1

SUMMARY OF THE ASSIGNMENT

The project is an attempt to consolidate the Indian and International legal regime regarding
Informed Consent and Medical Ethics.
The project seeks to bring out the existing legal regime with regards the informed consent of
patient for undergoing medical treatment and related medical ethics to the effect. Many
accounts of informed consent in medical ethics claim that it is valuable because it supports
individual autonomy. Unfortunately there are many distinct conceptions of individual
autonomy, and their ethical importance varies. A better reason for taking informed consent
seriously is that it provides assurance that patients and others are neither deceived nor
coerced. Present debates about the relative importance of generic and specific consent
(particularly in the use of human tissues for research and in secondary studies) do not address
this issue squarely. Consent is a propositional attitude, so intransitive: complete, wholly
specific consent is an illusion. Since the point of consent procedures is to limit deception and
coercion, they should be designed to give patients and others control over the amount of
information they receive an opportunity to rescind consent already given.

TABLE OF CONTENTS
RESEARCH
METHODOLOGYiii
REFERENCES ..vi
1) CHAPTER I .....7
INTRODUCTION

2) CHAPTER II..9
CONSENT FACTOR MEANING
3) CHAPTER III....11
BASIS OF CONSENT
4) CHAPTER IV...15
ETHICAL AND LEGAL ISSUES INVOLVED
5) CHAPTER V19
INDIAN LAW ON CONSENT TO MEDICAL TREATMENTS
6) CHAPTER VI..25
TYPES OF CONSENT
7) CHAPTER VII.27
EMERGENCY SITUATION AND CONSENT
8) CHAPTER VIII..34
COMPETENCY TO CONSENT
9) CHAPTER XI36
THE VALUE OF INFORMED CONSENT
10) CHAPTER X.42
THE INCOMPETENCE EXCEPTION TO INFORMED CONSENT
11) CHAPTER XI45
LEGAL CONSEQUENCES OF ILLEGAL TREATMENT WITHOUT CONSENT
12) CHAPTER XII..45
INFORMED CONSENT IN PSYCHIATRY
13) CHAPTER XII....47
GROUNDS FOR TREATMENT OF INCOMPETENT PATIENTS
14) CHAPTER XIII..55
EFFECTIVENESS OF INFORMED CONSENT IN MEDICAL TREATMENT
15) CHAPTER XIV..56
HOW CONSENT SHOULD BE OBTAINED
16) CHAPTER XV...59
RIGHT TO REFUSE CONSENT
17) CHAPTER XVI...67

CAN CONSENT BE DONE AWAY

18) CHAPTER XVII.69
INFORMED CONSENT IN CLINICAL TRIALS
19) CHAPTER IX..70
CONCLUSIONS
BIBLIOGRAPHY.......73

RESEARCH METHODOLOGY
The researcher has adopted a purely Doctrinal method of research as the research paper
discusses the matter in which no field work is required for the same and the Doctrinal
approach is perfectly suited for the same. The researcher has made extensive use of several
libraries, namely, the library at the Chanakya National Law University, Indian Law Institute,
New Delhi, the Indian Society of International Law library, and also the Internet sources.
_________________________________________________

REFERENCES

TABLE OF CASES
LIST OF CASES
1) Salgo v. Leland Stanford Jr. University Board of Trustees.
2) Natanson v. Kline
3) Potts v. NWRH
4) SR v. GMC
5) YF v. Turkey
6) Re B (Consent to treatment capacity)case
7) Chester v. Afshar
8) Sidaway v. Bethlem R HG
9) Pt. Parmanand Katara v Union of India
10) Dr. T.T. Thomas vs. Elisa
11) Sukhrao, O. Khobiraj V. state
12) Gillick V West Norfolk and Wisbeck, Area health authority
13) Samera Kohli v Dr. Prabha Manchanda and Another
14) Chandra Shukla v Union of India
15) C A Muthu Krishnan v M. Rajyalakshmi
16) Ram Bihari Lal v Dr. J. N. Srivastava
17) Maneka Gandhi v Union of India
18) Canterbury v Spencer

CHAPTER - I
INTRODUCTION

Over the last few decades, we have moved from a paternalistic view of medicine in which the
doctor decided what was best for the patient to a discussion about whether in some cases full
disclosure might harm the patient. Traditional doctor-patient relationship was one in which
the doctor and the patient were unequal bargaining partners in a contract for services with the
doctors special knowledge creating the advantage. Informed consent is meant to force the
doctor to give the patient the knowledge that will make him or her an equal bargaining

partner. Thus informed consent is meant to transform the essence of the doctor-patient
relationship to a contractual one as contractual relationships are thought to promote
individual autonomy and freedom of choice.1

In psychiatric practice, one sometimes deals with patients whose judgment may be impaired
at times due to mental illness. Doctors may also be privy to many intimate details of their
patients, involving their personal, emotional and social life. Hence role of consent in
psychiatry (especially the ethical and legal aspects) becomes very important. The practice of
informed consent has historical roots in various disciplines, including medicine, moral philosophy,
and the law. It is closely tied to philosophical notions of respect for persons and respect for individual
autonomy. Consent to treatment is rooted in case law. Consent to research, in contrast, has its basis in
ethical codes, statutes, and administrative regulations, with the courts playing a lesser role. In this
article, we define the elements of informed consent in the treatment setting, outline its ethical and
legal foundations, and explore some of its limitations.

We contend that informed consent plays a critical role in clinical medicine but that other models of
decision making deserve consideration under particular circumstances. We also delineate the current
federal regulatory schemes guiding human subject research in the U.S., highlight how consent to
research differs from consent to treatment, and explore the difficulties that arise in research involving
cancer patients and certain vulnerable populations.

In India in recent years there has been an increase in the number of malpractice suits that
have arisen because of lack of consent or inadequate consent from the patients for various
procedures. Many clinicians are unaware of the legal and ethical requirements and clinical
aspects of consent in Medicine in India. Unlike many other countries, the Indian Statute Book
does not contain separate legislation regarding age for consent to medical treatment. This
paper discusses the ethical, legal and clinical aspects of informed consent. For effective legal
protection, suggestions have been given for taking proper informed consent in various
scenarios. There is a need to frame guidelines for signing consent forms. Need for legislation
with regard to age for consent for medical treatment has also been highlighted.
The element of consent is one of the critical issues in medical treatment. The patient has a
legal right to autonomy and self determination enshrined within Article 21 of the Indian
1

Stone AA. Informed Consent. Special Problems for Psychiatry. Hospital and Community Psychiatry. 1979;
80(5): 321-7.

Constitution. He can refuse treatment except in an emergency situation where the doctor need
not get consent for treatment. The consent obtained should be legally valid. A doctor who
treats without valid consent will be liable under the tort and criminal laws. The law presumes
the doctor to be in a dominating position, hence the consent should be obtained after
providing all the necessary information.

CHAPTER - II
CONSENT FACTOR MEANING

Consent means an agreement, compliance or permission given voluntarily without any

compulsion.2 Section 13 of The Indian Contract Act states that 'two or more persons are said
to consent when they agree upon the same thing in the same sense'. Common meaning of
consent is permission whereas the law perceives it as a contract i.e. an agreement enforceable
by law. In consent there are four separate but correlated elements that are: voluntary ness,
capacity, knowledge and decision-making. Voluntary ness suggests willingness of patient to
undergo treatment. Capacity means a degree of ability of the patient to understand the nature
2

Physicians Law Review [homepage on the Internet] Anatomical Gift Law [cited 2007, Apr 20]. Available
from: http://www.thesullivangroup.com/physician_law_review/anatomical_gifts/anatomical_5_curr ent.html.

and consequences of the treatment offered. Knowledge means that sufficient amount of
information about the nature and consequence of the treatment has been disclosed .Decisionmaking means the ability to take decisions regarding consent. To be legally valid all these
elements must be present in the consent.

Consent means an agreement, compliance or permission given voluntarily without any

compulsion.3 Section 13 of The Indian Contract Act states that 'two or more persons are said
to consent when they agree upon the same thing in the same sense'. Common meaning of
consent is permission whereas the law perceives it as a contract i.e. an agreement enforceable
by law. In consent there are four separate but correlated elements that are: voluntary ness,
capacity, knowledge and decision-making. Voluntary ness suggests willingness of patient to
undergo treatment. Capacity means a degree of ability of the patient to understand the nature
and consequences of the treatment offered. Knowledge means that sufficient amount of
information about the nature and consequence of the treatment has been disclosed to the
patient. Decision-making means the ability to take decisions regarding consent. To be legally
valid all these elements must be present in the consent.

Consent can be implied, expressed or presumed. When a patient comes to a doctor an implied
consent is there for taking history, general physical examination etc. The limitations of
implied consent are that there is always a scope for misunderstanding between the doctor
and patient on what was actually implied by the patient's actions. An expressed consent can
be written or oral. This is taken if there is no implied consent or when any material risk is
involved. Expressed consent includes informed consent, which is the ideal form of consent
because it includes all aspects of meaningful decision-making. Informed consent involves
telling the patients about the nature of their condition, the nature of the proposed treatment,
benefits of the proposed treatment, risks of the proposed treatment, and available alternatives
to the proposed treatment along with their benefits and risks.

Presumed consent is important in cases of emergency when consent cannot be taken.

Another example of presumed consent as practiced in some countries (U.S.A., Spain, France)
is in postmortem cases where unless there is a pre-recorded objection or an intimation of
objection from the next of kin of deceased prior to death, corneas can be removed for
3

Ibid.

transplantation.4, (In India there is a proposed amendment in the Human Organ

Transplantation Act along these lines). Presumed consent allows the removal of organs,
unless the decedent has opted out or the family objects i.e. unless there is a pre-recorded
objection or an intimation of objection from the next of the kin of the deceased. 5 Tacit
consent describes consent that is expressed silently or passively by omission.

The element of consent is one of the critical issues in the area of medical treatment today. It
is well known that the 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. No doubt
this raises many ethical debates and falls at the heart of medical law today. 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.6
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
by adequately informing the subjects of the aims, methods, anticipated benefits, potential
hazards, and discomforts that the study may entail7Several international conventions and
declarations have similarly ratified the importance of obtaining consent from patients before
testing and treatment. The present paper examines the entire gamut of issues pertaining to
consent from the point of view of the legal environment as it exists in India today. The circle
of legal development in the area (i.e., consent) appears to be almost complete when the apex
court in India recently ruled that, it is not just the consent or informed consent (as it is
known worldwide) but it shall also be prior informed consent generally barring some
specific cases of emergency. This places a medical professional in a tremendous dilemma.
Hence, it is time to revisit the area of consent and medical treatment to understand the
sensitive and underpinning elements.

Sharma RK. Concise Textbook of Forensic Medicine and Toxicology.1st ed. India: Elsevier;
2005. p. 161-2.
5
Bastia BK, Kuruvilla A, Saralaya KM. Validity of consent- A review of statutes. Indian J Med Sci.
2005 Feb; 59(2): 74-8.
6
1947. Neurenberg Code
7
ibid

CHAPTER III
BASIS OF CONSENT
There are three factors in the practice of medicine: the disease, the patient, and the
physician. The physician is the servant of science, and the patient must do what he can to
fight the disease with the assistance of the physician.
Hippocrates, The Epidemics, Book I

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. Tort is a civil wrong for
which the aggrieved party may seek compensation from the wrong doer. The consequences
would be payment of compensation (in civil) and imprisonment (in criminal). To commence,
the patient may sue the medical practitioner in tort for trespass to person. Alternatively, the
health professional may be sued for negligence. In certain extreme cases, there is a theoretical
possibility of criminal prosecution for assault or battery. The traditional definition of battery
is an act that directly and either intentionally or negligently causes some physical contact
with another person without that person's consent. If a person has consented to contact
expressedly or by implication, then there is no battery. It is a rare case in which a doctor
would be held liable for criminal breach, unless there is gross disrespect to the patient's
bodily autonomy, for instance, if a patient's organs are taken without his consent.

In tort law, usage of force against any human body, without proper justification, is actionable
irrespective of the quantum of force. If the medical practitioner attempts to treat a patient
without obtaining proper consent, he will be held guilty under tort law. Consent for treatment
may be expressed or implied. The patient entering the consultation chambers by his own
volition may be considered to have given consent for a clinical diagnosis to be carried out.
Consent may be inferred from the general submission by a patient to orders given by a doctor
during clinical diagnosis. This is an excellent example of implied consent. During the clinical
examination, there might arise the need for an intimate examination of the patient, such as a
vaginal examination. For such an examination, the medical practitioner must ideally obtain

10

another consent by asking the patient's permission orally. Furthermore, if there is a need to
undergo an invasive examination, such as an incision or drawing of samples of body fluids, a
written consent of the patient is ideally required.

Often medical practitioners ask for precise prescriptions for the situations when written
consent is needed. It is interesting to note that what law demands is mere consent and not
written consent and does not prescribe such requirement on a mandatory basis. In fact, the
medical practice itself determines the need for written consent. Ideally, where the patient is
subjected to anesthesia (either local or general) or where the patient is subjected to severe
pain during administration of the treatment, a written consent would be helpful. There is no
mandate that a doctor should always obtain written consent and failure of which would hold
him liable. However, if there is written consent, the medical practitioner would have greater
ease in proving consent in case of litigation. To standardize the practice, the 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.8The MCI guidelines are
applicable to operations and do not cover other treatments. For other treatments, the
following may be noted as general guidelines:
1. For routine types of treatment, implied consent would suffice
2. For detailed types of treatment, ideally express oral consent may be needed
3. For complex types of treatment, written express consent is required
There are two more additional aspects to be borne in mind: first, valid consent can be
obtained only from a patient who is competent to consent and secondly, such consent must
also be informed consent. To be competent to give a legally effective consent, the patient
must be endowed with the ability to weigh the risks and benefits of the treatment that is being
proposed to him. The law presumes that such an ability is generally acquired with the
attainment of the age of maturity. A person who has attained the competent age and who has
sound mind can give valid consent to the medical practitioner for any treatment. Persons who
have attained the age of 18 are generally considered to have attained the age of maturity and
are competent to give consent.

Practice, legally and ethically. The patient has right to full information in one professional term with
advancement of medical technology and increasing sect. 3(22).

11

The law thus presumes capacity, rationality, autonomy, and freedom if the person has
attained the age of so called maturity. On the other hand, where there is reason to believe that
a patient is unable to understand the nature of the treatment and its benefits or side effects
before making the decision, it is necessary to consider whether an adult presumption of
capacity is rebutted in that particular case. If the patient is incompetent to give consent, then
the consent may be obtained from the attendant of the patient.9 In the UK, there are several
ethical issues raised regarding the proxy consent on behalf of such persons. Even the Law
Commission Report (Mental Incapacity, 1995) suggests few reforms. Irrespective of the age,
for a person who is incompetent due to unsoundness of mind, consent will be obtained from
the guardian of the patient. In India, the court has not come across borderline cases of an
adult refusing treatment leading to emergency and leaving the doctor in a dilemma, unlike in
the west.10
The law also presumes that the medical practitioner is in a dominating position vis--vis the
patient; hence, it is his duty to obtain proper consent by providing all the necessary
information. Consent without necessary information is no consent at all. Unfortunately, the
expression informed consent is often used without precision. The informed consent
doctrine is American in origin and relates to the amount of information that a patient should
be provided with to avoid any probable action in negligence. Rarely, a medical practitioner or
a hospital administrator can rely upon the consent form signed by the patient, when the
contention is that he was made to sign on the dotted lines of such format without proving
necessary information. This practice is also developed by the practice of treating the consent
form as a one of standard forms of contracts and eliminating all such unfair and sweeping
clauses, which will only benefit the medical practitioner. It is rather necessary as the proforma is prepared by the medical practitioner/hospital administration, and the patient is left
with the choice of either accepting it as whole or rejecting it. Therefore, it is absolute
imperative that a medical practitioner provide all relevant information relating to the
proposed treatment to the patient in a language understandable to him, while obtaining the
much needed consent for the treatment.

