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J Indian Acad Forensic Med. October-December 2015, Vol. 37, No.

4 ISSN 0971-0973

Review Research Paper

Patient Autonomy and Informed Consent: The Core of


Modern Day Ethical Medical
1 2 3
Dasari Harish, Ajay Kumar, Amandeep Singh

Abstract
The UN Charter of Human Rights says: ―All human beings are born free and equal in dignity and
rights. They are endowed with reason and conscience and should act towards one another in a spirit of
brotherhood.‖ In the words of Judge Cardozo, ―Every human being of adult years and sound mind has a
right to determine what shall be done with his own body; a surgeon who performs an operation without his
patient‘s consent commits an assault, for which he is liable‖. This in complete contradiction to the
Hippocratic Oath, which is the Oath taken by most medical graduates in the world.
The most important principle for modern medical ethics is respect for patient autonomy, informed
consent and patient confidentiality. The goal of informed consent is to respect patient autonomy and
enable him to make decisions regarding his medical care, of his free will, without coercion, after
understanding fully what he is consenting for. The Principle of Autonomy, its implications on informed
consent and patient care situations will be dealt with in this paper.

Key Words: Principle of Autonomy, Informed Consent, Ethical Medical Practice, Patient Autonomy,

Introduction: They have withstood challenge for


The Original Hippocratic Oath states: ―I nearly three decades and still form the basis for
swear by Apollo and Aesculepius that I will most decision making in both clinical practice
follow that system of regimen which according to and biomedical research. Collectively, these four
my judgment I consider best for the benefit of have been termed as ‗principilism‘. [5]
my patients…. Conceal most things from the Autonomy requires the ability to decide
patient……give necessary orders with for the self, free from control of the others, and
cheerfulness and serenity….revealing nothing with sufficient level of understanding so as to
of the patient‘s future or present condition‖. [1] arrive at a meaningful choice. [6] A person
We have come a long way from that should have the capacity to decide upon a
Paternalistic approach to the present, as course of action, and to put that plan into action.
exemplified by the words of Judge Cardozo in Beneficence implies that we ―do good‖
Schloendroff vs. Society of New York Hospital for the others and contribute towards their well
(1914, US)[2] and the United Nations Universal being. In order to give the ―optimum‖ good to
Charter of Human Rights adopted by the the patient, the doctor should be able to
General Assembly in 1948. [3] understand ―how much‖ good would give the
The foundation of modern day bioethics best result to the patient; that is; he should
stands on four principles enunciated by weigh the benefits with the risks involved and
Beauchamp and Childress [4]: Autonomy, then act accordingly.
Beneficence, Non-maleficence and Justice. However, Beneficence is hindered by
They have withstood challenge for nearly three Autonomy. It is not ethical to ―do good‖ for the
decades and still form the basis for most patient without obtaining an informed consent
decision making in both clinical practice and from him. Determining what is ―good‖ to oneself
biomedical research. is that person‘s personal decision and that may
differ from what the doctor/ relatives etc, think
Corresponding Author: would be best for the patient.
1
Prof & Head Non-maleficence: ―Primium non
Dept. Forensic Medicine & Toxicology, nocere‖ – ‗first does no harm‘, is another guiding
Govt. Medical College & Hospital, Chandigarh principle of bioethics. It may also be taken to
E-mail: [email protected] represent the risk side of risk-benefit analysis of
2, 3
Assoc. Prof, Dept. of FMT any regimen. Whatever the doctor does for the
DOR: 20.04.2015 DOA: 13.08.2015 patient should be done in ‗Good Faith‘ and for
DOI: 10.5958/0974-0848.2015.00106.2 his good health only.

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J Indian Acad Forensic Med. October-December 2015, Vol. 37, No. 4 ISSN 0971-0973

