CITI Training - Research Method
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 di cult for the researcher to appear neutral, as the researcher may have an interest in the research's success
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
What is the term for management controls that are built in to a research study (for example, independent data analysis)?
Inherent controls
The PHS regulations about nancial con ict of interests require which party to disclose signi cant nancial con icts of interest?
Researcher
An example of an individual nancial COI is:
A researcher's wife holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study.
An example of an institutional COI is:
An industry sponsor pays for the construction of a new research laboratory at the organization
The FDA regulations governing disclosure of individual COIs require:
Applicants submitting marketing applications to disclose nancial COIs of researchers who conducted clinical studies
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
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
The peer review process can create con icts 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
