CITI Training Conflicts of Interest in Human Subjects Research

CITI Training Conflicts of Interest in Human Subjects Research What is the term for management controls that are built into a research study (for example, independent data analysis)? - ANS Inherent controls During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should: - ANS Disclose their potential COI and may answer questions, but recuse themselves from voting The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest? - ANS Researcher The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: - ANS There may be bias by the peer reviewer as to the area of research 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. - ANS No later than the time of proposal submission An example of an individual financial COI is: - ANS A researcher's wife holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study.