Western IRB (WIRB)
Reliance on Western IRB (WIRB) Updated 08/15/17
This guidance reviews the process for use of Western IRB (WIRB) for IRB review and oversight of research involving University of Massachusetts-Worcester investigators. UMass-Worcester maintains an Agreement for Services with WIRB which sets forth understandings, authority, and responsibilities of both institutions.
The University of Massachusetts-Worcester, in an effort to create a framework that will facilitate the review of industry sponsored phase III multicenter research, has entered into an agreement with Western IRB (WIRB) whereby the UMass IRB may rely upon WIRB for IRB review and approval.
In order for the UMass IRB to be able to extend this agreement to include a specific research study all of the following conditions must apply:
The sponsor of the research is a for-profit entity/company
The project was designed and written by the sponsor
The sponsor holds all INDs/IDEs for the project
The research is a multicenter project
The research is in phase III or IV as defined by the FDA
The research is currently reviewed by WIRB for other sites
If you wish to rely on WIRB, contact the UMMS IRB WIRB Liaisons. Although UMass may rely upon WIRB for review of certain research projects, the Institution is still responsible for the conduct of that research. Therefore, while not responsible for IRB approval of WIRB-submitted studies, the UMass IRB must be aware of and approve of the submission being sent to WIRB through an administrative pre-review. WIRB will not review any UMass study prior to UMass administrative pre-review. Research studies that do not meet the criteria above will be considered by the UMMS IRB on a case-by-case basis.
UMMS IRB WIRB Liaisons:
- Primary: email@example.com and firstname.lastname@example.org
- Secondary: email@example.com
- Email a copy of the sponsor protocol and sponsor consent form template to the Primary and Secondary UMMS IRB WIRB Liaisons and confirm that the submission meets the criteria above.
- If the UMMS IRB grants permission to use WIRB, prepare the necessary documents.
- Ask the sponsor to invite you to the protocol in Connexus (WIRB’s electronic submission system). If the sponsor is not responding, WIRB Client Services can also assist you with an invitation.
- Complete the steps through document upload for Submit New Investigator Site in Connexus, but do NOT submit to WIRB.
- Add the UMMS IRB WIRB Liaisons to the workspace in Connexus so that the UMMS IRB can conduct an administrative review.
- The UMMS IRB office contacts you by email with any clarifications.
- Update Connexus to address any questions from the administrative review, but do NOT submit to WIRB. Respond to the administrative review by email with a point-by-point response.
- Once questions are resolved, the UMMS IRB submits to WIRB on your behalf.
- Once WIRB approval is granted:
- WIRB will contact you to conduct a site visit (at no cost to you) if the PI is conducting an investigational drug study and has not been previously approved by WIRB for a research study.
- Send subsequent submissions (e.g., modifications, continuing reviews, reportable events) directly to WIRB for review.
- Maintain a current HRP-270 External IRB Review Application and email updates to the UMMS IRB.
- Email the UMMS IRB when the study closes here at UMass Worcester.
- Once WIRB approval is granted:
For detailed instructions on how to submit, see the following:
- Western IRB (WIRB) Submission Instructions (Updated 3/31/16)
- HRP-270 External IRB Review Application
- My Connexus Quick Start Guide: The 'My Connexus Quick Start Guide' is located on the Connexus homepage that appears upon initially logging into the Connexus system. For screenshot of location, click here.