CITI IRB (Conflicts of Interest
& Basics of Info Security)
Study
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
During an Institutional Review Board (IRB) meeting, an 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
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
What is the term for management controls that are build 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 a 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 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:
There may be bias by the peer reviewer as to the area of research
Which of these is generally not a good practice with respect to oral communications (that is, talking)
in organizations like healthcare facilities?
Use of full names in public areas or on intercom/paging systems, because there is no security issue with
identifying persons in public areas and using full names helps avoid misidentification.
& Basics of Info Security)
Study
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
During an Institutional Review Board (IRB) meeting, an 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
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
What is the term for management controls that are build 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 a 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 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:
There may be bias by the peer reviewer as to the area of research
Which of these is generally not a good practice with respect to oral communications (that is, talking)
in organizations like healthcare facilities?
Use of full names in public areas or on intercom/paging systems, because there is no security issue with
identifying persons in public areas and using full names helps avoid misidentification.
