1. Informed Consent and Truth-telling: Changing Realities and Present Challenges 醫生、病人關係的世界性轉變 ：病人私隱有否限制？ 譚傑志教授 JOSEPH THAM, MD, PHD School of Bioethics, Regina Apostolorum, Rome, Italy

2. Outline 概要 Truth telling and Informed Consent Truth telling and Informed Consent Historical Background Historical Background Principlism, Autonomy Principlism, Autonomy Multiculturalism Multiculturalism Implications for China Implications for China Advance Directives Advance Directives 病情告知和知情同 意 历史背景 原则主义，自主权 多文化主 在中国的应用 預設醫療指示 ( 遺囑 )

3. Case: "I can put the medicine in his soup, Doctor!“ 案例 : “ 医生，我 能把药放进他的汤里让他喝 !" J G W S Wong, Y Poon and E C Hui, “I can put the medicine in his soup, Doctor!” Journal of Medical Ethics 2005; 31:262-265. J G W S Wong, Y Poon and E C Hui, “I can put the medicine in his soup, Doctor!” Journal of Medical Ethics 2005; 31:262-265. A young man with schizophrenia. A young man with schizophrenia. His mother had been giving him antipsychotic medication covertly in his soup. His mother had been giving him antipsychotic medication covertly in his soup. Should the doctor continue to provide a prescription, thus allowing this to continue? Should the doctor continue to provide a prescription, thus allowing this to continue? Truth telling and the balance between individual versus family autonomy. Truth telling and the balance between individual versus family autonomy. 一个还有精神分裂症的 年轻患者 患者母亲长期将安定药 物放进患者所食用的汤 里 在这种情况下，医生应 该继续给患者家属开具 处方吗？应该允许此类 情况继续发生吗？ 告知真相以及在个人和 家庭自主权之间的平衡

4. 5/20/20154 Case: 65 y.o. Mexican woman, immigrant dx with aggressive late stage ovarian cancer. Poor prognosis. 65 y.o. Mexican woman, immigrant dx with aggressive late stage ovarian cancer. Poor prognosis. Her family explicitly told MDs that she would not want to hear any bad news. It may cause too much trauma Her family explicitly told MDs that she would not want to hear any bad news. It may cause too much trauma What should the MD do in this case? What should the MD do in this case?

5. Historical Background 历史背景 Modern Medicine Modern Medicine Curing and treatment options Curing and treatment options Better diagnosis, prognosis Better diagnosis, prognosis Paternalism to Patient’s rights Paternalism to Patient’s rights Appearance of Bioethics Appearance of Bioethics Cultural changes in 1960s Cultural changes in 1960s Scandals and abuses became public Scandals and abuses became public Right’s movements, distrust with authority figures Right’s movements, distrust with authority figures Legal cases Legal cases 现代医学 多种处理和治疗方式的 选择 更好的诊断及预后 家长式作风对患者权利 的影响 生命伦理学的出现 在 1960s 年代出现的文 化改革 医学丑闻和陋习公开化 权利运动，对权威人士 的不信任 诉讼案件

6. A bit of history Abuses Abuses Patients’ rights to know Patients’ rights to know Legal challenges Legal challenges Ethics comes before the law? Ethics comes before the law? Protect the patients or protect MDs Protect the patients or protect MDs 濫用 患者的知情權 法律上的挑戰 倫理置於法律面前 ？ 保障病人或保護醫 生 ? 5/20/20156

