Conflicts of Interest in Human Subjects Research

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The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest?

Researcher

An example of an individual financial COI is:

A researcher's wife holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study.

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

What is the term for management controls that are built in to a research study (for example, independent data analysis)?

Inherent controls

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


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