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The Hutch IRB project is the implementation of the Huron Research Suite IRB module. The goal of this project is to implement an end-to-end, web-based, electronic IRB system that leverages the best practices of Huron while minimizing technical customizations. The Hutch IRB solution will tentatively launch in September 2022.
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.
The Hutch IRB project re-started in March 2021 to modernize the IRB process for Fred Hutch. This project will replace Fred Hutch’s current paper-based IRB process.
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, Hutch 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.
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: The dates are TBD at this stage. The tentative delivery timeframe for the launch is September 2022.
QUESTIONS: Please email questions to email@example.com.
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 (estimated launch Sept. 2022). 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.
As of April 2021, the project is in the Onboarding phase. The purpose of the Onboarding phase is to get our stakeholders familiar with the Huron platform, gather business requirements, and perform a fit/gap analysis between our requirements and the out-of-box Huron features.
After the Onboarding phase, we will start the Implementation phase, to design, develop, test, and deploy Hutch IRB. As the project progresses, we will update this website with additional detail and milestones.
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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