Exam 1 Flashcards
Basic Moral Principles
1) Autonomy - a persons rational capacity for self governance or self determination
2) Nonmaleficence/Beneficence - not inflicting harm on patients and helping avoid harm
4) Utility - we should produce the most favorable balance of good over bad for all concerned
5) Justice - people getting what is fair or what is their due.
Kantian Ethics
following a rationale and universally applicable morale rule solely out of a sense of duty
Generally, Kantian ethics rejects or accepts paternalism?
Rejects
Nazi Data Case
Questions: “How should the Nazi data be regarded? Should it be used if it can save lives? Is the data tainted by the Nazi crimes or is it morally neutral information? Should researchers treat this data any differently than data gathered in more conventional ways?”
Argument for: We have a fundamental obligation to save lives and advance knowledge.
Argument against: Tainted knowledge, desecrating memory of the victims, makes us “on lookers to evil”
Ethic Requirements for Clinical Trials
- Informed Consent: Subjects must give their informed voluntary consent to participate.
- Minimize Risk: The study must be designed to minimize risks to subjects and offer an acceptable balance of risks and benefits.
- Confidentiality: The subjects’ privacy should be protected, and the confidentiality of research data must be preserved.
- Fairness/Justice: Subjects must be selected fairly to avoid exploiting or unjustly excluding them. (e.g. Race and Sex)
- IRB review (Institutional Research Board) Before the
research is conducted, it mustbe reviewed and approved by an independent panel.
Clinical Trial
A scientific study designed to systematically test a medical intervention in humans
Blinding
A procedure for ensuring that subjects and researchers do not know which interventions the subjects receive (standard treatment, new treatment, or placebo)
Placebo
An inactive or sham treatment - vs. active-controlled trial with old vs. new treatment
Randomization
The assigning of subjects randomly to both experimental and control groups
Stages of Clinical Trials
Phase I trial—Tests the drug in a few people for safety and adverse reactions and ascertains safe and unsafe doses (nontherapeutic).
Phase II trial—Investigators give the drug to larger groups of subjects to get a preliminary indication of its effectiveness and to do more assessments of safety.
Phase III trial—Researchers try to finally establish whether the drug is effective, determine how it compares with other proven treatments, and learn how to use it in the safest way (therapeutic; largest trials; capable of providing definitive answers about a treatment’s worth).
Equipose
when a physician is rationally balanced between the alternative treatments
Descriptive Ethics
what are the moral beliefs and practices of individuals, cultures, societies (What to people believe)
Normative Ethics
The search for, and justification of,
moral standards, principles, norms.
What ought we believe?
Meta Ethics
The study of the status and justification of moral beliefs; and the meaning/semantics of moral language and discourse
Utilitarian Consequentialism
Maximize the happiness for all; the greatest good for the greatest number; the best possible consequences
Act Utilitarian/Consequentialist – case by case
Rule Utilitarian/Consequentialist – optimal rules
Kantian Deontology
– focuson Rights and Duties: Morality as Categorical Imperatives: Universalizability (what is everyone did the same?); Treating persons as ends and not means only; Respect for Autonomy and self-determination
Who are considered vulnerable subjects? When is it permissible to use them in a study?
Diminished Capacity: Infants and Children Mature Minors
Mentally incompetent, and the Elderly
Prisoners
Soldiers
Studies on impaired or vulnerable subjects are permissible, with adequate proxy consent & patient acceptance, if:
1. Minimal risk
2. Some risk, but likely net benefit to vulnerable subject
3. Some risk, but likely to provide important knowledge about illness
Cornell Haiti Case Study
Case was about couples that had parter with HIV in Haiti, Main Issue: Baseline treatment level for study?
(i) same as US standard of effective treatment?
or (ii) baseline of the country in question?
Arguments For: Baruch Brody
- Injustice to subject? – No, because subjects are not harmed relative to the baseline standard of care that otherwise should be available in light of practical realities of the country in question.
- Coercive Offers? - Not coercive, if there is (i) no threat, (ii) minimal risk (acceptable balance of risks and benefits), (iii) consent – to think otherwise is paternalistic and disrespectful.
