Research Gateway IRB Transition

Key Information
Information Sessions
Timeline
How to Prepare
- Current iRIS studies
- Pending Submissions
- Upcoming Submissions (including Continuing Reviews)
Training and Learning the New System
What to Expect at Go-Live
- Next Steps for Study Teams
- Key System Changes
OnCore Integration
Frequently Asked Questions
Contact
Previous Communications

UCSF is replacing the iRIS IRB submission system with a new system called Research Gateway IRB. This page explains why the change is happening, key transition dates, how to prepare, and what to expect during the transition.

This page will be continually updated with additional guidance—especially the FAQs—so please revisit often!

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Key Information

Change	Impact/Details
What is changing?	The iRIS IRB submission system will be replaced by Research Gateway IRB. Records of approved IRB studies—including key study information and the latest approved study documents – will appear in Research Gateway IRB.
Who is affected:	Principal Investigators (PIs) Study coordinators and research staff Anyone submitting materials to the UCSF IRB or accessing research records in iRIS
Key transition dates:	Submission Freeze: June 13-30, 2026 Go-Live Date: July 1, 2026 Important: No IRB submissions can be made during the submission freeze period while study data is migrated to the new system.

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Information Sessions

Sessions	Date/Time	Invite/Materials
Past
Research Gateway Town Hall: IRB System Replacement	March 25, 11:00–12:00	Slides Recording Town Hall FAQs If you work at an UCSF Affiliated Institution, you can request access to these materials by emailing Kate Nolan.
Clinical Trials Operations (CTO) Research Forum	April 9, 11:00–12:00

Sessions

Date/Time

Invite/Materials

Past

Research Gateway Town Hall: IRB System Replacement

March 25, 11:00–12:00

If you work at an UCSF Affiliated Institution, you can request access to these materials by emailing Kate Nolan.

Clinical Trials Operations (CTO) Research Forum

April 9, 11:00–12:00

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Timeline

Milestone	Description	Date
Submission Freeze	No IRB submissions accepted during migration preparation	June 13 - June 30, 2026
Research Gateway IRB Go-Live	New system opens for submissions	July 1, 2026
iRIS Sunset	Read-only access expected to end - archived data from iRIS will be accessible in another system.	Mid-2027 (tentative)

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Submission Freeze, June 13-30th, 2026

No submissions will be accepted in iRIS or Research Gateway IRB starting at 12:00AM on June 13, 2026. This includes:

New studies
Modifications & Personnel Changes
Continuing Reviews
Reportable New Information (Adverse Events, Protocol Violations, Incidents, and other reportable information)
Adding Relying Sites

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How to Prepare:

1. Manage Approved iRIS Studies

To help with a smooth migration of your study data from iRIS to Research Gateway IRB, please review your studies in iRIS and:

❌ Remove research personnel who are no longer part of the study according to IRB guidance on personnel changes. Some approved iRIS studies may fail to migrate to Research Gateway IRB if they include Key Study Personnel (KSP) who are no longer affiliated with UCSF. See the IRB quick guide for step-by-step instructions on updating study personnel.
🔒 Close studies that are complete and eligible for closure.
- 📨 Submit a Study Closeout Report to the IRB
- 🔒 Close the study in OnCore and APeX, if applicable
- 🔔 Notify sponsors or collaborators, if applicable

3. Consider Timing for Upcoming Submissions

If your submission does not require approval before July 1, consider waiting and submitting it in Research Gateway IRB. Submissions not approved in iRIS by June 24, 2026, will need to be re-submitted to the IRB via Research Gateway on or after July 1, 2026. To avoid duplicative work, plan your IRB submissions carefully between March and July.

