Conflicts of Interest in Human Subjects Research Module 13

The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show:

There may be bias by the peer reviewer as to the area of research

An example of an individual financial COI is:

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

The FDA regulations governing disclosure of individual COIs require:

Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies

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

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