CONSENT AND THE INDIAN MEDICAL

PRACTITIONER
Apurva Agarwal
Founder, Universal Legal I Real Estate Law I Corporate Law I Arbitrator I
Angel Investor

October 25, 2022

ABSTRACT

Consent is a legal requirement of medical practice and not a procedural formality. Getting
a mere signature on a form is no consent. If a patient is rushed into signing consent,
without giving sufficient 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 where either consent was not taken or when
an invalid consent was obtained have been a subject 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.

INTRODUCTION

Legally, two or more persons are said to consent when they agree upon the same thing in
the same sense[1]. Consent must be obtained prior to conducting any medical procedure
on a patient. It may be expressed or implied by patient's demeanour. A patient who comes
to a doctor for treatment implies that he is agreeable to general physical (not intimate)
examination. Express consent (verbal/written) is specifically stated by the patient. Express
verbal consent may be obtained for relatively minor examinations or procedures, in the
presence of a witness. Express written consent must be obtained for all major diagnostic,
anaesthesia and surgical procedures as it is the most undisputable form of consent.
The element of consent is one of the critical issues in the area of medical treatment today.
It is well known that the patient must give valid consent to medical treatment; and it is his
prerogative to refuse treatment even if the said treatment will save his or her life. No
doubt this raises many ethical debates and falls at the heart of medical law today. The
earliest expression of this fundamental principle, based on autonomy, is found in the
Nuremberg Code of 1947. The Nuremberg Code was adopted immediately after World
War II in response to medical and experimental atrocities committed by the German Nazi
regime[2]. The code makes it mandatory to obtain voluntary and informed consent of
human subjects. Similarly, the Declaration of Helsinki adopted by the World Medical
Association in 1964 emphasizes the importance of obtaining freely given informed
consent for medical research by adequately informing the subjects of the aims, methods,
anticipated benefits, potential hazards, and discomforts that the study may entail[3].
Several international conventions and declarations have similarly ratified the importance of
obtaining consent from patients before testing and treatment. The present paper
examines the entire gamut of issues pertaining to consent from the point of view of the
legal environment as it exists in India today. The circle of legal development in the area
(i.e., consent) appears to be almost complete when the apex court in India recently ruled
that, it is not just the ‘consent’ or ‘informed consent’ (as it is known worldwide) but it shall
also be ‘prior informed consent’ generally barring some specific cases of emergency. This
places a medical professional in a tremendous dilemma. Hence, it is time to revisit the area
of ‘consent and medical treatment’ to understand the sensitive and underpinning
elements.

THE LEGAL BASIS OF CONSENT

Consent is perhaps the only principle that runs through all aspects of health care
provisions today. It also represents the legal and ethical expression of the basic right to
have one's autonomy and self-determination. If a medical practitioner attempts to treat a
person without valid consent, then he will be liable under both tort and criminal law. Tort is
a civil wrong for which the aggrieved party may seek compensation from the wrong doer.
The consequences would be payment of compensation (in civil) and imprisonment (in
criminal). To commence, the patient may sue the medical practitioner in tort for trespass to
person. Alternatively, the health professional may be sued for negligence. In certain
extreme cases, there is a theoretical possibility of criminal prosecution for assault or
battery. The traditional definition of battery is an act that directly and either intentionally
or negligently causes some physical contact with another person without that person's
consent. If a person has consented to contact expressedly or by implication, then there is
no battery. It is a rare case in which a doctor would be held liable for criminal breach,
unless there is gross disrespect to the patient's bodily autonomy, for instance, if a patient's
organs are taken without his consent.

In tort law, usage of force against any human body, without proper justification, is
actionable irrespective of the quantum of force. If the medical practitioner attempts to
treat a patient without obtaining proper consent, he will be held guilty under tort law.
Consent for treatment may be expressed or implied. The patient entering the consultation
chambers by his own volition may be considered to have given consent for a clinical
diagnosis to be carried out. Consent may be inferred from the general submission by a
patient to orders given by a doctor during clinical diagnosis. This is an excellent example
of implied consent. During the clinical examination, there might arise the need for an
intimate examination of the patient, such as a vaginal examination. For such an
examination, the medical practitioner must ideally obtain another consent by asking the
patient's permission orally. Furthermore, if there is a need to undergo an invasive
examination, such as an incision or drawing of samples of body fluids, a written consent of
the patient is ideally required.

Often medical practitioners ask for precise prescriptions for the situations when written
consent is needed. It is interesting to note that what law demands is mere consent and not
written consent and does not prescribe such requirement on a mandatory basis. In fact,
the medical practice itself determines the need for written consent. Ideally, where the
patient is subjected to anesthesia (either local or general) or where the patient is subjected
to severe pain during administration of the treatment, a written consent would be helpful.
There is no mandate that a doctor should always obtain written consent and failure of
which would hold him liable. However, if there is written consent, the medical practitioner
would have greater ease in proving consent in case of litigation. To standardize the
practice, the Medical Council of India (MCI) has laid down guidelines that are issued as
regulations in which consent is required to be taken in writing before performing an
operation[4]. The MCI guidelines are applicable to operations and do not cover other
treatments. For other treatments, the following may be noted as general guidelines:

(i) For routine types of treatment, implied consent would suffice

(ii) For detailed types of treatment, ideally express oral consent may be needed

(iii) For complex types of treatment, written express consent is required

CAPACITY AND INFORMATION WHILE SEEKING CONSENT

There are two more additional aspects to be borne in mind: first, valid consent can be
obtained only from a patient who is competent to consent and secondly, such consent
must also be informed consent. To be competent to give a legally effective consent, the
patient must be endowed with the ability to weigh the risks and benefits of the treatment
that is being proposed to him. The law presumes that such an ability is generally acquired
with the attainment of the age of maturity. A person who has attained the competent age
and who has sound mind can give valid consent to the medical practitioner for any
treatment. Persons who have attained the age of 18 are generally considered to have
attained the age of maturity and are competent to give consent. The law thus presumes
capacity, rationality, autonomy, and freedom if the person has attained the age of so
called maturity. On the other hand, where there is reason to believe that a patient is
unable to understand the nature of the treatment and its benefits or side effects before
making the decision, it is necessary to consider whether an adult presumption of capacity
is rebutted in that particular case. If the patient is incompetent to give consent, then the
consent may be obtained from the attendant of the patient. In the UK, there are several
ethical issues raised regarding the proxy consent on behalf of such persons. Even the Law
Commission Report (Mental Incapacity, 1995) suggests few reforms. Irrespective of the
age, for a person who is incompetent due to unsoundness of mind, consent will be
obtained from the guardian of the patient. In India, the court has not come across
borderline cases of an adult refusing treatment leading to emergency and leaving the
doctor in a dilemma, unlike in the west[5].

