TOPIC – CONSENT IN

MEDICAL PRACTICE
CONDUCT PROTOCOL

 Introduction
 Historical background
 Defining consent
 Indian contract Act, 1872
 Types of consent
 How consent is given
 The Maturity Act' of 1875 (Indian Majority Act, 1875 earlier)
 Consent from children and young people
 loco parentis
 When consent isn't needed
CONDUCT PROTOCOL

 Consent and life-sustaining treatments

 What is capacity ?
 Changes in capacity
 How capacity is assessed
 Ethical and legal angle of consent
 Conclusion
 References
 INTRODUCTION
 Medical practice today is not simple because of various factors impinging on the doctor-
patient relationship

 Mutual trust forms the foundation for good relationship between doctor and patient. Today,
patients tend to be well- or ill-informed about the disease and health

 Therefore, providing adequate information and educating the patient about realities and
obtaining informed consent before subjecting a patient to any test/procedure/surgery is
very essential
 HISTORICAL BACKGROUND(1/3)

NUREMBERG CODE (1947)

 When World War II ended in 1945, the victorious Allied powers enacted the
International Military Tribunal on November 19th, 1945. As part of the Tribunal, a
series of trials were held against major war criminals and Nazi sympathizers
 he first trial conducted under the Nuremberg Military Tribunals in 1947 became known
as The Doctors’ Trial, in which 23 physicians from the German Nazi Party were tried for
crimes against humanity for the atrocious experiments they carried out on unwilling
prisoners of war
 HISTORICAL BACKGROUND(2/3)

This leads to the creation of the Nuremberg Code, a set of ten ethical principles for
human experimentation. These are :-
1. Voluntary Consent is essential
2. The results must be for the greater good of society
3. Should be based on previous animal experimentation
4. Should be conducted by avoiding physical/mental suffering and injury
 HISTORICAL BACKGROUND(3/3)

5. No experiments should be conducted if it is believed to cause death/disability

6. Risks should never exceed the benefits
7.Adequate facilities should be used to protect subjects
8.Conducted only by qualified scientists
9.Subject should always be at liberty to stop at any time
10.Scientist in charge must be prepared to terminate the experiment when injury,
disability, or death is likely to occur
 DEFINING CONSENT(1/5)

 Consent refers to the provision of approval or agreement,

particularly and especially after thoughtful consideration and
understanding
 As per jurisprudence prior provision of consent signifies a
possible defense (justification) against civil or criminal
liability by the doctor
 Practitioners who use this defense claim that they should not
be held liable for a tort or a crime
 DEFINING CONSENT(2/5)

 Consent to treatment is the principle that a person must give

permission before they receive any type of medical treatment,
test or examination
 This must be done on the basis of an explanation by a clinician
 Consent from a patient is needed regardless of the procedure,
whether it's a physical examination, organ donation or something
else
 The principle of consent is an important part of medical ethics
and the international human rights law
 DEFINING CONSENT(3/5)

 For consent to be valid, it must be voluntary and informed, and the

person consenting must have the capacity to make the decision
 These terms are explained below:
 Voluntary – the decision to either consent or not to consent to
treatment must be made by the person themselves, and must not be
influenced by pressure from medical staff, friends or family
 DEFINING CONSENT(4/5)

 informed – the person must be given all of the information in terms

of what the treatment involves, including the benefits and risks,
whether there are reasonable alternative treatments, and what will
happen if treatment doesn't go ahead
 Capacity – the person must be capable of giving consent, which
means they understand the information given to them and they can
use it to make an informed decision
 If an adult has the capacity to make a voluntary and informed
decision to consent to or refuse a particular treatment, their decision
must be respected
 DEFINING CONSENT(5/5)

 This is still the case even if refusing treatment would result in their
death, or the death of their unborn child
 If a person doesn't have the capacity to make a decision about their
treatment, and they haven't appointed a lasting power of attorney
(LPA), the healthcare professionals treating them can go ahead and
give treatment if they believe it's in the person's best interests
 But clinicians must take reasonable steps to seek advice from the
patient’s friends or relatives before making these decisions
Indian Contract Act, 1872

