Informed consent
in oral surgery
INTRODUCTION
• Consent simply means agreement/ permission.
• Informed consent is the process in which a healthcare provider
educates a patient about the benefits, risks, and alternatives of a
given procedure or intervention.
• The patient must be competent to make a voluntary decision
whether to undergo the procedure or intervention.
• informed consent is an ethical and legal obligation of medical
practitioners and originates from the patient's right to direct
what happens to their body.
• The idea of providing informed consent is an assessment of
the patient's understanding, rendering an actual
recommendation, and documentation of the process in a legal
context.
Requirements Of Informed Consent
• The subject must be competent to understand and decide.
• The subject has received full disclosure about benefits, risks,
complications, and prognosis.
• Subject comprehends the disclosure.
• Subject acts voluntarily (should not be pressurized to any action)
• 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 after taking it.
• 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
1. Implied Consent: consent is implied when the behavior of the
person indicates that he is willing for examination and treatment
(e.g., saying “yes” by nodding his head to take an x-ray),
2. Expressed Consent: can be verbal or written, the latter is more
genuine.
a) Verbal (oral) Informed Consent:
The patient gives consent orally after receiving information about
the proposed treatment or procedure.
Common for less invasive or routine procedures. e.g., physical
examination.
b) Written Informed Consent:
• Involves obtaining the patient’s consent through a written
document.
• Typically used for more complex or high-risk procedures.
• In minor procedures, verbal consent is sufficient. In major
procedures, written consent must be obtained
3. Recorded consent: it is oral consent before the treatment or
procedure that is recorded by audio or video.
4. Online consent: like an electronic form used before the start of
research or experimental trial for participants.
What is considered an invasive procedure?
Any penetration of the skin, use of radiation for treatment, or
comparable invasive procedure involving interference with the body
tissues.
Also, it can be any other procedure that entails substantial risk to the
patient.- Angiographic procedures- Anything with scalpels, needles,
Injection of diagnostic substances into body cavities or internal
organs, etc.
OBTAINING INFORMED CONSENT
• The 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 anesthesia.
• 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 ; pain, infection, bleeding,
etc.
• Explain procedures using diagrams and patient information
sheets
• 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.
Decision makers
• Adults above 18 years.
• Legal surrogate: parents or legal guardians are authorized to give
informed consent on behalf of the minor or children; then, it will
termed 'informed permission‘ not ‘informed consent‘.
• Emancipated minors: minors can give consent if they are married,
have children, or served in the military.
• Proxy Decision-Makers: When a patient lacks decisional capacity
due to illness, injury, or incapacity, a designated healthcare proxy
may be authorized to provide informed consent on behalf of the
patient.
CONSENT IN UNCONSCIOUS PATIENTS
• The surgeon can perform any life-saving procedure,
then consent obtained later from the patient when recovering
for further interventions.
• Consent of a relative/ friend is not required.
• There is no legal proxy for adults.
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 the
patient's best interest.
• The legal proxy can give consent on behalf of a mentally
incapacitated patient.
• If the patient is unwilling to receive treatment, it should not be
performed.
• Mentally ill patients have the same rights as other patients.
CONSENT FORM
• It should contain the following items:
• Name of the hospital.
• Patient's name, address, and signature hospital number.
• Name of the procedure.
• Possible complications.
• Surgeon's name and signature.
• Anesthetist's name and signature.
• Name and signature of the relative as witness.
• Date and time of taking the consent.
Consent to be Valid...
• Free, voluntary, without undue influence.
• Respond honestly to any question.
• Given by a competent person.
• Is informed involving: nature of illness-prognosis-options available
and risks involved.
• Guardian ( proxy consent) in the case of the mentally retarded,
minors.
Informed refusal
• Is a person’s right to refuse all or a portion of the proposed
treatment.
• Alternative treatment options should be explained in a
language the patient understands.
• Patients who refuse to follow the recommendation of the
dental provider must be advised of the consequences of refusal.
CONCLUSION
• Consent is a legal tool for the surgeon.
• It should not be neglected
• Failure to obtain informed consent renders any physician liable for
negligence or battery and constitutes medical malpractice.
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.

dental INFORMED CONSENT seminar at .pptx

  • 1.
  • 2.
