{"id":2614,"date":"2016-07-07T17:25:30","date_gmt":"2016-07-07T21:25:30","guid":{"rendered":"https:\/\/www.bumc.bu.edu\/irb\/?page_id=2614"},"modified":"2023-06-28T07:17:52","modified_gmt":"2023-06-28T11:17:52","slug":"ceding-review","status":"publish","type":"page","link":"https:\/\/www.bumc.bu.edu\/irb\/submission-requirements\/when-to-submit\/ceding-review\/","title":{"rendered":"Ceding Review"},"content":{"rendered":"<p><strong>Before you can participate in a study being conducted through an outside IRB of Record, the BMC\/BU Medical Campus IRB must first review your INSPIR cede application to (1) verify that you meet all the institutional requirements (such as CITI training); (2) verify that all applicable institutional and departmental electronic sign-offs have been obtained (such as by the Department Chair, Pharmacy, GCRU, etc.); and (3) decide whether it will agree to cede review to the outside IRB of record based on your research activities.\u00a0 If the BMC\/BU Medical Campus IRB agrees to cede review, then this will be documented in a reliance agreement with the outside IRB of Record (either by a SMART IRB reliance agreement, or a traditional reliance agreement).<\/strong><\/p>\n<p><strong>For general guidance on reliance agreements, SMART IRB, and different types of External Investigators, see the <a href=\"https:\/\/wwwapp.bumc.bu.edu\/ocr\/ClinicalResearchNewsletter\/article.aspx?article=760\" target=\"_blank\" rel=\"noopener noreferrer\">October 2019 CR TIMES Feature Article, SMART IRB and You<\/a>. \u00a0For a detailed reference list of all available HRPP resources related to ceding review, please click <a href=\"https:\/\/www.bumc.bu.edu\/irb\/submission-requirements\/when-to-submit\/ceding-review\/cede-review-resources\/\" target=\"_blank\" rel=\"noopener noreferrer\">here<\/a>.<\/strong><\/p>\n<p><strong>Following are instructions for different types of research studies in which Principal Investigators may wish to cede review to an outside IRB of Record rather than the local BMC\/BU Medical Campus IRB.\u00a0 Identify the type of research study from the list below, then prepare the INSPIR cede application, following any special variations to the cede application for your type of study.<\/strong><\/p>\n<h2><br style=\"clear: both;\" \/><br style=\"clear: both;\" \/>INSPIR Cede Application<\/h2>\n<p>These are basic instructions for participating in a study being conducted by an outside institution or IRB of Record; however, note the special instructions to the application below for multi-center industry-sponsored studies involving an investigational drug (IND) or investigational device (IDE); or NIH federally-funded studies requiring a Single IRB; or studies initiated by special consortium groups with a central institutional review board.\u00a0 For questions, send an email to <a href=\"mailto:medirb@bu.edu\">medirb@bu.edu<\/a>.<\/p>\n<ul>\n<li><a href=\"\/irb\/files\/2019\/10\/Cede-Application.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Creating Your INSPIR Cede Application<\/a><\/li>\n<\/ul>\n<h2><br style=\"clear: both;\" \/><br style=\"clear: both;\" \/>Ceding Review for IND\/IDE Studies<\/h2>\n<h4>New Multi-Centered Industry-sponsored Studies Involving an IND or IDE<\/h4>\n<p>Principal Investigators have the following two options for submitting new multi-centered industry-sponsored protocols involving an investigational drug (IND) or investigational device (IDE):<\/p>\n<ol>\n<li>To the local BMC\/BU Medical Campus IRB for full board review (in Section 4.1 of the INSPIR application, select the 5th option, None of the above. This study requires Expedited review or the review of the Full Board.<\/li>\n<li>To the industry sponsor\u2019s central Commercial IRB through an INSPIR cede application if the Commercial IRB is AAHRPP-accredited and a Smart IRB Participating Member. In this arrangement, the sponsor is invoiced for all reviews performed by the Commercial IRB for Boston Medical Center and BU Medical Campus as Relying Sites.\u00a0 See\u00a0<a href=\"https:\/\/wwwapp.bumc.bu.edu\/ocr\/ClinicalResearchNewsletter\/article.aspx?article=808\" target=\"_blank\" rel=\"noopener noreferrer\">Preparing Commercial IRB Submissions for Multi-Center Industry-Sponsored Trials Where the Sponsor Holds the IND\/IDE &#8211; Oct 2021<\/a>.<\/li>\n<\/ol>\n<h2><br style=\"clear: both;\" \/><br style=\"clear: both;\" \/>Ceding Review for NIH-funded Studies Requiring a Single IRB for a Specific Study<\/h2>\n<ul>\n<li>\u00a0If the Single IRB is a Commercial IRB:\n<ul>\n<li>Follow the instructions for \u201c<a href=\"\/irb\/files\/2019\/10\/Cede-Application.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Creating an INSPIR Cede Application<\/a>\u201d.\u00a0 For Section 6.3 &#8211; Option 1 Commercial Institutional Review Board:\u00a0 Answer YES; then select the Commercial IRB from the IAA list.