 The Indian Contract Act, 1872 prescribes the law relating to contracts in India
 The Act is based on the principles of English Common Law
 It is applicable to all the states of India except the state of Jammu and Kashmir
 It determines the circumstances in which promises made by the parties to a
contract shall be legally binding
 Under Section 2(h), the Indian Contract Act defines a contract as an agreement
which is enforceable by law
 TYPES OF CONSENT

 INFORMED CONSENT
 ADVANCE/ EXPRESSEDCONSENT
 CONSENT SURRGATE
 IMPLIED CONSENT
 IMPLIED VS. EXPRESSED CONSENT(1/3)

 The very act of a patient entering a doctor's chamber and expressing

his problem is taken as an implied (or implicit) consent for general
physical examination and routine investigations
 Intimate examination, especially in a female, invasive tests and risky
procedures require specific expressed consent
 Expressed (explicit) consent can be oral or written
 Written consents are preferable in situations involving long-term
follow-up, high-risk interventions and cosmetic procedures and
surgeries
 IMPLIED VS. EXPRESSED CONSENT(2/3)

 It is also needed for skin biopsy, psoralen with ultraviolet A (PUVA)

therapy, intralesional injection, immunosuppressive therapy,
electrocautery etc.
 Consent is necessary for photographing a patient for
scientific/educational/research purpose or for follow up. Specific
consent must be taken if the identity of the patient is likely to be
revealed while publishing
 Consent is a must for participation in clinical trials and research
projects
 IMPLIED VS. EXPRESSED CONSENT(3/3)

 Written consent is mandatory in every invasive diagnostic/

therapeutic procedures or any medico legal examination
 Consent should be taken in the patients own language
 INFORMED CONSENT

 Informed consent must be preceded by disclosure of sufficient information

 Consent can be challenged on the ground that adequate information has not been
revealed to enable the patient to take a proper and knowledgeable decision
 Therefore, accurate, adequate and relevant information must be provided
truthfully in a form (using non-scientific terms) and language that the patient can
understand
 It cannot be a patient's signature on a dotted line obtained routinely by a staff
member
 DISCLOSURE OF INFORMATION(1/2)

The information disclosed should include:

 The condition/disorder/disease that the patient is
having/suffering from
 Necessity for further testing
 Natural course of the condition and possible complications
 Consequences of non-treatment
 Treatment options available
 Potential risks and benefits of treatment options
DISCLOSURE OF INFORMATION(2/2)

 Duration and approximate cost of treatment

 Expected outcome
 Follow-up required
 Patient should be given opportunity to ask questions and clarify all doubts.
There must not be any kind of coercion
 Consent must be voluntary and patient should have the freedom to revoke the
consent
 Consent given under fear of injury/intimidation, misconception or
misrepresentation of facts can be held invalid
 SURROGATE CONSENT

 This consent is given by family members for minors or

dead
 Generally, courts have held that consent of family
members with the written approval of 2 physicians
sufficiently protects a patients interest
 PROXY CONSENT
 When a patient is unable to give an informed consent to a proposed therapeutic intervention,
the principal health care provider is legally bound to secure a consent to treatment from the
patient's legally authorized guardian or proxy
 The appointment of a proxy decision-maker is a legal
 the nature of the proxy appointment, which varies from state to state, is complicated by an
absence of well-defined guidelines relating to the conditions under which a proxy is needed,
who may serve as a proxy, how the proxy should be selected, and the scope of the proxy's
authority
 INFORMED REFUSAL(1/2)

 Patient has got the right of self-determination. If, a doctor diagnoses varicella in a
child, the parent may choose to avail no treatment because of religious belief
 Doctor's duty is to explain the possible consequences of non-treatment and
benefits of treatment and leave the decision to the parent
 Such informed refusals must be documented clearly But, a patient's freedom
cannot impinge on the rights of others or cause harm to a third party or
community. Therefore, the said parent's freedom of choice cannot extend to
sending the child to school, as the infection can spread to other children
 INFORMED REFUSAL(2/2)
 Discharge against medical advice also falls into this category and needs to be properly
recorded in the case sheet with signature of the patient/guardian
 In an emergency situation, for example intestinal perforation, a doctor may have to operate
even in the absence of consent, to save the life of the patient
 It is possible that even with such an intervention, the patient may not survive
 Assuming that the doctor is competent and has exercised due care and diligence, doctor
cannot be held responsible for patient's death, as he has acted in good faith and in the best
interest of the patient. This protection is given under Section 88 of Indian Penal Code
 BLANKET CONSENT(1/2)

