Info Security) UPDATED Exam Questions
and CORRECT Answers
A researcher's membership on an advisory board with an organization sponsoring research
can create a COI because: - Correct Answer- It may be difficult for the researcher to appear
neutral, as the researcher may have an interest in the research's success
During an Institutional Review Board (IRB) meeting, an 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
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
What is the term for management controls that are build in to a research study (for example,
independent data analysis)? - Correct Answer- Inherent controls
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
An example of a COI is: - Correct Answer- An industry sponsor pays for the construction of a
new research laboratory at the organization
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.
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