Special Article

Consent and the Indian medical practitioner

Address for correspondence: Ajay Kumar, Parul Mullick1, Smita Prakash1, Aseem Bharadwaj2
Dr. Parul Mullick, Department of Anaesthesia and Critical Care, Deen Dayal Upadhyay Hospital, 1Department of Anaesthesia
257, Sector A, Pocket C, and Intensive Care, Vardhman Mahavir Medical College and Safdarjang Hospital, New Delhi, India,
Vasant Kunj, 2
Practicing Advocate, Rohini District Court, Delhi, India
New Delhi - 110 070,
India.
E-mail: parash93@yahoo.com ABSTRACT

Consent is a legal requirement of medical practice and not a procedural formality. Getting a mere
Access this article online signature on a form is no consent. If a patient is rushed into signing consent, without giving sufficient
Website: www.ijaweb.org information, the consent may be invalid, despite the signature. Often medical professionals either
ignore or are ignorant of the requirements of a valid consent and its legal implications. Instances
DOI: 10.4103/0019-5049.169989
where either consent was not taken or when an invalid consent was obtained have been a subject
Quick response code
matter of judicial scrutiny in several medical malpractice cases. This article highlights the essential
principles of consent and the Indian law related to it along with some citations, so that medical
practitioners are not only able to safeguard themselves against litigations and unnecessary
harassment but can act rightfully.

Key words: Doctor‑patient relationship, Indian law, informed consent

INTRODUCTION mental stress or under influence of pre‑medicant

drugs which may hamper his decision‑making ability.
Legally, two or more persons are said to consent when Consent remains valid for an indefinite period,
they agree upon the same thing in the same sense.[1] provided there is no change in patient condition or
Consent must be obtained prior to conducting any proposed intervention.[4] It should be confirmed at the
medical procedure on a patient. It may be expressed or time of surgery.[4]
implied by patient’s demeanour. A patient who comes
to a doctor for treatment implies that he is agreeable to Consent must be taken from the patient himself
general physical (not intimate) examination.[2] Express The doctor before performing any procedure must
consent (verbal/written) is specifically stated by the obtain patient’s consent.[5] No one can consent
patient. Express verbal consent may be obtained for on behalf of a competent adult. In Dr. Ramcharan
relatively minor examinations or procedures, in the Thiagarajan Facs versus Medical Council of India
presence of a witness.[3] Express written consent must case,[6] disciplinary action was awarded to the surgeon
be obtained for all major diagnostic, anaesthesia and for not taking a proper informed consent for the entire
surgical procedures as it is the most undisputable procedure of kidney and pancreas transplant surgery
form of consent. from the patient. In some situations, beside patient
consent, it is desirable to take additional consent of
ESSENTIAL PRINCIPLES OF A VALID CONSENT AND
spouse. In sterilisation procedures, according to the
THE INDIAN LAW
Ministry of Health and Family Welfare, Government of
A doctor must take the consent of the patient before India guidelines, consent of spouse is not required.[7]
commencing a treatment/procedure The Medical Council of India (clause 7.16) however
Except in emergencies, informed consent should be states that in case an operation carries the risk of
obtained sometime prior to the procedure so that the sterility, the consent of both husband and wife is
patient does not feel pressurised or rushed to sign. On needed.[8] It is advisable to take consent of spouse
the day of surgery, the patient may be under extreme when the treatment or procedure may adversely

How to cite this article: Kumar A, Mullick P, Prakash S, Bharadwaj A. Consent and the Indian medical practitioner. Indian J Anaesth
2015;59:695-700.