 An all-encompassing consent to the effect “I authorize so and so to carry out any

test/procedure/surgery in the course of my treatment” is not valid
 It should be specific for a particular event. If, consent is taken for microdermabrasion, it
cannot be valid for any other procedure like acid peel
 BLANKET CONSENT(2/2)

 Additional consent will have to be obtained before proceeding with the latter
 If a consent form says that patient has consented to undergo laser resurfacing by Dr.
X, the procedure cannot be done by Dr. Y, even if Dr. Y is Dr. X's assistant, unless it is
specifically mentioned in the consent that the procedure may be carried out by Dr. X
or Dr. Y (or his authorized assistants)
 HOW CONSENT IS GIVEN(1/2)

 Consent can be given:

1. verbally – for example, by saying they're happy to have an
X-ray
2. writing – for example, by signing a consent form for surgery
3. Someone could also give non-verbal consent, as long as they
understand the treatment or examination about to take place –
for example, holding out an arm for a blood test
 HOW CONSENT IS GIVEN(2/2)
 Consent should be given to the healthcare professional directly responsible for the person's
current treatment, such as:
1. a nurse arranging a blood test
2. a GP prescribing new medication
3. a surgeon planning an operation
 If someone is going to have a major medical procedure, such as an operation, their consent
should ideally be secured well in advance, so they have plenty of time to obtain information
about the procedure and ask questions
 If they change their mind at any point before the procedure, the person is entitled to withdraw
their previous consent
The Maturity Act' of 1875 (Indian
Majority Act, 1875 earlier)
(1) Every person domiciled in India shall attain the age of
majority on his completing the age of eighteen years and not
before

(2) In computing the age of any person, the day on which he was
born is to be included as a whole day and he shall be deemed
to have attained majority at the beginning of the eighteenth
anniversary of that day
 CONSENT FROM CHILDREN AND YOUNG
PEOPLE(1/4)

 People aged 18 or over are entitled to consent to their own

treatment, and this can only be overruled in exceptional
circumstances
 Children under the age of 18 can consent to their own treatment if
they're believed to have enough intelligence, competence and
understanding to fully appreciate what's involved in their treatment
 This is known as being Gillick competent
 CONSENT FROM CHILDREN AND YOUNG
PEOPLE(2/4)

 Otherwise, someone with parental responsibility can consent for

them.
 This could be:
1. the child's mother or father
2. the child's legally appointed guardian
3. a person with a residence order concerning the child
4. a local authority designated to care for the child
5. a local authority or person with an emergency protection order for
the child
 CONSENT FROM CHILDREN AND YOUNG
PEOPLE(3/4)
Parental responsibility:-
 The person with parental responsibility must have the capacity to give consent
 If a parent refuses to give consent to a particular treatment, this decision can be overruled by
the courts if treatment is thought to be in the best interests of the child
 If one person with parental responsibility gives consent and another doesn't, the healthcare
professionals can choose to accept the consent and perform the treatment in most cases
 If the people with parental responsibility disagree about what's in the child's best interests, the
courts can make a decision
 In an emergency, where treatment is vital and waiting to obtain parental consent would place
the child at risk, treatment can proceed without consent
 loco parentis

 The term loco parentis, Latin for "in the place of a parent" refers to the
legal responsibility of a person or organization to take on some of the
functions and responsibilities of a parent
 This doctrine can provide a non-biological parent to be given the legal rights
and responsibilities of a biological parent if they have held themselves out
as the parent
 In children in an emergency, when parents / guardians are not
available,consent can be obtained from the person bringing the child (school
teacher,)
 WHEN CONSENT ISN'T NEEDED(1/3)

