Question: Which of the following brought increased public attention to the problems with the IRB system?

Answer Options: 1983 Presidential Commission Report “Shut Downs” by OHRP Death of Research Subject (Jesse Gelsinger) HHS Inspector General Report of 1998

Answer: Death of Research Subject (Jesse Gelsinger)

Question: Which of the following is included in the Nuremberg Code?

Answer Options: Confidentiality of data Additional protection for vulnerable subjects Equitable selection of subjects Voluntary consent

Answer: Voluntary consent

Question: Informed consent is considered an application of which Belmont principle?

Answer Options: Beneficence Respect for Persons Justice Non-maleficence

Answer: Respect for Persons

Question: Issued in 1974, 45 CFR 46 raised to regulatory status:

Answer Options: The Nuremberg Code The 1974 National Research Act Kefauver-Harris Drug Amendments to the Federal Food, Drug & Cosmetics Act US Public Health Service Policy

Answer: US Public Health Service Policy

Question: The National Research Act of 1974

Answer Options: Required that all federal agencies have the same regulations governing human subjects research. Identified the basic ethical principles of human subjects research. Identified guidelines to ensure the ethical conduct of research. Established the National Commission.

Answer: Established the National Commission.

Question: A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?

Answer Options: Report the adverse drug experience as part of the continuing review report. Do not report the adverse drug experience to the IRB since it is a common adverse experience. Report the adverse drug experience to the IRB only if there are several other occurrences. Report the adverse drug experience in a timely manner, in keeping with the IRB’s policies and procedures, using the forms or the mechanism provided by the IRB.

Answer: Report the adverse drug experience in a timely manner, in keeping with the IRB’s policies and procedures, using the forms or the mechanism provided by the IRB.

Question: How long is an investigator required to keep consent documents, IRB correspondence, and research records?

Answer Options: Until the study is closed Until data analysis is complete For a minimum of three years after completion of the study As long as the investigator is at that institution

Answer: For a minimum of three years after completion of the study

Question: According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?

Answer Options: The study is required for a student research project The study does not require informed consent or survey instruments. The study includes only research subjects that are healthy volunteers. The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations

Answer: The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations

Question: Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if:

Answer Options: The changes must be immediately implemented for the health and well-being of the subject. The investigator keeps careful records of all changes and includes them in the final report. They only involve changes to the consent form. They are eligible for review using expedited procedures.

Answer: The changes must be immediately implemented for the health and well-being of the subject.

Question: IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must:

Answer Options: Occur at least annually. Be conducted by an expedited review. Include copies of all signed consent forms. Occur only when the level of risk changes.

Answer: Occur at least annually.

Question: Identify the following groups that are protected in the federal regulations, 45 CFR 46, specifically in Subparts B, C, and D with additional protections:

Answer Options: Pregnant women, prisoners, and mentally disabled Children, prisoners, and terminally ill Prisoners, children, and elderly Pregnant women, prisoners, children

Answer: Pregnant women, prisoners, children

Question: Which is true of inducements in research?

Answer Options: Offering $10 for an hour long research study constitutes undue inducement. Inducements constitute an “undue influence” if they alter a potential subject’s decision-making processes, such that they do not appropriately weigh the risk-benefit relationship of the research. Inducements, like coercion, are always inappropriate, as they violate the ethical principle of respect for persons. Like coercion, undue inducement is easy for IRBs to determine.

Answer: Inducements constitute an “undue influence” if they alter a potential subject’s decision-making processes, such that they do not appropriately weigh the risk-benefit relationship of the research.