An Essay Likely About Nothing

1334 Words Aug 30th, 2015 6 Pages
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
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c) Exclude the man from the study.
d) Request the IRB waive the requirement for a signed informed consent.

167) An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent for the individual's legal representative. Under the FDA regulations for using test articles, which of the following describes the best course of action for the investigator:
a) Use the test article without obtaining consent from the subject or the legal representative then notify the IRB.
b) The investigator and another physician agree that the situation necessitates the use of the test article. An exception or waiver for informed consent can be made under these circumstances. The IRB will be notified later.
c) Submit a research protocol to the IRB and justify an expedited review approval of the consent document so test article can be used immediately.
d) Do not use the test article until either the subject or the subject's legal representative can give consent.

168) A general requirement for the informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject’s legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example