However, the nature of the information that a patient must have in order to give informed
consent is a debatable question, as the American and English viewpoints differ to some
extent. Informed consent from the American sense is often described from the viewpoint of a
9

Regulation 7.16, of Medical Council of India (Professional Conduct, Etiquette and Ethics) Regulations. 2002
Law Commission. Mental Capacity, Law. Com. 1995;231.

10

12

prudent patient, popularly know as the prudent patient test. In this approach, the highest
respect for the patient's right of self-determination about a particular therapy is recognized.
This will lead to a so-called objective test of disclosure wherein the doctor will keep in mind
the patient and disclose all such information which is required to be given. In other words,
there is a presumption that some standard information is required to be disclosed to every
patient, and the extent of such disclosure is neither left to the discretion of the doctor (of
course leaving out special circumstances where the doctor might have strong reasons for
concealing) nor he can rely upon the defense of disclosure like a reasonable medical practice
or practitioner.11

In contrast to this, the English approach is doctor centric, which is also popularly narrated as
the prudent doctor test of disclosure. Here, the doctor is taken as a professional-man endowed
with greater prudence to protect the right interest of the patient and bestowed with the final
right to decide what information shall be divulged to the patient considering the
circumstances and how much information is to be divulged. Lord Templeman in Sidway
encapsulated this as follows:
When the doctor himself is considering the possibility of a major operation, the doctor is
able with his medical training, with his knowledge of the patient's medical history, and with
his objective position to make a balanced judgment as to whether the operation should be
performed or not. The duty of the doctor in these circumstances, subject to his overriding
duty to have regard to the best interests of the patient, is to provide the patient with
information which will enable the patient to make a balanced judgment if the patient chooses
to make a balanced judgment.12

Finally, whatever might be the difference of approach it is evident that a medical practitioner
is obligated to provide the necessary information before obtaining consent from a patient. To
account for the Indian position, although we do not have much litigation, unlike in the West,
it may be concluded that the courts have assigned immense significance to the requirement of
informed consent. A medical practitioner in India has a duty to provide all the necessary
information to the patient in a language that is understandable to him. Regarding the quantum
11

Canterbury v Spence. 1972. 464 F 2d 772.

Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others [1985] 1
AC 871, HL.
12

13

of information, there are no clear parameters laid down by the courts. Therefore, it is
reasonable information which a doctor deems fit considering best practices. Considering the
knowledge gap in this regard, the professional regulatory body for medicine can play an
important role in establishing standards.

CHAPTER IV
ETHICAL AND LEGAL ISSUES INVOLVED

1. First and foremost is the age at which valid consent can be given in India.
2. Relative importance of written and verbal consent.
3. When and how the consent should be taken. Who should sign the forms?
4. Circumstances in which full disclosure of medical facts can be dispensed with.
5. Role of proxy consent.
6. Consent in Medical Emergencies.
7. Problems and dilemmas faced when taking consent in Psychiatric Practice.

Ethical, Legal and Clinical Principles of Informed Consent

The principle of autonomy is enshrined within Art. 21 of the Indian Constitution, which deals
with the right to life and personal liberty. The expression personal liberty under Art. 21 is of
the widest amplitude and covers a wide variety of rights, including the right to live with
human dignity and all that goes along with it, and any act which damages, injures, or
interferes with the use of any limb or faculty of a person, either permanently or temporarily.13
However, the common law application of consent is not fully developed in India, although
the Indian courts have often referred to these principles. In such situations, obviously one has
to refer to the principles of the Indian Contract Act and the Indian Penal Code. The
relationship between a medical professional and his patient is a contract by parties competent
to contract giving rise to contractual obligations.

13

Maneka Gandhi v Union of India. AIR 1978 SC 597

14

Parties are generally competent (in accordance with the Indian Majority Act) (i) if they have
attained the age of 18, (ii) are of sound mind, and (iii) are not disqualified by any law to
which they are subject to. Furthermore, there is a stipulation in the contract law stating that
consent of any party (in our case it is the patient) that is obtained by coercion, undueinfluence, mistake, misrepresentation or fraud, will render the agreement invalid. However, in
England, the General Medical Council guidelines state that the consenting age is 16 years old.
A young person can be treated as an adult and can be presumed to have the capacity to
decide. If the child is under the age of 16 he or she may have the capacity to decide,
depending on his/her ability to understand what is involved. Where a competent child refuses
treatment, a person with parental responsibility or the court may authorize investigation or
treatment which is in the child's best interests. Interestingly, the position is different in
Scotland where those with parental responsibility cannot authorize procedures a competent
child has refused.

The consent obtained, of course, after getting the relevant information will have its own
parameter of operation to render protection to the medical practitioner. If the doctor goes
beyond these parameters, he would be treating the patient at his risk, as it is deemed that there
is no consent for such treatment at all. A doctor who went ahead in treating a patient, to
protect the patient's own interest, was held liable as he was operating without consent.14The
patient was suspected to have appendicitis. After obtaining due consent, she was subjected to
an operation. However, upon incision, it was found that her appendix was normal and not
inflamed. To protect the interest of the patient, the doctor removed her gangrenous gall
bladder. Later, it was discovered that the kidney of the patient was affected. The doctor was
held liable as he was operating without consent. This case law also signifies the traditional
notion of paternalism prevalent among the members of the medical fraternity. It is a notion
where the doctor takes-up the role of a parent of the patient and starts deciding on behalf of
the patient himself. Unfortunately, the law does not accept this notion. The first priority of
law is always the right of autonomy of the patient provided he is endowed with necessary
capacity.

A medical practitioner who believes that a medical procedure is appropriate and necessary
for a patient's well being can perhaps be forgiven for believing that the principle of autonomy
14

Ram Bihari Lal v Dr. J. N. Srivastava. AIR 1985 MP 150

15

should be sacrificed in the best interest of the patient. In the present case, had the doctor
stopped after realizing that the patient's appendix was normal, he would have been protected
as he was working under the valid consent of the patient, and more importantly, mere error of
judgment is not culpable. When he proceeded in removing her gall bladder, he was acting
sans valid consent, which was an extreme case of professional paternalism and gross
disobedience to the right of the patient's autonomy. Hence, some commentators like Mill, et
al. have advocated for minimal level of paternalism in the interest of the medical profession
and the overall inability of humans in taking rational decisions, during the time of crises.15

Regarding proxy consent, when the patient is unable to give consent himself, there are no
clear regulations or principles developed in India. If such a situation exists, the medical
practitioner may proceed with treatment by taking the consent of any relative of the patient or
even an attendant. In one case, the wife of a patient informed the hospital authorities in
unambiguous terms that she had no objection to her husband undergoing bypass surgery, her
consent was deemed sufficient for the purpose of any formalities with which the hospital was
required to comply.16
Interestingly, in another case the relationship between the patient and his wife were strained.
A patient was operated on for sterilization. While giving consent he deposed that he is
married and has two baby girls. In fact, he was undergoing an operation only for getting the
money as incentive. After the operation, his father contended that the patient was of unstable
mind and was not competent to give consent. The court held that if there are no
circumstances for a doctor to sense foul play or doubtabout the capacity of the patient, he is
protected17These two cases demonstrate that a doctor acting reasonably under normal
circumstances is always protected and he is never expected to play the role of an investigative
agency.

Recently, the apex court gave an impacting judgment in the area. Wherein the court observed
that where a surgeon is consulted by a patient and consent of the patient is taken for
diagnostic procedure/surgery, such consent can't be considered as authorization or permission
to perform therapeutic surgery either conservative or radical (except in a life-threatening

15

Mill, J.S., On Liberty Harmondsworth: Penguin; 1982. p. 68

C A Muthu Krishnan v M. Rajyalakshmi. AIR 1999 AP 311.
17
Chandra Shukla v Union of India. AIR 1987 ACJ 628.
16

16

emergent situation).18 For the fist time in India, the court ruled that however broad consent
might be for diagnostic procedure, it can not be used for therapeutic surgery. Furthermore,
the court observed that where the consent by the patient is for a particular operative surgery
it can't be treated as consent for an unauthorized additional procedure involving removal of
an organ only on the ground that it is beneficial to the patient or is likely to prevent some
danger developing in the future, where there is no imminent danger to the life or health of the
patient.
This proposition puts fetter upon the role of a paternal doctor in the Indian scenario. In one
case, a 44-year-old unmarried female consulted her doctor and was advised to undergo a
laparoscopy. A few consent forms were taken from her of which one was for admission and
another one was for the surgery. The relevant one among such consent forms gave the doctor
an allowance to carry out a diagnostic and operative laparoscopy and there was an
additional endorsement that a laparotomy may be needed. When the patient was in the
operation theater (and was unconscious), another proxy consent was taken from her attending
mother for a hysterectomy. Her uterus, ovaries, and fallopian tubes were removed.
Subsequently, when an action was brought, it was held that the operation was conducted
without real consent and the doctors were held liable.

This decision is of very far reaching consequences, pushing the development of consent law
to new heights. It is contended that it is not only informed consent which is imperative now,
but the same shall be prior informed consent unless there is imminent threat to the patient's
life. In addition, this decision curtails the scope of proxy consent from the person having
parental authority or an attendant.

CHAPTER - V
INDIAN LAW ON CONSENT TO MEDICAL TREATMENTS

18

Samera Kohli v Dr. Prabha Manchanda and Another. 2008;(1) SCALE 442.

17

Sections 87 to 91 of Indian penal code deals with consent. Section 88 of IPC lays down that
an act is not offence if it is not intended or not known to be likely to cause death, which
causes any harm to a person from whose benefit it is done in good faith with his consent to
suffer it. Thus after a valid consent if surgeon operates on patient and patient dies on the
operation table, then the surgeon can not be held guilty of murder. Persons who are nonqualified in medical profession are not allowed to take the plea of this section, as they are not
said to do the act in good faith. IPC 52 says that an act is only done in good faith if it is done
with due care and attention. Section 91 of IPC serves as a corollary to sections 87 to 89. It
states that the exceptions contained in sect 87 to 89 do not extend to acts, which are offences
independently of any harm, which they may cause to the person, giving consent.
Thus causing miscarriage (unless caused in good faith for the purpose of saving the life of the
women) is an offence independently of any harm which it may cause or be intended to cause
to the women and the consent of the women or of her guardian for causing such miscarriage
does not justify the act ( 91 IPC )19 . Barring physical examination, any medical procedure
requires written consent. Written consent should refer to one specific procedure and not
blanket permission on admission to hospital. It is on the safest side to take the consent of a
spouse if the operation destroys or limits sexual function. While not legally necessary it is
good medical practice to consult with relatives of patient in patients best interest and ones
this has been established then doctor can continue to give treatment in good faith.
Consultation, consent and clinical confidence will never put the doctor in any tort fessors
cases.
1. Consent is said to be free when it is not caused by coercion, undue influence, fraud,
misinterpretation or mistake. The consent must be to do a lawful act and it must not disobey
any provision of the law.

Consent by intoxicated person, person of unsound mind or a person below twelve years of
age is invalid {Section 90 IPC( Indian Penal Code)}.

19

The law of torts by Ratanlal (Ed 25th, page 75) Vadhwa and Co., Nagpur.

18

2. Many countries have legislated age for giving valid consent for medical examination and
procedures. In England sixteen years is the age for giving valid consent for medical
examination and procedures. But unfortunately the Indian Statue Book does not contain
separate legislation regarding consent to medical treatment nor do the various acts relating to
majority, minority and guardianship throw any light on the subject. As a result, the laws for
consent in general are also being applied to the medical profession.

According to Section 90 IPC a child less than twelve years of age or insane person cannot
give valid consent.By implication from Section 90 IPC, one can say that in general a boy or
girl can consent to medical or surgical treatment if he or she is above twelve years of age
provided the treatment is intended for his or her benefit and is undertaken in good faith.
Section 88 and Section 90 of the IPC suggest that the age for giving valid consent for any
medical procedure is twelve years. Hence a doctor taking consent for medical or surgical
treatment from a person aged twelve years or more can be legally said to have taken a valid
consent and cannot be held criminally liable on this account.

However, Sections 87 IPC mentions eighteen years as the age for giving consent for acts not
intended and not known to be likely to cause death or grievous hurt. These acts are not
necessarily for the benefit of the person. Hence, Section 87 IPC is not applicable to the
medical profession as here (in Section 87 IPC), the acts are NOT done for the person's
benefit.
Another school of thought however feels that valid consent can only be given at or above
eighteen years of age.20They feel that consent is a contract between two parties and as the
Indian Contract Act states that to enter into a contract both parties must be at least eighteen
years of age, this should be the age for giving valid consent in medicine. However it should
be noted that the Indian Contract Act is for conditions like marriages, financial agreements
etc. and is not specific for the medical profession.

Further, even though consent is said to be a contract (under Indian Contract Act), various
Acts do not override the Indian Penal Code. Those doctors who do consider consent to be a
contract take the consent of the parent or guardian for medical procedures in which death or

20

Lepping P. Consent in Psychiatry- an ethical review. Psychiatric Bulletin. 2003; 27:2859.

19

grievous injury can occur when the age of the patient is less than eighteen years. They feel
this will be of benefit in cases involving civil liability.

All this has led to ethical and legal dilemmas in the minds of the doctors in many cases. A
sixteen- year- old girl coming for gynecological examination and asking for a pregnancy test
is one such example. Is the consent of the parents required in this case or is the girl's consent
valid (if she refuses the involvement of her parents)? There is also the need to respect the
confidentiality between the patient and the doctor. A seventeen-year-old boy desiring an
operation which his parents are refusing is another.

In practice in the absence of clear-cut legal provisions most doctors consider the consent of a
person less than eighteen years sufficient for medical examination only and for any other
medical procedure ask for the consent of the parents. All this highlights the need for specific
legislation for age for giving valid consent for medical procedures.

3. Oral consent is legally valid when taken for some specific procedures like injecting
medication, drawing blood for pathological examination, gynecological examinations etc.
Oral consent can be proved in court if it was taken in the presence of witnesses or if the
doctor records in the case record of the patient that oral consent was taken. For major
procedures and surgery, written consent should be taken but if for some reason only oral
consent is possible then the doctor should enter it into the case record of the patient.

The value of signed written consent is important for those cases that go to court as a written
consent will be of great value for the doctor when he defends himself. According to the
Indian Medical Council (Professional Conduct and Ethics) Regulations 2002, before
performing an operation written consent should be obtained. Those doctors who take consent
to be legal contracts between two parties feel that both the doctor and patient should sign the
consent form as this is the basic requirement of a contract, otherwise it becomes null and
void. Two witnesses who are uninterested third parties should preferably also sign it.5 The
Consent form used in All India Institute of Medical Sciences, New Delhi (our country's
premier medical institute) also requires the form to be countersigned by the treating doctor
who certifies that informed consent has been taken.21
21

Buchanan A, Brock D. Deciding for Others. Cambridge: Cambridge University Press; 1989. p. 51-70.

20

Consent should be individual and procedure specific. It should be taken before the procedure
as blanket consents are not acceptable.

4. Full disclosure must be there for consent to be legally valid. There should not be any
suppression of facts. All relevant information of the disease and treatment, material risks
involved, other alternative treatment, must be given by the doctor himself to the patient as it
is a contract between the patient and the doctor. Legal standards may require physicians to
disclose information that a reasonable practitioner in a similar situation would disclose
('professional standard of disclosure'), or information that a reasonable patient would find
material to his or her decision ('materiality standard'). Exceptions to disclosure requirements
are:

A. Emergencies: When the time required for disclosure would create a substantial risk of
harm to the patient or third parties, full disclosure requirements may not apply.

B. Waiver: Patients may waive their rights to receive information. This should be a
knowledgeable waiver, i.e. patients should be made aware that they have a right to receive the
information, to designate a surrogate to receive the information, or to be informed at a later
date.
C. Therapeutic privilege: Information can be withheld, when disclosure per se would be
likely to cause harm to patients (e.g. when a patient with an unstable cardiac arrhythmia
would have his or her situation exacerbated by the anxiety attendant on full disclosure of the
risk of treatment). In emotionally disturbed patients the doctor should request a specialist
consultation to establish that the patient is emotionally disturbed. The doctor should also note
his decision in the patient's records explaining his intentions and the reasons for it.

