Human Subjects Research UPDATED
ACTUAL Exam Questions and CORRECT
Answers
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
The PHS regulations about financial conflict of interests require which party to disclose
significant financial conflicts of interest? - CORRECT ANSWER - Researcher
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
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 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.
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