Submission Type	Guidance/Next Steps
Any submission that does not fit into one of the below categories	If possible, wait until after July 1, 2026. If your submission does not require approval before the transition, consider delaying it until the new system launches. This includes: New Studies Modifications & Personnel Changes Exception: See “How to Prepare: Manage Approved iRIS Studies” for personnel changes that should be submitted prior to the transition. Continuing Reviews Tip: Submissions made after July 1, 2026, may help avoid the need to recreate submissions in the new system. If approval is needed before the transition: If your study requires approval before the system change, submit as early as possible. Please note: 📩 Respond promptly to IRB stipulations during the review process. ⏳ Expect longer processing times during the transition period. ⚠️ Approval is not guaranteed for submissions made close to the submission freeze.
New Full Committee Studies	Full committee studies must be scheduled for review at a convened IRB meeting. Because there are a limited number of meetings before the system transition, study teams should plan submissions accordingly. If you are preparing a new study that requires full committee review, follow the guidance below to give your study the best chance of approval before the transition: 📨 Submit new full committee studies by April 1, 2026. We strongly suggest submitting new full committee studies by April 1, 2026. We will still accept new studies after this date, but the likelihood of review and approval before the system transition decreases as we approach the submission freeze dates. ✔️ Ensure submissions meet IRB submission standards at the time of submission. Submissions that do not meet submission standards will be retracted by the IRB and returned to the PI in draft form. Retracted submissions will not retain the original submission date; once resubmitted they will return to the end of the review queue. Study teams must be prepared to respond promptly and completely to IRB stipulations during the review process. Note: ⚠️ Approval by a specific date cannot be guaranteed.
Continuing Review	Use this chart to determine when and how to submit your Continuing Review: IRB Continuing Review Schedule April-September 2026.
Reportable New Information: Adverse events, protocol violations & incidents, and reportable safety information	🛑 Do not submit reportable new information during the submission freeze unless it may affect whether the study can continue. In such cases, notify us via the Ask Andy form. If the event does not impact study continuation, wait to submit it in Research Gateway IRB.
Reliance	If you plan to add external sites: 🤝 Request a Reliance team consultation early, as the process will change with the new system. If you wish to rely on an external academic medical center IRB, or any IRB other than WCG, Advarra, Jaeb, NCI CIRB, or Fresno Community Health System (formerly Community Medical Centers in Fresno): 🔗 Please refer to the process for relying on external academic medical center IRBs 🕒 Allow sufficient time for the UCSF HRPP screening and external IRB approval. ⏳ Estimated Timeline: In our experience, it may take approximately 2 months for the external IRB to approve UCSF as a study site. Studies relying on WCG, Advarra, Jaeb, NCI CIRB, or Fresno Community Health System (formerly Community Medical Centers in Fresno) will follow the standard submission freeze timeframe.
Just-In-Time (JIT) Submissions	If you anticipate a JIT submission near the transition: June 2026 submissions: ⚖️ IRB will assess feasibility of timely approval. ⏳ If not feasible, PI will be advised to resubmit in new system and request ≥4-week sponsor extension. Note: Extension requests are common and have not historically jeopardized funding. Conditional approvals: During the freeze, IRB may approve submissions with outstanding documents to expedite JIT clearance. During the submission freeze (June 13-30, 2026): 🚫 Do not submit in iRIS. 📤 Submit in Research Gateway IRB starting July 1, 2026. ⏳ Expect ≥2-week turnaround for minimal risk (longer if stipulations). Full committee timelines differ. OSR planning: Anticipate extension requests and variable approval timing during transition. Submit an Ask Andy if there is an urgent situation or timeline question.

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Training and Learning the New System

Training will begin in June 2026.

Available training resources will include:
- Live instructor-led training sessions
- Job aids and step-by-step guides
- Video demonstrations
- Recorded sessions
- Drop-in office hours after go-live

Training schedules and materials will be posted on this page.

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What to Expect at Go-Live

What should you do after July 1, 2026?

Your next steps depend on your study's status in iRIS. Choose your situation:

If this applies to you	Go to section
My study is already approved in IRIS	Approved studies
My submission was under review in iRIS but not approved before July 1, 2026	Resubmitting after the transition
I am submitting a new study, modification, personnel change, continuing review, or reportable new information after July 1, 2026.	New submissions after go-live

Study Status	Guidance
Approved Studies	If your study was approved in iRIS before the transition: A shell record will appear in Research Gateway IRB with key study information and the latest approved documents. iRIS study numbers will be preserved. iRIS will remain available in read-only mode Prior submission history and documentation will be accessible through an archived library linked to each study record. 👉 What you need to do: Review your study in Research Gateway IRB to confirm everything is accurately migrated.
Resubmitting After the Transition	If your study was under review in iRIS but not approved before July 1, 2026: Your submission will not continue in iRIS. You will need submit your study again in Research Gateway IRB Tools will be available to help transfer your information 👉 What you need to do: Resubmit your study in the new system.
New Submissions After Go-Live	🚀 Beginning July 1, 2026 All IRB submissions will be processed in Research Gateway IRB, including: New studies, Modifications, Personnel changes, Continuing reviews, and Reportable New Information (adverse events, protocol violations, incidents, and other safety reports) ⚠️ Required for New Studies, Modifications, and Personnel Changes Study teams must: 📎 Attach a UCSF Investigator Protocol (Word Document) to the study record in Research Gateway IRB. 📅 Investigator Protocol templates will be released in June, so you can start preparing your submission before go-live.

Study Status

Guidance

Approved Studies

If your study was approved in iRIS before the transition:

A shell record will appear in Research Gateway IRB with key study information and the latest approved documents.
iRIS study numbers will be preserved.
iRIS will remain available in read-only mode
Prior submission history and documentation will be accessible through an archived library linked to each study record.

👉 What you need to do: Review your study in Research Gateway IRB to confirm everything is accurately migrated.

Resubmitting After the Transition

If your study was under review in iRIS but not approved before July 1, 2026:

Your submission will not continue in iRIS.
You will need submit your study again in Research Gateway IRB
Tools will be available to help transfer your information

👉 What you need to do: Resubmit your study in the new system.

