UCI IRB accepts Western IRB Review
UCI has established an IRB Authorization Agreement with Western IRB (WIRB). WIRB is an independent IRB, located in Olympia, Washington, that provides review services for academic and non-academic institutions. WIRB is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
Why has UCI established this agreement?
For many years the default IRB review model for multi-site clinical trials has been for each site to obtain IRB review from its own IRB. This model, first developed when a clinical trial was conducted at a single study site or at a small number of sites, results in duplication of effort, delays and increased expenses. To reduce IRB burden and delays, the Food and Drug Administration and the Office for Human Research Protection now support the use of a single centralized IRB review process for the conduct of multi-site clinical trials.
What Type of Studies Qualify for WIRB Review?
Studies meeting all of the following criteria are eligible for WIRB review:
- Phase III or Phase IV clinical trials
- Industry authored
- Industry funded
- Sponsor/CRO has contracted with WIRB to provide IRB services for the study
Exceptions
Studies involving the following procedures or populations do not qualify for WIRB review:
- Surgical techniques or procedures
- Transplant techniques, procedures or other interventions
- Stem cell therapies
- Gene therapy or gene transfer
- Investigational radiologic procedures or investigational radiological agents
- Neonates
Points to Consider:
· Who pays WIRB Fees? The Study Sponsor should pay WIRB fees. Obtain documentation from the Sponsor/CRO that they have contracted with WIRB to provide IRB services and that the Sponsor will cover cost of IRB review.
· WIRB will not review until UCI IRB verifies eligibility.
· UCI IRB will charge the expedited IRB fee rate for WIRB submissions for administrative review and oversight. Be sure to include these fees in the clinical trial budget.
· The UCI-WIRB process is a new process. There may be additional revisions or changes as we continue to develop this process.
· UCI IRB reserves the right to make additional exceptions and has final say on whether UCI IRB review is required.
For More Information about the UCI WIRB review process or to get started, please visit the Using the Western Institutional Review Board (WIRB) at UCI web page.
UCI IRB will also be establishing additional IRB agreements to facilitate the single centralized IRB review of industry-authored, industry-funded clinical trials at UCI. Stay tuned!