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Module 6: Informed Consent

Upon completion of this module, the resident should be able to:

  1. Identify four (4) consensus principles and three (3) unresolved issues concerning a patient's right to self-determination in healthcare decision making.
  2. Identify the four (4) essential elements of valid consent/refusal:
    • Describe four (4) elements of disclosure, the standards of disclosure, and exceptions to disclosure requirements.
    • Define capacity and identify - as well as critique - the common standards used to determine patient decision making capacity.
    • Identify the most reliable indicator of capacity.
    • Identify health care professional and other variables that may constrain voluntariness.
  3. Identify ethical perspectives and frameworks critical to informing and justifying decisions concerning capacity determinations and informed, valid decision making.

Module: 6 / Valid Decision Making: The Law and Ethics of Informed Consent or Refusal

Contents

  1. Framing the Challenges: Clinical Scenarios
  2. Valid Decision Making: The Historical, Legal, and Ethical Background to Informed Consent and Refusal
  3. The Ethics of Valid Decision Making: Consensus Principles and Unresolved Questions
  4. Case
  5. Questions for Discussion, Analysis, and Reflection

Framing the Challenges: Clinical Scenarios

Mr. X is an 82 year old man with Parkinson’s disease and suspected recurrent cancer of the bladder. Further diagnostic evaluation is required to confirm as well as to determine the nature and extent of the suspected malignancy. Mr. X appears to be severely depressed; his speech is, as well, slurred and his ability to understand your questions and directions during the physical examination seems to wax and wane. How should you proceed?

Mr. Y is a 29 year old man who presents with severe right lower quadrant pain of several hours duration. He states that he has experienced a sense of malaise, decreased interest in sex, back pain, and weight loss for almost a year now. During physical examination, a large right lower quadrant mass, and a hard right testicular mass are detected. What are the next steps you would recommend to Mr. Y and what information would you disclose to him?

Mr. Z is a 42 year old man who has been referred to you for evaluation and treatment of suspected male infertility. It is clear, however, that Mr. Z was reluctant in making the appointment and resistant to the idea that he may be the cause of the problems he and his wife are having in conceiving. In response to your questions about any past history of sexually transmitted disease, Mr. Z confesses that he contracted gonorrhea several times in his 20s. How would you describe the significance of this information for your next steps in evaluating Mr. Z? What next steps would you recommend to him?

Mrs. A is a 79 year old Spanish-speaking woman with incontinence. You are faced with the task of evaluating her condition to better determine its cause and to communicate the viable options for treatment. How would you proceed?

Baby B was born yesterday to Mr. and Mrs. C; the baby has ambiguous genitalia. What will you recommend as next steps to Mr. and Mrs. C? What information will you disclose to buttress your recommendation? What alternatives to your recommendation will you describe? What information about the alternatives will you disclose?

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Valid Decision Making: The Historical, Legal, and Ethical Background to Informed Consent and Refusal

Historical and Legal Background: The modern doctrine of valid decision making -- of informed consent to, or refusal of treatment – emerged in the historical context of the gradual triumph of certain “rights” of the individual, particularly in the West and beginning in the 18th century. Through such events as the American and French Revolutions, the idea that individuals possess certain “inalienable” rights – to freedom of self-determination and person – became integral to the politics, philosophy, and culture of the United States, Great Britain, and Western Europe. It was in this context that the modern doctrine of informed consent took shape, largely fueled by landmark legal decisions.

The Schloendorff Decision (New York, 1914). In this well-known case, a patient, Mrs. Schloendorff, brought suit against her surgeon for removing a fibroid tumor against her express wishes. She had agreed to undergo surgery to determine whether the tumor was or was not malignant, but stated that she did not wish to have the tumor removed. Concerned the tumor was malignant, the surgeon removed it. Although Mrs. Schloendorff failed to win her case (because she failed to prove that she incurred serious harm as a result of the surgeon’s actions), Justice Benjamin Cardozo’s decision included the following precedent-setting statements in the legal history of informed consent: Every human being of adult years and sound mind has a right to determine what shall be done with his own body, and a surgeon who performs an operation without his patient’s consent commits an assault, for which he is liable for damages. The Schloendorff decision thereby established the legal requirement for consent.

The Salgo Decision (California, 1957). In this case, the patient, Mr. Salgo, was suffering chronic leg pain. Upon the recommendation of his physician, he consented to a translumbar aortography, a procedure intended to diagnose the cause of his pain – and one that resulted in paralysis for Mr. Salgo. Mr. Salgo brought suit against the hospital and physicians for negligence in performing the procedure and for failing to provide him with adequate information, particularly about the risks of this diagnostic procedure. A trial court decision ruling for the defendants was reversed by the California Court of Appeals. In its decision, the court, ironically, used the language of an amicus curiae (friend of the court) brief submitted by the American College of Surgeons on behalf of the defendants: [I]n discussing the element of risk a certain amount of discretion must be employed consistent with the full disclosure of facts necessary to an informed consent. Thus, although the California Court of Appeal’s decision recognized the role of physician discretion in disclosing the information needed for consent to treatment, it underscored the patient’s critical need for information, ruling, in effect, that the patient’s need to know should be accorded more weight than the physician’s rationale for discretion. Hence, consent must be informed consent: physicians must disclose the relevant information to the patient.

