Guidance Documents When WVU IRB Reviews
Step-by-Step Process when WVU acts as Reviewing IRB (or Single IRB of Record)
Step 1:
WVU researcher completes a reliance request form that will be sent to: reliance@mail.wvu.edu. The reliance request form provides the WVU OHRP with a summary of the information necessary to determine whether a reliance agreement is appropriate for the project and whether WVU’s IRB can act as the Reviewing IRB of Record. The WVU OHRP will respond to the request form via email within 3 business days to communicate next appropriate steps.
Step 2:
If the WVU OHRP confirms that WVU is willing to serve as the IRB of record, the WVU PI will be instructed to proceed with the submission to the WVU IRB through WVU+kc (either as a new submission or as an amendment if a new site is being added to an existing protocol) and a standard WVU IRB review will take place. The WVU OHRP will provide an IRB reliance agreement, also called an IRB Authorization Agreement (or IAA), to be completed by each institution’s Institutional Official (IO). The WVU PI should include the Reliance Request form and the IAA as part of the protocol submission through WVU+kc. The WVU IRB may also require researchers at the relying sites to complete local context forms.
The WVU OHRP will assist with obtaining the IO’s signature from each engaged institution to formalize the IRB reliance arrangement between institutions.
Step 3:
The WVU IRB review will include consideration of the involvement of the collaborating site(s) during its review of the protocol. Once the WVU IRB has approved the WVU project and provided an approval letter for the relying site to participate the researchers may begin work on the research pending all fully executed reliance agreement details and documentation.
When an IAA has been signed to document the reliance agreement, a copy of the signed agreement will be included in WVU+kc.
Step 4:
WVU researchers are responsible for submitting amendments, renewals, and reportable events according to WVU IRB Standard Operating Procedures (SOPs) and should contact the relying institutions annually to determine if reportable events or significant changes have occurred. Reportable events and amendments should be submitted to the IRB using WVU+kc.