What may be reviewed by WIRB?
All industry sponsored research involving human participants should be submitted in RAMS-IRB requesting review by WIRB, except projects that meet one or more of the following criteria:
- Funding provided by the Department of Defense directly to VCU or as a sub-award
- Involve human subject activities conducted by U.S. Navy and Marine Corps personnel
- Involve naval military personnel and U.S. 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
- Are using DoN property, facilities or assets
How do I submit to WIRB?
All new WIRB Submissions from VCU must first be submitted to the VCU IRB for institutional review and not directly to WIRB. All new WIRB protocols should be submitted through RAMS-IRB. Please review the following submission steps carefully:
- OSP Red (Contracts) Injury Language Review: OSP reviews informed consent forms (ICF’s) for industry funded clinical trials to ensure compliance with subject injury language in contracts. An OSP Subject Injury Language Review Task List has been created in OnCore to track OSP subject injury language review and approval for submission to WIRB.
Please contact email@example.com with any questions.
- Prior to submitting a WIRB study in RAMS-IRB, the PI/study staff reviews consent form for revisions to non-injury language and coordinates with their school/department for the creation of a funding proposal in RAMS-SPOT for subsequent notification to OSP.
- School/department reviews ICF, makes any changes related to costs, uploads latest ICF redline (as appropriate) to OnCore under Task Number 1 of the OSP Subject Injury Language Review Task List and records the date under “Completed Date”.
- School/department creates a review record in RAMS-SPOT via the Submit Document for Review section, uploads the contract, links the funding proposal and logs a comment in the Funding Proposal stating that the consent form is available through OnCore for review.
- The Document Review should include sponsor/CRO contact information for both the consent form and the contract for negotiation purposes.
- School/department will access OnCore and record the “Completed Date” that contract was uploaded to SPOT under Task Number 2 of the OSP Subject Injury Language ReviewTask List.
- OnCore will generate a report to OSP Red indicating an ICF Subject Injury Language review is needed. OSP will access OnCore and record the “Completed Date” under Task Number 3 when the reviewer begins ICF review and will review and negotiate the appropriate revisions to the subject injury language directly with the sponsor or contract research organization (CRO), as appropriate.
- Once OSP has completed negotiation of the language, it will upload an approval memo with the VCU/Sponsor approved ICF template to OnCore under Task Number 4 of the OSP Subject Injury Language Review Task List and record the “Completed Date.” OnCore will generate a report and send it to the school indicating: OSP Approval and Upload of Approved Injury Language ICF and Memo.
- Study team/school (as appropriate) will access approval documents in OnCore under the OSP Subject Injury Language Review Task List and will mark the “Completed Date” under Task Number 5 of the task list.
- Submit WIRB submission through RAMS-IRB: Study teams should initiate a submission in RAMS-IRB and complete the smart form. When requested, select External IRB (WIRB) as the reviewing IRB. When the smart form is complete, submit the study.
- Documents that should be uploaded into the RAMS-IRB study workspace include:
- Study protocol
- Informed consent form(s)
- HIPAA Authorization(s) if separate from informed consent(s)
- Investigator brochure
- PI curriculum vitae
- Memo from OSP indicating injury clause language in consent has been approved
- The submission will be routed to the ORSP for a compliance review.
- The ORSP will:
- Request that a COI review be conducted
- Verify mandatory training completion (human subjects and GCP)
- Ensure the PI is appropriately credentialed and privileged to perform clinical work
- Confirm appropriate HIPAA PHI pathway
- Verify documentation of how payment will be made for WIRB review
- Ensure that the documentation of injury clause review and approval has been done
- Ensure compliance with VCU policy, "Reporting Sponsor-Investigator INDs or IDEs"
- Upon completion of the ORSP review, the PI will receive an email memo indicating the review is complete and the study may be submitted to WIRB.
- The study team submits the study to WIRB
- The PI/study team is responsible for submitting all required documents to WIRB via the WIRB electronic submission system. In addition to all study related documents, the following documents must be included with the WIRB submission for a review to occur:
- ORSP memo indicating institutional review is complete
- Verification that injury clause language has been reviewed
Please contact OSPRed@vcu.edu if you have questions about ICF injury clause review. Please contact ORSP@vcu.edu for questions about WIRB submissions in RAMS-IRB.
Maintaining approval and ongoing submissions
- Once the initial submission is approved, the PI 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 should be provided to ORSP by performing a “document upload” in the study workspace in RAMS-IRB, as well as to WIRB.
- RAMS-IRB will send a reminder to the PI/study team around the expiration date of the study. The PI/study team is responsible for updating the expiration date based on the most recent continuing review completed by WIRB and providing a summary of progress. WIRB will send continuing review reminder notices to principal investigators. Please pay close attention to the reminders. WIRB strictly enforces deadlines.
WIRB submission forms
The most efficient way to submit to WIRB is directly through the WIRB electronic system called Connexus. If choosing to submit application documents via document upload, be sure to use the most recent forms obtained directly from the WIRB website.
VCU requires that specific informed consent template language be used. Be sure to use the template below when creating a consent form.