IRB Updates

New guidance regarding the Conflict of Interest policy was recently released in a response to the University’s accreditation through AAHRPP (http://aahrpp.org). As a result of this new guidance, several changes have been made to the ERICA system related to Conflict of Interest disclosures and the IRB application. These changes will take effect on Monday, February 28, 2011.

Please read the information below to understand how these changes will affect the IRB application and review process.

Changes to the IRB Application

• On the Contacts page of the IRB application, you are now asked to list “Internal Staff and Sub-Investigators”, not just sub-investigators. Internal staff and sub-investigators are those persons who are responsible for the design, conduct or reporting of research. This definition is directly from the Conflict of Interest policy (www.regulations.utah.edu/general/1-006.html). For guidance about how to determine who meets the requirements of this definition, please refer to the Conflict of Interest Guidance for Investigators available at www.research.utah.edu/irb/news/newsArchive(PDF)/CoI_GuidanceForInvestigators-Feb2011.doc, or contact the Conflict of Interest Office at 801-581-6351.
• The Conflict of Interest section has been moved to the second page of the IRB application. The format of this page has been changed so that the PI’s existing disclosures are displayed in a searchable format. You are still required to select the relevant Conflict of Interest Disclosure(s) for the PI from this list. The PI’s most recent disclosures appear first in the list.
• If you select more than one relevant disclosure in the IRB application, you are asked to indicate which disclosure is the primary/main disclosure for the study. This is indicated on a new page in the IRB application, which appears when you click “Continue” after selecting the disclosures. If you have only selected one disclosure, this page does not appear.

Changes to the IRB Review Process

• When the PI submits a new study to the IRB, all persons listed as “Internal Staff and Sub-Investigators” are automatically sent an email notice to complete a Conflict of Interest Disclosure if they have not previously done so for this project. The notice includes a link to the Conflict of Interest Project Information Page in ERICA where a new disclosure can be created. These disclosures are linked to the PI’s disclosure, so they do not need to be linked to the IRB application independent from the PI’s disclosure.
• Review by ancillary committees in ERICA and pre-review for the IRB proceeds while the internal staff and sub-investigators complete and submit their disclosures. However, the IRB cannot assign a study for exemption, expedited, or full board review until all disclosures are submitted and finalized. Disclosures with potential conflicts of interest are not finalized until they are reviewed and resolved by the Conflict of Interest Committee. Studies will enter a “Pending COI” state after IRB pre-review if disclosures are not finalized for all internal staff and sub-investigators.
• Continuing Review for studies originally approved before February 1, 2011: Current internal staff and sub-investigators listed on the IRB application are required to submit their disclosures at Continuing Review. The IRB cannot assign a continuing review application for expedited or full board review until all disclosures are submitted and finalized. This means that studies will enter a “Pending COI” state after IRB pre-review if disclosures are not finalized for all internal staff and sub-investigators. No exceptions will be made for studies that are expired or will expire before IRB approval can be issued. Please submit continuing review applications with enough time for COI disclosure submission, COI review of potential conflicts, and IRB review.
• Amendments for studies originally approved before February 1, 2011: Current internal staff and sub-investigators listed on the IRB application are not required to submit their disclosures at the time of an amendment; however, they are notified via email that they will need to complete a disclosure prior to continuing review. If the amendment adds a new person, the new person being added will be required to submit a disclosure. The IRB cannot assign an amendment application for expedited or full board review until the disclosure for the new person is submitted and finalized. This means that studies will enter a “Pending COI” state after IRB pre-review if disclosures are not finalized.

For frequently asked questions, please view this document.

If you have any questions, about these changes and requirements, please contact

Conflict of Interest Office
Phone: 801.581.6351

Institutional Review Board
Phone: 801.581.3655
Email: IRB@hsc.utah.edu