Hutch IRB Launches March 29 – Important Information

Dear Colleagues,

As you may be aware, the Fred Hutch Institutional Review Office (IRO) has been working to implement an end-to-end, web-based, electronic institutional review board (IRB) system for the past two years. This system is known as “Hutch IRB” and is essential as we modernize our tools, systems, and processes. We are pleased to announce that Hutch IRB will launch on March 29, 2023. Additional details on the project can be found here, and we will continue to communicate more information through launch.

What is changing?

After March 29, all submissions to the Fred Hutch Cancer Consortium IRB will be submitted and returned via Hutch IRB, which you will access via your web browser. In addition, new documents will support the new system, including updated IRB forms.

How will this affect my existing studies that are approved prior to Hutch IRB?

For existing studies approved prior to Hutch IRB (“legacy” studies), we will migrate data only (not documents) for existing approved studies. The first data migration will occur immediately before the launch of Hutch IRB.

During the first data migration, we cannot migrate the following legacy studies:

Any study that has an “in-flight” submission at the time the data migration occurs. This means any study with a pending Modification (Mod) or Continuing Review will not be migrated in the first round.
New studies that remain in “Approved with Minor Modifications” (AMM) status. For these, you should work to get the study into a fully approved status as soon as possible, and ideally before March 20 so that the study can be migrated before launch. Please contact IRO@fredhutch.org if you anticipate not being able to resolve an AMM study before that date.

There will be a subsequent data migration after March 29 (date to be determined) for studies that miss the first data migration. If you have a study that misses the planned data migrations, then there may be a need to resubmit the submission in the new system.

Please Plan Ahead

We strongly encourage everyone to get their open studies into an approved status with no in-flight items for the launch. This means carefully planning the timing for any new submissions. As we get closer to launch, you may want to hold any new submissions that are not time-sensitive until after the launch. Contact IRO@fredhutch.org with questions about specific scenarios.

If you have a study you plan to close, please consider submitting your final Continuing Review as soon as possible, and by March 20 at the latest, to close it before it migrates into the new system. (For Exempt studies, email IRO@fredhutch.org with your closure date.)

What will I have to do after my study is migrated into Hutch IRB?

For migrated legacy studies, at the time of your first follow-on submission (Modification or Continuing Review) in Hutch IRB, you will be asked to:

1) verify the migrated data are accurate with your records

2) upload currently approved documents into Hutch IRB to complete the record (similar to today’s Continuing Review process)

As for study team member data, our current database only has the PI and the Primary Contact (“IRO Contact”). Therefore, you will also need to consider the following steps for legacy studies:

Study team members: Add any study team members who need to be able to view, edit, or be added as a PI Proxy for the study in Hutch IRB.
PI Proxies: If the Principal Investigator (PI) wishes for other individuals to submit follow-on submissions (Mods, CRs) on a legacy study, the PI must first delegate them as PI Proxies in the system. If the PI chooses not to delegate a PI Proxy, then the PI must regularly log-in to the system to formally submit items and respond to the IRB. Once the PI designates a proxy for a particular study in Hutch IRB, then the PI Proxy can execute all necessary actions in Hutch IRB on behalf of the PI for that study.

When will I get the opportunity to train on the new system?

The training rollout starts in late February. First, you will be required to complete a brief System Access training course to obtain a log-in for Hutch IRB. You will then have access to a training environment where you can tour the site and practice. We will also offer video modules, online training, and 1:1 coaching. Dates for live training sessions will be announced soon.

What else do I need to know?

There will be a blackout period, during which IRO cannot accept any new submissions of any kind. The blackout period is anticipated to run March 23 to March 28. You can also expect IRO will have delayed responses to inquiries during this time as we work to cut over to the new system.

Date	Event	Notes
Late February	New IRB forms released	Use new forms to start preparing for submissions in Hutch IRB.
Late February	Hutch IRB system training available	Complete the “System Access” training first. Video modules, live training sessions, and 1:1 coaching are all options.
Week of March 20	First data migration	Legacy studies that are in an Approved status, with no in-flight submissions as of March 23, will migrate to Hutch IRB via the main data migration wave
March 23 – 28	Blackout period	No new IRB submissions accepted. Also expect delayed responses from IRO.
March 29	Launch of Hutch IRB	You can begin submitting new studies and follow-on submissions to migrated legacy studies in the new system.
4 to 6 weeks after launch, to be determined	Second data migration	A second data migration will occur about 4 to 6 weeks after launch, to sweep up the remaining studies that were in AMM status or had in-flight submissions at the time of the first data migration.

Where can I get more information and stay informed on Hutch IRB?

Please watch for further emails from IRO with additional details soon. Please use the following resources too:

Visit the project webpage here. We will continue to update this page with relevant information prior to the launch of Hutch IRB. After launch, the project page will transition to the Hutch IRB resource webpage.
Email the IRO with your specific question at IRO@fredhutch.org
Join the Hutch IRB ListServ (if this email was forwarded to you) by sending an email to hutchirb-join@lists.fhcrc.org with “subscribe” in the subject line.