The law also presumes that the medical practitioner is in a dominating position vis-à-vis
the patient; hence, it is his duty to obtain proper consent by providing all the necessary
information. Consent without necessary information is no consent at all. Unfortunately, the
expression ‘informed consent’ is often used without precision. The “informed consent”
doctrine is American in origin and relates to the amount of information that a patient
should be provided with to avoid any probable action in negligence. Rarely, a medical
practitioner or a hospital administrator can rely upon the consent form signed by the
patient, when the contention is that he was made to sign on the dotted lines of such
format without proving necessary information. This practice is also developed by the
practice of treating the consent form as a one of standard forms of contracts and
eliminating all such unfair and sweeping clauses, which will only benefit the medical
practitioner. It is rather necessary as the pro-forma is prepared by the medical
practitioner/hospital administration, and the patient is left with the choice of either
accepting it as whole or rejecting it. Therefore, it is absolute imperative that a medical
practitioner provide all relevant information relating to the proposed treatment to the
patient in a language understandable to him, while obtaining the much needed consent
for the treatment.

However, the nature of the information that a patient must have in order to give informed
consent is a debatable question, as the American and English viewpoints differ to some
extent. Informed consent from the American sense is often described from the viewpoint
of a prudent patient, popularly know as the prudent patient test. In this approach, the
highest respect for the patient's right of self-determination about a particular therapy is
recognized. This will lead to a so-called objective test of disclosure wherein the doctor will
keep in mind the patient and disclose all such information which is required to be given. In
other words, there is a presumption that some standard information is required to be
disclosed to every patient, and the extent of such disclosure is neither left to the discretion
of the doctor (of course leaving out special circumstances where the doctor might have
strong reasons for concealing) nor he can rely upon the defense of disclosure like a
reasonable medical practice or practitioner[6]. In contrast to this, the English approach is
doctor centric, which is also popularly narrated as the prudent doctor test of disclosure.
Here, the doctor is taken as a professional-man endowed with greater prudence to protect
the right interest of the patient and bestowed with the final right to decide what
information shall be divulged to the patient considering the circumstances and how much
information is to be divulged. Lord Templeman in ‘Sidway’ encapsulated this as follows:

“When the doctor himself is considering the possibility of a major operation, the doctor is
able with his medical training, with his knowledge of the patient's medical history, and
with his objective position to make a balanced judgment as to whether the operation
should be performed or not. The duty of the doctor in these circumstances, subject to his
overriding duty to have regard to the best interests of the patient, is to provide the patient
with information which will enable the patient to make a balanced judgment if the patient
chooses to make a balanced judgment”[7].

Finally, whatever might be the difference of approach it is evident that a medical

practitioner is obligated to provide the necessary information before obtaining consent
from a patient. To account for the Indian position, although we do not have much
litigation, unlike in the West, it may be concluded that the courts have assigned immense
significance to the requirement of informed consent. A medical practitioner in India has a
duty to provide all the necessary information to the patient in a language that is
understandable to him. Regarding the quantum of information, there are no clear
parameters laid down by the courts. Therefore, it is reasonable information which a doctor
deems fit considering best practices. Considering the knowledge gap in this regard, the
professional regulatory body for medicine can play an important role in establishing
standards.

ESSENTIAL PRINCIPLES OF A VALID CONSENT AND THE

INDIAN LAW

A doctor must take the consent of the patient before commencing a

treatment/procedure

The principle of autonomy is enshrined within Art. 21[8] of the Indian Constitution, which
deals with the right to life and personal liberty. The expression personal liberty under Art.
21[9] is of the widest amplitude and covers a wide variety of rights, including the right to
live with human dignity and all that goes along with it, and any act which damages, injures,
or interferes with the use of any limb or faculty of a person, either permanently or
temporarily[10]. However, the common law application of consent is not fully developed in
India, although the Indian courts have often referred to these principles. In such situations,
obviously one has to refer to the principles of the Indian Contract Act and the Indian Penal
Code. The relationship between a medical professional and his patient is a contract by
parties competent to contract giving rise to contractual obligations

Except in emergencies, informed consent should be obtained sometime prior to the

procedure so that the patient does not feel pressurised or rushed to sign. On the day of
surgery, the patient may be under extreme mental stress or under influence of pre-
medicant drugs which may hamper his decision-making ability. Consent remains valid for
an indefinite period, provided there is no change in patient condition or proposed
intervention. It should be confirmed at the time of surgery.
Consent must be taken from the patient himself

The doctor before performing any procedure must obtain patient's consent[11]. No one
can consent on behalf of a competent adult. In Dr. Ramcharan Thiagarajan Facs versus
Medical Council of India case[12], disciplinary action was awarded to the surgeon for not
taking a proper informed consent for the entire procedure of kidney and pancreas
transplant surgery from the patient. In some situations, beside patient consent, it is
desirable to take additional consent of spouse. In sterilisation procedures, according to the
Ministry of Health and Family Welfare, Government of India guidelines, consent of spouse
is not required[13]. The Medical Council of India however states that in case an operation
carries the risk of sterility, the consent of both husband and wife is needed. It is advisable
to take consent of spouse when the treatment or procedure may adversely affect or limit
sex functions, or result in death of an unborn child. In case of minor, consent of person
with parental responsibility should be taken. In an emergency, the person in charge of the
child at that time can consent in absence of parents or guardians (loco parentis). In a
medical emergency, life-saving treatment can be given even in absence of consent.

