WCG IRB Copernicus Group (WCG) has combined its five IRBs into a single IRB called “WCG IRB.”  This includes Western IRB, Copernicus Group IRB, Aspire IRB, New England IRB, and Midlands IRB.  All new studies are managed under WCG IRB’s OHRP/FDA IRB registration number (IRB00000533), which was previously the registration number for Western IRB.

If you do not already have a WCG IRB Connexus account, please request one immediately on the WCG IRB website (https://www.wcgirb.com/). Anyone who needs access to the submission documents must have a WCG IRB Connexus account.

Procedure for new submissions

1. The principal investigator (PI) or the PI's contact person submits the following required and other applicable documents in IRAP.

Documents required for all submissions

• Completed Institution Review Form Relying on Outside IRB
  
• Protocol Oversight Review Form or CTRC Approval if protocol is cancer related
• WCG Consent Language Checklist with a statement/instructions on how to complete/attach
• Sponsor’s Consent Form Template (or WCG IRB approved stamped template, if available)
• Sponsor’s Protocol

Documents required as applicable

• Release of Drugs for Human Research Use (if any drugs will be used in the protocol)
• Radiation Safety Approval
• Infection Control Approval
• Release of Pathologic Materials
• FDA Form 1572

2.  A member of the OIRB staff reviews and verifies the submission materials, and then forwards the stamped Institution Review form (along with any required attachments) to the PI and the PI's contact.

3. The PI or PI's contact uploads their documents via WCG IRB Connexus, including the stamped Institution Review Form.

The UAB OIRB is notified when WCG IRB receives the submission.

Procedure for Other Reviews and Correspondence

Personnel Changes

Submit an updated Responsible Personnel List (RPL) to the Office for Sponsored Programs (OSP) via email and copy (“cc”) the UAB IRB e-mail address, This email address is being protected from spambots. You need JavaScript enabled to view it.. The UAB IRB will update IRAP to reflect the change in key personnel and provide you with a Received and Noted email to you. If you are changing the study’s Principal Investigator or changing a Sub-investigator who is listed on the consent form, you must also notify WCG IRB of this change.

Unanticipated Problems

When WCG IRB has made a determination of an unanticipated problem, the UAB research staff notifies the UAB OIRB via email to This email address is being protected from spambots. You need JavaScript enabled to view it. of whether the event occurred at the UAB site or involved a UAB participant. The designated member of the OIRB staff notifies the appropriate officials as required by institutional policies and procedures.

Monitoring Reports

The PI or contact still must submit any monitoring reports documenting deficiencies to the UAB IRB via Revision Amendment submission in IRAP.

Questions

For WCG IRB Connexus help, see the Connexus User Guide, under Forms & Guides, at the WCG IRB Connexus site: www.wcgirb.com