When an institution uses an external IRB, it remains responsible for the remaining Human Research Protection Program components. UIUC manages these responsibilities with a Facilitated Review application. The Facilitated Review application is available as a project type in the IRBOnline system.
The IRB does not review the Facilitated Review application, because the external IRB is conducting IRB review as a part of a reliance agreement. OPRS reviews the Facilitated Review application via an administrative review process. The Facilitated Review application contains only information needed in order for UIUC to meet its regulatory responsibility for the conduct of human subject research by UIUC faculty, staff, and students.
As part of the Facilitated Review application, the UIUC PI should include a draft version of the full protocol and consent documents. Although these do not need to be the final IRB-approved versions of the protocol and consent document, they should be finalized draft versions.
Once the PI submits the application in IRBOnline, OPRS will begin its administrative review of the Facilitated Review application. Staff members may request revisions, similar to a standard IRB review process.
The Facilitated Review cannot be finalized until the sIRB has approved UIUC as a site and provided final IRB-approved consent documents and protocol. However, reviewing IRBs often request the HRPP review or local context review to be completed prior to approving the site.
To accommodate this, UIUC will provide a letter to the UIUC PI once the Facilitated Review is nearly complete but without final IRB approvals. OPRS will return the Facilitated Review application to the UIUC PI with a revision request to attach the IRB approved documents along with a letter that can be provided to the reviewing IRB stating the aspects of the review that have been completed.
Once the reviewing IRB has approved UIUC as a site, the UIUC PI provides the IRB approval letter and approved documents to OPRS. OPRS will confirm the HRPP review is complete and consistent with the reviewing IRB’s approval. OPRS will then send the UIUC PI an HRPP activation letter. Once the UIUC PI has received the IRB approval letter and the HRPP activation letter, research activities can begin.
When relying on an external IRB, the UIUC PI does not submit continuing review applications to the UIUC IRB. The reviewing IRB oversees any continuing review requirements. It is the UIUC PI’s responsibility to ensure all reviewing IRB policies are followed and applications are submitted.
When relying on an external IRB, the UIUC PI need not submit any amendment applications to UIUC unless the change impacts the HRPP review. For example, if the change to the study impacts questions on the Facilitated Review form or site-specific areas of the consent documents, an amendment to the Facilitated Review application may be needed.
The UIUC PI must always submit to OPRS any changes to the research team. OPRS must approve these before the individual can begin conducting research procedures. The HRPP, rather than the reviewing IRB, is responsible for approval of individual members of the research team, as part of the training verifications and conflict of interest review.
Contact OPRS with any questions to determine if an amendment is needed.
When relying on an external IRB, the UIUC PI is responsible for following all of the reviewing IRB’s policies, including the reporting of problems or events. The UIUC PI should become familiar with the reviewing IRB’s prompt reporting timeline as well as criteria for what needs to be reported.
Additionally, any events that occur at UIUC must be reported to UIUC via a report form and according to UIUC IRB reporting criteria and timeline. Even though UIUC is not the reviewing IRB for the study, when the event occurs at UIUC, the institution is responsible for assisting the reviewing IRB and ensuring that institutional policies and concerns are met.
When the reviewing IRB closes the study or closes UIUC as a site because no research activities are remaining, the UIUC PI must submit a Final Project Report to close out the Facilitated Review application.