151110P - AUTONOMY AND INFORMED CONSENT TO TREATMENT

151110P - AUTONOMY AND INFORMED CONSENT TO TREATMENT

Presentation at a Surgical Specialties Grand Round King Fahad Medical City Riyadh on 10 November 2015; by Professor Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Chairman of the Ethics Committee King Fahad Medical City

The Patient's Autonomous Right to Consent

• No medical procedures can be carried out without informed consent of the patient except in cases of legal incompetence.
• The patient has the purest intentions in decisions in the best interests of his or her life. Others may have bias in their decision-making.
• The patient is free to make decisions regarding the choice of physicians and treatments.
• Consent can be by proxy in the form of the patient delegating decision making to a proxy or can be prospective by means of a living will.
• Spouses and family members do not have an automatic right to consent for a competent patient. A spouse cannot overrule the patient’s choice.

Conditions of Informed Consent

• Disclosure by the physician
• Understanding by the patient
• Voluntariness of the decision
• Legal competence of the patient
• Explanation of all alternatives
• Recommendation of the physician on the best course of action
• Decision by the patient
• Authorization by the patient to carry out the procedures.
• Consent is limited to what was explained to the patient except in an emergency.

Refusal of Consent

• Refusal to consent must be an informed refusal (patient understands what he is doing).
• Refusal to consent by a competent adult even if irrational is conclusive and treatment can only be given by permission of the court.
• Doubts about consent are resolved in favor of preserving life.

Proxy Consent

• Decision by a proxy can work in two ways: (a) decide what the patient would have decided if able (b) decide in the best interests of the patient.
• The living will has the following advantages:
• reassuring the patient that terminal care will be carried out as he or she desires
• providing guidance and legal protection and thus relieving the physicians of the burden of decision making and legal liabilities
• relieving the family of the mental stress involved in making decisions about terminal care.
• The disadvantage of a living will is that it may not anticipate all developments of the future thus limiting the options available to the physicians and the family.
• The device of the power of attorney can be used instead of the living will or advance directive.
• A do not resuscitate order (DNR) by a physician could create legal complications that have not been discussed thoroughly.

Consent for Children

• Competent children can consent to treatment but cannot refuse treatment.
• The consent of one parent is sufficient if the other one disagrees and the treatment is life saving
• Parental choice takes precedence over the child’s choice.
• The courts can overrule parents.
• Life-saving treatment of minors is given even if parents refuse.
• Parental choice is final in therapeutic or non-therapeutic research on children.

Mental Patients

• Mental patients cannot consent to treatment, research, or sterilization because of their intellectual incompetence.
• Mental patients are admitted, detained, and treated voluntarily or involuntarily for their own benefit, in emergencies, for purposes of assessment, if they are a danger to themselves, or on a court order.
• Suicidal patients tend to refuse treatment because they want to die.

Consent for the Unconscious

• For patients in coma, proxy consent by family members can be resorted to.
• If no family members are available, the physician does what he as a professional thinks is in the best interest of the patient.

Discussion Case # 1

A patient was brought to the emergency room by the police after attempting to kill himself by hanging. He was unconscious when first brought in and had a signed suicide note in his shirt pocket saying that he wanted to die. The doctors ignored the note and started resuscitation measures. The patient became conscious after 30 minutes and protested at the medical treatment arguing that he wanted to die. The doctor was thinking of stopping resuscitation measures when the patient’s father and wife arrived and instructed the doctor to continue resuscitation.

Discussion Case # 2

A 40-year old policeman refused surgery to drain a pyomyositis abscess. He still refused surgery after the abscess burst spontaneously. The surgeons sedated him and carried out the surgery without his consent.

Discussion Case # 3

A 42-year old actress pregnant for the first time refused an elective caesarean section because an abdominal scar would ruin her career. She continued to refuse the procedure when labor became obstructed and signs of fetal distress appeared. The obstetrician went ahead to operate on the basis of consent by the husband. The baby was delivered alive and well.

Discussion Case # 4

A conscious and competent patient told nurses on admission to the ICU that he did not want his family to be told anything about his condition. When his condition deteriorated the physicians wanted to consult his family about end of life decisions but he refused to give up his right to confidentiality.

Discussion Case # 5

A surgeon had seen a patient in OPD and had explained the surgical procedure to the patient, benefits and side-effects. The patient gave oral approval. He asked the resident to take the formal consent and have all forms signed. When the patient was wheeled into the OR the consent form was not available and the resident concerned was not on duty

Discussion Case # 6

A nurse told the surgeon that the patient on the OR table had not given anesthesia consent. The surgeon told the anesthetist to take consent quickly so that the surgery can commence.

Discussion Case # 7

A surgeon obtained consent for appendicectomy. During the procedure he noticed that the patient had an enlarged ovarian cyst with a high likelihood of torsion and further complications. He decided to remove it despite protests by the nurse that he had no consent for that procedure.

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.