What is reviewed?
All investigators are required to submit financial interest disclosures in the eCOI system. When first submitted, the disclosures are reviewed to see if they meet specific criteria to be considered "significant" financial interests. Records that meet this criteria are flagged in the system and then compared to specific research projects as they are submitted in UIRIS (for sponsored research) or HawkIRB (for human subjects research).
Who does the reviewing?
The Institutional Official, or Conflict of Interest Officer, is responsible for reviewing disclosure reports and determining all instances of significant financial interest. This activity is carried out by the staff of the Conflict of Interest in Research Office.
Not only is the Conflict of Interest Officer responsible for determining significant financial interests, but also when a significant financial interest intersects directly with a research project. When these two circumstances converge, then a financial conflict of interest in research is created.
Reporting, reviewing and management of financial conflicts of interest in research is required by federal regulations and certain accreditation requirements.
How can financial interests and research projects intersect?
Financial interests and research projects become associated when a UI investigator has a financial interest (personal compensation, royalties, ownership, fiduciary duty, etc.) in an organization or company that also seeks to sponsor research at the University.
After a financial interest disclosure has been flagged as "significant," each time that investigator is named on an IRB application or a routing form, the COIR Office reviews for relatedness. If there is an appearance that the financial interest and the research project is related, information will be gathered for the Conflict of Interest in Research Committee to review.
What information is required?
COIR Staff will contact the investigator with the financial interest and request the following information:
- Confirmation that the information on the eCOI disclosure is correct and complete
- Copy of the contract to the University of Iowa
- Copy of the full research proposal
- Memo of Compelling Circumstance (Human Subjects Research only), or
- GAP Email
In the last two documents, the investigator will be asked specific questions about his/her role in the research, and how the research may impact the financial interest. Information about student/trainee/post-doc involvement will also be collected. The COI Officer will also notify the DEO or the relevant dean of the investigator's department/college so they are aware that the interest and the research will be reviewed by the Committee.