BIOETHICS:

INFORMED CONSENT

DR. INAYAT ULLAH MEMON

MBBS, MCPS (Path), MMedSc (Australia)
PGD Bioethics (CBEC, SIUT), Masters Bioethics (AKU),
PGDip-Telemedicine/E-Health

1st Lecture, 2nd Year

INDUS MED. COLLEGE. TMK
17th July 2020
 Plan of today’s lecture
1. What is informed consent / Definition?
2. Why we do need Informed Consent?
3. Who is responsible for taking Informed Consent?
4. When informed Consent is required?
5. Contents and components of Informed Consent
6. Who can give valid Informed Consent?
7. Who can be statutory surrogate?
8. Conditions making Informed Consent invalid.
9. Potential consequences of lack of true Informed
Consent.
10. Informed consent for children and incompetent persons
11. Presumed / Implicit Informed Consent
12. Case study
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 1. CONSENT?

Difference between:

 CONSENT

 INFORMED CONSENT

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 What is informed consent?

 Informed Consent is not just a Form to be

filled
 It’s more than a signature on a piece of
paper

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What is informed consent?

 The process of communication between a

patient and physician that results in the
patient’s authorization of agreement
to undergo a specific medical intervention
(American Medical Association)

 Failure to obtain informed consent renders

any physician liable for negligence and
constitutes medical malpractice.

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 What is informed consent?

• Informed consent is the process by which a

fully informed patient (or a research
subject) can participate in choices (options)
about her health care (or research).

• It originates from the legal and ethical right,

i.e. the patient has to choose (exercise his
autonomy) what happens to his/her body and

• From the ethical duty of the physician to

involve the patient in his/her health care.
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Informed Consent is to Protect the patient,
Not the physician

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 2. Why we do need Informed Consent

• Greater patient safety and satisfaction

• Attainment of higher ethical standards and
organizational morale
• Closer adherence to legal requirements and
reduced risk of litigation
• Increased levels of institutional quality (e.g.
compliance with accreditation standards)
• Potential time and money savings related to
reduced litigation
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3. Who is responsible for
taking Informed Consent
• The clinician has core responsibility but a
team approach is required with
contributions from:

• Entire clinical staff (clinician, nurse,

technologist)
• Administrative and clinical leadership
• Legal counsel

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4. When informed consent is required

• Any type of surgery

• Other invasive procedures
• Anaesthesia
• Research participation
• Some investigative e.g. radiologic
(invasive) procedures

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 What is considered as Invasive
Surgery?

• Any penetration of the skin, use of

radiation for treatment, or comparable
invasive procedure involving interference
with the body tissues.
• Also can be any other procedure that entails
substantial risk to the patient.
• Angiographic procedures
• Anything with scalpels, needles’ use
• Injection of diagnostic substances into body
cavities, internal organs, etc.

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 5. What are contains Informed
Consent?
• The diagnosis, if known
• The nature and purpose of a proposed
treatment or procedure
• The risk and benefits of proposed
treatment or procedures
• Alternatives (regardless of costs or extent
covered by insurance)
• The risk and benefits of alternatives
• The risks and benefits of not receiving
treatments or undergoing procedures
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 Components: informed consent
■ Information about: The nature of the procedure
(or research) with reasonable alternatives to the
proposed treatment (or research) and resultant
risks, benefits and uncertainties (if any) related
to the alternative (DISCLOSURE)
■ Assessment of the patient’s understanding
(COMPREHENSION)
■ Patient or participant’s ability to make a decision
(COMPETENCY)
■ Patient’s acceptance of the intervention
(treatment or research) with his free will
(VOLUNTARINES)
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 6. Who can give valid Informed
Consent?

• Patient, if adult and competent

• Healthcare Power of Attorney or
legal guardian
• In the absence of a legally authorized
representative, a “statutory
surrogate” may give consent.

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 7. Who can be Statutory Surrogate?

• Patient’s spouse
• Adult child of the patient.
• Parent of the patient
• If the patient is unmarried, the patient's domestic
partner.
• Brother or sister of the patient
• A close friend of patient who is familiar with the
patient's health care views/desires and is willing to
become involved in the patient's healthcare and to
act in the patient's best interest.
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8. Conditions: making Informed consent invalid:

■ Mental retardation
■ Severe mental illness
■ Intoxication
■ Sleep deprivation
■ Coma
■ Underage
■ Undue incentives etc

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9. Potential adverse consequences of lack of true
Informed Consent

• Increased chance of risk to patient’s

safety or medical error
• Increased chance for malpractice cases
• Violation of professional and ethical
obligations to clinicians to communicate
clearly

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Incompetent persons:
Surrogate decision maker / guardian
Caregiver for mentally ill

Children’s consent: Assent

By legal guardian of child

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 10. Informed consent: children and
incompetent persons

• For incompetent persons:

• Surrogate decision maker / guardian
• Caregiver for mentally ill

• Children’s consent: Assent

• By legal guardian of child

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11. Presumed /Implicit Informed Consent

• In emergency situation the patient's consent

should only be "presumed", rather than
obtained, when the patient is unconscious or
incompetent and there is no surrogate
decision maker available.
• In these situations:
• Give value to the patient’s ‘autonomy’
• Also consider ‘beneficence’ to the patient

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 How to improve obtaining Informed
Consent?

• Simplify the language

• Allow time in-between questions and to
respond them
• Make sure the patient understands
• Plan for language assistance (interpreter)
in advance of appointment
• Train support staff

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 12. A case Study

A 55-year-old man has a 3-month history of

chest pain and fainting episodes. You feel his
symptoms require cardiac catheterization. You
explain the risks and potential benefits to him,
and include your assessment of his likely
prognosis without the intervention.
Patient is able to demonstrate that he
understands all of this, but refuses the
intervention.
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 Discussion:
• This patient understands what is at stake with
his treatment refusal.
• As he is competent to make this decision, you
have a duty to respect his choice.
• However, you should also be sure to explore
his reasons for refusing treatment and
continue to discuss your recommendations.
• A treatment refusal should be honored, but it
should also not be considered as the end of
the discussion.
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Many Thanks For Patient Listening

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