- Exploitation of developing countries? (i) Local IRB approval; (ii) the subjects themselves should be guaranteed access to any successful therapies resulting from the studies.
Arguments Against: Marcia Angell
Same standards as host country/USA. Best available treatment as control group or historical control group results – Otherwise it is analogous to the unethical Tuskegee study
Additional issues – International exploitation of developing world as research subjects.
Less regulated and competitive environments
Arguments for confidentiality in reference to the moral principles
- Beneficence: Without respect for confidentiality, physicians would have a difficult time fulfilling their duty of beneficence; that is, helping patients.
- Trust: Without respect for confidentiality, trust between physician and patient would break down.
- Non-maleficence: Disclosure of confidential medical information could harm patients.
- Autonomy: Self-determination over personal information. Promise/Expectation of confidentiality
What is Rachel’s argument for relationships and privacy?
YES, Privacy and consequences:
Embarrassing personal information
Harmful consequencesto relationships, employment … Unfair or discriminatory use of personal information
Competitive secrets
Tarasoff Case Arguments
Majority Opinion of the Court: “The protective privilege
ends where the public peril begins.”
Argument against breaking confidentiality:
- Deters treatment
- Undermines full disclosure
- Undermines trust in on-going relationship
- Over-reaction because of the disproportion of verbal threats v. true risk of violent acts
How does Kant view confidentiality versus act utilitarianism and rule utilitarianism
Kantian – absolute duty: honesty, privacy & autonomy BUT - Does the wrongful conduct of others matter?
Act Utilitarian/Act Consequentialist – case by case analysis
Rule Utilitarian/ Rule Consequentialism – what are the optimal moral rules and principles?
Legal Limits on confidentiality
Gunshot &weaponwounds
Legal & Judicial proceedings; psychological evaluations Child Abuse &ElderAbuse, perhaps Adult Domestic Abuse Contagious disease reporting
Suicide (intention,plan, means)
Serious threat to others – the public peril (Tarasoff)
Others situations
Insurance Billing; Collections
Siegler’s Views on confidentiality
Avoid indiscretions in discussing cases in public …
“Need to Know” principle; partition and number/code
(electronic) medical records; differentiate psychiatric record?; distinguish financial/billing v. medical team; balance patient need for holistic medical care team!
Disclosure of limits on confidentiality
Patient determination of privileged information? - unworkable
Results of the Oken and Novak Study, and what they showed
Oken Study 1962:
◦ 12% of physicians disclose a diagnosis of cancer ◦ But 87% of patients want to know
Novak Study 1979:
◦ 98% of physicians report that their usual policy is
full disclosure of all serious medical conditions, including cancer.
Demonstrated a shift from paternalism to autonomy
Hippocratic Approach to Medical Paternalism
- The main duty of a physician is to help (the principle of beneficence), but above all do no harm (the principle of non-maleficence).
- “Preserve life” is the fundamental goal of medicine. Death is always a harm, and it is thus a defeat of medical practice.
- Paternalistic authority: the physician is the judge of what is a benefit or harm to the patient.
Autonomy model of consent
- The first duty is to respect patient autonomy and self-determination.
- In judging beneficence and non-maleficence, the physician must base these judgments on the particular patient’s values.
- The patient is the final judge of his or her own best interests, and thus of what is a benefit and what is a harm (the principle informed consent).
- The fundamental goal of medicine is to preserve thedignityofpatients. Thisusuallyinvolves saving lives and restoring health, but it may involve allowing “death with dignity”
Kant views on self determinism vs. Mill’s views on self determinism
Kant: treating people as ends and not mere means includes respecting the capacity for self-determination.
Full disclosure respects patient autonomy and is necessary for effective self-determination.
Mill: “Each is the proper guardian of his own health, whether bodily, or mental, or spiritual. Mankind are the greater gainers by suffering each other to live as seems good to themselves, than by compelling each to live as seems good to the rest”
Therapeutic Privilege Argument for and against full disclosure
For: truth-telling can be injurious, causing feelings of panic, hopelessness, fear, and depression.
