CITI Modules study guide UPDATED
ACTUAL Exam Questions and CORRECT
Answers
The COI management plan aims to - CORRECT ANSWER - Provide procedures or extras
steps to be taken to minimize the risk of bias when a COI is disclosed
During an Institutional Review Board (IRB) meeting, any IRB member who may have a
potential COI with a study under review should - CORRECT ANSWER - Disclose their
potential COI and may answer questions, but recuse themselves from voting
A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects
research study. He wants to know at what point he and his study team must submit COI
disclosures to comply with the PHS regulation. - CORRECT ANSWER - No later than the
time of proposal submission
The FDA regulations governing disclosure of individual COIs require: - CORRECT
ANSWER - Applicants submitting marketing applications to disclose financial COIs of
researchers who conducted clinical studies
An example of an individual financial COI is: - CORRECT ANSWER - A researcher's
wife holds equity in a publicly traded pharmaceutical company that is also the sponsor of the
researcher's study.
The peer review process can create conflicts of interest because the choice of who reviews a
potentially publishable project may show: - CORRECT ANSWER - There may be bias by
the peer reviewer as to the area of research
The PHS regulations about financial conflict of interests require which party to disclose
significant financial conflicts of interest? - CORRECT ANSWER - Researcher
, What is the term for management controls that are built in to a research study (for example,
independent data analysis)? - CORRECT ANSWER - Inherent controls
During an Institutional Review Board (IRB) meeting, any IRB member who may have a
potential COI with a study under review should: - CORRECT ANSWER - Disclose their
potential COI and may answer questions, but recuse themselves from voting
Which of the following studies is linked most directly to the establishment of the National
Research Act in 1974 and ultimately to the Belmont Report and Federal regulations for human
subject protection? - CORRECT ANSWER - The Public Health Service Tuskegee Study
of Untreated Syphilis in the Negro Male.
The researcher's failure to protect research subjects from deductive disclosure is the primary
ethical violation in which of the following studies? - CORRECT ANSWER - Harvard
"Tastes, Ties, and Time (T3)" study (2006-2009)" study
Which of the following is an example of how the principle of beneficence is applied to a study
involving human subjects? - CORRECT ANSWER - Ensuring that risks are reasonable in
relationship 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.
According to the Belmont Report, the moral requirement that there be fair outcomes in the
selection of research subjects, expresses the principle of: - CORRECT ANSWER - Justice.
The Belmont principle of beneficence requires that: - CORRECT ANSWER - Potential
benefits justify the risks of harm.
A medical record is an example of - CORRECT ANSWER - Private information.
ACTUAL Exam Questions and CORRECT
Answers
The COI management plan aims to - CORRECT ANSWER - Provide procedures or extras
steps to be taken to minimize the risk of bias when a COI is disclosed
During an Institutional Review Board (IRB) meeting, any IRB member who may have a
potential COI with a study under review should - CORRECT ANSWER - Disclose their
potential COI and may answer questions, but recuse themselves from voting
A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects
research study. He wants to know at what point he and his study team must submit COI
disclosures to comply with the PHS regulation. - CORRECT ANSWER - No later than the
time of proposal submission
The FDA regulations governing disclosure of individual COIs require: - CORRECT
ANSWER - Applicants submitting marketing applications to disclose financial COIs of
researchers who conducted clinical studies
An example of an individual financial COI is: - CORRECT ANSWER - A researcher's
wife holds equity in a publicly traded pharmaceutical company that is also the sponsor of the
researcher's study.
The peer review process can create conflicts of interest because the choice of who reviews a
potentially publishable project may show: - CORRECT ANSWER - There may be bias by
the peer reviewer as to the area of research
The PHS regulations about financial conflict of interests require which party to disclose
significant financial conflicts of interest? - CORRECT ANSWER - Researcher
, What is the term for management controls that are built in to a research study (for example,
independent data analysis)? - CORRECT ANSWER - Inherent controls
During an Institutional Review Board (IRB) meeting, any IRB member who may have a
potential COI with a study under review should: - CORRECT ANSWER - Disclose their
potential COI and may answer questions, but recuse themselves from voting
Which of the following studies is linked most directly to the establishment of the National
Research Act in 1974 and ultimately to the Belmont Report and Federal regulations for human
subject protection? - CORRECT ANSWER - The Public Health Service Tuskegee Study
of Untreated Syphilis in the Negro Male.
The researcher's failure to protect research subjects from deductive disclosure is the primary
ethical violation in which of the following studies? - CORRECT ANSWER - Harvard
"Tastes, Ties, and Time (T3)" study (2006-2009)" study
Which of the following is an example of how the principle of beneficence is applied to a study
involving human subjects? - CORRECT ANSWER - Ensuring that risks are reasonable in
relationship 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.
According to the Belmont Report, the moral requirement that there be fair outcomes in the
selection of research subjects, expresses the principle of: - CORRECT ANSWER - Justice.
The Belmont principle of beneficence requires that: - CORRECT ANSWER - Potential
benefits justify the risks of harm.
A medical record is an example of - CORRECT ANSWER - Private information.
