CITI Exam Questions and Answers
100% Pass
Which of the following is an example of how the principle of beneficence can be
applied to a study employing human subjects? - CORRECT ANSWER-
Determining that the study has a maximization of benefits and a minimization of
risks.
Which of the following are the three principles discussed in the Belmont Report? -
CORRECT ANSWER-Respect for Persons, Beneficence, Justice
The Belmont Report's principle of respect for persons incorporates at least two
ethical convictions: first, that individuals should be treated as autonomous agents,
and second, that: - CORRECT ANSWER-Persons with diminished autonomy are
entitled to protection.
An investigational biologic administered to the first two subjects in a Phase II
clinical trial was not appropriately screened for two viral contaminants, HIV and
Hepatitis B, due to human error in the screening process. Follow-up testing
indicated that the subjects and their partners were not infected. The subjects and
others were notified of the increased risk. - CORRECT ANSWER-There was no
need to inform the IRB because this was a screening procedure.
, Housekeeping employees of the medical center were recruited for a federally
funded study of blood pressure, blood count levels, infectious disease history, and
job stress. The interviews and blood tests were conducted in a private location not
affiliated with the study center. Follow-up interviews were conducted in the same
location. The study coordinator stopped at the cafeteria on her way back to the
study office after the second study visit for the last three study subjects and lost the
three file folders. Records of one subject indicated he had a history of a sexually
transmitted disease and another had recently been treated for tuberculosis. The
subjects were notified of the loss. Following this event, the IRB approved a
protocol change requiring that all records be transmitted electronically to the study
office using the medical center's secure network. - CORRECT ANSWER-This is
an unanticipated problem and not an adverse event.
A study requires that each subject be given two study drugs. The first study drug is
given on Day 1. A second study drug is given on Day 7 to counteract the toxicity
of Drug 1. Subject # 4-706 is given Drug 1 on Day 1. Due to a snowstorm,
Subject 4-706 is delayed for several days before returning to the site for Drug 2.
Missing the administration of Drug 2 on Day 7 placed the subject at risk of
significant toxicity. This event required the subject be notified of the increased risk
and required close monitoring of the subject by phone. - CORRECT ANSWER-
This is an unanticipated problem that does not include an adverse event.
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100% Pass
Which of the following is an example of how the principle of beneficence can be
applied to a study employing human subjects? - CORRECT ANSWER-
Determining that the study has a maximization of benefits and a minimization of
risks.
Which of the following are the three principles discussed in the Belmont Report? -
CORRECT ANSWER-Respect for Persons, Beneficence, Justice
The Belmont Report's principle of respect for persons incorporates at least two
ethical convictions: first, that individuals should be treated as autonomous agents,
and second, that: - CORRECT ANSWER-Persons with diminished autonomy are
entitled to protection.
An investigational biologic administered to the first two subjects in a Phase II
clinical trial was not appropriately screened for two viral contaminants, HIV and
Hepatitis B, due to human error in the screening process. Follow-up testing
indicated that the subjects and their partners were not infected. The subjects and
others were notified of the increased risk. - CORRECT ANSWER-There was no
need to inform the IRB because this was a screening procedure.
, Housekeeping employees of the medical center were recruited for a federally
funded study of blood pressure, blood count levels, infectious disease history, and
job stress. The interviews and blood tests were conducted in a private location not
affiliated with the study center. Follow-up interviews were conducted in the same
location. The study coordinator stopped at the cafeteria on her way back to the
study office after the second study visit for the last three study subjects and lost the
three file folders. Records of one subject indicated he had a history of a sexually
transmitted disease and another had recently been treated for tuberculosis. The
subjects were notified of the loss. Following this event, the IRB approved a
protocol change requiring that all records be transmitted electronically to the study
office using the medical center's secure network. - CORRECT ANSWER-This is
an unanticipated problem and not an adverse event.
A study requires that each subject be given two study drugs. The first study drug is
given on Day 1. A second study drug is given on Day 7 to counteract the toxicity
of Drug 1. Subject # 4-706 is given Drug 1 on Day 1. Due to a snowstorm,
Subject 4-706 is delayed for several days before returning to the site for Drug 2.
Missing the administration of Drug 2 on Day 7 placed the subject at risk of
significant toxicity. This event required the subject be notified of the increased risk
and required close monitoring of the subject by phone. - CORRECT ANSWER-
This is an unanticipated problem that does not include an adverse event.
COPYRIGHT ©️ 2025 ALL RIGHTS RESERVED
