“DOCTRINE OF INFORMED CONSENT IN DOCTOR PATIENT

RELATIONSHIP”

A PROJECT SUBMITTED IN PARTIAL FULFILMENT OF THE REQUIREMENTS FOR

THE AWARD OF THE DEGREE B.A. L.L.B. (Hons.) FOR THE SUBJECT HEALTH
LAW

SUBMITTED BY:

ABHISHEK KUMAR

ROLL NUMBER – 1906

B.A. L.L.B (Hons.)

XTH SEMESTER, 5TH YEAR.

SUBMITTED TO:

MR. KUMAR GAURAV

ASSISTANT PROFESSOR OF LAW

CHANAKYA NATIONAL LAW UNIVERSITY, PATNA

NYAYA NAGAR, 800001

 DECLARATION BY THE CANDIDATE

I hereby declare that the work reported in the B.A. L.L.B. (Hons.) Project Report entitled ―

“DOCTRINE OF INFORMED CONSENT IN DOCTOR PATIENT RELATIONSHIP”

submitted at Chanakya National Law University, Patna is an authentic record of my work
carried out under the supervision of MR. KUMAR GAURAV for the subject HEALTH
LAW. I have not submitted this work elsewhere for any other degree or diploma. I am fully
responsible for the contents of my Project Report.

(Signature of the Candidate)

ABHISHEK KUMAR

ROLL NO.- 1906

XTH SEM, 5TH YEAR

B.A.L.L.B.(Hons.)

Chanakya National Law University, Patna

 ACKNOWLEDGEMENT

Writing a project is one of the most significant academic challenges I have ever faced. Though
this project has been presented by me but there are many people who remained in veil, who
gave their all support and helped me in the completion of this project. First of all, I am very
grateful to my subject teacher MR. KUMAR GAURAV, without the kind support and help of
whom the completion of this project was a herculean task for me. He donated her valuable time
from his busy schedule to help me to complete this project and suggested me from where and
how to collect data. I am very thankful to the librarian who provided me several books on this
topic which proved beneficial in completing this project. I acknowledge my friends who gave
their valuable and meticulous advice which came out to be very useful and could not be ignored
in writing the project. Last but not the least, I am much thankful to my parents and family, who
always stood aside me and helped me a lot in accessing all sort of resources.

ABHISHEK KUMAR

Roll no.- 1906

Xth Semester, 5th Year

Contents
INTRODUCTION ..................................................................................................................... 5
IMPORTANCE OF INFORMED CONSENT .......................................................................... 7
DOCTRINE OF INFORMED CONSENT IN PATIENT DOCTOR RELATIONSHIP ........ 10
LEGAL SCENARIO RELATING TO INFORMED CONSENT ........................................... 13
CONCLUSION AND SUGGESTION .................................................................................... 15
BIBLIOGRAPHY .................................................................................................................... 16
 INTRODUCTION

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. The patient must be
competent to make a voluntary decision about whether to undergo the procedure or
intervention. Informed consent is both an ethical and legal obligation of medical practitioners
in the US and originates from the patient's right to direct what happens to their body. Implicit
in providing informed consent is an assessment of the patient's understanding, rendering an
actual recommendation, and documentation of the process. The Joint Commission requires
documentation of all the elements of informed consent "in a form, progress notes or elsewhere
in the record." The following are the required elements for documentation of the informed
consent discussion:

(1) the nature of the procedure,

(2) the risks and benefits and the procedure,

(3) reasonable alternatives,

(4) risks and benefits of alternatives, and

(5) assessment of the patient's understanding of elements 1 through 4.

It is the obligation of the provider to make it clear that the patient is participating in the
decision-making process and avoid making the patient feel forced to agree to with the provider.
The provider must make a recommendation and provide their reasoning for said
recommendation.

The 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 in it

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.

OBJECTIVES OF THE STUDY:

• To study about the effectiveness of informed consent.
• To study about the limitations in the exercise of informed consent.
SOURCES OF DATA
Primary: Research, field word, etc.
Secondary: Books, journals and internet.

