CITI MODULES STUDY GUIDE 2025
QUESTIONS AND ANSWERS
The COI management plan aims to - ....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 - ....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. - ....ANSWER ...-No
later than the time of proposal submission
The FDA regulations governing disclosure of individual COIs require: -
....ANSWER ...-Applicants submitting marketing applications to disclose financial
COIs of researchers who conducted clinical studies
An example of an individual financial COI is: - ....ANSWER ...-A researcher's wife
holds equity in a publicly traded pharmaceutical company that is also the sponsor of the
researcher's study.
...©️ 2025, ALL RIGHTS RESERVED 1
, The peer review process can create conflicts of interest because the choice of who
reviews a potentially publishable project may show: - ....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? - ....ANSWER ...-Researcher
What is the term for management controls that are built in to a research study (for
example, independent data analysis)? - ....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: - ....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? - ....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? - ....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? - ....ANSWER ...-Ensuring that risks are
reasonable in relationship to anticipated benefits.
...©️ 2025, ALL RIGHTS RESERVED 2
QUESTIONS AND ANSWERS
The COI management plan aims to - ....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 - ....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. - ....ANSWER ...-No
later than the time of proposal submission
The FDA regulations governing disclosure of individual COIs require: -
....ANSWER ...-Applicants submitting marketing applications to disclose financial
COIs of researchers who conducted clinical studies
An example of an individual financial COI is: - ....ANSWER ...-A researcher's wife
holds equity in a publicly traded pharmaceutical company that is also the sponsor of the
researcher's study.
...©️ 2025, ALL RIGHTS RESERVED 1
, The peer review process can create conflicts of interest because the choice of who
reviews a potentially publishable project may show: - ....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? - ....ANSWER ...-Researcher
What is the term for management controls that are built in to a research study (for
example, independent data analysis)? - ....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: - ....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? - ....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? - ....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? - ....ANSWER ...-Ensuring that risks are
reasonable in relationship to anticipated benefits.
...©️ 2025, ALL RIGHTS RESERVED 2
