Search Fred Hutch Extranet

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. The Hutch IRB solution will tentatively launch in September 2022.

 

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:  The project Design phase starts August 2021. The tentative delivery timeframe for the launch is September 2022.
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
Step 1 Onboarding to June 2021. Step 2 Implement IRB to Sept 2022. Step 3 Establish Steady State Release Cadence late 2022.

Step 1: Onboarding –

Complete!

Outcomes:

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

Step 2: Implement Hutch IRB - In Process!

Outcomes:

  • Design & Configure Huron IRB for Fred Hutch
  • HRPP Toolkit
  • Build in-scope system integrations
  • Rollout Hutch IRB
  • Implement support model

Step 3: 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:

  • September 2021
    • The IRO Core team continues to focus on the design of Hutch IRB.  We meet for six hours each week as a Core team to articulate the needed system changes to deliver Hutch IRB. 
  • 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 (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.

 

What is the status of the Hutch IRB project?

We are currently in the Design stage of the project, during which the IRO Core team is working with Huron Consulting Services to customize the Hutch IRB technology solution to meet Fred Hutch needs. This Design phase will continue through Feb. 2022. The project is on track to go-live to all users in Sept. 2022.

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.

 


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.