Series 202 Conflicts of Interest

The Utah State University Institutional Review Board adheres to the University’s Conflict of Interest policies, and to the procedures established by the Office of Research Integrity and Compliance, which govern all research projects at Utah State University. All investigators engaged in research are required to comply with these policies and procedures. 

The Institutional Review Board requires financial interests of investigators, study personnel, and relevant institutional officials to be managed so that they do not adversely impact participant protections or the credibility of the human research protection program or research enterprise at Utah State University. 

The protection of human research participants requires objectivity in identifying and communicating risks; selecting participants; promoting informed consent; and gathering, analyzing, and reporting data and findings. Therefore, conflict of interest matters are considered in the IRB’s deliberations on all types of submissions. 

Principal Investigator’s Role in Identifying and Declaring Conflicts

All Principal Investigators must complete a disclosure form, at least annually, through the Research Integrity and Compliance Office’s portal in Kuali. They must declare any significant financial interests related to their role at Utah State University. This should occur prior to any filing of any protocol with the Institutional Review Board.

Separately, the Principal Investigator is responsible for reviewing the definition of a Conflict with their research team for each individual protocol they oversee. They must request information from their research team about any potential conflicts, and disclose those conflicts in the Kuali protocol submission template. Disclosures will be reviewed by the Office of Research Integrity and Compliance, and if required, a management plan will be determined. Disclosures which appear only within a protocol submission may trigger a requirement that the annual conflict of interest disclosure be updated. A protocol cannot be approved until the Office of Research Integrity & Compliance has cleared or managed the conflict.

It is the Principal Investigator’s responsibility to ensure that disclosures related to Conflicts of Interest are kept up-to-date throughout the lifecycle of a project. If a new conflict arises after approval of a project has been granted, it should be disclosed via an amendment to the protocol within 30 days of the discovery of the new conflict.

Institutional Review Board Review of Management Plans

The Office of Research Integrity & Compliance has the sole responsibility for designing and approving management plans for research-related conflicts of interest, broadly speaking. The Institutional Review Board has the final authority over the requirements necessary to safely proceed with research involving human participants. Thus, the Institutional Review Board may require additional safeguards to be put into place before a research project involving human participants can begin. However, at no time may the IRB approve of a research project that has an unmanaged conflict of interest. Neither can the Institutional Review Board discard a management requirement that has been decided upon by the Office of Research Integrity & Compliance.