\u00a0 If the Commercial IRB is not in the Commercial IRB IAA list, then send an email to medirb@bu.edu to request that the Commercial IRB be added to the Commercial IRB IAA list in the INSPIR cede application \u2013 clarify that this is the designated Single IRB for an NIH-funded study, and explain whether you will be recruiting and consenting subjects.<\/li>\n<li>Then, complete the rest of the INSPIR application sections as they appear.\u00a0 Attach any documentation in which the NIH has designated the single IRB for the study.<\/li>\n<\/ul>\n<\/li>\n<li>If the Single IRB is an Institution:\n<ul>\n<li>Follow the instructions for \u201c<a href=\"\/irb\/files\/2019\/10\/Cede-Application.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Creating an INSPIR Cede Application<\/a>\u201d.\u00a0 For Section 6.3 and Section 6.4:\u00a0 Answer NO.\u00a0 For Section 6.5 &#8211; Option 3 Other Reviewing Institutions:\u00a0 Answer YES, then select the institution from the IAA list.\u00a0 If the institution is not on the IAA list, then send an email to medirb@bu.edu to request that the institution be added to the Institution IAA list in the INSPIR cede application \u2013 clarify that this is the designated Single IRB for an NIH-funded study and explain whether you will be recruiting and consenting subjects.<\/li>\n<li>Then, complete the rest of the INSPIR application sections as they appear.\u00a0 Attach any documentation in which the NIH has designated the single IRB for the study.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h2><br style=\"clear: both;\" \/><br style=\"clear: both;\" \/>Ceding Review for Studies Initiated by a Special Multi-Site Research Collaboration Group<\/h2>\n<ul>\n<li>This is typically a consortium or association of institutions dedicated to research for a specific disease, medical specialty, or research topic.\u00a0 The member institutions will designate a central institutional review board as the IRB of Record for all research studies initiated by the consortium member institutions.<\/li>\n<li>The BMC\/BU Medical Campus IRB will be required to pre-sign a reliance agreement with the IRB of Record of the consortium prior to review of any specific studies initiated by the consortium members.<\/li>\n<li>Follow the instructions for \u201c<a href=\"\/irb\/files\/2019\/10\/Cede-Application.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Creating an INSPIR Cede Application<\/a>\u201d.\u00a0 For Section 6.3:\u00a0 Answer NO.\u00a0 For Section 6.4 &#8211; Option 2 Central Institutional Review Board:\u00a0\u00a0 Answer YES, then select the consortium group from the Central IRB list.\u00a0 If the consortium is not on the Central IRB list, then send an email to medirb@bu.edu to request that the consortium be added to the Central IRB list in the INSPIR cede application \u2013 clarify that this is the central IRB for a consortium group and explain whether you will be recruiting and consenting subjects.\u00a0 Then, complete the rest of the INSPIR application sections as they appear.<\/li>\n<\/ul>\n<p>More information about ceding review may be found by <a href=\"https:\/\/www.bumc.bu.edu\/irb\/contact-us\/\">contacting us<\/a> or at the following links:<\/p>\n<ul>\n<li><a href=\"http:\/\/www.bumc.bu.edu\/ohra\/hrpp-policies\/hrpp-policies-procedures\/#2.5\">HRPP Policies and Procedures<\/a><\/li>\n<li><a href=\"https:\/\/wwwapp.bumc.bu.edu\/ocr\/ClinicalResearchNewsletter\/article.aspx?article=760\">SMART IRB AND YOU<\/a> \u2013 Oct 2019<\/li>\n<li><a href=\"https:\/\/www.bumc.bu.edu\/irb\/files\/2019\/11\/Local-Responsibilities-Lessons-Learned-from-Cede-Review.pdf\">Local Responsibilities: Lessons Learned from Cede Review<\/a> (AAHRPP poster presentation, May 2019)<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Before you can participate in a study being conducted through an outside IRB of Record, the BMC\/BU Medical Campus IRB must first review your INSPIR cede application to (1) verify that you meet all the institutional requirements (such as CITI training); (2) verify that all applicable institutional and departmental electronic sign-offs have been obtained (such [&hellip;]<\/p>\n","protected":false},"author":1250,"featured_media":0,"parent":2599,"menu_order":4,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages\/2614"}],"collection":[{"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/users\/1250"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/comments?post=2614"}],"version-history":[{"count":32,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages\/2614\/revisions"}],"predecessor-version":[{"id":4524,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages\/2614\/revisions\/4524"}],"up":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages\/2599"}],"wp:attachment":[{"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/media?parent=2614"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}