D. Incompetence: Incompetent patients may not, as a matter of law, give an informed

consent. State law generally provides alternative mechanisms by which consent can be
obtained, and requires disclosure to a substitute decision-maker.
E. Involuntary treatment: Many states allow psychiatric treatment to occur without patients'
informed consent. This occurs most commonly when patients' refusals of treatment are
specifically overridden following clinical, administrative, or judicial review.

21

5. Proxy consent or Surrogate decision maker. When a person is incapable of giving

expressed consent a substituted consent can be taken from the next of kin. Generally accepted
order is spouse, adult child, parents, siblings, and lawful guardian.

6. In medical emergencies consent need not be obtained if circumstances are such that it is
impossible for that person to give consent (Section 92 IPC). Locoparentis: In an emergency
involving children when their parents or guardians are not available, consent is taken from
the person in charge of the child e.g. school teacher.

7. With regard to any person charged with criminal acts who has not been arrested, ethical
considerations preclude forensic evaluation prior to access to, or availability of legal counsel.
The only exception is an examination for the purpose of rendering emergency medical care
and treatment.

8. It is important to appreciate that in a particular situation such as court ordered evaluations

for competency to stand trial, consent is not required. In such a case a psychiatrist should
inform the subject and explain that the evaluation is legally required and if the subject refuses
to participate in the evaluation this fact will be included in any report or testimony.

9. Consent of an intoxicated person is invalid (Section 90 IPC).

10. An arrested person can be examined without consent if requested to do so by a police

officer not below the rank of a Sub-Inspector (Section 53 IPC).

11. A prisoner can be treated without consent in the interest of society.

12. Consent of one spouse is not necessary for an operation (including MTP) or treatment of
another. For contraceptive sterilization consent of both husband and wife should be taken.
Prisoners and persons released on bail can be treated without their consent in the interest of
justice of society. A registered medical practitioner can examine an accused by using
reasonable force if the examination is requested by the investigating police officer not below
the rank of police sub inspector (CrPC 53).(Force should be applied by police.) Under
subsection 2 of CrPC 53 which lays down that, whenever the person to be examined is female
the examination shall be made only by or under the supervision of female registered medical

22

practitioner. The obtaining of such evidence, it has been held, is not violative of article 20(3)
of constitution, which grants protection against self-incrimination, it was held so by high
court in Bombay vs. Kathi Kalu case22.
Consent of the patient cannot be defense to medical practitioner in negligence. Whole law of
negligence assumes the principle of consent23. Not to be applicable when the act is not done
with reasonable care and competence. If found under the influence of alcohol, then consent of
such person will not be valid, so it is always better to obtain consent from guardian /
parents.(Exception- Section 53 CrPc and Bombay prohibition act.)

CHAPTER - VI
TYPES OF CONSENT

Depending upon the circumstances, in each case, consent may be implied, expressed or
informed.

Implied Consent
Much of physicians work is done on the basis of consent, which is implied either by the
words or behaviour of the patient or by the circumstances under which treatment is given, e.g.
it is common for a patient to arrange an appointment with a Doctor, to keep the appointment,
to volunteer the history, to answer question relating to the history and to submit without
objection to physical examination. In these circumstances consent for the examination is
clearly implied. An implied consent is a consent which is not written, that is, its existence is
not expressly asserted, but nonetheless, it is legally effective. It is provided by the demeanour

22

Gillick V West Norfolk and Wisbeck, Area health authority 1985.3, AIIER 402 (HL).

23

Sukhrao, O. Khobiraj, V. state 1887, 14, Calcutta 566.

23

of the patient and is by far the most common variety of consent in both general sense but not
to procedures more complex than inspection, palpation, percussion, and auscultation.

Expressed Consent
An express consent is one the terms of which are stated in distinct and explicit language. It
may be oral or written. For the majority of relatively minor examinations or therapeutic
procedures, oral consent is employed but this should preferably be obtained in the presence of
a disinterested party. Oral consent, where properly witnessed, is as valid as written consent,
but the latter has the advantage of easy proof and permanent form. It should be obtained
when the treatment is likely to be more than mildly painful, when it carries appreciable risk,
or when it will result in diminishing of a bodily function. Consent may be confirmed and
validated adequately by means of a suitable contemporaneous notation by the treating
physician in the patients record.
Expressed consent in written form should be obtained for surgical operations and invasive
investigative procedures. It is prudent to obtain written consent, also where never analgesic,
narcotic or anesthetic agents will significantly affect the patients level of consciousness
during the treatment.24

Informed Consent as a Right

Informed consent is the legal embodiment of the concept that each individual has the right to
make decisions affecting his or her well-being. It is generally accepted that individuals should
consider the risks and potential benefits flowing from their decisions. To do so, decisionmakers must have knowledge of those risks and potential benefits. The law protects the
individuals right to give informed consent by requiring the disclosure of information by the
party to whom consent is given. In the case of the doctor-patient relationship the onus of
disclosure of information lies with the doctor and the right to decide the manner in which
his/her body will be treated lies with the patient.
Ethical basis for an informed consent is that it respects the autonomy of the individual and
protects the patient from any form of physical or psychological harm, thus ensuring active
participation of the individuals in treatment intended to restore their health. It is also

24

Medico Legal System Module x p-2 Symbiosis Centre of Health Care, Pune.

24

considered a legal document to protect the practitioner from claims associated with
miscommunication.
Hence, it is the duty of the doctor to disclose information on the risks emanating from the
treatment to the patient.25

Informed Consent

Therefore all information should be explained in comprehensive, non-medical terms

preferably in patients own language about the:
i. Nature of the illness
ii. Nature of the proposed treatment or procedure
iii. Alternative procedure
iv. Risks and benefits involved in both the proposed and alternative procedure
v. Potential risks of not receiving the treatment
vi. Relative chances of success or failure of both procedures. Yet, in practice this is not
always so simple. Because in certain situations the patient may be in dire need of treatment,
but revealing the risks involved (the law of full disclosure) may frighten him to refusal. The
doctor may not reveal the risks involved, if a patient prefers not to be informed or when
complications are trivial or when revealing complications is likely to have a gross impact on
psychology of the patient (a close relative of the patient can be informed of the complications
and a colleague should be consulted, preferably patients family physician for the treatment
of the patient). This is known as Therapeutic privilege. But the doctor should note his
decision and reasons for the same in patients case record.26
The informed consent when expressed by the patient in writing is termed as, informed
expressed written consent. This is a must in all surgeries, administration of anaesthesia and
all complicated therapeutic and diagnostic procedures.
Physicians failure to provide the patient with information necessary to make an informed
and intelligent choice, is a breach in standard of disclosure, which, if found to be the cause of
alleged injury, makes a prima facie case for negligence on part of the physician.

25

Merz JF. An Empirical Analysis of the Medical Informed Consent Doctrine: Search for a Standard of
Disclosure, cited from http://www.fplc.edu/RISK/vol2/winter/merz.htm.
26
Renu Sobti Medical Service and Consumer Protection Act, New Century Publication, New Delhi 2001;23.

25

CHAPTER - VII
EMERGENCY SITUATION AND CONSENT

Interestingly, in India, the entire gamut of laws on consent turns into complex propositions if
an emergency medical situation arises. In a few of the milestone decisions, the apex court
ruled that a medical practitioner has a duty to treat a patient in an emergency. Emphasizing
the paramount duty of any welfare state, the Supreme Court stated that Art. 21 imposes an
obligation on the State to safeguard the right to life of every person. Preservation of human
life is thus of paramount importance. The government hospitals run by the state are bound by
duty to extend medical assistance for preserving human life. Failure on the part of a
government hospital to provide timely medical treatment to a person in need of such
treatment results in the violation of his right to life guaranteed under Art. 21.27 Proceeding in
the same direction, the court emphasized further that every doctor whether at a Government
hospital or otherwise has the professional obligation to extend his services with due expertise
for protecting life. No law or state action can intervene to avoid or delay the discharge of the
paramount obligation cast upon members of the medical profession. The obligation of a
doctor is total, absolute, and paramount. Laws of procedure whether in statutes or otherwise
that would interfere with the discharge of this obligation cannot be sustained and must,
therefore, give way.28

In one case, the apex court laid down some important guidelines such as (i) The doctor when approached by an injured person, shall render all such help which is
possible for him at that time, including referring him to the proper experts, (ii) the doctor
treating such persons shall be protected by law, as they are not contravening any procedural
laws of the land (regarding jurisdictions etc.), and (iii) all legal bars (either real or perceived
by the doctors) are deemed to have been eliminated by the verdict. This is in consonance with
the hypocratic oath, which a doctor takes when entering the profession. Hence, a doctor is
duty-bound to treat a patient in the case of an emergency, without waiting for any formalities.
There are several statutes (like medical institutions regulation acts in various states) imposing

27
28

Paschim Banga Khet Mazdoor Samity and Ors v State of West Bengal and Another. 1996. 4 SCC 37.
Pt. Parmanand Katara v Union of India. AIR 1989 SC 2039.

26

this duty upon medical establishments to treat emergency patients, especially accident
victims.
The initial proposition (and the attempt of the Supreme Court) is quiet understandable as the
doctor has to do his best to save life in emergency situations. This is irrespective of
complying with any of the formalities, including consent. Hypothetically, if a patient in an
emergency resists taking treatment, what shall be the way out? Indian courts are not very
clear on that. The above decisions are delivered keeping in mind the accident victims who
were denied medical treatment by doctors, terming them as medico-legal cases. Moreover, in
the above instances, the patient would go himself, or be taken by someone (due to an
unconscious state) to the doctor to seek medical treatment.

In Dr. T.T. Thomas vs. Elisa, the patient was admitted into the hospital on March 11, 1974.
Upon admission, the patient was diagnosed as a case of perforated appendix with peritonitis
requiring an operation. But, unfortunately no operation was done until his death on March 13,
1974. The contention of the doctor was that no surgery could be adhered to, albeit the
suggestion, because the patient did not consent for the surgery. Therefore, other measures
were taken to ameliorate the condition of the patient, which grew worse by the next day.
Although the patient was then willing to undergo the operation, his condition did not permit
it. On the other hand, the version of the respondent (i.e., the Plaintiff) was that the doctor
demanded money for performing the surgery. Furthermore, the doctor was attending to some
chores in an outside private nursing home to conduct operations on the other patients and that
the appellant doctor came back only after the death of the patient.

The two versions before the court were: 1) the plaintiff (the deceased patient's wife) said that
the doctors concerned demanded a bribe, hence the operation was delayed until it proved fatal
and 2) the version of denial for consent. Finally, the court delivered a verdict in favor of the
plaintiffs stating that consent under such an emergent situation is not mandatory.29 It is
interesting to note the following observations:
The consent factor may be important very often in cases of selective operations, which may
not be imminently necessary to save the patient's life. But there can be instances where a
surgeon is not expected to say that I did not operate on him because, I did not get his
29

TT Thomas (Dr.) vs Elisa. AIR 1987 Ker. 52.

27

consent. Such cases very often include emergency operations where a doctor cannot wait for
the consent of his patient or where the patient is not in a fit state of mind to give or not to give
a conscious answer regarding consent. Even if he is in a fit condition to give a voluntary
answer, the surgeon has a duty to inform him of the dangers ahead of the risks involved by
going without an operation at the earliest time possible.
When a surgeon or medical man advances a plea that the patient did not give his consent for
the surgery or the course of treatment advised by him, the burden is on him to prove that the
non-performance of the surgery or the non-administration of the treatment was on account of
the refusal of the patient to give consent thereto. This is especially so in a case where the
patient is not alive to give evidence. Consent is implicit in the case of a patient who submits
to the doctor and the absence of consent must be made out by the patient alleging it.
Finally, as stated above, before holding the doctor liable, the court said that we also hold
that the failure to perform an emergency operation on the deceased on 11-3-1974 amounts to
negligence and the death of the deceased was on account of that failure. This decision makes
the entire discussion of consent law more complex. Although this case law can't be given
more accent (because it is a High Court decision), the viewpoint is an interesting one to note.
In light of all these developments, it may be concluded that there are many grey areas in this
field of consent law in India, which can be eliminated by pro-active intervention by the
concerned professional regulatory body.
The concept of consent comes from the ethical issue of respect for autonomy, individual
integrity and self determination. Every individual has the right of self-determination with
regard to his body and the right to have his bodily integrity protected against invasion by
others.30 However, in certain narrowly defined circumstances, this integrity may be
compromised without individuals consent. It is a fundamental principle of medical law and
ethics that before treating a competent patient a medical professional should get the patients
consent.31
Capacity plays a vital role in determining whether a person can exercise autonomy in making
choices in all aspects of life, from simple decisions to far-reaching decisions such as serious
medical treatment medical or psychiatric treatment. In a legal context it refers to a persons
30
31

YF v. Turkey, (2004) 39 EHRR 34.

Re B (Consent to treatment capacity) (2002) EWHC 429.

28

ability to make a decision, which may have legal consequences for the person themselves or
for other people. Loss of capacity to make our own decisions is amongst the worst fates that
can befall us. Concerns surrounding lack of capacity versus patient incompetence have long
beleaguered health care staff with regard to patient consent for care and treatment. Given its
broad role, the concept of capacity has now evolved into a sophisticated ethical and legal
construct.
Forcing a treatment on an unwilling patient is likely to be counter-productive. The consent
requirement also protects the rights of patients.
Lord Steyn in a House of Lords decision, explained:
A rule requiring a doctor to abstain from performing an operation without the informed
consent of a patient serves two purposes. It tends to avoid the occurrence of the particular
physical injury the risk of which a patient is not prepared to accept. It also ensures that due
respect is given to the autonomy and dignity of each patient.32
The basic legal starting point is that a health professional who intentionally or recklessly
touches a patient without her or his consent is committing a crime (battery) and a tort
(trespass to the person or negligence).

33

To be acting lawfully in touching a patient, the

professional needs a defence or what the Court of Appeal has called as legal flak jackets
which are:
1. The consent of the patient;
2. The consent of another person who is authorised to consent on the patients behalf (eg. The
consent of a parent for the treatment of a child);
3. The defence of necessity.
Without one of these flak jackets, touching a competent patient without their consent will be
unlawful. Where a competent patient makes it clear that he does not wish to receive treatment
which is, objectively, in his medical best interests, it is unlawful for doctors to administer that
treatment.34 Personal autonomy or the right of self-determination prevails.35

32

Chester v. Afshar, (2004) UKHL 41, para 18.

Sidaway v. Bethlem R HG, (1985) 1 All ER 643.
34
Jonathan Herring, Medical Law & Ethics, 2nd ed., p. 134.
35
R v. GMC, (2005) 3FCR 169.
33

29

When taking consent from an incompetent patient, careful thought must be given as to the
appropriate person who can give consent prior to treatment. The term incompetent patient
refers to a person who is unable to give consent himself, such as unconscious patients, minors
and mentally incapacitated patients.
Although the law takes seriously the right to be able to refuse treatment, it does not follow
that if a patient wishes to receive the treatment, she or he must be given it. As the Court of
Appeal in R v. GMC,36 put it:
Autonomy and the right of self-determination do not entitle the patient to insist on receiving
a particular medical treatment regardless of the nature of the treatment. Insofar as a doctor
has a legal obligation to provide treatment this cannot be founded simply upon the fact that
the patient demands it. The source of the duty lies elsewhere.
The case for imposed treatment can also be couched in social terms, illness is costly to the
community and it could be argued that the individual is not entitled to refuse treatment which
may minimise that cost. The direct relationship of the individual with the community as a
whole, the most obvious example being the person who is suffering from an infectious or
otherwise dangerous illness; few would then argue that he should be allowed to refuse
treatment if such treatment- or, in the alternative, isolation is the only way of reducing the
consequent risks. Freedom of the individual is, however, a deeply ingrained feature of a
civilised society and the universal caveat to the application of imposed treatment is that it
should be as non-coercive as is compatible with containment of the threat a prime example
of the human rights concept of proportionality.37
It follows that, as a general rule, medical treatment, including physical examination, should
not proceed unless the doctor has first obtained the patients consent. This may be expressed
or it may be implied, as it when the patient presents him - or herself to the overwhelming
majority of cases but there are limited circumstances in which a doctor may be entitled to
proceed without his consent. Essentially, these can be subsumed under the heading of nonvoluntary therapy which has to be distinguished from involuntary treatment. The latter
implies treatment against the patients expressed wishes; the occasions on which this would
be ethical are, indeed, very few, although a case can be made out when the interests of a third
party or of the society itself are involved. Non-voluntary treatment is that which is given
36
37

Supra 6.
M Brazier & J Harris, Public Health & Private lives, (1996) 4 Med L. Rev 1.

