Institutional Review Board
(IRB)

Submitting a Research Project to Western IRB

As of September 15, 2005, Western IRB (WIRB®) has been established as a fourth MSC IRB for industry-sponsored protocols conducted at the UPR-Medical Sciences Campus (MSC).   However, MSC IRB is required by its policies and by its Federalwide Assurance, to review and maintain files on all clinical research conducted within the institution.  This includes the industry-sponsored protocols that are reviewed by Western IRB per contract between the institution and Western IRB.

All industry-sponsored protocols will be submitted to the Western IRB Liaison (MSC IRB Office, Cardiovascular Hospital - Eight Floor Office 819-821) prior to it submission to WIRB. The Initial Submission documents will include MSC IRB-specific needs to meet institutional requirements and to provide the MSC IRB with all the information needed for our files.  The Western IRB Liaison will retain copies of necessary documents and then will authorize the Principal Investigator to submit the Initial Submission documents to Western IRB for full board review.  After this Initial Submission to the MSC IRB, all other correspondence, including renewals, amendments, and adverse events, will be sent directly to Western IRB by the Principal Investigator. MSC IRB will maintain its files by receiving copies of approvals directly from Western IRB.

The MSC IRB charges a one-time fee of $500.00 for the processing of industry-sponsored protocols submitted to the Western IRB for review.  This fee provides funds to the MSC IRB to assist in the costs associated with review.  The MSC IRB uses the fee to pay for the staff time involved in the pre-review of the protocol for institutional and WIRB requirements. The fee also covers the maintenance and update of the file throughout the life of the protocol at MSC.

Studies eligible for WIRB® submission:

Studies may be submitted to WIRB® only if they meet ALL of the following conditions:

1. The trial is industry-sponsored, industry-written; FDA regulated and meets the definition of a clinical trial "A controlled study involving human subjects, designed to evaluate prospectively the safety and effectiveness of new drugs or devices or of behavioral interventions".
   
   
2. The investigator has not previously submitted the clinical trial to another MSC IRB.
   
   
3. The proposed research does not involve gene transfer or embryonic stem cell Research.
   
   
4. The individual responsible for the conduct of the study (the PI) must be an MSC faculty member or a MSC associated member. MSC student are not allowed to submit research projects to WIRB even if it meets the above conditions.
   
   

WIRB® services fees:

Your contract with the study sponsor should provide for WIRB® fees as well as for the MSC-IRB pre-review process fee ($500.00). You should have provisions for the initial fees, as well as for the ongoing fees (amendments, annual reviews, PI changes, etc). Note: when establishing your contract with your sponsor you can either budget a flat dollar amount in anticipation that it will cover all WIRB costs. However we advise to word the contract such that the sponsor is responsible for all WIRB fees (without an upper limit). Projects can take longer than expected, or may require more revisions than expected. Since WIRB charges for all submissions a flat sum budgeted for IRB related costs can easily be exceeded before the study is completed.

Click here for MSC-IRB Instructions and Application for Protocol Review by WIRB.