Kyle Conner, MA, CIP Associate Director, Office of Human Research COI & Human Research Kyle Conner, MA, CIP Associate Director, Office of Human Research

COI Disclosure for Researchers All individuals involved in conduct of human research must have a current conflict of interest disclosure on file with the institution In general, IRB approval for a research study will be withheld until this is confirmed, OR that delinquent individuals have been removed from the study Disclosures are made via the COI-Smart system, accessible from the OHR website

COI Review Process The OHR-1 gathers preliminary information from the researchers on a per study basis that is reviewed by the COI administrator on a weekly basis: Do you have a current Conflict of Interest Disclosure on file with the University? Do you or an immediate family member have any financial interests as defined in the TJU Conflicts of Interest Policy 107.03? Do you or an immediate family member have a significant financial interest that may pose a conflict of interest as defined in the TJU Conflicts of Interest Policy 107.03?

COI Review Process The COI administrator reports to OHR: those researchers who have not filed a COI disclosure those who have potential COIs in regard to a particular study the outcome of the COI Committee’s review of the potential COI If the COI Committee issues a management plan for a particular researcher, the COI administrator will post it to the pertinent IRB agenda. The IRB has the opportunity to accept or modify the management plan to increase protections for subjects in the study.

COI Policy University COI Policy 107.03 stipulates that $5,000 is the threshold at which an individual’s annual financial income from an external entity represents a significant financial interest that bears scrutiny by the COI Committee The financial income could take the following forms: Significant financial interest in the sponsor or subcontractor, i.e., paid consultancy, stock, stock options, ownership, etc. Intellectual property rights (patents, pending patents, copyrights, trademarks, licensing agreement, royalties) Honoraria, speaker’s fees, paid authorship Gifts Trips Service on Board Paid expert testimony Compensation for employment (by other than TJU/TJUH) Other

What’s At Stake? Financial COIs have the potential to affect, consciously or unconsciously, an investigator’s interactions with research subjects, handling of data, and objectivity in regard to the outcomes of the research The job of the COI Committee and IRB is to ensure that any financial conflicts are managed in such a way that the integrity of the research, the investigators, and the institution is maintained, and the research subjects are not adversely affected or harmed as a result of the investigator’s COI.

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