7. Principlism 原则主义 Product of modern philosophy 现代哲学的产物 Product of modern philosophy 现代哲学的产物 Analytic philosophy 分析性哲学 Analytic philosophy 分析性哲学 Normative ethics 规范伦理 Normative ethics 规范伦理 National Commission for the Protection of Human Subjects 1974-1978 National Commission for the Protection of Human Subjects 1974-1978 Abuses 滥用 Abuses 滥用 National Research Act 1974: 12 commissioners to identify ethical principles (Engelhardt's sin of his youth) National Research Act 1974: 12 commissioners to identify ethical principles (Engelhardt's sin of his youth) Belmont Report 1978 Belmont Report 1978 Principles 原则 Principles 原则 Respect for persons 对人的尊重 —informed consent 知情同意 Respect for persons 对人的尊重 —informed consent 知情同意 Beneficence 行善原则 —risk-benefit ratio 风险 - 利益比 Beneficence 行善原则 —risk-benefit ratio 风险 - 利益比 Justice 公平 —subject selection 受试者选择 Justice 公平 —subject selection 受试者选择 Quasi-official status 似乎获得官方正式的地位 Quasi-official status 似乎获得官方正式的地位

8. Principlism 原则主义 Beauchamp and Childress: Principles of Biomedical Ethics Beauchamp and Childress: Principles of Biomedical Ethics Autonomy, beneficence, nonmaleficence, justice Autonomy, beneficence, nonmaleficence, justice Prima facie principles Prima facie principles Popularity and practicability: clinics, public policy, doctor-patient relationship Popularity and practicability: clinics, public policy, doctor-patient relationship Presumes common morality Presumes common morality Intuitionism or emotivism Intuitionism or emotivism Beauchamp 和 Childress: 生命医学伦 理学原则 自主权，行善，不作恶 ，公平 初次印象原则 普及性和实用性：临床 ，公共卫生政策，医患 关系 假定拥有共同的道德标 准 直觉主义，动感情主义

9. Challenges to Principlism 原则主义面临的挑战 Tyranny of autonomy Tyranny of autonomy Trumping all other principles Trumping all other principles No consensus No consensus Law (Patient Self- determination Act 1990) Law (Patient Self- determination Act 1990) Anti-paternalism, anti- authority Anti-paternalism, anti- authority Individualism Individualism Inadequate: not all choices are good Inadequate: not all choices are good 自主权的 “ 独断专行 ” 以其他所有原则为幌子 无法达成一致意见 法律 ( 患者自主决策法案 Patient Self- determination Act 1990) 反家长主义，反权威主 义 个人主义 不足之处：并不是所有 的选择都是有好处的

10. Challenges to Principlism 原则主义面临的挑战 Autonomy and informed consent Autonomy and informed consent Signing a paper Signing a paper Reasonable and prudent person standard. Reasonable and prudent person standard. Patient’s right NOT to know? Patient’s right NOT to know? Autonomy and truth-telling Autonomy and truth-telling Never lie to patient. Never lie to patient. Truth could never be harmful? Truth could never be harmful? Autonomy and family decisions Autonomy and family decisions Ambiguity of 4 principles and their secularized context Ambiguity of 4 principles and their secularized context 自主权与知情同意 签署某种文件 合适而谨慎的个人标准 患者拥有 “ 不知情 ” 的权 利吗 ? 自主权与告知真相 永远不向患者撒谎 难道真相永远都不会造 成伤害吗 ? 自主权与家庭决策 4 项原则的模糊表述以 及各自的俗世语境

11. Challenges to Principlism 原则主义面临的挑战 Principlism Principlism Neo-casuistry Neo-casuistry Consensus ethics Consensus ethics Engelhardt’s content-less consensus ethics Engelhardt’s content-less consensus ethics Contextual ethics Contextual ethics Pragmatic ethics Pragmatic ethics Utilitarian ethics Utilitarian ethics Liberalism and nihilism Liberalism and nihilism 原则主义 新诡辩论 共识伦理学 Engelhardt 無內容 的共识伦理学 背景性伦理学 实用主义伦理学 功利主义伦理学 自由主义和虚无主 义

