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

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

that have risk/adverse effects or that covers almost everything that a doctor
complications. or hospital might do to a patient, without
4. Consent is very much essential in mentioning specifically. Blanket consent
all medicolegal cases. is legally inadequate for any procedure
that has risks and alternatives. 4
Types of Consent
Doctrine of Informed Consent
1. Implied Consent
Literally informed consent means
In implied consent, the behaviour and
permission granted in the knowledge of
the conduct of a patient indicate his
the possible consequences, typically that
consent. It implies consent to medical
which is given by a patient to a physician
examination in a general sense e.g. when a
for treatment or for any other procedure
patient put forth his arm for
with full knowledge of the possible risks
intramuscular injection. Though it is not
and benefits.2 The basic aim of informed
expressed it is legally effective. This is the
consent is to give sufficient information to
most common form of consent seen in
a patient so that he can take a
medical practice. But such type of consent
knowledgeable and informed decision
is generally restricted to general and
about the drug, device or procedure
common procedures of medical
proposed for him in the course of
examination. Beyond basic procedures it
treatment after having him explained
is necessary to take a full expressed
about all the known possible and
informed consent.
foreseeable risks associated with it. The
2. Expressed consent doctrine of informed consent also gives a
In expressed consent, a patient patient the right to refuse the proposed
specifically expresses his free consent to a treatment.
physician to undertake diagnostic or Physicians have a moral, ethical and
therapeutic treatment. This may be legal duty to provide all the necessary and
expressed either verbally or in writing after relevant information to a patient that
having the patient informed about all the helps him to make a rational and
aspects of the diagnostic and therapeutic intelligent decision about the proposed
procedure. treatment, whether to accept or refuse the
When the patient conforms verbally to treatment. Legally, treating a patient
a specific diagnostic or therapeutic without his valid informed consent may
procedure it is called as oral or verbal entice action for negligence. Even if
expressed consent and when he gives it in implied consent is taken before treatment
writing it is called as written expressed of the patient and the treatment is
consent. Both the forms of expressed satisfactory, action for negligence can still
consent are accepted in the court of law as be initiated if the physician has not
proof of consent, but it is the written adhered to all the components of doctrine
expressed consent, which has more value, of informed consent. Depriving patient by
as it is a permanent record. But expressed nondisclosure of relevant information that
consent must conform to the doctrine of would enable a patient to make a wise
informed consent to be legally acceptable. choice, and which is the cause of alleged
injury, may form a prima facie case for
3. Blanket Consent
negligence.
It is a consent taken on a printed form

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

Elements of informed consent c) Capacity to decide
a) Disclosure of information This forms the most important aspect
b) Free and voluntary decision of informed consent. A competent person
who is able to understand the nature of the
c) Capacity to decide
act and logical consequences of the act
a) Disclosure of information should give consent. The person should be
It includes the following : mature enough to understand, analyse
1. A doctor should explain to his and assess the risks and benefits
patient the exact nature of the disease or associated with such form of proposed
the ailment. treatment and accept the responsibility for
the informed consent given to such
2. A patient must be explained the
treatment. A competent person must fulfil
need for the treatment and the nature of
following criteria's,
the procedure along with the expectation
form the line of treatment recommended 1. He should be of sound disposing
along with the likely chances of success. mind.
3. He should be made aware of the 2. He should be legally competent to
alternative forms of treatment available do so.
with benefits and reasonably foreseeable 3. He should have proper reasoning
adverse effects/risks and complications for his decision.
involved in both the proposed and 4. He should be able to understand
alternative procedure. the implications of his consent.
4. The right to choose between 5. He should be at least 12 years of
proposed and alternative procedure. age.
5. The right to refuse all of them and 6. The informed consent will be
the medicolegal consequences of such legally valid when all the above-
refusal. mentioned components of
6. Informed consent is an ongoing informed consent are met.
process rather than a mere signed form Disclosure
which involves doctor's readiness to listen
The word disclosure means the action
and discuss patients problems especially
of making new or secret information
concerned with the proposed treatment.
known or a fact, especially a secret that is
b) Free and voluntary consent made known (The New Oxford Dictionary
The patient's consent must be of English).
voluntary and free from coercion, force The responsibility of disclosure of
and misrepresentation of facts. Consent to information relevant to a case rests with
be legally valid must be intelligent, the treating physician. The physician
informed and voluntary and should be decides what and how much information
taken freely and exclusively by the patient. to be disclosed by taking the patient’s
Nobody is authorized to give consent on psychological condition into
behalf of the patient (with few exception consideration. Once a physician patient
discussed later). relationship is established then it is the
legal duty of the physician to explain him

