Western IRB (WIRB)

Reliance on Western IRB (WIRB)

This guidance reviews the process for use of Western IRB (WIRB) for IRB review and oversight of research involving UMass investigators. UMass 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 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 multi-center project

The research is in Phase III as defined by the FDA

The research is currently   reviewed by WIRB for other sites

If the study does not meet all of the conditions above, and you wish to rely on WIRB, contact the UMass IRB before preparing the submission to WIRB.  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.

For detailed instructions on how to submit, see the following two documents:

Western IRB (WIRB) Submission Instructions

HRP-270 External IRB Review Application