[S. 52 IPC] [[7] states: Nothing is said to good, happiness, needs, interests, or values of
be done or believed in good faith if it is not done the person being constrained.‖
or believed with due care and attention. Justice Even with such justifications,
addresses the question of paternalism presents number of moral problems
a. Distribution of scare health care resources. and has been held to be an unethical practice. It
b. Respect for people‘s rights and negates patient autonomy completely and is
c. Respect for morally acceptable laws. considered an unethical practice. Such doctors
It is also one of the toughest Principles do not respect their patients as autonomous
of Bioethics as it raises one serious question – individuals and perceive informed consent as a
Is there a universal right to health care? mere legal formality designed to protect them
If there is not, how to provide care for from malpractice litigations.
those who cannot afford it? If there is, to what Failure to obtain informed consent of the
level in such case to be offered and who will patient is an infringement on the autonomy of
fund it? How will fairness be ensured? [5] the patient, regardless of the fact whether a
The Principle of Autonomy: potential for harm exists and is a failure on part
The Greek definition of Autonomy of the doctor to respect a patient as an equal
implies ―Self-rule & Self-determination‖, which individual. Even when only one type of medical
comes from the term ―autos nomos‖. treatment available to the patient, he still has
It implies that the doctor is obligated not two choices: Accept/ Refuse the said treatment.
only to respect the free choice of his patient, but Thus, the principle of beneficence
more importantly, to facilitate in every appears to contradict the principle of patient
reasonably possible way the making of such a autonomy. But, both these principles, when
free choice by the patient. Autonomy is the brought to play in such a way as to complement
capacity for self-determination. each other, form the basis for another very
To respect a person‘s autonomy is to important concept of Bioethics Informed
acknowledge his right to make choices and take Consent. The doctor explains to the patient in a
action based on his own values and belief simple, clear, non technical language the
system. The principle of respect for autonomy ailment/ disease condition he is suffering from,
implies that one should be free from coercion in the proposed treatment which the doctor thinks
deciding to act, and that others are obligated to is the best for the patient, the proposed cons
protect confidentiality, respect privacy, and tell (including risks, etc), alternatives, prognosis with
the truth. Respect for patient autonomy involves the proposed plan and without it.
not only ethical obligations to respect patient The patient, after understanding the
choices, but also obligation to promote both whole proposed treatment regime and after
patient autonomy and autonomous choice. satisfying himself completely, makes a decision-
In the practice of health care, a person‘s accepting or refusing the same. The doctor has
autonomy is exercised through the process of to abide by this decision.
obtaining informed consent. Patients who do not Informed consent is not just a legal duty
comply with the instructions given by the doctor to warn the patient about potential risks and
or who refuse investigations/ blood transfusions, obtain this signature on the dotted line. It is not
etc. pose a great challenge for their doctors. just a formality for ensuring that the ―conditions
The main reason is that non-compliance of understanding between the doctors and his
generally leads to undesirable/ bad medical patient are placed in writing‖. [9]
outcomes; whereas patient‘s good health is the It is a process that underlies the doctor -
main goal of the physician. Hence, these doctors patient relationship an ongoing ―dialogue‖
tend to develop a ―paternalistic‖ attitude towards between the patient and his doctor and not
their patients and try to influence/ manipulate/ or merely a dateable event that occurs when ever a
outright coerce the patients into following the decision must be made because of the potential
treatment regimen to the hilt. harmful consequences. [10]
Many doctors/ health care workers tend It brings about a different equation to the
to override the patient‘s autonomous decision in doctor-patient relationship: one based on mutual
the mistaken belief that their primary duty is the trust and respect. It becomes an ongoing
good, healthy outcome for their patient. This is dialogue where in the risks and benefits of all
an instance of ‗Medical Paternalism‘, which, treatment alternatives are explained and
according to Zenbaty: [8] ―Paternalism is the explored so as to customize (tailor) the same for
interference with a patient‘s autonomy justified the patient, keeping in view his personal values,
by reasons referring exclusively to welfare; interests and goals.

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J Indian Acad Forensic Med. October-December 2015, Vol. 37, No. 4 ISSN 0971-0973