Refusing treatment in life-threatening situations due to non-availability of consent may

hold the doctor guilty, unless there is a documented refusal to treatment by the patient. In
Dr. TT Thomas versus Smt. Elisa and Ors case[14], the doctor was held guilty of negligence
for not operating on a patient with life-threatening emergency condition, as there was no
documented refusal to treatment.

The patient should have the capacity and competence to consent

A person is competent to contract[15] if

(i) he has attained the age of majority[16],

(ii) is of sound mind[17] and

(iii) is not disqualified from contracting by any law to which he is subject. The legal age
for giving a valid consent in India is 18 years[18]. A child >12 years can give a valid consent
for physical/medical examination[19]. Prior to performing any procedure on a child <18
years, it is advisable to take consent of a person with parental responsibility so that its
validity is not questioned. If patient is incompetent, then consent can be taken from a
surrogate/ proxy decision maker who is the next of kin (spouse/adult child/ parent/
sibling/ lawful guardian).

Consent should be free and voluntary

Consent is said to be free[20] when it is not caused by coercion[21], undue influence[22],

fraud[23], misrepresentation[24], or mistake[25] [26] [27].

Consent should be informed

Consent should be on the basis of adequate information concerning the nature of the
treatment procedur[28]. Consent should be informed and based on intelligent
understanding. The doctor must disclose information regarding patient condition,
prognosis, treatment benefits, adverse effects, available alternatives, risk of refusing
treatment and the approximate treatment cost. He should encourage questions and
answer all queries.

If the possibility of a risk, including the risk of death, due to performance of a procedure or
its refusal is remote or only theoretical, it need not be explained[29]. Exceptions to
physician's duty to disclose include:

(i) Patient refusal to be informed; this should be documented.

(ii) If the doctor feels that providing information to a patient who is anxious or
disturbed would not be processed rationally by him and is likely to psychologically harm
him, the information may be withheld from him (therapeutic privilege); he should then
communicate with patient's close relative, family doctor or both.

The “adequate information” must be furnished by the doctor (or a member of his team)
who treats the patient[30].

The consent obtained, of course, after getting the relevant information will have its own
parameter of operation to render protection to the medical practitioner. If the doctor goes
beyond these parameters, he would be treating the patient at his risk, as it is deemed that
there is no consent for such treatment at all. A doctor who went ahead in treating a
patient, to protect the patient's own interest, was held liable as he was operating without
consent[31]. The patient was suspected to have appendicitis. After obtaining due consent,
she was subjected to an operation. However, upon incision, it was found that her appendix
was normal and not inflamed. To protect the interest of the patient, the doctor removed
her gangrenous gall bladder. Later, it was discovered that the kidney of the patient was
affected. The doctor was held liable as he was operating without consent. This case law
also signifies the traditional notion of paternalism prevalent among the members of the
medical fraternity. It is a notion where the doctor takes-up the role of a parent of the
patient and starts deciding on behalf of the patient himself. Unfortunately, the law does
not accept this notion. The first priority of law is always the right of autonomy of the
patient provided he is endowed with necessary capacity. A medical practitioner who
believes that a medical procedure is appropriate and necessary for a patient's well being
can perhaps be forgiven for believing that the principle of autonomy should be sacrificed
in the best interest of the patient. In the present case, had the doctor stopped after
realizing that the patient's appendix was normal, he would have been protected as he was
working under the valid consent of the patient, and more importantly, mere error of
judgment is not culpable. When he proceeded in removing her gall bladder, he was
acting sans valid consent, which was an extreme case of professional paternalism and
gross disobedience to the right of the patient's autonomy.

Regarding proxy consent, when the patient is unable to give consent himself, there are no
clear regulations or principles developed in India. If such a situation exists, the medical
practitioner may proceed with treatment by taking the consent of any relative of the
patient or even an attendant. In one case, the wife of a patient informed the hospital
authorities in unambiguous terms that she had no objection to her husband undergoing
bypass surgery, her consent was deemed sufficient for the purpose of any formalities with
which the hospital was required to comply[32].
Interestingly, in another case the relationship between the patient and his wife were
strained. A patient was operated on for sterilization. While giving consent he deposed that
he is married and has two baby girls. In fact, he was undergoing an operation only for
getting the money as incentive. After the operation, his father contended that the patient
was of unstable mind and was not competent to give consent. The court held that if there
are no circumstances for a doctor to sense foul play or doubt about the capacity of the
patient, he is protected[33]. These two cases demonstrate that a doctor acting reasonably
under normal circumstances is always protected and he is never expected to play the role
of an investigative agency.

Recently, the apex court gave an impacting judgment in the area. Wherein the court
observed that “where a surgeon is consulted by a patient and consent of the patient is
taken for diagnostic procedure/surgery, such consent can't be considered as authorization
or permission to perform therapeutic surgery either conservative or radical (except in a
life-threatening emergent situation)”[34].

This decision is of very far reaching consequences, pushing the development of consent
law to new heights. It is contended that it is not only informed consent which is imperative
now, but the same shall be “prior informed consent” unless there is imminent threat to the
patient's life. In addition, this decision curtails the scope of proxy consent from the person
having parental authority or an attendant.

Information imparted should enable the patient to make a balanced judgment as to

whether he should submit himself to the particular treatment or not[35].

Consent should be procedure specific

Consent given only for a diagnostic procedure, cannot be considered as consent for the
therapeutic treatment[36]. Consent given for a specific treatment procedure will not be
valid for conducting some other procedure[37]. In Samira Kohli versus Dr. Prabha
Manchanda and Anr case[38], the doctor was held negligent for performing an additional
procedure on the patient without taking her prior consent. An additional procedure may
be performed without consent only if it is necessary to save the life or preserve the health
of the patient and it would be unreasonable to delay, until patient regains consciousness
and takes a decision[39].

