{"id":16386,"date":"2026-07-01T16:20:22","date_gmt":"2026-07-01T20:20:22","guid":{"rendered":"https:\/\/www.rochester.edu\/ohsp\/?page_id=16386"},"modified":"2026-09-30T13:44:21","modified_gmt":"2026-09-30T17:44:21","slug":"institutional-review","status":"publish","type":"page","link":"https:\/\/www.rochester.edu\/ohsp\/irb-review\/institutional-review\/","title":{"rendered":"Institutional Review Process"},"content":{"rendered":"","protected":false},"excerpt":{"rendered":"","protected":false},"author":36,"featured_media":0,"parent":356,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":"","_members_access_role":[],"_members_access_error":""},"class_list":["post-16386","page","type-page","status-publish","hentry"],"acf":{"lead_in":"","display_title":"Institutional Review Process","subtitle":"When an institution uses an external IRB, it remains responsible for the remaining Human Research Protection Program components.","call_to_action":"","hero_image_placement":"no_image","hero_media":"images","hero_pattern_option":"","hero_video":"","hero_image_landing":"","hero_image_landing_two":"","hero_image_landing_three":"","content_modules":[{"acf_fc_layout":"text","anchor":"","css_class":"","title":"","content":"University of Rochester manages its HRPP responsibilities with an Institutional Review application. The Institutional Review application is available as a project type in the CLICK IRB system.\r\n\r\nThe 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 University of Rochester to meet its regulatory responsibility for the conduct of human subject research by University of Rochester faculty, staff, and students.","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"text","anchor":"","css_class":"","title":"<h2><strong>About the Institutional Review Process<\/strong><\/h2>","content":"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.\r\n\r\nOnce 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.","background_color":"#f4f4f4","width":"width-medium"},{"acf_fc_layout":"text","anchor":"","css_class":"","title":"<h2>Working with sIRBs<\/h2>","content":"The Institutional Review cannot be finalized until the sIRB has approved University of Rochester 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.\r\n\r\nTo accommodate this, University of Rochester 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 \u201cPending sIRB Review\u201d state.\r\n\r\nOnce the reviewing IRB has approved University of Rochester 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\u2019s 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.","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"text","anchor":"","css_class":"","title":"<h2>Continuing Reviews<\/h2>","content":"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\u2019s responsibility to ensure that all reviewing IRB policies are followed and that applications are submitted. However, University of Rochester OHSP does require an Annual Update at the time of Continuing Review.\u00a0 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.","background_color":"#f4f4f4","width":"width-medium"},{"acf_fc_layout":"text","anchor":"","css_class":"","title":"<h2>Modifications<\/h2>","content":"When relying on an external IRB, the University of Rochester PI need not submit any Modification applications to University of Rochester 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.\r\n\r\nThe University of Rochester 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.\r\n\r\n<a href=\"https:\/\/www.rochester.edu\/ohsp\/contact\/\">Contact OHSP<\/a> with any questions to determine if a modification is needed.","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"text","anchor":"","css_class":"","title":"<h2>Reporting Problems or Events<\/h2>","content":"When relying on an external IRB, the University of Rochester PI is responsible for following all of the reviewing IRB\u2019s policies, including the reporting of problems or events. The University of Rochester PI should become familiar with the reviewing IRB\u2019s prompt reporting timeline as well as criteria for what needs to be reported.\r\n\r\nAdditionally, any events that occur at University of Rochester must be reported to University of Rochester via a <a href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/rsrb-submissions\/reports-of-new-information\/\">Report of New Information<\/a> and according to University of Rochester IRB <strong><a href=\"https:\/\/www.rochester.edu\/ohsp\/resources\/unanticipated-problems\/\">reporting criteria and timeline<\/a>.<\/strong>\u00a0Even though University of Rochester is not the reviewing IRB for the study, when the event occurs at University of Rochester, the institution is responsible for assisting the reviewing IRB and ensuring that institutional policies and concerns are met.","background_color":"#f4f4f4","width":"width-medium"},{"acf_fc_layout":"text","anchor":"","css_class":"","title":"<h2>When the study is complete<\/h2>","content":"When the reviewing IRB closes the study or closes University of Rochester as a site because no research activities are remaining, the University of Rochester PI must submit a \u00a0<a href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/irb-submissions\/study-closure\/\">Study Closure Form<\/a> to close out the Institutional Review application.","background_color":"#ffffff","width":"width-medium"}]},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.4 - 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