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Overview

The Hutch IRB project is the implementation of the Huron Research Suite institutional review board (IRB) module. This system will be known as "Hutch IRB" and will be an end-to-end, web-based, electronic IRB system that will replace Fred Hutch's current paper-based IRB process. We are pleased to announce that Hutch IRB launches March 29, 2023.

Background

The overall Fred Hutch IRB process is managed by the Institutional Review Office (IRO), which supports the four Fred Hutch IRB committees. The IRB committees are responsible for the initial and on-going review of research involving human subjects. Per federal regulations, the IRB has the authority to approve, require modifications (to secure approval), or disapprove research. The IRB serves as a key component of the Fred Hutch Human Research Protection Plan (HRPP) and fills an essential role in protecting the rights and welfare of human research subjects.

 

Important Communications and Dates

As we approach the go-live date, please keep the following information in mind:

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.

Preparing for March 29

What is changing?

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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?

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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?

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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?

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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?

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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.


Hutch IRB - At A Glance

WHAT:  The implementation of the Huron IRB module to manage the Fred Hutch IRB process.
WHY:  We need to modernize our tools, systems, and processes to improve transparency, keep our data secure, leverage technology improvements, simplify maintenance and support, and make collaboration easier. The current paper-based IRB process is inefficient, and this move to electronic record-keeping should improve the IRB function. 
WHEN:  Hutch IRB launches March 29, 2023.
QUESTIONS:  Please email questions to IRO@fredhutch.org.


Benefits

Hutch IRB will improve efficiency of the IRB process, provide greater transparency for researchers on the status of submissions in the review process, and facilitate regulatory compliance.

As part of this project, the IRO and IRB will adopt the Huron HRPP Toolkit, which includes standardized documents to support Human Research Protection Programs, including standard operating procedures, checklists, worksheets, and templates. This library of documents is in use by other research institutions across the U.S., and by adopting it we will be assisted to stay current with regulatory compliance for research involving human subjects.   


Project Roadmap

Gradient rule Hutch colors

Step 1: Onboarding –

Complete

Outcomes:

  • High-level requirements
  • Gap analysis
  • Development estimates
  • Implementation plan
  • Support model
  • Rollout strategy

Step 2: Design Hutch IRB - 

Complete

Outcomes:

  • Design & Configure Huron IRB for Fred Hutch
  • HRPP Toolkit customization
  • Build in-scope system integrations

Step 3: Develop & Implement - 
In Process

Outcomes:

  • Build the solution
  • Test the solution and business processes
  • Data migration from PIRO
  • HRPP Toolkit Customization
  • Prepare Fred Hutch for the implementation

Step 4: Establish Release Cadence
 

Outcomes:

  • Prioritize enhancements across Hutch IACUC and Hutch IRB
  • Build a continous improvement culture to address process and system enhancements for the IRO

Key Milestones Completed

The project completed the following recent key milestones:

  • January 2023
    • User Acceptance Testing (UAT) conducted the week of January 23. The Change Champions along with IRO staff members simulated the processing of IRB studies to ensure the system and process would work as expected.
    • The data migration and validation activities continued for the project. The project team is working to ensure the legacy approved studies can migrate successfully to Hutch IRB. We will lock the scope of our data migration for go-live in early February.      
    • The project team continued work on the HRPP Toolkit with plans to rollout with the system implementation.
    • Completed the Hutch IRB Steering Committee meeting and scheduled the next meeting for mid-March 2023.
    • Continued planning and coordination of upcoming go-live activities.  
  • December 2022
    • The data migration and validation activities continued. The project team is working through mock migrations with the intention of validating that a full data migration can occur just prior to go-live. 
    • The project team continued work on the HRPP Toolkit with plans to rollout with the system implementation.
    • UAT planning and preparation continued for the project.
    • Continued planning and coordination of upcoming go-live activities.
    • Conversations continued with partners to align on the business process for Single Sign-On across partner institutions.
    • Received confirmation from ISO that our handling of environments and FH security requirements are in alignment.
    • Incorporated Champion feedback on “Creating and Submitting a New Study” online training and continued work across training deliverables.
  • November 2022
    • Shared v1 of “Creating and Submitting a New Study” online training with our Champions. 
    • The data migration activities continued in preparation for our first mock data migration in mid-December. There will be three mock migrations. 
    • Conversations continued with partners to align on the business process for Single Sign-On across partner institutions. 
    • The project team continued work on the HRPP Toolkit with plans to rollout with the system implementation. 
    • Continued planning and coordination of go-live activities. 
    • Completed quarterly steering committee meeting.
    • Completed the three integration specifications and requirements.
    • Shared communication with IRO stakeholders about upcoming deadline changes for Continuing Reviews, as part of preparation for go-live.

Frequently Asked Questions

 

How was Hutch IRB selected?

Fred Hutch evaluated multiple research administration software options in 2011 and 2012. A Research Management System Planning Team conducted a selection process. The group consisted of current and past departments: IRO, CIT, CRDS, Industry Relations (BD&S), Finance, OSR, and Regulatory Affairs (CRS), with input from PIs, research coordinators, and division administrators. At the time, Huron Research Suite was identified as the strongest candidate, but the project was not funded at the time.

In 2015, OSR conducted an evaluation of software for pre-award support. They selected Huron’s Grants system as their solution.

In 2016, Fred Hutch leadership funded the investment in the Huron Research Suite software for Grants, IACUC, and IRB. These solutions are branded Hutch Grants (which launched Nov. 2017), Hutch IACUC (which launched July 2019), and Hutch IRB (to launch March 2023). The Huron Research Suite is a comprehensive suite of software solutions designed to facilitate research administration service delivery and compliance. With the launch of Hutch IRB, Fred Hutch will join our consortium partners at University of Washington and Seattle Children’s in using Huron’s IRB product.

 

What is the status of the Hutch IRB project?

We are currently in the later stages of the Develop & Implement phase. The technical development work is complete. The project is planning out a successful implementation.

As of January 2023, the project is working through the data migration and validation activities to ensure the data for approved studies migrate successfully to Hutch IRB at launch. The project also completed User Acceptance Testing (UAT).  During UAT, a number of Change Champions and IRO staff tested the system workflows and future IRB process, with the goal of ensuring the system and process work as expected.

 

How will you involve the research community in this project?

We know the importance of involving the research community in this project. We have a steering committee with division leadership. Our steering committee helped us select “Champions” from within our research community to provide input and guidance during the project. The Champions will be our Change Agents and help ensure a successful implementation.

 

Where can I get more information?

Please email questions to IRO@fredhutch.org.


Subscribe to Project Updates

To receive updates about the Hutch IRB project, subscribe here. (Fred Hutch VPN or on-campus network connection is required to access the link.) Alternatively, send an email to hutchirb-join@lists.fhcrc.org to subscribe. You will be sent an email requesting confirmation, to help prevent others from subscribing you without your permission. This is a private list, which means that the list of members is not visible to members or non-members.

You can also unsubscribe from the Hutch IRB listserv, get a password reminder, or change your subscription options at any time here. Alternatively, email hutchirb-leave@lists.fhcrc.org to unsubscribe. You will be sent an email requesting confirmation, to help prevent other from unsubscribing you without your permission.