Institutional Review Board
(IRB)

New study Submission to WIRB

1. The Principal Investigator must obtain a signed endorsement from the Department Director for the research project.
   
   
2. Submit the following documents to the Western IRB Liaison, located at The Office of Compliance, Cardiovascular Hospital at the Eight Floor (Office 819-821), for the pre-review process:
   
   

1. Application to submit protocols to Western IRB
   
   
2. Copy of the Human Subject protection training certificate (Principal Investigator and sub-investigators)
   
   
3. Copy of the HIPAA training certificate (Principal Investigator and Sub-Investigators)
   
   
4. Protocol
   
   
5. informed consents (English and Spanish versions) with MSC IRB Specific requirements (see template). Please be advice that the confidentiality, compensation and new information statements are standard and not negotiable. Also the Informed consent must include the MSC signature page.
   
   

2. The Principal Investigator (PI) must receive approval from the Western IRB Liaison prior to submit the protocol to WIRB. A protocol is approved once the PI receives the approval for submission to WIRB included in the application form and the MSC IRB signed letter of approval by the Western IRB Liaison.
   
   
3. The PI must submit all documents required by WIRB to begin the review process for the research study. (http://www.wirb.com).
   
   
4. The PI must submit to WIRB the MSC IRB Submission Approval cover letter signed by the WIRB Liaison to ensure that WIRB will send copy of all WIRB authored correspondence to MSC IRB. WIRB will not review any protocol that does not comply with this requirement.

If you have any question regarding new study submission to WIRB you should contact WIRB for assistance at the following telephone number: 1-800-562-4789

Revisions to WIRB approved protocol

After the initial approval of your research protocol by WIRB any document that requires IRB revision and approval (new material, amendments, continuing reviews, adverse event reports etc.) will be submitted directly to WIRB. The PI is responsible for submitting all documents required by WIRB to proceed with the review of this research material (http://www.wirb.com.

If you have any question regarding submission of documents to WIRB after protocol has been approved, you should contact WIRB for assistance at the following telephone number: 1-800-562-4789.