CIT 594 FINAL EXAM SCRIPT TESTED
QUESTIONS WITH VERIFIED ANSWERS
PRACTICE SOLUTION GRADED A+
⩥ What is the term for management controls that are built in to a
research study (for example, independent data analysis)?
A.Objective controls
B.Inherent controls
C.Mandated controls
D.Required controls.
Answer: B.Inherent controls
⩥ During an Institutional Review Board (IRB) meeting, any IRB
member who may have a potential COI with a study under review
should:
A. Disclose their potential COI, but not answer any questions about the
study
B. Disclose their potential COI and not participate in any action
C. Disclose their potential COI and may answer questions, but recuse
themselves from voting
D. Leave the meeting immediately.
,Answer: C. Disclose their potential COI and may answer questions, but
recuse themselves from voting
⩥ Which of the following was the result of the Beecher article?.
Answer: Realization that ethical abuses are not limited to the Nazi
regime
⩥ The use of prisoners in research is a concern under the *Belmont
principle of Justice* because:.
Answer: Prisoners may be used to conduct research that only benefits
the larger society
⩥ Issued in 1974, 45 CFR 46 raised to regulatory status:.
Answer: US Public Health Service Policy (45 CFR 46 raised to
regulatory status the US Public Health Service policy of 1966 "Clinical
research and investigation involving human beings".)
⩥ Which of the following brought increased public attention to the
problems with the IRB system?.
Answer: Death of Jesse Gelsinger (Although all of these are related to
the problems with the IRB system, the death of Jesse Gelsinger was
what received public attention.)
⩥ Which of the following is included in the Nuremberg Code?.
,Answer: Voluntary Consent
⩥ Informed consent is considered an application of which Belmont
principle? ****.
Answer: Respect for Persons (Respect for persons involves respecting
individual autonomy in the decision to participate in research. That
respect is implemented through the process of informed consent)
⩥ How should the investigator proceed, with respect to the IRB, after
the discovery of the adverse event occurrence?.
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.
⩥ How long is an investigator required to keep consent documents, IRB
correspondence & research records?.
Answer: For a *minimum of three years* after completion of the study.
(May be required to keep them longer than 3 years)
⩥ 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: The study involves no more than minimal risk & meets one of
the allowable categories of expedited review specified in federal
regulations.
, ⩥ Amendments involving changes to IRB approved protocols do not
need prior IRB approval if:.
Answer: The changes must be immediately implemented for the health
& well being of the subject.
⩥ IRB continuing review of an approved protocol must:.
Answer: Occur at least annually.
⩥ A 46-year-old man is currently enrolled in a Phase 2 study of a drug
for severe diabetic neuropathy. While the study is on going, a new drug
becomes commercially available that may have equal or greater benefit
to the subject. The investigator should do which of the following?.
Answer: Give the subject comprehensive information about the new
drug, including its side effects. Discuss the pros and cons of both the
investigational drug and the commercially available drug and then allow
the subject to decide whether to withdraw from the research to take the
new drug.
⩥ 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 of exculpatory language?.
QUESTIONS WITH VERIFIED ANSWERS
PRACTICE SOLUTION GRADED A+
⩥ What is the term for management controls that are built in to a
research study (for example, independent data analysis)?
A.Objective controls
B.Inherent controls
C.Mandated controls
D.Required controls.
Answer: B.Inherent controls
⩥ During an Institutional Review Board (IRB) meeting, any IRB
member who may have a potential COI with a study under review
should:
A. Disclose their potential COI, but not answer any questions about the
study
B. Disclose their potential COI and not participate in any action
C. Disclose their potential COI and may answer questions, but recuse
themselves from voting
D. Leave the meeting immediately.
,Answer: C. Disclose their potential COI and may answer questions, but
recuse themselves from voting
⩥ Which of the following was the result of the Beecher article?.
Answer: Realization that ethical abuses are not limited to the Nazi
regime
⩥ The use of prisoners in research is a concern under the *Belmont
principle of Justice* because:.
Answer: Prisoners may be used to conduct research that only benefits
the larger society
⩥ Issued in 1974, 45 CFR 46 raised to regulatory status:.
Answer: US Public Health Service Policy (45 CFR 46 raised to
regulatory status the US Public Health Service policy of 1966 "Clinical
research and investigation involving human beings".)
⩥ Which of the following brought increased public attention to the
problems with the IRB system?.
Answer: Death of Jesse Gelsinger (Although all of these are related to
the problems with the IRB system, the death of Jesse Gelsinger was
what received public attention.)
⩥ Which of the following is included in the Nuremberg Code?.
,Answer: Voluntary Consent
⩥ Informed consent is considered an application of which Belmont
principle? ****.
Answer: Respect for Persons (Respect for persons involves respecting
individual autonomy in the decision to participate in research. That
respect is implemented through the process of informed consent)
⩥ How should the investigator proceed, with respect to the IRB, after
the discovery of the adverse event occurrence?.
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.
⩥ How long is an investigator required to keep consent documents, IRB
correspondence & research records?.
Answer: For a *minimum of three years* after completion of the study.
(May be required to keep them longer than 3 years)
⩥ 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: The study involves no more than minimal risk & meets one of
the allowable categories of expedited review specified in federal
regulations.
, ⩥ Amendments involving changes to IRB approved protocols do not
need prior IRB approval if:.
Answer: The changes must be immediately implemented for the health
& well being of the subject.
⩥ IRB continuing review of an approved protocol must:.
Answer: Occur at least annually.
⩥ A 46-year-old man is currently enrolled in a Phase 2 study of a drug
for severe diabetic neuropathy. While the study is on going, a new drug
becomes commercially available that may have equal or greater benefit
to the subject. The investigator should do which of the following?.
Answer: Give the subject comprehensive information about the new
drug, including its side effects. Discuss the pros and cons of both the
investigational drug and the commercially available drug and then allow
the subject to decide whether to withdraw from the research to take the
new drug.
⩥ 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 of exculpatory language?.
