Transcript MCRTP Responsible Conduct of Research

MCRTP
Responsible Conduct of Research
GENETICS AND HUMAN REPRODUCTION
DR. BEN A. RICH
PROF. LISA IKEMOTO
Approach
 Review - history of biomedical ethics
 Discuss
 Review – history and practice of eugenics in the U.S.
 Discuss
 Case studies
History of Biomedical Ethics
 Historical antecedents
 e.g. Hippocrates
 19th century: development of clinical research
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Breakthroughs and abuses
Early 20th century
Observation to intervention
 Increase in private funding
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WWII
Research as part of the war effort
 Federal funding
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History of Biomedical Ethics
 Key events
 Nazi War Crimes Trials: the Nazi Doctors and the Nuremberg
Code
 Thalidomide (1957-1962)
 The Beecher article (1966)
 Jewish Chronic Disease Hospital (1963) and Willowbrook
(1956-1971)
 Tuskegee (1932-1972)
History of Biomedical Ethics
 Regulation of biomedical research
 Nuremberg Code (1946)
 Kefauver-Harris Amendments to the FDCA of 1938 (1962)
 National Research Act of 1974
>> Belmont Report (1979)
>> Federal Regulation of Human Subject Research
 Federal Common Rule (1991)
The Belmont Report (1979)
 Part A: Boundaries Between Practice & Research
 Part B: Basic Ethical Principles
1. Respect for Persons
2. Beneficence
3. Justice
Belmont Report:
Ethical Principles and Applications
1) Respect for persons
Application: Informed Consent
2) Beneficence
Application: Assessment of Risks and Benefits
3) Justice
Application: Selection of Subjects
History: Other Key Events – 1970s
 Roe v. Wade (U.S. 1973) – woman’s right to decide
whether or not to terminate a pregnancy.
 In re Quinlan (N.J. 1976) – right to refuse treatment
(ventilator)
 Birth of Louise Brown, 1978 – first child born as a
result of IVF.
Core Bioethical Principles . . .
 The “Georgetown
Mantra”
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respect for individual
autonomy
beneficence
nonmaleficence
justice
 Benefit and harm
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Value-laden concepts
Whose perspective?
Core Principles …
 Respect for individual autonomy
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Etymological roots: self-rule
Premised on dignity and moral worth of each person qua
person
Not a traditional core value of medicine
Constitutional dimension – substantive due process
(privacy as “the right to be let alone”)
Underlying moral principle more aptly captured by term
“authenticity” when patient lacks decisional capacity
Balanced in so-called “right to die” litigation by
“countervailing interests of the state”
… Core Principles
 Beneficence/nonmaleficence
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Deep roots in Hippocratic medicine
Primum non nocere (first do no harm)
Critical moral question: who shall be the final arbiter of what
constitutes benefit and harm?
 Query: Is life-sustaining treatment always beneficial? Is
allowing a patient to die always harmful? – concept of a
“medical fate worse than death”
 Tradition of medical paternalism presupposed that
physician determined patient benefit and harm
 Hard vs. soft paternalism
Alternative Ethical Approaches
 Virtue Ethics
 Roots in classical Greek philosophy
 Focus on character traits, e.g., integrity, honesty, fidelity,
generosity, compassion
 Virtuous person not only acts morally, but does so out of
authentic moral motivation and not to avoid sanction
 Ethics of Care
 Response to emotional detachment of traditional theories
 Particularly pertinent to bioethical analysis
 Casuistry
 Reliance on paradigm cases and precedent
 Application of principles to cases with discernment
Elements of Sound Ethical Analysis
 Gather relevant data
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discussions with involved parties
examination of medical records & other documentation
review organizational policy/guidelines
 Clarify relevant concepts
confidentiality, privacy, informed consent
 Clarify related normative issues
 societal values
 legal provisions (case law, statutes, etc.)
 Identify range of morally acceptable options
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Analytic Matrix
 Medical Indications
Does the proposed
measure/intervention
fulfill any goal of health
care?
 What is the likelihood of its
success
 Quality of Life
 Describe from patient’s
perspective
 Other qualitative
considerations from
patient’s perspective
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Patient Preferences
 Expressed in terms of goals,
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values, priorities
Consistency of wishes with
core values
Indications of decisional
capacity
Contextual Features
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Social, economic, and
institutional features, e.g.,
inability to cover cost of
measures; inadequate social
support
Legal, regulatory, policy
constraints/requirements
An Ethics Workup
 Clearly and concisely state issue or issues
 Ascertain the legitimate decision makers (stakeholders)
 Describe pertinent facts – medical, psychosocial,
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situational, institutional
Identify relevant interests – patient, family, professional,
institutional – and their interrelationships
Delineate the range of options for action
Facilitate discussion among all parties in interest in
pursuit of consensus
Determine risks and benefits of acting without consensus
if the dispute proves intractable
Formulate and follow a process for acting without
consensus that accurately reflects the basis for doing so
History of Eugenics in the U.S.
Francis Galton & Co. founded the eugenics movement
>> Western Europe and U.S.
Early 20th Century:
Involuntary sterilization laws
Race & ethnicity-based immigration restrictions
Examples:
Buck v. Bell (1927)
Skinner v. Oklahoma (1942)