Institutional Review Board

Status Update to the Virginia Tech IRB User Community

PROGRESS NOTICE - VT-IRB/WIRB COLLABORATION TO ADDRESS IRB BACKLOGS

[CHECK BACK TO THIS PAGE FOR UPDATES]

7-2-18

The VT IRB has made progress addressing the internal review of backlogged protocols and on-going heavy volumes of new protocol submissions received from our VT researchers, but there is still work to be done. Toward achieving the goal of continued improvement of services, the IRB has hired a new IRB Administrative Specialist and will be gradually reassigning an additional .5 FTE to the internal protocol review team over the next several months. Benefits of these changes will be realized once on-boarding and training of the new staff have been completed and VT procedures have been developed to meet existing and new Federal policies and regulations. Further strategic enhancement of VT IRB staff will be foremost among the objectives of the new AVP for Scholarly Integrity and Compliance, Dr. Lisa Lee, after she assumes leadership of the Office for Research Compliance (ORC) on August 10.

In the interim, we continue to strongly encourage investigators to use our commercial contract provider, Western IRB (WIRB), for all eligible protocols, but especially when more expeditious review times are needed. The VT IRB has a well-defined process for review and referral to WIRB that prevents re-work, allows investigators to enjoy a seamless transition, and routinely leads to a much faster final determination that we are currently able to achieve for protocols processed within the internal VT IRB.

Transient improvements in VT IRB's review time have been intermittently achieved but because of the erratic nature of submission rates, times to completion of initial review continue to be unstable. Recent average time-to-initial review dipped to 3-5 weeks, well within our stated 4-6 weeks target, however, we cannot assume that this turn-around time can be routinely sustained especially as heavier submission rates return as the fall semester begins. Note that these are the times-to-initial review; time to final determination are typically longer if revisions are requested.

In our last message (March 5, 2018) we indicated that the VT-IRB administrative office was temporarily changing the current estimated/average time to return of initial review in the Protocol Management (PM) system and on the IRB website to:

  • Four to six weeks for protocols that are classified as exempt, expedited or full-board reviews, AND remain within the VT-IRB process until final determination
  • Three weeks for amendments
  • Five business days for interim reviews
  • Ten business days for continuing reviews

These estimates still apply for protocols processed by the VT IRB but planned personnel realignments and recruitments during the second half of 2018 and beyond are expected to help reduce dependence on WIRB and begin to further decrease VT-IRB queue size and turn-around times.

We continue to emphasize that regardless of reviewing body, IRB review times vary greatly depending on the quality of the initial submission, study complexity, and the number of revisions. We have discovered that poor quality of initial protocol submissions, especially from students, translates into a disproportionately large consumption of time by the IRB administrative review team. One essential part of the solution to this is greater faculty advisor commitment to the training of their students as to what constitutes as a high-quality initial submission. The IRB will begin offering training to stakeholders, including faculty and students, once IRB staffing levels are achieved that enable the team to achieve its primary objective of assuring timely processing of all submitted protocols.

In the meantime, our commercial IRB contractor, WIRB, has delivered on its promise to relieve some of the pressure from a submission queue backlog that had grown to nearly 200 pending protocols early in 2018. Processing through WIRB has provided substantially faster submission-to-approval intervals: average processing times for high-quality submissions have been impressive:

  • Five-seven business days (and sometimes less) for exempt and expeditable protocols
  • Seven-ten business days for full board review

Again, we encourage investigators to continue to use WIRB when possible to allow the VT IRB opportunity to implement planned improvements to the overall process and strategic workforce realignments and enhancements. Once acceptable review times are reliably achieved with WIRB's help, success with unfolding strategic personnel planning efforts will allow gradual shifting of the workload away from WIRB, back to the VT IRB team while maintaining favorable review turn-around times and limiting queue size. For now, however, WIRB remains an essential partner providing excellent and expeditious service.

As always, thank you for your patience and please contact my office if you have questions or suggestions.

Gary

Gary B. Sherman, DVM, Ph.D.
Interim Associate Vice President for Research Compliance
VT-IRB office phone: 231-3732
VT-IRB office email: irb@vt.edu


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.