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PA Profession

PA Profession. ETHICS COMMITTEE RIGHT TO REFUSE TREATMENT Salvatore Barese, PA-C. Healthcare Ethics Committees. IRB - INSTITUTIONAL REVIEW BOARD - more than 2,000 in the US HIC - HUMAN INVESTIGATION COMMITTEE ETHICS COMMITTEE OFFICE OF PROTECTION FROM RESEARCH RISKS (OPRR) - 45 CFR 46

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PA Profession

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  1. PA Profession ETHICS COMMITTEE RIGHT TO REFUSE TREATMENT Salvatore Barese, PA-C

  2. Healthcare Ethics Committees • IRB - INSTITUTIONAL REVIEW BOARD - more than 2,000 in the US • HIC - HUMAN INVESTIGATION COMMITTEE • ETHICS COMMITTEE • OFFICE OF PROTECTION FROM RESEARCH RISKS (OPRR) - 45 CFR 46 • BELMONT REPORT

  3. BELMONT REPORT • Ethical Principles and Guidelines for the Protection of Human Subjects of Research - 1979 • Three basic principles • Respect for Persons • Beneficence • Justice • Applications: informed consent, assessment of risks and benefits, selection of subjects

  4. IRB/HIC • Issues • Inclusion of women, pregnant women, and minorities in clinical research (illegal to discriminate) • Compensation for research participants (coercion and undue influence) • Advertising of research • Blood drawing - amount of blood & # sticks

  5. INFORMED CONSENT • Elements: • Preconditions: • Capacity (to understand and decide) • Voluntariness (in deciding) • Information elements • disclosure (of material information) • recommendation (of a plan) • Understanding (of disclosure and recommendations)

  6. INFORMED CONSENT • Elements - continued • Consent elements • Decision (in favor of a plan) • Authorization (of the chosen plan)

  7. IRB/HIC • Issues • Consent from legally authorized representative • Vulnerable Subjects: • Normal volunteers • Prisoners (federal regulation)

  8. Controversial Research Projects • Tuskegee (PHS, CDC) 1932-1972 • Thalidomide and the FDA 1962 • Jewish Hospital Cancer Study, 1963 • Baboon-to-human Heart Transplant, 1964 • Willowbrook Hepatitis Study, 1965 • Beecher article, 1966 • Tea Room Trade, 1967 • Fetal research, 1973

  9. Treatment Refusals • Dax Cowart • Right to refuse treatment • Right to informed consent • Ethical Principle • Autonomy • Positive right: Self determination • Negative right: Noninterference

  10. TREATMENT REFUSAL Patient’s Bill of Rights “The patient has the right to refuse treatment to the extent permitted by law and to be informed of the medical consequences of his action.” American Hospital Assn

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