2. OUTLINE
• Introduction
• General principles
• Types of consent
• Process of obtaining informed consent
• Consent in children, unconscious patient and
mentally ill
• Consent in Jehovah’s Witnesses
• Special consideration
• Consent form
• Conclusion
3. INTRODUCTION
• Consent simply means agreement/permission
• Informed consent is the process in which a
healthcare provider educates a patient about
the risks, benefits, and alternatives of a given
procedure or intervention.
• The patient must be competent to make a
voluntary decision whether to undergo the
procedure or interventon.
4. • Both an ethical and legal obligation of medical
practitioners and originates from the patient’s
right to direct what happens to their body.
• Implicit in providing informed consent is an
assessment of the patient’s understanding,
rendering an actual recommendation, and
documentation of the process.
5. Requirements Of Informed Consent
• Subject must be competent to understand and
decide
• Subject has received full disclosure
• Subject comprehends the disclosure
• Subject acts voluntarily
• Subject consents to the proposed action
6. GENERAL PRINCIPLES
• Obtained prior to a procedure
• Sedation free
• Obtained by a qualified clinician
• Not under coercion
• No alteration should be made
• Should not exceed authority given
• In emergency, clinicians may undertake any
procedure to save life
• In elective procedures, ample time is needed
8. • Implied Consent: verbal agreement to
undergo procedure with no associated risk eg
physical examination.
• Expressed Consent: can be oral or written, the
latter is more genuine.
• In minor procedures, verbal consent is
sufficient. In major procedures, written
consent must be obtained
9. OBTAINING INFORMED CONSENT
• Clinician should introduce himself to the patient
• Assess the patient’s level of understanding of the
procedure/ pathology
• Explain to the patient freely
• Re-emphasize the diagnosis and the natural history of
the disease with and without treatment
• Give treatment options and types of anaesthesia
• Explain the purpose of a proposed investigation or
treatment
• Describe the likely benefits and probability of success,
cost, and long-term follow-up if needed
10. • Describe any possible adverse effects; fertility,
potency, continence, etc
• Explain procedures using diagrams and patient
information sheets
• Information given is influenced by patient’s
understanding, educational, social background
and translation if necessary
• The help of another healthcare professional
may be needed
11. • Ask patients if they have understood and give
room for questions
• Answer questions honestly
• Make sure patient reads consent and signs it
• Clinician should sign the form, print his name
and date.
12. SURGICAL BIOETHICS AND CONSENT
• Ethics is an accepted way of doing things.
• Surgical bioethics are
• Principles of bioethics
– Autonomy
– Beneficience
– Nonmaleficience
– Justice
13. • Autonomy- all persons have intrinsic and
unconditional worth. Each person has a right
to self determination and reserve the power
to make moral choices.
• Informed consent
• Truth telling
• Confidentiality
• Exceptions to autonomy
• Children except emancipated minors
• Persons with developmental, physical or mental
incompetence.
15. CONSENT IN CHILDREN
• Under 18yrs of age
• Cannot provide informed consent
• Written consent is required from the parent/guardian
• Not termed ‘informed consent’ but ‘informed
permission’
• If surgeon believes proxy’s decision not in child’s best
interest, child can be made a ward of court and
appropriately treated
• Exceptionally, adolescents(14-16yrs) consent
adequately if sufficiently mature
16. • Exception to this rule is a legally emancipated
child who may provide informed consent for
himself
• Examples of emancipated minor:
• Under 18 and married
• Serving in the military
• Able to prove financial independence
• Mothers of children(married or not)
• All subject to the laws of the state, however
17. CONSENT IN UNCONSCIOUS PATIENTS
• Surgeon may treat if procedure is life-saving
• Consent of relative/friend not required
• No legal proxy for adult
18. MENTALLY ILL/HANDICAPPED
• Not competent to consent
• If detained under mental health act, only procedures to
preserve life can be performed
• Surgeons and psychiatrists must agree that treatment
is in patient’s best interest
• No one can give or withhold consent on behalf of
mentally incapacitated patient
• If patient is unwilling to have treatment, then it should
not be performed
• Mentally ill patients have same rights as other patients
19. CONSENT IN JEHOVAH’S WITNESSES
• In emergency life threatening situation, the
surgeon will have to proceed with an acceptable
alternative
• In elective situation, the surgeon has the right to
refuse to treat
• Patient must be fully counselled as to the
possible dangers of their action and must sign a
specially prepared consent form noting all these
• All discussion must be clearly documented in the
notes
20. • After discussion with the patient, the
management plan must be communicated to
all staffs responsible for the patient
21. SPECIAL CONSIDERATION
• In procedures that involve sensitive body
function, eg amputations, colostomies,
prostatectomies, etc
• Consent must not be from a third party
• Ample time should be given to a patient to make
decisions
• Consent must be signed more than once and at
different occasions
• Pictures and video taping
• Confidentiality all through
22. CONSENT FORM
• Should contain the following items:
• Name of the hospital
• Patient’s name, address and signature
• Hospital number
• Name of the procedure
• Surgeon’s name and signiture
• Anaesthetist’s name and signature
• Name and signature of the relative as witness
• Date and time of taking the consent
23. CONCLUSION
• Consent is a legal tool for the surgeon
• It should not be neglected
• Thoroughness is of essense and should be a
continuous process pre-, per-, and post-
operatively
24. References
• Slim K, Bazin JE. From informed consent to
shared decision-making in surgery. J Visc Surg.
2019 Jun;156(3).181-184
• Shah P, Thornton I, Turrin D, et al. Informed
consent. [Updated 2022 June 11]
• Bashir Bin Yunus. Compendium for surgery
tutorials.