There are a few exceptions when treatment may be able to go ahead without the person's
consent, even if they're capable of giving their permission
 It may not be necessary to obtain consent if a person:
 requires emergency treatment to save their life, but they're incapacitated (for example,
they're unconscious) – the reasons why treatment was necessary should be fully explained
once they've recovered
 immediately requires an additional emergency procedure during an operation – there
has to be a clear medical reason why it would be unsafe to wait to obtain consent, and it
can't be simply for convenience
 WHEN CONSENT ISN'T NEEDED(2/3)
 With a severe mental health condition, such as schizophrenia, bipolar disorder or dementia,
lacks the capacity to consent to the treatment of their mental health – in these cases,
treatment for unrelated physical conditions still requires consent, which the patient may be
able to provide, despite their mental illness
 Medico-legal cases bought by police consent is implied under sec 53 of criminal procedure code
 Consent is not required in medical examination and issue of certificate for insurance policies
 Examination under Court Order
 Request by a police officer under Cr.P.C. Section 53(1)-To avoid insufficient legal interpretations
WHEN CONSENT ISN'T NEEDED(3/3)

 is a risk to public health as a result of rabies, cholera or tuberculosis

(TB)
 is severely ill and living in unhygienic conditions – a person who is
severely ill or infirm and is living in unsanitary conditions can be
taken to a place of care without their consent
 THERAPEUTIC PRIVILEGE
 A therapeutic privilege (or therapeutic exception) refers to an uncommon situation
whereby a physician may be excused from revealing information to a patient when
disclosing it would pose a serious psychological threat, so serious a threat as to be
medically contraindicated
 The therapeutic privilege is an exception to the general rule of informed consent
 It only applies when disclosure of the information itself could pose serious and immediate
harm to the patient, such as prompting suicidal behavior
 The exception of therapeutic privilege does not apply when disclosure will merely lead to
refusal of care that the physician thinks beneficial
 CONSENT AND LIFE-SUSTAINING TREATMENTS(1/2)

 A person may be being kept alive with supportive treatments – such as lung ventilation –
without having made an advance decision, which outlines the care they would refuse to
receive
 In these cases, a decision about continuing or stopping treatment needs to be made based on
what that person's best interests are believed to be
 To help reach a decision, the healthcare professionals responsible for the person’s care should
discuss the issue with the relatives and friends of the person receiving the treatment
 They should consider, among other things:
1. what the person's quality of life will be if treatment is continued
2. how long the person may live if treatment is continued
 CONSENT AND LIFE-SUSTAINING
TREATMENTS(2/2)
3. whether there's any chance of the person recovering
 Treatment can be withdrawn if there's an agreement that continuing treatment isn't in the
person's best interests
 The case will be referred to the courts before further action is taken if:
 an agreement can't be reached
 a decision has to be made on whether to withdraw treatment from someone who has been in
a state of impaired consciousness for a long time (usually at least 12 months)
 It's important to note the difference between withdrawing a person's life support and taking a
deliberate action to make them die. For example, injecting a lethal drug would be illegal
 WHAT IS CAPACITY?(1/2)
 Capacity means the ability to use and understand information to make a decision, and
communicate any decision made
 A person lacks capacity if their mind is impaired or disturbed in some way and this
means the person is unable to make a decision at that time
 Examples of how a person's brain or mind may be impaired include:
 mental health conditions – such as schizophrenia or bipolar disorder
 dementia
 severe learning disabilities
 brain damage – for example, from a stroke or other brain injury
 WHAT IS CAPACITY?(2/2)

 Physical or mental conditions that cause confusion, drowsiness or a loss of consciousness

 intoxication caused by drug or alcohol misuse
 Someone with such an impairment is thought to be unable to make a decision if they can't:
1. understand information about the decision
2. remember that information
3. use that information to make a decision
4. communicate their decision by talking, using sign language or by any other means
 CHANGES IN CAPACITY(1/2)
 A person's capacity to consent can change. For example, they may have the capacity to
make some decisions but not others, or their capacity may come and go
 In some cases, people can be considered capable of deciding some aspects of their
treatment but not others
 For example, a person with severe learning difficulties may be capable of deciding on
their day-to-day treatment, but incapable of understanding the complexities of their
long-term treatment
 CHANGES IN CAPACITY(2/2)

