By: Ronald F. White, Ph.D.
Professor of Philosophy
College of Mount St. Joseph
• Information
– Rationality
– Self-interest
• Consent
– Free Will
• Personal coercion
– Exploitation
» Buyers v. sellers
» Harm v. benefit
– Paternalism
» Control Body (Physical Force)
» Control Information (withhold, lies)
•
•
•
Why biomedical research?
Institutional Foundations
Conflict of interest
–
–
–
–
•
Moral Principles
–
–
–
–
–
•
Physicians (MD) vs. Researchers PH.D)
future patients v. present patients
Medicine v. business
Institutional: professional, scientific, funding, government)
UtilityLiberty (autonomy)
BeneficenceNon-Maleficence
Justice
Classic Cases
–
Nazi Experiments
•
–
Tuskegee Syphilis Study
•
•
•
Nuremberg Code
Belmont Report
Problematic Cases: incompetents: mentally ill, children and fetuses, comatose, elderly, desperate,
inmates.
Role of Government
–
National Institutes of Health (NIH)
•
–
Institutional Review Boards (IRB)
Food and Drug Administration (FDA)
•
Safety and effectiveness of drugs and medical devices
Belmont Report
•
•
•
•
April 18, 1979
Boundaries Between Practice and Research
Basic Ethical Principles
– Respect for Persons
– Beneficence
– Justice
Applications
– Informed Consent
– Assessment of Risk and Benefits
– Selection of Subjects
• Vulnerable Groups
–
–
–
–
Racial minorities
Economically disadvantaged
Very sick
institutionalized
Institutional Review Boards
• 1. The proposed research design is scientifically sound & will not
unnecessarily expose subjects to risk.
• 2. Risks to subjects are reasonable in relation to anticipated
benefits, if any, to subjects, and the importance of knowledge that
may reasonably be expected to result.
• 3. Subject selection is equitable.
• 4. Additional safeguards required for subjects likely to be vulnerable
to coercion or undue influence.
• 5. Informed consent is obtained from research subjects or their
legally authorized representative(s).
•
•
•
Evolutionary Foundations of Beneficence
– Feelings of Empathy and Sympathy
Paternalism (beneficence/liberty)
– Violation of liberty to provide a benefit
• Coercion
– History: “Take two of these and call me in the morning.”
– Forms of Paternalism
• Individual paternalism, state paternalism
• Pure paternalism, impure paternalism
– Criteria for Paternalistic Intervention
• Harm
• Competence
• Redounding good (effectiveness: harm v. intervention)
• Least restrictive alternative
Informed Consent
– Canterbury v. Spence
• Canterbury Standard
– “ All risks must be unmasked.”
– Defects in information disclosure
– Personal coercion (exploitation or paternalism)