for human subject protection?
a) The Public Health Service (PHS) syphilis study
b) Nazi medical experiments
c) Jewish chronic disease study
d) Obedience to authority study (Milgram study)

160) IRB continuing review of an approved protocol must:
a) Must occur only when the level of risk changes.
b) Occur at least annually.
c) Must be conducted by a convened IRB.
d) Include copies of all signed consent forms.

161) A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed after the discovery of the adverse event occurrence?
a) Report the adverse drug experience to the IRB only if there are several other occurrences.
b) Report the adverse drug experience as part of the continuing review report.
c) Do not report the adverse drug experience to the IRB since it is a common adverse experience.
d) Report the adverse drug experience immediately to the IRB using the forms or the mechanism provided by the institution.

162) How long is an investigator required to keep consent documents, IRB correspondence, and research records?
a) As long as the investigator is at that institution
b) Until the IRB gives permission for them to be destroyed
c) Until the study is closed
d) For a minimum of three years after completion of the study

163) Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if:
a) They are eligible for review using expedited procedures.
b) They only involve changes to the consent form.
c) The changes must be immediately implemented for the health and well being of the subject.
d) The investigator keeps careful records of all changes and includes them in the final report.

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