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 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 facilitates the review of industry-sponsored multicenter research, has entered into an agreement with Western IRB (WIRB) whereby the UMMS IRB may rely upon WIRB for IRB review and approval.
In order for the UMMS 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 II or higher 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 UMMS may rely upon WIRB for review of specific research projects, the Institution is still responsible for the conduct of that research. Therefore, the UMMS IRB must be aware of and approve of the submission being sent to WIRB through an administrative pre-review. WIRB will not review any UMMS study prior to UMMS IRB 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, unless they are Phase I trials. The UMMS IRB will not currently cede review for Phase I trials.
UMMS IRB WIRB Liaisons:
- Email the UMMS IRB WIRB liaisons and request permission to use WIRB. Provide a copy of the sponsor protocol, the name of the UMMS PI, and a brief description of how the protocol fits the criteria listed above or merits an exception.
- If the UMMS IRB grants permission to use WIRB, ask the sponsor, firstname.lastname@example.org, or UMMS-WIRB Account Manager Jon Gellert (email@example.com) to invite you to the protocol in Connexus and to send you the WIRB approved Sponsor Template ICF.
- Read the instructions posted below and prepare the materials offline, including the Initial Review Submission Form PDF from WIRB http://www.wirb.com/Pages/DownloadForms.aspx
- Login to Connexus and select "My Studies." Select the correct study, and then select "Submit New Investigator." Upload your documents into Connexus. 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 may 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.
- Email the liaisons with any proposed changes to research injury compensation or conflict of interest declarations before submitting to WIRB. Otherwise, send all subsequent submissions (e.g., modifications, continuing reviews, reportable events) directly to WIRB for review. IMPORTANT: Changes to research injury compensation or conflict of interest require UMMS IRB review before submission to WIRB.
- Email the liaisons with changes in study staff, financial interests related to the research, etc., via an updated HRP-270 External IRB Review Application.
- Email the liaisons when the study closes here at UMass Worcester and notify them of any unanticipated problems involving risks to subjects or others, reports of serious and/or continuing non-compliance, or IRB suspension or termination.
- Once WIRB approval is granted:
For detailed instructions on how to submit, see the following:
- Western IRB (WIRB) Submission Instructions (Updated 03/04/19)
- HRP-270 External IRB Review Application
- The 'My Connexus Quick Start Guide' is located under Quick Access Links on the Connexus homepage that appears upon initially logging into the Connexus system. Look under My Connexus Training.