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Question 1 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, but not answer any questions about the study Leave the meeting immediately Disclose their potential COI and may answer questions, but recuse themselves from voting Disclose their potential COI and not participate in any action Question 2 The FDA regulations governing disclosure of individual COIs require: Sponsors to annually disclose to the FDA financial COIs of researchers who conducted clinical studies Organizations to disclose financial COIs to the FDA no later than the time of submission of the IND application Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies Researchers to annually self-disclose financial COIs to the FDA Question 3 An example of an institutional COI is: The organization gives scholarships to some post-doctoral researchers An industry sponsor pays for the construction of a new research laboratory at the organization The organization’s president is a member of the board of trustees for a local non-profit organization that does not sponsor research at the organization One of the organization’s deans is the vice-chair of the organization’s IRB Question 4 The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest? Researcher Applicants submitting marketing applications for drugs, biologics, or devices Sponsor IRB Member Organization Question 5 A researcher’s membership on an advisory board with an organization sponsoring research can create a COI because: The research result could be flawed from missing data The members of the advisory board know each other The organization can have policies that affect the research It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research’s success

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