What do I need to know about conflict of interest regarding my clinical trial?
A financial conflict of interest may arise when an investigator has a significant financial interest that may compromise -- or have the appearance of compromising -- his or her professional judgment in the design, conduct, or reporting of research. Per Federal regulations and University policies, investigators must disclose and manage actual or apparent conflicts of interests in relation to any sponsored project. Note that such conflicts must be disclosed at the proposal stage. The Division of Sponsored Programs is unable to forward an application until/unless all potential financial conflicts of interest have been disclosed. The University will develop specific mechanisms by which any conflicts of interest will be satisfactorily managed, reduced, or eliminated prior to the expenditure of any funds on an award. Sponsored project-related COIs are disclosed to the UI Conflict of Interest in Research office. Full information on COI definitions as well as disclosure forms and procedures are available through the COI in Research website.
In addition to the UI conflict of interest policy, Federal Code Part 54 requires that investigators disclose financial interests in sponsors of clinical trials. Typically, the corporate sponsor will provide its own disclosure form which details what must be disclosed (royalties, patents, equity interest, etc.). The company's disclosure form does not serve as a replacement or substitute for the UI's form -- the Statement of Financial Interest form. The company's form should be sent directly to the company, rather than a UI office.