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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.
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.
As we approach the go-live date, please keep the following information in mind:
|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.|
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.
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:
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.)
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:
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:
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.
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.
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.
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.
The project completed the following recent key milestones:
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.
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.
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.
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