Consent and Indian Law

[free and voluntary] Consent means free, voluntary agreement or compliance.

The term ‘consent’ can be linked to the medical profession and has been interpreted in the
following acts:

Indian contracts act, §11 and 13.

Sec.13 of Indian contract act lays down that two or more persons are said to be in consent with
each other when they agree upon the same thing in same manner.

IPC,

Sections 87 to 91 of Indian penal code deals with defence of consent.

Section 88 of IPC- Consent with Good faith act not intended to cause
death, done by consent in good faith for person’s benefit. Thus after a
valid consent if surgeon operates on patient and patient dies on the operation table, then the
surgeon cannot be held guilty of murder. Persons who are non-qualified in medical profession
are not allowed to take the plea of this section, as they are not said to do the act in good faith.

According to Section 89 of IPC--For a person who is under twelve years of age, or is of unsound
mind, his/her guardian or any other person who has lawful charge of that person, can give
consent,

Sec 90 of IPC excludes consent given under misconception of fact or fear, unsoundness of mind.

Indian Medical Council Code of Ethics Regulations, 2002, §7.16

Section 7.16 of the Indian Medical Council Code of Ethics Regulations, 2002, states: 'Before
performing an operation the physician should obtain in writing the consent from the husband or
wife, parent or guardian in the case of minor, or the patient himself as the case maybe. In an
operation which may result in sterility the consent of both husband and wife is needed.

Consumer protection act.

Failure of taking informed consent is considered as a deficiency in medical services under the
section 2(1)(f) of the Consumer Protection Act, 1986 or section 2(11) of the New consumer
protection act of 2019. Deficiency has been stated in the 2019 act as –

"deficiency" means any fault, imperfection, shortcoming or inadequacy in the quality, nature and
manner of performance to any service and includes—

(i) any act of negligence or omission or commission by such person which causes loss or
injury to the consumer; and
(ii) deliberate withholding of relevant information by such person to the consumer;

Doctrine of loco parentis

The legal doctrine of Locoparentis means in place of the parent. It states that in
emergency involving children, when their parents or guardian are not available, consent
is taken from the person in charge of the child. Caregivers and management in hospital
have the duty of care in place of the parent. And hence this doctrine is being followed in
the medical profession.

Situations Where Consent Need Not be Taken

There are 4 exceptions where treatment can begiven to a patient without obtaining consent.

1. First, the patient can be treated in an emergency situation without obtaining consent.
2. when the patient is psychotic, senile, an infant, or otherwise not in a position to give
consent.
3. Treatment can be given without consent if the medical professional believes strongly that
obtaining informed consent would be harmful to the patient. This is known as therapeutic
privilege
4. If the patient asks specifically not to be told about treatment decisions and asks the
medical professional to carry out treatment which is in his or her best interest.
Consent need not be taken under the following circumstances as well-

1. Examination under court order,

2. New admissions to prisons,
3. Members of armed forces, and
4. Immigrants

Types of Consent

Two types of consents are taken by medical professionals in India before commencing treatment.
These are implied and expressed consent.

1. Implied consent ---is a verbal consent which is legally valid. Such implied consent is only
for ordinary medical examination like examination of pulse, recording of blood pressure
etc. It does not cover the consent for pelvic examination, injections, or any major
interventions. For further treatment, an expressed consent is required.
2. The second type of consent is expressed consent--- which may be oral or written. This
type of consent is mainly taken before a major diagnostic or therapeutic modality which
carries a definite and major risk. An oral consent is sometimes legally valid, but in the
current situation of medical litigation, written consent is preferred for major procedures
because patient may, at later stage, deny that any oral consent was given.

Informed Consent --- Concept of USA

Informed consent is the process in which a health care provider educates a patient about the
risks, benefits, and alternatives of a given procedure or intervention. Informed consent is
considered an essential safeguard of patient autonomy, where autonomy means, 'a capacity for
independent decisions and action. Informed consent must be preceded by disclosure of sufficient
information. Consent can be challenged on the ground that adequate information has not been
revealed to enable the patient to take a proper and knowledgeable decision.