The principle of autonomy also places Even though the facts are the same for both the
important responsibilities on the patient. The ladies, their decisions are different, based on
most important of these is the fact that the non-medical issues: minimal recovery period
patient accepts responsibility for his own and surgical scar for Ankita and the past
decisions. Once, it is clear that there was no experience of her mother‘s prolonged fight with
deception /manipulation /undue influence/ breast cancer for Harleen.
coercion and that there was no negligence on Components of Patient Autonomy:
part of the doctor, once an autonomous decision Patient autonomy includes
is made by the patient, the responsibility for all confidentiality and their right to privacy
the consequences of that decision lies with him regarding their body, health information and their
only. This responsibility does not shift even if the decisions. When they choose to surrender some
decision so taken was ―medically in correct.‖ of their privacy, they expect that what they say
The second responsibility of the patient or what is done to them is kept confidential.
is to ―contribute freely and truthfully to the going This expectation dates way back to the
medical dialogue‖ for obtaining his informed Hippocratic Oath [3], when physicians were
consent. [11] cautioned not to disclose what was said to them
One important duty of an individual is to in confidence by their patients – ―And whatever I
respect other individuals as beings with dignity. shall see or hear in the course of my profession,
This implies that a person should respect as well as outside my profession in any
another person‘s decisions and not override interaction with men, if it be what shall not be
those decisions. published abroad, I will never divulge, holding
It means that no person should use such things to be holy secrets…‖.
another as merely a means to achieve some The Oath by Charaka, [13] which
result, even if that result benefits the other predates the Hippocratic Oath says, ―….. The
person. By doing so, the patient is not perceived peculiar customs of the household of the patient
as an individual with dignity. Hence, the principal shall not be made public…‖
foundation of informed consent is the principle of What about patient confidentiality in
autonomy; the primary goal is the protection and today‘s world of electronic record maintenance,
enhancement of autonomy. billing, etc and the Right to Information Act? [14]
In Harnish vs. Children‘s Hospital Electronic data can be retrieved/ and is being
Medical Center [12], the court ruled: ―A retrieved by unauthorized personnel and
physician owes to his patient the duty to disclose hackers for reasons best known to them. The
in a reasonable manner all significant medical rd
RTI Act has made it possible for 3 party
information that he possess or should persons to have access to one‘s medical record
reasonably possess that is material to an on one ground or the other.
intelligent decision by the patient whether or not The wards, OPDs, semi private/ private
to undergo that procedure‖. It is important for the rooms and corridors of the hospitals are usually
physician to understand that for proper decision full of relatives/ friends of the patients, other
making, ‗not all medical facts are material ones patients, their relatives and friends, etc making it
and not all material facts are medical ones‘. almost impossible to maintain strict
Let‘s take an example: Ankita and confidentiality while dealing with a patient.
Harleen are 39 years old and both are The case file needs to be sent to
diagnosed as case of breast cancer (2 cm different investigative departments. Paramedical
lump). They were told by their doctors that they staff, OT attendants, pharmacy, laboratories, etc
have two choices, each with almost similar cure all have to be given information regarding the
rates: Lumpectomy with adjunctive case to enable them to do their part in the whole
chemotherapy or mastectomy with treatment regimen. Number of hospitals post OT
chemotherapy. Ankita decides to undergo lists on the notice board near their OT, detailing
lumpectomy as she is more interested in having the patient‘s particulars, ailment and surgery to
minimal recovery time and a minimal surgical be performed for the convenience of the staff
scar, confident in the belief that there would be and the relatives. But what if someone with an
almost no recurrence. ulterior motive got hold of a copy of that OT list
Harleen is also worried about the or for that matter someone, whom the patient did
surgical scar and recovery time but she is afraid not want to know, reads the list and gets to know
of recurrence as her mother died of breast of the patient‘s condition? All these compromise
cancer after protracted treatment and suffering. the patient confidentiality and require special
She hence, goes for bilateral care to be taken by the treating doctor in a bid to
mastectomy to ease her fears of recurrence.

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J Indian Acad Forensic Med. October-December 2015, Vol. 37, No. 4 ISSN 0971-0973

