INFORMED CONSENT IN
SURGERY
DR. IZEVBEKHAI FELIX U.
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
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.
• 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.
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
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
TYPES OF CONSENT
• Implied consent
• Expressed consent
• 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
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
• 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
• 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.
SURGICAL BIOETHICS AND CONSENT
• Ethics is an accepted way of doing things.
• Surgical bioethics are
• Principles of bioethics
– Autonomy
– Beneficience
– Nonmaleficience
– Justice
• 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.
Decision makers
• Above 18 years
• Waived consent
• Emancipated minor
• Legal surrogate
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
• 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
CONSENT IN UNCONSCIOUS PATIENTS
• Surgeon may treat if procedure is life-saving
• Consent of relative/friend not required
• No legal proxy for adult
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
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
• After discussion with the patient, the
management plan must be communicated to
all staffs responsible for the patient
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
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
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
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.
THANK
YOU
FOR
LISTENING

INFORMED CONSENT IN SURGERY.pptx

  • 1.
  • 2.
    OUTLINE • Introduction • Generalprinciples • 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 simplymeans 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 anethical 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 InformedConsent • 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 • Obtainedprior 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
  • 7.
    TYPES OF CONSENT •Implied consent • Expressed consent
  • 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 anypossible 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 patientsif 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 ANDCONSENT • Ethics is an accepted way of doing things. • Surgical bioethics are • Principles of bioethics – Autonomy – Beneficience – Nonmaleficience – Justice
  • 13.
    • Autonomy- allpersons 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.
  • 14.
    Decision makers • Above18 years • Waived consent • Emancipated minor • Legal surrogate
  • 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 tothis 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 UNCONSCIOUSPATIENTS • Surgeon may treat if procedure is life-saving • Consent of relative/friend not required • No legal proxy for adult
  • 18.
    MENTALLY ILL/HANDICAPPED • Notcompetent 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’SWITNESSES • 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 discussionwith the patient, the management plan must be communicated to all staffs responsible for the patient
  • 21.
    SPECIAL CONSIDERATION • Inprocedures 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 • Shouldcontain 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 isa 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.
  • 25.