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Ethical Considerations 

Ethical Considerations
Chapter:
Ethical Considerations
Author(s):

Robert B. Schoenberger

and Stanley H. Rosenbaum

DOI:
10.1093/med/9780199377275.003.0017
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date: 21 September 2020

Informed Consent

Definition

The key components of informed consent are 1) an understanding of what the patient is consenting to, 2) an understanding of the major risks and benefits, and 3) an understanding of the alternatives to the proposed care.

Presentation

  • As a general rule, informed consent is required prior to all invasive procedures.

  • In an emergency in which no decision maker is available, physicians should act in accordance with what a reasonable person would consider to be in the best interests of the patient.

As both a legal and ethical matter, informed consent must be obtained prior to the performance of any invasive procedure.

  • Competent patients may refuse to give consent for any procedure for any reason.

  • For competent patients, informed consent must be obtained from the patient and must explain the purpose of the proposed procedure as well as the major risks, benefits, and alternatives to the procedure.

  • In the case of incompetent patients who were formerly competent, a surrogate decision maker must be sought. The essential elements and requirements of the informed consent process are the same when dealing with surrogates as with patients themselves. The surrogate’s role is to act in substituted judgment, that is, to authorize what the patient’s wishes would be if the patient were in a position to express them.

  • In the case of a minor child or individual who has never been competent, informed consent must be obtained from the legal guardian or conservator whose role is to represent the best interests of the incompetent person.

  • In an emergency for which delay would result in the loss of life or limb or cause serious morbidity, and in which a competent decision maker cannot be located, physicians have an ethical duty to act in accordance with what a reasonable person would believe is in the best interest of the patient until informed consent can be sought.

Exceptions to the Need for Informed Consent

  • Patients may be incapable of informed consent due to acute injury, chronic brain disease, medication, intoxication, mental impairment, mental illness, or young age. In all of these cases, the physician’s obligation to obtain informed consent does not go away; the process is transferred from the patient to the surrogate decision maker.

  • Physical disability or language barrier may make obtaining consent inconvenient, but has no impact on a patient’s competency or on the obligation of the caregiver to obtain consent from the patient.

  • An emergency exemption to obtaining informed consent can be considered to be a reasonable presumption of consent. If consent is later withdrawn by the patient or a surrogate, the emergency exemption no longer applies.

  • In the case of minor children, some treatments may be mandated by the courts despite the parents’ refusal to give informed consent. Keeping in mind the emergency exemption, it is prudent for a care provider to seek institutional administrative support in such situations.

Further Reading

For a discussion of the typology of informed consent as distinct from shared decision making and simple consent, see:

Whitney SN, McGuire AL, McCullough LB. A typology of shared decision making, informed consent, and simple consent. Ann Intern Med. 2004; 140(1): 54–59.Find this resource:

Organ Harvesting and the Declaration of Brain Death

The Ethical Standard of Care

  • Outside the domain of the consenting living donor, organ harvesting may occur after either cardiac or brain death.

  • The declaration of brain death in the United States requires documentation that the entire brain, including the brain stem, has permanently ceased to function.

  • The declaration of brain death must generally be made by at least one physician who is not connected to the transplantation process.

  • Comatose patients with residual brain function, including persistently vegetative patients, do not meet the legal definition of brain death and may not undergo organ harvesting unless a donation after cardiac death has been arranged.

  • A patient who shows evidence of spontaneous respiration or other brain stem activity is not legally dead in the United States.

Determination of Brain Death

  • Reversible causes of apparent coma must be ruled out both by history and physical examination. Severe metabolic derangement, intoxication, hypothermia, and residual neuromuscular blockade must be considered and, where appropriate, treated.

  • The clinical determination of brain death requires:

    • Unresponsiveness, including to painful stimuli in cranial nerve territories

    • The absence of all brain stem reflexes

    • Apnea in response to a hypercarbic challenge

  • Most US jurisdictions hold that the clinical determination of brain death is sufficient in adults for the determination of death without the need for further neurophysiologic testing.

  • If in doubt, or if clinical tests for the determination of brain death cannot be performed, diagnosis of brain death may also be based on an electroencephalogram showing absent brain activity, or perfusion studies that demonstrate the absence of brain blood flow.

  • Legal and institutional guidelines vary but may require that the determination of brain death be performed by more than one physician or at more than one point in time.

  • Some United States jurisdictions allow for the next of kin to refuse that the medical determination of brain death be used as the basis to declare the death of the patient.

