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

Informed Consent. By: Ronald F. White, Ph.D. Professor of Philosophy College of Mount St. Joseph. Basic Principles. Information Rationality Self-interest Consent Free Will Personal coercion Exploitation Buyers v. sellers Harm v. benefit Paternalism Control Body (Physical Force)

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

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

  2. Basic Principles • 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. Informed Consent in Research • 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. Informed Consent in Treatment • 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)

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