RM: Citi Modules Questions with Answers
Which of the following was the result of the informed consent)
Beecher article? - ANSWER -
Realization that ethical abuses are not
limited to the Nazi regime How should the investigator proceed, with
respect to the IRB, after the discovery of the
adverse event occurrence? - ANSWER -
The use of prisoners in research is a concern Report the adverse drug experience in a
under the *Belmont principle of Justice* timely manner, in keeping with the IRB's
because: - ANSWER -Prisoners may be policies and procedures, using the forms or
used to conduct research that only benefits the mechanism provided by the IRB.
the larger society
How long is an investigator required to keep
Issued in 1974, 45 CFR 46 raised to consent documents, IRB correspondence &
regulatory status: - ANSWER -US Public research records? - ANSWER -For a
Health Service Policy (45 CFR 46 raised to *minimum of three years* after completion of
regulatory status the US Public Health the study. (May be required to keep them
Service policy of 1966 "Clinical research and longer than 3 years)
investigation involving human beings".)
According to federal regulations, which of the
Which of the following brought increased following best describes when expedited
public attention to the problems with the IRB review of a new, proposed study may be used
system? - ANSWER -Death of Jesse by the IRB? - ANSWER -The study
Gelsinger (Although all of these are related to involves no more than minimal risk & meets
the problems with the IRB system, the death one of the allowable categories of expedited
of Jesse Gelsinger was what received public review specified in federal regulations.
attention.)
Amendments involving changes to IRB
Which of the following is included in the approved protocols do not need prior IRB
Nuremberg Code? - ANSWER - approval if: - ANSWER -The changes
Voluntary Consent must be immediately implemented for the
health & well being of the subject.
Informed consent is considered an
application of which Belmont principle? **** IRB continuing review of an approved
- ANSWER -Respect for Persons protocol must: - ANSWER -Occur at
(Respect for persons involves respecting least annually.
individual autonomy in the decision to
participate in research. That respect is
implemented through the process of A 46-year-old man is currently enrolled in a
1/4
Which of the following was the result of the informed consent)
Beecher article? - ANSWER -
Realization that ethical abuses are not
limited to the Nazi regime How should the investigator proceed, with
respect to the IRB, after the discovery of the
adverse event occurrence? - ANSWER -
The use of prisoners in research is a concern Report the adverse drug experience in a
under the *Belmont principle of Justice* timely manner, in keeping with the IRB's
because: - ANSWER -Prisoners may be policies and procedures, using the forms or
used to conduct research that only benefits the mechanism provided by the IRB.
the larger society
How long is an investigator required to keep
Issued in 1974, 45 CFR 46 raised to consent documents, IRB correspondence &
regulatory status: - ANSWER -US Public research records? - ANSWER -For a
Health Service Policy (45 CFR 46 raised to *minimum of three years* after completion of
regulatory status the US Public Health the study. (May be required to keep them
Service policy of 1966 "Clinical research and longer than 3 years)
investigation involving human beings".)
According to federal regulations, which of the
Which of the following brought increased following best describes when expedited
public attention to the problems with the IRB review of a new, proposed study may be used
system? - ANSWER -Death of Jesse by the IRB? - ANSWER -The study
Gelsinger (Although all of these are related to involves no more than minimal risk & meets
the problems with the IRB system, the death one of the allowable categories of expedited
of Jesse Gelsinger was what received public review specified in federal regulations.
attention.)
Amendments involving changes to IRB
Which of the following is included in the approved protocols do not need prior IRB
Nuremberg Code? - ANSWER - approval if: - ANSWER -The changes
Voluntary Consent must be immediately implemented for the
health & well being of the subject.
Informed consent is considered an
application of which Belmont principle? **** IRB continuing review of an approved
- ANSWER -Respect for Persons protocol must: - ANSWER -Occur at
(Respect for persons involves respecting least annually.
individual autonomy in the decision to
participate in research. That respect is
implemented through the process of A 46-year-old man is currently enrolled in a
1/4