Against: (1) Exaggerates the harm done to patients by full disclosure, underestimate the clinical beneficial effects of truthfulness – (next slide)
(2) fails to recognize that misleading or lying to patients can also do damage to patients non- health values – (see Goldman)
Clinical Benefits of disclosure and informed consent
Diminishes patients’ misconceptions or inaccurate fears about their situation and prospects.
Increases patient compliance and self- monitoring
Improves patient recovery and/or acceptance with a better understanding of the process
Sides for Presumed Consent Argument
Against : Patients do not want to know the truth, especially if the prognosis is grim.
For: Data from surveys suggest that most patients really do prefer to be told the truth about their diagnosis.
Incapacity Consent Argument
For: Physicians have NO duty to tell patients the truth because patients are incapable of understanding the medical facts and probabilities, especially when faces with serious illness. (Lipkin article)
Counterargument: Even if communicating the whole truth is impossible, physicians still have an obligation to try to convey to patients the more essential information in an accessible and compassionate manner (Schwartz article)
Elements of Informed Consent
- Competence and capacity to understand and decide
Informational Elements: - Disclosure of relevant information
◦ Recommendation of a course of treatment - Understanding of Disclosure and Recommendation
Consent (or Refusal) Elements: - Voluntariness in deciding on a plan
◦ Patient’s Decision - Consent – Official Authorization/ConsentForm
The 3 Disclosure Standards
- Professional Practice Standard
◦ What is the common professional practice? ◦ NOTE: This is the standard before 1972
After (Jerry) Canterbury v Spence (1972): - Reasonable Person/Patient Standard
◦ What would a reasonable patient want to know?
◦ This is the basic legal standard - Pure Autonomy/Subjective Standard
◦ What does the particular patient want to know? ◦ When is this an appropriate standard?
What is given during disclosure?
- Nature of the Procedure
- Risks of Procedure; kind & probability
- Alternatives – including no treatment
- Benefits Expected; degree & probability
Proxy Consent Standards
- Substituted Judgment Standard What would the patient want if competent?
[and Not: what do you want for the patient?] ◦ Based on prior statements and known values ◦ Presupposes patient was once competent - Best Interest Standard
Is the treatment beneficial to the patient?
◦ Objective pain & suffering or health & comfort
◦ Involves quality of life judgment; but not social worth } 3. Reasonable Patient Standard
What would a reasonable person want?
Consider PVS patients and broader social considerations
Proxy Consent for Medical Gamble Case
viral vs bacterial meningitis, husband says no
Argument for consent: respects autonomy
Against: Woman and baby could die
Emanuel’s 4 Models
• Paternalism Model – Benevolent Guardian
• Informative Model
– Fact v Value divide; Autonomy: Choice and control
– Physician as technical expert • Interpretive Model
– Health values are fluid
– Autonomy: Self-understanding – Medical counselor
• Deliberative Model
– Health and other related social values
– Autonomy: Self-development, including moral character
and responsible choices
– Medical and Overall counsel for health related decisions
Forms of Voluntariness and Influence
◦ Rational Persuasion = Appeal to good reasons
◦ Manipulation = Appeal to emotions and
counteracting common forms of irrationality
◦ Deception = Passive/omission or Active lying
◦ Coercion = use of Force or Threats,
Forms of Consent/refusal
- Explicit Consent - a specific authorization
- Tacit or Implicit Consent
◦ presupposes possibility of refusal or dissent - Presumed Consent or Hypothetical Consent
◦ If one could consent, or knew more, one would
◦ Assumption of after the fact (ex post facto) consent - Deemed Consent
◦ a permission to act as if the patient/person has consented; there is no right to withdraw or withhold consent.
Types of Paternalism
- Strong Paternalism
◦ Substantially autonomous & informed patient - Weak Paternalism
◦ Diminished capacity and understanding - Active Paternalism – actively treating a patient
- Passive Paternalis m – refusal of patient requests
“Aint nobody gonna cut my head” case
Many losing physical and memory control is asked to undergo minor surgery, outright refuses.
DNI When no means no case
Man has allergy attack from anti bionics after signing DNI agreement through proxy
For: dont incube, no means no
Against: The proxy didn’t fully clarify under what circumstances DNI would apply
Basics of Confucianism
Confucius (551-479 BCE): founder of a tradition
Primarily a social system aimed at harmonious social
relations
Natural hierarchy of social relations.
