Overview
Commercial IRBs are independent pay-for-service IRBs that provide regulatory and ethical review services for academic and non-academic institutions to conduct reviews of research involving human subjects. Commercial IRBs will not review research on behalf of WVU researchers without notification (electronic IRB system assigned protocol number) that the WVU OHRP has cleared the study for commercial IRB oversight.
When to use a Central IRB for Multisite Studies
| Type | Phase I | Phase II | Phase III | Phase IV | Expedited |
|---|---|---|---|---|---|
| Investigator-Initiated or Single Site | Must use WVU IRB | Must use WVU IRB | Must use WVU IRB | Must use WVU IRB | Must use WVU IRB |
| Industry Funded\Multisite
|
Must use WVU IRB | May use Central IRB | May use Central IRB | May use Central IRB | May use Central IRB |
*Please note: Investigator-initiated studies where WVU is the only institution engaged in the research do not qualify for Central IRB oversight. These studies should be submitted to WVU's local IRB.
Types of Studies That Qualify for Commercial IRB Review
- Clinical trials (Phase 1 and Phase 1/2 clinical trials must be reviewed and approved through WVU's local IRB, unless the trial is sponsored and/or overseen by NCI-CIRB.)
- Industry sponsored
- Federally funded/sponsored
WVU Has Established Master Service Agreements With the Following Commercial IRBs:
- Advarra (Chesapeake IRB, Schulman IRB, Advarra IRB)
- WIRB-Copernicus Group (Western IRB, Copernicus IRB, New England IRB)
- BMT CTN (Bone Narrow Transplant Clinical Trials Network)
- NCI CIRB (National Cancer Institute)
Each commercial IRB has its own submission requirements, which are detailed on their websites. WVU PIs are required to submit their applications directly to the commercial IRB along with all supporting documents. The commercial IRB will communicate directly with the WVU PI and, when the review is complete, will provide the WVU PI with an approval notice and stamped versions of the WVU site-specific consent and recruitment documents (if applicable).
WVU PIs are also required to submit a WVU reliance request form and “shell study” protocol submission through WVU+kc for tracking purposes. The procedures for this are:
- PIs should begin the WVU+kc CIRB submission process to obtain a protocol number prior to submitting the study to the commercial IRB.
- Once the commercial IRB has approved the project, the WVU PI will be provided with
an approval notice and stamped versions of the WVU site-specific consent and
recruitment documents (if applicable). The reliance request form, the IRB of
Record approval letter, the approved protocol, the approved consent form with
WVU-required language and any ancillary reviews/approvals (PRMC, IRB, Tissue
Banking, Data Protection, HIPAA waivers, etc.) should be uploaded into the CIRB
project in WVU+kc and submitted for WVU OHRP review and acknowledgment.
- The WVU PI should not begin work on the project until the WVU OHRP has acknowledged
the CIRB project in WVU+kc.
For more detailed instructions on submitting a shell study when WVU is relying on another IRB, please visit When WVU IRB Relies on Another IRB.