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Western Institutional Review Board (WIRB)

About the WIRB/RCA Process

WIRB is an independent IRB which provides IRB services to institutions and individuals across the country.  IUPUI/Clarian has partnered with WIRB to provide an alternative method of IRB review for protocols which meet certain criteria. 

Submissions may now be made to WIRB. Please follow the instructions below and contact the Clinical Trials Office with any questions. All submissions should be sent to iuwirb@iupui.edu.

 

Eligibility

Studies which meet the following criteria are eligible for submission to WIRB:

  • Meets the NIH definition of a clinical trial: “a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices)”
  • Phase II/III/IV multicenter clinical trial
  • Designed and written by the sponsor
  • Sponsor is a for-profit entity/company
  • Sponsor holds all INDs/IDEs
  • Not previously submitted to a Clarian or IU IRB

Studies which involve any of the following are NOT eligible for submission to WIRB:

  • Planned emergency research
  • Xenotransplantation
  • Gene transfer
  • Embryonic stem cells
  • VA hospital
  • Research funds from a federal or non-profit funding agency
  • Medical devices
  • Children
  • Waivers of informed consent or authorization

How to Submit to WIRB

  1. Use the eligibility checklist found below or on the IU Application for Protocol Review by WIRB to determine whether the protocol is eligible for submission to WIRB.  If not, please submit the protocol through the normal IUPUI/Clarian IRB process.
  2. If you determine that the protocol is eligible for submission to WIRB, fill out and collect all required documents (see below).  All documents should be in electronic form.    
  3. Submit your documents via email to iuwirb@iupui.edu.   
  4. The Clinical Trials Office will verify eligibility and, if eligible, will submit the documents to WIRB within three (3) business days.
  5. WIRB will contact the PI regarding the submission and all further communication will take place directly between the PI and/or study contact and WIRB. 

What to Submit

The following documents should accompany your initial submission to iuwirb@iupui.edu.

  • IU Application for Protocol Review by WIRB
  • WIRB Initial Submission Form (available at WIRB website)
  • CVs for all investigators listed on the WIRB Initial Submission Form (question 37) or the WIRB Investigator Submission Form for Multi-Center Protocols (question 27) 
  • Protocol, drug brochure, advertisements, solicitation scripts
  • Proposed informed consent and HIPAA authorization forms  

As WIRB-eligible studies are multi-center trials, WIRB may already be reviewing your study at another site.  Please take a moment to contact WIRB to determine if they have already reviewed your study.  If so, you may submit the Investigator Submission Form for Multi-Center Protocols (available at WIRB website [http://www.wirb.com/content/quick_download_forms.aspx]) instead of the WIRB Initial Submission Form.  Using this form requires less time to complete and may result in lesser fees from WIRB.

Fees and Billing

WIRB submissions will be subject to a one-time $500 IRB fee, as well as any fees charged by WIRB. For more information about WIRB fees, please click here. 

Contact Information

IUPUI:

WIRB:

Important Documents