COI Conflict of Interest

Conflict of Interest Policy – IRB members

An IRB member may not vote on a project and is not counted towards a quorum, when:

• Conflict of interest in research involves situations in which an investigator has a significant financial interest that may compromise, or have the appearance of compromising, professional judgment in the design, conduct, or reporting of research. The terms "investigator" and "significant financial interest" are defined below.
• Investigators conducting research funded by the Public Health Service (including National Institutes of Health) and National Science Foundation, as well as those conducting studies regulated by the Food and Drug Administration, are subject to agency specific regulations (II-18.8 below). These regulations set forth the obligations of investigators, sponsors and institutions for research involving significant financial or other conflicts of interest, and affected parties are advised to review the relevant regulations prior to submission of a research proposal or application.

1. "Investigator" means the principal investigator and any other person, whether faculty, staff, or student, who is responsible for the design, conduct, or reporting of research. "Investigator" also includes the investigator's spouse and dependent children.
2. "Significant financial interest" means anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options, or other ownership interests); and intellectual property rights (patents, copyrights, and royalties from such rights) held by an investigator or the investigator's immediate family(Immediate family means spouse or domestic partner, and dependent children), individually or in aggregate, when such interest involves:
   • Payments in excess of $10,000 (including salary, consulting fees, royalty or licensing payments from intellectual property, and honoraria and/or gifts) received within the past 12 months or anticipated for the next 12 months (excluding salary and other payments for services from the University);
   • An equity interest in a publicly traded company worth more than $10,000 or more than 5 percent of the business entity as determined by reference to its publicly listed price (excluding mutual funds);
   • Any equity interest if the value cannot be determined by reference to publicly listed prices (i.e., an equity interest in a privately held company, such as a start-up company);
   • A position giving rise to a fiduciary duty, such as director, officer, partner, trustee, employee, or any other position of management; or 
   • Intellectual property rights (patents or copyrights) or royalties from such rights whose value may be affected by the outcome of the research, including royalties distributable under University policy or any royalty-sharing agreements involving the University.

• Personal agreements between sponsors and investigators, IRB members, or their immediate family members where the amount of compensation (consulting, board honoraria, or any other kind) could change depending on the outcome of a study or any other activity the faculty/IRB member performs as part of their University service are prohibited. In some cases, such arrangements are illegal under state law.