Conflicts of Interest in Human Subjects 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.

No later than the time of proposal submission

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

Researcher

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

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

Inherent controls