CITI TRAINING - RESEARCH METHOD
EXAM QUESTIONS WITH CORRECT
ANSWERS
What is the term for management controls that are built in to a research study (for
example, independent data analysis)? - Answer-Inherent controls
The FDA regulations governing disclosure of individual COIs require: - Answer-
Applicants submitting marketing applications to disclose nancial COIs of researchers
who conducted clinical studies
The PHS regulations about nancial con ict of interests require which party to disclose
signi cant nancial con icts of interest? - Answer-Researcher
An example of an individual nancial 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.
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
The peer review process can create con icts 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
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
A researcher's membership on an advisory board with an organization sponsoring
research can create a COI because: - Answer-It may be di cult for the researcher to
appear neutral, as the researcher may have an interest in the research's success
An example of an institutional COI is: - Answer-An industry sponsor pays for the
construction of a new research laboratory at the organization
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
EXAM QUESTIONS WITH CORRECT
ANSWERS
What is the term for management controls that are built in to a research study (for
example, independent data analysis)? - Answer-Inherent controls
The FDA regulations governing disclosure of individual COIs require: - Answer-
Applicants submitting marketing applications to disclose nancial COIs of researchers
who conducted clinical studies
The PHS regulations about nancial con ict of interests require which party to disclose
signi cant nancial con icts of interest? - Answer-Researcher
An example of an individual nancial 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.
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
The peer review process can create con icts 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
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
A researcher's membership on an advisory board with an organization sponsoring
research can create a COI because: - Answer-It may be di cult for the researcher to
appear neutral, as the researcher may have an interest in the research's success
An example of an institutional COI is: - Answer-An industry sponsor pays for the
construction of a new research laboratory at the organization
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
