IRB Process & Conflict of Interest

Please visit: Conflict of Interest

The University of Utah IRB follows and adheres to the University’s Conflict of Interest policy (U Pol 1-006). The principal investigator and all faculty, staff, postdoctoral appointees, residents or students, whether paid by the University or not, who are responsible for the design, conduct or reporting of research conducted in whole or in part at the University must disclose significant financial interests. For additional guidance on those required to complete conflict of interest disclosures, please visit Conflict of Interest.

Process for IRB and Conflict of Interest Review:

1. Log on to “Business Relationship Reporting” and complete the Disclosure Form.  For instructions on how to use Business Relationship Reporting, click here: http://coi.utah.edu/. 

2. Complete an IRB New Study Application in the ERICA system. 

3. Business Relationship Reporting automatically communicates with the ERICA system to provide information about the principal investigator’s (PI), sub-investigator’s, and internal staff’s Disclosure Forms.

4. The PI submits the new study in ERICA.  The PI is unable to submit unless his/her Disclosure Form has been completed.

5. While the IRB pre-review process (or ancillary review process) is occurring, the Conflict of Interest Office reviews the Disclosure Forms.  

6. When the IRB pre-review is complete, ERICA checks the following:

1. The PI’s, sub-investigator’s, and internal staff’s Disclosure Forms have been certified within the last 90 days.  Any members of the research team who have not certified their disclosure in the last 90 days will be notified by email. 

2. If the Conflict of Interest Committee has any conflict of interest management plans for the PI, sub-investigator, and internal staff.

7. ERICA holds the study in the COI Pending state until all Disclosure Forms are certified and necessary management plans are in determined.
   
   

Additional Information

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. The Conflict of Interest Committee is required to report all conflicts of interest and provide a management plan to the IRB. The IRB will review the conflict of interest reports and management plans to consider the effect of financial interests on participant protections.
 
The IRB requires financial interests of investigators to be managed so that they do not adversely affect participant protections or the credibility of the human research protection program. Disclosure alone can not be used to manage investigators’ financial interests that might adversely affect participant protections. The IRB has the final authority to decide whether the conflicting interest and its management plan allow the research to be approved.

Conflict of Interest Office

For more information about the Conflict of Interest policy or for any questions about completing the conflict of interest disclosure, please contact the Conflict of Interest Office:
 
Phone: 801.581.7170
Website: http://coi.utah.edu/