{"id":4522,"date":"2023-06-28T07:14:51","date_gmt":"2023-06-28T11:14:51","guid":{"rendered":"https:\/\/www.bumc.bu.edu\/irb\/?page_id=4522"},"modified":"2023-11-01T14:44:08","modified_gmt":"2023-11-01T18:44:08","slug":"cede-review-resources","status":"publish","type":"page","link":"https:\/\/www.bumc.bu.edu\/irb\/submission-requirements\/when-to-submit\/ceding-review\/cede-review-resources\/","title":{"rendered":"Cede Review Resources"},"content":{"rendered":"

BU CTSI Executive Advisory Board Question \u2013 Single IRB<\/u><\/em><\/p>\n

How are you addressing the challenges of using SMART-IRB for multicenter trials, regarding preparing teams to use other IRB, or, preparing the BMC\/BU Medical Campus IRB to be the IRB of record for external investigators?<\/em><\/p>\n

IRB Staff: <\/strong><\/p>\n

IRB reliance specialist Roz Schomer is the contact for all questions regarding reliance agreements, whether the arrangement involves BMC\/BUMC IRB acting as the IRB of record, or ceding to an external IRB.<\/p>\n

Roz Schomer<\/strong><\/a>,\u00a0IRB Reliance Specialist
\n<\/em>roz@bu.edu<\/em><\/a>\u00a0\u2013 (617) 358-5329<\/em><\/p>\n

IRB Website:<\/strong><\/p>\n

Ceding Review<\/a>: The IRB website contains detailed instructions for preparing the IRB application for ceding review.<\/p>\n

Adding External Investigators<\/a>: The IRB website contains instructions for adding external investigators to a study in which the BMC\/BUMC IRB is the IRB of record.<\/p>\n

INSPIR Application<\/a>:<\/strong><\/p>\n

Our electronic IRB application within the INSPIR system is a \u201csmart\u201d form that guides investigators through the submission process for studies seeking to cede review to an external IRB, or studies seeking to propose that the BMC\/BUMC IRB act as the IRB of record for external sites.<\/p>\n

For multi-site research where the BMC\/BUMC IRB as the IRB of record for external site(s), our IRB application collects the following information reflected in our HRPP Policies and Procedures here:<\/p>\n

7.2.2.16.6\u00a0\u00a0 Requirements for Multi-Site Research \u00a0Reviewed by the Boston Medical Center and Boston University Medical Campus IRB<\/strong><\/a><\/p>\n

For studies seeking to cede review to an external IRB, we have a Review Path dedicated to cede studies only, which is generated by selecting the following option in the application:<\/p>\n

\u201cBMC\/BU Medical Campus (the Relying Institution) cedes IRB review to another institution (the Reviewing Institution) under an Authorization Agreement.\u201d<\/p>\n

The information that is collected in this cede application is reflected in our HRPP Policies and Procedures here:<\/p>\n

7.2.2.18\u00a0 Requirements for Relying on another IRB<\/strong><\/a>\u00a0<\/strong><\/p>\n

BU CR TIMES:<\/strong><\/p>\n

I Have Ceded Review: Now What Do I Do?<\/a> (October 2023)<\/p>\n

Preparing Commercial IRB Submissions for Multi-Center Industry-Sponsored Trials Where the Sponsor Holds the IND\/IDE<\/a> (October 2021)<\/p>\n

SMART IRB AND YOU<\/a> (October 2019)<\/p>\n

*Note: the above article is an update of two previous CR TIMES articles,\u00a0When Ceding Review:
\nAdding BMC or BUMC as a Site through an External IRB<\/a>, March 2018 Issue; \u00a0and\u00a0The Complexities of \u201cSimplification\u201d \u2013 Using a Single IRB to Review for Multiple Sites<\/a>, October 2017 Issue.<\/p>\n

What\u2019s New with Ceded Studies<\/a> (October 2018)<\/p>\n

*Also, the Things to Know<\/a> section of the BU CR TIMES newsletter is used to communicate changes\/updates to HRPP Policies and Procedures<\/a> that affect cede review\/single IRB.<\/p>\n

CRRO Seminar:<\/strong><\/p>\n

I Have Ceded Review \u2013 Now What to Do? (10\/11\/2023)<\/o:p><\/span><\/u><\/p>\n

Slides<\/a>
\nVideo<\/a><\/p>\n

Cede Review and You \u2014 How to Navigate this Evolving \u201cNew World\u201d of IRB Review (9\/2020):<\/u><\/p>\n

Slides<\/a>
\nVideo<\/a><\/p>\n

Ceding Review and SMART IRB\u00a0(1\/2019):<\/u><\/p>\n

Slides<\/a>
\n<\/u>Video<\/a><\/p>\n

When a Single IRB Reviews for Multiple Sites: The Complexities of \u201cSimplification\u201d (10\/2017): <\/u><\/p>\n

Slides<\/a>
\nVideo<\/a><\/p>\n

RPN Workshop<\/strong>:<\/p>\n

Multi-Site Studies and Single IRB Review (10\/23\/2023):<\/p>\n

Slides<\/a>
\nVideo<\/a><\/p>\n

Cede Review: Navigating the World of Single IRB (1\/2022): <\/u><\/p>\n

Slides<\/a>
\nVideo<\/a><\/p>\n

What You Need To Know About Single IRB (10\/2018):<\/u><\/p>\n

Slides<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

BU CTSI Executive Advisory Board Question \u2013 Single IRB How are you addressing the challenges of using SMART-IRB for multicenter trials, regarding preparing teams to use other IRB, or, preparing the BMC\/BU Medical Campus IRB to be the IRB of record for external investigators? IRB Staff: IRB reliance specialist Roz Schomer is the contact for […]<\/p>\n","protected":false},"author":874,"featured_media":0,"parent":2614,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages\/4522"}],"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\/874"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/comments?post=4522"}],"version-history":[{"count":9,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages\/4522\/revisions"}],"predecessor-version":[{"id":4566,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages\/4522\/revisions\/4566"}],"up":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages\/2614"}],"wp:attachment":[{"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/media?parent=4522"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}