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Presentation at KFMC on 09 November 2015 by Professor
Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard), DrPH (Harvard)
Informed Consent
·
Right to Informed Consent: An informed consent from the patient/guardian shall be obtained prior
to invasive diagnostic and therapeutic procedures. Informed consent is obtained
before surgery, anaesthesia, procedural sedation, administration of blood and
blood products, and other high-risk treatments and procedures.
·
Process of Informed Consent: Patient informed consent is obtained through a process defined in this
policy and carried out by trained staff in a manner and language the patient
can understand. In cases where physicians do not speak the same language of the
patient, an interpreter, preferably a KFMC staff will sign as a witness.
·
Who Takes Consent: The
responsibility of obtaining the informed consent lies with the physician
performing the procedure or his designee.
·
Signing Informed Consent: The informed consent is signed by the patient or his/her guardian and
witnessed prior to the procedures.
·
Informed Consent in Life-Threatening Emergencies: In life-threatening situations in which consent
from a patient/guardian cannot be obtained, the consultant can act as guardian
if 2 other physicians (one of them must be a consultant.) concur
·
Information Elements for Informed Consent:
- The nature of the patient's condition.
- The proposed treatment, possible treatment alternatives, and no treatment.
- The benefits of the proposed procedure, as well as frequently occurring and significant risks of the proposed treatment and alternatives.
- The consequences of no treatment.
- The patient/guardian should be given the opportunity to ask questions and receive additional information as requested.
·
When treatment requires several episodes (e.g., radiotherapy, dialysis,
multiple blood and blood products transfusion) signing one consent form will
suffice provided it includes the number of treatments and the duration for a
maximum duration of one year.
Consent by the
Guardian
·
For Muslim patients, the following shall act as guardians: one of the
parents in case of minors, the legal guardian, the husband, the father, the
son, the brother, the uncle, and grandfathers.
·
For non-Muslim patients any of the following can act as guardian: the
parents in case of minors, the husband/wife, and any other immediate family
members.
·
In the absence of a guardian consent shall be obtained from the office
of the governor of Riyadh for Saudi citizens and from the respective embassy
for non-Saudis.
Consent to
Transfusion of Blood and Blood Products
·
In cases where the patient requires or may require transfusion of blood
or blood products, the procedure must be explained by the physician and the
blood transfusion consent signed by the patient/guardian.
·
The consent for Blood and Blood product Transfusion is valid for that
episode of care.
Consent to
Conscious Sedation
·
Process of Consent: Informed
consent is obtained after the physician educates the patient regarding the risk
and benefits of the sedation and the consent is signed by the patient/guardian.
Consent for
Anaesthesia and Surgery
·
Right to Consent: Surgical
procedures cannot be carried out without fully informing the patient/guardian
and signing the consent form prior to any surgical or invasive procedure with
exception of life saving procedure.
·
Right to Disclosure: The
risks, benefits, and alternatives shall be discussed with the patient/guardian.
·
Process of Consent: Surgical
or special procedure consent shall be obtained for all procedures that require
general anaesthesia, in addition to minor surgery and endoscopies.
- Consent shall not be taken or shall not be modified in the operation theatre after sedating the patient.
·
Change of Mind during the Procedure: If the patient or the guardian changes his/her mind during the procedure,
the procedure shall be stopped immediately if that is medically feasible.
·
Whenever a patient require a multiple procedure on the same time by
different physician, each physician shall obtain the consent related the
procedure he is performing.
Signing Consent
·
Signing consent by a competent patient: Any male or female patient who is an adult and
competent can sign the consent.
·
Signing for the incompetent patient: In cases where the patient is incompetent (including minors) to sign,
the legal guardian can sign for the patient after a proper identification
displayed and the name is written clearly.
·
Consent in Emergencies: In
case of a life threatening condition or a threat of losing limb or sight and
when the patient is incompetent and in the absence of a legal guardian, the
consultant can act as guardian if 2 other physicians (one of them must be a
consultant.) concur.
Witnessing
Consent
·
Two witnesses are required for the informed consent to be valid.
·
The witnesses can be a KFMC employee, a patient's relative, or any
other person.
·
Signing as a witness on the consent form shall not indicate or imply
responsibility regarding the nature of the information given, received, or
understood by the patient.
·
When signing, witnesses must write their full name, ID number (Saudi
ID, Iqama, KFMC employee number), the date and time of signature.
- The date, and time of the witness signature shall match the date and time of the patient/guardian signature.
·
Physician who is performing the procedure shall not be a witness.
·
Patient/Guardian signing the consent cannot be a witness.
Revoking Consent
·
A patient/guardian has a right to rescind his/her consent.
·
The revocation shall be communicated to the patient's physician and
documented in the medical records.
·
The patient/guardian shall sign the refusal of medical treatment form.
Refusal of
Medical Treatment
·
KFMC respects the patient's right to refuse medical treatment.
·
When patient refuses any medical treatment, the patient must sign a
form indicating informed refusal.
·
The physician shall make the patient fully aware of the potential
consequences that may occur as a result of the refusal and shall be documented
in the patient's medical record.