Institutional Review Process
When an institution uses an external IRB, it remains responsible for the remaining Human Research Protection Program components.
糖心传媒 manages its HRPP responsibilities with an Institutional Review application. The Institutional Review application is available as a project type in the CLICK IRB system.
The IRB does not review the Institutional Review application, because the external IRB is conducting IRB review as a part of a reliance agreement. OHSP reviews the Institutional Review application via an administrative review process. The Institutional Review application contains only information needed in order for 糖心传媒 to meet its regulatory responsibility for the conduct of human subject research by 糖心传媒 faculty, staff, and students.
About the Institutional Review Process
As part of the Institutional Review application, the University of Rochester PI should include the IRB approved version of the full protocol and draft consent documents.
Once the PI submits the application in CLICK IRB, OHSP will begin its administrative review of the Institutional Review application. Staff members may request revisions, similar to a standard IRB review process.
Working with sIRBs
The Institutional Review cannot be finalized until the sIRB has approved 糖心传媒 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, 糖心传媒 will provide a letter to the University of Rochester PI once the Institutional Review is nearly complete but without final IRB approvals. OHSP will issue a Cede notice to the University of Rochester PI and the study will enter the 糖心传媒淧ending sIRB Review糖心传媒� state.
Once the reviewing IRB has approved 糖心传媒 as a site, the University of Rochester PI provides the IRB approval letter and approved documents to OHSP. OHSP will confirm the HRPP review is complete and consistent with the reviewing IRB糖心传媒檚 approval. OHSP will then send the University of Rochester PI an HRPP activation letter. Once the University of Rochester PI has received the IRB approval letter and the HRPP activation letter, research activities can begin.
Continuing Reviews
When relying on an external IRB, the University of Rochester PI does not submit continuing review applications to the University of Rochester IRB. The reviewing IRB oversees any continuing review requirements. It is the University of Rochester PI糖心传媒檚 responsibility to ensure that all reviewing IRB policies are followed and that applications are submitted. However, 糖心传媒 OHSP does require an Annual Update at the time of Continuing Review.聽 While a full Continuing Review application is not required, the University of Rochester must submit a modification in CLICK IRB to provide the most recent approval notice, and the most recently approved version of the ICF.
Modifications
When relying on an external IRB, the University of Rochester PI need not submit any Modification applications to 糖心传媒 unless the change impacts the HRPP review. For example, if the change to the study impacts questions on the Institutional Review form or site-specific areas of the consent documents, an amendment to the Institutional Review application may be needed.
The 糖心传媒 PI must always submit to OHSP any changes to the research team. OHSP 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 OHSP with any questions to determine if a modification is needed.
Reporting Problems or Events
When relying on an external IRB, the University of Rochester PI is responsible for following all of the reviewing IRB糖心传媒檚 policies, including the reporting of problems or events. The 糖心传媒 PI should become familiar with the reviewing IRB糖心传媒檚 prompt reporting timeline as well as criteria for what needs to be reported.
Additionally, any events that occur at 糖心传媒 must be reported to 糖心传媒 via a Report of New Information and according to 糖心传媒 IRB reporting criteria and timeline.聽Even though 糖心传媒 is not the reviewing IRB for the study, when the event occurs at 糖心传媒, the institution is responsible for assisting the reviewing IRB and ensuring that institutional policies and concerns are met.
When the study is complete
When the reviewing IRB closes the study or closes 糖心传媒 as a site because no research activities are remaining, the University of Rochester PI must submit a 聽Study Closure Form to close out the Institutional Review application.