CITI IRB (Conflicts of Interest and Basics of Info Security)
CITI IRB (Conflicts of Interest and Basics of Info Security) 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:
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