INFORMED CONSENT DR FAISAL GHANI SIDDIQUI MBBS, FCPS, PGD-BIOETHICS, DCPS-HPE ASSOCIATE PROFESSOR SURGERY & IN CHARGE BIOETHICS PROGRAM LIAQUAT UNIVERSITY OF MEDICAL & HEALTH SCIENCES, JAMSHORO
…21slides 25 minutes
PREAMBLE What is an informed consent? Why informed consent is important? Is it always necessary to take an informed consent?
It is important to obtain consent from patients before performing any procedure involving them!
WHAT IS INFORMED CONSENT? It is a permission for a medical procedure given by an individual who: • Is COMPETENT • Has received all the necessary INFORMATION • Has UNDERSTOOD the information • Has given the permission VOULUNTARILY Source: CIOMS International Guidelines) (Source: CIOMS International Guidelines)
COMPETENT INDIVIDUAL? Any adult with asound mind is competent because he: Can understand the information, Can deliberate upon the information, and Is able to make a decision based upon it
NON-COMPETENT INDIVIDUALS Minors, Mentally retarded Unconscious Source: Google. images
WHAT INFORMATION? • Diagnosis • Nature of the proposed treatment • Associated risks • Likely benefits • Alternatives
Informed consent is a process and not just a signature on a standardized form
Minors, Mentally retarded Unconscious Source: Google. images
INFORMED CONSENT & MINORS • Young people >16 are competent to give consent • Children under 16 can also give consent if they have the ability to understand the information • Gillick test (Age of Legal Capacity (Scotland) Act, 1991; Family Law Reform Act 1969; Good Practice in consent implementation guide- Department of Health 2001) (
THE GILLICK TEST Doctors are empowered to make an assessment of the maturity of a child and to decide whether he can give a valid consent (Gillick V. West Norfolk and Wisbech AHA 1985)
SUBJECTS WITH MENTAL DISORDERS & DISABILITIES No one can give consent on behalf of such individuals Decision taken in the best interest of the patient Help must be sought from family
UNCONSCIOUS INDIVIDUALSThe Non-voluntary Consent The health care professional may perform as much as necessaryto stabilize the patient to such an extent as it permits competent informed consent
The Birth of Modern Informed Consent 1914 Judicial Ruling* “Every adult of sound mind has a right to determine what shall be done to his body”*Schloendorff vs. Society of New York Hospital (1914) 211 N.Y. 125.
Seeking informed consent is a means of RESPECTING AUTONOMY
Without consent, touching, no matter how well intentioned, is considered as an assault and leaves the practitioner open to litigation (Source: Schloendorff vs Society of New York Hospital (1914) 211 N.Y. 125)
BUILDS AND CONSOLIDATES TRUST between the patient and the health care professional
The process of disclosing the inherent risks TRANSFERS THE RISK FROM THE PHYSICIAN TO THE PATIENT (risk shift)
Risk shift Patient & Physician relationship Respect to Patient’s autonomy
SUMMARY Informed consent is: A permission given by a person who is competent, has received all the information and has understood it. Who cannot give consent? Children Mentally retarded Unconscious
SUMMARY What information should be given? Description of the treatment Associated risks Benefits incurred Alternatives Confidentiality Voluntary participation Informed consent is important because: It shows respect to patient’s autonomy It builds patient-physician relationship Risk shift