Conflicts of Interest

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.

Policy Information

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:

HRP-054 – SOP – Institutional Conflicts of Interests

HRP-055 – SOP – Financial Conflicts of Interests

HRP-056 – SOP – PPM 230-05 Public Health Service Regulations on Objectivity in Research

HRP-057 – SOP – University of California Policy on Financial Conflicts of Interests

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 hs-irbeducation@ucdavis.edu

What to Submit for IRB Review

New Projects

Enter information into the Initial Review Application and submit the supporting documentation. A brief statement of the nature, type, and value of the interest—even one or two sentences—is often sufficient for oversight of human subject research. If available, upload copies of Form 700-U and/or Form 800 as required for COIC review.  Upload the determination of the Conflict of Interest Committee if available; if not, provide a copy of the determination at the earliest opportunity to the IRB Committee Analyst who facilitates the IRB review of your project.

Active projects

Submit FROM HRP 213 Amendment/Modification form and include a description of the related financial interest in the description field. Submit revised study documents (including, for example, the informed consent form) as appropriate. If the submission is made later than 30 days after the acquisition or discovery of the conflict of interest, submit FORM HRP 214 Reportable New Information in addition to the Modification form to describe the reason for reporting the disclosure late and the preventive action plan for management and reporting of future COIs.

NOTE: A conflict of interest routinely requires disclosure in subject facing documents, especially informed consent forms, as well as public documents such as publications of study outcomes.  COIs may also require individuals to be removed from certain research activities such as subject recruitment, data collection, and independent data analysis. It may be advisable to incorporate anticipated requirements in study documents so as to avoid a halt of enrollment or required study modifications following conflict of interest determinations in either the COIC or the IRB.
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