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CITI MODULES STUDY GUIDE 2025 QUESTIONS AND ANSWERS The COI management plan aims to - ....ANSWER ...-Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should - ....ANSWER ...-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. - ....ANSWER ...-No later than the time of proposal submission The FDA regulations governing disclosure of individual COIs require: ....ANSWER ...-Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies An example of an individual financial COI is: - ....ANSWER ...-A researcher's wife holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study. ...©️ 2025, ALL RIGHTS RESERVED 1