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

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.

Question 3Additional safeguards that may be included in a social and behavioral study may include: Requiring pregnancy tests before administration of the study drug. Frequent monitoring of the subject’s heart through ECG after administration of the study drug. Remove all direct identifiers from the data as soon as possible. Requiring a legally authorized representative to provide signed consent for an incapacitated subject.

An Investigator participating in a clinical trial is responsible for protecting the rights, safety, and welfare of trial participants. Part of this responsibility is:A. Ensuring all subjects are consented appropriately and documented using the IRB approved Informed Consent form.B. Making sure that target enrollment goals are met.C. Enrolling subjects into the study who meet the exclusion criteria.D. Ensuring that the names of all subjects participating in the study are available to the general public.

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.

The three key principle(s) that underlie the current system of human research protections include which of the following?