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CONFLICTS OF INTEREST IN HUMAN
SUBJECTS RESEARCH (ID 17464)
Q1: The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show:
A: There may be bias by the peer reviewer as to the area of research.
Q2: The FDA regulations governing disclosure of individual COIs require:
A: Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies.
Q3: The COI management plan aims to:
A: Provide procedures or extra steps to be taken to minimize the risk of bias when a COI is disclosed.
Q4: 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.
A: No later than the time of proposal submission.
Q5: An example of an individual financial COI is:
A: A researcher’s spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher’s study.
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