protect it. Otherwise, patients, in the fear of their There are essentially two types of consent:
secrets becoming public would not approach the 1. The „clinician–centered‟ one which,
doctor with their ailments and problems, according to the doctor, involves divulging
resulting in more harm than good and the minimum required to be told to the
completely negating both the principles of patient to protect the doctor from a charge of
autonomy and beneficence. assault on the patient.
Truth telling (Veracity) is another vital 2. The „patient – centered‟ one in which the
ingredient of Autonomy. A patient expects that doctor gives all information required by the
his doctor give him truthfully, without mincing patient to make an informed choice. This is
words, a clear picture of his condition. the ―Informed Consent‖ and is always
The fiduciary genre of the doctor-patient patient-specific.
relationship demands that the physician owe the The patient should be able to
highest degree of fidelity, honesty and lack of understand:
self-interest to his patient. However, absolute 1. Nature of the procedure – what is to be done
truth may not be digestible to the patient and and how is it to be done
may actually be harmful to him. 2. Risks involved – the most likely risks; if a
That is when; the doctor can invoke the patient asks about a risk not told to him, he
Doctrine of Therapeutic Privilege and refrain should be explained about it.
from telling the whole truth to the patient. [If the 3. Consequences – likely outcomes of the
doctor is of the opinion that disclosure of the procedure and alternatives
complete information can seriously harm the 4. Alternatives – what would be the possible
patient‘s life, he has the privilege to withhold outcome if the patient chooses not to have
such information, but he has to take any of the the procedure performed/ have an
close relatives of the patient in to confidence alternative procedure.
and share this information with them; otherwise Full disclosure includes:
he cannot claim this privilege.]  The condition/ disorder/disease that the
Many doctors choose to give information patient is suffering from
in pieces over a period of time so as not to  Necessity for further testing
overwhelm the patient. This is ethically  Natural course of condition and possible
acceptable and justified because no one complications
ultimately knows how well the patient would  Consequences of non-treatment
respond to treatment.  Treatment options available
Fidelity or „promise-keeping‟ is also  Potential risks and benefits of treatment
important ingredient of Autonomy. For any options
relationship to sustain, the partners must keep  Duration and approximate cost of treatment
their promises. Same is the case in a doctor-
 Expected outcome
patient relationship. The doctor, by getting the
 Follow—up required
license to practice puts forth the promise to treat
The patient should be given opportunity
the patients with dignity and fairness and
to ask questions and clarify all doubts. There
provide due care in ―good faith‖. The society
must not be any kind of coercion, misconception
expects this from him. The doctor, on his part,
or misrepresentation of facts and the consent
expects the patient to promise to tell the truth
must be ―full, free and voluntary‖. The patient
and diligently follow his instructions.
should also have the freedom to revoke the
Informed consent: consent, if he feels like it, at any later stage.
Informed consent, in the medical field, is The elements of informed consent
the procedure whereby a patient consents to or include: disclosure of information, competence,
refuses (informed refusal) a medical understanding, voluntariness and decision-
intervention based on the information provided making. A doctor provides information to a
by a health care worker regarding the nature competent patient, who after understanding the
and potential consequences of the proposed information, makes a valid decision.
treatment regimen. The goal of the informed Consent is based on the Latin maxim
consent is to respect patient autonomy and ―volenti non fit injuria‖ – he who consents cannot
enable him to make important decisions complain. It may be defined as ―A free and
regarding his medical care. The principle of voluntary agreement, compliance or permission
autonomy emphasizes that a competent adult given for a specified act or purpose.‖
always has the right to decide what ought or As per S. 90 IPC [7] Consent is not valid
ought not to be done to them. if given:

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J Indian Acad Forensic Med. October-December 2015, Vol. 37, No. 4 ISSN 0971-0973

a) By a person under fear/ injury or and their ability to take actions. It includes
b) By a person under misconception of facts issues of informed consent, confidentiality of
and the person obtaining knows or has a information, truth telling and promise keeping.
reason to believe this or The principles of Privacy and
c) By an intoxicated person or Confidentiality are intimately related to
d) By a person of unsound mind or Autonomy as disclosure and dissemination of a
e) By a person of less than 12 years person‘s intimate information and thoughts
As per S.13 of the Indian Contract Act destroys this important Ethical and Moral
[15]: two or more persons are said to be in Principle. The patient, in fear of the
consent if they agree upon the same thing in the dissemination of his intimate secrets, would
same sense. S. 14 [15] says: consent is ―free never confide in the doctor and this will lead to a
and voluntary‖ when it is NOT obtained by number of problems in future both to the doctor
a) coercion/ force, b) fraud, c) under and to the patient.
influence, d) intoxication, e) misrepresentation, f) The consent given by the patient should
from mistaken subjects, and g) mentally be voluntarily, free, fair, uninhibited, clear, direct
unsound persons. and personal; without any fear, force, fraud,
Informed Consent has become misrepresentation of facts, threat of physical
extremely important in the present day settings. injury or death, etc. The information given by the
As the doctor-patient relationship is physician to the patient must include the disease
primarily contractual by nature, it requires condition, nature and consequences of the
agreement between the parties as to the treatment procedure/ examination, alternatives,
proposed medical intervention. Hence, patient's prognosis, etc. The disclosure so made should
consent is fundamental to lawful medical be complete, honest and truthful and should be
interventions. This includes the physician‘s made prior to implementation of the procedure.
ability to properly explain to the patient regarding References:
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the patient; combined with the patient‘s Informed Consent – Must It Remain a Fairy Tale? Accessed 10th
November 2013.
understanding of the same and ability to form a 2. Universal Declaration of Human Rights. Available at:
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facts put forward to him. declaration-of-human-rights.pdf. Accessed on 10th November 2013
In a number of cases, improper/partial 3. 1914, 211 N.Y.R. 125, quoted by Rudra A, Dogra TD. Eds. Lyon‟s
Medical Jurisprudence and Toxicology. 11th Ed. Delhi Law House.
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for current bioethical debate. J. Chirpr Humanit 2007; 14: 34-40.
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