Western IRB (WIRB) Submissions

WIRB Submission Instructions

WIRB Submission Forms

Submission Instructions

What Needs to be Submitted to WIRB?
All industry sponsored research involving human participants should be submitted to WIRB for review, except projects that meet one or more of the following criteria:

involve human subject activities conducted by Navy and Marine Corps personnel;
involve naval military personnel and Department of Navy (DoN) employees as research subjects;
are supported by naval activities through any agreement (e.g., contract, grant cooperative agreement, development agreement [CRADSs], or other arrangement), regardless of the source of funding, funding appropriation, nature of support, performance site, or security classification; or
are using DoN property, facilities or assets.

How do I Submit to WIRB?
Initial Submissions

Step 1: Access the appropriate WIRB submission forms below. Be sure to complete both WIRB submission forms as well as VCU Cover Memo, which provides pertinent information to the VCU IRB to maintain for tracking purposes.
Step 2: Submit all materials electronically via email to the Clinical Trials Office (CTO) at CTOadmin@vcu.edu. If you need assistance scanning paper documents to PDF files, scanning capabilities are available for your use at the CTO (Richmond Academy of Medicine Building, 1st Floor, 1200 E. Clay Street). Direct questions to Jose Rodriguez in the CTO at 804-628-2942 or jmrodriguez@vcu.edu.

CTO will review the study budget and consent form. When the submission is complete and ready to move forward, CTO will forward submission materials to the Office of Research Subjects Protection (ORSP).
Step 3: Respond to any requests for additional information from ORSP, if applicable.
Step 4: When all submission requirements are met, ORSP will upload all electronic submission documents to WIRB and notify the PI that the submission has been done.
Step 5: Respond to requests for additional information requests from WIRB as necessary to secure approval.

Maintaining Approval and Ongoing Submissions
Once the initial submission is approved, the Principal Investigator is responsible for directly submitting all future submissions to WIRB including:

Changes in research (amendments)
Unanticipated problems
Continuing reviews
Study closure.

A copy of ALL submissions must be provided to ORSP via IRBIntake@vcu.edu, as well as to WIRB.

NOTE: Paper submissions will be accepted at ORSP until May 1, 2011. All submissions to ORSP after May 1, 2011 must be submitted via email.

WIRB will send continuing review reminder notices to principal investigators. Please pay close attention to the reminders. WIRB strictly enforces deadlines.

WIRB Submission Forms

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, 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 6/1/10)
WIRB Consent Template
DNA Consent Addendum
Initial Review Cover Letter (rev 1-31-10)
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 - click on menu item, "Forms Related to Ongoing Research"
Study Reporting Cover Letter
Unanticipated Problem Reporting Forms - click on menu item, "Forms Related to Ongoing Research"
HIPAA Partial Waiver of Authorization - click on menu item, "Supplemental initial review forms"
HIPAA Full Waiver of Authorization - click on menu item, "Supplemental initial review forms"
Study Closure - click on menu item, "Forms Related to Ongoing Research"

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