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Informed Consent

Informed Consent

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Informed Consent

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  1. Informed Consent Philosophy 2803 Lecture IV Feb. 5, 2003

  2. Issues • Why does informed consent matter? • How should we understand the idea of informed consent? • How should the issue of consent be dealt with when a patient is incompetent? • The distinction between legal and moral versions of informed consent

  3. Case 1 • A 2001 study surveyed 108 4th year med students at U of T about their experiences as clinical clerks • See Hicks et al, British Medical Journal March 24, 2001 • Several students reported being asked to perform pelvic examinations on patients under general anesthesia without the patients’ knowledge

  4. Case 2 • “Once, when I was on call, there was a patient who was palliative, in a vegetative state. The resident I was working with decided that this would be a good opportunity for me to learn how to do a femoral stab, even though it was not medically required. The patient was not expected to [recover] from his current condition, and wasn’t in a position to argue … we don’t really get a lot opportunity to practise those types of procedures.” (Hicks et al, 2001)

  5. The Importance 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” (Justice Cardozo, p. 159) • “all of medical ethics is but a footnote to informed consent” (Mark Kuczewski, 1996) • “Our common view of informed consent is that, when at all relevant, it represents a minimum condition which ethics imposes upon the physician” (p. 169) • But why is informed consent so important?

  6. Resources • Deontology • Respect for persons • Consequentialism • Promoting good outcomes • Principilism • Autonomy, Beneficence, Non-maleficence, Justice

  7. Why Value Informed Consent? • Justification #1: via The Principle of Autonomy (self-rule) • Control typically requires consent • Very deontological • Today, thought of as the main reason for requiring consent • “our capacities for personhood ought to be recognized by all – these capacities including the capacity for rational decision” (Freedman, 170)

  8. Why Value Informed Consent? • Justification #2 • via The Principles of Beneficence and Non-maleficence • We're generally thought to be the best judges of our own best interest • As such, obtaining consent is an effective way of doing good and avoiding harm. • Very consequentialist • Today, usually thought of as a secondary reason for consent, although this might be a mistake

  9. Potential for Conflict • Notice the potential for conflict between the two justifications • What if we don’t think you know your best interest in a particular case? • Some might say this means you’re incompetent but best interest is a slippery notion • Also perhaps: best interest ¹ medical best interest

  10. Research Subject vs. Patient • Generally, it is thought that requirements for consent should be stronger in ‘pure’ research contexts than therapeutic contexts. • Why? Because generally in research, the beneficence justification isn’t available to us • The Nuremburg Code (1947) “The voluntary consent of the human subject is absolutely essential.” • We’ll talk more about this in a future class (Lecture 6)

  11. Elements of Informed Consent* • I Information Elements 1. Disclosure of Information 2. Comprehension of Information • II Consent Elements 3. Voluntary Consent 4. Competence to Consent * follows Beauchamp & Childress, Principles of Biomedical Ethics

  12. 4. Competence • No competence, no consent • We often talk about parents or guardians consenting for you, but we need to remember this is really a very different thing. • Competence is not all or nothing • Perhaps I am competent to drive a car, but not to make complicated medical decisions about myself

  13. What is Competence? • Being rational? • i.e., using reason to pursue your own goals? • What about the person who carefully figures out how to pursue his project of dismembering himself? • Having the right goals? • A competent person reaches reasonable conclusions based on reasonable goals? • There’s a danger of paternalism here

  14. Incompetence • What if the patient isn’t competent? • How can we treat the patient in such a case? • We’ll discuss this at length later on

  15. 3. Voluntariness • Consent must be free of corercion or undue influence from others • Simple in theory although often trickier in practice • Pressure from family • Health care providers

  16. 2 & 1. Disclosure & Comprehension • Disclosure: How much information must be given? • “Full disclosure is impossible” (Freedman, p. 171) • Remember that how information is presented is crucial • An overload of information can actually hamper informed consent • Patients may decide they want only limited disclosure • Comprehension: What must you do to ensure the patient has consented?

  17. Disclosure & Comprehension • Disclosure must: • Be specific to the intervention • Explain alternatives • Explain prognosis with and without treatment • Explain risks and benefits of treatment and alternatives • Involve an opportunity for questions form patient

  18. What is adequate disclosure? • 3 Standards: 1. Medical Community: What a typical physician/researcher would disclose 2. Subjective: What the patient wanted to know 3. Objective: What a reasonable person would want to know

  19. Reibl v. Hughes (S.C.C. 1980) • Sets Canadian standard on disclosure • Reibl - 44 year old man with a history of severe migraines • Dr. Hughes – removes blockage in left internal carotid artery • Surgery is “competently performed” (p. 157) • Reibl suffers a stroke which leaves him impotent and paralyzed on right side • Reibl had not been warned about this specific risk • Sues Hughes claiming he had not given an informed consent

  20. Reibl v. Hughes • “in obtaining consent … a surgeon, generally, should answer any specific questions posed by the patient as to the risks involved and should, without being questioned, disclose to him the nature of the proposed operation, its gravity, any material risks and any special or unusual risks attendant upon the performance of the operation.” (p. 158) • “even if a certain risk is a mere possibility…, yet if its occurrence carries serious consequences, as for example, paralysis or even death, it should be regarded as … requiring disclosure.” (p. 158)

  21. Reibl v. Hughes • Significant here is the fact that Reibl was 1.5 years away from qualifying for a lifetime pension for Ford • Reibl claimed he would at least have delayed the surgery if he had fully understood its risks • Are these specific facts about Reibl relevant to whether he was fully informed about the surgery?