12. Challenges to Principlism 原则主义面临的挑战 Controversial Controversial Inhuman and unrealistic Inhuman and unrealistic Ignores the fact hat the person is not just an isolated individual, but has ties to family, friends, religion, society. Ignores the fact hat the person is not just an isolated individual, but has ties to family, friends, religion, society. Immigrants and multurculturalism: importance of family in healthcare decision-making Immigrants and multurculturalism: importance of family in healthcare decision-making 富有争议的 不人道而且不现实 忽略了人不是一个 孤立的个体，而是 与家庭、朋友、宗 教、以及社会等紧 密相连这一事实。 移民和多文化主义 : 家庭在医疗决策中 的重要性

13. Autonomy Autonomy = self- determination Autonomy = self- determination No more “paternalism” No more “paternalism” Tyranny of autonomy? Tyranny of autonomy? Must MD do everything patients request? Eg. female circumcision, etc. Must MD do everything patients request? Eg. female circumcision, etc. 自治 = 自決 沒有更多的 “ 家長式 “ 自主權暴的政？ 醫師必須盡一切病 人要求？例如。女 性割禮等 5/20/201513

14. Challenges Becomes a piece of paper Becomes a piece of paper How much information is needed? How much information is needed? Can informed consent be truly informed? Can informed consent be truly informed? 變成了一張紙 需要多少信息？ 知情同意是真正可 以告知情況？ 5/20/201514

15. Relational Self 關係性自我 The enhanced patient autonomy approach requires the inclusion of family members in the decision making process. (Surbone, 2006) The enhanced patient autonomy approach requires the inclusion of family members in the decision making process. (Surbone, 2006) Patient autonomy = complex concept referring to both one’s capacity to choose and to one’s ability to implement one’s choices Patient autonomy = complex concept referring to both one’s capacity to choose and to one’s ability to implement one’s choices 得到提升的患者的自 主权需要将家庭成员 纳入到决策制定过程 中来 (Surbone, 2006) 患者的自主权 = 与个 人的选择能力以及执 行个人选择的能力相 关的复杂概念

16. New paradigm Autonomy as individual self vs relational self Autonomy as individual self vs relational self Family, other members, etc. Family, other members, etc. Decision making Decision making Truth telling Truth telling Breaking bad news Breaking bad news Placebo Placebo 自治 = 個人自我還 是關係自我 家庭其他成員等 決策 病情告知 壞消息 安慰劑 5/20/201516

17. New Paradigm Do patients want to know bad news? Do patients want to know bad news? Fear from MD > patient Fear from MD > patient Not to let hope die? Deception to maintain hope? Not to let hope die? Deception to maintain hope? When to tell, how to tell (sequence), who to tell… When to tell, how to tell (sequence), who to tell… Family involvement can soften the impact Family involvement can soften the impact Rights to refuse to know? Rights to refuse to know? 病人想知道壞消息 ？ 醫師 > 病人害怕 不要讓希望死嗎？ 騙保持希望？ 當告之，如何辨別 真假（序列），誰 告訴... 家庭的參與可以軟 化影響 有權拒絕知道嗎？ 5/20/201517

18. Multiculturalism Challenging the individualist approach Challenging the individualist approach Patient’s culture, religion, values system, etc. Patient’s culture, religion, values system, etc. MD’s knowledge of these systems, strategies to be culturally sensitive MD’s knowledge of these systems, strategies to be culturally sensitive 挑戰個人主義方法 病人的文化，宗教 ，價值觀系統等 醫師對這些系統的 知識，在文化識相 的戰略 5/20/201518

19. In China 對於中国 In China 對於中国 家庭主义為成在中国的初 次印象 家庭主义為成在中国的初 次印象 家庭，村，县 ，省，国家 ，民族 … 家庭，村，县 ，省，国家 ，民族 … 原则主义的知情同意以及 告知真相在实践中所遇到 的困难 原则主义的知情同意以及 告知真相在实践中所遇到 的困难 家庭主义与西方的關係性 自我概念的趋同 家庭主义与西方的關係性 自我概念的趋同 挑战：逐渐缩小的家庭规 模，个人主义 挑战：逐渐缩小的家庭规 模，个人主义 Familism as prima facie in China Family, village, province, nation Difficulties with informed consent and truth telling practices of principlism Convergence of familism with the relational self concept in the West Challenges: smaller family units, individualism

