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. 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