According to the American Academy of Neurology, brain death may be diagnosed even if any of the following are present:

  • Spontaneous movements of limbs other than pathologic flexion or extension

  • Intercostal expansion without significant tidal volumes

  • Sweating, blushing, or tachycardia

  • Hemodynamic stability

  • Absence of diabetes insipidus (i.e., preservation of hypothalamic function)

  • Deep tendon reflexes

  • Babinski reflex

Donation after Cardiac Death

Donation after cardiac death (DCD) refers to the practice of removing a severely ill patient from active life support in the expectation that the patient will have a cardiac arrest within a few minutes. This is distinct from donation after brain death, in which asystole is not required. A DCD donor is pronounced dead after asystole has lasted for a specified period (usually 5 minutes). The transplant team then removes organs, generally just the liver and kidneys, for transplantation. This procedure must satisfy strict constraints:

  • The patient’s surrogate decision makers must have given formal consent for withdrawal of active life support.

  • To avoid any potential conflicts of interest, there must be a sharp separation between the medical team caring for the patient and the transplant team.

  • A formal institutional protocol must describe the details of the process, including the acceptable participants, the venue for the withdrawal of active support, the allowed time for the patient to expire after withdrawal of life support, and the period of asystole needed for the declaration of death.

  • If the patient does not become apneic and pulseless during the waiting time after withdrawal, generally 1 hour, the patient is returned to regular hospital care as may be appropriate for the patient.

Further Reading

American Academy of Neurology, Quality Standards Subcommittee. Practice parameters: determining brain death in adults, Neurology. 1995; 45: 1012–1014.Find this resource:

Van Norman GA. A matter of life and death: what every anesthesiologist should know about the medical, legal, and ethical aspects of declaring brain death. Anesthesiology. 1999; 91(1): 275–287.Find this resource:

Refusal of Blood Transfusion

The Ethical Standard of Care

  • Competent adult patients may refuse blood transfusion or any other treatment for any reason, even if withholding such treatment may cause death.

  • Patients should be asked before their surgery whether they have any objections to receiving blood products. If the patient denies the use of blood products, his or her wishes should be honored.

  • Individual patient preferences may differ regarding cell saver systems and extracorporeal blood circuits. The specifics of a patient’s preferences should be clarified prior to surgery.

  • A care provider who objects to withholding appropriate blood products may defer care to a colleague who is able to honor the patient’s autonomy. In cases in which alternative providers do not exist, physicians may have an obligation to provide care despite their own objections.

Exceptions to the Refusal of Blood Transfusion

  • United States case law generally holds that parents of preadolescent children may not refuse blood transfusions on behalf of their minor children.

  • Older adolescent children with objections to blood transfusion fall into a gray area in which an ethics consult should be requested.

  • Gravid patients with viable fetuses present another ethical dilemma for which conflicting case law exists, and for which an ethics consult may be warranted.

Treatment Modalities for Patients Who Refuse Transfusion

  • A variety of techniques may reduce risk to patients who refuse blood transfusion.

  • Before surgery, patients may be given recombinant erythropoietin in an effort to increase hemoglobin concentration. Some insurance carriers will not pay for this treatment without sustained advocacy on behalf of the patient.

  • Occasionally, patients who refuse anonymous-donor banked blood may still consent to autologous blood banking.

  • Patients who refuse autologous blood banking may sometimes consent to the withdrawal of blood if it is kept in a continuous circuit with the body. Such patients may undergo intraoperative withdrawal of blood into a blood donation bag that is left connected to the IV circuits. The blood can be slowly reinfused until a transfusion is needed.

  • Deliberate hemodilution techniques are commonly used, but evidence-based guidelines have yet to be developed.

  • Steps to reduce blood loss include modifications of surgical technique, controlled hypotension, use of ddAVP, use of anti-thrombolytics, and use of recombinant Factor VIIa.

  • Cell saver systems can reduce the need for transfusion if patients consent to them. In situations, such as oncologic surgery, where cell saver is normally contraindicated, surgical blood loss may still be collected in a cell saver system. This blood should then be discarded unless the need for blood becomes critical.

  • Patients also may be given recombinant erythropoietin after surgery. There are also case reports of salvage therapy using hypothermia, sedation, and neuromuscular blockade to reduce oxygen consumption in patients with otherwise fatal anemia.

Further Reading

For a discussion of some relevant case law, see:

Benson KT. The Jehovah’s Witness patient: considerations for the anesthesiologist. Anesth Analg. 1989; 69(5): 647–656.Find this resource: