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

History of Eugenics in the U.S.

Francis Galton & Co. founded the eugenics movement>> Western Europe and U.S.

Early 20th Century: Involuntary sterilization lawsRace & ethnicity-based immigration restrictions

Examples:Buck v. Bell (1927)Skinner v. Oklahoma (1942)