20. 保持信任 尊敬他人 維持联络 的价值 避免强迫或操縱 真相

21. Advanced Directives from a Catholic Perspective Francisco de Vitoria Francisco de Vitoria ordinary vs. extraordinary means ordinary vs. extraordinary means 普通 vs. 特殊的手段 Medical advances now gave doctors much more options to cure and prolong life, and even prolong the dying process. Medical advances now gave doctors much more options to cure and prolong life, and even prolong the dying process. Pope Pius XII in 1957. Pope Pius XII in 1957.

22. Ordinary vs extraordinary means Ordinary (proportionate) means are those basic care and treatments which doctors are obligated to provide and which under normal circumstances, patients should not refuse—run of the mill medical treatment, hygiene, antibiotics, etc. Ordinary (proportionate 相稱 ) means are those basic care and treatments which doctors are obligated to provide and which under normal circumstances, patients should not refuse—run of the mill medical treatment, hygiene, antibiotics, etc. Extraordinary (disproportionate ) means are those medical measures that can cause undue burden on the patients and the family, and therefore patients are not obliged to undergo these (experimental) treatments, or if they have been started could ask for their withdrawal. Extraordinary (disproportionate 不相稱 ) means are those medical measures that can cause undue burden on the patients and the family, and therefore patients are not obliged to undergo these (experimental) treatments, or if they have been started could ask for their withdrawal.

23. Ordinary vs extraordinary means There are objective and subjective elements that the patients and doctors must weigh the risks and benefits in each case. There are objective and subjective elements that the patients and doctors must weigh the risks and benefits in each case. Objective elements such as the difficulties, pain risk, cost and success rates, etc. Objective elements such as the difficulties, pain risk, cost and success rates, etc. Subjective elements include fear, anxiety, physical or psychological suffering, shame, the desire to live on, the time to settle affairs, etc. Subjective elements include fear, anxiety, physical or psychological suffering, shame, the desire to live on, the time to settle affairs, etc. Preferred term is proportionality, since some ordinary means can become disproportionate in very ill patients, and some extraordinary means can be proportionate to patient needs when the risk and benefits are weighed. Preferred term is proportionality, since some ordinary means can become disproportionate in very ill patients, and some extraordinary means can be proportionate to patient needs when the risk and benefits are weighed.

24. Therapeutic obstinacy and Euthanasia Therapeutic obstinacy and Euthanasia Two extremes to be avoided. Two extremes to be avoided. Therapeutic obstinacy : When all available treatments have been tried and patient is dying, doctors should accept this rather than employing all technology to prolong the dying process, thus causing more suffering and does not respect the dignity of the person. (Unrealistic expectations from patients, family and doctors: Medicine or doctors seen as saviors, failure). Pius XII: extraordinary means can be withheld or withdrawn. Therapeutic obstinacy 治療頑固 : When all available treatments have been tried and patient is dying, doctors should accept this rather than employing all technology to prolong the dying process, thus causing more suffering and does not respect the dignity of the person. (Unrealistic expectations from patients, family and doctors: Medicine or doctors seen as saviors, failure). Pius XII: extraordinary means can be withheld or withdrawn.

25. Therapeutic obstinacy and Euthanasia Therapeutic obstinacy and Euthanasia CCC 2278 Discontinuing medical procedures that are burdensome, dangerous, extraordinary, or disproportionate to the expected outcome can be legitimate; it is the refusal of “over-zealous” treatment. “ 過分熱心 ” 治療 Here one does not will to cause death; one's inability to impede it is merely accepted. CCC 2278 Discontinuing medical procedures that are burdensome, dangerous, extraordinary, or disproportionate to the expected outcome can be legitimate; it is the refusal of “over-zealous” treatment. “ 過分熱心 ” 治療 Here one does not will to cause death; one's inability to impede it is merely accepted. The decisions should be made by the patient if he is competent and able or, if not, by those legally entitled to act for the patient, whose reasonable will and legitimate interests must always be respected. The decisions should be made by the patient if he is competent and able or, if not, by those legally entitled to act for the patient, whose reasonable will and legitimate interests must always be respected.

