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 |
An example of an institutional COI is: |
An industry sponsor pays for the construction of a new research laboratory at the organization |
What is the term for management controls that are built in to a research study (for example, independent data analysis)? |
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. |
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. |
The FDA regulations governing disclosure of individual COIs require: |
Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies |
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 |
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 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 |
CITI quiz
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