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Western IRB (WIRB) Reliance

Western IRB (WIRB) Reliance

What is WIRB?

Western Institutional Review Board (WIRB) is an independent IRB located in Olympia, Washington that provides services for academic and non-academic institutions. WIRB is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).  WIRB is part of the WIRB-Copernicus Group (WCG) which includes Copernicus Group IRB, Aspire IRB, MidLands IRB and New England IRB.

What Type of Studies Qualify for WIRB Review?

Studies that meet all of the following criteria are eligible for WIRB review (see exceptions below):
  • Phase IIb, III or IV clinical trials
  • Industry authored
  • Industry funded
  • Sponsor/CRO has contracted with WIRB or with an affiliated IRB (i.e., Copernicus Group IRB, Aspire IRB, MidLands IRB and New England IRB) to provide IRB services for the study (documentation required)

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
  • FDA-approved or investigational radiological agents
  • Neonates
UCI IRB reserves the right to make additional exceptions and has final say on whether UCI IRB review is required. 

 


WIRB Submission and Review Process

WIRB will not review research on behalf of UCI without a ‘Clearance Notice’ issued by UCI IRB. The process for submitting an application to WIRB and communicating WIRB approval is as follows:

 

A.   Pre-Submission

The UCI Lead Researcher (LR):

  • Determines that study meets eligibility criteria for WIRB review. If there are any questions, contact the UCI IRB staff for guidance.
  • Confirms that Sponsor/CRO has contracted with WIRB or its affiliates to provide IRB services for this study and that sponsor will cover cost of WIRB review.  Documentation required.
  • Includes the UCI IRB fees (expedited IRB fee rate) in the clinical trial budget for administrative review and oversight.
  • Initiates process, if not already started or completed, to obtain other UCI regulatory committee/ institutional approvals (i.e., Radiation Safety Committee (RSC), Conflict of Interest Oversight Committee (COIOC)), as needed.

 

B. Submission to UCI (ie, to obtain a ‘Clearance Notice’)

The UCI LR must submit the following documents, as applicable, online via a New Application:

  • WIRB Submission Form – Investigator Submission Form for Multi-Center Protocols or complete via WIRB’s online submission portal, WIRB Connexus. You can register for an WIRB Connexus account on the WIRB site. Here is the link to sign-up for WIRB Connexus training session: Western Institutional Review Board WebEx Enterprise Site.
  • Sponsor/CRO documentation confirming that WIRB or its affiliates is providing IRB services and that sponsor/CRO will cover WIRB review fees
  • Master Protocol (MP) and any applicable Amendments not included in MP
  • Investigator Brochure
  • Sponsor Template Consent
  • Draft of UCI WIRB consent using UCI template language
  • Recruitment Materials (if specific to UCI as a site only)
  • UC/UCI HIPAA Research Authorization Form
    • Appendix T: If a partial waiver of HIPAA is requested to access medical records in order to screen for eligibility, please submit Appendix T to request a ‘Partial Waiver of HIPAA for Recruitment Purposes only’
  • Self-Certification of Surrogate Decision Makers for Potential Subject’s Participation, as applicable
  • FDA Investigational New Drug (IND) Letter indicating Sponsor’s IND filing date
  • FDA Investigational Device Exemption (IDE) Letter or Non-Significant Risk (NSR) Determination Letter
  • Other UCI regulatory and institutional approvals/acknowledgements (e.g., PRMC, COIOC, RSC)
    For more info, see Reference Chart or ‘Other Reviews Required by UCI.'

 

C.  Review Process

1.  UCI IRB confirms that study is eligible for reliance on WIRB, the paperwork is complete, and all other required UCI regulatory committee approvals are obtained.
  • If study is eligible, paperwork complete and all required approvals in place, UCI IRB will send an email notification called a 'Clearance Notice' to the UCI LR indicating that the study is eligible for WIRB review. 
  • If study is not eligible and/or the paperwork is incomplete, or other regulatory committee approvals are not provided, UCI IRB will notify UCI LR in writing of the determination or additional requirements.

2.  Once eligibility is confirmed, a notice is sent to the UCI LR that the study may be submitted for WIRB review through WIRB Connexus. Please forward the ‘Clearance Notice’ to WIRB as part of the submission packet.

3.  WIRB reviews LR's documentation and communicates directly with UCI LR with respect to any required revisions or additional information needed.

4.  WIRB sends the UCI IRB notification that study has been approved. 

  • WIRB provides an approval notice, a stamped version of the approved recruitment and consent documents, which includes the UCI IRB previously-approved and agreed upon consent template language.

5.  UCI IRB staff releases the WIRB Approval letter and other relevant study documents to IRB Doc Depot.  For more info, see Recordkeeping Responsibilities.

D.  Post WIRB Approval

The UCI LR submits all other transactions to WIRB:

  • Amendments, Continuing Approval, Unanticipated Problems are reported directly to WIRB.
  • UCI IRB is notified of all WIRB approved transactions by WIRB.

         Exceptions

  • All changes in study team personnel must be submitted to UCI through a modification request.
  • Requests for a Partial or Full Waiver of HIPAA are to be submitted to UCI through modification request online, given UCI serves as the HIPAA Privacy Board (not WIRB).  Appendix T is required for review.

Important Points to Keep in Mind:

Other Regulatory/Institutional Approvals

Additional UCI regulatory committee approvals may be needed prior to review by WIRB, as described above. UCI IRB will coordinate with the LR, study staff and WIRB to ensure that these approvals are in place before the review. These include:

  • Conflict of Interest Oversight Committee (COIOC)
  • Institutional Biosafety Committee (IBC)
  • Radiation Safety Committee (RSC)
  • Clinical Research Finance Assessment (CRFA)

Other Important Points:

  • WIRB will not review until UCI IRB confirms eligibility by issuing a ‘Clearance Notice’ to the UCI LR.
  • The consent form submitted to WIRB must follow UCI WIRB template.  The UCI PI and WIRB are responsible for ensuring consistency with the template
  • Only initial submission to UCI IRB is necessary. Once eligibility has been confirmed, all future submissions and reporting are between the UCI PI and WIRB.  Exception:  Changes in study team personnel.

Contact Information:

Western Institutional Review Board

Western Institutional Review Board
1019 39th Avenue SE  Suite 120
Puyallup, WA 98374-2115

Office: (360) 252-2500 or (800) 562-4789

Fax: (360) 252-2498

Email: clientservices@wirb.com

UCI Human Research Protections

IRBReliance@uci.edu

Resources:

WIRB Templates for Use at UCI:

 

Contact:

Carmen Thompson
(Account Manager, Institutions)
W: 360-252-2447
cbthompson@wirb.com

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