genetics and human reproduction dr. ben a. rich prof. lisa ikemoto mcrtp responsible conduct of...
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GENETICS AND HUMAN REPRODUCTIONDR. BEN A. RICH
PROF. LISA IKEMOTO
MCRTP Responsible Conduct of
Research
Approach
Review - history of biomedical ethicsDiscuss Review – history and practice of eugenics in
the U.S.DiscussCase studies
History of Biomedical Ethics
Historical antecedents e.g. Hippocrates 19th century: development of clinical research
Breakthroughs and abuses Early 20th century
Observation to intervention Increase in private funding
WWII Research as part of the war effort Federal funding
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 Principles1. Respect for Persons2. Beneficence3. Justice
Belmont Report: Ethical Principles and Applications
1) Respect for persons
Application: Informed Consent
2) BeneficenceApplication: Assessment of Risks and Benefits
3) JusticeApplication: 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” respect for individual
autonomy beneficence nonmaleficence justice
Benefit and harm Value-laden concepts Whose perspective?
Core Principles …
Respect for individual autonomy 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 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 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
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
Patient Preferences Expressed in terms of
goals, values, priorities Consistency of wishes
with core values Indications of decisional
capacity
Contextual Features 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,
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
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