26. Therapeutic obstinacy and Euthanasia Therapeutic obstinacy and Euthanasia Euthanasia: to end someone’s suffering by intentionally ending his or her life. Euthanasia: to end someone’s suffering by intentionally ending his or her life. “By euthanasia is understood an action or an omission which of itself or by intention causes death, in order that all suffering may in this way be eliminated.” (Declaration on Euthanasia 1980, EV, CCC) “By euthanasia is understood an action or an omission which of itself or by intention causes death, in order that all suffering may in this way be eliminated.” (Declaration on Euthanasia 1980, EV, CCC) Level of intention, includes omission if the intention is there to provoke death. Could be voluntary or non-voluntary. Level of intention, includes omission if the intention is there to provoke death. Could be voluntary or non-voluntary. 安樂死：結束一個 人的痛苦，故意結 束她的生命。 意向的層次 包括不行動故意造 成死亡 可能是自願或不自 願的。

27. PVS and ANH PVS and ANH 植物人, 人工營養與水分 Water and nutrition are basic needs, not therapy. Water and nutrition are basic needs, not therapy. Withdrawal with the intention to cause death, since PVS patients could live on indefinitely. That is, cause of death is starvation and dehydration. Withdrawal with the intention to cause death, since PVS patients could live on indefinitely. That is, cause of death is starvation and dehydration. Recent report form NEJM—some of them can have thought processes. Recent report form NEJM—some of them can have thought processes.

28. Historical Background on Advanced directives Quinlan Case: Natural Death Act 1979 Quinlan Case: Natural Death Act 1979 Karen Ann Quinlan, PVS and on ventilator. Parents petitioned for withdrawal of respirator, but doctors refused. Court decided that ventilator is an extraordinary means, and can be withdrawn, citing Pius XII. Karen Ann Quinlan, PVS and on ventilator. Parents petitioned for withdrawal of respirator, but doctors refused. Court decided that ventilator is an extraordinary means, and can be withdrawn, citing Pius XII. Natural Death Act: There is a right to express one’s will regarding life sustaining treatments, and the right to withdraw or withhold them. In the case of mental incapacity, these rights can be expressed by either Advanced Directives (written document) or durable power of attorney (proxy) by naming someone who could make the decision on behalf of the patient. Natural Death Act: There is a right to express one’s will regarding life sustaining treatments, and the right to withdraw or withhold them. In the case of mental incapacity, these rights can be expressed by either Advanced Directives (written document) or durable power of attorney (proxy) by naming someone who could make the decision on behalf of the patient.

29. Historical Background on Advanced directives Cruzan Case: Patient Self-determination Act 1991 Cruzan Case: Patient Self-determination Act 1991 Nancy Cruzan also PVS, on artificial nutrition and hydration (PEG). Family wanted removal of tube feeding against doctor’s judgment. They were able to demonstrate retrospectively that this was the patient’s desire. Nancy Cruzan also PVS, on artificial nutrition and hydration (PEG). Family wanted removal of tube feeding against doctor’s judgment. They were able to demonstrate retrospectively that this was the patient’s desire. Patient Self-determination Act requires all health care institutions to advise all patients admitted to their facilities the availability of advanced directives. Patient Self-determination Act requires all health care institutions to advise all patients admitted to their facilities the availability of advanced directives. Terri Schiavo Terri Schiavo

