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Presentation at the P&O Diploma Program Female held in King Fahad Medical City, Riyadh on 16 April 2016. 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 - 1
} No medical
procedures can be carried out without the 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 a bias in their decision-making.
} The patient is
free to make decisions regarding the choice of physicians and treatments.
The
Patient's Autonomous Right to Consent - 2
} 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 - 1
} Disclosure by the
physician.
} Understanding by
the patient.
} Voluntariness of
the decision.
} Legal competence
of the patient.
} Explanation of all
alternatives.
Conditions
of Informed Consent - 2
} 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 - 1
} 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.
Proxy
Consent - 2
} 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 lifesaving.
} 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 appendectomy. 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 - 1
} 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 - 2
} 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.)
} 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.
Informed
Consent - 3
} 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 - 1
} 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.
Consent
for Anaesthesia and Surgery - 2
} 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.
Consent
for Anaesthesia and Surgery - 3
} 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 - 1
} 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.
Witnessing
Consent - 2
} 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.