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Overview

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. Hutch IRB will launch in early 2023. We'll provide more clarity on the exact timing three months prior.

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.   

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 - 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 will launch in early 2023. We'll provide more clarity on the exact timing three months prior.
QUESTIONS:  Please email questions to iro-support@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, 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.   


Project Roadmap

Gradient rule Hutch colors
Project timeline view - Step 1 Onboarding runs to June 2021. Step 2 Design Hutch IRB runs to Feb 2022. Step 3 Develop and Implement runs to Jan 2023. Step 4: Establish Steady State Release Cadence early 2023..

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

To date, we have completed the following key milestones:

  • March 2022
    • Continued analysis of system notifications to ensure the recipient knows the correct course of action.
    • Continued work on technical integrations to document specifications and the prototype of potential solutions.
    • Continued work on the HRPP Toolkit with plans to rollout with the system implementation.
    • Development activities continue for the Huron team.
    • Completed organization design meetings. These meetings help ensure the IRO office can operate effectively with this new electronic solution (Hutch IRB). We agreed that implementation of the organizational changes will occur in concert with the system go-live (e.g., job descriptions, roles & responsibilities, etc.).  
  • February 2022
    • The IRO Core team focused on the design of Hutch IRB (customization of the Huron IRB technology to meet Fred Hutch needs). Continued to meet weekly to address business process and readiness activities to support a successful implementation.
    • Completed the Workflow specifications.
    • Continued working the Requirements and Specifications for the technical integrations.
    • Continued assessing the Hutch IRB templates and requirements.
    • Continued work on the HRPP Toolkit customizations with plans to deploy changes with the system rollout.
  • January 2022
    • Completed drafts of the Workflow and Workspace Design specification and awaiting Huron technical feedback.
    • Updated the Meeting Minutes and Meeting Agenda templates. There will be ongoing work to further update templates that will originate from Hutch IRB.
    • Huron completed a portion of SmartForm development and deployed an initial patch to staging for validation and demonstration to Super Users.
    • Restarted work on the HRPP Toolkit customizations
  • December 2021
    • The IRO Core team continued to focus on the design of Hutch IRB (customization of the Huron IRB technology to meet Fred Hutch needs). 
    • Started review of smartform test cases. The test cases will ensure the smartform customizations meet the business requirements.
    • Focused on completing the design for Workflow, Workspaces, and Ancillary Review process. Started discussions on system notifications and letters.
    • Initiated meetings to gather requirements for the People & Organizations design integration specification document.
  • November 2021
    • The IRO Core team continued focus on the design of Hutch IRB.   
    • We agreed on the timing for the gathering of the requirements and v1 of the design specifications for the technical integration work (LMS Integration, Single Sign-On, and People & Org.).     
    • Initiated discovery sessions with Fred Hutch Center IT to determine whether a data warehousing solution would help meet our reporting needs after go-live.
  • October 2021
    • The IRO Core team continued focus on the design of Hutch IRB.   
    • Completed SmartForm design (questions the research team will answer in Hutch IRB) and reviewed with our Super Users and other stakeholder groups.
    • Completed our October 2021 Steering Committee meeting to update stakeholders on the overall progress of the project.
  • September 2021
    • The IRO Core team focused on the design of Hutch IRB with six hours of meetings each week. 
  • August 2021
    • The IRO Core team started Design meetings in late August. We are updating our business requirements and designing the changes we need to see in the technology (Hutch IRB). 
    • Secured formal approval from Fred Hutch leadership to use the Huron IRB hosted solution vs. software-as-a-service (SaaS) solution.
  • July 2021
    • Completed a formal Request For Proposal (RFP) with Fred Hutch Procurement to select vendor(s) to lead us through Design and Implementation of Hutch IRB.
    • Started design of the HRPP Toolkit from Huron. The Toolkit is a collection of standard operating procedures, worksheets, checklists, and templates supporting the IRB process. 
  • June 2021
    • Prioritized the business requirements for Design & Implementation of Hutch IRB.
  • May 2021
    • Completed the Onboarding phase with the Core team. During Onboarding, the Core team got exposure to the Huron out-of-box technology, gathered business requirements, and performed a fit/gap analysis. 
    • Identified the Change Champions from the research community and met with them to introduce the project.
  • April 2021
    • Kicked off project with the IRO Core team
    • Kicked off meeting with the cross-division steering committee

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 (launch in early 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 Develop & Implement stage of the project, during which Huron Consulting Services will take the Fred Hutch design and develop the product to customize the Hutch IRB technology solution to meet Fred Hutch needs. This phase will continue through go-live, in early 2023.

As the project progresses, we will update this website with additional detail and milestones.

 

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-support@fredhutch.org.

 


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