-------Origin of ‘Informed Consent’

The legal precedent for informed arises from the case of Schloendorff v. Society of New York
Hospitals in 1914, USA, in which a surgeon failed to take consent for hysterectomy. Benjamin
Cardoza, J. observed that “Every human being of adult years and sound mind has a right to
determine what shall be done with his own body and the surgeon who performs operation
without his (patient's) consent commits assault for which he is liable in damages.” This case
established the concept of autonomy of a patient undergoing treatment and a competent adult's
right to refuse treatment.

The expression “informed consent “entered American jurisprudence in 1957 in a California

medical malpractice case. In Salgo V Stanford University, patient’s legs were paralyzed when his
physician performed aortography to locate an obstruction in his abdominal aorta. Apparently, the
treating physician had not counseled the patient at the risk inherent in the procedure. In its
decision, the court held that “a physician violates his duty to his patient and subjects himself to
liability if he holds any facts which are necessary to from the basis of an intelligent consent by
the patient to the proposed treatment.”

Bolam Test and it’s applicability

The law for consent has evolved to a great extent in USA and UK. In UK, it is called real consent
while in USA it is called 'informed consent'. The English law regarding disclosure of risk follows
the Bolam principle which originated from the case of in the case of Bolam v Friern Hospital
Management Committee [1957] 1 WLR 582. According to this case, a doctor is not negligent if
he acts in accordance with the practice accepted at the time as proper by a responsible body of
medical opinion, even though other doctors adapt a different practice.

In Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Mandsley Hospital,
the House of Lords adopted the Bolam test and followed the reasonable doctor standard
regarding the duty of disclosure risk of proposed treatment. It is important for medical
professionals to provide as much information as possible for informed decision making.

A similar view is adopted by the Supreme Court of India in the Samira Kohli case. The SC
observed that, 'In India, Bolam test has broadly been accepted as the general rule.'
Cases

Cases

1. In Rambiharilal v. Dr JN. Shrivasta The surgeon did not explain the side effects of
chloroform anaesthesia before taking consent of the patient for an operation for
appendicitis. During operation, the patient's appendix was found to be normal. The
surgeon proceeded to remove the gall bladder without the consent of the husband waiting
outside and without caring for the ill effects of keeping the patient under chloroform. The
patient died. The surgeon was held negligent.
2. In Arun Balakrishnan Iyer v. Soni Hospital, during an operation for ovarian cysts, there
was an emergency situation and the uterus was removed. The consent of the patient could
not be taken as she was under anaesthesia but her husband's consent was taken. It was
held that the removal of uterus without the consent of patient was not negligence.
3. In Dr. Janaki Kumar versus Mrs. Sarafunnisa case 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. It was observed that
when one speaks of consent, that should be informed consent.
4. In a case Aplarain Jayanand Rathod v. Dr. Shailesh Shah the operation of appendicitis
was performed without written consent under the guise of removal of stitches and no
explanation was given for the second operation. The State commission found that the
Doctor was deficient in service and was liable for compensation.
5. Malay Kumar Ganguly v. Dr. Sukumar Mukherjee,
a. The deceased approached Dr. Sukumar Mukherjee complaining of acute pain,
fever and rashes, where she was administered a v. high dosage. No sign of
improvement could be seen and hence, she died on 28 May 1998.
b. The supreme court without reference to its previous judicial opinion in Samira
Kohli emphasized on the need of doctors to engage with the patients during
treatment, especially when the line of treatment is contested, has serious side
effects and alternative treatments exist, and observed that “[i] n the times to come,
litigation may be based on the theory of lack of informed consent.”
 6. Samira Kohli vs Dr. Prabha Manchanda (2008)- In following case, a patient was
admitted to a private hospital for diagnostic and operative laparoscopy but instead a
hysterectomy (removal of uterus and of fallopian tubes) was performed, rendering her
incapable of bearing any children in the future. It was held by the Supreme Court that
consent taken for diagnostic procedure/surgery is not valid for performing therapeutic
surgery either conservative or radical except in life-threatening or emergent situations.
The Supreme Court held the doctor liable for malpractice

Procedure:

The information disclosed should include:

• The condition/disorder/disease that the patient is having/suffering from

• Necessity for further testing

• Natural course of the condition and possible complications- symptoms

• Consequences of non-treatment

• Treatment options available- alternatives

• Potential risks and benefits of treatment options

• Duration and approximate cost of treatment- cost

• Expected outcome

• Follow-up required