Patient Consent

CONSENT

DR. N. C. DAS

CONSENT
Consent refers to the provision of approval or
agreement, particularly and especially after
thoughtful consideration and understanding
As per jurisprudence prior provision of consent
signifies a possible defense (justification) against
civil or criminal liability by the doctor.
Practitioners who use this defense claim that
they should not be held liable for a tort or a crime,
as the consequence in question occurred with the
prior consent and permission of the patient without
realising whether it is a commission or an omission
and the extent of negligence.

MEDICAL CONSENT
Consent is one of the critical issues in the area of
medical treatment.
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 .
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.
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.
The MCI guidelines are applicable to operations
and not cover to the extent other treatments or
procedures
These are covered under Implied and expressed
consent

MEDICAL 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.
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.

LAW AND MEDICAL CONSENT
The rights (autonomy) of the patient have deeply
eroded the old model of doctor-patient relationship.
“Doctors are no more Gods”.
There have been significant changes in the
doctor patient relationship with the advancement of
technology in day-to-day practice.
More and more patients are becoming aware of
their rights and are keen to make free choice and
decision on their treatment.
This helps them to choose the treatment of their
choice from the options available and to select a
physician of their choice

Informed consent was practically non-existent till
the time COPRA (Consumer Protection Act) came
into existence.
This is seen as more of a legal requirement than
an ethical moral obligation on part of the doctor
towards his patient.
The patient has now the ability to select or dismiss
their doctors and to choose the treatment of their
choice from the options available.
Important aspect of several Medical Consumer
litigations is improper consent .

CONSENT AND MEDICAL PRACTICE
There exists a duty to obtain prior consent (with
respect to living patients) for the purpose of
diagnosis, treatment, organ transplant, research
purposes, disclosure of medical records, and
teaching and medico-legal purposes.
With respect to the dead with regard to
pathological autopsy, organ transplant (for legal
heirs), and for disclosure of medical record, it is
important that prior informed consent of the patient,
or relative is obtained after death.

CONSENT AND MEDICAL ETHICS
The Hippocratic Oath prevalent for centuries has
granted doctors the right to decide in the best interest
of the Patient.
But the same has been conflicted with the trend of
twentieth century right of “freedom to control health as
well as avoiding non-consensual medical treatment.”
Clinical ethics teaches physicians, a wide range of
specific ethical issues.
•Informed consent, truth telling,
•End-of-life decisions,
•Advance directives (substitute decision making for
incompetent patients)
•Emergency consent

TYPES OF CONSENT
INFORMED
CONSENT

ADVANCE EXPRESSED
CONSENT CONSENT

SURRGATE IMPLIED
CONSENT CONSENT

1.INFORMED CONSENT:
It is defined as voluntary acceptance after full understanding
,by a competent patient , of a plan for medical care after
physician adequately discloses the proposed plan, its risks
and benefits, and alternative approaches.
The decision-making capacity is free from coercion or
manipulation by the patient/doctor
COMPONENTS :
Informed consent must contain four vital components:-
Mental capacity of the patient to enter into a contract (This
also includes his ability to understand information given)
Complete Information to be provided by doctor
Voluntary acceptance of the procedure by the patient
Should be person and the procedure specific

CONTENTS OF THE CONSENT:
Condition (Disease) of the patient
Purpose and Nature of intervention
Consequences of such intervention
Any alternatives available
Risks involved
Prognosis in the absence of intervention
The immediate and future cost
The knowledge regarding the intervention should be
in an understandable language and format so that
decision in the form of authorization by patient can
be made.

ELIGIBILITY FOR CONSENT:
 Age,
 Soundness of mind,
 Ability to understand
 Remember the information given,
 Ability to deliberate and decide the
treatment choices,
 Believes that the information applies to the
said patient and specific purpose.