For the first time in India, the court ruled that however broad consent might be for
diagnostic procedure, it cannot be used for therapeutic surgery. Furthermore, the court
observed that “where the consent by the patient is for a particular operative surgery it
can't be treated as consent for an unauthorized additional procedure involving removal of
an organ only on the ground that it is beneficial to the patient or is likely to prevent some
danger developing in the future, where there is no imminent danger to the life or health of
the patient”. This proposition puts fetter upon the role of a “paternal doctor” in the Indian
scenario. In one case, a 44-year-old unmarried female consulted her doctor and was
advised to undergo a laparoscopy. A few consent forms were taken from her of which one
was for admission and another one was for the surgery. The relevant one among such
consent forms gave the doctor an allowance to carry out a “diagnostic and operative
laparoscopy” and there was an additional endorsement that a “laparotomy may be
needed”. When the patient was in the operation theater (and was unconscious), another
proxy consent was taken from her attending mother for a hysterectomy. Her uterus,
ovaries, and fallopian tubes were removed. Subsequently, when an action was brought, it
was held that the operation was conducted without real consent and the doctors were
held liable.

A common consent for diagnostic and operative procedures may be taken where they are
contemplated[40].

Consent obtained during the course of surgery is not acceptable

In Dr. Janaki S Kumar and Anr versus Mrs. Sarafunnisa case[41], in an allegation of
performing sterilisation without consent, it was contended that consent was obtained
during the course of surgery. The commission held that the patient under anaesthesia
could neither understand the risk involved nor could she give a valid consent.

Consent for blood transfusion

When blood transfusion is anticipated, a specific written consent should be taken,
exception being an emergency situation where blood transfusion is needed to save life
and consent cannot be attempted. In M. Chinnaiyan versus Sri. Gokulam Hospital and Anr
case[42], court awarded compensation as patient was transfused blood in the absence of
specific consent for blood transfusion.

Consent for examining or observing a patient for educational purpose

Prior to examining or observing patients for educational purpose, their consent must be
taken.

Blanket consent is not valid

Consent should be procedure specific. An all-encompassing consent to the effect ‘I

authorize so and so to carry out any test/procedure/surgery in the course of my treatment’
is not valid.

Fresh consent should be taken for a repeat procedure

A fresh written informed consent must be obtained prior to every surgical procedure that
includes re-exploration procedure. In Dr. Shailesh Shah versus Aphraim Jayanand Rathod
case[43], the surgeon was found deficient in service and was liable for compensation as he
had performed a re-exploration surgery without a written consent from the patient.

Surgical consent is not sufficient to cover anaesthesia care

The surgeons are incapable to discuss the risks associated with anaesthesia. Informed
consent for anaesthesia must be taken by the anaesthesia provider as only he can impart
anaesthesia related necessary information and explain the risks involved. It may be
documented by the anaesthesiologist on the surgical consent form by a handwritten note,
or on a separate anaesthesia consent form.

Patient has the right to refuse treatment

Competent patients have the legal and moral right to refuse treatment, even in life-
threatening emergency situations. In such cases informed refusal must be obtained and
documented, over the patient's witnessed signature. It may be advisable that two doctors
document the reason for non-performance of life-saving surgery or treatment as express
refusal by the patient or the authorised representative and inform the hospital
administrator about the same.

To detain an adult patient against his will in a hospital is unlawful. If a patient demands
discharge from hospital against medical advice, this should be recorded, and his signature
obtained.

Unilaterally executed consents are void

Consent signed only by the patient and not by the doctor is not valid.

Witnessed consents are legally more dependable

The role of a witness is even more important in instances when the patient is illiterate, and
one needs to take his/her thumb impression.
Consent should be properly documented

Video-recording of the informed consent process may also be done but with a prior
consent for the same. This should be documented. It is commonly done for organ
transplant procedures. If consent form is not signed by the patient or is amended without
his signed authorisation, it can be claimed that the procedure was not consented to.

Patient is free to withdraw his consent anytime

When consent is withdrawn during the performance of a procedure, the procedure should
be stopped. The doctor may address to patient's concerns and may continue the
treatment only if the patient agrees. If stopping a procedure at that point puts patient's life
in danger, the doctor may continue with the procedure till such a risk no longer exists.

Consent for illegal procedures is invalid

There can be no valid consent for operations or procedures which are illegal. Consent for
an illegal act such as criminal abortion is invalid.

Consent is no defence in cases of professional negligence.

EMERGENCY SITUATION AND CONSENT

Interestingly, in India, the entire gamut of laws on consent turns into complex propositions
if an emergency medical situation arises. In a few of the milestone decisions, the apex
court ruled that a medical practitioner has a duty to treat a patient in an emergency.
Emphasizing the paramount duty of any “welfare state“, the Supreme Court stated that Art.
21[44] imposes an obligation on the State to safeguard the right to life of every person.
Preservation of human life is thus of paramount importance. The government hospitals run
by the state are bound by duty to extend medical assistance for preserving human life.
Failure on the part of a government hospital to provide timely medical treatment to a
person in need of such treatment results in the violation of his right to life guaranteed
under Art. 21[45]. Proceeding in the same direction, the court emphasized further that
every doctor whether at a Government hospital or otherwise has the professional
obligation to extend his services with due expertise for protecting life. No law or state
action can intervene to avoid or delay the discharge of the paramount obligation cast
upon members of the medical profession. The obligation of a doctor is total, absolute, and
paramount. Laws of procedure whether in statutes or otherwise that would interfere with
the discharge of this obligation cannot be sustained and must, therefore, give way[46]. In
one case, the apex court laid down some important guidelines such as (i) The doctor when
approached by an injured person, shall render all such help which is possible for him at
that time, including referring him to the proper experts, (ii) the doctor treating such
persons shall be protected by law, as they are not contravening any procedural laws of the
land (regarding jurisdictions etc.), and (iii) all legal bars (either real or perceived by the
doctors) are deemed to have been eliminated by the verdict. This is in consonance with
the hypocratic oath, which a doctor takes when entering the profession. Hence, a doctor is
duty-bound to treat a patient in the case of an emergency, without waiting for any
formalities. There are several statutes (like medical institutions regulation acts in various
states) imposing this duty upon medical establishments to treat emergency patients,
especially accident victims.

The initial proposition (and the attempt of the Supreme Court) is quiet understandable as
the doctor has to do his best to save life in emergency situations. This is irrespective of
complying with any of the formalities, including consent. Hypothetically, if a patient in an
emergency resists taking treatment, what shall be the way out? Indian courts are not very
clear on that. The above decisions are delivered keeping in mind the accident victims who
were denied medical treatment by doctors, terming them as medico-legal cases.
Moreover, in the above instances, the patient would go himself, or be taken by someone
(due to an unconscious state) to the doctor to seek medical treatment.

In Dr. T.T. Thomas vs. Elisa[47], the patient was admitted into the hospital on March 11,
1974. Upon admission, the patient was diagnosed as a case of perforated appendix with
peritonitis requiring an operation. But, unfortunately no operation was done until his
death on March 13, 1974. The contention of the doctor was that no surgery could be
adhered to, albeit the suggestion, because the patient did not consent for the surgery.
Therefore, other measures were taken to ameliorate the condition of the patient, which
grew worse by the next day. Although the patient was then willing to undergo the
operation, his condition did not permit it. On the other hand, the version of the
respondent (i.e., the Plaintiff) was that the doctor demanded money for performing the
surgery. Furthermore, the doctor was attending to some chores in an outside private
nursing home to conduct operations on the other patients and that the appellant doctor
came back only after the death of the patient. The two versions before the court were: 1)
the plaintiff (the deceased patient's wife) said that the doctors concerned demanded a
bribe, hence the operation was delayed until it proved fatal and 2) the version of denial for
consent. Finally, the court delivered a verdict in favor of the plaintiffs stating that consent
under such an emergent situation is not mandatory. It is interesting to note the following
observations:

“The consent factor may be important very often in cases of selective 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 on him because, I did not
get his consent’. Such cases very often 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. Even if he is in a fit condition
to give a voluntary answer, the surgeon has a duty to inform him of the dangers ahead of
the risks involved by going without an operation at the earliest time possible”.

“When a surgeon or medical man advances a plea that the patient did not give his consent
for the surgery or the course of treatment advised by him, the burden is on him to prove
that the non-performance of the surgery or the non-administration of the treatment was
on account of the refusal of the patient to give consent thereto. This is especially so in a
case where the patient is not alive to give evidence. Consent is implicit in the case of a
patient who submits to the doctor and the absence of consent must be made out by the
patient alleging it”.

Finally, as stated above, before holding the doctor liable, the court said that “we also hold
that the failure to perform an emergency operation on the deceased on March 11, 1974
amounts to negligence and the death of the deceased was on account of that failure”. This
decision makes the entire discussion of consent law more complex. Although this case law
can't be given more accent (because it is a High Court decision), the viewpoint is an
interesting one to note. In light of all these developments, it may be concluded that there
are many grey areas in this field of consent law in India, which can be eliminated by pro-
active intervention by the concerned professional regulatory body.

HOW TO OBTAIN A VALID CONSENT AND CONSENT

FORMAT

Always maintain good communication with your patient and provide adequate
information to enable him make a rational decision. It is preferable to take consent in
patient's vernacular language. It may be better to make him write down his consent in the
presence of a witness. It is desirable to use short and simple sentences and non-medical
terminology that is written/ typed legibly. Patient information sheets (PIS) depicting
procedure related information, including pre-operative and post-operative pre-cautions in
patient's understandable local language with pictorial representation may facilitate the
informed consent process. These may help in providing consistently accurate information
to the patients. PIS should be handed over to the patients after explaining the contents.
Even videos may be used as an aid in increasing patient understanding.

Though there is no standard consent format, it may include the following:

Figure 1

Anaesthesia informed consent form

· Date and time

· Patient related: Name, age and signature of the patient/proxy decision maker

· Doctor related: Name, registration number and signature of the doctor

· Witness: Name and signature of witness

· Disease-related: Diagnosis along with co-morbidities if any

· Surgical procedure related: Type of surgery (elective/emergency), nature of

surgery with antecedent risks and benefits, alternative treatment available, adverse
consequences of refusing treatment

· Anaesthesia related: Type of anaesthesia (general and/or regional, local

anaesthesia, sedation) including risks

· Blood transfusion: Requirement and related risks

· Special risks: Need for post-operative ventilation, intensive care, etc

· Document the fact that patient and relatives were allowed to ask questions, and
their queries were answered to their satisfaction.

CONSENT IN RELATION TO PUBLICATION

A registered medical practitioner is not permitted to publish photographs or case reports

of his/ her patients without their consent, in any medical or another journal in a manner by
which their identity could be revealed. However, in case the identity is not disclosed,
consent is not needed

CONSENT IN RELATION TO MEDICAL RESEARCH

Consent taken from the patient for the drug trial or research should be as per the Indian
Council of Medical Research guidelines; otherwise it shall be construed as misconduct.

COMMON FALLACIES IN THE CONSENT PROCESS

The anaesthesiologist must ensure that consent is given maximum importance, and all the
legal formalities are followed before agreeing to provide the services. Following are some
frequent mistakes and omissions that can cost him/her dearly in the event of a mishap:

(i) Procedure is considered trivial, and consent is not taken

(ii) Consent of relative is taken instead of the patient, even when patient is a competent
adult.

(iii) Consenting person is minor, intoxicated or of unsound mind

(iv) Blanket consent is taken.

(v) It is not procedure specific

(vi) Consent for blood transfusion is not obtained.

(vii) Fresh consent is not taken for a repeat procedure

(viii) Procedure related necessary information is not given

(ix) Even if the information given, it is not documented

(x) Consent lacks the signature of the treating doctor

(xi) Consent is not witnessed

(xii) Alterations or additions are made in the consent form without patient's signed
authorisation.

SUMMARY
It is not only ethical to impart correct and necessary information to a patient prior to
conducting any medical procedure, but it is also important legally. This communication
should be documented. Even professional indemnity insurance may not cover for lapses in
obtaining a valid consent, consid

[1] Indian Contract Act, 1872, Sec 13 reads as

‘Consent’ defined.—Two or more persons are said to consent when they agree upon the
same thing in the same sense. —Two or more persons are said to consent when they
agree upon the same thing in the same sense."

[2] 1947. Neurenberg Code.

[3] 1964. Declaration of Helsinki

[4] Regulation 7.16, of Medical Council of India (Professional Conduct, Etiquette and
Ethics) Regulations. 2002

[5] Re C (Adult: Refusal of Treatment) [1944] 1 All ER 819, Re T (Adult: Refusal of

Treatment), [1992] 4 All ER 649, F v West Berkshire Health Authority, [1989] 2 All ER 545,
and Gillick v West Norfolk and Wisbech AHA, [1985] 3 All ER 402.

[6] Canterbury v Spence. 1972. 464 F 2d 772.

[7] Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley
Hospital and Others [1985] 1 AC 871, HL.

[8] Protection of life and personal liberty - No person shall be deprived of his life or
personal liberty except according to procedure established by law

[9] Protection of life and personal liberty - No person shall be deprived of his life or
personal liberty except according to procedure established by law

[10] Maneka Gandhi v Union of India. AIR 1978 SC 597.

[11] Samira Kohli vs. Dr. Prabha Manchanda and Anr on 16 January, 2008. Civil Appeal No.
1949 of 2004. (2008) 2 SCC 1; AIR 2008 SC 1385

[12] Dr. Ramcharan Thiagarajan Facs vs Medical Council of India on 3 April, 2014.
Karnataka High Court. Writ Petition No. 11207/2013 (GM-RES)
[13] Standards for Female Sterilization (1.4.4), Standards for Male Sterilization
(2.4.4) Standards for Female and Male Sterilization Services. Research Studies and
Standards Division, Ministry of Health and Family Welfare Government of India. 2006.

Available
from: http://www.nrhmtn.gov.in/modules/Guidelines%20for%20Standard%20for%20
female%20 & %20 male%20sterilization%20services.pdf

[14] Dr. TT Thomas vs Smt Elisa and Ors on 11 August, 1986. Kerala High Court. AIR 1987
Ker 52: 1986 Ker LT 1026 (DB)

[15] Indian Contract Act 1972, Sec 11 reads as

Who are competent to contract.—Every person is competent to contract who is of the age
of majority according to the law to which he is subject,1 and who is of sound mind and is
not disqualified from contracting by any law to which he is subject. —Every person is
competent to contract who is of the age of majority according to the law to which he is
subject,1 and who is of sound mind and is not disqualified from contracting by any law to
which he is subject."

[16] Indian Majority Act. 1875

[17] Indian Contract Act,1872 Sec 12 reads as

What is a sound mind for the purposes of contracting.—A person is said to be of sound
mind for the purpose of making a contract, if, at the time when he makes it, he is capable
of understanding it and of forming a rational judgment as to its effect upon his interests.
—A person is said to be of sound mind for the purpose of making a contract, if, at the
time when he makes it, he is capable of understanding it and of forming a rational
judgment as to its effect upon his interests." A person who is usually of unsound mind, but
occasionally of sound mind, may make a contract when he is of sound mind. A person who
is usually of sound mind, but occasionally of unsound mind, may not make a contract
when he is of unsound mind. Illustrations

(a) A patient in a lunatic asylum, who is, at intervals, of sound mind, may contract
during those intervals. (a) A patient in a lunatic asylum, who is, at intervals, of sound mind,
may contract during those intervals."

(b) A sane man, who is delirious from fever, or who is so drunk that he cannot
understand the terms of a contract, or form a rational judgment as to its effect on his
interests, cannot contract whilst such delirium or drunkenness lasts. (b) A sane man, who is
delirious from fever, or who is so drunk that he cannot understand the terms of a contract,
or form a rational judgment as to its effect on his interests, cannot contract whilst such
delirium or drunkenness lasts.

[18] Indian Majority Act. 1875

[19] Indian Penal Code, section 89

Act done in good faith for benefit of child or insane person, by or by consent of guardian.
—Nothing which is done in good faith for the benefit of a person under twelve years of
age, or of unsound mind, by or by consent, either express or implied, of the guardian or
other person having lawful charge of that person, is an offence by reason of any harm
which it may cause, or be intended by the doer to cause or be known by the doer to be
likely to cause to that person: Provisos—Provided—

(First) — That this exception shall not extend to the intentional causing of death, or to the
attempting to cause death;

(Secondly) —That this exception shall not extend to the doing of anything which the
person doing it knows to be likely to cause death, for any purpose other than the
preventing of death or grievous hurt, or the curing of any grievous disease or infirmity;

(Thirdly) — That this exception shall not extend to the voluntary causing of grievous hurt,
or to the attempting to cause grievous hurt, unless it be for the purpose of preventing
death or grievous hurt, or the curing of any grievous disease or infirmity;

(Fourthly) —That this exception shall not extend to the abetment of any offence, to the
committing of which offence it would not extend. Illustration A, in good faith, for his
child’s benefit without his child’s consent, has his child cut for the stone by a surgeon.
Knowing it to be likely that the operation will cause the child’s death, but not intending to
cause the child’s death. A is within the exception, inasmuch as his object was the cure of
the child.

[20] The Indian Contract Act, 1874, Sec 14

‘Free consent’ defined.—Consent is said to be free when it is not caused by— —Consent is
said to be free when it is not caused by—"

(1) coercion, as defined in section 15, or

(2) undue influence, as defined in section 16, or

(3) fraud, as defined in section 17, or

(4) misrepresentation, as defined in section 18, or

(5) mistake, subject to the provisions of sections 20, 21 and 22. Consent is said to be
so caused when it would not have been given but for the existence of such coercion,
undue influence, fraud, misrepresentation or mistake.

[21] ‘Coercion’ defined.— ‘Coercion’ is the committing, or threatening to commit, any act
forbidden by the Indian Penal Code (45 of 1860) or the unlawful detaining, or threatening
to detain, any property, to the prejudice of any person whatever, with the intention of
causing any person to enter into an agreement. —‘Coercion’ is the committing, or
threatening to commit, any act forbidden by the Indian Penal Code (45 of 1860) or the
unlawful detaining, or threatening to detain, any property, to the prejudice of any person
whatever, with the intention of causing any person to enter into an agreement."
Explanation.—It is immaterial whether the Indian Penal Code (45 of 1860) is or is not in
force in the place where the coercion is employed. Illustrations A, on board an English ship
on the high seas, causes B to enter into an agreement by an act amounting to criminal
intimidation under the Indian Penal Code (45 of 1860). A afterwards sues B for breach of
contract at Calcutta. A afterwards sues B for breach of contract at Calcutta." A has
employed coercion, although his act is not an offence by the law of England, and although
section 506 of the Indian Penal Code (45 of 1860) was not in force at the time when or
place where the act was done. A has employed coercion, although his act is not an offence
by the law of England, and although section 506 of the Indian Penal Code (45 of 1860) was
not in force at the time when or place where the act was done."

