Review of Research by the Western Institutional Review Board (WIRB)
The Health Sciences Institutional Review Boards (HS IRBs) have contracted with a well-known and widely used commercial IRB, the Western IRB (WIRB), for the review of the majority of industry-sponsored research studies that are not investigator-initiated. As of May 1, 2008, industry-sponsored protocols, with some exceptions, will be reviewed by WIRB instead of the HS IRBs.
When using the WIRB, your contact within the HS IRBs Office is the Commercial IRB Specialist. The Commercial IRB Specialist is the UW-Madison research team’s liaison between the HS IRBs Office and WIRB and can provide guidance regarding the preparation of submissions for WIRB and their submission.
Commercial IRB Specialist
Colette Wagner
608-262-7544
caw@medicine.wisc.edu
Health Sciences IRBs
Office, VA Hospital, Room B3063
Mandatory Training is required for all new users and all new employees of current users that will be engaged in WIRB regulatory process. Please contact Molly Lumley at 265-2304, mal@medicine.wisc.edu or Mike Bates at 265-1982, bates3@wisc.edu to make an appointment.
Which research studies are likely to qualify for submission to WIRB?
Any industry-sponsored study that does NOT meet any of the following criteria can qualify for submission to WIRB:
- Research that involves any federal funds
- Research that is investigator-initiated
- Phase I studies (including I/II, Ib or similar studies)
- Research involving the Meriter Hospital or Madison VA
- Research involving embryonic stem cells, gene transfer or xenotransplantation
- Research conducted by trainees or students
- Research is a non-therapeutic interventional study
How do I request submission to WIRB?
Currently, only the Commercial IRB Specialist within the HS IRBs Office can submit a new study, changes of protocol, or continuing reviews to WIRB. Please submit the WIRB Worksheet, sponsor consent form(s), sponsor protocol(s) and a PDF of the signed COI form to submitwirb@medicine.wisc.edu to initiate submission to WIRB. The Commercial IRB Specialist evaluates the WIRB Worksheet and informs the research team whether the study can be sent to WIRB review.
Topics of Interest for Research Team Working with WIRB
(Click on the topic for detailed helpful comments and directions)
- Presentations: Use of WIRB by UW-Madison Research Team
- 1572 Form and WIRB
- Broadcast Advertisement
- Changes: Small Demographic
- Changes: Modifications to Research Document
- Checklist: Research Team WIRB Email Submission
- Checklist: WIRB Consent Language
- Checklist: WIRB Worksheet
- COI: UW vs. WIRB
- Communications: When can the research team speak to WIRB
- Consent: Example of Expiration Label Use
- Consent: Expiration Label
- Consent: Expiration Label Printing Instructions
- Consent: How to prepare for WIRB submission
- Consent: How to Use the Expiration Label
- Consent: UW/WIRB Template Language
- CTRC: Usage of the CTRC with WIRB
- Register for Listserve Updates
- For the Sponsor/CRO: Institutional Requirements
- HIPAA Form
- IDB Updates: How WIRB Wants them Submitted
- IND Safety Reports: How WIRB Wants them Submitted
- Important Facts to Remember
- Language Translations and Working with WIRB
- Naming Conventions/Electronic Submission
- PRMC Review
- Scientific Review
- Sponsor/CRO working with UW-Madison Researchers and WIRB
- Tracking your protocol with WIRB
- UW-Madison CTA Form for Initial Application
- UW-Madison Tracking Numbers for WIRB Studies
- Who is My IRB of Record?
- WIRB Application: Billing Information
- WIRB Application: Certification of Training
- WIRB Application: Site
- WIRB Application: State Law Question
- WIRB Application: How to fill out the CTA section
- WIRB Application: Who needs a CV and License
Power Point Presentations: