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CITI Training Conflicts of Interest in Human Subjects Research Exam – 9 Q’s and A’s
CITI Training Conflicts of Interest in Human Subjects Research Exam – 9 Q’s and A’s
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CITI Training Conflicts of Interest inHuman Subjects Research Exam – 9 Q’s
and A’s
What is the term for management controls that are built in to a research
study (for example, independent data analysis)? - -Inherent controls
-During an Institutional Review Board (IRB) meeting, any IRB member who
may have a potential COI with a study under review should: - -Disclose their
potential COI and may answer questions, but recuse themselves from voting
-The PHS regulations about financial conflict of interests require which party
to disclose significant financial conflicts of interest? - -Researcher
-The peer review process can create conflicts of interest because the choice
of who reviews a potentially publishable project may show: - -There may be
bias by the peer reviewer as to the area of research
-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. - -No later than the time of proposal submission
-An example of an individual financial COI is: - -A researcher's wife holds
equity in a publicly traded pharmaceutical company that is also the sponsor
of the researcher's study.
-A researcher's membership on an advisory board with an organization
sponsoring research can create a COI because: - -It may be difficult for the
researcher to appear neutral, as the researcher may have an interest in the
research's success
-The COI management plan aims to: - -Provide procedures or extras steps to
be taken to minimize the risk of bias when a COI is disclosed
-The FDA regulations governing disclosure of individual COIs require: - -
Applicants submitting marketing applications to disclose financial COIs of
researchers who conducted clinical studies
-
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