Western Institutional Review Board (WIRB^®) now known as WIRB-Copernicus Group (WCG^® IRB) is an option for industry-sponsored clinical trials protocol submissions.

WCG^® is an independent central IRB located in Puyallup, Washington. WSU has implemented processes to (1) review requests to use WCG^® and, (2) manage protocol submissions to WCG^®.

FAQs

• What WSU studies are eligible for WCG^® submission?

  Studies may be considered for submission to WCG^® if they are industry-sponsored clinical trials and the sponsor has requested the study be submitted to WCG^® for IRB review.

• If WCG^® will be the IRB for my study, why must I go through the Research Compliance Office?

  WCG^® provides ethical review, which is only one part of clinical trial oversight. Certain regulatory responsibilities still remain the responsibility of WSU. These responsibilities include:

  • Ensuring adequate personnel training in Protection of Human Subjects and Good Clinical Practice.
  • Maintaining a compliance oversight role locally.
  • Ensuring that site specific requirements are in place.
• How much money should be budgeted for WCG^® studies?

  Make sure you include WCG's fees as direct charges in your budget, and plan enough funds to cover amendments, continuing reviews, and other actions during the life of the study. Contact Sponsored Programs for additional assistance regarding budgeting fees.  For fee regarding WSU IRB local context review see IRB Fees.

• How does the process work?

  The Division of Research recognizes that the process of starting a clinical research study has many components that often need to occur simultaneously. However, to ensure the process runs efficiently, please follow the steps below as closely as possible:

  See submission instructions below and for more information an External IRB Guidance Tool is available.

  Initial Submissions

  • Complete the Initial External IRB Worksheet and attach to the eProtocol submission.
  • Create an eProtocol submission.
  • For detailed guidance regarding the eProtocol external IRB submission process see the External IRB Guidance Tool
  • Download the WCG® initial review submission form (Click here to get WCG^® forms) and prepare the WCG^® submission materials indicated on the checklist.
  • Use WCG^® - WSU Clinical Trials Consent form template  (updated February 2021, when preparing consent document. Follow the template provided, tailoring the procedures and language to that of your study. Remember, keep the language simple.
  • Pregnant Partner Consent Template (June 2021 update)
  • Submit the WCG^® submission materials and WSU IRB Authorization email to WCG^® via your mechanism of choice (mail, email, or online submission). 
  • Notify your Proposal and Contract Administrator in Sponsored Programs once you receive a WCG^® approval letter; your account cannot be set up without this approval letter.
  • Note: DMC Review Authorization - If DMC Review is required DMC Review Authorization can be submitted concurrently at the time of IRB submission. More information regarding DMC Review is available. 

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  Modifications:

  Changes to local research arrangements (i.e. key personnel & HIPAA) should be submitted to the IRB Administration Office for review.

  eProtocol submissions:

  • For Active protocols on the submitter's dashboard select "Start Amendment" and complete the Amendment Form.
  • Follow instructions on the eProtocol Amendment Form. 
  • Provide highlighted copies of revised documents and attach for the appropriate sections of eProtocol
  • Do not submit any additional Amendment or Modification Forms.
  • Key Personnel Changes:
    • make modifications to the eProtocol Personnel Information section
    • complete the applicable sections of the eProtocol Amendment Form
  • HIPAA Changes:
    • make modifications to the eProtocol HIPAA section and applicable HIPAA Authorization Forms.
  • Consent/Assent Changes:
    • Attach highlighted revised consent/assents for the consent/assent sections. 
  • For detailed guidance regarding the eProtocol Amendment submission process see the External IRB Guidance Tool.

  Non eProtocol submissions: 

  • Complete the External Modification Worksheet (admin correction June 2023)and email to wirb@wayne.edu
  • Follow instructions on the External Modification Worksheet
  • Provide highlighted copies of revised documents (i.e. consent/assents)
  • If making key personnel additions or HIPAA changes additional submission forms may be required (noted below).

  Additional Submission Forms:

  • Key Personnel List (updated September 2021 open and save as an Adobe Acrobat)
  • HIPAA Summary Form (updated August 2023)

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  Regulatory Reporting & Site Visits 

  UP Reporting: All SERIOUS unanticipated problems/adverse events occurring at WSU and its affiliated institutions should be submitted to the WSU IRB within 5 working days. 

  Protocol Violations/Deviations submitted/being submitted to the Reviewing (External) IRB:

  Non eProtocol submissions:

  • Complete the External IRB Modification Worksheet follow the instructions for the Modification Worksheet, and include any supporting documents/forms provided to the external IRB and email to: wirb@wayne.edu

  eProtocol submissions:

  • Start a Protocol Violation/Deviation Form and attached any supporting documents/forms provided the external IRB.

  Local Context Protocol Violations/Deviations:

  Local Context Protocol Violations/Deviations include HIPAA, key personnel, and breach of confidentiality.

  • Complete the Unanticipated Problem Event & Reporting Form (pdf) (pdf) and follow submission instructions per this form. 

  Site Visits: Upon notification of an impending regulatory site visit, hold notification, and/or external audit, the WSU IRB Administration Office must be contacted immediately. Please e-mail Amanda Jointer, Associate Director IRB Administration at areese@wayne.edu

• How can I obtain assistance with the WCG^® submission?

  You can visit the WCG^® web site in order to learn more about WCG^® and download their submission forms. You may also contact WCG^® at: 855-818-2289 or via e-mail at clientservices@wcgirb.com

If you have additional questions for the WSUIRB, please contact irbquestions@wayne.edu.

Tools to assist in your WCG request submission process

• WCG IRB Connexus Submission Quick Reference Guide (NEW)
• Checklist to Prevent the 7 Most Common Delays to HIPAA Review
• Checklist to Prevent the Most Common Delays to the Authorization Process 
• External IRB Policy: To view the External IRB & Reliance Agreements for Multi Site Research Policy (policy 4-17) visit the IRB's policy website.