[22] Undue influence’ defined.—

A contract is said to be induced by ‘undue influence’ where the relations subsisting

between the parties are such that one of the parties is in a position to dominate the will of
the other and uses that position to obtain an unfair advantage over the other. 1[16.
‘Undue influence’ defined.—(1) A contract is said to be induced by ‘undue influence’ where
the relations subsisting between the parties are such that one of the parties is in a position
to dominate the will of the other and uses that position to obtain an unfair advantage over
the other."

(1) In particular and without prejudice to the generality of the foregoing principle, a
person is deemed to be in a position to dominate the will of another—

(a) where he holds a real or apparent authority over the other, or where he stands in
a fiduciary relation to the other; or

(b) where he makes a contract with a person whose mental capacity is temporarily or
permanently affected by reason of age, illness, or mental or bodily distress.
(3) Where a person who is in a position to dominate the will of another, enters into a
contract with him, and the transaction appears, on the face of it or on the evidence
adduced, to be unconscionable, the burden of proving that such contract was not induced
by undue influence shall be upon the person in a position to dominate the will of the
other. Nothing in the sub-section shall affect the provisions of section 111 of the Indian
Evidence Act, 1872 (1 of 1872). Illustrations

(a) A having advanced money to his son, B, during his minority, upon B’s coming of
age obtains, by misuse of parental influence, a bond from B for a greater amount than the
sum due in respect of the advance. A employs undue influence. (a) A having advanced
money to his son, B, during his minority, upon B’s coming of age obtains, by misuse of
parental influence, a bond from B for a greater amount than the sum due in respect of the
advance. A employs undue influence."

(b) A, a man enfeebled by disease or age, is induced, by B’s influence over him as his
medical attendant, to agree to pay B an unreasonable sum for his professional services, B
employes undue influence. (b) A, a man enfeebled by disease or age, is induced, by B’s
influence over him as his medical attendant, to agree to pay B an unreasonable sum for his
professional services, B employes undue influence."

(c) A, being in debt to B, the money-lender of his village, contracts a fresh loan on
terms which appear to be unconscionable. It lies on B to prove that the contract was not
induced by undue influence. (c) A, being in debt to B, the money-lender of his village,
contracts a fresh loan on terms which appear to be unconscionable. It lies on B to prove
that the contract was not induced by undue influence."

(d) A applies to a banker for a loan at a time when there is stringency in the money
market. The banker declines to make the loan except at an unusually high rate of interest.
A accepts the loan on these terms. This is a transaction in the ordinary course of business,
and the contract is not induced by undue influence.] (d) A applies to a banker for a loan at
a time when there is stringency in the money market. The banker declines to make the
loan except at an unusually high rate of interest. A accepts the loan on these terms. This is
a transaction in the ordinary course of business, and the contract is not induced by undue
influence

[23] ‘Fraud’ defined. — ‘Fraud’ means and includes any of the following acts committed by
a party to a contract, or with his connivance, or by his agent1, with intent to deceive
another party thereto or his agent, or to induce him to enter into the contract:— —‘Fraud’
means and includes any of the following acts committed by a party to a contract, or with
his connivance, or by his agent1, with intent to deceive another party thereto or his agent,
or to induce him to enter into the contract\:—"

(1) the suggestion, as a fact, of that which is not true, by one who does not believe it
to be true;
(2) the active concealment of a fact by one having knowledge or belief of the fact;

(3) a promise made without any intention of performing it;

(4) any other act fitted to deceive;

(5) any such act or omission as the law specially declares to be fraudulent.
Explanation.—Mere silence as to facts likely to affect the willingness of a person to enter
into a contract is not fraud, unless the circumstances of the case are such that, regard
being had to them, it is the duty of the person keeping silence to speak2, or unless his
silence, is, in itself, equivalent to speech. Illustrations

(a) A sells, by auction, to B, a horse which A knows to be unsound. A says nothing to

B about the horse’s unsoundness. This is not fraud in A. (a) A sells, by auction, to B, a horse
which A knows to be unsound. A says nothing to B about the horse’s unsoundness. This is
not fraud in A."

(b) B is A’s daughter and has just come of age. Here the relation between the parties
would make it A’s duty to tell B if the horse is unsound. (b) B is A’s daughter and has just
come of age. Here the relation between the parties would make it A’s duty to tell B if the
horse is unsound."

(c) B says to A—‘‘If you do not deny it, I shall assume that the horse is sound”. A says
nothing. Here, A’s silence is equivalent to speech. (c) B says to A—‘‘If you do not deny it, I
shall assume that the horse is sound”. A says nothing. Here, A’s silence is equivalent to
speech."

(d) A and B, being traders, enter upon a contract. A has private information of a
change in prices which would affect B’s willingness to proceed with the contract. A is not
bound to inform B. (d) A and B, being traders, enter upon a contract. A has private
information of a change in prices which would affect B’s willingness to proceed with the
contract. A is not bound to inform B."

[24] Misrepresentation” defined.—“Misrepresentation” means and includes—

—“Misrepresentation” means and includes—"

(1) the positive assertion, in a manner not warranted by the information of the
person making it, of that which is not true, though he believes it to be true;

(2) any breach of duty which, without an intent to deceive, gains an advantage of the
person committing it, or any one claiming under him, by misleading another to his
prejudice, or to the prejudice of any one claiming under him;
(3) causing, however innocently, a party to an agreement, to make a mistake as to
the substance of the thing which is the subject of the agreement.

[25] Agreement void where both parties are under mistake as to matter of fact.—Where
both the parties to an agreement are under a mistake as to a matter of fact essential to
the agreement the agreement is void. Explanation.—An erroneous opinion as to the value
of the thing which forms the subject-matter of the agreement, is not to be deemed a
mistake as to a matter of fact. Illustrations

(a) A agrees to sell to B a specific cargo of goods supposed to be on its way from
England to Bombay. It turns out that, before the day of the bargain the ship conveying the
cargo had been cast away and the goods lost. Neither party was aware of these facts. The
agreement is void. (a) A agrees to sell to B a specific cargo of goods supposed to be on its
way from England to Bombay. It turns out that, before the day of the bargain the ship
conveying the cargo had been cast away and the goods lost. Neither party was aware of
these facts. The agreement is void."

