The paper contains introduction to the informed consent and its
basic format as a procedure, with feature and responsibility of the doctors and
patient as well. Informed consent requirement and its actual importance, legally
can anybody fill this or not. Type of informed consent, about legal status and
legal scenario, informed consent is not a mere do form, it is a procedure.
Special conditions and circumstances and how doctors should react in such
condition with their patients with that a brief view of conclusion.
Starting from the beginning, let's talk about what informed means ,basically
informed means having knowledge or information about something. In detail it
turns out to be the required information to the person whom it is necessary,
there should be a complete knowledge about the facts and information without any
Informed consent is a process with respect of which the patient learns about an
actual procedure of the medical and surgical intervention as this includes
everything such as clinical trials, and here patient understands the risk and
benefits of the procedure of the treatment.
Informed consent is a normal and a starting process of giving all the
information to the patients regarding everything. Basically, this is purposed so
that the patients or the responsible whoever is so agreed to all the statements
and try to figure out all the consequences from treatment. This is done by
keeping the safety feature in the sight.
This informed consent process provides you with all the health care factors and
gives you all the opinion regarding the treatment and procedural way to be
Whereas, now we will discuss what this informed consent form contains and what
is the responsibility of a patient.
This information includes:
- The exact position of the patient.
- Treatment procedure and its name which is provided by the health care
- Benefits and risk of the treatment procedure.
- If treatment is not given to the patient then what will be the
Responsibility of the patient:
- The sign you have done on the basis of reading all the treatment
procedure and you are agreeing to all the facts and the circumstances.
- Patient can ask questions and before that you must completely understand
all the points of the information.
- You can further talk to the health care providers so that they can help
you with the exact satisfaction and you may choose the whole treatment
procedure or the one portion.
Whereas, if there is any query then the patient should consult to the health
Informed consent is the main responsibility of the doctors to provide the
required information to the patient and make sure that the information is
correct to the point and this information should be provide in simple words
without creating hectic words. It is good if the information is shared verbally
as patients are not from the background of medical so it is not that easy for
them to understand. However,written informed consent is also valid.
Why informed consent is required?
In the report of Nuremberg Code (Ref.1) addresses that the voluntary informed
consent is required as it is the fundamental ethical principle. The participant
has to give their autonomy which implies the responsibility must be given to the
individual to make the decision and give consents related to their medical
conditions. It is not only essential for the safety and the protection of the
patient but also for the respect and integrity of the patient.
The form signed is a legal document that shows the acceptance of a patient and
agreement to the medical procedure specified by the healthcare providers. Once
the consent form is signed it means that the patient has received all the
relevant information about the procedure and agreed with their free will. This
signifies that the healthcare provider can proceed with the treatment. If any
participant denies to the treatment suggested by the doctors, then may not sign
the form. Everyone has the right to refuse to the treatment if they are capable
of taking decisions. The legal competent that is capable to make medical
decisions have the legal and moral right to refuse any treatment.
Can other person sign a consent form on the behalf of the patient?The following are such cases where another person can sign the consent form:
- Minor- When the patient is a minor who is incapable of making
decisions for their betterment. The parents or guardian of the minor can
sign the form on their behalf.
- Advance Directive - In this case, the patient himself has
directed the other person to make their future medical decisions. A form has
to fill prior to giving consent which is called an advance directive. It
will allow someone else to be consent on your behalf.
- Cannot give consent- when the person is incapable to give consent
then the other can give the consent. These are the cases where the patient
is in coma and Alzheimer.
Types of Informed ConsentThe following are the types of informed consent:
- Consent- A participant who is an adult is capable to give permission or
consent on their own provided that they must be 18 years old and above.
- Parental Permission- When the patient is a minor then there is the need
to take the parental permission which is duly signed by the parents or the
guardians of the child. A child is incapable to know what is right and wrong
for them, that's why there is a need of parental permission.
- Assent- It is the child's affirmative agreement where the content of the
informed consent form is written with simple terms and is easy to be read by the
child. The reading level of the content should be written in such a way that the
child of age 7 to 17 years can understand it easily.
- Verbal- In this type, the participant verbally read the content and
verbally gives their consent. Although it contains all the written contents
- Short Form- There is various challenges when it comes to informed
consent. The short form is required when there is a language barrier. In
India, this problem is very common because many people are unable to
understand English. So, the approved consent is translated to the patients
in their native language for better understanding of the concerned matter.