New Submissions After Go-Live

🚀 Beginning July 1, 2026

All IRB submissions will be processed in Research Gateway IRB, including:

New studies, Modifications, Personnel changes, Continuing reviews, and Reportable New Information (adverse events, protocol violations, incidents, and other safety reports)

⚠️ Required for New Studies, Modifications, and Personnel Changes

Study teams must:

📎 Attach a UCSF Investigator Protocol (Word Document) to the study record in Research Gateway IRB.
📅 Investigator Protocol templates will be released in June, so you can start preparing your submission before go-live.

📣 Three Big Changes to Expect in Research Gateway IRB

Change

Detailed Guidance

Study SmartForm + Investigator Protocol

The current IRB Application in iRIS is a highly programmed SmartForm that uses show/hide logic. In the new Research Gateway IRB system, we are moving to a more document-driven approach. You will still complete an IRB Study SmartForm, but it will be significantly shorter.

Most study information will instead be captured in a Word document called the Investigator Protocol, which you will complete using a template and upload in the SmartForm. This approach makes it easier for study teams to collaborate and allows you to view all IRB questions at once, rather than navigating through them step by step.

Detailed mapping documents will be available to show how current iRIS questions align with the new Investigator Protocol template. Templates will be shared in June. Note: While some questions have been reworded or combined, most will feel familiar. And you’ll be pleased to hear that several questions have been removed entirely.

Approved studies being migrated will receive a partially pre-populated Investigator Protocol based on information from their most recent iRIS application.

Separate Submission to GESCR via the Safety Module

Another change involves the Human Gamete, Embryo, and Stem Cell Research (GESCR) submission process. In iRIS, the GESCR application is embedded within the IRB application. However, not all GESCR studies require IRB review, which means some study teams currently answer IRB questions that do not apply to their research.

In the Research Gateway IRB system, GESCR and IRB submissions will be separated. GESCR studies will be submitted through the Safety Module and can be linked to a corresponding IRB submission when review by both groups is required.

System Roles and Notification Recipients

Some system roles and notification recipients are changing in the Research Gateway IRB system.

The PI Proxy Role

The PI Proxy is a new system role that allows a designated individual to submit an IRB submission on behalf of the PI. Key details regarding this role include:

Only the PI of a study can assign a PI Proxy.
Multiple PI Proxies can be assigned to a single study.
The PI Proxy must be a member of the study team and listed in the IRB Study SmartForm.
The PI assigns a PI Proxy from the study's main workspace. A modification is only required if the individual also needs to be added to the study team.
The PI Proxy role applies only within the system and does not grant authority to act for the PI in other contexts.

Here’s a table summarizing these changes:

What's Changing	Current: iRIS	New: Research Gateway IRB
PI Proxy role	N/A	System role that allows a designated study team member to submit on the PI’s behalf. Only the PI can assign a PI Proxy. Multiple PI Proxies are allowed.
Contacts	Multiple Study Contacts allowed	Only one Primary Contact per study
Who can submit	Study team members can submit some types of IRB submissions, while the PI must submit others	Only the PI or PI Proxy can submit to the IRB – the only exception is post-approval event reports, which are called Reportable New Information (RNI) reports in the Research Gateway IRB
Notification recipients	PI + Study Contacts	PI, PI Proxies, and Primary Contact

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OnCore Integration

For detailed OnCore workflow and system changes, see the Office of Clinical Trial Administration (OCTA) guidance at OnCore Changes with Research Gateway IRB - 2026.

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Frequently Asked Questions

This FAQ provides guidance on what to expect, including system integrations, workflow changes, and the management of existing studies. This is a living document that will be updated as new information becomes available. For specific questions raised during the March 25th Town Hall, please refer to our separate supplemental Q&A document.

System Transition

1. Why is iRIS being replaced?

Reliability and sustainability: The iRIS system experiences frequent timeouts that delay submissions and frustrate users. The system can no longer be upgraded, and UCSF needs a reliable IRB submission platform for the long term.
Part of a broader research systems initiative: The new system is part of a larger initiative to consolidate research compliance tools into a single shared platform. Research Gateway currently supports Conflict of Interest and will support IRB, Grants & Agreements, and Export Control over time.

Submissions & Workflow

System Integration

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Contact

If you have questions about this transition, please contact:

Research Gateway Project Team at [email protected].

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Previous Communications

Earlier communications about this transition include:

Office	Communication
Academic Research Services (ARS)	November 2024 announcement letter from UCSF Research leadership September 2025 Research Gateway Project update email and video
Office of Research (OoR)	November–December 2024 Research Resource article
Clinical Trials Operations (CTO)	July 2025 CTO Research Forum presentation (Recording, external site (opens in a new window)Slides) November 2025 CTO Research Forum presentation (Recording, external site (opens in a new window)Slides)

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Research Gateway IRB Transition