Single IRB (sIRB) Workflow Update
NOVEMBER 20, 2019
The 2018 Common Rule requires use of a Single IRB (sIRB) for NIH studies as of January 2020; while we are rebuilding capacity internally, we would like to recommend an alternative to our clinical trialists that will save work for you and your teams and will provide a faster turnaround than we can currently offer amidst our staffing challenges. Along with NIH studies, we’re encouraging investigators to use sIRB for Phase II and Phase III industry sponsored protocols. Any central IRB is acceptable, but we would recommend Western IRB (WIRB) - http://wirb.com/Pages/ContactUs.aspx.
We would also like to take this opportunity to share the new sIRB workflow that is now live in iRIS.
When creating a new project application, you may now select the IRB of record. In this section the study team must indicate if the IRB of record is DFCI, the NCI cIRB, or an external IRB. Downstream form questions and logic depend on this question.
If using an sIRB you must navigate to special purpose submission forms and complete a request to rely and enter the iRIS submission reference number before completing the rest of your new project application.
It is a requirement that new submissions be made in iRIS for all appropriate Feasibility Reviews prior to study team acknowledgement of participation with the sIRB.
Updated Forms: On the study dashboard you will now see the amendment and continuing review/ progress report forms are separated via the IRB of record. Both will be visible on the study dashboard, but the form questions and routing are different. Please ensure you select the correct form when creating a new submission.
Dose/Cohort Open/ Closure Form, Events, and Study Completions will remain in the General category and are the same regardless of the IRB of record. Please see below for more details on the Dose/Cohort Open/ Closure Form and Study Completion forms.
When submitting an sIRB submission, you will now see it route to a sIRB Triage Committee. This committee is managed by OHRS where they will determine appropriate SRC and ancillary routing. All other feasibility, review and sign-off only committees will be routed according to how the form is completed.
Please reference the Wiki for full detailed workflow instructions.