Question 1Issued in 1974, 45 CFR 46 raised to regulatory status: The Nuremberg Code The 1974 National Research Act Kefauver-Harris Drug Amendments to the Federal Food, Drug & Cosmetics Act US Public Health Service PolicyQuestion 2Which of the following brought increased public attention to the problems with the IRB system? HHS Inspector General Report of 1998 1983 Presidential Commission Report Death of Research Subject (Jesse Gelsinger) “Shut Downs” by OHRPQuestion 3Which of the following is included in the Nuremberg Code: Equitable selection of subjects Additional protection for vulnerable subjects Voluntary consent Confidentiality of dataQuestion 4Which of the following was the result of the Beecher article? An identification of basic ethical principles Multiple Congressional hearings Additional FDA regulations Realization that ethical abuses are not limited to the Nazi regimeQuestion 5Informed consent is considered an application of which Belmont principle? Beneficence Justice Non-maleficence Respect for Persons

Question 1Issued in 1974, 45 CFR 46 raised to regulatory status: The Nuremberg Code The 1974 National Research Act Kefauver-Harris Drug Amendments to the Federal Food, Drug & Cosmetics Act US Public Health Service PolicyQuestion 2Which of the following brought increased public attention to the problems with the IRB system? HHS Inspector General Report of 1998 1983 Presidential Commission Report Death of Research Subject (Jesse Gelsinger) “Shut Downs” by OHRPQuestion 3Which of the following is included in the Nuremberg Code: Equitable selection of subjects Additional protection for vulnerable subjects Voluntary consent Confidentiality of dataQuestion 4Which of the following was the result of the Beecher article? An identification of basic ethical principles Multiple Congressional hearings Additional FDA regulations Realization that ethical abuses are not limited to the Nazi regimeQuestion 5Informed consent is considered an application of which Belmont principle? Beneficence Justice Non-maleficence Respect for Persons

Question 1The National Research Act of 1974 Identified the basic ethical principles of human subjects research. Required that all federal agencies have the same regulations governing human subjects research. Established the National Commission. Identified guidelines to ensure the ethical conduct of research.Question 2Which of the following was the result of the Beecher article? Realization that ethical abuses are not limited to the Nazi regime An identification of basic ethical principles Additional FDA regulations Multiple Congressional hearingsQuestion 3Which of the following is included in the Nuremberg Code: Confidentiality of data Voluntary consent Equitable selection of subjects Additional protection for vulnerable subjectsQuestion 4Issued in 1974, 45 CFR 46 raised to regulatory status: Kefauver-Harris Drug Amendments to the Federal Food, Drug & Cosmetics Act The Nuremberg Code US Public Health Service Policy The 1974 National Research ActQuestion 5The use of prisoners in research is a concern under the Belmont principle of Justice because: Prisoners are not a representative sample of the general population Prisoners may not be used to conduct research that only benefits the larger society Prisoners are less educated that the general population and have difficulty understanding research Prisoners are not free to say no

Which law defines what drugs require a prescription?10 pointsFood Drug and Cosmetic Act (1938)Kefauver-Harris Amendment (1962)Food and Drug Act (1906)Durham-Humphrey Amendment (1951)3.Question 3Following the discovery that thalidomide causes severe birth defects, which federal drug law requires manufacturers to provide proof of both safety and efficacy before marketing in the United States?10 pointsFood and Drug Act (1906)Harrison Tax Act (1914)Food Drug and Cosmetic Act (1938)Kefauver-Harris Amendment (1962)4.Question 4Which law requires pharmacists to dispense most prescription drugs in child-proof packaging?10 pointsOrphan Drug Act (1983)Poison Prevention Packaging Act (1970)Fair Packaging and Labeling Act (1966)Prescription Drug Marketing Act (1987)5.Question 5Which law established the DEA as a division of the Justice Department?10 pointsOmnibus Budget Reconciliation Act (1990)Controlled Substances Act (1970)Food and Drug Act (1906)Food Drug and Cosmetic Act (1938)6.Question 6Which law provides incentives to promote research, approval, and marketing of drugs needed for the treatment of rare diseases?10 pointsHatch-Waxman Act (1984)Orphan Drug Act (1983)Kefauver-Harris Amendment (1962)Durham-Humphrey Amendment (1951)7.Question 7Which law requires pharmacists to offer counseling to Medicaid patients receiving prescriptions?10 pointsPrescription Drug Marketing Act (1987)Omnibus Budget Reconciliation Act (1990)Kefauver-Harris Amendment (1962)Health Insurance Portability and Accountability Act (1996)8.Question 8Which law provides regulations for the transfer of patient health information?10 pointsHatch-Waxman Act (1984)Omnibus Budget Reconciliation Act (1990)Kefauver-Harris Amendment (1962)Health Insurance Portability and Accountability Act (1996)9.Question 9Which law put into place voluntary prescription drug cover to eligible patients?10 pointsOrphan Drug Act (1983)Durham-Humphrey Amendment (1951)Medicare Modernization Act (2003)Kefauver-Harris Amendment (1962)The following question contains 1 dropdown response.

Which act streamlined the generic drug approval process, and gave incentives to manufacturers to develop new drugs?Question 1Answera.Orphan Drug Act of 1983.b.Drug Price Competition Act of 1984.c.Kefauver-Harris Amendment of 1962.d.Food and Drug Administration Modernization Act of 1997.

Following the fatal poisoning by untested sulfanilamide, which federal drug law requires new drugs be shown to be safe before marketing?10 pointsFood Drug and Cosmetic Act (1938)Food and Drug Act (1906)Poison Prevention Packaging Act (1970)Harrison Tax Act (1914)