The Canterbury Decision (District of Columbia, 1972). In this case, the patient, a 19-year old man, sought medical treatment for chronic back pain. After surgery to correct a ruptured disk, the patient, Mr. Canterbury, slipped out of his bed and, as a result, suffering paralysis from the waist down. Although emergency surgery restored some movement and feeling to his lower body and limbs, he required crutches for support and was plagued by chronic urologic problems. He brought suit against the hospital and physicians in district court, but the judge ordered a directed verdict in favor of the defendants. Mr. Canterbury’s attorneys appealed the district court decision to the U.S. Court of Appeals, which sent the case back to the district court for a full trial by jury – a jury that eventually also ruled in favor of the hospital and physicians. In its decision sending the case back to the district court, the Court of Appeals enunciated four “first principles” to guide physicians in a process of shared decision making and informed consent:

One, given an individual’s right to self-determination, including determination of what can or cannot be done to one’s body, the physician has an obligation to disclose to the patient the information needed by that patient to make an informed, rational decision, even if the patient does not specifically request such information.

Two, although what is or is not appropriate treatment is to be determined by standards promulgated by the medical profession, what is or is not appropriate disclosure is to be determined, not by the medical profession, but by a more general standard of what is “reasonable under the circumstances.”

Three, “what is reasonable under the circumstances” is what a “reasonable person” in the patient’s position and circumstances would consider important in deciding whether to consent to or refuse the recommended treatment.

Four, the duty or obligation to disclose may be set aside by the physician in only two exceptional circumstances: (1) in emergencies where treatment is life-saving and disclosure cannot be made effectively or in a timely manner and (2) in those rare situations in which disclosure presents the threat of harm to the patient’s well-being.

The Ethics of Valid Decision Making and Informed Consent/Refusal:

  • Elements of Informed Consent/Refusal: Four elements are fundamental to valid decision making and the process of informed consent to or refusal of treatment:
    1. The patient or surrogate must possess the capacity to make a decision consenting to, or refusing treatment
    2. There must be disclosure by the physician of the information that the patient or surrogate needs in order to be adequately informed
    3. The patient or surrogate must demonstrate comprehension of the information
    4. The patient or surrogate must consent to or refuse treatment in a voluntary fashion
  • Determining Patient/Surrogate Decision Making Capacity: Decision making capacity refers to the ability to make a particular health care decision in a particular clinical context. The word “competence” is often used interchangeably with “capacity”; strictly speaking, whether or not an individual is competent – for example, to manage his/her own affairs – is a legal determination made by courts of law. “Capacity” is a determination that is ordinarily made by physicians in the clinical encounter with any patient or surrogate and, in the event that there are concerns about an individual’s ability to participate in health care decision making, a psychiatric consultation may be helpful.

There are three standards for determining health care decision making capacity, only one of which is considered ethically valid:

  1. The outcome-based standard: With this standard, the physician makes a determination of the decision making capacity of the patient or surrogate based on the outcome of the patient’s or surrogate’s own decision making process. For example, the patient or surrogate is determined to possess decision making capacity if he or she agrees with the physician’s recommended treatment – or, conversely, to lack capacity if he or she disagrees.
  2. The category-based standard: With this standard, determinations of decision making capacity are inappropriately based on some specific characteristic of the patient or surrogate: for example, his/her gender, race/ethnicity, religion, or – with certain exceptions – age. Infants and young children are generally held to lack the developmental (i.e., cognitive) bases for capacity. Advanced age, in the absence of evidence of cognitive impairment, is not an appropriate basis for determinations that an elderly patient or surrogate lacks decision making capacity.
  3. The function-based standard: This is the only ethically valid standard for determining a patient’s or surrogate’s decision making capacity. In applying the standard, the physician assesses the patient’s or surrogate’s ability to:
    • understand information necessary to make this decision [task specific],
    • reason in accord with a relatively consistent set of values,
    • communicate preferences

In utilizing these criteria for the function-based standard, it is prudent to employ a “sliding scale” in “measuring” a given patient’s or surrogate’s abilities to understand, reason, and communicate: that is, consent for high-benefit, low-risk treatments demands a less exacting measurement of these abilities, than does consent for low-benefit, high-risk treatments. The diagnosis of depression in a patient or surrogate is not automatic grounds for doubting that s/he possesses capacity: depression may or may not alter decision making capacity. A psychiatric consultation may prove helpful in making the determination.

