VCU new IRB system implementation 2025 timeline

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RAMS IRB submission deadlines

System activity	Submission date
Continuing review submissions for all study approvals expiring before 9/13/25	All CRs were DUE in RAMS by 7/2/25
Continuing review submissions for all study approvals expiring 9/13/25 or later	HOLD to submit in VIRBs starting 8/7/25
Submissions requiring convened IRB review	Last day to submit in RAMS 7/11/25
Initial requests to rely on an external IRB; study updates (mods, CRs) approved by an external IRB	Last day to submit in RAMS 7/11/25
Requests for VCU to serve as the IRB of record for other sites	Last day to submit in RAMS 7/11/25
Submissions eligible for expedited review, exempt determination, or administrative review (NHSR)	Last day to submit in RAMS 7/18/25
Response to changes requested by IRB staff, conditional approval, and deferral issued before 7/18/25	Last day to submit response in RAMS 7/18/25
Response to changes requested by IRB staff, conditional approval, and deferral issued after 7/18/25	Last day to submit response in RAMS 7/30/25 *Does not guarantee review to final state by 7/31/25. Please submit as early as possible.

ALL studies must be in a complete state by 7/31/25 in order for the submission to convert to VIRBs. Submissions in an incomplete state will require new submission in VIRBs. Please ensure timely responses to IRB staff throughout this time.

Contact the HRPP with any questions about conversion activities and deadlines: hrpp@vcu.edu or irbreliance@vcu.edu.  

Previously posted information

IRB meeting and full board continuing review submission deadlines

Current approval expiration*	Target RAMS submission deadline	Latest RAMS submission deadline	Target IRB meeting date**
7/10 - 7/16/25	6/2/25	6/11/25	7/2/25
7/17 - 7/23/25	6/9/25	6/18/25	7/9/25
7/24 - 8/31/25	6/16/25	6/25/25	7/16/25 or 7/23/25 (overflow)
9/1 - 9/12/25	6/23/25	7/2/25	7/23/25
9/13/25 or later	Submit in NEW system starting 8/7***		8/27/25 - variable

*Current approval expiration for greater than minimal risk studies currently open to enrollment and/or where study is active with treatment, interventions or ongoing interactions. Does NOT include studies active for data analysis or long-term follow-up only. Studies requiring continuing review that are eligible for expedited review may be submitted by the 7/18/25 deadline, but should still be submitted at least 30 days in advance of approval expiration. Contact the HRPP with study-specific renewal considerations.

**The IRB does not meet the 5^th Wednesday of the month (7/30/25) and will not meet 8/6/25 due to system conversion. The 8/13/25 and 8/20/25 IRB meeting will be held if needed for timely review of mods or RNI submitted in the new system beginning 8/7/25.

***The HRPP requires studies to be submitted at least 30 days in advance of approval expiration. For studies transitioning to protocol-based applications, submit 60 days in advance of expiration. Please plan ahead.

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VIRBs, the new VCU IRB system, goes live on August 7, 2025.

The deadline to submit a new reliance application in RAMS IRB is July 11, 2025. Only studies that have been fully approved in RAMS IRB by July 31, 2025 will transition to the new VIRBs system.

For reliance studies, this means the following must be completed by the deadline:

The study must be approved by the external IRB, and RAMS IRB must be updated to acknowledge that external approval. If your reliance study is not approved in RAMS by July 31, it will not transition to VIRBs.

If you miss the July 11, 2025 deadline, please prepare your study documents so that you are ready to submit them in VIRBs once the system goes live on August 7, 2025.

If you have an urgent reliance study that falls outside of this timeline, please contact us at irbreliance@vcu.edu for guidance.

You may access the VIRBs stage site to explore the new IRB system any time: https://hrspvcustage.huronclick.com/irb.

• Enter your VCU single sign on information, similar to what you do when logging in to RAMS IRB
• Practice creating new submissions and exploring VIRBs navigation – the stage site will remain available after go-live and will be loaded with shadow submissions from the live site at that time

For most submissions that entered RAMS IRB as new projects before the 7/14/23 compliance date for use of protocol templates: a transition to protocol-based applications will be required.

This will apply to studies with an extended RAMS IRB smartform application and no stand-alone protocol template (HRP-503 / 503a, or a sponsor protocol with HRP-508 - Site Supplement, or another approved protocol template). See comparison of smartform application fields further below.

The HRPP has implemented a flexible transition approach so that study teams may pursue timing most conducive to each respective study.

1. Transition before go-live by opening an Amendment: select the option to “Convert to Protocol Template” and click “OK” to permanently convert to the reduced smartform template. Use Protocol Upload to attach HRP-503 or an approved protocol template. 
   
   
   
   

   This may also be done after system go-live using the Create Modification/CR activity.

2. Alternatively, study teams may wait until the first study modification after go-live to transition to a protocol. Personnel-only modifications do not require transition to a protocol.

3. By the time of required continuing review, all studies must complete transition to a protocol template. Exceptions to this are listed below.

HRS IRB system transition 

First touch options for active studies

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Summary

Which studies do NOT need to transition to protocol based applications?

• Exempt studies
• Expedited studies that do not require continuing review
• Full board / greater than minimal risk studies that are active for data analysis only or are in long term follow-up 

Which studies DO need to transition to a protocol?

• Any study, including studies eligible for expedited review, required to undergo at least annual continuing review, including FDA or DOJ-regulated research
• Full board / greater than minimal risk studies that are open to enrollment or where research interactions (apart from those qualifying as long-term follow-up) and interventions are ongoing 
• Individual studies at the discretion of the IRB (e.g., studies not requiring continuing review but where changes continue to be made over time)  

Please contact the HRPP with questions about whether your study is required to transition to a protocol in the coming months.

Example RAMS IRB extended smartform fields (pre-Toolkit go-live 7/14/23):	Reduced RAMS IRB smartform effective  7/14/23:
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The HRPP is not currently planning to modify requirements around study team listing in VIRBs. The previous approach in RAMS IRB, consistent with prior HRPP guidance, to list COI Investigators including essential personnel remains acceptable.

Please note that Protocol Editors must be listed as study team members in VIRBs and will be designated under a new label: PI Proxy. Editors will be converted in the new system for existing studies.

VIRBs study team listing

Requirements and responsibilities

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Please reference the VCU Conflicts Of Interest in Research policy for additional information about COI Investigators.

Institutional reviews ancillary to IRB review and approval requirements may be referenced in HRP-309 - Ancillary review matrix. For all reviews required prior to or parallel with IRB review, upload the approval letter or confirmation of review under Local Site Documents as Other Attachments; e.g., PROC/PRMC, Informatics, Radiation Safety Committee, Institutional Biosafety Committee.

DMS plan and COI review will continue to take place in their current systems (Data Management System (DMS) and Activity and Interest Reporting System (AIRS), respectively).

• PIs will no longer have to link their DMS submission to their IRB submission.
• PIs will still need to upload any COI management plans to the applicable IRB submission in VIRBs, as indicated.

Department head, or designee, review and approval for new studies will still take place in VIRBs. Department head approval is required for:

• All new submissions: excludes NHSR and exemption determination requests
• Submissions requesting reliance on an external IRB
• Submissions involving Humanitarian Use Device(s)

To initiate a request for department head approval for new submissions:

1. Create new study in VIRBs
2. Select the “Manage Ancillary Reviews” activity
3. Request review by a Person; Review Type = Department; Response IS required; Enter Comments to communicate review request to the person identified; click OK
4. Upon submission to the IRB the department head will be notified; the review must be accepted before IRB review may commence – the IRB may put the study in Clarifications Requested to reflect the pending department head review state

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Training / demo topic	Target audience	Date and time	Link to sign-up / recordings from completed sessions
New system overview	All individuals supporting human subjects research at VCU	6/5/25 10 - 11:30 a.m.	Recording link for new system overview
Initial single-site submissions	All human subjects researchers and study teams	6/17/25 1:30 - 3 p.m.	Recording link for initial single-site submissions
Mods/CRs/RNI submissions	All human subjects researchers and study teams	6/23/25 10:30 a.m. - 12 p.m.	Recording link for mods/CRs/RNI submissions
Multi-site submissions	Researchers and study teams involved in multi-site research	7/14/25 10:30 - 11:30 a.m.	Register for multi-site submissions
Open labs (real-time practice, Q&A sessions)	All individuals supporting active human research at VCU	7/2/25 10 a.m. 7/10/25 1 p.m. 7/14/25 1 p.m. 7/24/25 11 a.m. 7/30/25 2 p.m. 8/5/25 10 a.m. 8/15/25 1 p.m. 8/19/25 10 a.m. 8/28/25 1 p.m.	Join open labs at this link / link will be opened at each date and time specified Registration is NOT required to attend open labs. Open labs will occur in real time. Recordings will NOT take place during open lab sessions.

 

Department head ancillary reviews in VIRBs

7/14/25 RNI training

7/14/25 Multi-site training

IRB community research system overview training

IRB research community initial single site submission training

IRB community research MOD, CR, MODCR, submission training

VIRBs training (single-site): IRB 10.5 single site on Vimeo (Huron)

Researcher's guide (pdf)

VIRBs training (multi-site): IRB 10.5 multi-site on Vimeo (Huron)

Multi-site guide (pdf)

*All training videos can be found on the HRPP Kaltura channel. Dual authentication sign-on is required for access to videos in Kaltura.

Our new system shares the same base platform as the current RAMS IRB system, meaning many features and workflows will be familiar to our research community. Enhancements to the PI Inbox and visualization of the review process, improved workflow reporting and data analytics capabilities and expanded RNI submission options are included in this updated system.

The new system will retain the ability to copy a submission, communicate with IRB staff and members to make changes to study materials or clarify submission content, maintain version history for IRB approved documents, and pull-down approval letters.

Visualize the review process

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Study teams may observe their submission moving through the staff-driven administrative pre-review process, into designated or committee IRB review phase, into post-review where approval letters may be obtained. Submissions requiring PI-responses will be indicated by the clarification requested or modifications requested workflow state.

