220125P - AUTONOMY, INFORMED CONSENT, PROXY DECISION, And The GUARDIAN

Presentation at a training workshop for physicians and nurses at King Abdullah bin Abdulaziz University Hospital, Riyadh on January 25-27, 2022 by Professor Omar Hasan Kasule Sr. MB ChB (MUK). MPH (Harvard), DrPH (Harvard) Chairman of the Institutional Review Board, Princess Noura University

 

 

Learning Objectives

• Definition and procedure of general consent
• Definition, conditions, and procedure of informed consent for a specific procedure
• Proxy/substitute decision-makers
• Ethico-legal issues relating to the guardian
• Case scenarios.

 

Autonomy/right to consent - 1:

• All patients and their guardians have an autonomous right to consent or refuse to any procedures including history taking, physical examination, investigation (radiological, phlebotomy etc.) and treatment (psychological, medical, physical, or surgical).
• The patients must be informed of their right to refuse treatment after explaining the consequences of such refusal. In case of refusal the patient must sign a specific form.

 

Autonomy/right to consent - 2:

• The patient is not penalized in any way for refusal of treatment.
• Refusal of treatment by a competent patient is respected even if the refusal is illogical.
• The patient has the right to revoke consent and procedures being undertaken are stopped as soon as it is safe to do so.

 

General consent:

• General consent is obtained from the patient on the first encounter with the hospital.
• General consent is valid as long as the hospital file is valid.
• General consent covers pre-defined general and routine procedures in the hospital including diagnosis and treatment.
• The general consent is signed by the patient or the legal guardian. In an emergency, the hospital director can sign. The general consent also includes agreeing to the right of the hospital to use patient data for research but specific research procedures will require specific consent.

 

Procedures covered by general consent

• Routine oral or parenteral agents for treatment or diagnosis.
• Phlebotomy, iv cannulas, arterial line for blood pressure monitoring, central line insertion in emergencies.
• Non-invasive diagnostic radiology, ECG, or EEG.
• Urethral catheter, nasogastric tube insertion.

 

Informed consent - 1:

• Informed consent is voluntary permission from the patient/guardian to perform a clearly defined procedure after the provision of full information (diagnosis, proposed treatment, and alternatives, consequences of non-treatment).
• Consent is voluntary and is given under assurance of confidentiality.
• Consent must be on the prescribed hospital forms to ensure uniformity.

 

Informed consent - 2:

• Informed consent is needed for surgery, anesthesia, procedural sedation, blood and blood products, chemotherapy, invasive diagnostic procedures (endoscopy, interventional radiology), genetic testing, and medical photography.
• Consent for organ donation and implantation has its own procedures under SCOT.

 

Signing the informed consent:

• The physician doing the procedure takes consent after providing a full explanation to the patient.
• The patient or guardian must sign the consent alongside 2 witnesses: the signers must write their full names and date.
• In emergency life-saving situations with an incompetent patient and the absence of a guardian, 3 physicians can sign the consent.

 

Validity of informed consent:

• Consent to a specific procedure or treatment regimen is valid for a maximum of 3 months as long as there is no change in the treatment, the physician, the medical condition, or the patient’s consent capacity.
• The maximum period of consent for defined multiple treatments is 1 year. For multiple procedures, each surgeon must take separate consent.

 

Proxy consent - 1:

• The proxy decision maker may be a guardian or a person designated by the patient as a proxy decision maker.
• The guardian is a legal representative who consents on behalf of an incompetent patient (a minor or intellectually deficient).
• Guardians are close relatives of the patient as defined by the Ministry of Health.
• An absent guardian can consent by phone but must come to the hospital at the earliest opportunity to counter-sign the consent.

 

Proxy consent - 2:

• The patient can through the power of attorney (wikaala) authorize a person even a non-relative to make decisions.
• A spouse is not always automatically the proxy decision maker. 
• Women can consent to their own treatment and the treatment of relatives according to MOH regulations.
• In case of contraceptive procedures, abortions, or treatment that can affect the fetus adversely both mother and father must consent.

