IRB Policy: Member Conflict of Interest (COI)
An IRB member is said to have a conflicting interest whenever that IRB member, or his/her spouse, domestic partner or first degree relative (e.g., child, sibling, or parent):
- is an investigator or key personnel on the protocol under consideration;
- acts as an officer or a director of the sponsor or an agent of the sponsor;
- is involved in the research as a coordinator, protocol consultant and/or primary advisor;
- has received any of the following from an entity whose financial interests would reasonably appear to be affected by the outcome of the research:
- non-university salary or other payments for services (e.g., consulting fees or honoraria) exceeding $10,000 over a 12-month period;
- equity interests (e.g., stocks, stock options or other ownership interests) exceeding $10,000 or 5% of the equity of the entity; or
- intellectual property rights (e.g., patents, copyrights, royalties from such rights); or
- has identified him/her self for any other reason as having a conflicting interest (e.g., having a close personal or professional association with the submitting investigator, serving as co-investigator and/or the primary mentor for a student or post doc investigator).
Disclosure and Documentation of Financial Interest and COI
Responsibility
The Vice Chancellor for Research is responsible for articulating and enforcing the research conflict of interest policy at UCSC. The IRB Chair is responsible for identifying COI disclosures at IRB meetings before each protocol review and discussion. The Director serves as the liaison between UCSC’s COI Committee Chair and/or COI Coordinator and the IRB. ORCA staff are responsible for documenting all conflicts of interest in the IRB meeting minutes. IRB members and ORCA staff are required to be knowledgeable about conflict of interest issues and institutional policies pertaining to COI.
Process Overview
Applicable Regulations and Guidelines
45 CFR 46.107
21 CFR 56.107 OHRP’s “Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection” (5/12/2004)