Western Institutional Review Board (WIRB)
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®.
- 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:
- Download the WSU Initial External IRB Request Form (updated 10.2020 admin correction 2/2021)
- Submit the Wayne State University required items indicated on the form's checklist by e-mailing them to firstname.lastname@example.org. Include documents in an electronic folder labeled with the study number (if applicable) and PI's Name. The folder should include the following: All Consents/Assents, HIPAA Summary Form, Participant Materials, Flyers, Protocol, Administrative Approvals, etc.
- 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 2/17/2021, previous version accepted by WCG until 4/1/2021) 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 (6/25/2021 update)
- E-mail the WIRB® submission materials along with the WSU/WIRB® Cover Sheet and Review Authorization form to the IRB Administration Office at: email@example.com
- Obtain a signed copy of the WSU Cover Sheet and Review Authorization form after review by The IRB Administration Office. The IRB Administration Office will email you a signed copy when it is approved. This process will take from 7 - 10 business days. Initial submissions and modification requests reviews are conducted 7 to 10 business days from receipt of the complete submission. Note, missing items may result in delay of review.
- Submit the WCG® submission materials and signed Authorization form to WCG® via your mechanism of choice (mail, email, or online submission). Note: WCG® will not review your submission without the WSUCover Sheet and Review Authorization form signed by an authorized signatory from The IRB Administration Office.
- 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. For more information regarding DMC Review: https://www.dmc.org/for-health-professionals/clinical-translation-research-office
- If making key personnel, HIPAA, or any local context modifications please submit the:
- WSU External IRB Request Modifications & Event Reporting Form (updated 10.2020 admin correction 2/2021) to firstname.lastname@example.org
- Additional Key Personnel List (New with esignature update 3/2020)
- How can I obtain assistance with the WCG® submission?
If you have additional questions, please contact email@example.com.
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 (PDF)
- Checklist to Prevent the Most Common Delays to the Authorization Process (PDF)
- External IRB Policy: To view the External IRB & Reliance Agreements for Multi Site Research Policy (policy 4-17) visit the IRB's policy website.