RM Citi Modules Answers / Test Answers
Which of the following was the result of the Beecher article?
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:
Prisoners may be used to conduct research that only benefits the larger society
Issued in 1974, 45 CFR 46 raised to regulatory status:
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?
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?
Voluntary Consent
Informed consent is considered an application of which Belmont principle? ****
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?
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?
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?
Which of the following was the result of the Beecher article?
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:
Prisoners may be used to conduct research that only benefits the larger society
Issued in 1974, 45 CFR 46 raised to regulatory status:
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?
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?
Voluntary Consent
Informed consent is considered an application of which Belmont principle? ****
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?
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?
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?