30

when the patient is not in a position to have or to express any views as to his or her
management and these will include, first, when the patient is unconscious; secondly, when
the patients state of mind is such as to render an apparent consent or refusal invalid and
finally, when the patient is minor i.e., lacks capacity by virtue of status.
The law has attempted, and continues to attempt to provide, a stopgap for certain sociomedical shortcomings. For a competent adult patient, the law, medicine and ethics are in
agreement about only proceeding with treatment which is acceptable to that patient . Whether
we argue from a utilitarian viewpoint to maximise the greatest good for the greatest number,
or whether we present a Kantian or duties-based argument, the result is largely
uncontroversial. In the case of the incompetent patient, however, I hope to suggest that
existing mechanisms are inadequate, even if they are the best that can be offered from a legal
context.

The American system relies heavily on the substituted judgement standard. The system,
which is some 15 years old, seeks to identify a surrogate to make the decision that the patient
would have made - putting oneself in the patients shoes as it were. It relies and falls on the
premiss that the surrogate knows something of the patients preferences as expressed when
the patients decision-making capacity was intact. The fallacy of such an assumption is
demonstrated by a large number of studies and, although it still has heavy support in law,
there is little controversy about the inability to make substituted judgements.

One of the great games that judges play is to act as if their decisions are based on objective
standards. For understandable reasons, judges prefer that their decrees be seen as resting on
accepted principles of law rather than on a judicial choice between two competing, plausible
opinions. One such accepted principle has been that decisions giving consent for medical
treatment of incompetent patients should be made to serve the "best interests" of the patients.
In recent years, courts increasingly have used a new, seemingly less objective standard called
"substituted judgment" to replace the best interests standard in certain situations. Under this
new standard, a court substitutes the judgment of a third party for that of the incompetent
patient. The third party tries to make the decision the incompetent patient would have made if
competent. The Supreme Court of New Jersey has taken the lead in this emerging trend with
the decisions in In re Controy38 and its progeny,39 developing an analytical scheme that
38

In re Conroy, 98 N.J. 321, 486 A.2d 1209 (1985).

31

incorporates both the best interests standard and the substituted judgment standard.

The thesis of this paper is that the limited recognition of the substituted judgment standard
should be expanded to the point that best interests considerations are understood to be only
an ingredient in substituted judgment decision making. It specifically focuses on how thirdparty decisions regarding consent to treatment should be made. Final decisions about
treatment will not always be dictated by expressions of consent. Historically other factors
have overridden patient preferences: the public welfare when vaccinations have been ordered
and the needs of innocent third parties when medical treatment has been ordered. Just as the
autonomy of competent patients is not the only value to be honored in medical decisions,
respect for the wishes of surrogate decision makers should not always control these medical
decisions. While third-party consent is not determinative of choices of treatment in every
case, it should play a major role, and we should be very clear about what a person is being
asked

to

do

in

considering

whether

to

grant

such

consent.

CHAPTER - VIII
COMPETENCY TO CONSENT

A patient must be competent in order to be able to provide legally effective consent. The
Mental Capacity Act makes it clear that a medical professional should presume that a patient
is competent, unless there is evidence that she or he is not.40 The burden is on the doctor to
demonstrate that the patient lacks capacity on the balance of probabilities. To be competent,
the patient must be able to use the information, weigh it, and be able to make a decision. In
Bolton Hospitals NHS Trust v. O, 41 a pregnant woman needed a caesarean section operation
without which her life, and that of the child she was carrying was in danger. She consented to
the operation, but later withdrew her consent. She was found to be incompetent on the basis
that her refusal was not the result of reasoned decision and the court declared it lawful to
perform the operation.

39

In re Farrell, 108 N.J. 335, 529 A.2d 404 (1987); In re Peter, 108 N.J. 365, 529 A.2d 419 (1987); In re Jobes,
108 N.J. 394, 529 A.2d 434 (1987).
40
S- 1(2) of MCA.
41
(2003) 1FLR 824.

32

A patient can only provide effective consent if given the relevant and necessary information
to make a proper decision. The patient must understand in broad terms the nature of the
procedure which is intended.in Potts v. NWRHS,42 a woman consented to the giving of what
was described as a routine post-natal vaccination. Infact it was a long acting contraceptive. It
was decided that the treatment was not consented to and so amounted to a battery.
Even if a patient is competent and is aware of the crucial issues, if his consent is not given
freely, it will not be legally valid consent. It is difficult to demonstrate that an apparent
consent was only given under coercion or undue influence.

The term consent means voluntary agreement, compliance, or permission. Section 13 of the
Indian Contract Act lays down that two or more persons are said to consent when they agree
upon the same thing in the same sense (meeting of the minds).43 In law, the tort of battery is
defined as Application of force to the person of another without lawful justification and
therein lies the essence of requirement of consent for any medical treatment.44 Every human
being of adult years and sound mind has a right to determine what should be done with his
body and the surgeon who performs operation without his patients consent commits assault
for which he is liable in damages.45 This principle is applicable not only to surgical
operations but also to all forms of medical treatment and to diagnostic procedures that
involve intentional interference with the person.

A valid consent can be given by competent adults. There is no doctrine of consent by proxy
in English Medical law. However, it is accepted that a competent patient can provide an
advance directive which is a document which sets out what treatment a patient would or
would not consent to in the event that she or he becomes incompetent. Where the patient is an
incompetent adult, a relative does not automatically have the power to consent on her or his
behalf. So, if a woman collapses unconscious after a stroke, her husband cannot necessarily
consent to treatment on her behalf. The medical professionals can provide the treatment
which is in the best interests of a patient. The MCA enables a competent adult to create an
enduring power of attorney which enables its donee to make decisions on the behalf of the
42

(2000) L1Rep Med 404.

Singh J, Bhushan. Medical Negligence and Compensation. Bharat Law Publications, Jaipur. 2nd edition
1999;11-4.
44
Palmer RN. A Physicians Guide to Clinical Forensic Medicine, Humana Press, New Jersey 2000;17-23.
45
Singhal SK. The Doctor and Law. MESH Publishing House, Mumbai. 1st edition 1999;166-9.
43

33

patient when he becomes incompetent. If a child is incompetent, then consent for treatment
can be provided by anyone with parental responsibility for the child. All mothers have
parental responsibility for their children, but not all fathers. Fathers who are married to the
mother or are registered on the childs birth certificate do, but otherwise a father will need to
enter a Parental Responsibility Order or Residence Order. If a child is mature enough to be
able to consent, then she or he can provide effective consent to treatment. However, this does
not mean that those with parental responsibility cannot make decisions for the child.
Healthcare of older children and adolescents is complex as they are in the process of
developing competence to participate in decision making on their health. A childs agreement
to medical procedures in circumstances where he or she is not legally authorized or lacks
sufficient understanding for giving consent competently is called assent. Children are
considered to assent when they have sufficient competence to understand the nature, risks,
and benefits of a procedure, but not enough competence to give fully informed consent.46
It is considered by age of seven years, a child develops competence to distinguish right from
wrong and can assent to treatment/procedure. A child of age 7-14 years is capable of
understanding the outcome of a procedure. However the age of seven has been challenged by
a study that indicated that a child of less than 9 years is not capable to assent.
Ideally, consent may be obtained by a person who is capable of communicating all the
necessary information required to make a decision regarding their health care. The physician
rendering the care may obtain the consent himself. It remains unclear whether a house
surgeon/intern can obtain an informed consent. Staff nurses or other health care providers are
not entitled to obtain the consent although they can bridge the communication gap between
the physician and the patient. In case where the patient is treated in a hospital, failure to
obtain consent has implication on both the employee (doctor) and employer (hospital).47

CHAPTER - XI
THE VALUE OF INFORMED CONSENT

46

Foreman DM. The family rule: a framework for obtaining ethical consent for medical interventions from
children. J Med Ethics 1999; 25: 491-496.
47
BS Yadwad, H Gouda. Consent - Its medico legal aspects. J Assoc Physcians India 2005; 53: 891-894.

34

Today the notion of "informed consent" is in vogue. It seems almost silly to spend time
identifying the value of informed consent in light of the prominence -- the almost sacred
status -- accorded this concept in recent years. The idea of informed consent, however, does
not have a long and honored position in the history of the practice of medicine. 48Traditionally
the physician has assumed an authoritative role that includes discretion to make decisions on
behalf of patients. Hippocrates counseled physicians to hide most things from their patients
while caring for them and to distract patients from thinking about their illnesses. 49 While this
view of the physician-patient relationship may seem hopelessly antiquated today, the belief
that the doctor should control information about the patient's condition persisted well into
modern times. In 1847 the American Medical Association adopted a code of ethics that
encouraged doctors to bring hope and comfort to their sick patients .
Consent became a prominent concern within the medical community as a result of the
Nuremberg trial revelations of medical atrocities inflicted by physicians in Nazi Germany.50
However, change came to the world of medicine not through internal reform but through
challenges from the outside. Over seventy years ago, Justice Benjamin Cardozo in
Schloendorff v. Society of New York Hospital51 set the stage for the development of a
modern doctrine of consent when he said that all adults should be able to decide what would
be done to their bodies.52 Cardozo was expounding not a doctrine of knowledgeable selfdetermination but protection against unauthorized bodily invasion. Cardozo's consent
doctrine became the informed consent doctrine in the 1957 case of Salgo v. Leland Stanford
Jr. University Board of Trustees.53
Prior to 1957 legal charges could be brought for unlawful -- i.e., unauthorized -- touching of
one's body, but the concern was with the presence of consent, not the nature or extent of
disclosure. While much of the decision in Salgo addressed traditional concepts of malpractice
and negligence, the court also explicitly laid down a standard for disclosure. In Salgo a
patient had entered the hospital for diagnostic tests related to circulatory problems. When he
48

J. KATZ, THE SILENT WORLD OF DOCTOR AND PATIENT 4 (1984) (citing 2 HIPPOCRATES,
DECORUM 297 (W. Jones trans. 1967)).
49
CODE OF ETHICS OF THE AMERICAN MEDICAL ASSOCIATION (1847), reprinted in part in J. KATZ,
zupra note 8, at 230-31.
50
211 N.Y. 125, 105 N.E. 92 (1914).
51
Id. at 129, 105 N.E. at 93.
52
154 Cal. App. 2d 560, 317 P.2d 170 (1957).
53
See Tancredi & Weisstub, Malpractice in American Psychiatry: Toward a Restructuring of the PsychiatristPatient Relationship, in 2 LAW AND MENTAL HEALTH: INTERNATIONAL PERSPECTIVES 83,103 (D.
Weisstub ed. 1986).

35

became paralyzed from the waist down following one of these tests, he charged, among other
things, that his physician had not informed him of the nature of the planned test. Finding in
the patient's favor, the court ruled that if physicians do not disclose all of the information to
their patients that would be needed in order to make intelligent decisions about proposed
medical

treatments,

they

breach

their

duties

to

patients

and

face

liability.

The doctrine of informed consent injected a significant element of patient participation into
medical decision making, a realm long dominated by paternalistic concerns and physician
prerogative with regard to patient care. Commentators have formulated various definitions of
informed consent. Tom Beauchamp and James Childress have identified the fundamental
elements of informed consent as: (1) disclosure of information, (2) comprehension of
information, (3) voluntary consent, and (4) competence to consent. 54
Thus, the requirement for informed consent is met when competent patients have received
and understood information relevant to their condition and proposed procedures and have
freely

authorized

the

implementation

of

those

procedures.55

Why is such informed consent important? What basic values, what root concerns, underlie
our confidence that informed consent is an important matter? A number of scholars have
identified benefits that flow from adherence to the doctrine. Alexander Capron, for example,
has described six functions served by informed consent: (1) promotion of individual

54

T. BEAUCHAMP & J. CHILDRESS, PRINCIPLES OF BIOMEDICAL ETHICS 70 (2d ed. 1983). Some
commentators have suggested that informed consent be replaced by a lower level of patient involvement, such
as patient assent. See generally P. APPELBAUM, C. LIDZ & A. MEISEL, INFORMED CONSENT: LEGAL
THEORY AND CLINICAL PRACTICE (1987).
55
There is the question of whether fully informed consent is ever possible, much less practical. The problem has
been articulated by William Curran:
I do not believe that a fully informed consent can be obtained from nonscientifically trained subjects, if by this
we mean a complete understanding of the entire project, its objectives, its risks, its benefits, etc. Even the
research team may not understand all of these aspects, not only because of self-interest but also because of their
own limits of knowledge and experience.
Curran, Ethical Issues in Short Term and Long Term Psychiatric Research, in MEDICAL, MORAL AND
LEGAL ISSUES IN MENTAL HEALTH CARE 18, 24 (F. Ayd, Jr. ed. 1974) (emphasis in original).
Studies have shown that strict requirements of patient informed consent are often not met.
See, e.g., C. LIDZ, A. MEISEL, E. ZERUBAVEL, M. CARTER, R. SESTAK & L. ROTH, INFORMED
CONSENT: A STUDY OF DECISIONMAKING IN PSYCHIATRY 136-39 (1984) [hereinafter LIDZ &
MEISEL].

36

autonomy, (2) protection of patients and subjects, (3) avoidance of fraud and duress, (4)
encouragement of self-scrutiny by medical professionals 56.
Scholars have identified other ends as being served by informed consent. Patients are more
likely to get appropriate treatment if they are informed and involved. Patient support and
cooperation can aid in the success of treatment, and in obtaining patient compliance with
medical advice. Studies show that patients involved in treatment are more comfortable, less
worried, less withdrawn, and experience shorter hospital stays.57 Granting self-determination
to psychiatric patients tempers the intrusion of psychiatry on important social values.
58

Obtaining consent provides protection to medical researchers and care givers from

accusations of improper treatment. On a grander scale, requiring truly informed consent may
avoid domination by experts and thus foster democracy and freedom. 59
Many commentators justify informed consent requirements with these sorts of beneficial
consequences in mind, and in doing so implicate the basic bioethical principle of
beneficence.60 The principle of beneficence is based on the idea that medical treatment should
provide some benefit. When this value controls, decisions about treatment are basically
teleological in character -- that is, we evaluate any potential course of action in terms of the
positive consequences that will result. 61
Whereas beneficence leads us to think teleologically, in terms of ends and consequences, the
bioethical principle of autonomy leads us to think deontologically, in terms of fidelity to first
principles and established values. In the informed consent context, autonomy leads us to
think specifically in terms of principles and values related to the dignity of persons.
56

Capron, Informed Consent in Catastrophic Disease Research and Treatment, 123 U. PA. L. REV. 340-76
(1974); see also J. KATZ & A. CAPRON, CATASTROPHIC DISEASES: WHO DECIDES WHAT? 82-89
(1975).
57
Tobiasen & Hiebert, Burns and Adjustment to Injury: Do Psychological Coping Strategies Help? 25 J.
TRAUMA 1151 (1985).
58
LIDZ & MEISEL, supra note 17, at 7. Our society's individualistic strand places value on personal autonomy
and independence, resisting efforts to label particular persons as deviant and favoring protection of the weak
from those in more powerful positions.
59
See E. FREIDSON, PROFESSION OF MEDICINE 335-36 (1970).
60
See, e.g., Guttmacher, Whole in Body, Mind, and Spirit: Holistic Health and Limits of Medicine, in
CONTEMPORARY ISSUES IN BIOETHICS 55-59 (2d ed. 1982).
61
Beneficence can be further divided into individual beneficence and general beneficence -- a distinction that is
particularly important in research contexts. Individual beneficence focuses on the benefit received by the person
who is the subject of a particular procedure. General beneficence, on the other hand, is concerned with the
benefit that could accrue to a broader spectrum of society, perhaps humankind as a whole. In each case, the
moral calculus is one of pursuing a course of action that will lead to medical benefit.

