Ceding Review for IND/IDE Studies

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

Principal Investigators have the following three 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 Hummingbird IRB (HIRB) through an INSPIR cede application.  In this arrangement, the BMC/BU Medical Campus IRB is invoiced for all of HIRB’s reviews for Boston Medical Center and BU Medical Campus as Relying Sites. See HIRB.
  3. 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, such as Western Institutional Review Board (WIRB) or Advarra.  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.