    INTRODUCTION • Consent simplymeans agreement/ permission. • Informed consent is the process in which a healthcare provider educates a patient about the benefits, risks, and alternatives of a given procedure or intervention. • The patient must be competent to make a voluntary decision whether to undergo the procedure or intervention.
  • 3.
    • informed consentis an ethical and legal obligation of medical practitioners and originates from the patient's right to direct what happens to their body. • The idea of providing informed consent is an assessment of the patient's understanding, rendering an actual recommendation, and documentation of the process in a legal context.
  • 4.
    Requirements Of InformedConsent • The subject must be competent to understand and decide. • The subject has received full disclosure about benefits, risks, complications, and prognosis. • Subject comprehends the disclosure. • Subject acts voluntarily (should not be pressurized to any action) • Subject consents to the proposed action.
  • 5.
    GENERAL PRINCIPLES • Obtainedprior to a procedure • Sedation free Obtained by a qualified clinician • Not under coercion • No alteration should be made after taking it. • Should not exceed authority given. • In emergency, clinicians may undertake any procedure to save life. • In elective procedures, ample time is needed.
  • 6.
    TYPES OF CONSENT 1.Implied Consent: consent is implied when the behavior of the person indicates that he is willing for examination and treatment (e.g., saying “yes” by nodding his head to take an x-ray), 2. Expressed Consent: can be verbal or written, the latter is more genuine. a) Verbal (oral) Informed Consent: The patient gives consent orally after receiving information about the proposed treatment or procedure.
  • 7.
    Common for lessinvasive or routine procedures. e.g., physical examination. b) Written Informed Consent: • Involves obtaining the patient’s consent through a written document. • Typically used for more complex or high-risk procedures. • In minor procedures, verbal consent is sufficient. In major procedures, written consent must be obtained
  • 8.
    3. Recorded consent:it is oral consent before the treatment or procedure that is recorded by audio or video. 4. Online consent: like an electronic form used before the start of research or experimental trial for participants. What is considered an invasive procedure? Any penetration of the skin, use of radiation for treatment, or comparable invasive procedure involving interference with the body tissues. Also, it can be any other procedure that entails substantial risk to the patient.- Angiographic procedures- Anything with scalpels, needles, Injection of diagnostic substances into body cavities or internal organs, etc.
  • 9.
    OBTAINING INFORMED CONSENT •The 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 anesthesia. • 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 ; pain, infection, bleeding, etc. • Explain procedures using diagrams and patient information sheets • 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.
  • 11.
    Decision makers • Adultsabove 18 years. • Legal surrogate: parents or legal guardians are authorized to give informed consent on behalf of the minor or children; then, it will termed 'informed permission‘ not ‘informed consent‘. • Emancipated minors: minors can give consent if they are married, have children, or served in the military. • Proxy Decision-Makers: When a patient lacks decisional capacity due to illness, injury, or incapacity, a designated healthcare proxy may be authorized to provide informed consent on behalf of the patient.
  • 12.
    CONSENT IN UNCONSCIOUSPATIENTS • The surgeon can perform any life-saving procedure, then consent obtained later from the patient when recovering for further interventions. • Consent of a relative/ friend is not required. • There is no legal proxy for adults.
  • 13.
    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 the patient's best interest. • The legal proxy can give consent on behalf of a mentally incapacitated patient. • If the patient is unwilling to receive treatment, it should not be performed. • Mentally ill patients have the same rights as other patients.
  • 14.
    CONSENT FORM • Itshould contain the following items: • Name of the hospital. • Patient's name, address, and signature hospital number. • Name of the procedure. • Possible complications. • Surgeon's name and signature. • Anesthetist's name and signature. • Name and signature of the relative as witness. • Date and time of taking the consent.
  • 15.
    Consent to beValid... • Free, voluntary, without undue influence. • Respond honestly to any question. • Given by a competent person. • Is informed involving: nature of illness-prognosis-options available and risks involved. • Guardian ( proxy consent) in the case of the mentally retarded, minors.
  • 16.
    Informed refusal • Isa person’s right to refuse all or a portion of the proposed treatment. • Alternative treatment options should be explained in a language the patient understands. • Patients who refuse to follow the recommendation of the dental provider must be advised of the consequences of refusal.
  • 17.
    CONCLUSION • Consent isa legal tool for the surgeon. • It should not be neglected • Failure to obtain informed consent renders any physician liable for negligence or battery and constitutes medical malpractice.
  • 18.
    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.