Conflicts of Interest in Human Subjects Research

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