1. By: Ronald F. White, Ph.D. Professor of Philosophy College of Mount St. Joseph

2. 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)

3. Why biomedical research? Institutional Foundations Conflict of interest –Physicians (MD) vs. Researchers PH.D) – future patients v. present patients –Medicine v. business –Institutional: professional, scientific, funding, government) Moral Principles –Utility- –Liberty (autonomy) –Beneficence- –Non-Maleficence –Justice Classic Cases –Nazi Experiments Nuremberg Code –Tuskegee Syphilis Study 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

4. 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

5. 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).

6. 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)