2. EXPRESSED CONSENT:
• It may be oral or in writing.
•Though both these categories of consents are of equal value, written
consent can be considered as superior because of its evidential value.
Oral:
•Oral consent should be taken in the presence of uninterested third party
•Mainly in cases where intimate examination of female is required.
•Tests necessitating removal of body fluids, radiological examination can
be done after securing oral consent.
Written:
• It is advisable to take written consent in the presence of disinterested
third party (this third party is only to attest the signature of the patient).
•Consent should be taken in the patients own language.
• Written consent is mandatory in every invasive diagnostic/ therapeutic
procedures or any medico legal examination.

3. IMPLIED CONSENT:
Implied consent may be implied by patient's conduct.
So it is basically the conduct of the patient when he comes to
the doctor for examination / treatment.
Doctor should remember that this is only for routine
examination as well as treatment.
This does not extend to the performance of intimate
examination or diagnostic procedures.
If there is slightest chance of any complication express
consent should be taken.
4. TACIT CONSENT:
Tacit consent means implied consent understood without being
stated.
Usually the way a patient present him self for treatment imply
consent.

5.SURROGATE CONSENT:
This consent is given by family members for minors or dead.
Generally, courts have held that consent of family members
with the written approval of 2 physicians sufficiently protects a
patient's interest.
6. ADVANCE CONSENT :
It is the consent given by patient in advance before death
7. PROXY CONSENT :
It indicates consent given by an authorized person before or
after death.
If an unconscious patient brought by police from road and
operation essential to save life 2 or 3 doctors to give consent
by signing on consent form, preferably along with police.
Informed consent obtained after explaining all possible risks and side
effects is superior to all other forms of consent and legally defensive.

CONSENT PROFORMA
I _____S/D/W of ______ aged __ address ______under the treatment of Dr
______do hereby give consent to the performance of _____(
procedure/treatment) and to the administration of _____(anaesthesia) upon
myself/upon ____ aged __who is related to me as _____.
The nature and purpose has been explained to me by Dr _______.
I declare that I am more than 18 years of age.
I have been informed that there are inherent risks involved in the treatment.
No assurance has been given to me regarding the success of the treatment.
I have given this consent voluntarily out of my free will without any pressure.
Place:
Date & Time:

SIGNATURE

I hereby declare that I have explained in detail regarding the case to the patient
and answered all his queries to his satisfaction in a language that he could
understand.
Place:
Date & Time:

Signature of the Doctor

WHO CAN GIVE CONSENT
Simple medical examination the minimum age
of consent is 12 years.
For consenting to have any major diagnostic
or therapeutic procedure or surgery the age is
above 18 years (I.P.C. Sections 87-93).
The patient should be mentally sound and
he/she should not be under any fear or threat or
any false conception.
The patient should not be intoxicated or
sedated.
Incomplete information about the patient’s
diagnosis, therapeutic plan etc. is a
commission than misconception of omission.

CONSENT REQUIRED
i) Some body else other than the “patient” wants
him to be medically examined and a medical certificate
to be issued (employers,),
ii) Consent of the concerned person must be obtained
otherwise the doctor runs the risk of liability to pay damages.
Such as:-
a. Issuing certificate involving complicated process of
examination or infertility in women.
b. When the process is likely to affect the physical or
mental well being of the patient e.g financial loss,
c. damage to reputation, social status (STD, HIV etc.).
d. Procedures violating rights of spouse is in cases such as
Sterilisation, artificial insemination.
Even after the consent is taken the examination should be done in
presence of third person (nurse ,Female attendant) while examining
a female patient.

