The Ethics of the Doctrine of Informed Consent

1. The Ethics of the Doctrine of Informed Consent Prof. Edwin C. Hui Medical Ethics Unit Faculty of Medicine University of Hong Kong <edwinhui@hku.hk>

2. Some historical aspects: • Common law principle establishing the need of consent before treatment: • “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… (Cardoza J, in Schloendorff v Society of New York Hospital (1914) 211 NY 125)

3. Philosophical underpinnings • Human rights of freedom and individuality • Ethical principle of respect for a person’s autonomy or self-determination • Legal doctrine of being informed before giving consent • To be legally and ethically acceptable, consent must always be informed.

4. Informed Consent (IFC) Supported by Bioethical and Legal Principles • In the West,particularly in the U.S. IC has become popular since the middle of last century. It is now accepted as part of medical professionalism, and considered both a moral and legal obligation. • IFC doctrine is supported by three bioethical principles: • Respect for patient autonomy • Beneficence • Justice (not so clear)

5. IFC & Bio-ethical Principles: • RPA: IFC  patient self-determination • BNF: IFC  autonomous decision consistent with patient’s own values and life goals

6. Components of theIFC Process: (1) Threshold component • Patient must be mentally competent to cognitively understand and retain the health-related information provided • “Understand” refers to “knowing what one is doing” • Patient only needs to be competent to understand and process the specific decision at hand • Patient must be able to make her decision voluntarily and without pressure, undue influence or coercion from other people

7. Nature of information to be disclosed : • Nature of the medical illness • Nature of the recommended treatment • Purpose, benefits and probability of success of treatment • Risks and side-effects of treatment • Possible alternative treatments, their benefits and risks • Risks of not receiving recommended and/or any treatment

8. (2)Informational component (cont’d) • Risk = magnitude of potential harm x probability of harm occurring • Major harm x high probability = disclose • Major harm x low probability = disclose • Minor harm x high probability = disclose

9. Standards of disclosure • Professional standard of disclosure (PSD) • Reasonable person standard (RPS) • Subjective standard of particular patient (SSPP) • RPS + particular patient (RPS/SSPP) • RPS + therapeutic privilege (RPS/TP)

10. Subjective Standard of particular patient: • To disclose whatever information material to the decision-making of a particular patient, taking into consideration of the patient’s unique circumstances, values, interests and goals. • Rationale: MDM essentially entails non-medical judgment, unique personal reasons must play an important part. • SSPP puts heavy burden on physicians to provide information

11. Professional Practice Standard (PPS) • Amount & scope of information disclosed to be determined by professional community • Part of professional responsibility & autonomy to establish standard of care • Objections: doubt existence of such consensus • Risk of perpetuation of inadequate disclosure for professional solidarity • Doubt physicians’ expertise in knowing patients’ personal values & best interests • Consent decisions: medical or non-medical?

12. The Bolam test (BT): • “A doctor is not negligent if he acts in accordance with a practice accepted at the time as proper by a responsible body of medical opinion.” • The struggle is whether to apply the BT to information disclosure in the same way to Dx and Rx. • Many UK courts not at ease with Bolam, but not ready to abandon it altogether for ID.

13. Advantages of PPS standard: • Provides a coherent body of principles for practitioners to follow and for judges to adjudicate disputes • Sensitive to doctors’ situation of not having enough time to spend on unduly lengthy disclosures • Encourages trust & confidence in PPR

14. Disadvantages of PPS: 1 . Allows physicians too much latitude for non- disclosure and invites paternalistic practice. 2. No evidence that the medical profession has a consensus regarding a standard of disclosure. 3. Professional standard may not contain the information that is material to the patient’s decision making process. 4. Amount of information that should be disclosed is unrelated to medical knowledge or skills, and hence it is not a matter of medical standard or judgment.

15. Reasonable Person Standard (RPS): • The standard, scope and adequacy of disclosure is to be decided by the patient’s requirement of information in order to make the decision in the circumstances at hand. • Amount & scope of disclosure as what a “reasonable” person needs to know • Rationale: patient knows best what information is “material” or significant for the kind of decision that has to be made • Adequacy of disclosure judged by judge or jury, not expert testimony

16. Disadvantages of RPS: • RPS unable to specify physician’s duty of disclosure since a “reasonable person” is undefined • Reasonable-ness & materiality are context-dependent in concrete cases

17. History of RPS: • In US, the District of Columbia Court of Appeals in Canterbury v. Spence (1972) decided to replace PSD with RPS, requiring the physician “to disclose all information about a proposed treatment which a reasonable person in the patient’s circumstances would find material to his decision either to undergo or to forego treatment.”

18. RPS and Disclosure of Risks: • It was held by the Canterbury court that it is up to law courts to determine any breach of the doctor’s duty to inform the patient, including warning patients of risks. • Australian High Court held: “…the consenting party must have knowledge, awareness, appreciation and understanding of the nature and extent of the harm or risk involved…the patient has otherwise not voluntarily assumed the risks in question.”