30. Context of the Living Will movement Fear of technology: hooked up to machine and living an undignified existence Fear of technology: hooked up to machine and living an undignified existence Euthanasia movement in the 1980s found it difficult to change the laws to permit euthanasia. Euthanasia movement in the 1980s found it difficult to change the laws to permit euthanasia. More emphasis on who decides rather than what is best for the patient. More emphasis on who decides rather than what is best for the patient. Individualism: Self-determination often becomes the only criteria Individualism: Self-determination often becomes the only criteria

31. Critiques Difficulties in explaining to patients the medical conditions, and they could be subject to manipulation, undue fears and ideological pressures. Not truly informed consent. Difficulties in explaining to patients the medical conditions, and they could be subject to manipulation, undue fears and ideological pressures. Not truly informed consent. Difficulty in foreseeing all possible future situations which can be complex. When circumstances change, people can change their minds (eg. Charles Kao) Difficulty in foreseeing all possible future situations which can be complex. When circumstances change, people can change their minds (eg. Charles Kao) Damaging relationships between doctors and patients: Doctors just execute the patient decision as a robot Damaging relationships between doctors and patients: Doctors just execute the patient decision as a robot Tyranny of Autonomy: Respect of the person includes looking for what is best for the patient. Tyranny of Autonomy: Respect of the person includes looking for what is best for the patient. Not all decisions are wise and good. One can choose the wrong thing. “No man is an island”—recent shift of emphasis that decision making is best when made in a wider “relational” context including family, friends, and co-religionists. Familism in Asia. Not all decisions are wise and good. One can choose the wrong thing. “No man is an island”—recent shift of emphasis that decision making is best when made in a wider “relational” context including family, friends, and co-religionists. Familism in Asia.

32. Legal frameworks Legally binding (USA, Australia, UK, Holland, Belgium) or just consultative and indicative (Italy, Germany, Austria) Legally binding (USA, Australia, UK, Holland, Belgium) or just consultative and indicative (Italy, Germany, Austria) Existence of Catholic versions of “Advanced Directives” that respect the Catholic teaching (e.g. NCBC). In general, resistance to its use because of these problems. Existence of Catholic versions of “Advanced Directives” that respect the Catholic teaching (e.g. NCBC). In general, resistance to its use because of these problems.

33. Introduction of the Concept of Advanced Directives in Hong Kong Terminal illness / irreversible coma / PVS, are very different conditions. Different principles apply here—for eg., any treatment in truly irreversible coma would be wrong, even ANH. Whereas in the case of PVS, withdrawal of ANH would be euthanasia. Terminal illness / irreversible coma / PVS, are very different conditions. Different principles apply here—for eg., any treatment in truly irreversible coma would be wrong, even ANH. Whereas in the case of PVS, withdrawal of ANH would be euthanasia. Euthanasia defined as “direct intentional killing of a patient as a part of the medical care being offered.” Omission can also be a means of intentional killing. Euthanasia defined as “direct intentional killing of a patient as a part of the medical care being offered.” Omission can also be a means of intentional killing. Artificial vs. natural rather than proportionality the criteria. That is, artificial means are always inappropriate or burdensome… Definition of life-sustaining treatment includes ANH. (Catholic hospitals should not cooperate with this) Artificial vs. natural rather than proportionality the criteria. That is, artificial means are always inappropriate or burdensome… Definition of life-sustaining treatment includes ANH. (Catholic hospitals should not cooperate with this) Family or relatives seen as enemies to patient self-determination. Elimination of proxy as an option. This is absurd in the Asian context, especially in view of the recent shift of opinion coming from the Western experience. Family or relatives seen as enemies to patient self-determination. Elimination of proxy as an option. This is absurd in the Asian context, especially in view of the recent shift of opinion coming from the Western experience. Options only to withdraw or withhold treatments, no mention of desire to continue treatments under these conditions. Doubt: cost saving measures? Options only to withdraw or withhold treatments, no mention of desire to continue treatments under these conditions. Doubt: cost saving measures?