The Disclosure Rule
Researchers are required to disclose any related financial interest. A related financial interest is an interest pertaining to or associated with a specific research project that includes income, equity, intellectual property, and/or sponsored travel. The UCOP policies related to conflicts of interest (COIs) can be found here.
At UC Davis, the IRB is charged with oversight of COIs in human subjects research as part of its mandate to protect the rights and welfare of human subjects. This charge includes oversight of financial COIs and other conflicts including conflicts of commitment. Oversight of conflicts promotes transparency with research subjects (typically through disclosure in consent documents); supports the principle of equipoise among investigators and staff; avoids bias in subject recruitment and contributes to good study design.
Review and management of COIs at UC Davis are guided by UC Davis Policy and Procedure Manual (PPM) under “Individual COIs Involving Research (230-05)” and/or “Public Health Service Regulations on Objectivity in Research (230-07),” and also in the University of California’s policy under “Disclosure of Financial Interests & Management of COIs, Public Health Service Research Awards (UC-RG-12-0133).”
The following are additional resources the IRB uses to support review of research projects that present potential and actual COIs:
The Researcher's Responsibility
All individuals involved in the design, conduct, or reporting of human subjects research are required to submit information about COIs to both the IRB and the Conflict of Interest Committee (COIC) at UC Davis. The website containing forms for submission to the COIC is found here.
When to Submit COI Information for IRB Review
- On submission of an initial review in the electronic INITIAL REVIEW APPLICATION.
- At least annually as part of continuing review using FORM HRP-212 CONTINUING REVIEW PROGRESS REPORT.
- Within 30 days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new financial interest using FORM HRP-213 Modification.
To disclose a conflict of commitment or other, non-financial conflict, contact firstname.lastname@example.org
What to Submit for IRB Review