19. RPS: what risks are material and to be disclosed by doctors? • A risk is material if a reasonable person in the patient’s position, if warned of the risk, would likely attach significance to it. (Canterbury) • Risk includes both risks in treatment as well as risk of treatment not being effective. • Risk is material if doctor is/should aware that “the particular patient”, if warned of the risk, would likely attach significance to it. (Rogers v Whittaker)

20. RPS+PP: Risks v Possibilities Sidaway considered risk of 1% or less non-disclosure • F v R (1983) accepted 200 : 1 or less as not being material • Most important factor: particular patient’s requirement by direct questioning. • Australian court “converted” a 1:14,000 chance of blindness into a risk due to patient’s direct questioning of & concern for this possibility

21. RPS and Therapeutic Privilege: • “Therapeutic privilege” as an exception to the general rule of “full disclosure” according to RPS and still accepted as a valid consent. • Rationale: to withhold information that might be emotionally disturbing for patient to make a rational decision or psychologically damaging to the patient. (Accepted by Sidaway)

22. Exceptions to TP: TP should not apply when the physician expects that full disclosure would cause the patient to forego treatment. (Canterbury) TP usually not allowed if patient questions about the information; doctor needs to have strong justification for insisting on TP.

23. Standard of TP: • Should it be a medical professional judgment or should there be a lay standard of what information would emotionally harm a reasonable person in similar situations such that it can be withheld. • The Canterbury court favored a narrow “therapeutic privilege” and used a “lay” standard in the same way the standard for disclosure is to be determined.

24. (3) Decisional Component: • Patient must be able to rationally processthe information by being able to assess the pros and cons of the options • Patient should be able to consider her personal viewpoints, values, goals and preferences and how they may be significantly affected by the choice • Patient must be able to make and articulate a choice, and to provide her reasons for the choice • Some believe that the outcome of the patient’s choice must be intelligible to an average person;

25. Case 1: Schizophrenic MIP Refuses/Resists Dialysis • Ethical dilemma: should dialysis be forced on or withheld from this patient?

26. Relevant medical factors and doctors’ perspectives: • ESRD potentially life-threatening • Recommended dialysis necessary to save pt’s life . • Patient not a good candidate for renal transplant. • Psychiatrist determined patient not capable of giving consent. • Dialysis, if performed, had to be performed by considerable force and with patient actively and violently struggling against it.

27. Patient’s perspectives: • Patient refused dialysis • Patient’s refusal was legally and ethically not valid since he was declared incompetent to give consent. • Patient resisted dialysis by force.

28. Family or legal guardian’s perspectives: • Patient’s wife was a mental patient, and was not considered fit to provide consent to dialyze her husband. Her consent would have no legal force anyway. • Legal guardian (LG) was appointed and provided consent for dialysis. • What were the bases of the LG’s consent?

29. Family or legal guardian’s perspectives: • By HK and UK’s statutes, LG should consent on the basis of patient “best interests” that include not only medical “best interests” but also patient’s non-medical interests such as patient’s past wishes, preferences, values, beliefs, patient’s family’s wishes etc (see below). This information was lacking, and in general many if not most LG tend to follow the doctor’s medical opinion based on simple risk-benefit calculations.

30. Societal, institutional and cultural factors: • Societal factor: whether the allocation of limited resources on a patient who persisted in refusing the treatment was justified. • Institutional factor: potential danger to hospital staffs and ward patients.

31. Legal guidance: • Hong Kong Mental Health Ordinance Section 59ZA of Part IVC of says: "in the best interests" ----- means in the best interests of that person in order to -- (a) save the life of the mentally incapacitated person; (b) prevent damage or deterioration to the physical or mental health and well-being of that person; or (c) bring about an improvement in the physical or mental health and well-being of that person.'

32. Legal guidance: • UK Mental Capacity Bill (2005) recently passed requires that the proxy decision-maker, in assessing the patient’s “best interest”must consider, “so far as is reasonably ascertainable, (i) the person’s past and present wishes and feelings,(ii) the beliefs and values that would be likely to influence his decision if he had capacity, and (iii) the other factors that he would be likely to consider if he were able to do so.”

33. Missing information: • Indication of patient’s prior wishes or preferences with respect to dialysis either before he developed ESRD, or during some lucid moments after dialysis when his wish/preference may be better ascertained. • Any information from patient’s social circles?

34. Assumptions made: • Assume that all the requirements listed in 6(b) cannot be met i.e. the patient’s wish and preferences for dialysis when he was competent was not known so that a “substituted judgment” is no longer possible. • Assume that the legal guardian made his/her consent on a “restricted” best interest based on the patient medical and healthcare needs. • Assume that patient has lost capacity to make medical decisions on a permanent basis.

35. Values involved in case: • For HCP: preserve life, relief pain and suffering, promote patient best interest, and do not inflict harm. • For patient: can we actually say that patient has no value/interest? Or, we can only say that patient’s value/interest system has been reduced to the sensory level i.e. in his mentally incapacitated state, his only value/interest is not to be restrained and dialyzed. • For LG: to promote patient’s best interest?