37

Respecting a patient's autonomy does not necessarily entail concern for consequences and
thus can be at odds with a physician's vision of medical benefit. When such a conflict arises,
an approach to informed consent that begins with patient autonomy places a priority on
adherence to that principle over considerations of beneficial results.
While informed consent can be grounded either teleologically or deontologically, 62 the
principle retains its integrity only when the latter course is taken. All of the benefits that have
been identified as following from an insistence on informed consent may be worthwhile. But
this kind of calculation does not provide the proper basis for valuing informed consent. We
value informed consent not in order to achieve certain other goals, but because of our respect
for persons, their bodily autonomy, and their self-determination. We do not view a person's
right to control both treatment and research protocols as an instrumental good that serves
some of the other benefits listed previously. Rather, respect for persons is an intrinsic good.
Through informed consent we recognize and give force to our respect for an individual's
autonomy. In other words, we require informed consent not because we hope to maximize
benefit, but because we believe each person should be treated as an autonomous human
being.63
By requiring informed consent in treatment and research settings, our society has established
the priority of individual autonomy over calculations of benefit.

64

In the landmark case of

62

E.g., LIDZ & MEISEL.

A distinction should be made between insisting that informed consent be grounded in deontological
considerations and insisting that all specific decisions regarding informed consent in concrete situations be made
through deontological reasoning. The author has argued that neither the teleological nor the deontological model
provides an adequate framework for moral decision making. See Welch, The Moral Dimension of Law, in LAW
AND MORALITY 8-12 (D. Welch ed. 1987).
This type of distinction may help make sense of what could be seen to be incompatible statements in R. FADEN
& T. BEAUCHAMP, supra note 7. On the one hand, they state that respect for autonomy is a prima facie
principle "equally weighted" with other moral principles (e.g., beneficence, justice) "in abstraction from
particular circumstances." Id. at 18. On the other hand, they assert that autonomy is "the single most important
moral value for informed consent." Id.
It is not inconsistent to hold that autonomy is the primary value which grounds and gives meaning to informed
consent and, at the same time, to argue that medical problems cannot be resolved with a preemptive weight
given to concerns for autonomy and informed consent. Indeed, acceptance of the recognized exceptions
toinformed consent rests upon this distinction.
63

64

This clear separation of the autonomy based deontological grounding from the benefit oriented teleological
argument is, unfortunately, not always observed. For example, one study used an ends oriented statement to
make the deontological argument: "[T]he requirement of informed consent is justifiable to the extent that it is
reasonably calculated to promote the autonomy of individuals. A further deontological justification for informed
consent arises from the fact that it also promotes another important and widely held value, rationality." LIDZ &
MEISEL, supra note 17, at 328.

38

Natanson v. Kline

65

the court embraced this ordering of concerns. The court stated that

Anglo-American law is premised upon the principle of self-determination. All individuals of

sound mind are viewed as masters of their own bodies with the freedom to refuse lifesaving
or other medical treatments. The President's Commission for the Study of Ethical Problems in
Medicine and Biomedical and Behavioral Research concluded that patient self-determination
should receive priority over the value of life.
Numerous examples exist, however, of a willingness to "trade off" the concern for autonomy
for projected benefits. Fay Rozovsky, in a study of statutory standards regarding consent,
suggested that patients' rights to autonomy and privacy should prevail unless state interests
compel a different decision or unless the best interests of patients would be better served by
overriding patient autonomy and privacy.66 James F. Drane has described the doctrine of
informed consent as balancing the values of beneficence and autonomy.67
Patient autonomy, as given meaning through informed consent, takes precedence over
benefits from medical treatments and, in certain contexts, the courts have readily and clearly
expressed this priority.

68

We have little difficulty in accepting the priority of patient choice

for competent patients. Ill or injured persons who seek medical assistance are asking medical
providers "to put themselves -- their knowledge, time, energies, and experience -responsively at their disposal."
The key to effective care is responsiveness, not only to the results of diagnostic tests but to
the patients seeking help. Incompetent patients are no less deserving of responsive care from
others than are competent patients. Our reasoning should be just as clear when considering
the plight of incompetent patients, else we compound their plight by refusing to respect what
we know about them as unique individuals. Such a refusal would mean that their
These observers recognize, however, that the beneficial consequences flowing from enforcement of informed
consent could probably not justify the required expenditure of time, resources, and good will required to meet
this standard and thus conclude: "Yet we believe, on deontological grounds, that informed consent must not be
abandoned." Id. at 330 (emphasis in original).
65

186 Kan. 393, 350 P.2d 1093 (1960).

F. ROZOVSKY, CONSENT TO TREATMENT: A PRACTICAL GUIDE 371 (1984).
67
See Drane, The Many Faces of Competency, 15 HASTINGS CENTER REP., Apr. 1985, at 17.
68
See, e.g., Montgomery v. Board of Retirement of Kern County Employees' Retirement Ass'n, 33 Cal. App. 3d
447, 109 Cal. Rptr. 181 (1973) (finding that the courts do not have the power to protect the state's interests in
preserving life by forcing a competent adult to accept unwanted treatment); Satz v. Perlmutter, 379 So. 2d 359
(Fla. 1980) (upholding a decision to remove life-sustaining mechanical respirator on right to privacy grounds);
Mercy Hosp., Inc. v. Jackson, 62 Md. App. 409, 489 A.2d 1130 (1985) (upholding a refusal to appoint a
guardian when a competent patient refused transfusion on religious grounds), vacated.
66

39

incompetence not only entails the loss of ability to exercise autonomous judgment but also a
loss of dignity, as they are reduced to someone else's version of a reasonable person.

CHAPTER - X
THE INCOMPETENCE EXCEPTION TO INFORMED CONSENT

If we view informed consent as a reflection of our respect for individual autonomy and not as
a means of achieving some other good end, what does this view say about our second
question? What is the meaning of the incompetence exception to the requirement of informed
consent?69
A full discussion of the meaning of competence and appropriate tests for its determination is
not possible here. However, there are a few general implications of the concern for autonomy
in competence considerations that should be mentioned. Competence is the measure of
whether persons possess the capability for autonomous action. Incompetence means that
persons are not able to exercise self-determination in a meaningful way. When persons are
not able to understand their own situations, when they are unable to comprehend the likely

69

here are other recognized exceptions to the requirement of informed consent: medical emergency, danger to
others, patient waiver, and therapeutic privilege. While this Essay focuses on the incompetent patient, this
analysis is not irrelevant to formulating a conceptual basis for other exceptions. It could be argued that the only
exceptions to the requirement of informed consent that should be allowed are those that can be supported by
concerns for respect for persons, not by considerations of medical benefit.

40

results of alternative procedures, then those persons are not autonomous in the context of the
particular purpose and setting at hand.
Persons are judged to be incompetent legally when they are found to be incapable of making
personal decisions regarding their care and welfare. This judgment may be made because of
age (in the case of children) or condition (mental illness, retardation, senility, or a comatose
state). Incompetence is not always an either/or proposition. Often physicians deal with
gradations along a continuum, and certification of a patient as incompetent requires drawing a
line through an unbroken string of progressions. Patients may be competent for one purpose
but not for another; a particular patient may be competent one day and incompetent the next.
Such cases present a danger of measuring competence by the degree to which a patient agrees
with

physician's

decisions.

The

following

story

reflects

this

problem:

In Melbourne, Australia, John McEwan, a 27-year-old quadriplegic on a respirator, was

certified insane by hospital officials when he expressed a wish to die and went on a hunger
strike. McEwan's treatment continued on the basis of the certification. When he changed his
mind, he was certified as sane. The hospital also denied the validity of a . . . [Do Not
Resuscitate] order McEwan signed, saying he was too depressed to be responsible for this
document. McEwan was eventually released from the hospital, and died ten weeks later.

70

A Massachusetts appellate court commented upon a similar confusion of competence and

agreement in reviewing a probate court's judgment of the competence of a woman refusing
amputation of her gangrenous leg.71 The probate court judge had ruled that the patient was
legally incompetent because she had not made a rational choice after careful consideration of
the medical alternatives. The appellate court, however, noted that (1) her competence was not
questioned until she withdrew her consent to the treatment preferred by the attending
physicians,72 and (2) the fact that her decision is unfortunate, or seen to be medically
irrational, does not justify a conclusion that her capacity to make the decision is impaired to
the point of legal incompetence. 73

70

The Latest Word, 16 HASTINGS CENTER REP., Aug. 1986, at 52 (citation omitted).
See Lane v. Candura, 6 Mass. App. Ct. 377, 376 N.E.2d 1232 (1978).
72
376 N.E.2d at 1235.
73
Id. at 383, 376 N.E.2d at 1235-36.
71

41

A very real difficulty often exists, however, in deciding whether competence can be
determined apart from judging particular decisions. On the one hand, we want to avoid the
danger of judging as incompetent those with whom we disagree. This goal can be
accomplished by separating respect for persons from respect for their decisions.74 In this vein,
our respect for a person's autonomy is not predicated on a case by case examination of each
decision. We do not determine whether each decision appears to meet our expectations of
what a deliberate, informed, consistent choice would be.
On the other hand, an analysis of a patient's decision has a role in determining competence. It
is difficult to know how to judge a person's competence apart from looking at that person's
decisions. We have a clearer notion of what an autonomous decision is than we do of what an
autonomous person is. Further, a focus on particular decisions is certainly more in keeping
with the nature of our desire to require informed consent, which in turn is concerned with
specific people making specific decisions. An autonomous person can fail to act
autonomously in certain situations, such as when that person is overwhelmed by information,
lacks necessary facts, or is manipulated by clever presentations of information.

75

One test physicians use to assess competence is to ask whether a patient makes a choice
similar to that which a reasonable person would make; another is to ask whether the choice is
based on rational reasons. Each of these tests is biased toward the patient who chooses to
accept the treatment advice of physicians.76 Such a bias is particularly pronounced in
psychiatric settings in which resistance to following drug therapy instructions is often viewed
as "a form of symptomatic behavior, involving hostility, acting out, and paranoid
delusions."77 "Whatever mental illness is, the belief that patients are mentally ill affects both
the staff's and the patients' perceptions of [the] patients' abilities to participate in
decisionmaking, regardless of the legal presumption of competency."78 Such a slant in
perceptions of competence is not relegated to psychiatric settings: "A particular medical
74

An example of the kind of approach that should be avoided is found in the language of a Colorado Supreme
Court decision in which the court implied that statutory and common-law protection of the right to withhold
consent exists unless it is clear that the patient "lacked the capacity to participate in such decisions or that his
refusal to submit to treatment with prolixin was itself irrational or unreasonable." Goedecke v. Department of
Insts., 198 Colo. 407, 411, 603 P.2d 123, 125 (1979) (emphasis added).
75
R. FADEN & T. BEAUCHAMP, supra note 7, at 237.
76
Brown, Psychiatric Treatment Refusal, Patient Competence, and Informed Consent, 8 INT'L J.L. &
PSYCHIATRY 83, 90 (1986).
77
Id. at 85.
78
LIDZ & MEISEL at 326.

42

setting establishes certain expectations about what a reasonable person would do, and these
expectations play an important role in competency determinations."79

The finding of incompetence should precede any calculation of medical benefits. It is a very
troubling fact, if it is true, that decisions as to patient competence often involve a tradeoff
between respect for autonomy and beneficence. When we think about treatment of
incompetent patients without their consent, we should not think in terms of medical necessity
overriding the value of informed consent. Instead, we should only think in terms of acting in
circumstances in which informed consent is not possible.
When we allow an incompetence exception to informed consent, we are not balancing the
value of autonomy with the value of beneficence. Rather, we are admitting that our normal
way of showing respect for that person is not appropriate and that another vehicle must be
found. That vehicle is third-party consent.

CHAPTER - XI
LEGAL CONSEQUENCES OF ILLEGAL TREATMENT WITHOUT CONSENT
A medical professional who intentionally or recklessly touches a patient without consent
could be charged with the criminal offence of battery. However, it is in fact very unlikely that
that would happen, unless he or she was acting maliciously. Proceedings under torts are more
likely. Generally a claim under negligence is brought in. In the tort of battery, the claim is
that the patient did not consent to the touching. In the case of negligence, the claim is that,
even though there may have been apparent consent, the doctor acted negligently in failing to
provide a sufficient amount of information or making a misrepresentation concerning the
treatment or the patients condition. To succeed in a claim of negligence, it must be shown
that the patient suffered some harm. Therefore, if a doctor operates without the patients
consent, some harm should be caused. By contrast in a case of battery there is no need to
show that a patient suffered loss because the battery will be in itself a legal wrong.

79

Drane at 18.

43

CHAPTER - XII
INFORMED CONSENT IN PSYCHIATRY

In its ethical dimension informed consent encourages respect for individual autonomy in
medical decision-making. There are however conditions and circumstances that limit
autonomy and therefore also autonomous choice. People with a learning disability or a mental
or physical illness may be temporarily incapacitated to make autonomous choices due to their
condition. In these cases the concepts of capacity and competence become paramount in
determining the extent to which a person's autonomy is restricted. Competence is a legal
term, and courts decide on the competence of a person based on the inputs provided to it by
the doctors who give an opinion on the capacity of the patient to comprehend facts and make
independent decisions. Capacity in contrast is a medical term and doctors determine a
person's capacity to make certain choices.80 It is worth noting that this distinction often
breaks own in practice. When clinicians determine that a patient lacks decision making
capacity the practical consequences may be the same as those attending a legal determination
of incompetence.

Two basic preconditions have to be met to render a person incapable of managing his or her
own affairs. Firstly, there needs to be an objective cognitive deficit that impairs problem
solving and decision-making. Secondly, there must be an incapability to sensibly delegate
responsibility to someone else. Some authors have suggested a 'sliding scale' of ability to take
into account that different decisions require different levels of understanding. Thus decisions
of most potential risk, such as death, demand greater levels of capacity than decisions of
minor potential risk.81

Hence if the consequences for welfare are grave our need to be able to certify that the patient
possesses the requisite capacity increases, but if little in the way of welfare is at stake, we can
lower the level of capacity required for decision making. Every effort should be made to

80

Pillay VV. Handbook of Forensic Medicine and Toxicology. 13th ed. Hyderabad: Paras Publication; 2003. p.
24-5.
81
O'Reilly RL. Mental Health Legislation and the right to appropriate treatment. Can J Psychiatry. 1998 Oct;
43(8): 811-5.

44

minimize the time taken to determine a patients' capacity.82 Some psychiatric disorders can
impair decision-making functions to some extent, but not to the point where patients would
be considered legally incompetent. In such cases, clinicians can make disclosure in a manner
that takes patients' limitations into account. This may include simplifying elements of the
disclosure, offering information in smaller amounts stretched out over time, and repeating
disclosure several times. The implication of these accommodations to patients' impairments is
that some patients may be asked to consent to treatment (when it needs to be implemented
promptly) before having received a disclosure comparable to that offered to non-impaired
persons.

Some psychiatric patients may manifest impairments of decision-making capacities that are
likely to resolve quickly, especially if effective treatment can be implemented. In such cases
short term treatment of the patient can be initiated, even in the absence of a fully adequate
consent, obtaining such consent as soon as the patients' condition permits it. This practice is
acceptable when recovery of decision-making capacities is likely to occur.
Psychotherapy and other psychiatric records may contain sensitive and deeply personal
information about patients. These records should not be released without patient consent.
Patients should understand to whom the information will be disclosed, what information will
be discussed, how the information will be used and what the potential consequences might
occur.

CHAPTER - XII
GROUNDS FOR TREATMENT OF INCOMPETENT PATIENTS

While much of the discussion about medical care for the incompetent has focused on the right
to refuse treatment, that discussion begins with the premise that incompetence does not
compromise a patient's right to treatment. The impossibility of securing a patient's consent in

82

Beck P. The confidentiality of psychiatric records and the patients right to privacy. Can J Psychiatry. 2001
Apr; 46(3): 6.