1. Streamlined SmartForm with protocol-based application (HRP-503/a)
2. Other VCU Requirements has been removed from the VIRBs SmartForm
   1. Reference HRP-309 - Ancillary Review Matrix for required institutional approvals
3. Protocol Editors are now PI Proxies
   1. Must be listed as study personnel
   2. Included in conversion from RAMS to VIRBs for current studies
4. Department head approval facilitated through new IRB system activity
   1. PI will initiate review via the Manage Ancillary Reviews activity
   2. Submission will be able to enter the IRB workflow but review will not commence before sign-off
5. VIRBs now has an IRB Staff Pre-Review Clarifications Requested state
   1. Staff will communicate clarifications or changes needed to proceed with IRB review
   2. VIRBs does not have SmartForm Reviewer Notes
6. New external IRB reliance workflow
   1. Approval to Rely on an External IRB is granted in the administrative Pre-Review state
   2. Study teams will upload the external IRB approval letter and final approved local study documents (e.g., ICF, recruitment material) in the Pending sIRB Review state
7. External IRB reliance workload utilizes Study Updates for follow-on submissions related to CR, mods, updates or reportable new information
8. sIRB reliance workflow is reflected differently in VIRBs
   1. Approval for VCU to serve as the IRB of record (sIRB) is reflected in the main study submission SmartForm
9. Participating Sites (pSites) are added after initial study approval

Q: What if I have a timely submission need that falls during the RAMS IRB downtime (July 18 – August 6)?

A: We strongly encourage researchers and study teams to anticipate any initial or follow-on (modification or study updates, continuing review) study submissions in consideration of system downtime. Requests for rare exceptions may be made directly to the HRPP director. Study closures and reliance requests must be submitted in the system (old or new). 

Q: How will I report emergency use during system downtime?

A: Please call the HRPP to discuss your emergency use further: (804) 828-0868.

Q: How will I make reports to the IRB during system downtime? 

A: Required reports of new information may be made using HRP-214 - FORM - Reportable New Information; submit to hrpp@vcu.edu. Please reference HRP-103 - Investigator Manual to determine reporting requirements.  

Q: What happens if I forget to renew my study and it expires during system downtime?

A: The HRPP will be sending individual study team reminders starting 2 months in advance of system transition. RAMS IRB also issues reminders several months in advance of approval expiration and regularly leading up to expiration. If a study lapse occurs, it will be administratively closed and you will be required to initiate a new study submission in the new system before any research activity may commence.

Q: What happens if I submitted before the deadline (July 11 for full board submissions / July 18 for all other submissions) but the IRB was not able to issue an approval before the transition?

A: Submissions that have not reached a final determination state (e.g., approved, approved exempt) by July 31 will NOT be converted to the new IRB system and will need to be resubmitted in the new system on August 7 or later. Please ensure timely responses to all changes requested by IRB staff and determination letters (modifications required/conditional approval or deferral) so your study transitions correctly. Studies in development or in an incomplete state will not convert to the new system.

Q: What about my study that relies on an external IRB (Advarra, WCG, NCI, etc)?

A: Reliance studies in only the following state will transition to VIRBs: approved by external IRB. Studies in the following states will not transition:

• External IRB review
• External IRB compliance review
• PI action required: external IRB compliance review

*If the parent study is approved by the external IRB, but a sub-application requires a response, the parent study will transfer as approved, without the sub-application.

Q: What is the submission deadline for a new reliance submission- external IRB?

A: Reliance studies requesting to rely on an external IRB must be submitted by July 11, 2025. Once the internal compliance review is completed, you will receive the RAMS IRB cede memo which is needed to submit to the external IRB. You should be very responsive to the external IRB’s queries, as you must upload approved study documents in RAMS IRB by 7/31/25 to ensure the study transitions.

*If external approval is not posted by 7/31/25, the study will not transition and you will need to resubmit in VIRBs after 8/7/25. While VCU staff will work with you and external IRBs to try to avoid this, please understand that VCU staff cannot control delays at other sites.

**In limited instances, the IRB will consider requests to replace the new VIRBs HM# with one previously assigned in RAMS IRB but where the study did not convert due to being in an incomplete state. Please contact irbreliance@vcu.edu to request this override as soon as the new VIRBs submission is created. All requests are due by 8/29/25 to be considered for manual override.

Q: How do I know if my RAMS IRB submission did NOT convert to VIRBs effective 8/7/25?

A: The HM# assigned in RAMS IRB will convert to VIRBs and will be available for reference on the IRB workspace, active tab. You may search by ID (HM#), PI last name, name (of study), etc. If the study is not pulling up in VIRBs, check the status in RAMS IRB (in read only state after 8/1/25). Any project or follow-on submission not in a final state (e.g., approved, exempt, approved by external IRB) would not have converted to VIRBs and will need to be newly submitted.

IRB staff will be working diligently through 7/31/25 to complete review of all timely submissions and responses. Please review posted comments for response deadlines to ensure your submission is able to be processed in advance of system downtime.