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Dear Colleagues,

This is the latest communication preparing you for the upcoming Hutch IRB electronic system launch on March 29, 2023. This is the new end-to-end, web-based IRB submission system for the Fred Hutch/Cancer Consortium IRB. See prior communications on the project page.

We are now pleased to announce the following training requirements and opportunities.
 

1. REQUIRED SYSTEM ACCESS TRAINING

To gain access to Hutch IRB upon launch, you must first complete a brief System Access Training module in Hutch Learning. It should take about 5 to 10 minutes to complete.

  • Everyone who is a PI or an IRO Contact for a current study in our current database (regardless of your affiliation):  Within the next day or so, you will receive an email directly from Hutch Learning with instructions on how to access that System Access Training. Even if you are UW affiliated and/or have never used Hutch Learning, you should watch for that email from Hutch Learning.
  • For other study team members who will need access, but who are not a current PI or IRO Contact:  Those with an account in Hutch Learning can self-assign the training and complete it. Once you have completed the training, IRO will process your system access. For this group, contact IRO@fredhutch.org if you do not have a Hutch Learning account. Here are the links to self-assign the training:  Fred Hutch   Legacy SCCA   Other Affiliations
  • For anyone in the Cancer Consortium who requires access but does not have Fred Hutch or legacy SCCA credentials: We will also need you to fill out this REDCap form so that we can process your access.

Once you have completed the training, and submitted the REDCap form if applicable, IRO will process your access to the system.

The System Access Training is the only training required to obtain access to Hutch IRB. However, we strongly recommend you also take part in the other training opportunities listed below.
 

2. ONLINE, SELF-SERVE TRAINING MODULES

Online training modules will be available on our Hutch IRB training webpage:

  • An online training module about Creating and Submitting a New Study Through to Approval in Hutch IRB. This training is optional, but strongly recommended.  Links:  Fred Hutch   Legacy SCCA   Other Affiliations
  • Additional training modules specific to Hutch IRB will be posted to the webpage as the modules become available, both before and after the launch.
  • Standard video modules from Huron, the software vendor, will also be available soon on the training webpage. They do not include Fred Hutch’s customizations, so there are some slight variations from our system.
     

3. OPTIONAL LIVE TRAINING SESSIONS

We invite you to attend one of the following live sessions via Microsoft Teams. The sessions will be focused primarily on existing studies that are migrating into Hutch IRB and will include a demonstration of how to complete the record with your first submission in the new system.

  • Friday, March 3 at 1:00 PM
  • Tuesday, March 7 at 10:00 AM
  • Thursday, March 9 at 11:00 AM

Go here to select one of the training sessions and register: 
Fred Hutch   Legacy SCCA   Other Affiliation

These sessions are optional but highly recommended. Each session will cover the same content, so you only need to attend once. A recording will also be posted to the project page.
 

4. OPTIONAL TRAINING ENVIRONMENT

We are excited to offer a training environment as a sand box. Try out Hutch IRB before submitting a live application! A few notes about the training environment:

  • All data entered in the training environment is visible to everyone. Do not enter any personal or confidential information or attachments.
  • The training environment will occasionally be scrubbed of all submissions, so projects you create there will not remain indefinitely.
  • The “help text” in the training environment does not match what will be present in the system upon launch. (This refers to instructional text available at the blue “?” icons.)


5. OPTIONAL ONE-ON-ONE COACHING AND OFFICE HOURS

After the launch, office hours and 1:1 coaching will both be available to help you with the system. We will send more information about this before the launch.

Contact IRO@fredhutch.org with questions about training.

 

What else do I need to know?

As a reminder, below are the important dates to keep track of for the Hutch IRB project:

 

Date

Event

Notes

February 27

New IRB forms released

Use new forms to start preparing for submissions in Hutch IRB.

Week of March 20

First data migration

Legacy studies that are in an Approved status, with no in-flight submissions as of March 23, can expect to be migrated to Hutch IRB via the main data migration wave

March 23 – 28

Blackout period

No IRB submissions accepted. Also expect delayed responses from IRO.

March 29

Launch of Hutch IRB

You can begin submitting new studies as well as follow-on submissions to migrated legacy studies.

4 to 6 weeks after launch, to be determined

Second data migration

A second data migration will sweep up remaining studies that were in “Approved with Minor Mods” status or that had in-flight submissions at the time of the first data migration.

 

To plan ahead for migrated studies, please also know that you will need to complete the record by attaching all currently IRB-approved documents, via a Modification in Hutch IRB. Written instructions will be provided, but we encourage you to start gathering all your clean Word documents of IRB approved materials, because you will need to upload these into the system at the time of your first submission (Modification or Continuing Review). We will also ask you to upload currently approved IRB Supplement forms, such as the Multi-Center Supplement and Repository Supplement.

In the new system, you will only submit Word documents (unless you have an industry-sponsored protocol document only in PDF format).

 

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

Please watch for further emails from IRO with additional details soon. Note 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 IRO with your specific questions, including about training, at IRO@fredhutch.org
  • If this email was forwarded to you, join the Hutch IRB ListServ by sending an email to hutchirb-join@lists.fhcrc.org with “subscribe” in the subject line.

Thank you, and we look forward to working with you through this transition to Hutch IRB.

Institutional Review Office (IRO)