Disclosure: Physician disclosure is a duty: in order to participate, integrally, in health care decision making, patients or their surrogates need adequate information about:

  • The nature of the proposed therapeutic (or diagnostic) intervention
  • The purpose and intended benefits
  • The possible risks and consequences
  • The probability of success
  • The feasible alternatives
  • The patient’s prognosis without the proposed intervention

There are exceptional circumstances in which it may be permissible for physicians to set aside the duty of disclosure. In emergencies, disclosure may be impossible or so time-consuming as to jeopardize the health of the patient. Patients or surrogates may also waive their rights to information that would otherwise be disclosed. In exceedingly rare instances, physicians may invoke therapeutic privilege out of concern that disclosure may actually harm, rather than benefit, the patient.

Comprehension and Voluntariness: The best and most practical way to ensure that patients or surrogates have understood or comprehended the disclosed information is to ask them to repeat in their own words what they believe they are consenting to or refusing. To consent to or refuse treatment in a voluntary way is to do so without controlling influences. Physicians should make recommendations to the patient or surrogate and it is legitimate to use persuasion in making these recommendations; it is not legitimate, however, to use either manipulation or coercion in an effort to secure consent.

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The Ethics of Valid Decision Making: Consensus Principles and Unresolved Questions

Consensus Principles

  • All competent patients have the right to consent to – or to decline – any and all presented (i.e., medically indicated) treatment options;
  • Incapacity does not, of itself, cause patients to lose that right;
  • If the incapacitated patient's wishes are known [e.g., thru written advance directive or oral discussions], those wishes must be honored;
  • These principles apply whether or not patient is "terminal," and to all forms of medical treatment, including, e.g., nutrition and hydration "by tube"

Unresolved Issues

  • Who makes decisions (and on what basis) for patients lacking decision making capacity and in the absence of "clear & convincing evidence" of their wishes?
  • Do patients or surrogate decision makers have the prerogative to demand treatment that clinicians are reluctant to provide, e.g., because of alleged futility, scarcity, cost?
  • Do clinicians have the right to limit (medically futile) life-sustaining interventions without the informed consent of the patient or surrogate?

Nine Basic Rules For Obtaining Informed Consent Or Refusal:

  1. Identify the appropriate decision maker, either
    The patient who has decision making capacity, or
    The patient’s morally and legally valid surrogate
  2. Sit face-to-face in a private place and have the discussion at a time when the patient/surrogate is not distracted or in great pain.
  3. Determine that the patient or surrogate is communicating voluntarily
  4. Disclose the following:
    The nature of the proposed intervention
    The purpose
    The risks and consequences
    The benefits
    The probability that the intervention will be successful
    The feasible alternatives; and
    The prognosis if the intervention/therapy is not given
  5. Offer a recommendation.
  6. Ensure comprehension. Give the information in “small chunks” and stop occasionally to check that the information is being understood; have the decision maker describe what he or she believes he was told in his or her own words
  7. Acknowledge any emotional reaction from the patient and respond to that reaction with sincerity and empathy.
  8. Validate what you take to be the patient/surrogate’s decision.
  9. Summarize, ask for questions and have a clear idea of when you will meet again.

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Case

The patient is a 65-year old man who has been admitted to the hospital with advanced prostate cancer with metastases to the liver and bone. He suffers chronic pain and is depressed. His family includes his 49-year old wife, two sons and a daughter, all in their 20s. The daughter is 2 months pregnant. The patient’s family is desperate for their husband/father to seek whatever experimental treatment is available in the hope of extending his life, at least until his first grandchild is born.

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Questions for Discussion, Analysis, and Reflection

  1. Is it possible that the patient’s pain and depression are having an adverse impact on his decision making capacity?
  2. How could you proceed to determine this?
  3. How would you go about determining the appropriate goals for the patient’s ongoing care?
  4. How would you evaluate options for treatment in the context of those goals?
  5. How would you convey this evaluation and the options to the patient? To his family? What specific information would you disclose to the patient? To his family?

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Additional Resources


A good general resource on the topic of truth telling in medicine can be found at http://sprojects.mmi.mcgill.ca/ethics/X/topics/truthtelling/truthtelling_main.htm

A succinct, well written overview of truth telling in medicine is offered by James Drane at http://www.uchile.cl/bioetica/doc/honesty.htm

Another useful overview is found at http://2006.confex.com/uicc/uicc/techprogram/P10511.HTM

The topic of hope and truth telling in the context of serious illness is explored at http://www.eperc.mcw.edu/fastFact/ff_021.htm

Truth telling in the context of terminal cancer is analyzed at http://www2.unescobkk.org/eubios/BetCD/Bet11.doc

A sophisticated academic exploration of truth telling is found at http://www.blackwell-synergy.com/doi/pdf/10.1111/j.1749-6632.2000.tb05161.x



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