Types of IRBs (including External IRB and Reliances)
There are multiple types of IRBs that can approve human subjects research protocols. For questions specific to reliance, please contact the WVU reliance team at firstname.lastname@example.org.
Please note: whether a WVU PI is requesting to use WVU's IRB as the Single IRB
of Record for multiple sites, or is requesting to rely on an external IRB, the
PI should complete a
Reliance Request Form before submitting a protocol to WVU+kc.
Also referred to as an institutional IRB or Local IRB. An example is WVU IRB which is operated by West Virginia University under the oversight of the WVU human research protection program institutional policy. WVU operates two IRBs: Blue Board and Gold Board.
One that is not associated with WVU. It can be another institution’s IRB (single IRB) or a commercial IRB (central IRB). When external IRBs are involved in research conducted under the auspices of WVU, a reliance request form and an abbreviated protocol application is required in WVU+kc. WVU OHRP will review and acknowledge the information to ensure compliance. Complete the Reliance Request Form before continuing.
Single IRB or sIRB
The Revised Common Rule's (January 20, 2020) Single IRB Mandate is a federal requirement for all non-exempt, federally funded, multi-site research studies (cooperative/collaborative research). The sIRB requirement was implemented with the goal of streamlining the IRB review processes by eliminating unnecessary repetition without compromising ethical principles and protections for human research participants. WVU's IRB, another institution's IRB, or a Central IRB (cIRB) can serve as the Single IRB (sIRB) for a multi-site research study. The IRB that oversees the study is known as the Reviewing IRB or IRB of Record. The IRB that cedes review or relies on another IRB is known as the Relying IRB, Relying Institution, or Participating Site.
Central IRB or cIRB
Conducts reviews on behalf of all study sites in a multi-center study that agree to participate in the centralized review process. While the definition is shifting, many still use the term cIRB to refer to commercial IRBs or IRBs that oversee clinical trials (i.e, Western IRB-Copernicus Group (WCG), Advarra, National Cancer Institute (NCI) CIRB, etc.).
*Please Note: 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.
Types of Reliance Agreements
This agreement is used for research projects where WVU does not have a master agreement in place with the IRB. IRBs must have a Federalwide Assurance (FWA) to enter into an IAA with WVU. In these agreements, one IRB will be the IRB of Record and the other will be the Relying IRB. WVU uses two types of agreements for reliance: “WVU IS the IRB of Record” and “WVU IS NOT the IRB of Record.” WVU will assume responsibility as the IRB of Record for Full Board and Expedited protocols. WVU will NOT assume responsibility as the IRB of Record for Flex and Exempt protocols.
WVU IRB is registered with multiple IRB reliance platforms (web portals). Some, such as SMART IRB, utilize a reliance agreement. The PI is often required by the External IRB to register on one of these web portals and provide WVU local context information when WVU is NOT the IRB of Record. WVU is registered with SMART IRB, IRB Exchange, and Strokenet. When WVU IS the IRB of Record, PIs are required to register their project on IRB Exchange (IREx).
WVU has master reliance agreements in place with Western IRB-Copernicus Group (WCG), Bone Marrow Transplant clinical trials network (BMT CTN), NCI CIRB (National Cancer Institute) and Advarra.
WVU - Required Information (Use the CIRB Submission Type)
The following information is required to be submitted in WVU+kc as a CIRB Submission when WVU is NOT the IRB of Record, before research can begin:
- Reliance Request Form
- IRB of Record Approval Letter
- Approved Protocol
- Approved Informed Consent Form with approved WVU language
- Ancillary Review Approvals as needed from WVU (PRMC, IBC, Tissue Banking, etc)
- Letter of Permission (may be required in some cases)
90-Day PI Site-Specific Holds
Protocols overseen by an external IRB where it is discovered the WVU PI did not submit a reliance request and/or did not register and receive acknowledgement from WVU OHRP prior to initiating research activities will be subject to a 90-day PI site-specific hold. This site-specific hold will be communicated to the external IRB of Record and will be in effect until the PI submits the reliance application to WVU and receives acknowledgement to begin human subject research at WVU. Additional requirements, such as relying site investigator training/education, may be imposed on a case-by-case basis, at the discretion of the WVU OHRP staff.
Direct-Sponsor Submissions to Central IRBs
WVU site PIs and research teams must submit protocol materials received by the Sponsor to the Central IRB. Sponsors may not submit protocol materials to Central IRBs directly, on behalf of the WVU site PI and research team.