Ceding Review

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.  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).

For general guidance on reliance agreements, SMART IRB, and different types of External Investigators, see the October 2019 CR TIMES Feature Article, SMART IRB and You.

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.  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.



INSPIR Cede Application

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.  For questions, send an email to medirb@bu.edu.



Ceding Review for IND/IDE Studies

New Multi-Centered Industry-sponsored Studies Involving an IND or IDE

Principal Investigators have the following two options for submitting new multi-centered industry-sponsored protocols involving an investigational drug (IND) or investigational device (IDE):

  1. 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.
  2. To the industry sponsor’s 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.  See PROCEDURE FOR PREPARING COMMERCIAL IRB SUBMISSIONS THROUGH SMART IRB FOR MULTI-CENTERED INDUSTRY-SPONSORED SUBMISSIONS WHERE THE INDUSTRY SPONSOR HOLDS THE IND OR IDE.



Ceding Review for NIH-funded Studies Requiring a Single IRB for a Specific Study

  •  If the Single IRB is a Commercial IRB:
    • Follow the instructions for “Creating an INSPIR Cede Application”.  For Section 6.3 – Option 1 Commercial Institutional Review Board:  Answer YES; then select the Commercial IRB from the IAA list.  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 – clarify that this is the designated Single IRB for an NIH-funded study, and explain whether you will be recruiting and consenting subjects.
    • Then, complete the rest of the INSPIR application sections as they appear.  Attach any documentation in which the NIH has designated the single IRB for the study.
  • If the Single IRB is an Institution:
    • Follow the instructions for “Creating an INSPIR Cede Application”.  For Section 6.3 and Section 6.4:  Answer NO.  For Section 6.5 – Option 3 Other Reviewing Institutions:  Answer YES, then select the institution from the IAA list.  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 – clarify that this is the designated Single IRB for an NIH-funded study and explain whether you will be recruiting and consenting subjects.
    • Then, complete the rest of the INSPIR application sections as they appear.  Attach any documentation in which the NIH has designated the single IRB for the study.



Ceding Review for Studies Initiated by a Special Multi-Site Research Collaboration Group

  • This is typically a consortium or association of institutions dedicated to research for a specific disease, medical specialty, or research topic.  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.
  • 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.
  • Follow the instructions for “Creating an INSPIR Cede Application”.  For Section 6.3:  Answer NO.  For Section 6.4 – Option 2 Central Institutional Review Board:   Answer YES, then select the consortium group from the Central IRB list.  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 – clarify that this is the central IRB for a consortium group and explain whether you will be recruiting and consenting subjects.  Then, complete the rest of the INSPIR application sections as they appear.

More information about ceding review may be found by contacting us or at the following links: