VCU new IRB system implementation 2025 timeline

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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.

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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Training / demo topic	Target audience	Date and time	Link to sign-up
New system overview	All individuals supporting human subjects research at VCU	6/5/25 10 - 11:30 a.m.	Register for new system overview
Initial single-site submissions	All human subjects researchers and study teams	6/17/25 1:30 - 3 p.m.	Register 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.	Register 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 lab (real-time practice, Q&A sessions coming soon)	All individuals supporting active human research at VCU	Coming soon	Coming soon

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

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

*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.

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 August 1 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.