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Question 1An example of an individual financial COI is: A researcher’s spouse works at the same university as the researcher. A researcher’s spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher’s study. A researcher’s 10-year-old child wins a local science competition, the prize for which is a $5,000 scholarship to a workshop sponsored by a local company that sponsors one of the researcher’s ongoing projects. A researcher is considering buying stock in a publicly traded company that specializes in making and delivering hand tossed pizza.Question 2What is the term for management controls that are built in to a research study (for example, independent data analysis)? Mandated controls Required controls Inherent controls Objective controlsQuestion 3The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest? Applicants submitting marketing applications for drugs, biologics, or devices Sponsor Researcher IRB Member OrganizationQuestion 4During 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 Disclose their potential COI and not participate in any action Disclose their potential COI, but not answer any questions about the study Leave the meeting immediatelyQuestion 5An example of an institutional COI is: One of the organization’s deans is the vice-chair of the organization’s IRB 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 The organization gives scholarships to some post-doctoral researchers An industry sponsor pays for the construction of a new research laboratory at the organization

Question

Question 1An example of an individual financial COI is: A researcher’s spouse works at the same university as the researcher. A researcher’s spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher’s study. A researcher’s 10-year-old child wins a local science competition, the prize for which is a $5,000 scholarship to a workshop sponsored by a local company that sponsors one of the researcher’s ongoing projects. A researcher is considering buying stock in a publicly traded company that specializes in making and delivering hand tossed pizza.Question 2What is the term for management controls that are built in to a research study (for example, independent data analysis)? Mandated controls Required controls Inherent controls Objective controlsQuestion 3The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest? Applicants submitting marketing applications for drugs, biologics, or devices Sponsor Researcher IRB Member OrganizationQuestion 4During 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 Disclose their potential COI and not participate in any action Disclose their potential COI, but not answer any questions about the study Leave the meeting immediatelyQuestion 5An example of an institutional COI is: One of the organization’s deans is the vice-chair of the organization’s IRB 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 The organization gives scholarships to some post-doctoral researchers An industry sponsor pays for the construction of a new research laboratory at the organization

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Solution

Question 1: The example of an individual financial COI (Conflict of Interest) is: A researcher’s spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher’s study.

Question 2: The term for management controls that are built into a research study (for example, independent data analysis) is: Inherent controls.

Question 3: The PHS (Public Health Service) regulations about financial conflict of interests require the Organization to disclose significant financial conflicts of interest.

Question 4: 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.

Question 5: An example of an institutional COI is: An industry sponsor pays for the construction of a new research laboratory at the organization.

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