(b) A agrees to buy from B a certain horse. It turns out that the horse was dead at the
time of the bargain, though neither party was aware of the fact. The agreement is void. (b)
A agrees to buy from B a certain horse. It turns out that the horse was dead at the time of
the bargain, though neither party was aware of the fact. The agreement is void."

(c) A, being entitled to an estate for the life of B, agrees to sell it to C, B was dead at
the time of agreement, but both parties were ignorant of the fact. The agreement is void.
(c) A, being entitled to an estate for the life of B, agrees to sell it to C, B was dead at the
time of agreement, but both parties were ignorant of the fact. The agreement is void."

[26] Section 20 in The Indian Contract Act, 1872

Agreement void where both parties are under mistake as to matter of fact.—Where both
the parties to an agreement are under a mistake as to a matter of fact essential to the
agreement the agreement is void. Explanation.—An erroneous opinion as to the value of
the thing which forms the subject-matter of the agreement, is not to be deemed a mistake
as to a matter of fact. Illustrations

(a) A agrees to sell to B a specific cargo of goods supposed to be on its way from
England to Bombay. It turns out that, before the day of the bargain the ship conveying the
cargo had been cast away and the goods lost. Neither party was aware of these facts. The
agreement is void. (a) A agrees to sell to B a specific cargo of goods supposed to be on its
way from England to Bombay. It turns out that, before the day of the bargain the ship
conveying the cargo had been cast away and the goods lost. Neither party was aware of
these facts. The agreement is void.
(b) A agrees to buy from B a certain horse. It turns out that the horse was dead at the
time of the bargain, though neither party was aware of the fact. The agreement is void. (b)
A agrees to buy from B a certain horse. It turns out that the horse was dead at the time of
the bargain, though neither party was aware of the fact. The agreement is void."

(c) A, being entitled to an estate for the life of B, agrees to sell it to C, B was dead at
the time of agreement, but both parties were ignorant of the fact. The agreement is void.
(c) A, being entitled to an estate for the life of B, agrees to sell it to C, B was dead at the
time of agreement, but both parties were ignorant of the fact. The agreement is void."

[27] Section 22 in The Indian Contract Act, 1872

Contract caused by mistake of one party as to matter of fact.—A contract is not voidable
merely because it was caused by one of the parties to it being under a mistake as to a
matter of fact. —A contract is not voidable merely because it was caused by one of the
parties to it being under a mistake as to a matter of fact."

[28] Samira Kohli vs. Dr. Prabha Manchanda and Anr on 16 January, 2008. Civil Appeal No.
1949 of 2004. (2008) 2 SCC 1; AIR 2008 SC 1385

[29] Samira Kohli vs. Dr. Prabha Manchanda and Anr on 16 January, 2008. Civil Appeal No.
1949 of 2004. (2008) 2 SCC 1; AIR 2008 SC 1385

[30] Samira Kohli vs. Dr. Prabha Manchanda and Anr on 16 January, 2008. Civil Appeal No.
1949 of 2004. (2008) 2 SCC 1; AIR 2008 SC 1385

[31] Ram Bihari Lal v Dr. J. N. Srivastava. AIR 1985 MP 150

[32] C A Muthu Krishnan v M. Rajyalakshmi. AIR 1999 AP 311

[33] Chandra Shukla v Union of India. AIR 1987 ACJ 628

[34] Samira Kohli vs. Dr. Prabha Manchanda and Anr on 16 January, 2008. Civil Appeal No.
1949 of 2004. (2008) 2 SCC 1; AIR 2008 SC 1385

[35] Samira Kohli vs. Dr. Prabha Manchanda and Anr on 16 January, 2008. Civil Appeal No.
1949 of 2004. (2008) 2 SCC 1; AIR 2008 SC 1385

[36] Samira Kohli vs. Dr. Prabha Manchanda and Anr on 16 January, 2008. Civil Appeal No.
1949 of 2004. (2008) 2 SCC 1; AIR 2008 SC 1385

[37] Samira Kohli vs. Dr. Prabha Manchanda and Anr on 16 January, 2008. Civil Appeal No.
1949 of 2004. (2008) 2 SCC 1; AIR 2008 SC 1385
[38] Samira Kohli vs. Dr. Prabha Manchanda and Anr on 16 January, 2008. Civil Appeal No.
1949 of 2004. (2008) 2 SCC 1; AIR 2008 SC 1385

[39] Samira Kohli vs. Dr. Prabha Manchanda and Anr on 16 January, 2008. Civil Appeal No.
1949 of 2004. (2008) 2 SCC 1; AIR 2008 SC 1385

[40] Samira Kohli vs. Dr. Prabha Manchanda and Anr on 16 January, 2008. Civil Appeal No.
1949 of 2004. (2008) 2 SCC 1; AIR 2008 SC 1385

[41] Dr. Janaki S Kumar and Anr vs Mrs. Sarafunnisa on 21 June, 1999. Kerala State
Consumer Disputes Redressal Commission, Thiruvananthapuram. Appeal No. 850 of
1998. (1999) I CPJ 66

[42] M. Chinnaiyan vs. Sri. Gokulam Hospital and Anr on 25 September, 2006. III (2007) CPJ
228 NC

[43] Dr Shailesh Shah vs Aphraim Jayanand Rathod. National Consumer Disputes Redressal
Commission New Delhi, FA No. 597 of 1995. From the order dated 8 Nov, 1995 in
complaint No. 31/94, State Commission Gujarat

[44] Protection of life and personal liberty - No person shall be deprived of his life or
personal liberty except according to procedure established by law

[45] Paschim Banga Khet Mazdoor Samity and Ors v State of West Bengal and Another.
1996. 4 SCC 37

[46] Pt. Parmanand Katara v Union of India. AIR 1989 SC 2039

[47] TT Thomas (Dr.) vs Elisa. AIR 1987 Ker. 52