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Quorum IRB Reliance

 

What is Quorum?

Quorum Review IRB was founded in 1991 and is an independent IRB located in Seattle, Washington that provides services for academic and non-academic institutions.  Quorum has been accredited by the Association for the Accreditation of Human Research Protection Program (AAHRPP) since 2006, has a North American Board to review research in Canada, and also a Cambridge Board to review Oncology research.  

 

What Type of Studies Qualify for Quorum Review?

Studies that meet all of the following criteria are eligible for Quorum review: 

  • Phase IIb, III or IV clinical trials
  • Industry authored
  • Industry funded
  • Sponsor/CRO has contracted with Quorum or with Quorum

Exceptions

Studies involving the following procedures or populations do not qualify for Quorum 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. 

 

How do I obtain clearance from UCI to submit to Quorum?

Quorum IRB will not review research on behalf of UCI without a formal ‘Clearance Notice’ issued by UCI IRB.  

A.   Pre-Submission

The UCI Lead Researcher (LR):

  • Determines that study meets eligibility criteria for Quorum review. If there are any questions, contact the single IRB (sIRB) Staff with UCI IRB via email at IRBReliance@uci.edu for guidance.
  • Confirms that Sponsor/CRO has contracted with Quorum or its affiliates to provide IRB services for this study and that sponsor will cover cost of Quorum 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

The UCI LR must submit the following documents, as applicable:

  • Submit a new application online along with the following documents:
  • Master Protocol (MP) and any applicable Amendments not included in MP
  • Investigator Brochure
  • Sponsor Template Consent
  • Draft of UCI-Quorum Consent using UCI template language
  • UC/UCI HIPAA Research Authorization Form – UCI Health Care Provider, non-UCI Provider
  • Recruitment Materials
  • Appendix T (HIPAA) if a partial waiver of HIPAA for recruitment purposes only is requested to review UCI Medical Records to screen for eligibility
  • Other UCI regulatory and institutional approvals/acknowledgements (e.g., PRMC, COIOC, RSC)
  • Appendix R (Reliance)

    C.  Review Process

    1.  UCI IRB confirms that study is eligible for reliance on Quorum, 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 (ie, ‘Clearance Notice’) to the UCI LR indicating that the study is eligible for Quorum 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 formal ‘Clearance Notice’ is sent to the UCI LR that the study may be submitted for Quorum review through Quorum’s OnQ Portal. For questions, please contact submissions@quorumreview.com.

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

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

    • Quorum 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.
    • UCI IRB Staff releases an Acknowledgement Letter and other relevant study documents through the UCI IRB Doc Depot.

    D.  Post Quorum Approval

    The UCI LR submits all other transactions to Quorum:

    • Amendments, Continuing Approval, Unanticipated Problems are reported directly to Quorum.
    • UCI IRB is notified of all Quorum approved transactions by Quorum.
    • Exceptions
    • All changes in study team personnel must be submitted to both Quorum IRB online through Quorum’s OnQ Portal and UCI IRB through a modification request.
    • Request to access Personal Health Information (PHI) covered under HIPAA, as UCI serves as its own Privacy Board.

     

    Quorum Submission and Review Process

    • If the Lead Researcher is working with Quorum for the first time, please submit a CV signed and dated within the last two years to Quorum
    • During the IRB review process, you may receive emails from different Quorum staff members who are working on your submission.
    • Once your submission has been approved by the IRB, you will receive an email notification informing you of the approval. The email will include a direct link to access the approval documents. You can also access your approval documents by signing in to Quorum’s OnQ Portal.  

Resources:

Quorum Templates for Use at UCI:

 

Contact:

Greg Schomaker
Institutional Account Manager
W:  206-832-0794
gschomaker@quorumreview.com
submissions@quorumreview.com

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