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West Virginia University Office of Human Research Protections
WVU Research Office

Single IRB (sIRB Platform, IAA)

When to use an sIRB platform:

  • Federally Funded, Non-Exempt Multisite\Cooperative Research (using the same protocol)
  • Domestic sites
  • Does not apply to: non-federally funded research studies (unless previously approved) - Research that is not federally funded does not have a mandate for a single IRB of Record. Contact WVU OHRP for additional information.
  • Does not apply to: career development, research training\fellowship awards
  • Does not apply to cooperative research where more than one IRB is required by law (tribal law passed by the official governing body of an American Indian or Alaska Native tribe; or for research where a Federal department or agency determines and documents that the use of an sIRB is not appropriate including VA sites.
  • HHS Exception Determinations

Preparing for an sIRB Submission

Prior to beginning research, determine which organization will be the IRB of Record.  Do not assume as the IRBs must agree to this designation. If WVU is intended to be the IRB of Record for a multisite project, contact OHRP and discuss the project before starting the process. Complete the required agreements  (IAA) depending on whether or not WVU IS or IS NOT the IRB of Record in the cooperative research project. 

Single IRB Platforms (WVU is registered for the platforms listed below)

  • SMART IRB   
    A national platform (web-based portal system) used to facilitate a single IRB of Record for multisite research projects. The system includes corresponding documents such as he SMART IRB Master Reliance Agreement). The NIH National Center for Advancing Translational Sciences sponsors this platform but it can be used for any study regardless of funding type. Since SMART IRB includes a Master Reliance Agreement, an IAA is not required, however the master agreement must be reviewed by WVU. 
  • *IRB Reliance Exchange (IREx) - Use IREx when WVU is the IRB of Record 
    A free web-based portal supporting IRB review documentation and coordination for multi-center clinical trials.  IREx is offered by Vanderbilt University Medical Center and is required when WVU is the IRB of Record. An IRB Authorization Agreement is required for IREx as a master agreement is not included with the platform.
  • NIH Strokenet
    A network of 27 regional centers across the U.S., which involves approximately 500 hospitals, and is designed to serve as the infrastructure and pipeline for new treatments for patients with stroke and those at risk for stroke. 

Procedures

When WVU is the IRB of Record (Considered the Reviewing IRB):
  1. Discuss the project with WVU OHRP prior to agreeing to become the IRB of Record
  2. Create an entry in the IRB Reliance Exchange (IREx).
  3. Complete the IAA in coordination with WVU OHRP.
  4. The other institutions are notified and their local information is uploaded (SOPs, local context information, etc.).
  5. The other institutions make the determination of whether or not to rely on WVU for IRB review.
  6. If agreement has been reached, the platform notifies the PI and personnel listed.
  7. Submit the protocol in WVU+kc and standard review procedures begin.
  8. Submit Renewals according to WVU requirements.
  9. Contact the relying institutions annually to determine if reportable events or significant change has occurred.
  10. Report events and amend the protocol as needed using WVU+kc.
When WVU is NOT the IRB of Record (Considered the Relying IRB):
  1. Request that the IRB or Record add the PI as a contact in the platform.
  2. Submit a registration in WVU+kc using the CIRB submission type. Enter one of the following before the title of the research: sIRB, SmartIRB, IREx. Example: "sIRB This is the title of the Research"
  3. Include the following information with the CIRB Submission in WVU+kc
    • Completed IAA
    • IRB of Record Approval Letter
    • Approved Protocol
    • Approved Informed Consent Form with WVU language
    • Ancillary Review Approvals (PRMC, IBC, Tissue Banking, etc.)
    • Letter of Permission (may be required in some cases)
  4. Enter the WVU local context information in the platform.
  5. WVU OHRP will receive a notification from the platform, review the entry and make the determination to agree to the reliance agreement. If the determination is made to not agree, WVU OHRP will contact the PI. 
  6. WVU OHRP enters the required information in the platform.
  7. When the IRB of Record approves the protocol, notifications are sent to the PI and WVU OHRP via the platform
  8. Notify the WVU IRB of adverse events using WVU+kc.