Indian Journal of Anaesthesia | Vol. 59 | Issue 11 | Nov 2015 695

 Kumar, et al.: Consent

affect or limit sex functions, or result in death of an refusal is remote or only theoretical, it need not be
unborn child.[9] In case of minor, consent of person explained.[5] Exceptions to physician’s duty to disclose
with parental responsibility should be taken.[10] In include[24]: (i) Patient refusal to be informed; this should
an emergency, the person in charge of the child be documented. (ii) If the doctor feels that providing
at that time can consent in absence of parents or information to a patient who is anxious or disturbed
guardians (loco parentis).[11] In a medical emergency, would not be processed rationally by him and is likely
life‑saving treatment can be given even in absence of to psychologically harm him, the information may be
consent. withheld from him (therapeutic privilege); he should
then communicate with patient’s close relative, family
Refusing treatment in life‑threatening situations due to doctor or both.
non‑availability of consent may hold the doctor guilty,
unless there is a documented refusal to treatment by The “adequate information” must be furnished by
the patient. In Dr. TT Thomas versus Smt.Elisa and the doctor (or a member of his team) who treats the
Ors case,[12] the doctor was held guilty of negligence patient.[5]
for not operating on a patient with life‑threatening
emergency condition, as there was no documented Information imparted should enable the patient to
refusal to treatment. make a balanced judgment as to whether he should
submit himself to the particular treatment or not.[5]
The patient should have the capacity and competence
to consent Consent should be procedure specific
A person is competent to contract[13] if (i) he has Consent given only for a diagnostic procedure, cannot
attained the age of majority,[14] (ii) is of sound mind[15] be considered as consent for the therapeutic treatment.[5]
and (iii) is not disqualified from contracting by any Consent given for a specific treatment procedure will
law to which he is subject. The legal age for giving a not be valid for conducting some other procedure.[5] In
valid consent in India is 18 years.[14] A child >12 years Samira Kohli versus Dr. Prabha Manchanda and Anr
can give a valid consent for physical/medical case,[5] the doctor was held negligent for performing
examination (Indian Penal Code, section 89).[3] Prior an additional procedure on the patient without taking
to performing any procedure on a child <18 years, it her prior consent. An additional procedure may be
is advisable to take consent of a person with parental performed without consent only if it is necessary to
responsibility so that its validity is not questioned. save the life or preserve the health of the patient and it
If patient is incompetent, then consent can be taken would be unreasonable to delay, until patient regains
from a surrogate/proxy decision maker who is the consciousness and takes a decision.[5]
next of kin (spouse/adult child/parent/sibling/lawful
guardian).[11] A common consent for diagnostic and operative
procedures may be taken where they are contemplated.[5]
Consent should be free and voluntary
Consent is said to be free[16] when it is not caused Consent obtained during the course of surgery is not
by coercion,[17] undue influence,[18] fraud,[19] acceptable
misrepresentation,[20] or mistake.[21‑23] In Dr. Janaki S Kumar and Anr versus Mrs. Sarafunnisa
case,[25] in an allegation of performing sterilisation
Consent should be informed without consent, it was contended that consent was
Consent should be on the basis of adequate information obtained during the course of surgery. The commission
concerning the nature of the treatment procedure.[5] held that the patient under anaesthesia could neither
Consent should be informed and based on intelligent understand the risk involved nor could she give a
understanding. The doctor must disclose information valid consent.
regarding patient condition, prognosis, treatment
benefits, adverse effects, available alternatives, risk of Consent for blood transfusion
refusing treatment and the approximate treatment cost. When blood transfusion is anticipated, a specific
He should encourage questions and answer all queries.[2] written consent should be taken,[24] exception being an
emergency situation where blood transfusion is needed
If the possibility of a risk, including the risk of to save life and consent cannot be attempted.[26] In M.
death, due to performance of a procedure or its Chinnaiyan versus Sri. Gokulam Hospital and Anr

696 Indian Journal of Anaesthesia | Vol. 59 | Issue 11 | Nov 2015

 Kumar, et al.: Consent

case,[27] court awarded compensation as patient was Unilaterally executed consents are void
transfused blood in the absence of specific consent for Consent signed only by the patient and not by the
blood transfusion. doctor is not valid.[33]

Consent for examining or observing a patient for Witnessed consents are legally more dependable
educational purpose The role of a witness is even more important in
Prior to examining or observing patients for educational instances when the patient is illiterate, and one needs
purpose, their consent must be taken.[28] to take his/her thumb impression.[34]

Blanket consent is not valid Consent should be properly documented

Consent should be procedure specific. An Video‑recording of the informed consent process may
also be done but with a prior consent for the same.
all‑encompassing consent to the effect ‘I authorize so
This should be documented. It is commonly done for
and so to carry out any test/procedure/surgery in the
organ transplant procedures. If consent form is not
course of my treatment’ is not valid.[29]
signed by the patient or is amended without his signed
Fresh consent should be taken for a repeat authorisation, it can be claimed that the procedure
procedure was not consented to.[10]
A fresh written informed consent must be obtained
Patient is free to withdraw his consent anytime
prior to every surgical procedure that includes When consent is withdrawn during the performance
re‑exploration procedure. In Dr. Shailesh Shah of a procedure, the procedure should be stopped. The
versus Aphraim Jayanand Rathod case,[30] the surgeon doctor may address to patient’s concerns and may
was found deficient in service and was liable for continue the treatment only if the patient agrees. If
compensation as he had performed a re‑exploration stopping a procedure at that point puts patient’s life in
surgery without a written consent from the patient. danger, the doctor may continue with the procedure
till such a risk no longer exists.[10]
Surgical consent is not sufficient to cover anaesthesia
care Consent for illegal procedures is invalid
The surgeons are incapable to discuss the risks There can be no valid consent for operations or
associated with anaesthesia. Informed consent for procedures which are illegal.[24] Consent for an illegal
anaesthesia must be taken by the anaesthesia provider act such as criminal abortion is invalid.[9]
as only he can impart anaesthesia related necessary
information and explain the risks involved. It may be Consent is no defence in cases of professional
documented by the anaesthesiologist on the surgical negligence.[9]
consent form by a handwritten note, or on a separate
HOW TO OBTAIN A VALID CONSENT AND CONSENT
anaesthesia consent form.[31]
FORMAT
Patient has the right to refuse treatment
Always maintain good communication with your
Competent patients have the legal and moral right to
patient and provide adequate information to enable
refuse treatment, even in life‑threatening emergency
him make a rational decision.[35] It is preferable to
situations.[31] In such cases informed refusal must take consent in patient’s vernacular language. It may
be obtained and documented, over the patient’s be better to make him write down his consent in the
witnessed signature.[32] It may be advisable that two presence of a witness.[34] It is desirable to use short
doctors document the reason for non‑performance and simple sentences and non‑medical terminology
of life‑saving surgery or treatment as express refusal that is written/typed legibly.[36] Patient information
by the patient or the authorised representative and sheets (PIS) depicting procedure related information,
inform the hospital administrator about the same. including pre‑operative and post‑operative
pre‑cautions in patient’s understandable local
To detain an adult patient against his will in a hospital language with pictorial representation may facilitate
is unlawful.[9] If a patient demands discharge from the informed consent process. These may help in
hospital against medical advice, this should be providing consistently accurate information to the
recorded, and his signature obtained.[9] patients.[35] PIS should be handed over to the patients