METHOD OF WRITING
The method of writing followed in the course of this research project is primarily analytical.
Mode of Citation: The researchers have followed a uniform mode of citation throughout the
course of this project.
 IMPORTANCE OF INFORMED CONSENT
Consent codes and laws protect both caregivers and care receivers. They help establish trust in
your caregiver while respecting your autonomy as a care seeker. They help to prevent
misunderstandings and lapses in communication that could lead to you being unhappy with the
care that you receive. They make sure that you understand what to expect, including the
chances of less-than-optimal outcomes. Most healthcare providers have good intentions to treat
care seekers ethically, including being honest about their options, their risks and their
prognosis. But sometimes practical limitations and human error thwart these intentions. That’s
where formal processes and laws can help. These processes and laws have evolved over time
to take into account some of the stumbling blocks we’ve met along the way.

For example:

• What if you and your healthcare provider don’t speak the same first language?

• What if they’ve given you information in writing, but it reads like a medical textbook
and you find it hard to grasp?

• What if you’ve agreed to have a procedure at a teaching hospital, but you didn’t realize
students or residents would be involved?

Scenarios like these have required healthcare providers to revise their approach.

Which medical procedures require informed consent?

Laws vary, but in general, informed consent applies whenever you’re accepting a risk. Many
medical procedures carry a low risk of complications or a moderate risk of minor side effects.
In addition to protecting your body, you also have the right to protect your privacy. The
principles of informed consent protect all of these rights. In practice, procedures that are likely
to require signed consent include:

• Treatment with high-risk medications, such as opioids.

• Tests and medical interventions that go inside your body, such as endoscopy.

• Childbirth interventions, such as forceps delivery or episiotomy.

• Surgery.

• Biopsy.
 • Medical implants.

• Use of anesthesia.

• Use of radiation.

• Chemotherapy.

• Blood transfusions.

• Genetic testing.

• Clinical trials involving human research subjects (including psychology research).

• Procedures involving medical students.

• Certain vaccines.

• Any transfer of your personal information.

What are some examples of informed consent in healthcare practice?

• Treatment planning: You’ve just learned that you have cancer, and based on the type
and stage that you have, there are a few different treatment options. All of the options
have different risks and side effects. Your doctor recommends one option, but you read
about an alternative treatment that interests you. It’s your doctor’s job to explain their
opinion while also fairly addressing your concerns and personal preferences. This is
how both of you can cooperate in the decision process.

• Unplanned interventions: You’ve been in labor for several hours, but labor isn’t
progressing. You didn’t want medical intervention, but now your healthcare team is
telling you that they’re concerned for you or your baby. There are a few different ways
they could intervene to assist you, but they will have to act quickly if they do. All
options have risks, including not intervening. Your team will explain your options and
their recommendations so that you can decide how you want them to proceed.

• Authorized consent: You’ve been diagnosed with a complex condition that you’ve
never heard of before. Your doctor has explained it, but you find the details confusing
and overwhelming to consider. You don’t really want to become an amateur researcher
or second-guess your doctor’s judgment. You just want to trust your doctor to take care
 of it for you. You can authorize this. They’ll tell you what they want to do and why, but
you can request minimal details and decision-making.1

1
hhtp:www.cirp.org/library/ethics/nuremberg
DOCTRINE OF INFORMED CONSENT IN PATIENT DOCTOR
RELATIONSHIP

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 providers.

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 Code2 (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

2
hhtp:www.cirp.org/library/ethics/nuremberg
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.

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.3

3
Ibid.
 LEGAL SCENARIO RELATING TO 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 4, 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.5

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
court.

• 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.

4
Devi v. West Midlands AHA,(1980)7 C.L.44
5
Cold v. Haringey Health Authority(1988)QB 481
Special circumstances

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:

1. There should be a proper explanation.

2. There is a requirement of individual assent.

3. Person best preference should be considered and for their best interest.

4. 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.
 CONCLUSION AND SUGGESTION
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 information.

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 understand properly.

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 demographical scenarios.
 BIBLIOGRAPHY
Websites:

• www.irda.gov.in
• Nationalinsurance.co.in
• www.wikipedia.com
• www.policybazaar.com

Books:

• Research Methodology from D.D. Sharma.