 

Definition Of Competence (تعريف الاهلية):

• A person with full legal competence has full rights in decisions and actions regarding his person and property. He also has full responsibility for his actions of commission or omission.
• Legal competence (ahliyyat) is the basis for intention (niyyat) which is the basis of validity of human actions. Therefore human actions cannot be valid without legal competence.
• There is a difference between competence and capacity. A competent adult may not be capacious because of the inability to speak.

 

Guardianship (wilaayat):

• Legal guardianship, wilaayat, is legal authority given to a guardian, wali, to make and carry out decisions regarding the person, nafs, or wealth, maal.
• Two types: general guardianship (wilaayatshar’iyyat) and specific medical guardianship (wilaayattibbiyat).
• Qualifications of the guardian (shuruut al waliy): he must be legally competent and must be able to carry out the duties of guardianship.
• The decisions of the guardian are binding unless they are clearly not in the best interests of the patient.
• Who is the waliy: A blood relation or a representative of the government? If several blood relations are in the hospital the guardian is selected according to the rules on inheritance.
• 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 guardian must abide by the advance directive or living will.

 

Ministry Of Health Circular 2/50/101994 dated 26/3/1433:

• Consent for children <18yr are: father, mother, brother, and sister.
• Consent for incompetent adults: father, mother, brother, sister, son.
• Consent for adult competent male or female patient >18yr by himself/herself.

 

Ministry Of Health Circular 2/50/101994 dated 26/3/1433:

• The next of kin must be: >18yr, related by blood to the patient, has an identification card.
• A competent adult signs himself/herself but if not physically able a next of kin can sign on behalf.
• The authorized next of kin signs on behalf of the children.
• A legal representative (wakil) who is not a next of kin signs if legally authorized.
• The wife signs by herself for all operations except tubal ligation or hysterectomy that require the husband's consent.

 

• Parents As Guardians Of Children:
• Below the age of 7 (age of discrimination sinn al tamyiiz) all decisions are made by the legal guardian. Between 7 and puberty children can assent but guardians must approve.
• If the 2 parents disagree, the physician can proceed if one of the parents consents. If the child disagrees with the parent, the parental choice is followed.
• The court can override parental consent if not in the best interests of the child.
• The physician can proceed to give life-saving treatment to a child even if parents refuse to give consent.
• Parental decisions on organ donation to a relative may be a conflict of interest.
• Children who are parents decide for themselves.
• Children above puberty or 18 years may not be intellectually mature to be competent.

 

Case Study #1:

• A 30-year-old patient with multiple sclerosis had 5 years before while in good health designated her husband as the decision maker. When she lost consciousness the doctors needed a decision whether to put her on life support. The husband who had by that remarried and lived in a separate house decided against life support because it would prolong her suffering. Her father intervened and decided on life support because that would be in her best interests.

 

Case Study #2:

• 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 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.

 

Case Study #3:

• A university professor with previous episodes of transient stroke had written a directive and had it witnessed that if he lost consciousness he would not like to be resuscitated. Years later he was brought to the hospital unconscious from head injuries sustained in a car accident. The doctors reading his directive in his shirt pocket decided not to resuscitate him but his wife insisted that he be resuscitated.

 

Case Study #4:

• A 70-year-old man was admitted with severe MI. After initial treatment and stabilization, the doctors decided to offer him a coronary graft operation. His sons told the doctors to go ahead with the operation without telling the patient the diagnosis because knowing he had a heart problem would depress him and he might refuse the operation.

 

Case Study #5:

• The thoracic surgeon wanted to carry out a de-bulking operation to decrease lung cancer mass to enable the patient to breathe easier and he told the patient of the high risk of death from hemorrhage.
• The patient 85-year-old patient was drowsy because of medication and was suspected of suffering from dementia.
• The doctor was not sure whether the patient was capable of understanding the explanations given and making serious decisions about the operation and he had no relatives nearby.
• What should the doctor do? Provide your moral reasoning.