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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). UCLA allows the use of WIRB under the specific conditions outlined below.

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What Kind of Studies Qualify for WIRB?

 

Studies that meet the following criteria are eligible for WIRB review (see exceptions below):

  • Phase III or Phase IV clinical trials.
  • Industry funded.
  • Industry authored.

 

Exceptions

The following types of studies do not qualify for WIRB submission:

  • Research on surgical techniques or procedures.
  • Research on transplant techniques, procedures or other interventions.
  • Research on neonates.
  • Research involving stem cell therapies.
  • Research involving gene therapy or gene transfer.
  • Research involving investigational radiologic procedures.

 

The OHRPP reserves the right to make additional exceptions and has final say on whether research must be reviewed by a UCLA IRB. 

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WIRB Submission and Review Process

 

WIRB will not review research on behalf of UCLA without notification that the UCLA OHRPP has cleared the study for WIRB oversight. The process for submitting an application to WIRB and communicating WIRB approval is as follows:

 

Pre-Submission

UCLA PI

  • Makes an initial evaluation that study meets eligibility criteria for WIRB review. If there are any questions, PI contacts OHRPP for guidance.
  • Confers with study sponsor to ensure that WIRB is acceptable and that sponsor will cover costs of WIRB review.

 

Submission

1. UCLA PI

  • Submits a completed UCLA-WIRB Initial Review Submission Package Cover Sheet with all the submission package requirements as noted on Cover Sheet.
  •  Initiates process, if not already started or completed, to obtain other UCLA regulatory committee approvals (see below) as needed.

2.  OHRPP staff confirms that study is eligible for reliance on WIRB and that paperwork is complete

  • If study is eligible, and paperwork complete, UCLA OHRPP will forward directly to WIRB.
  • If study is not eligible and/or paperwork is not complete, UCLA will notify UCLA PI in writing of the determination or additional requirements.

3.  WIRB reviews the study and communicates directly with UCLA PI with respect to required revisions or additional information needed.

4.  Once approved, WIRB

  • Sends the UCLA OHRPP notification that study has been approved and includes an approval notice and a stamped version of the approved recruitment and consent documents, which includes UCLA-WIRB previously approved and agreed upon consent template language.
  • Puts a five-day hold on the release of the documents to the UCLA PI.

5.  The UCLA OHRPP performs a final review of the recruitment and consent documents to assure that all required UCLA language is in documents and then contacts WIRB either to

  • Make any required changes or
  • Release the approval notice and stamped approved consent documents to UCLA PI.

6.  WIRB notifies PI and UCLA of final approval.

 

Other Regulatory Approvals

Additional UCLA regulatory committee approvals may be needed prior to the final approval by WIRB. UCLA OHRPP will coordinate with the PI, study staff and WIRB to ensure that these are in place before the final approval. These include:

  • Confilict of Interest Advisory Committee (COIAC)
  • Instititutional Biosafety Committee (IBC)
  • Radiation Safety Committee (RSC)
  • Institutional Scientific Peer Review Committee (ISPRC) for cancer-related studies only

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UCLA Forms, Links & Documents

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Contact Information

 

For all enquiries regarding Western IRB submissions, contact:

 

Daniel Gonzalez

Senior Analyst

(310) 206-7270

dgonzalez@research.ucla.edu

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How is Western-IRB Different from UCLA-IRB

 

  Western IRB UCLA IRB
Submission to IRB PI does not submit study directly to WIRB but has to submit paperwork to UCLA OHRPP which will perform an administrative review and then forward to WIRB PI submits the study directly to UCLA IRB.
Monetary Considerations and Requirements WIRB charges fees for each type of change to the study in addition to the yearly renewal. Examples include protocol or consent form changes, change of PI/co-PI, change in recruitment level, new or updated recruitment materials, site prepared translations and other changes. UCLA charges a one-time fee for industry-sponsored studies only on a per-study basis regardless of the complexity or the number of reviews per study. UCLA does not charge for amendments or continuing review.
Other UCLA Committee Approvals Applications for other UCLA regulatory committee approvals such as ISPRC,* CIRC,** MRSC*** and IBC**** can be submitted in parallel along with the Initial Review form. However, final approval will be withheld until all relevant approvals are in place. Any subsequent changes to the protocol or the consent form required by CIRC, MRSC or IBC will be considered an amendment and result in an additional cost. UCLA IRB also allows parallel submissions for most other UCLA committee approvals. However, final approval is withheld until all relevant approvals are in place. Such changes do not result in additional fees.
Multi-Institutional Trials For a multicenter study with a pre-approved protocol, a shorter version of the initial review form is required. WIRB develops the consent form using the UCLA template and the sponsor sample consent form. WIRB will also write consent forms for an additional fee. PI/study staff use the regular UCLA application forms and create consent documents based on UCLA template and sponsor sample consent form.
Consent Forms For a fee, WIRB will draft consent forms, using the UCLA template. UCLA has no provisions for preparing a consent form for researchers, though the IRB staff will consult with a PI before, during or after the preparation of a consent form.

 

* Internal Scientific Peer Review Committee

** Conflict of Interest Review Committee

*** Medical Radiation Safety Committee

**** Institutional Biosafety Committee

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Page Last Updated: January 11, 2016