Office of Research Conflicts of Interest - Office of Research

Conflicts of Interest

Requirements

Researchers engaged in human subjects research are required to report any related financial interest (RFI) to the IRB. Click here for the UC Davis IRB’s definition of “related financial interest.” Click here for UC Davis IRB’s policy on reporting of a related financial interest.

In some instances investigators must also report an RFI to the Conflict of Interest Committee (COIC).  Click here for information on the RFIs that need to be reported to the COIC, how to report them, and when to report them. Click here for the UCOP policies related to conflicts of interest (COIs)

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 and the integrity of the research data. 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.

Investigator Responsibilities

Investigators and research staff must report RFIs to the IRB at initial review and within 30 days of acquiring a new RFI or receipt of additional unreported income from the same entity. A complete description of the RFI must be provided. The description must include:

  • The nature of the RFI;
  • The relationship of the RFI to the study;
  • The amount of income (including travel expenses) received, if any;
  • A description of the services performed, if any;
  • The value of any equity interest in the sponsor or sponsor competitor;
  • The position title, if the RFI involves employment;

Investigators may satisfy this requirement by uploading a narrative description of the RFI or submitting the COIC Forms 700-U, 800 and the Supplemental Form.

If additional, related income is expected before the study expires, Investigators may report the amount of the expected income in the description to avoid having to submit additional modifications when the additional income is received.  However, if the income exceeds the amount included in the report, investigators must submit a modification and report the additional income.

Policy Information

The following are links to IRB Administration policies associated with RFIs:

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

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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