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• BELMONT REPORT

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

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

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)

INFORMED CONSENT

• Elements - continued– Consent elements

• Decision (in favor of a plan)• Authorization (of the chosen plan)

IRB/HIC

• Issues– Consent from legally authorized

representative– Vulnerable Subjects:

• Normal volunteers• Prisoners (federal regulation)

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

Treatment Refusals

• Dax Cowart– Right to refuse treatment– Right to informed consent

• Ethical Principle– Autonomy

• Positive right: Self determination• Negative right: Noninterference

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