45

the moment of decision should not become a barrier to the patient's receiving appropriate
medical care.83
Because of the variety of circumstances in which this issue has arisen, a patchwork of judicial
precedents on the right of an incompetent to refuse treatment has resulted. The right has been
noted in common law 84 and in constitutional law.85 While courts most easily deal with cases
in which a person expressed a desire, when competent, to invoke the right to refuse treatment,
the recognition of that right has not been limited to that fact situation. Courts have also
recognized the "right to refuse treatment and allow life to terminate through natural forces"
for incompetent patients who have not expressed clearly their wish for that choice. 86 The
issue, then, is not whether incompetent patients have a right to receive or reject medical
treatment, but how and by whom decisions about such treatment should be made.

The Appropriateness of Substituted Judgment

If it is determined that a patient is not competent to consent to certain procedures, and if we
then turn to a third party to give consent, what are we asking that third party to do? What is
the nature of the decision to be made? While there are many variations on this theme, third
parties have been asked to render their judgment in accord with the two different guidelines:
the

incompetent

person's

best

interests

and

substituted

judgment.

The best interests standard fits well with the concern for beneficence. Under this approach,
decisions are made for the incompetent person which promote that person's best interests.
Courts and others who adhere to this guideline often use a fairly narrow, explicitly medical
view of what the person's best interests are. Providers choose or avoid procedures with an eye
toward the consequences that will result and the benefit of those consequences.

Substituted judgment is an effort to make the decision the person would have made if
83

See, e.g., In re Quinlan, 70 N.J. 10, 41, 355 A.2d 647, 664, cert. denied, 429 U.S. 922 (1976).
E.g., Eichner v. Dillon, 73 A.D.2d 431, 426 N.Y.S.2d 517 (980) (right to privacy), modified sub nom. In re
Storar, 52 N.Y.2d 363, 420 N.E.2d 64, 438 N.Y.S.2d 266, cert. denied, 454 U.S. 858 (1981).
84

85

E.g., Foody v. Manchester Memorial Hosp., 40 Conn. Supp. 127, 482 A.2d 713 (Super. Ct. 1984); Quinlan,70
N.J. at 38-42, 355 A.2d at 662-64.
86
In re Beth Israel Medical Center, 136 Misc. 2d 931, 937, 519 N.Y.S.2d 511, 515 (Sup. Ct. 1987).

46

competent. As we have seen time and time again, subjects and patients do not always make
the decisions that others feel are in their best interests. The substituted judgment standard
requires the third party giving consent to sort through the incompetent person's particular
preferences. The factors to be weighed always will include medical benefit, but they also may
include such matters as a person's aversion to or preference for risk, the way particular
alternatives affect the person's lifestyle, the person's religious beliefs, the impact on family,
and

other

considerations

that

are

highly

particular

to

an

individual.

The substituted judgment standard should be chosen over the best interests standard when a
third party attempts to make a treatment decision for another. The primary value to be
protected is individual autonomy, not well being. Informed consent is a measure of our
respect for that person's values, beliefs, and preferences, and third-party consent should be
viewed as an extension of that respect.
While a great deal has been written on the best interests and substituted judgment standards
in recent years, considerable imprecision and confusion still exist. As evidence such leading
authorities as Paul Appelbaum, Charles Lidz, and Alan Meisel could write the following:
All surrogate decision makers are, in a general way, under a duty to act in the best interests of
incompetent patients. The difficulty with the best interests standard is not in the statement of
it but in giving content to it. The substituted judgment approach is, in fact, one way of doing
so. That is, a surrogate who makes a decision for an incompetent patient on the basis of that
patient's instructions -- written or oral, express or implied -- is seeking to implement the
patient's best interests as that patient would have defined them. Thus, the substituted
judgment approach is merely one way in which the best interests standard is given content. 56

This statement is exactly wrong. Substituted judgment is not a way of giving content to the
best interests standard. Rather, best interests is one item that should be taken into account
when making a substituted judgment. The inverted relationship in which these authors place
the two concepts reflects their failure to acknowledge the priority that autonomy should have
over beneficence in their development of a theory of informed consent. Autonomy may not
always trump beneficence in final decisions about treatment, but we should never lose sight
of the fact that informed consent -- and by extension, third-party consent -- is a process in the
service of respect for persons.

47

One approach to third-party consent incorporates both best interests and substituted
judgment. For example: The court should take the next occasion to carefully define a
substituted judgment and best interest rule that supports good faith decisions by families and
physicians to implement the wishes of incompetent patients if known, or to make treatment
decisions consistent with the patient's best interests if the patient's wishes are not known.87

However, the real world seldom presents us with such alternative choices. The Supreme
Court of New Jersey, faced with the application of a guardian to remove a nasogastric feeding
tube from an incompetent nursing home patient, moved from the two categories of best
interests and substituted judgment to three tests: subjective, limited objective, and pure
objective. This modification represents a recognition of the difficulties posed by a bifurcation
of patients' conditions, but simply increasing the number of categories from two to three does
not offer a workable solution to the problem.
The dual-option approach dictates that one criterion be used for one type of patient and a
different criterion for a second type of patient. Patients who clearly fall into the substituted
judgment category are ones who gave clear, comprehensive (preferably written) statements of
their treatment preferences for a specific set of diagnostic, prognostic, and life style
circumstances prior to encountering such circumstances. In addition, they reaffirmed those
preferences when the particular situation developed. Further, patients falling into the
substituted judgment category made both statements of preference while fully informed, with
no hint of duress, at a time when they were indisputably competent. On the other hand,
patients who clearly fall into the best interests category are unable to give any indication of
their wishes at the time and have given no prior indication of beliefs, values, or preferences
through direct statements or life style choices.
Obviously, most patients present themselves somewhere between these two extremes. As a
result, placing a patient into one category or the other, or even within one of the three Conroy
categories, is often an arbitrary decision, difficult to justify when the consequence is so
fundamental to the right to affect one's own medical treatment.

87

Annas, Precatory Prediction and Mindless Mimicry: The Case of Mary O'Connor, 18 HASTINGS CENTER
REP., Dec. 1988, at 31, 33

48

Most often those we label as incompetent come to us with histories within which we can
recognize meaningful value clusters. Exceptional cases exist involving infants or persons who
have had such severe mental deficiencies throughout their lives that nothing can be identified
that approaches the valuing of a centered self. In those rare cases in which we have no clues
to patient preference, substituted judgment may look like an objective process. With no
evidence to the contrary we assume this patient would want what a normal, rational person
would want. As we shall see below, however, such a process has only the appearance of
objectivity. Aside from such special cases, decisions should take into account any evidence
available concerning the beliefs, values, and priorities of the unique individual.

Those who work with handicapped persons sometimes refer to those of us without serious
handicaps as the "temporarily able bodied." In the same sense, people we consider competent
are temporarily competent. We have all been children and thus legally incompetent. Many of
us will be considered incompetent for certain purposes near the end of life. Between these
phases is a host of physical, mental, and social factors that may render each of us incompetent
at one time or another. In

that vast majority of cases which involve persons with some

history of competence, when consent is required of a third party, the third party should try to
extend that person's right to self-determination through the time of incompetence.

If we view third-party decisions in the context of acting out of respect for the incompetent
patient, the narrowness of any objective best interests test becomes clear. Justice Stanton, in
In re Visbeck,88 offered a criticism of the Conroy "objective" tests89 that illustrates the
problem. Justice Stanton states, very straightforwardly, "I must say that I think that rule
[objective test] is wrong because it manifests a much too limited view of what is at stake in
these cases."90 Stanton urges that such quality of life considerations as losing mental capacity,
being totally dependent on others, and being deprived of all privacy be considered. Using
these quality of life standards clearly involves a substituted judgment: Responsible people
who believe these factors should be considered "are looking at the matter from the viewpoint
88

89

90

210 N.J. Super. 527, 510 A.2d 125 (1986).

210 N.J. Super. 527, 510 A.2d 125 (1986).

In re Conroy, 98 N.J. 321, 361-64, 486 A.2d 1209, 1229-31 (1985) (stating that a subjective test allows
surrogate decision makers to make the decision they believe the patient would have made when there have been
clear expressions by the patient, when competent, of desires about life-sustaining treatment).

49

of the patient herself. They are thinking about whether the patient's life has meaning for the
patient herself, whether it has become impossibly burdensome to the patient herself."

91

The Conroy court required the pain standard because it was looking for some way to make
these decisions that could be based on objective data. In its desire to limit the grounds for
decision making to something that can be measured, such as physical pain, the Conroy court
reduced a human being to a biological response system. An appropriate response to the
predicament of sick and damaged human beings does not simply measure the severity of
pain, but understands suffering in a more comprehensive way and looks to the desires of the
patient to find the best way to cope with such suffering. For the incompetent patient,
indications of those desires can include prior expressions of preference, even advance written
directives. The patterns of patients' lives provide additional information about their values,
goals, beliefs, and lifestyle preferences. These decisions should not be thought of as falling in
line with some objective, reasonable standard. Instead, we should recognize that subjective
factors will influence each decision made by a third party for an incompetent patient.

92

Attempts to ground third-party consent decisions in a substituted judgment model are not
without their critics. The New Jersey court in Conroy, for example, concluded that "in the
absence of adequate proof of the patient's wishes, it is naive to pretend that the right to selfdetermination serves as the basis for substituted decision-making."93 Robert Destro picks up
on this theme, expressing his concern that once privacy and self-determination rationales are
used to permit third parties to exercise the rights of the mentally disabled, the decisions are
reduced to a functional analysis, creating "an open invitation to the making of legal policy
which is based on precisely the 'irrational prejudice against the mentally retarded'" which the
Supreme

91

Court

condemned

in

the

Cleburne

Living

Center

case.

94

Visbeck, 210 N.J. Super. at 539, 510 A.2d at 131.

92

As Richard Zaner has observed: "Every case uniquely evokes prominent modalities of feeling. Emotion,
passion, striving, wanting . . . all are in many modalities invariably found as texturing every case of distress or
damage." Zaner, Is "Ethicist" Anything to Call a Philosopher?, 7 HUM. STUD. 71, 83 (1984) (emphasis in
original). All too often feelings in a medical context "are apparently deliberately ignored as extraneous to the
problems of medical management." Id. at 86.
93

94

Conroy, 98 N.J. at 364, 486 A.2d. at 1231.

Destro, Quality-of-Life Ethics and Constitutional Jurisprudence: The Demise of Natural Rights and Equal
Protection for the Disabled and Incompetent, 2 J. CONTEMP. HEALTH L. & POL'Y 71, 115 (1986) (quoting

50

Other commentators have noted problems with substituted judgment decisions because the
decisions require the decision makers to construct a patient's self without any meaningful
background information. These commentators argue that such a construct conceals the
"vacuum of subjective intentionality."95 Ultimately, they assert, substituted judgment simply
objectifies the standard of the patient which is reconstructed by the values of the decision
makers. 96
The response to such charges is fairly straightforward. Substituted judgment does not involve
making decisions without background information. To the extent the standard is used to hide
a vacuum of intentionality, it is used wrongly. The purpose of the construct is to avoid an
objectified standard, to reject the too easy reliance on the values of surrogate decision
makers.

The strength of the substituted judgment standard lies precisely in the help it gives us in
avoiding the dangers identified by the Conroy court and others. The point is, of course, that
some third party must make these decisions, lest the incompetent be denied any right to
treatment,

and

the

questions

are

which

party

and

on

what

grounds.

One clue about making substituted judgments lies in what Richard Zaner calls affiliative
feeling. He explains that effective clinical thinking requires that the clinician appreciate the
patient's experiences and feelings, and understand their significance to the patient.97 Zaner's
point is that the patient's subjective life is not inaccessible to others. While he is not directing
his comments to incompetent patients, and is urging clinicians actively to elicit patient
responses repeatedly until the clinician actually almost feels the patient's pain or symptoms,
the same concern should apply to incompetent patients. The mode of discovery may be more

City
95

of

Cleburne

v.

Cleburne

Living

Center,

Inc.,

473

U.S.

432,

450

(1985)).

Tancredi & Weisstub at 107.

96

Id. In the same vein, Walter Weber has urged that the substituted judgment standard be rejected as a
"dangerous sham." Weber, Substituted Judgment Doctrine: A Critical Analysis, 1 ISSUES L. & MED. 131, 153
(1985).
97

R. ZANER at 318.

51

varied and imaginative with those who are unable clearly to voice their needs and wishes, but
the goal is the same: do not take patients for granted. Do not assume any patient fits into a
standard mold. Strive to understand each patient's individuality, to emphathize with the
patient's suffering and distress, and then to act on that understanding.

CHAPTER - XIII
EFFECTIVENESS OF INFORMED CONSENT IN MEDICAL TREATMENT

Medical profession in India practices concept of informed consents in medical treatment.

Implied consent is one, which is not written but legally effective. When patient comes to
doctors consulting room or hospital and waits for the doctor, implied consent is presumed.
Such implied consent only goes to history taking and ordinary medical examination like
inspection, palpation and auscultation; it does not cover the consent for examination of
private parts of the patient or matters such as vein punctures or injections or any major
intervention. If any material risk is involved the specific or expressed consent must be
obtained. The above discussion, thus, shows that in certain circumstances an implied consent
may not be considered as sufficient. In the case of Male v. Hopkins98it was observed that it
was not negligence of a doctor, who had the patients consent for general treatment, to
prescribe a particular drug known to have side effects, without first obtaining specific
consent.
The observation was that it was a proper exercise of his discretion to prescribe the drug even
with the risk involved. However, negligence did not arise in his failure to carry out
recommended tests for the presence of other side effects, once the prescription of the drug
had commenced. A good case of implied consent came up before the National Commission99

98

Practice, legally and ethically. The patient has right to full information in one professional term with
advancement of medical technology and increasing sect. 3(22).
99

Criminal procedure code 1973 (act number 2 of 1974) Govt. of India, New Delhi.

52

where one of the witnesses had stated that once the consent for excision biopsy through
thoracotomy was given, the consent for removal of the mass was implied. The Commission
observed (Para 19) that the surgeon need not limit the operation to diagnostic purpose but can
proceed with the same for curative purposes also.
The express or specific consent may be oral or written. An oral consent is legally valid, but it
is preferred to obtain written consent for major procedures because there is risk involved that
the patient, in the case of oral consent, may at later stage deny that any oral consent was
given by him. If, for whatever reason, only oral consent is possible, it is appropriate to make
an entry in the patients clinical record which may be of use in future if any action is brought
on this count and this entry in the clinical record may afford corroborative evidence to
support the defense taken by the medical practitioner concerned.
In a Tamil Nadu case100 it was observed that in all cases where a treatment consists of certain
dangerous instruments, it is the duty of medical authority to take the consent of patient,
preferably in writing. However, in that case an oral consent was taken and the Commission
regarded this consent as proper. This shows that written consent is not an absolute necessity
to defend an action for assault or battery, but a written consent would afford documentary
evidence that the consent was actually obtained. The cases are not rare where the action has
been brought after several years prefer the evidence of the patient if a documentary evidence
of express consent is not provided.
Informed consent is an ongoing process that includes the exchange of information and
development of choices. This does not say that the same should be in writing. Emphasis on
informed consent has been laid in Dr. Janki S. Kumar v. Mrs. Sarafunnisa101where the
sterilization was done without consent. It was observed that when one speaks of consent, that
should be informed consent. The person who should give consent must be aware of the risks
involved and on that awareness the patient should give consent. When, as indicated, the
patient was in general anesthesia neither could she understand the risks involved nor could
she give consent. It may be understood that it is only in emergency that the consent may be
done away.

100

M Hidayat Ullah and SP Sathe. The code of criminal procedure 13th ed. 1987, Vadhava & Co. Private Ltd.
Page 43-44.
101
Transplantation of human organs acts 1994.

53

Otherwise, the consent is necessary and that to in writing. In a case Aplarain Jayanand
Rathod v. Dr. Shailesh Shah102 the operation of appendicitis was performed without written
consent under the guise of removal of stitches and no explanation was given for the second
operation. The State commission found that the Doctor was deficient in service and was
liable for compensation. In patients who are more prone for anxiety / full disclosure in
presence of malignancy or unavoidable total results the doctor should use therapeutic
privilege in the interest of patient, disclose the fact to the kin rather than to the patient.
Presently in India, doctrine of informed consent is not in routine practice. This type of
consent may take routes in the Indian medical practice soon, since advancement in
technology and information is taking place very fast and increase consumer awareness.