Informed consent is a process not a mere form
It is an important document which is related to your health factors so that the
patient is aware of every situation regarding to the health and what should be
the upcoming treatment related to the human body. There are few requirements
which should be considered in the informed consent document i.e. it should be in
the simple and plain language there should not be any use of hard words or
ambiguity. There should also some extra information regarding the informed
consent so that it is easy for everyone to get the actual extract of the
Moreover, this should not be treated as a formality, it should be taken as much
as serious and the complete procedure should be followed by doctors and patient
as well. There should be a proper management so that it will become easy for
everyone. To make it easy doctors can provide them counseling and this
counseling procedure should be done in easy language, so that they can
Legal Scenario of Informed Consent
The duty of doctors is to inform the patient about their conditions and all the
possible risks involved. But if the doctor is unable to perform their duties
then they will be liable for medical negligence. In medical negligence cases,
the doctors carelessly or improperly treat the patient it can be either without
adequate technical skills or knowledge. There was a case where, the surgeon
while performing the surgery discovered that her womb was ruptured. He
sterilized her without taking consent of her. The doctor was held liable for
medical negligence. The liability of the doctors in case of absence of
disclosure of the information will be as medical negligence and hence the doctor
will be liable for the same.
The following are the cases where the consent is required to be taken and if not
then the legal actions will be taken:
- Right to Refusal- the patient has the right to protect their body
from any kind of interventions. If any patient has not given consent for the
treatment then the doctors cannot perform the treatment on them and if they
operate then it will be punishable. In Indian, the burden of proof lies on
the doctor to justify their actions which would be illegal in the absence of
consent. Indian courts may presume the consent to be implied but up to
certain limits. Beyond that, the specific proof needs to be presented to the
- Minor's consent-Section 3 of Indian Majority Act, 1875, sets the age
of majority as 18 years in India. Therefore, the person below the age is minor
and cannot give consent. The parental consent will be considered lawful.
- Medical termination of Pregnancy- In the minor or a lunatic for
termination of pregnancy, the parental consent is required. The Medical
Termination of Pregnancy Act, 1971 provisions ensures that no pregnancy
shall be terminated without the consent of the women. The termination must
be done only in good faith and n the benefit of a person's life.
If there is any condition in which a person is somehow incapable of giving the
informed consent then there are certain requirements which must be followed by
that person so that there should not be any query:
- There should be a proper explanation.
- There is a requirement of individual assent.
- Person best preference should be considered and for their best interest.
- If there is any substitute consent then that must be verified that is
this sufficient toall the essential requirements. Similarly, if doctors do the same
then they should also have a very clear explanation regarding everything.
Moreover, it is not expected from the doctors but still if there is any issue
then they should present it very carefully.
The main importance of this document is that it gives you the surety of
treatment and make sure that if there is any risk related to your health then it
should be already discussed with you.
Doctors' duty towards the informed consent
As the health and life is the most basic requirement of the human body so there
should not be any risk related to the health status of a human body. In
India, doctors are considered as equal to the god who are lifesavers for us and
give us the ray of hope in the toughest time. There should not be lack of
knowledge from their side because it is considered that doctors are the one who
always serve their patient in any situation and it is clearly visible by the
recent example of coronavirus in the society.
Sometimes doctors forget about the informed consent document due to any of the
reason such as not sufficient time, lack of their duty or due to any other
reasons. So it is very important that doctors should perform their duty
perfectly, there should not be any lacking point which can raise question on
their profession. Health is the most preferred thing for a normal human being
and if a doctor shows any point of carelessness towards it, this would be
totally wrong. Throughout the whole treatment, a doctor should act as
responsible and should work with complete dedication.
The rights of a person are determined through their human status. The informed
consent is an important tool in clinical trials. The responsibilities and
importance of this consent must be ethical and genuine for the betterment of the
participant. This paper involves a brief description of informed consent. The
legal perspective, its importance and the requirement of the consent form is
explained. The guidelines on informed consent in India should be based on
complex factors such as diversity, culture, level of education and the
- Devi v. West Midlands AHA,(1980)7 C.L.44
- Cold v. Haringey Health Authority(1988)QB 481