36. Ethical principles: • Respect for patient autonomy • Beneficence • Non-maleficence • Justice

37. Prioritization and justification of values: • The most important value in this case is to promote patient best interest, in the restricted sense, confining largely to the patient’s medical and healthcare benefits that can be more objectively determined. • This value points to a prima facie duty for HCP to provide dialysis. • Any medical treatment is rendered on a favorable burden-to-benefit ratio (BBR).

38. Prioritization and justification of values: • Benefit includes the preservation of life in quantitative and qualitative terms. • Burden includes physical and psychological harm/risk to patient, cost of treatment in terms of monetary cost and human resources. Human resources can be further sub-divided into quantitative and qualitative aspects. • The benefit of providing dialysis is preservation of the patient’s life in quantitative terms by preventing renal failure and death.

39. The burden of providing dialysis include: • Physical harm to the patient by forcing treatment including anesthesia. • Psychological harm to patient by use of force. • Violation of the patient’s dignity by use of force. • Quality of patient’s “preserved” life compromised because patient is required to experience harm on a continuing basis.

40. The burden of providing dialysis include: • Excessive cost to the healthcare system due to extra manpower and resources (if anesthesia and/or sedation is used) to force the treatment on the patient. • Cost of human resources include physical and emotional abuses/injury sustained by HCP • On a BBR calculation, the prima facie duty to dialyze the patient becomes ethically unwarranted and possibly unsustainable.

41. The burden of providing dialysis include: • Decision NOT to treat patient can be sustained by principles of beneficence, non-maleficence and justice. The burdens of forced dialysis on the patient listed in #1 to #4 compromise the first 2 ethical princ. • Burden #5 is consistent with prudent allocation of limited resources. • Burden #6 is related to preservation of professional value, dignity and autonomy.

42. The burden of providing dialysis:a case for professional autonomy? • Doctors may be required to treat patients who refuse to consent due to mental disability. • Are doctors obligated to treat patients who resist treatments by force for whatever reason. • Doctors are not obligated.

43. The burden of providing dialysis in UK Re D (1997) 41 BMLR 81 (Fam Div): • D aged 49 chronic psychiatric patient who has spent most of his life in and out of mental hospitals developed near ESRF requiring renal dialysis 3-4 times per week. “Unfortunately, because of his mental disability, this patient is unable to recognize the importance of co-operating and to actually co-operate….The doctors are anxious to do all they can to preserve this man’s life, but it is becoming increasingly difficult to do so.”

44. The burden of providing dialysis in UK Re D (1997) 41 BMLR 81 (Fam Div): • The doctors therefore applied to the court for a declaration in the following terms: “that notwithstanding the defendant’s (patient’s) inability to consent or refuse medical treatment, it is lawful, as being in the best interests of the patient, for the plaintiff (that is, the hospital authority) not to impose hemodialysis upon him in circumstances in which, in the opinion of the medical practitioners responsible for such treatment, it is not reasonably practicable to do so…”

45. The burden of providing dialysis in UK Re D (1997) 41 BMLR 81 (Fam Div): • The legal and ethical underpinning of the declaration is far from clear. It is as if “the judge ruled that it was not in the patient’s interest to impose dialysis on him where in the doctors’ opinion ‘it is not reasonably practicable to do so.’”.

46. Case #2: A Patient Refusing Transfusion • Ethical questions raised: Can the patient’s “well-documented refusal” be overridden by either: 1. patient’s girl-friend’s allegation that the patient has reversed the refusal; 2. doctors who may consider patient’s decision as “unreasonable”

47. Girlfriend’s allegation • Is her alleged report reasonable? “…that he would accept the transfusion when his life was threatened.” Ans. Yes. That is what you expect from a reasonable person. • Is her alleged report credible? Ans. That will require more evidence. If she can produce “clear and convincing” evidence that the patient has made such a statement, it possibly may be acceptable to reverse the signed refusal.

48. Doctor’s judgment that patient’s refusal is “unreasonable” • A competent patient’s refusal of treatment does not have to be “reasonable” and conform to “common sense”, even if the decision is a “life and death decision.” • This is to use a so-called “outcome standard” (the outcome of the decision has to be “reasonable” for it to be acceptable); too paternalistic

49. Anything wrong with the original refusal? • Medical context under which the patient opted for “refusal” to be transfused: 1. Hgb was low but clinically stable; 2. Doctors recommended “top-up” transf; 3. Patient “refused” under duress of fear 4. No evidence of medical attempt to resolved patient’s fear

50. Is the original refusal “informed” ? • Did doctors made the distinction between “top-up” and “bottom-out” transfusions? • If not, then… • Was the patient “refusing a “top-up” trans- fusion or a “life-saving” transfusion? • If we are not sure… • We doubt if the “refusal” was “informed”.