Existing IRB Reliance Agreements

Children's Hospital of Orange County (CHOC) and MemorialCare Health System (MHS)

CHOC, MHS and UCI, established an IRB Reliance agreement that allowed for human subjects research to be reviewed by a single IRB rather than submitting for IRB approval at each institution where the research would take place. This agreement was intended to simplify and streamline the IRB review process by facilitating single-IRB review.

CHOC-MHS-UCI (CMU) IRB Reliance

In an effort to promote a more streamlined process, effective in 2020, CMU has agreed to utilize the SMART IRB agreement instead of the prior CMU IRB Reliance process.  SMART IRB is a platform designed to ease common challenges associated with initiating multisite research.  Important note: SMART IRB is not an actual IRB that provides regulatory approval. SMART IRB provides a roadmap for institutions to implement the Single IRB Review requirements. Through a flexible master IRB reliance agreement, standard operating procedures, and complementary tools and resources, SMART IRB supports and encourages collaboration and harmonization across the nation. SMART IRB is funded by the National Center for Advancing Translational Sciences (NCATS). For more information, visit SMART IRB.

Researchers can initiate an IRB Reliance through the UCI IRB Application process in Kuali Research (KR) ProtocolsNote: Requests for collaborating sites to rely on the UCI IRB must be made via a formal amendment to the UCI IRB approved study.  Reliance agreements where UCI serves as the IRB of record will not be considered at initial review due to the amount of time involved as this often protracts the initial IRB approval timeframe for the UCI site.

Advarra IRB

What is Advarra?

What is Advarra?

Advarra Institutional Review Board (IRB) is an independent IRB formed in 2017 from the merging of two major central IRBs - Chesapeake IRB and Schulman IRB. Advarra provides services for academic and non-academic institutions.

What Type of Studies Qualify for Advarra Review?

What Type of Studies Qualify for Advarra Review?

Most human subject protocols may be considered for commerial review with the exeption of investigator intitiated protocols. Contact the sIRB team at UCI for more information at IRBReliance@uci.edu.

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

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

Submit to the UCI IRB via Kuali Research (KR) Protocols and under submission type select, "Administrative Determination or Registration." Follow the prompts to request to rely on a non UCI IRB. Continue along and indicate the request to rely on a commercial IRB (Advarra). The sIRB team at UCI will provide a clearance notice in Kuali Research (KR) Protocols when the protocol is ready to submit to Advarra.

A.   Pre-Submission

The UCI Lead Researcher (LR):

  • Determines that study meets eligibility criteria for Advarra review. If there are any questions, contact the UCI IRB staff via email at IRBReliance@uci.edu for guidance.
  • Confirms that Sponsor/CRO has contracted with Advarra or its affiliates to provide IRB services for this study and that sponsor will cover cost of Advarra review.  Documentation required.
  • Includes the UCI IRB fees 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:

  • Sponsor Study Documents
    • Master Protocol
    • Investigator Brochure(s)
    • Sponsor Consent Template

C.  Review Process

1.  UCI IRB confirms that study is eligible for reliance on Advarra, attachments are submitted and all other required UCI regulatory committee approvals are obtained.

2. The Reliance team provides an ancillary committee clearance notice in Kuali Research (KR) Protocols.
3. The study may now be submitted by the LR for Advarra review through CIRBI.

4.  Advarra reviews the LR's documentation and communicates directly with the UCI LR.

5.  Advarra sends the UCI IRB notification that study has been approved.

  • Advarra 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 the initial approval notice and other relevant study documents through Kuali Research (KR) Protocols.

D.  Post Advarra Approval

The UCI LR submits all other transactions to Advarra:

  • Amendments, Continuing Approval, Unanticipated Problems are reported directly to Advarra.
  • UCI IRB is notified of all Advarra approved transactions by Advarra.
  • The LR can access their approval documents by signing in to Advarra’s CIRBI.

Exceptions

  • All changes in study team personnel must be submitted to UCI through an amendment request in Kuali Research (KR) Protocols.
  • Request to access Personal Health Information (PHI) covered under HIPAA, as UCI serves as its own Privacy Board.
Advarra Submission and Review Process

Advarra Submission and Review Process

  • If the LR is working with Advarra for the first time, they must submit a CV signed and dated within the last two years.
  • During the IRB review process, the LR may receive emails from different Advarra staff members working on their submission.
Resources

Resources

Considering Advarra?

