BLG 699 Study Guide - Midterm Guide: Insomnia, Blood Transfusion, Public Health Service Act
Document Summary
Who -> 10 years of these ethical principles. National research act 1974: by national commission for the protection of human subjects of biomedical and behaviour research. Document was written: ethical principles + guidelines for the protection of human subjects of research. Respect for persons as well as safe guards for the vulnerable populations. Beneficence 2 general characteristics: do no harm, max benefit by minimizing risk. Justice implies fairness: equal selection of subjects for research. 3 extreme abuse: 1932 tuskegee syphilis study black males, not informed, not given penicillin, jewish chronic disease hospital study deliberately injected live cancer cells into elderly patients suffering from chronic diseases. Fda became partners to ensure: adequate trail design, generation of data under rigorous inspection. 1988: expedited ind approval process for life threatening illnesses. Allowed the companies to collapse phase ii + iii. Drug approval process in us takes longer than in eu. Enacted in 1992 more people reviewed human drugs.