Organized through a system of education necessary for public officials
Focused on self-development and the virtues of character.
Social harmony and responsibility more important than individual rights and freedoms
The confucian prime virtues
The following of Li - Right behavior & the principles of good government- protocol, etiquette, propriety, and ritual
The cultivation of Ren (or Jen), which is benevolence and humaneness, is equally emphasized and balances Li.
Reciprocity – Confucian Golden Rule: “never impose on others what you would not choose for yourself.”
Sincerity is an internal orientation manifest in proper action.
The 5 relationships in confucianism
Parent and child Elder brother and younger brother Husband and wife Friend and friend Ruler and subject
Filial Piety
honoring and caring for one’s parents and elders - is the central and distinctive virtue of Confucian thought. A hierarchy of age is respected throughout each relationship.
Difference between traditional and progressive confucianism
Traditional Confucianism is distinctly gendered. Progressive Confucianism is more egalitarian.
4 Nobel Truths of Buddhism
The Truth of Suffering, Dukkha:
All existence is unsatisfactory and filled with suffering. Even those things that seem to bring joy and pleasure in the end are unsatisfying and unfulfilling, and thus leave us unhappy and craving for something more.
The Truth of the Arising of Suffering in Craving:
The root of suffering can be defined as a craving or clinging; the endless seeking for fresh experiences; the thirst for sensual pleasure, for existence, for non-existence. It is craving itself that gives rise to the endless cycle of rebirth.
The Truth of the Cessation of Suffering through Transcendence, Nirvana:
It is possible to find an end to all forms of suffering, through the cessation of craving with its associated attachment, hatred, and delusion, and thereby achieve liberation from the otherwise endless cycle of rebirth. The
Truth of the Noble Eightfold Path that leads to Nirvana:
The path is the Middle Way between a life of self indulgence and a life of harsh austerity or self denial. It involves wisdom, moral conduct, and transformative meditation:
Five Basic Moral Precepts of Classic Theravada Buddhism
- killing and injury, in general
- stealing and cheating
- sexual immorality
- lying and all forms of deception
- avoiding intoxication/intoxicants
4 Immeasurables (virtues) of buddhism
Developing Loving-Kindness counteracts ill-will, anger, and hatred.
Developing Compassion counteracts malice and cruelty.
Developing Sympathetic Joy (in the good fortune of others) counteracts envy, resentment, and jealousy.
Developing Equanimity counteracts indifference, partiality, and egoism.
Principles of Buddhist Bioethics
Following the Middle Path:
Wisdom, Morality & Insight Meditation not Autonomy of the will
Interconnectedness & Selflessness not individualism
Focus on Responsibilities; not rights-based
Non-Maleficence – do not intentional harm or kill
any person or sentient creature
Beneficence – Boundless Compassion
Justice and Equity – Universal Health Care
5 Pillars of Islam
Declaration of Faith (Shahada) Prayer (Salah) Charity (Zakat) Fast/Ramadan Pilgrimage/Hajj
What do Sharia Moral principles state
a) take the lesser ofthe two evils - “God
desires your well-being, not your discomfort.”
b) necessity overrides prohibition
Basics of Islamic Medical Ethics
Submission to the Divine Will through the Qur’an, Hadith, consensus, and analogical reasoning; Ethics is not based on respect for individual autonomy.
Honor the dignity of patients by respecting privacy, confidentiality, and securing informed consent.
Non-maleficence - Life and Death lies ultimately in God’s hands
Principle of Necessity (necessity cancels normal prohibition)
Beneficence, Charity and Compassion .
Principle of Lesser Evil (whenever possible, minimize harm or wrong-doing)
Justice and Equity – Universal access to health care services
Community and Family focused
Islamic patients face particular medical issues linked to the Islamic way of life (daily prayer, the fast, the Hajj, and gendered expectations).
Individual autonomy is not the central concept of Islamic bioethics.
Moral Principles in Islamic medical ethics are similar to Western bioethics.
Physician Preference Order
Muslim same sex
Non-Muslim same sex
Muslim different sex & same sex nurse or assistant
Non-Muslim different sex & same sex nurse or assistant