CHAPTER - XIV
HOW CONSENT SHOULD BE OBTAINED

The elements that a physician must discuss with his / her patient to fully obtain informed
consent are the following:

The diagnosis and the nature of the condition or illness calling for medical intervention.

The nature and purpose of the treatment or procedure recommended.

The material risks and potential complications associated with the recommended Treatment
/ procedure.

102

K. Grackutty v. Dr. Annama 1992(1) CPR 25 Ip- 260 (Kerala SCDRC).

54

All feasible alternative treatments or procedures, including the option of taking no action,
with description of material risks and potential complications associated with the
alternatives.

The relative probability of success for the treatment or procedure in understandable terms.
A recent case103 came up before the Pondicherry State Commission where the question of
obtaining consent was involved. In this case consent was on printed form except the
following portion: I Vasanthakumari Hosp. No. in my full senses hereby give my complete consent for
flap cover and SSG or any other procedure deemed fit, which is a diagnostic procedure /
biopsy / transfusion/operation to be performed on me / my son / my daughter / my ward
age under any anesthesia deemed fit. The nature and the risks involved in the
procedures have been explained to me to my satisfaction.
The expected chances of success and failure, the risk and benefit of procedure, the hazards
and complications of the particular surgery, should be explained to the patient before
obtaining his written consent for the operation. To avoid future allegations of negligence the
surgeon may record in the case history the points of discussion as far as possible.
Therefore, the legal formalities regarding consent shall be fulfilled only if the discussion is
recorded in the case history and simply obtaining the form may not be sufficient. The
commission also observed that the dialogue between the patient and a surgeon is an utmost
necessity and at each stage the patient or his relatives should be informed of all the
possibilities and pros and cons of the various possibilities and the patient is allowed to decide
freely without any amount of influence by the surgeon who may have his own ideas and his
own preferences. The commission also observed that there is no record whatsoever in the
case sheet or any explanations or information passed on to the patient.
It should also be borne in mind that merely singing the consent form does not exclude
doctors responsibility if he is negligent in carrying on his duties14. In this case a consent
form was obtained from the patient by virtue of whom she had consented to be responsible
for the consequences of anesthesia being administered. Thus, the argument was the
103

Sideway V Benthlem, Royal Hospital Governer, 1 All ER 543- Doctrine of informed consent first
considered.

55

complainant was stopped from claiming damages. In these circumstances the Maharastra
State Commission observed that the signing of the consent from doesnt exclude doctors
responsibility if he is negligent in carrying his duties.104

CHAPTER - XV
RIGHT TO REFUSE CONSENT
A competent adult has a right to refuse treatment even if others, including the medical
practitioners, believe that the refusal is neither in his / her best interest nor reasonable. In a
Canadian case13 the lady patient / plaintiff who was seriously injured in a road accident was
taken to the hospital where the defendant treated her. As her condition worsened and she
lapsed into unconsciousness, the need to treat her as an emergency arose. It became necessary
to give her blood transfusion. A Jehovahs Witness card was found among her belongings.
The card when translated read as under:
As one of the Jehovahs Witness with firm religious convictions, I request that no blood
products be administered to me under any circumstances. I fully realize the implications of
the position but have absolutely decided to obey the Bible command
The defendant doctor was made aware of both the card and its contents but, as the patients
condition deteriorated, he decided to administer blood. The patients daughter on arrival at
the hospital confirmed her mothers wish not to be given a blood transfusion and actually
signed a consent to treatment and release of liability for. Despite this the defendant
continued to administer the blood. The Ontario Court of Appeal held that the defendant was
liable in trespass. As Robin JA said, the instructions imposed a valid restriction on emergency
treatment that could be provided and precluded blood transfusion.
This case precisely and accurately represent the position in English law that may
unauthorized touching is technically a battery and a civil claim can be maintainable even if
there is no evidence of damage to the plaintiff. It may seem harsh to conclude that a
104

V. Vassanda Caumary v. T. Ramachandrudu (Dr), 1998 (3) CPR 227

56

defendant is legally liable in damages when the only thing that he is guilty of is trying, must
be respected if autonomy is to have any meaning.
ADVANCE DIRECTIVES
Also known as living wills. Some patients (especially in Western countries) elect to express
their wishes concerning their future treatment of a condition that has not yet arisen, or of a
current condition that may deteriorate in future. These are made by the competent patients
with the intention that they will remain effective if the patient becomes incompetent. There is
no direct law regarding such advance directives. The advance directives made when the
patient had the capacity to consent or refuse, the treatment in question may be binding on the
medical practioners. When it expresses a refusal to treatment in circumstances that the patient
had anticipate. In our country, there is no law regarding advance directives. A refusal to treat
the patient can only be acceptable if this possesses no additional risk to the patient and a
colleague was available to take over the patients case. The medical practitioner should also
make a note of refusal placed upon him by the patient.
A refusal to accept a specific aspect of treatment doesnt remove a patients entitlement to
reasonable and proper care, nor it confers upon the patient a right to an alternative form of
treatement.105

CHAPTER - XVI
CAN CONSENT BE DONE AWAY

The consent can be done away if there is emergency and there is no advance directive or
refusal to take treatment. The most sacred duty of the medical practitioner is to save the life
of his patient. If the patient needs emergent and immediate surgery and the waiting for the
consent may prove fatal for the patient, the surgeon may go ahead with the operation without
waiting for the consent of the patient because it is an attempt to save the life of the patient.
This view has been taken by our Indian courts also. It was observed in the case of

105

Raja ram S. Parab v. Kalpana Desai (Dr) 1998 (3) CPR 398, Para 13, Maharashtra state Commission.

57

T.T.Thomas (Dr.) v. Smt. Elisa that a106 surgeon who failed to perform an emergency
operation must prove with satisfactory and convincing evidence that the person had refused
to undergo the operation, not only at the initial stage but even after the patient was informed
about the dangerous consequences of not undergoing the operation.
One case came up before Gujarat State Commission107where the complainant, a lady, having
the son and the daughter, both minors, contacted the doctor while she was carrying 13 weeks
pregnancy. She was advised Medical Termination of Pregnancy (MTP) and consent in
writing was taken. After the operation the husband of the complainant was informed that the
uterus was removed. The complainant filed a case alleging that no consent for the removal of
uterus was obtained either from the patient or from her husband. It was found the eminent
gynecologist had participated in order to save life of the patient and they all were unanimous
for removal of the uterus, as there was continuous bleeding and the condition of the patient
was deteriorating. Thus, no negligence regarding removal of uterus was found on the part of
doctors.
Consent of maternity patients
Consent to obstetric procedure should be discussed during the antenatal period. If the medical
practitioner finds that the wishes of the pregnant woman are unusual, these should be noted
carefully in the antenatal record. It is necessary because the practitioner who discussed the
matter with the lady may not be on duty when that lady is admitted in labor.108 If the pregnant
woman insists on restrictions that were unsafe in view of the doctor attending her, or the
woman places such restrictions which make the doctor reluctant to accept the responsibility,
he (the doctor) should frankly say so to the patient and, if possible, refer her to a colleague for
further advice.
If no immediate necessity for operation, consent should be obtained.

106

(1994) 4 All ER 649.

107

AIR 1987 Kerala 52

108

Marshall v. Curry, (1933) 3 DLR 260.

58

In the case of Devi v. West Midland Area Health Authority109

The plaintiff, aged 29, had 4 children and longed for more. Her religious belief precluded
sterilization and contraception. She was admitted to the hospital for a minor operation on her
womb. Without her consent and knowledge the surgeons decided to sterilize her because they
feared that if she becomes pregnant again her womb would rupture. Although acting in the
patients interest, there was no immediate urgency to perform the operation without
permission. The defendants admitted the liability, and damages to the tune of 4000 pounds
were awarded.
In a Canadian case110 the doctor tied the patients fallopian tubes during a caesarian
operation, as he was concerned about the consequences of a second pregnancy. No consent
for it had been obtained. It was held that there was no immediate danger and therefore, the
liability existed. But in another Canadian case111the patients diseased testicle was removed
in the course of an operation of hernia. It was observed that there was no liability, as it was an
emergency.

CHAPTER - XVII
INFORMED CONSENT IN CLINICAL TRIALS

The development of a new drug is a lengthy process. Once a promising compound is

identified, it must be investigated in laboratory studies and tested on laboratory animals.
After years of work, the newly developed drug is ready for clinical trials, or the testing on
human volunteers.

This part of project deals with the ethics of clinical trials using the example of anti- fertility
109

Mrs. Manjulaben Vinodbhai Patel v. Dr. Harshida K.Patel and another, 1997 (3) CPR 264 Gujarat State
Commission
110

(1981) Kemp & Kemp, Vol 2, F5108 and F5 O17.

111

Murray v. McMurchy, (1949) 2 DLR 442.

59

vaccines. In particular I argue that the ethics of clinical testing are not confined to the
recruitment stage and information provided to participants. We need a more process-oriented
perspective on the ethics of trial participants involvement.

The research and development of anti-fertility vaccines have caused much concern among the
international womens health movement, involving many ethical and political problems .112

The development of anti- fertility vaccines began in the 1970s. Unlike hormonal methods, the
immunological mechanism of action causes temporary infertility by provoking the production
of antibodies against substances necessary to human reproduction, such as certain hormones
and molecules of the sperm and the ovum. Research has been carried out in various
institutions, predominantly in India and the United States.

Research on the vaccines discussed in this article, anti- human Chorionic Gonadotropin (CG)
vaccines, is carried out under the auspices of the World Health Organization (WHO) in
Geneva, by the National Institute of Immunology (NII) in New Delhi, and by the Population
Council in New York. Clinical trials with these vaccines to test the safety and the biological
effects have been carried out since the early 1970s, on small groups of women in the United
States, India, Brazil, Chile, Dominican Republic, Finland, and Sweden

113

In 1986, a WHO-

sponsored trial for safety was done in Australia, involving 30 women (8).A trial with 101
women was carried out in India in 1988 with the anti- hCG vaccine developed by the NII 114.

In 1991-1992 the first efficacy trial took place, and 148 women were vaccinated at the All
India Institute of Medical Sciences and the Safdarjung hospital in New Delhi, and the Post
Graduate Institute of Medical Education and Research in Chandigarh

115

. A efficacy trial of

the WHO anti- hCG vaccine started in Sweden in 1994, but was suspended a few months
later because all the first seven participants experienced serious side effects.

Testing contraceptives
112

Saheli: Target practice. Anti- fertility vaccine research and womens health. Saheli, New Delhi, 1998.
Richter J: Vaccination against pregnancy: miracle or menace? Zed Books, London and New Jersey, 1996
114
Stevens VC and Crystle CD: Effects of immunization with hapten- coupled hCG on the human menstrual
cycle. Journal of Obstetrics and Gynecology 1973; 42: 485- 495
115
Talwar GP et al: Clinical profile and toxicology studies on four women immunized with Pr--hCG-TT.
Contraception 1976; 13: 253-268.
113

60

When a person has a disease for which no effective drug or treatment is available,
participating in a trial is often the only way to get access to a potentially life- saving drug.
This was the case with the testing of new treatments for AIDS. In the development of new
contraceptives, the situation is quite different, because a number of more or less satisfying
forms of family planning are already available and because contraceptives are meant for
healthy people. Yet, biomedical researchers need the collaboration of trial participants to test
the safety and efficacy of a new drug.

Successful clinical trials are a core requirement for the approval of a new drug by regulatory
authorities. In order to enable researchers to recruit trial participants in an ethical manner,
clinical trials generally require an informed consent procedure. Candidates receive
information on the experimental drugs and on what their participation would involve. They
must sign an informed consent form to express their voluntary decision to participate.

Internationally endorsed guidelines to regulate informed consent procedures were recorded

for the first time in 1964 in the Declaration of Helsinki, prepared by the Council for
International Organizations of Medical Sciences in collaboration with the WHO. They have
been updated several times since then

116

. Worldwide, ethical review committees at research

centres and funding agencies scrutinise research proposals, information brochures, and final
reports on the basis of these guidelines. Ethical guidelines for biomedical research involving
human subjects are centred on the dual purpose of respect for a persons right to make
decisions, and protection of vulnerable persons in biomedical research 117.

I have studied the trials in Australia, Sweden and India in some detail

118

. In the informed

consent procedures of these trials, it was believed that women actively took the decision to
become research subjects on the basis of the information provided to them. For example, the
introduction to the extensive information brochure accompanying the informed consent form
for the 1994 efficacy trial in Sweden stated that the information was in order for you to
116

Nash H et al: Observations on the antigenicity and clinical effects of a candidate anti- pregnancy vaccine: subunit of human chorionic gonadotropin linked to tetanus toxoid. Fertility and Sterility 1980; 34: 328- 335.
117
Shahani SM et al: Clinical and immunological responses with Pr-- hCGTT vaccine. Contraception 1982;
25: 421-434.
118
Brache V et al: Whole - hCG: Tetanus toxoid. Paper presented at the scientific session on immunological
aspects of reproductive health, Moscow, June 16- 18 1992

61

reach a decision. The brochure answered questions likely to be asked by individuals who
volunteer to be in the study. Participants were free to ask questions at any time before and
during the study. The decision to participate in the trial would be of your own free will
and participants could decide to withdraw from the study, for any reason and at any time
119

. This mode of addressing assumed that women had different options for action.

Participation in the trial was envisioned as one option for women, the informed consent as a
communication process, and women were seen as decision-makers.

Informed consent in india

A different picture of womens options for action emerged from the performance of the
informed consent procedures in the phase II trial in India. The German documentary- maker
and womens health advocate Ulrike Schaz filmed the recruitment of some women for this
trial. The film showed a room in a public hospital in New Delhi where dozens of women
were standing in line waiting to see a doctor. The doctor was sitting behind her desk and told
a patient "We have got a new injection. The effect of the injection stops children for one year.
You need not be afraid about this. The injection has no side effects. You see this injection is
absolutely 100 per cent effective. We will also put in a copper- T. Continuous copper- T is
not very good. If you have it three years, six years, then there is the risk of cancer. That is
why we want you to change 120"
The doctors statements diverged from the protocol. She said the anti-fertility vaccine was a
new injection instead of an experimental method for which the duration and efficacy were yet
to be established. And there is no evidence three or six years of copper- T use increases the
risk of cancer. As a matter of fact the research protocol for this trial had been approved by the
Drugs Controller of India, the institutional ethics committees, and the ethics review
committee of the Canadian International Development and Research Center, one of the
funders of clinical research at the NII

The film caused concern among researchers and policy makers involved in the development

119

Jones et al: 1988 Phase I clinical trial of World Health Organizations birth control vaccine. The Lancet 1988;
1295-1298
120
Talwar GP et al: Phase I clinical trials with three formulations of anti- hCG vaccine. Contraception 1990; 41:
301- 316.

62

of anti- hCG vaccine. This representation of a trial participant differed from the one that
researchers had been addressing in their information brochures. While the scene underscored
the importance of proper information, the candidates options for action seemed to depend on
more than communication processes. Informed consent appeared not as a communication and
decision making process, but as a form of social intervention in a specific context, producing
and reproducing power-relations.

The context of research

Moreover, the ethics of clinical trials go beyond the need for well- performed informed
consent procedures. Ethics and politics are involved in the context in which clinical trials are
carried out, and in organisational features as well. This becomes very clear when we compare
the Indian and Swedish trials. In India, womens daily life situations facilitated their
enrollment and continuation in the trial. Researchers who studied the 1991- 1992 clinical
trials in India point out that the most frequently mentioned advantage of participation in
clinical trials was improved access to medical care. Private clinics are unaffordable and
government medical treatment usually meant missing work and waiting for hours at public
hospitals. As clinical trial participants, they and their families received priority treatment
(16). Researchers also make participation attractive to prevent drop- outs, by providing a
waiting area, cold drinks and snacks, and reimbursement for travel expenses and time lost
from employments 121.