EXCEPTIONS TO THE INFORMED
CONSENT
a. Doctrine of Therapeutic Procedure:
• Certain procedural details (especially invasive tests or
complicated surgery) may be difficult to explain to
the patient.
•Often patients themselves do not want to know about it.
•It is better to explain to the family members.
b. Doctrine of Emergency:
•Under section 92 of Indian Penal Code (IPC) treating without consent of
patient is permissible if patient is unconscious, mentally ill
or gravely sick and no attendant with the patient.
•It is implied that the procedure /surgery is done to save the
life or limb of the patient.
•If possible, surrogate/proxy consent should be taken.
c. Doctrine of Loco Parents:
•In children in an emergency, when parents / guardians are not available,
consent can be obtained from the person bringing the child (school teacher,)

EXCEPTIONS TO THE INFORMED
CONSENT
d)Incompetence: Incompetent patients such as delirious,
unconscious, senile, psychotic nature etc are unable to make
rational decision. In these cases they can be treated without
informed consent involving the “Emergency” doctrine.
e)Therapeutic privilege: If doctor suspects that passing full
information could have detrimental effect on the health of the
patient than he need not follow “Doctrine of Full Disclosure”
•And can be excused of obtaining consent from the patient.
•However, to take the privilege of the doctrine, he should
disclose full information to the competent relative of the patient.

DOCTRINE OF FULL DISCLOSURE
The Doctor is legally bound to pass on every
detail regarding the disease condition, nature of the
proposed treatment, any alternative treatment, and
prognosis with possible risks and benefits of the
procedure to the patient.
Mental capacity, physical condition as well as age
of the patient should be considered while delivering
this information and likely after effect or else the
same information can be passed on to any other
authorized person.
This therapeutic privilege of a doctor is an
exception to professional secrecy.

CONSENT NOT REQUIRED
i. Medico-legal cases bought by police consent is implied under sec 53
of criminal procedure code. Hence can be examined
ii. Consent is not required in medical examination and
issue of certificate for insurance policies .
iii. Cases where it is issued in the interest of the community
iv) A person suffering from disease under “notified” category( to notify the
authorities only)
v)Prisoners ( new entrants)
vi)Examination under Court Order
vii)Request by a police officer under Cr.P.C. Section 53(1)
-To avoid insufficient legal interpretations, Informed Consent (IC )
should be understood in terms of autonomy .
-A continuous interaction between the patient and the given
physician is considered as an essential pre requisite for
the realisation of the standards of IC

DIFFICULTY IN OBTAINING CONSENT
The difficulties in getting informed consent
include:
a. Incompetence and mental incapacity of the
patient,
b. Unusual (socio, religious) beliefs of patient.
c.. Extent of truthful disclosure,
d. Incompleteness of information disclosed
e. Advance directives by terminally ill patients or
those who anticipate grave illness.
f. Durability of power of attorney for health care,
when holder gives the consent and decisions in
advance

INDIAN LEGAL PROVISION
Section 53(1) Cr PC: In criminal cases when examination of an
arrested person can lead to vital evidence related with the
commission of crime, he can be examined by the doctor without his
consent and even using force, if the application for examination is
from a person not below the rank of sub Inspector.
Section 54 Cr PC: An arrested person can also request to be
examined by a doctor to detect any evidence which he feels is good
for him.
Section 87 IPC: A person above 18 yrs of age can give consent to
suffer any harm if the act is not intended and not known to cause
death or grievous hurt.
Section 89 IPC: A child under 12 yrs of age or a person of unsound
mind cannot give consent to suffer any harm for an act which may
cause grievous hurt or death even if done in good faith , but the
consent has to be obtained from the guardian of the child or insane
person.

Section 90 IPC: Consent given by an insane person or
given under fear of injury, death etc. or due to
misconception of a fact is invalid.
Section 92 IPC: Any harm caused to a person in good
faith even without the person’s consent is not an offence
if the circumstances were such that it was impossible to
obtain consent of the person or his lawful guardian at
that material time for that thing to be done for the
benefit of the person.
However the act should not extend to intentionally
causing hurt other than for preventing death, grievous
hurt or curing of disease or infirmity.
Consent of both spouse required in case of
sterilisation and Artificial insemination

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DR. N. C. DAS

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