Research Gateway IRB Transition

• 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.

• Principal Investigators (PIs)
• Study coordinators and research staff
• Anyone submitting materials to the UCSF IRB or accessing research records in iRIS

• Submission Freeze: June 13-30, 2026
• Go-Live Date: Wed, July 1, 2026
• Important: No IRB submissions can be made during the submission freeze period while study data is migrated to the new system.

❌ 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 instructionsexternal site (opens in a new window) on updating study personnel.

• 🔒 Close Eligible Studies: Submit a Study Closeout Report to the IRB
• 🔒 Close the study in OnCore and APeXexternal site (opens in a new window), if applicable
• 🔔 Notifications: Inform sponsors and collaborators of closures.

To increase the likelihood of IRB approval before the system transition, please: 

• 📩 Respond promptly to IRB stipulations.
• 🚫 Do not make unrequested changes when responding to stipulations.

Note: Submissions not approved before the transition must be resubmitted in Research Gateway IRB. 

If possible, wait until after Wed, 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.

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):

• We strongly discourage submitting any new iRIS studies that rely on an external IRB other than WCG, Advarra, Jaeb, NCI CIRB, or Fresno Community Health System (formerly Community Medical Centers in Fresno). Due to the upcoming system transition and data migration, it is unlikely that these submissions can be fully processed before the transition occurs.
• Please wait to submit in Research Gateway IRB on July 1.

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.  

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.

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

Beginning Wed, 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.

👉 Use Research Gateway IRB for all submissions.

👉 Prepare UCSF Investigator protocol using upcoming templates before go-live.

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.

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.

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

Here’s a table summarizing these changes: 

Most currently approved studies will have a “shell record” created in Research Gateway IRB. This means information from your iRIS study record will be migrated to pre-populate most – but not all – of the new Study SmartForm in Research Gateway IRB.

When you submit your first modification in Research Gateway IRB, you will need to review and validate this information, complete any missing fields, and upload a completed UCSF Investigator Protocol. Please see Key System Changes. 

Studies with the following statuses at the time of the submission freeze will be migrated:

• Active - Closed to Accrual;
• Active - Data Analysis Only
• Active - Data Analysis Only - NoExpire
• Active - Expedited
• Active - Expedited - No Continuing Review
• Active - Full Board
• Active - Hold on Accrual
• Active - No Subject Contact
• Active - No Subject Contact - NoExpire
• Active- Expedited C2A - NoExpire
• Active- FollowUp C2A- NoExpire
• CIRB Reviewed
• Expedited GESCR/Expedited IRB
• Expedited GESCR/Full IRB
• Expedited GESCR/Other Non-UCSF IRB
• Full GESCR/Full IRB
• HUD Study
• Other Non-UCSF IRB Reviewed
• Private IRB Reviewed
• sIRB Active Expedited
• sIRB Active Expedited NoExpire
• sIRB Active Full Board
• sIRB Active No Subject Contact
• sIRB Active No Subject Contact NoExpire
• Suspended
• UC BRAID Relying on Other UC
• UC MOU Relying
   

Only reports with any of the following outcomes will be migrated: 

• Serious Noncompliance, Continuing Noncompliance, and/or Unanticipated Problem
• Suspended

Note: In Research Gateway IRB, these are called Reportable New Information (RNI).

In Research Gateway, GESCR submissions will be separate from IRB submissions and will be managed within the Safety Module. Depending on whether your study involves human research, it will be migrated to both the IRB and Safety modules, or to Safety only.

A “shell record” will be created for each GESCR study in the Safety Module. Because only limited GESCR information can be migrated, you will need to review and validate the migrated data and complete any missing fields when prompted.
 

Your non-closed, exempt study is still considered “active” even though it has not been migrated to the Research Gateway IRB. You can continue to conduct the research. If you need to make changes to the study, first consider whether the changes are minor or significant.

• Minor Changes: You can make minor changes to the study without notifying the IRB. This only applies to exempt studies.

• Significant Changes: You will need to submit the research as a new study in Research Gateway IRB. The IRB will review the study and determine whether it still qualifies for exemption.

X (shell record)

X (some)

X (some)

X

X

X

X

X

X (shell record)

X

X

X

X

X

• Slides
• Recording
• Town Hall FAQs

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

• Slides
• Recording

• November 2024 announcement letter from UCSF Research leadership
• September 2025 Research Gateway Project update email and video

• November–December 2024 Research Resource article 

• 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)