Commercial IRB Reliance Agreements

What Type of Studies Qualify for Advarra Review?

Most human subject protocols may be considered for commercial review with the exception of investigator initiated protocols. For a list of studies that may be ceded, click here.  Contact the sIRB team at UCI for more information at IRBReliance@uci.edu.

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:

• 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

• UCI Specific Documents
  • UCI Consent (using Sponsor Template, inserting ‘UCI-Advarra’ Consent approved language).
  • HIPAA Research Authorization Form
  • Chart of Ancillary Committee Reviews

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

• 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

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