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PRINCIPLES OF BIOETHICS ERWIN P. CARABEO, M.D., FPCP I. Definition Bioethics - a discipline dealing with the ethical implications of biological research and applications especially in medicine - Websters Online Dictionary - implied consent - therapeutic privilege - emergencies IV. Factors that contribute to determining medical need 1. likelihood to benefit the patient 2. urgency of need 3. change in quality of life 4. duration of benefit II. Ethical Principles 1. Autonomy – right of individual to make choices; principle of informed consent 2. Beneficence – doing good or what will further the patient’s interest 3. Non maleficence – avoid harm to the patient 4. Justice – distribution of goods and services fairly; treat equal cases equally V. Non-medical criteria for limits that should not be used 1. ability to pay 2. social worth 3. obstacles to treatment 4. patient contribution to illness 5. use of past resources III. Informed Consent 1. Requirements - competent patient/surrogate - free from coercion or undue influence - provision of understandable necessary information VI. Research Ethics - the systematic analysis of ethical and legal questions to ensure that study participants are protected and, ultimately, that clinical research is conducted in a way that serves the needs of such participants and of society as a whole. 2. Surrogate Decision Makers - spouse - children of legal age - parents - siblings of legal age - grandchildren of legal age - cousins 3. Principles governing decision making when patient is no longer competent - known prior expressed of the patient - substituted judgment - best interest of the patient - hospital ethics committee - courts 4. Disclosure necessary for informed consent - diagnosis - nature and purpose of the treatment - known risks and consequences of treatment - doctor’s and hospital’s success and failure rates - benefits expected and the likelihood of their being realized - all alternative treatments - prognosis if no treatment is given - costs and burdens of the treatment 5. Exceptions to the Requirement of Informed Consent - Guiding principles: beneficence, justice respect for persons, - Other ethical requirements for clinical research: 1. A study must employ a scientifically valid design to answer the research question. 2. A study must address a question of sufficient value to justify the risk posed to participants. 3. A study must be conducted honestly. 4. Study findings must be reported accurately and promptly. - Reasons why patients volunteer for research studies: 1. to improve care for future patients with health problems like theirs 2. to receive the newest treatments 3. to have more careful monitoring of their conditions and treatments 4. to get free care they need, which they can’t afford