WIRB is now an option at Tufts Medical Center and Tufts University Health Sciences (TUHS) for select studies.
Only Phase III, industry (for-profit) sponsored, multi-centered, sponsor initiated (defined as sponsor created, designed, and developed) studies are eligible for WIRB review. A Principal Investigator (PI) may choose to submit such a study to either the Tufts MC/TUHS IRB or WIRB. An eligible research study may only be submitted to and reviewed by the Tufts MC/TUHS IRB or WIRB, not both. Please note: If the study involves a test article that has been issued an IND or IDE number, the IND or IDE number must be issued to the sponsor of the study and not an investigator. If a determination must be made by the IRB regarding the need for an IND or IDE for a test article (21 CFR 312 or 21 CFR 812) the study will not be eligible for WIRB review.
The internal Tufts MC/TUHS WIRB pre-submission process consists of a short review of a defined subset of study information (e.g., a complete copy of the sponsor’s protocol including appendices and supplemental documents, signed institutional Conflict of Interest forms) accompanied by the newly created Form VIII, the Tufts MC/TUHS WIRB submission form. Documents are to be submitted on a CD. All institutional committees that would normally conduct review (Radiation Safety Committee, Institutional Biosafety Committee, etc.) will continue to be a required part of the pre-review/internal process prior to submission to WIRB. Please read the WIRB submission process for more details about what to submit and how the process will be conducted. The entire WIRB policy, including the WIRB fee schedule, is also available online. There is also a Tufts MC/TUHS fee of $750 for studies reviewed by WIRB, in addition to WIRB’s fee schedule. For additional details, please see the Research Administration Policy Letter.
Once the PI receives the signed Form VIII for the study from the IRB office, the PI may submit the application directly to WIRB via the WIRB website or as hard copy documents. Please review the information provided by WIRB, WIRB Presentation and WIRBNet Instructions, for more information on the WIRB submission instructions.
The PI and research team members are to communicate directly with WIRB and submit all future study-related documents (e.g., changes among research team members, advertisements, amendments/revisions, continuing review, AEs/SAEs, unanticipated events, protocol deviations/violations, non-compliance,) directly to WIRB without submitting copies to Tufts MC/TUHS IRB office once the IRB has signed the Form VIII and provided it to the PI.
All Tufts MC/TUHS institutional policies pertaining to the institutional informed consent form (ICF) format (including the template Introduction), research-related record retention, consent procedures, SAE reporting, institutional inspection/monitoring, research education, etc., apply to studies submitted to WIRB for review.
Researchers are reminded to retain a copy of all correspondence with the Tufts MC/TUHS IRB and/or WIRB in their study files.
Please read the policy and instructions on the submission process, and submit a completed Form VIII and the required attendant information to the IRB office.
Please contact the IRB office at (617) 636-7512 or Julie Morelli Novak at (617) 636-1204 with questions about WIRB or if clarification about the WIRB process is needed.
The WIRB web site is: http://www.wirb.com
WIRB documents:
- Tufts MC/TUHS WIRB Policy
- Tufts MC/TUHS WIRB Submission
- Form VIII
- WIRB Presentation
- WIRBNet Instructions
