Western IRB (WIRB) Forms
NOTE (6/1/09): Submission of Unanticipated Problem reports to WIRB. See the following link on the WIRB site regarding how and whether adverse events are reported to WIRB: Unanticipated Problem Reporting Updated - March 2009
NOTE (6/1/09): Submission to Western IRB – The Office of Sponsored Programs – Industry Support requires two complete submission packages (one for WIRB and one for VCU) and a third abbreviated package for our files. The VCU COI forms are to be submitted for review at the time of IRB submission. These forms are reviewed by the VCU Conflict of Interest Committee, whose findings are communicated to WIRB. WIRB continues to evaluate COI concerns from the perspective of human subject protections. Please refer to the checklist - http://www.research.vcu.edu/forms/WIRB_checklist.doc - for the VCU COI forms and other submission information.
NOTE: Until further notice, the following industry-sponsored projects (normally submitted to Western IRB) must be submitted to the VCU IRB: Projects that meet one or more of the following criteria:
All New Project Submissions (original, one complete copy, and a condensed copy) must be submitted to and signed off by the VCU Office of Industry Partnerships (OIP) before they are delivered to the VCU Office of Research Subjects Protection (ORSP). A complete checklist of documents that must be submitted to WIRB, ORSP and OIP can be found at http://www.research.vcu.edu/forms/WIRB_checklist.doc
VCU Office of Sponsored Programs 800 East Leigh Street, Suite 113 Box 980568 Richmond VA 23298 VCU Office of Research Subjects Protection (ORSP) 800 East Leigh Street, Suite 114 Box 980568 Richmond, VA 23298
All other submissions can be made directly to Western IRB; however, ORSP must receive one copy of all such submissions.
Western IRB P.O. Box 12029 Olympia, Washington, USA 98508-2029
Be aware that WIRB updates its submission forms as much as twice yearly to improve the review of research and protection of human subjects. When preparing to submit research for review, please be sure to use the most current versions of WIRB submission forms by referring to this website and linking to the forms below. WIRB Fee Schedule (New rates effective 6/1/09) WIRB Fee Schedule for Multicenter Studies (rates effective 6/1/09) WIRB Consent Template DNA Consent Addendum Initial Review Cover Letter Initial Review Submission Form Investigator Submission Form for Multi-Center Trials – should be used by investigators participating in multi-center protocols for which the protocol has already been reviewed by WIRB Change in Research Submission Form Study Reporting Cover Letter Subject Recruitment Submission Form Protocol Deviations/Violations Reporting Unanticipated Problem Reporting Forms HIPAA Partial Waiver of Authorization HIPAA Full Waiver of Authorization Study Closure
Click here for a free download of Adobe Reader