Reminder: IRB Submission Freeze Starts June 13

 June 13-24

• IRB continues reviewing and approving items previously submitted in iRIS. Study teams should respond to stipulations as soon as possible, at least several days before June 24.

 June 13-30

• IRB submission freeze. No new submissions accepted in iRIS or Research Gateway IRB.

June 25-30

• No submission can be submitted or reviewed in Research Gateway IRB or iRIS.

July 1

• Research Gateway IRB launches for all IRB submissions. iRIS becomes read-only and will remain available for one year.

Ongoing

• Training sessions, templates, guides, and support resources are available.

❄️ What is the Submission Freeze?

As part of the transition from iRIS to the new Research Gateway IRB system, a temporary submission freeze will be in effect beginning 12:00 a.m. on June 13 through 11:59 p.m. on June 30. This freeze is necessary to support final data migration and system transition activities. 

During the submission freeze, no new submissions of any type will be accepted, including:

• New studies
• Modifications
• Continuing reviews
• Personnel changes
• Study closures
• Adverse events, protocol violations/incidents, or other reportable safety-related information (Note: See below for contingency plan) 

🚨 Important: iRIS may still appear to allow new submissions during this period. However, submissions made after June 12 will not be received or processed by the IRB.

🔍 I Have a Submission Under Review. What Should I Do?

The IRB will continue reviewing and processing submissions that were received before the submission freeze until 5:00 p.m. on June 24.

If your submission was submitted before June 13:

• Respond to stipulations thoroughly and quickly. Incomplete responses may not be reviewed. 
• 🚨 Important: Do not retract your submission. Retracting a submission permanently removes it from the IRB review queue and you will need to wait until July 1 to resubmit in Research Gateway IRB.

✍️ Responding to Stipulations

• If you receive stipulations for a submission currently under review in iRIS, you must submit your responses as soon as possible.
• To maximize the likelihood that your responses can be reviewed before iRIS closes, submit your responses several business days before June 24.
• The IRB will continue reviewing and processing submissions until 5:00 p.m. on June 24. Responses submitted close to this cutoff may not allow sufficient time for IRB review and approval before iRIS closes

🚨 Important: If your submission cannot be fully reviewed and approved before iRIS closes, it will need to be submitted in Research Gateway IRB after the system launches on July 1. Responding before June 24 does not guarantee review and approval before iRIS closes.

⚠️ How Do I Report an Adverse Event or Protocol Violation During the Freeze?

• During the submission freeze, only report events that affect the study’s ability to continue safely. In such cases, submit the information using the Ask Andy form.
• If the event does not affect the ability of the study to continue, wait and submit the report in Research Gateway IRB after July 1.

🎯 Just in Time Submissions

If you receive a Notice of Award for Just in Time (JIT) funding and the NIH requests IRB approval within a date range that falls within the Submission Freeze, please request an extension from the NIH. You can provide this memo to NIH when you request the extension: NIH Just-in-Time (JIT) Funding Notices During the IRB System Freeze memo.

🚀 What Happens on July 1?

Research Gateway IRB will be accessible via MyAccess. Beginning July 1, all IRB submission activities will take place in Research Gateway IRB, including:

• New studies
• Modifications
• Continuing reviews
• Personnel changes
• Reportable events
• Study closures