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SOP 801: Conflict of Interest

Version: E1821

POLICY

The University of Utah IRB will follow and adhere to the University’s Conflict of Interest policy. The full policy (1-006) is posted on the University Regulations website. All investigators engaged in research are required to comply with the policy. The IRB requires financial interests of investigators, study personnel, and relevant institutional officials to be managed so that they do not adversely affect participant protections or the credibility of the human research protection program.

The protection of human subjects requires objectivity in communicating risks, selecting subjects, promoting informed consent, and gathering, analyzing, and reporting data. Therefore, the IRB will consider conflict of interest issues in its deliberations of applications.

All principal investigators must complete a disclosure form within the University of Utah Business Relationship Reporting online system, declaring any significant potential financial interests related to the research. The ERICA online system communicates with the Business Relationship Reporting online system to determine if disclosure forms for individuals listed in the IRB application are completed and up to date as per the standards described in University Policy 1-006.

The Conflict of Interest Committee is required to report all conflicts of interest determinations related to human subject research and provide management plans to the IRB. Management plans are accessible to the IRB within the ERICA system. The IRB will review the conflict of interest decisions and management plans to consider the effect of financial interests on participant protections. The IRB may request that the investigator update the IRB application and/or consent documents to comply with the conflict of interest management plan if it has not already been updated. The IRB has the final authority to decide whether the conflicting interests and management plans adequately protect participants and allow research to be approved.

 

Please contact the IRB Office at (801) 581-3655 or irb@hsc.utah.edu for additional guidance.