COI: OU IRB Procedure for 91探花 Researchers
Conflict of Interest: 91探花 IRB Procedure for 91探花 Researchers
Purpose
For the protection of human subjects, the 91探花 Institutional Review Boards (IRB) have adopted a Conflict of Interest (COI) Procedure. This procedure provides a mechanism for investigators to inform the IRB of any actual or perceived financial conflicts of interest that could influence the study outcomes or any conflicts of commitment they have related to the study.
Scope
This procedure applies to investigators listed on studies that meet both the federal definition of 鈥渉uman subject鈥 and 鈥渞esearch鈥, reviewed by 91探花.
Definitions
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Investigator means an individual engaged in the conduct of human subjects research activities. See IRB Guidance 鈥淪tudy Roles and Engagement in Research with Human Subjects: 91探花 IRB Guidance鈥 for more information.
Financial Conflict of Interest (FCOI) means a Significant Financial Interest (SFI) that could directly and significantly affect the design, conduct, or reporting of the research.
Financial Interest means anything of monetary value, whether or not the value is readily ascertainable.
Significant Financial Interest (SFI) means an interest of an Investigator or his or her family that reasonably appears to be related to the Investigator's Institutional Responsibilities and meets one of the following:
- Receipt of income or other payment for services over the past 12 months from and/or equity interest(s) in a publicly traded entity totaling more than $5,000.
- Receipt of income or other payment for services over the past 12 months from a non-publicly traded entity totaling more than $5,000
- Any equity interest(s) in a non-publicly traded entity, regardless of value
- Receipt of payments for any intellectual property rights and interests (e.g., from patents, copyrights assigned to any entity other OU) totaling more than $5,000
- Reimbursed or sponsored travel (excluding U.S. government agencies or U.S. institutions of higher education)
Equity interest means any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
Conflict of commitment (COC) involves a situation in which an OU employee engages in an outside professional activity, paid or unpaid, that involves a commitment of time that may interfere, or appear to interfere, with fulfillment of the employee's obligations to the University. Typically, these activities occur in excess of one day per week. This can result in, or appear to result in, conflicting obligations between or among OU and the other entity.
Procedure
- The individual completing the IRB application will contact all investigators on the research team to determine if any team member has a FCOI or COC.
- If yes, the individual completing the IRB application will list the name of the investigator(s) who may have a financial conflict of interest that could influence or be influenced by the outcome of the research and/or an external conflict of commitment relative to the research study.
- Investigators with a potential FCOI or COC will complete the Outside Interest annual disclosure form in Cayuse. See link to instructions below.
- If the investigator(s) already has a current annual disclosure form, no further action is required.
- The annual disclosure form will be reviewed and issued a determination of:
- No COI determined
- COI determined and managed
- COI determined and not managed
The IRB will be notified of the determination. If a management plan is required, the IRB will be notified of the management plan, as it pertains to the IRB study. A typical management plan includes adding a statement to the informed consent form so that participants are aware of the perceived or actual FCOI/COC. The IRB can add additional requirements.
Instructions