Institutional Review Board

Status Update to the Virginia Tech IRB
NOTICE REGARDING
REVISED IRB SUBMISSION PROCESSING TIMES AND
AN ALTERNATIVE, POTENTIALLY FASTER, IRB REVIEW PATHWAY
[CHECK BACK TO THIS PAGE FOR REGULAR UPDATES]
3-5-18

The VT-IRB administrative office is temporarily changing the current estimated review times in the Protocol Management (PM) system and on the IRB web site to 4-6 weeks for protocols that are classified as exempt, expedited or full-board reviews, AND that remain within the VT-IRB process until final determination. Please note that shorter estimated review times apply to protocols selected for transfer to Western IRB (WIRB; www.wirb.com), the commercial service with which VT has recently contracted (see below). Other estimated current VT IRB review times include 3 weeks for amendments, 5 business days for interim reviews, and 10 business days for continuing reviews. While these VT IRB processing times are longer than our system had previously indicated, they are not inconsistent with many peer institutions and, at least temporarily, are more accurate estimates given the current backlog in the VT-IRB queue. It is important to understand that regardless of reviewing body, IRB review times vary greatly depending on quality of initial submission, study complexity, and number of revisions.

We are actively pursuing ways to reduce IRB protocol processing times. Chief among our efforts is making WIRB review services accessible to the VT. Processing through WIRB is expected to provide substantially faster submission-to-approval intervals: average processing times for high quality submissions are 5-7 business days for exempt and expeditable protocols and 7-10 business days for full board review. Our office will notify you within the next several days when and how you can begin requesting the VT-IRB to route your submission to WIRB.

Considerable resources are being expended to expeditiously develop guidelines and processes necessary for our office to reroute, at the discretion of submitters, as many eligible protocols already in the VT-IRB queue as possible to WIRB. Following a short pilot that is currently underway, our goal is to make the WIRB route more broadly accessible by Friday, March 9, first for all eligible protocols already in the VT-IRB queue and secondly for protocols that are intended for submission. Please note there will be a small subset of submissions requiring review by WIRB*. Similarly a subset of submissions must remain in the VT-IRB system**.

New protocols intended for routing to WIRB will first pass through an abbreviated VT-IRB PM submission process. Additional guidance for new submissions is forthcoming. This abbreviated process is necessary to allow VT's IRB administrative staff to capture basic information about the protocol and provide VT pre-authorization for routing to WIRB. VT-IRB pre-authorization is required by WIRB; VT gate-keeping and monitoring of protocols entering into, and returning from, WIRB review is essential because VT retains overarching responsibility for all protocols of VT origin, whether or not they are reviewed by VT IRB, WIRB (or any other entity's IRB).

Thank you for your patience and, again, please monitor this page for updates addressing IRB processing times which are expected to fluctuate.

Gary

Gary B. Sherman, DVM, PhD
Interim Associate Vice President for Research Compliance

VT-IRB office phone: 231-3732
VT-IRB office email: irb@vt.edu

*Categories that may be required to stay with VT-IRB: 1) those already in active review and/or in revision or amendment stages, 2) those that involve a multi-institutional study where VT relies on a collaborating institution's IRB (inclusive of cases officially classified as sIRB).

**Categories that may be required to be reviewed by WIRB: 1) Biomedical subject matter, 2) Device, drug or biologics development (FDA-related), 3) sIRB where VT is primary IRB, 4) judged by VT-IRB admin team to be too complex or on subject matter about which the VT-IRB lacks sufficient expertise.