  22. Reibl v. Hughes • Court rules that the appropriate standard of disclosure is what a reasonable person in the patient’s position would want to know • Dr. Hughes was found guilty of negligence by the Supreme Court of Canada • Compromise between objective and subjective view

  23. Ciarlariello v. Schacter (S.C.C., 1993) • Case involves a patient who asked to have an angiogram stopped mid-way through and then gave verbal go ahead to start up again (“Please go ahead”) • Question of the Case: How much did C’s physician have to do to ‘re-consent’ her? Did they have to go through a process of full disclosure?

  24. Ciarlariello v. Schacter • Central element of the verdict is reminiscent of Reibl v. Hughes although perhaps more subjective • “The appropriate approach is … to focus on what the patient would like to know concerning the continuation of the process once the consent has been withdrawn.” (p. 180) • “Changes may arise during the procedure which are not at all relevant to the issue of consent. Yet, the critical question will always be whether the patient would want to have the information…” (p. 180)

  25. Group Work • S, a severely brain damaged 9 year old child has had a series of heart surgeries since age 1 in order to save her life • S’s doctors say that she will die very soon unless another heart surgery is performed • S is clearly not capable of consenting to the surgery • How should the decision about whether to carry out the surgery be made? • On what basis? • What factors should be considered?

  26. Results of Group Work • Who should decide? • Decision should be made by parents (most) • Decision should be shared by parents & doctors (some) • What should be factored in? • Assessment of likely quality of life after surgery • Parent’s reasons for accepting/rejecting surgery • Likelihood of death without surgery • Impact on health care system – time, use of resources, cost • Emotional impact on family • Expenses for family

  27. What if the Patient Isn’t Competent? • “a proxy consent ought to be obtained on behalf of the incompetent subject.” (p. 169) • Who?  Parents? Doctors? Courts? • Living wills • Newfoundland: Advance Health Care Directives Act

  28. Advance Health Care Directives Act • Sets out conditions for setting up an advance health care directive. • If no directive in place, it sets out the rules for proxy decision making • Spouse • Children • Parents • Siblings … • Majority rules • One decision maker may be designated • In case of a tie, the decision goes to the next place on the list (See section 10)

  29. On What Basis Should Substitute Decisions Be Made? • 3 Possibilities • Best Interests of the Incompetent Person • Substituted Judgment • Interests of the Substitute Decision Maker • Eve vs. Mrs E. & Re. S.D. illustrate that the Canadian legal standard is ‘best interests’ • The NL Advance Health Care Directives Act shares this approach

  30. Re. S.D. (B.C.S.C., 1983) • B.C. Supreme Court • S.D. was a 7 year old boy with profound brain damage • “no control over his faculties, limbs or bodily functions.” (p. 184) • At 5 months, had a shunt (i.e., plastic tube) installed to draw excess cerebro-spinal fluid from the head • Shunt became blocked • Parents at first consented to having the blockage cleared, then withdrew consent “on the ground that the boy should be allowed to die with dignity” (p. 184)

  31. Verdict in Re. S.D. • Family and Child Services assumed custody of S.D. • A B.C. provincial court judge returned custody to the parents • The B.C.S.C. reversed this decision: • “I do not think that it lies within the prerogative of any parent or of this court to look down upon a disadvantaged person and judge the quality of that person’s life to be so low as not to be deserving of continuance.” (p. 185)

  32. Eve vs. Mrs. E. (S.C.C. 1987) • Eve = 24, extreme expressive aphasia • “at least mildly to moderately mentally retarded” • Incapable of being a mother other than ‘physically’ • Mother sought to have her daughter sterilized by tubal ligation • Mother feared her daughter would become pregnant and that the child would become her responsibility

  33. Eve vs. Mrs. E • Lower court (in PEI) rules Eve cannot be sterilized for non-therapeutic reasons • PEI Supreme Court reversed this decision, ordered a hysterectomy • Supreme Court of Canada reinstated original court’s order • Very clear: no non-therapeutic sterilization of incompetent patients • A controversial ruling, both legally and morally

  34. S.C.C. Verdict • “The grave intrusion on a person’s rights and the certain physical damage that ensues from non-therapeutic sterilization without consent, when compared to the highly questionable advantages that can result from it, have persuaded me that it can never safely be determined that such a procedure is for the benefit of that person.” (La Forest, p. 418) • Clear reliance on the best interests standard

  35. Advance Health Care Directives Act • 12.1c “when the substitute decision maker has no knowledge of the maker’s wishes, [the substitute decision maker shall act] in accordance with what … [he or she]… reasonably believes to be in the best interests of the maker.”

  36. A Last Point: Moral vs. Legal Consent • Moral informed consent • patient actually having made an informed voluntary decision with an appropriate level of disclosure • Legal informed consent • having gone through appropriate steps so that consent will be considered legally valid (e.g., signing documents) • Remember contrast between intrinsic and instrumental value • Sometimes things that are initially perceived as instrumentally valuable come to be mistaken for having intrinsic value

  37. Moral vs. Legal Consent • Legal consent requirements started out as means of ensuring moral consent had actually been sort • Today, we often pay more attention to legal consent than moral consent • Conversations are often about whether forms were signed • Sometimes seeking legal consent actually gets in the way of achieving moral consent • E.g., overly complicated consent forms