Consent is crucial to validate any act involving
two persons. A valid consent to medical procedures is an essential component
for every interaction between all doctors and patients.
Consent is considered as legally valid, if the
following hold true:
·
The patient is legally competent, i.e., he is an
adult, with a healthy mind and understanding
·
Consent is given voluntarily
·
The person giving consent has been well informed
·
Everything told to the patient must be recorded
·
Consent is patient-specific
·
If a competent adult refuses to get treatment, his
decision must be respected.
Consent of the patient or the legal guardian is
necessary to conduct an examination. In cases labeled as medicolegal, an
informed consent includes the following information:
a) the examination to be conducted is a medicolegal one and would be followed by the preparation of a medicolegal injury report,
b) all the necessary investigations required would be done, and
c) the findings of the report could go against the patient if they are not in line with the history given by the patient.
An accused arrested in a criminal offence can be
examined without his consent on the police’s request or on the orders of the
court, if the examination is believed to provide evidence that the offence has
been committed.
While examining a woman, examination by a lady
doctor should be preferred. If this is not possible, a female attendant such as
a nurse should be present at the time of examination.
·
Consent depicts the right of a patient to make a
decision regarding his medical treatment.
·
Consent refers to voluntary participation of the
patient in his own treatment by a physician or an institute.
·
Consent is essential for all diagnostic and therapeutic
procedures that are associated with risk/adverse effects or complications.
·
Consent is mandatory for all medicolegal cases.
Implied Consent
Implied consent is where the behavior and the
conduct of a patient suggest his consent. It implies consent to medical
examination in a general sense, for instance, when a patient puts forth his arm
for an intramuscular injection. This is the most common form of consent in
medical practice. It is not expressed, yet legally effective. However, implied
consent is generally limited to common procedures of medical examination.
Expressed Consent
Expressed consent is when a
patient clearly expresses his consent to undertake diagnostic or therapeutic
treatment. This may be either verbally
expressed or may be expressed in writing after the patient is informed about
all the aspects of the diagnostic and therapeutic procedure.
When the patient expresses consent to a specific diagnostic or therapeutic procedure verbally, it
is termed as oral or verbal expressed consent. When the consent is given in
writing, it is called as written expressed consent. Both these forms of
expressed consent are acceptable in the court of law as proof of consent;
however, written expressed consent is more valuable as it is a permanent
written record. To be legally acceptable, expressed consent must agree to the
doctrine of informed consent.
Blanket Consent
Blanket consent is taken on a printed form that
details almost everything that a doctor or hospital might do to a patient.
Blanket consent is legally inadequate for procedures that have risks and
alternatives.
Elements of informed consent
Disclosure of Information
The following are included in disclosure of
information:
·
A doctor is required to explain the exact nature of
the disease to the patient.
·
A doctor should explain the need for the treatment
and the nature of the procedure as well as the expectation from the recommended
therapeutic intervention besides the probability of success.
·
The patient must be informed about the alternative
forms of treatment available, with the associated benefits and anticipated
adverse effects or risks and complications linked with both the proposed
and alternative procedure.
·
The patient has the right to choose between
proposed and alternative procedure.
·
The patient’s right to refuse all of these
procedures and the medicolegal outcomes of refusal.
Voluntary Consent
The patient's consent must be voluntary and free
from any intimidation, force and misrepresentation of facts. A consent is
legally valid only if it is informed and voluntary and has been taken freely
and exclusively by the patient. No one else has the authority to give consent
on behalf of the patient (with few exceptions).
Capacity to Decide
Capacity to decide is a significant aspect of
informed consent. An individual who is able to understand the nature of the
act/procedure and its probable consequences should give consent. The person
giving the consent must be mature enough to understand, evaluate and estimate
the risks and benefits associated with the proposed treatment. He should be
able to accept the responsibility for the informed consent given to the
proposed treatment. Following are the characteristics that describe a competent
person:
·
A person with a sound mind
·
A person with proper reasoning
·
One who understands the implications of his consent
·
A person who is at least 12 years of age.
The informed consent is considered to be legally
valid if all the aforementioned components are fulfilled.
Special Circumstances
·
If the patient is a child <12 years of age, consent
is taken from the parent or guardian.
·
In an emergency involving a child where parents and
guardians are not available, consent can be obtained from the person who is in
charge of the child at that moment (Loco Parentis).
·
Consent given for an illegal act is not valid.
·
In an emergency where the patient is unconscious
and unfit to give consent, emergency doctrine is applicable.
·
Consent of spouse for operation and treatment in
the routine course is not necessary. However, consent is required if the
procedure/instrument used involves danger to life or can impair sexual
functions.
·
Consent of both the spouses is required in case of
an operation involving reproductive and sexual organs, such as sterilization.
In cases of artificial insemination donor, consent is need from both the
recipient husband and wife and the donor and his wife.
·
Under Medical Termination of Pregnancy Act 1972,
for MTP, the consent of pregnant woman is sufficient if she is >18 year of
age and has sound disposing mind. If the pregnant woman is <18 years old,
unconscious or is of unsound mind, consent is taken from her parent or legal
guardian.
·
Any information pertaining to the nature of illness
of the patient can not be disclosed to a third party without his consent except
in the following situations:
o
Privileged
communication.
o
Case
of negligence against the doctor where he can reveal the secrets in his
defense.
o
When
asked by the honorable court or judge.
·
Consent should be taken from the next of kin of a
deceased person for performing clinicopathological autopsy. Consent is not required for medicolegal autopsy since the law of
the land gives the consent.
·
For cadaveric transplantation, consent is taken
form the next of kin, who is in possession of the dead body.
·
For publication of patient's record or data or
photographs, in articles or journals, consent must be taken from them and
assurance should be given that their identity will be protected.
·
Written informed consent should be obtained from
individuals participating in a research program/clinical trial.