent from the subjects who
are participating in a biomedical research
programme (Clinical Trial). The guidelines
for this purpose has been inducted in
Declaration of Helsinki, Belmont Report,
ICH GCP guidelines, Nuremberg Code and
ICMR guidelines for participating in
208
biomedical research.
Conclusion
1. Examination and treatment of a
patient without his consent amounts to
battery and assault.
2. Disclosure of patient's nature of
illness without his consent amounts to
professional negligence.
3. C o n s e n t n o t r e q u i r e d i n
emergency case where there is danger to
the life of the patient (Emergency
Doctrine).
4. Mandatory to take consent in all
medicolegal cases.
5. B e y o n d r o u t i n e m e d i c a l
examination of a patient, expressed
written informed consent is essential.
6. Informed consent mandatory for
subjects participating in clinical trials.
7. Informed consent acts as best
defence for physician against the charges
of negligence.
References
1. Krishan Vij. Consent to and refusal of
treatment. In : Textbook of Forensic Medicine
and Toxicology, Principles and Practice. 3rd
edition. Elsevier, 2005; 527-34.
2. Dogra T D, Lt. Col. Abhijit Rudra. Consent in
medical practice. In : Lyon's Medical
Jurisprudence and Toxicology. 11th edition.
Delhi Law House, 2005; 180-208.
3. Dikshit PC. Laws in relation to medical practice.
In: Textbook of Forensic Medicine and
Toxicology. 1st edition. Peepee Publishers and
Distributors (P) Ltd, 2007; 19-20.
4. Yadwad BS, Gouda H. Consent - its medicolegal
aspects. JAPI Oct. 2005; 53:891-94.
5. The Code of Criminal Procedure, 1973 and The
Indian Penal Code, 1860 In: Criminal Manual.
Universal Law Publishing Company Pvt Ltd.
2002;368-72.
6. Reddy KSN. Medical law and ethics. In : The
Essentials of Forensic Medicine and Toxicology.
21st edition. Sugunadevi K, 2002;40 -44.
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