Question 1Which of the following brought increased public attention to the problems with the IRB system? Death of Research Subject (Jesse Gelsinger) HHS Inspector General Report of 1998 “Shut Downs” by OHRP 1983 Presidential Commission ReportQuestion 2The 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 noQuestion 3Informed consent is considered an application of which Belmont principle? Beneficence Justice Non-maleficence Respect for PersonsQuestion 4Which of the following is included in the Nuremberg Code: Confidentiality of data Voluntary consent Equitable selection of subjects Additional protection for vulnerable subjectsQuestion 5The National Research Act of 1974 Identified guidelines to ensure the ethical conduct of research. 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.

Question 2The 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 noQuestion 3Informed consent is considered an application of which Belmont principle? Beneficence Justice Non-maleficence Respect for PersonsQuestion 4Which of the following is included in the Nuremberg Code: Confidentiality of data Voluntary consent Equitable selection of subjects Additional protection for vulnerable subjectsQuestion 5The National Research Act of 1974 Identified guidelines to ensure the ethical conduct of research. 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.

Which of the following safeguards are included as protections for prisoners involved in research?A. The IRB must approve the study as prisoner research.B. The study must present no more than minimal risk to the participants.C. The IRB that reviews and approves the study must not include prisoners or prisoner advocates in its membership.D. The research must involve practices intended to improve the health or well-being of the participants.E. All of the above.F. A, B, and D

An example cited in the Belmont Report (The National Commission 1979) stated that "During the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients." This is an example of a violation of which Belmont principle? Respect for persons Beneficence Justice

Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and federal regulations for human subject protection? PHS Tuskegee Study Stanford Prison Experiment (Zimbardo) Tearoom Trade Study (Humphreys) All of the above None of the above

According to the Belmont Report, the requirement that the benefits and burdens of the research are equitably distributed, expresses the principle of: Justice Respect for persons Beneficence