CITIProgram_Conflicts_of_Interest_in_Human_Subjects_Research

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Southern New Hampshire University *

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423

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Management

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Jun 21, 2024

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docx

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1

Uploaded by mizzminizz

CONFLICTS OF INTEREST IN HUMAN SUBJECTS RESEARCH (ID 17464) Q1: The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: A: There may be bias by the peer reviewer as to the area of research. Q2: The FDA regulations governing disclosure of individual COIs require: A: Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies. Q3: The COI management plan aims to: A: Provide procedures or extra steps to be taken to minimize the risk of bias when a COI is disclosed. Q4: 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. A: No later than the time of proposal submission. Q5: An example of an individual financial COI is: A: A researcher’s spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher’s study.
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