Bombay Hospital Journal, Vol. 53 , No. 2 , 2011 205

about the diagnosis, treatment, 1. A person of sound disposing mind
alternative treatment available, their risks should give the consent.
and the benefits associated with it. 2. The consent should be given
Sometimes the disclosure of information voluntarily, without any fear,
may disturb the patient mentally and force, fraud, undue duress,
psychologically, and he may refuse the coercion, misrepresentation of
treatment that involves a minimal risk. In facts and threats of physical
such situation the treating physician may violence, death etc.
discuss and seek consent from one of his
3. The consent needs to be free, fair,
close relative (a condition called
uninhibited, clear, direct and
therapeutic privilege).
personal.
A full written informed consent forms
4. The consent should be well
the legal documentary proof of disclosure
informed.
of information. Verbal consent poses a
difficult challenge for the physician 5. The consent should be taken prior
regarding adequate disclosure of to the procedure (therapeutic or
information. To overcome this issue, it is diagnostic).
necessary that the treating physician 6. The consent should be complete
mention and record the material and specific.
information pertaining to the case in 7. The consent should be given by a
clinical indoor papers. Any competent person means by a
communication problems like illiteracy, person who is of sufficient
language need to be addressed properly. maturity to understand the
But there are certain exceptions to nature and consequence of the act
material disclosure : to which he has given consent.
Firstly, the disclosure of information 8. A third uninterested party must
may pose a psychological threat to the witness the consent.
patient (therapeutic privilege or
Consent for medical examination and
professional discretion).
care
Secondly, the patient may waive his
Consent is essential in all cases where
right to make an informed consent and
a patient comes or is brought for
may remain ignorant, as he is already
examination or treatment. The type of
aware of the risks or had undergone
consent varies from case to case pertaining
similar procedure in the past.
to the proposed treatment. If a patient
Thirdly, doctor need not explain or refuses to give consent then he cannot be
advise the patient what he already knows. examined nor can be treated. Informed
Fourthly, in cases of emergencies consent is necessary where the
where the patient is unconscious or examination and treatment involves
incapable to give valid consent. beyond routine medical examination.
Consent is obligatory for blood
Ingredients of a legally valid informed
transfusion, organ transplantation,
consent
artificial insemination, sterilization,
For consent to be legally valid it must medical termination of pregnancy and all
fulfil following criteria :

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

other forms of invasive diagnostic and Sec 53 CrPC - Examination of accused
therapeutic procedures. by medical practitioner at the request of
In case of emergency consent is taken police officer.
from the patient if he is conscious, Sec 54 CrPC - Examination of arrested
oriented, competent and able to freely person be medical practitioner at the
express his willingness to accept the request of the arrested person.
treatment. In emergency situation Consent in special circumstances
involving unconscious person and there is
no one who can give consent on his/her 1. If the patient happens to be a child
behalf, consent can be taken from the below 12 years of age, consent from the
Assistant Medical Officer (AMO) on duty or parent or guardian is taken.
rather the situation gives consent for 2. In emergency, involving child
treatment (Emergency Doctrine) when parents and guardians are not
immunity from prosecution by sec 93 of available consent can be taken from the
IPC (Act done in good faith for benefit of a person who is in charge of the child (Loco
person without his consent). Parentis).
The victim and the accused in all 3. Consent given for an illegal act is
medicolegal cases can be examined only not valid.
after they have given full written expressed 4. In case of emergency where the
informed consent. If he/she refuses, patient is unconscious and incapable to
nobody can force them for examination. give consent, emergency doctrine is
Procedure for examination and an accused applicable.
and victim is done as per sec 53 and sec 54
5. Consent of spouse for operation
of CrPC (Criminal Procedure Code).
and treatment in the routine course is not
Sections of IPC and CrPC related to necessary. But consent is required if the
consent 5 operation or instrument involves danger to
Sec 87 IPC - A person above 18 years of the life or impairment of sexual functions.
age can give valid consent to suffer any 6. Consent of both the spouses is
harm, which may result from an act not essential for an operation which involves
intended or not known to cause death or reproductive and sexual organs e.g.
grievous hurt. sterilization. For artificial insemination
Sec 88 IPC - A person can give valid donor the consent of both the recipient
consent to suffer any harm that may result husband and wife and that of the donor
from an act, not intended or not known to and his wife is obligatory.
cause death, done in good faith and for its 7. Under Medical Termination of
benefit. Pregnancy Act 1972, for MTP the consent
Sec 89 IPC - Act done in good faith for of pregnant woman is sufficient if she is
benefit of child or insane person, by or by above 18 year of age and has sound
consent of guardian. disposing mind. In case, if she is below 18
years of age, unconscious or insane
Sec 90 IPC - Consent to be given under
consent of parent or legal guardian is
fear or misconception.
essential.
Sec 92 IPC - Act done in good faith for
8. As per Sec 375 IPC, a female of
benefit of a person without consent.