 Some people with certain health conditions may have periods when they're
capable and periods when they're incapable
 For example, a person with schizophrenia may have psychotic episodes (when
they can't distinguish between reality and fantasy), during which they may not be
capable of making certain decisions
 A person's capacity can also be temporarily affected by:
Shock, Panic, Fatigue (extreme tiredness), Medication
 HOW CAPACITY IS ASSESSED(1/2)

 As capacity can sometimes change over time, it should be assessed at the time that
consent is required
 This will usually be done by an appropriately trained and experienced health professional
who is either:
1. recommending the treatment or investigation
2. involved in carrying it out
HOW CAPACITY IS ASSESSED(2/2)

 If the health professional feels you have the capacity to give your consent, your
decision will be accepted and your wishes will continue to be respected, even if
you lose capacity at a later stage
 If the health professional feels you don't currently have the capacity to give
consent, and you haven't made an advance decision or formally appointed
anyone to make decisions for you, they'll need to carefully consider what's in
your best interests before making a decision
RESPECTING PERSONAL BELIEFS(1/2)

 If someone makes a decision about treatment that other people would consider to be
irrational, it doesn't necessarily mean they have a lack of capacity, as long as they understand
the reality of their situation
 For example, a person who refuses to have a blood transfusion because it's against their
religious beliefs wouldn't be thought to lack capacity. They still understand the reality of their
situation and the consequences of their actions
RESPECTING PERSONAL BELIEFS(2/2)

 But someone with anorexia who is severely malnourished and rejects treatment
because they refuse to accept there's anything wrong with them would be
considered incapable
 This is because they're regarded as not fully understanding the reality of their
situation or their consequences
 DETERMINING A PERSON'S BEST
INTERESTS(1/2)
 If an adult lacks the capacity to give consent, a decision on whether to go ahead
with the treatment will need to be made by the health professionals treating
them
 To make a decision, the person's best interests must be considered
 There are many important elements involved in trying to determine what a
person's best interests are
 These include:
 considering whether it's safe to wait until the person can give consent if it's likely
they could regain capacity at a later stage
 DETERMINING A PERSON'S BEST INTERESTS(2/2)

 involving the person in the decision as much as possible

 Trying to identify any issues the person would take into account if they were making
the decision themselves, including religious or moral beliefs – these would be based
on views the person expressed previously, as well as any insight close relatives or
friends can offer
ADVANCE DECISIONS AND POWER OF ATTORNEY

 If a person knows their capacity to consent may be affected in the future, they can
choose to draw up a legally binding advance decision (also known as a living will)
 This sets out the procedures and treatments that a person refuses to undergo
 You can also choose to formally arrange for someone, often a close family member, to
have lasting power of attorney (LPA) if you wish to anticipate your loss of capacity to
make important decisions at a later stage
 Someone with LPA can make decisions about your health on your behalf, although you
can choose to specify in advance certain treatments you would like them to refuse
 ETHICAL ANGLE OF CONSENT

 The concept of consent arises from the ethical principle of patient autonomy and
basic human rights
 Patient's has all the freedom to decide what should or should not happen to
his/her body and to gather information before undergoing a
test/procedure/surgery
 No one else has the right to coerce the patient to act in a particular way
 Even a doctor can only act as a facilitator in patient's decision making
 LEGAL ANGLE OF CONSENT

 There is also a legal angle to this concept. No one has the right to even touch, let
alone treat another person
 Any such act, done without permission, is classified as “battery” - physical assault
and is punishable
 Hence, obtaining consent is a must for anything other than a routine physical
examination.
 CONCLUSION

 Obtaining consent is not only an ethical obligation, but also a legal compulsion.
The level of disclosure has to be case-specific. There cannot be anything called
a standard consent form
 “One cannot know with certainty whether a consent is valid until a lawsuit has
been filed and resolved”

 One can only take adequate precaution and act with care and diligence.
Maintaining good relationship with patient often works better than the best
informed consent
 REFERENCES

 Informed Consent: An Ethical Obligation or Legal Compulsion? K H Satyanarayana

Rao
 Proxy consent to medical treatment: implications for rehabilitation Banja JD
 National Health Service (NHS)