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 Kumar, et al.: Consent

Patient’s name….…………………………………..…Age/Gender…………………………

Medical record number………..……….Address…………………………………………….

Proposed surgical procedure………………………………………………………………….

I hereby give my free and voluntary consent in a fully alert state of mind to the administration of general and/
or regional anaesthesia with or without sedation/local anaesthesia with or without sedation/sedation only,
for the performance of …….………………………procedure on me/my patient. I agree to be supplemented or
administered any other mode of anaesthesia during the course of the procedure/surgery, if necessary.

I have been explained in a language that I understand the procedure involved in the administration of various
types of anaesthesia, together with the expected benefits and the associated risks including the risks that are
specific to me. I have had an opportunity, to discuss and clarify any concerns and ask questions regarding the
anaesthesia procedure and alternative methods and the same have been satisfactorily answered.

I have been given patient information sheets/information material on CD regarding the proposed anaesthetic
technique which I have fully understood.

I have been explained the risks associated with undergoing/not undergoing blood transfusion and am willing/
not willing to undergo transfusion if required during the perioperative period (if applicable).

I have been explained the additional/high risk of anaesthesia due to emergency nature/
inadequate fasting period/difficult airway/co-existing or co-morbid conditions such as
…………………………………………………………………... (if applicable).

I have been explained the risk of dental trauma and subsequent morbidity (if applicable).

I have been explained the need of post-operative ventilation and Intensive Care Unit following my/my patient’s
surgery (if applicable).

Patient’s signature/Proxy decision maker’s name and signature………………………….

Relationship to patient in case of proxy decision maker…………………………

Place…………………Date…………Time………..

I have explained verbally to the patient in detail about the anaesthesia technique and procedure, related risks,
advantages and disadvantages. I have given the patient opportunity to ask any questions and have satisfactorily
answered them.

Anaesthesiologist name and Signature………………………………

Place, Date and Time………………………………………

Witness Name and Signature……………………………Address………………………….….

Place, Date and Time………………………………………

Figure 1: Anaesthesia informed consent form

698 Indian Journal of Anaesthesia | Vol. 59 | Issue 11 | Nov 2015

 Kumar, et al.: Consent

after explaining the contents. Even videos may be used • Procedure is considered trivial, and consent is
as an aid in increasing patient understanding.[37] not taken
• Consent of relative is taken instead of the
Though there is no standard consent format, it may patient, even when patient is a competent adult.
include the following [e.g., Figure 1]:[38] • Consenting person is minor, intoxicated or of
• Date and time unsound mind
• Patient related: Name, age and signature of the • Blanket consent is taken.
patient/proxy decision maker • It is not procedure specific
• Doctor related: Name, registration number and • Consent for blood transfusion is not obtained.
signature of the doctor • Fresh consent is not taken for a repeat
• Witness: Name and signature of witness procedure
• Disease‑related: Diagnosis along with • Procedure related necessary information is not
co‑morbidities if any given
• Surgical procedure related: Type of • Even if the information given, it is not
surgery (elective/emergency), nature of surgery documented
with antecedent risks and benefits, alternative • Consent lacks the signature of the treating
treatment available, adverse consequences of doctor
refusing treatment • Consent is not witnessed
• Anaesthesia related: Type of anaesthesia (general • Alterations or additions are made in the consent
and/or regional, local anaesthesia, sedation) form without patient’s signed authorisation.
including risks
• Blood transfusion: Requirement and related SUMMARY
risks
• Special risks: Need for post‑operative It is not only ethical to impart correct and necessary
ventilation, intensive care, etc information to a patient prior to conducting any
• Document the fact that patient and relatives medical procedure, but it is also important legally.
were allowed to ask questions, and their queries This communication should be documented. Even
were answered to their satisfaction. professional indemnity insurance may not cover for
lapses in obtaining a valid consent, considering it to
CONSENT IN RELATION TO PUBLICATION be an intentional assault.

A registered medical practitioner is not permitted to ACKNOWLEDGMENTS

publish photographs or case reports of his/her patients
We gratefully acknowledge the invaluable contribution and
without their consent, in any medical or another
irreplaceable advice extended to us during the preparation
journal in a manner by which their identity could be
of this article by Mr. M Wadhwani, Advocate.
revealed. However, in case the identity is not disclosed,
consent is not needed (clause 7.17).[8]
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