General Questions:

Betsy Casillo
Study Manager
betsy.casillo@advarra.com
513-619-1679

Study-specific Questions:

Jayla Robtoy
Client Services Coordinator
jayla.robtoy@advarra.com
410-884-2900 or cirbi@advarra.com

WIRB Copernicus Group, Inc. (WCG) IRB

What is WCG?

What is WCG?

WCG is an independent IRB located in Olympia, Washington that provides services for academic and non-academic institutions.

What Type of Studies Qualify for WCG Review?

What Type of Studies Qualify for WCG Review?

Most human subject protocols may be considered for commercial review, except for investigator initiated protocols. Contact the sIRB team at UCI for more information at IRBReliance@uci.edu.

WCG IRB Submission and Review Process

WCG IRB Submission and Review Process

Submit to the UCI IRB via Kuali Research (KR) Protocols and under submission type select, "Administrative Determination or Registration." Follow the prompts to request to rely on a non UCI IRB. Continue along and indicate the request to rely on a commercial IRB (WCG). The sIRB team at UCI will provide a clearance notice in Kuali Research (KR) Protocols when the protocol is ready to submit to WCG.

The process for submitting an application to WCG and communicating with WCG is as follows:

A.   Pre-Submission

The UCI Lead Researcher (LR):

  • Determines that study meets eligibility criteria for WCG. If there are any questions, contact the UCI IRB staff via email at IRBReliance@uci.edu for guidance.
  • Confirms that Sponsor/CRO has contracted with WCG or its affiliates to provide IRB services for this study and that sponsor will cover cost of WCG review.  Documentation required.
  • Includes the UCI IRB fees 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:

  • WCG Submission Form – Investigator Submission Form for Multi-Center Protocols or complete via WCG's online submission portal, WCG IRB Connexus. You can register for an WCG IRB  account on the WCG IRB site.

Submit in Kuali Research (KR) Protocols and add the following under the "Attachments" section:

  • Sponsor Study Documents:
    • Master Protocol
    • Investigator Brochure(s)
    • Sponsor Consent Template
    • Sponsor/CRO documentation confirming that WCG IRB or its affiliates is providing IRB services and that sponsor/CRO will cover WCG IRB review fees

 C.  Review Process

1.  UCI IRB confirms that study is eligible for reliance on WCG, attachments are submitted and all other required UCI regulatory committee approvals are obtained.

2. The Reliance team provides an ancillary committee clearance notice in Kuali Research (KR) Protocols.

3. The study may now be submitted by the LR for WCG review through WCG IRB Connexus.

4.  WCG reviews the LR's documentation and communicates directly with the UCI LR.

5.  WCG sends the UCI IRB notification that study has been approved. 

  • WCG 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 the initial approval notice and other relevant study documents through Kuali Research (KR) Protocols.

D.  Post WCG Approval

The UCI LR submits all other transactions to WCG:

  • Amendments, Continuing Approval, Unanticipated Problems are reported directly to WCG IRB.
  • UCI IRB is notified of all WCG IRB approved transactions by WCG IRB.
  • The LR can access their approval documents by signing in to WCG IRB Connexus.

         Exceptions

  • All changes in study team personnel must be submitted to UCI through an amendment request in Kuali Research (KR) Protocols.
  • Request to access Personal Health Information (PHI) covered under HIPAA, as UCI serves as its own Privacy Board.

Important Points to Keep in Mind

  • The consent form submitted to WCG must follow UCI WCG template.  The UCI PI and WCG 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 WCG IRB.  Exception:  Changes in study team personnel
Resources

Resources

WCG IRB Templates for Use at UCI:

For UCI Questions, Contact:

IRBReliance@uci.edu

For WCG Questions, Contact:

WIRB Copernicus Group Institutional Review Board, Inc.

WCG IRB, Inc.
1019 39th Avenue SE  Suite 120
Puyallup, WA 98374-2115

Phone: (855) 818-2289

Email: clientservices@wcgirb.com

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