Bombay Hospital Journal, Vol. 53 , No. 2 , 2011 207

more than 16 years of age can give valid biomedical research.
consent for sexual intercourse. Therefore Conclusion
sexual intercourse by a man with a woman
of less than 16 yrs even with her consent 1. Examination and treatment of a
amounts to rape.6 patient without his consent amounts to
battery and assault.
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 2. Disclosure of patient's nature of
of the patient should not be disclosed to a illness without his consent amounts to
third party without his consent except in professional negligence.
i) Privileged communication. 3. C o n s e n t n o t r e q u i r e d i n
ii) In case of negligence against the emergency case where there is danger to
doctor where he can reveal the the life of the patient (Emergency
secrets in his defence. Doctrine).
iii) When asked by the honorable 4. Mandatory to take consent in all
court or judge. medicolegal cases.
10. It is mandatory to take consent 5. B e y o n d r o u t i n e m e d i c a l
from the next of kin of a deceased person examination of a patient, expressed
for performing clinico pathological written informed consent is essential.
autopsy. No consent required for 6. Informed consent mandatory for
medicolegal autopsy as the law of the land subjects participating in clinical trials.
gives the consent.
7. Informed consent acts as best
11. Under The Transplantation of defence for physician against the charges
Human Organs Act 2000, a donor means a of negligence.
person who is above 18 years of age and
voluntarily authorizes the removal of any References
of his organ for therapeutic 1. Krishan Vij. Consent to and refusal of
treatment. In : Textbook of Forensic Medicine
transplantation. For cadaveric
and Toxicology, Principles and Practice. 3rd
transplantation, consent form the next of edition. Elsevier, 2005; 527-34.
kin, who is in possession of the dead body, 2. Dogra T D, Lt. Col. Abhijit Rudra. Consent in
is taken. medical practice. In : Lyon's Medical
12. For publication of patient's record Jurisprudence and Toxicology. 11th edition.
Delhi Law House, 2005; 180-208.
or data or photographs, in articles or
journals, it is necessary to take consent 3. Dikshit PC. Laws in relation to medical practice.
In: Textbook of Forensic Medicine and
from them with the assurance of
Toxicology. 1st edition. Peepee Publishers and
protection of their identity. Distributors (P) Ltd, 2007; 19-20.
13. Mandatory to take written 4. Yadwad BS, Gouda H. Consent - its medicolegal
informed consent from the subjects who aspects. JAPI Oct. 2005; 53:891-94.
are participating in a biomedical research 5. The Code of Criminal Procedure, 1973 and The
Indian Penal Code, 1860 In: Criminal Manual.
programme (Clinical Trial). The guidelines
Universal Law Publishing Company Pvt Ltd.
for this purpose has been inducted in 2002;368-72.
Declaration of Helsinki, Belmont Report, 6. Reddy KSN. Medical law and ethics. In : The
ICH GCP guidelines, Nuremberg Code and Essentials of Forensic Medicine and Toxicology.
ICMR guidelines for participating in 21st edition. Sugunadevi K, 2002;40 -44.

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