Women participating in clinical trials often use it as a means for improving their existing
situation. They are in their own way getting access to an extra income, improved health care,
and a sense of identity and social space outside their homes. On the other hand, one can argue
that these motivations provided by the research center in some ways take undue advantage of
the situation of low income, uneducated women by providing them with opportunities they
would otherwise not have 122.

As Kirbat has signalled there is a tension between women as actively seeking to become

121

Talwar GP et al: A vaccine that prevents pregnancy in women. Proceedings of the National Academy of
Science, USA 1994; 91: 8532- 8536
122
Council for International Organizations of Medical Sciences: International ethical guidelines for biomedical
research involving human subjects. Prepared by the CIOMS in collaboration with the WHO, Geneva, 1993.

63

research in a specific situation. Importantly, health care, reimbursement and other such
provisions were effective only for poor women. The provision of a social space outside the
home might not have been significant to men, and access to good-quality health care was not
an issue for richer people. The researchers arrangements suited a specific category of clinical
trial participants.

Participants in the 1994 Swedish trial, too, were reimbursed for travel expenses, time lost for
employment, and other trial- related expenses. However, participation provided no personal
benefits, apart from the eventual anti- fertility effect during the efficacy stage of the trial and
a thorough medical examination 123. The researchers encountered many problems in enrolling
and keeping a sufficient number of trial participants. The original recruitment targets in the
Swedish trial were 50 subjects in each of the two participating hospitals. A total of 61 women
contacted the Karolinska Hospital in Stockholm in response to its initial publicity about the
trial, and 17 of them remained potentially available after the interview and the screening. In
the Uppsala University Hospital, a total of 16 women expressed interest and three of them
passed the interview and the screening stages

124

. The representative of a company involved,

Mats Ehrnebo, wrote in a progress report to the WHO:

There has been a slower than expected patient recruitment. (...) It is planned then for a more
extensive patient recruitment. (...) every aspect that could raise the number of patients that
could be screened should be encouraged 125.

Researchers in Sweden had fewer opportunities to make participation in the trial attractive to
women. Improved access to health care was not relevant for these women. For poor women
in India, the clinical trials could provide a welcome opportunity to obtain better access to
superior health care, an extra income and a social space outside their homes. Because of
womens different spectrum of options, it was easier to recruit and keep women in the trials
in India than in Sweden. This illustrates how the politics and ethics of clinical trials are not

123

Cook RJ and Dickens BM: Legal and ethical aspects of development and use of fertility regulating vaccines.
In Ada GL and Griffin PD (Ed): Vaccines for fertility regulation: the assessment of their safety and efficacy.
Cambridge: Cambridge University Press, 1991, pp 201- 232.
124
Van Kammen J: Conceiving contraceptives, the involvement of users in anti- fertility vaccines development.
Dissertation, University of Amsterdam, 2000.
125
WHO/ HRP Task Force on Vaccines for Fertility Regulation: Phase II clinical trial protocol. Prototype antihCG vaccine. Geneva, May 28, 1992.

64

confined to obtaining womens informed consent to participate. Their participation and

continuation in the trial depended not only on their understanding of the information provided
to them, but also on the contexts and the power relations in which they were engaged.

How could this finding be handled in practice? First, the provision of clear and adequate
information remains a key issue, and ethic committees should intensify their surveillance of
clinical testing. Second, the finding that womens options for action differ according to their
situation - and hence the ethicality of their participation should play a role in the selection of
trial centres. Finally, persons who can represent the users perspectives should be involved in
the planning, organisation, and evaluation of clinical trials. In the case of anti- hCG vaccines,
some researchers from the WHO have proposed that womens health advocates could play a
role in monitoring the conduct of clinical trials of new contraceptive methods.

CHAPTER IX

CONCLUSIONS

Twelve years is the age for giving valid consent. However this is true as far as criminal
liability is concerned. For cases involving civil liability eighteen years is the age for taking
valid consent (taking into account the Indian Contract Act). In view of this ambiguous
position there is an urgent need for legislation in India regarding age of consent for medical
treatment. This will go a long way in removing ethical and legal dilemmas being faced by the
doctors in this regard.

65

It is always advisable to take written consent. Whether both the patient and doctor should
sign the consent form is another point for which no clear-cut guidelines exist. The Medical
Council of India or the lawmakers should issue clear-cut guidelines in this regard. Consent
should be individual and case specific and be taken just before the procedure. Consent should
be open for discussion and potentially retractable at any time during the course of treatment.
In an emergency it is sometimes impossible to know the patients will in which case it is
practical and justifiable to act in the patients' best interest. The ethical rather then the legal
consideration should prevail.
Full disclosure is necessary before taking informed consent. The legal exceptions to this are
important for doctors to understand as they are often called upon to treat patients in
emergency situations, to treat patients who lack capacity to make decisions and to treat
patients whose disorders influence their ability to tolerate detailed explanations. Legal
reasons restricting choice can also be there as in case of prisoners.
The right of patients to consent or refuse consent to medical treatment is an important right
incorporated into the legal framework. In psychiatry important exceptions to this rule exist
because of ethical, legal and practical reasons. Some persons do not have the mental capacity
to make an informed choice in which case it is ethical to consider acting in their best interest.
Concept of therapeutic privilege allows physicians to modify only the degree of disclosure
the ensuring basic treatment must still be explained to the patient. In psychotic conditions
therapeutic privilege can be invoked and details regarding long-term side effects can be
temporarily postponed. Such cases should be carefully documented and full disclosure should
take place once the patient's conditions have improved. Careful documentation, ongoing
education and provision of opportunities for collaborative decision-making in such cases may
be more effective and can provide effective legal protection.

In the health care setting, informed consent is necessary to legally and ethically provide
treatment to patients. When a patient is no longer capable of making decisions, a substitute
decision maker (SDM), surrogate, or proxy is asked to step in to make decisions on behalf of
the incapable person. Rules to guide how decisions are made for incapable patients vary. Best
interests are generally invoked when it is necessary to provide the means of decision making
for persons who are not capable. Although not perfect, some argue that appealing to best
interests is the preferred way to make decisions for patients who are no longer capable. 126
126

Coggon J, Holm S. Best interests: a reappraisal. Health Care Anal 2008;16(3):193-6.

66

Moreover, best interests, Coggon argues,127 need to be considered as a construct rather than a
concept that aid in good decision making to avoid the challenges of appropriately being
applicable in varying and diverse situations. That is, a single concept could not properly be
applied in every single unique case and be meaningful. As such, in areas that invoke best
interests, such as the English Mental Capacity Act, 2005, there are questions and processes
that are recommended for people in their decision-making.

At the end of life, best interests are important because so few critically ill patients have the
capacity to participate in treatment decisions themselves or have left detailed instructions
with their surrogates.
Whether from a tragic accident, or a long and protracted illness, there can come a point
where health care practitioners, spouses, parents or other family members must decide
whether potentially life-sustaining treatment should be withheld or withdrawn from a patient
no longer competent or capable to consent. Often a consensus is reached based on knowledge
of the wishes of the patient through an advanced directive or some other previous expression
of their wishes. Other times, a consensus is reached through recognition that further treatment
is of no benefit to the patient. All involved agree it is in best interests of the patient to
withhold or withdraw life-sustaining treatment.
In Canada, it has been acknowledged that physicians "pull the plug" on incompetent patients
daily without any interference from the law. In the United Kingdom, the Intensive Care
Society estimates 15,000 people die annually in intensive care wards and that most result
from the withdrawal or limiting of treatment. The question one is left with is what happens
when the recommendation of the health care practitioner conflicts with the expressed wish or
advanced directive of an incompetent patient, or that patient's substitute decision-maker?
Although provinces and territories in Canada have enacted statutes governing issues of
consent, advanced directives, and/or substitute decision-making for incompetent patients, the
question of who has the final authority when a demand for life-sustaining treatment is made
has not been answered by statute.
When substitute decision-makers or family members disagree with the recommendation of a
health care practitioner, aside from an informal dispute resolution system that may exist
under hospital policy, the only recourse appears to be the courts. Although case law suggests

127

Ibid.

67

this decision is to be made by the doctor, it remains unresolved as to whether there could be a
rights-based argument in favour of life-sustaining treatment.
The call by Beard J. in Sawatzky for a role for the courts is closer to the state of the common
law in the United Kingdom. In Bland 40 the House of Lords held that the withdrawal of life
support, specifically artificial nutrition and hydration (ANH), was not illegal without a court
order, however for at least some time, an application should be made to court for approval
before any decision to do so. It was believed that court review would protect patients and
doctors, and reassure patients' families and the public. 128
The England and Wales High Court in MB 42 took the view that the consent of family
members is irrelevant to the final decision. This was the case of an infant hospitalized almost
since birth. The doctors brought an application to withdraw life-sustaining treatment. The
Court stated that although it must be mindful to the views of the parents, those views are
"wholly irrelevant to consideration of the objective best interests of the child."129 It has been
suggested that the position of the court in M.B. was that determining the child's objective best
interests remains solely the court's responsibility.130
In Burke the applicant, Oliver Leslie Burke, was competent at the time of the application. He
suffered from cerebellar ataxia, a degenerative neuro-logical condition, and knew in the
future he would require ANH in order to survive.

131

Medical evidence at trial indicated that

he would likely "retain full cognitive faculties even during the end stage of this disease" and
would be aware of the "pain, discomfort and extreme distress that would result from
malnutrition and dehydration." 132
In his application, he sought clarification as to the circumstances in which doctors may
withdraw ANH, and challenged the lawfulness of the Guidance issued on this subject by the
General Medical Council (GMC). 133Burke believed 134 the Guidance was unlawful in certain
respects as it violated his rights under Articles 2 (right to life), 3 (right to protection from
128

Child and Family Services of Manitoba v. R.L., [1999] M.J. No. 568, 154 D.L.R. (4th) 109 (C.A.).
An NHS Trust v. MB, [2006] EWHC 507 (Fam) [MB].
130
Ibid. at 16.
131
Joan Gilmour, "Death, Dying and Decision-making about End of Life Care" in Timothy Caulfield, Jocelyn
Downie and Colleen M. Flood, eds. Canadian Health Law and Policy, 3d ed. (Markham: LexisNexis, 2007) 437
at 458.
132
Burke, supra note 4 at para. 1.
133
Ibid.
134
Id.
129

68

inhuman or degrading treatment), 6 (right to a fair hearing), 8 (right to respect private life)
and 14 (prohibition of discrimination) of the European Convention for the Protection of
Human Rights and Fundamental Freedoms .135
In what can be described as a comprehensive and exhaustive 225-paragraph judgment,
Munby J.

136

reviewed the case law in this area and, controversially in the opinion of some

commentators, placed considerable emphasis "on the 'absolute nature' of the right to respect
for autonomy and self-determination." 137
Justice Munby concluded health authorities and the National Health Service Trusts were
public authorities for the purposes of the Human Rights Act and as such, were required to act
in a manner consistent with the rights of a patient under the Convention.138 He then found
that "the dignity interests protected by the Convention include, under Article 8, the
preservation of mental stability and, under Article 3, the right to die with dignity and the right
to be protected from treatment, or from a lack of treatment."
Based on these conclusions, he held that in the presence of a clearly expressed wish to the
opposite in a valid advanced directive, a decision to withdraw ANH at any stage before Burke
finally lapsed into a coma would in principle involve clear breaches of Articles 3 and 8. 139 He
did note that it would not be a breach of these rights where, in the case of a patient who is
being treated with dignity, ANH is "withdrawn in circumstances where it is serving
absolutely no purpose other than the very short prolongation of life of a dying patient who
has slipped into his final coma and lacks all awareness of what is happening."

With the England and Wales Court of Appeal's damning dismissal

141

140

of Burke, one wonders

whether a rights-based argument could again be successfully advanced. However, a review of

the decision reveals the potential remains. Also, the argument advanced in Burke can be
informative as to the content and likely success of a similar rights-based argument made in
135

Id.
Council of Europe, Convention For the Protection of Human Rights and Fundamental Freedoms, P.A., ETS
no. 005 [Convention].
137
Munby J., prior to his appointment to the Court was the Barrister on behalf of the Official Solicitor in the
Bland case, supra note 18 at para. 7.
138
.K. Mason and G.T. Laurie, "Personal Autonomy and the Right to Treatment: A Note on R (on application of
Burke) v. General Medical Council" (2005) 9 Ed. L. Rev. 123 at 127.
139
(U.K.), 1998, c. 42.
140
Supra, note 4 at para. 117.
141
Ibid.
136

69

Canada.

One challenging aspect of applying Burke is the unique situation where the applicant was still
competent. Translating this decision to the position of an incompetent or incapable patient is
questionable. It was for this reason the Court of Appeal dismissed the action, finding that the
relief claimed extended beyond what was necessary to adequately allay any concerns Mr.
Burke had.142 The Court was of the view that the decision to withdraw treatment such as
ANH cannot lawfully be made against the express wishes of a competent patient to stay
alive.143
However, the Court went on to deal with many of the issues raised in the trial judgment,
noting that the common law duty of a doctor to continue to treat a patient once they have
taken them into their care is not absolute. There is no duty to keep a patient alive by ANH
where a competent patient refuses treatment, or where a patient is not competent and it is not
considered

in

their

best

interest

to

continue

treatment.

144

The Court of Appeal also dealt with the principles of autonomy and self-determination
heavily relied upon by Munby J. The Court found that these principles do not entitle a patient
to insist on receiving a specific medical treatment regardless of the nature of the treatment.
The Court found there was no positive right to demand health care treatment that is adverse to
a patient's clinical needs.
Finally, in what could be considered a small but significant step away from Bland, the Court
stated there was no legal duty to obtain court approval for the withdrawal of ANH in the
circumstances identified by Munby J. in the trial judgment. 145The Court notes there are times
when it would be advisable for a doctor to seek approval of the decision from the Courts146
but the court does not "authorize" treatment that would be unlawful, it simply makes
declarations that the proposed treatment or withdrawal of treatment is lawful.

147

In dealing with the appeal, the Court conceded that much of the body of the judgment was
142

Id.
Id.
144
R (Burke) v. The General Medical Council, [2005] EWCA Civ 1003 [Burke CA].
145
Ibid.
146
Id.
147
Id.
143

70

uncontroversial and a correct statement of the law, but advised counsel against selectively
using or parsing the judgment. 148What this leaves then is the potential for further exploration
of the rights-based argument. It is unclear whether Munby J. was wrong in his analysis or
simply that he went too far in setting out binding propositions of law. 149 In a different fact
scenario,

the

possibility

for

rights-based

argument

remains

to

be

made.

Burke CA also addressed the question of what weight should be given to a valid advanced
directive requesting all life-sustaining treatment be provided. The Court noted that while in
Bland it was held that "an advance directive that the patient should not be kept alive in a PVS
should be respected, we do not read that decision as requiring such a patient to be kept alive
simply

because

he

has

made

an

advance

directive

to

that

effect".

In United Kingdom, the courts will generally act as a final arbiter of the best interests of a
patient, particularly when the decision to withhold or withdraw life-sustaining treatment is in
dispute. In the United Kingdom, even in cases such as Bland, where there is agreement
between the family and the health care providers, it appears the courts remain willing and
able to play a role in confirming the decision.
Consent is necessary for every medical examination, which should be obtained in or in the
presence of disinterested party. Barring physical examination, any medical procedure requires
written consent. Written consent should refer to one specific procedure and not blanket
permission on admission to hospital. It is on the safer side to take the consent of spouse if the
operation destroys or limits sexual functions. While it is not legally necessary it is good
medical practice to consult with relatives of patient in patients best interest and ones this has
been established then doctor can continue to give treatment in good faith. Consultation,
consent and clinical confidence will never put the doctor in tort fessors cases. In the era of
advancement of knowledge and technique the belief that as long as the patient signs
everything will be, well misguided, if the doctor is not having reasonable care and skill.
Free, voluntary, informed consent is most essential in medical practice. The consent of
women concerned is useless in cases of criminal abortion since the act itself is crime. During
emergency, a doctor can treat a patient without the consent of the patient to preserve his
health, well being or life of the patient (IPC 92)
148
149

Id.
Id.

71

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