Office of Research, UC Riverside
Office of Research Integrity

WIRB

About WIRB

Western Institutional Review Board (WIRB) is an independent, commercial IRB that provides services for UCR. WIRB has been contracted to act as one of UCR’s IRBs to review, approve and monitor our Phase I - IV Clinical Trials.

UCR and WIRB have established an agreement whereby WIRB agrees to assume IRB oversight for some research conducted at or by UCR. The following describes the scope of research activities for which UCR will agree to allow WIRB to assume IRB oversight, and outlines the procedures for obtaining permission to submit to WIRB. UCR has sole discretion on a study-by-study basis for allowing WIRB to assume oversight.

 

SPA and ORI

The lifecycle of pre-trial administration activities leading to the start of a clinical trial involves several key steps, some of which should occur simultaneously, to prevent undue delays. This includes obtaining IRB approval and execution of a Clinical Trials Agreement (CTA). The information provided on this webpage is meant to be used in tandem with the Sponsored Programs Administration (SPA) required submissions. As soon as it appears likely that UCR will participate in a clinical trial, please initiate the process with SPA and also begin to prepare to work with the Office of Research Integrity (ORI) for an IRB submission to WIRB.

 

Procedures for Obtaining WIRB IRB Oversight of a Project

The process outlined here is only for investigator-initiated clinical trials. Sponsor-initiated trials will depend on the negotiated Clinical Trials Agreement (CTA) between the PI and the Sponsoring entity or IND holder. See the SPA site for more information on initiating the CTA process.

WIRB will review research on behalf of UCR only with notification that the UCR Office of Research Integrity (ORI) & IRB has cleared the study for WIRB oversight. UCR IRB staff will screen the application for eligibility for WIRB IRB oversight. Screening involves use of a checklist to ensure that:

  • The research fits the definition of a clinical trial (Phase I – IV)
  • The investigator(s) is (are) UCR Principal Investigators (PI) with research privileges.
  • All investigators and staff conducting research have completed the Collaborative Institutional Training Initiative (CITI) online course. Investigators and staff conducting clinical trials are also required to take GCP training, either through CITI or by providing a copy of their ACRP or SoCRA certification. Required training must be renewed every 3 years.
    • This training is only available individuals with a UCR email account
    • For IRB-Clin specific training, you will want to select the modules that specifically pertain to “Biomedical Research Investigators” and “Good Clinical Practice Course, US FDA Focus
    • For additional information on accessing CITI courses, please see our Instructions for Accessing the CITI program.

Important to know: If your research is not a clinical trial (Phase I-IV), WIRB review is not required. Instead, UCR’s IRB-Clin may review your study.


WIRB Submission & Review Process

The ORI utilizes an initial pre-review screening process whereby each application is reviewed for completeness and compliance. During this process, the researchers may be asked to make changes to the application before it is submitted to WIRB (pre-review). Once the researcher addresses the pre-review comments, ORI will submit the application to WIRB.  The WIRB review may also request changes or clarifications from the PI. Upon approval, the PI should notify ORI and SPA.

IRBprocess

*Setup and execution of the CTA should be concurrent with this process. SPA will need to be notified of IRB approval before the CTA can be finalized.

 

WIRB Forms and Templates

All WIRB Forms and Templates (from wirb.com)

Guide for Researchers – a WIRB resource

 

How to fill out and submit to WIRB

For investigator authored studies, the process to submit to WIRB is as follows:

  1. Please complete your WIRB submission packet via the Downloadable Forms webpage on WIRB.com
    1. Download the “Initial Review Submission Form” by right-clicking the link provided on that site and selecting 'Save Link As' to download the file. Once downloaded, open the destination folder to open the form to complete it
    2. Please use the following information for Section VI, Billing Information
      • University of California Riverside, Attn: Dario Kuzmanovic, Director, ORI; 900 University Ave. 215 University Office Building, Riverside CA 92521. Phone: 951-827-4818, Email: dario.kuzmanovic@ucr.edu
  2. When you are ready to submit the application to WIRB, please email the completed packet (preferably as a single attachment) to Heather Pham at IRB@ucr.edu. It will then be forwarded to WIRB after a pre-review of the documents and the addition of any supplementary required UCR information. You will be copied on the email so you will know when the packet has been forwarded to WIRB for review.
  3. WIRB may contact you directly with any questions or notifications and will inform you of the details regarding your online WIRB account that will be created based on the materials submitted.

WIRB approval does not constitute funding or other institutional required approvals, if required. It is the researcher’s responsibility to ensure that all approvals are in place prior to conducting research involving human subjects or their related specimens. For example, if human embryonic stem cells will be used, UCR's Stem Cell Research Oversight (SCRO) review and approval will be required as well as review and approval by UCR's Institutional Biosafety Committee (IBC). If UCR's review committee(s) requires revision of the informed consent/assent documents, an amendment must be provided to WIRB, and the WIRB fee for review will be paid by the study, per WIRB procedures.

 

WIRB Study Submissions for Ongoing Research

Continuing Review

WIRB will provide the investigator or designated continuing review contact with a continuation notice about 75 days before the expiration of the study.  All continuation requests must be sent directly to WIRB by the investigator using a WIRB Continuing Review Report Form (CRRF).

Modification/Amendments

All changes to the study must be submitted directly to WIRB by the investigator using a Change in Research Submission Form.

The UCR IRB must also be notified if you are making changes to any of the following: Principal Investigator, Study Personnel, Performance Site(s), and Change in Investigator*. Submit the WIRB documentation to IRB@ucr.edu as well.

Adverse Events & Unanticipated Problems

In the event of an adverse event or unanticipated problem involving risk to subjects or others, the investigator must submit a Promptly Reportable Information Form directly to WIRB. If it meets promptly reportable guidelines, the form should be submitted within 5 days.

If the occurrence is serious (deaths or life-threatening events) and occurred at a UCR site, a copy of the WIRB report form must be sent to IRB@ucr.edu within twenty-four(24) hours of discovery.

* Please contact WIRB Client Services for requirements for Change in Investigator or refer to WIRB’s Guide for Researchers.


Contact Information

Contact WIRB with any questions regarding WIRB procedures or forms:
Office: (360) 252-2500 or (800) 562-4789
Fax:     (360) 252-2498
Email: clientservices@wirb.com
Mailing Address: 1019 39th Avenue SE Suite 120, Puyallup, WA 98374-2115

Contact the UCR IRB for any questions regarding initiation of this process:
Office: (951) 827-4802
Email: IRB@ucr.edu

Contact the UCR SPA for any questions regarding CTAs
Office:  (951) 827-4918
Email: cta@ucr.edu

 

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