Citi exams UPDATED Exam Questions and
CORRECT Answers
A subject in a clinical research trial experiences a serious, unanticipated adverse drug
experience. How should the investigator proceed, with respect to the IRB, after the discovery of
the adverse event occurrence? - CORRECT 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, and
research records? - CORRECT ANSWER - For a minimum of three years after completion
of the study
According to federal regulations, which of the following best describes when expedited review
of a new, proposed study may be used by the IRB? - CORRECT ANSWER - The study
involves no more than minimal risk and 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:
- CORRECT ANSWER - The changes must be immediately implemented for the health
and well-being of the subject.
IRB continuing review of a greater than minimal risk approved protocol that is currently
enrolling subjects must: - CORRECT ANSWER - Occur at least annually.
According to the federal regulations, which of the following studies meets the definition of
research with human subjects? - CORRECT ANSWER - A developmental psychologist
videotapes interactions between groups of toddlers and their caregivers to determine which
intervention methods most effectively manage aggression.
According to the federal regulations, which of the following studies meets the definition of
research with human subjects? - CORRECT ANSWER - A cognitive psychologist enrolls
undergraduate students for a computer-based study about the effect of mood on problem-solving
behaviors.
, According to the federal regulations, which of the following studies meets the definition of
research with human subjects? - CORRECT ANSWER - An experiment is proposed on
the relationship between gender-related stereotypes in math and the subsequent performance by
males and females on math tests.
A researcher is interested in assessing risk-taking by individuals. The researcher is sitting on a
bench near a busy four-way stop intersection. She plans on recording the number of bike riders
wearing a safety helmet and whether they stop at the intersection before proceeding in order to
correlate use of safety apparel with risk-taking. This collection of information is an example of: -
CORRECT ANSWER - public behavior
According to the federal regulations, human subjects are living individuals about whom an
investigator conducting research obtains information through interaction or intervention with the
individual, and uses, studies, or analyzes the information; or: - CORRECT ANSWER -
Obtains, uses, studies, analyzes, or generates identifiable private information.
An example cited in the Belmont Report (The National Commission 1979) stated that "During
the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon
poor ward patients, while the benefits of improved medical care flowed primarily to private
patients." This is an example of a violation of which Belmont principle? - CORRECT
ANSWER - justice
The researcher's failure to protect research subjects from deductive disclosure of identity (that is,
the re-identification of subjects by other researchers) is the primary ethical violation in which of
the following studies? - CORRECT ANSWER - "Tastes, Ties, and Time (T3)" study
The Belmont principle of beneficence requires that: - CORRECT ANSWER - Risks to
subjects are reasonable in relation to anticipated benefits.
Humphreys' collecting data for the Tearoom Trade study under the pretense that he was a
lookout is an example of a violation of the principle of: - CORRECT ANSWER - Respect
for persons
CORRECT Answers
A subject in a clinical research trial experiences a serious, unanticipated adverse drug
experience. How should the investigator proceed, with respect to the IRB, after the discovery of
the adverse event occurrence? - CORRECT 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, and
research records? - CORRECT ANSWER - For a minimum of three years after completion
of the study
According to federal regulations, which of the following best describes when expedited review
of a new, proposed study may be used by the IRB? - CORRECT ANSWER - The study
involves no more than minimal risk and 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:
- CORRECT ANSWER - The changes must be immediately implemented for the health
and well-being of the subject.
IRB continuing review of a greater than minimal risk approved protocol that is currently
enrolling subjects must: - CORRECT ANSWER - Occur at least annually.
According to the federal regulations, which of the following studies meets the definition of
research with human subjects? - CORRECT ANSWER - A developmental psychologist
videotapes interactions between groups of toddlers and their caregivers to determine which
intervention methods most effectively manage aggression.
According to the federal regulations, which of the following studies meets the definition of
research with human subjects? - CORRECT ANSWER - A cognitive psychologist enrolls
undergraduate students for a computer-based study about the effect of mood on problem-solving
behaviors.
, According to the federal regulations, which of the following studies meets the definition of
research with human subjects? - CORRECT ANSWER - An experiment is proposed on
the relationship between gender-related stereotypes in math and the subsequent performance by
males and females on math tests.
A researcher is interested in assessing risk-taking by individuals. The researcher is sitting on a
bench near a busy four-way stop intersection. She plans on recording the number of bike riders
wearing a safety helmet and whether they stop at the intersection before proceeding in order to
correlate use of safety apparel with risk-taking. This collection of information is an example of: -
CORRECT ANSWER - public behavior
According to the federal regulations, human subjects are living individuals about whom an
investigator conducting research obtains information through interaction or intervention with the
individual, and uses, studies, or analyzes the information; or: - CORRECT ANSWER -
Obtains, uses, studies, analyzes, or generates identifiable private information.
An example cited in the Belmont Report (The National Commission 1979) stated that "During
the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon
poor ward patients, while the benefits of improved medical care flowed primarily to private
patients." This is an example of a violation of which Belmont principle? - CORRECT
ANSWER - justice
The researcher's failure to protect research subjects from deductive disclosure of identity (that is,
the re-identification of subjects by other researchers) is the primary ethical violation in which of
the following studies? - CORRECT ANSWER - "Tastes, Ties, and Time (T3)" study
The Belmont principle of beneficence requires that: - CORRECT ANSWER - Risks to
subjects are reasonable in relation to anticipated benefits.
Humphreys' collecting data for the Tearoom Trade study under the pretense that he was a
lookout is an example of a violation of the principle of: - CORRECT ANSWER - Respect
for persons
