Hutch IRB is an end-to-end, web-based, electronic IRB system. It adds greater efficiency to the IRB process, provides better transparency for researchers on the status of submissions in the review process, and facilitates regulatory compliance.
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 Program (HRPP) and fills an essential role in protecting the rights and welfare of human research subjects.
Hutch IRB Training
For training materials, access our Hutch IRB Training page. If you have a new submission and you are experiencing challenges getting started, please email us at iro@fredhutch.org.
One-on-one training is available to new investigators and research team members who manage submissions.
IRO Support
Are you experiencing a technical issue with Hutch IRB? Are you having trouble accessing the system? Please contact us!
Email: iro-support@fredhutch.org
Hutch IRB Tips
Below are additional tips that may enhance your use of the system.
What documents go where?
Refer to the Where to Attach Documents in Hutch IRB guidance document for information on where to attach documents in Hutch IRB.
System of Record
Hutch IRB is a system of record. Anything entered into Hutch IRB (including but not limited to study information, uploaded files, and comments) becomes part of the permanent study record. Please be thoughtful about what you add to Hutch IRB.
Helptext
For additional tips and information when completing a submission in Hutch IRB, utilize Helptext by clicking on the ? symbols. Helptext provides information specific to our system. Any feedback on how Helptext can be made clearer is welcome.
Is it multi-center or a single site study?
The involvement of two or more Cancer Consortium institutions makes a study “multi-site” in Hutch IRB. A “single-site” study is one where all research activities occur at only one single institution (for example, research where only Fred Hutch is involved).
Local Research Locations
A question in Hutch IRB requests a list of each Cancer Consortium location (site) where research activities will be conducted and directly overseen by the local investigator. For non-exempt human subjects research, this question is intended to capture all Cancer Consortium locations that are “engaged” in the research (according to the 2008 OHRP Guidance on engagement of institutions).
A few additional notes about local research locations:
- If Fred Hutch’s only involvement in the research is to serve as the prime awardee of a federal grant, we are still considered engaged per OHRP and must be listed as a location.
- If no research activities are being conducted at any Cancer Consortium locations, select No Research Location. However, we recommend you consult with IRO@fredhutch.org before selecting this option because this situation is rare.
A Modification is required to add an additional Cancer Consortium location or to close a particular Cancer Consortium site’s involvement with the study.
Transitioning to Hutch IRB
Beginning with the launch of Hutch IRB on March 29, 2023, all submissions to the Fred Hutch Cancer Consortium IRB must be submitted and returned via Hutch IRB. In addition, new documents are in use that support submission in the new system, including updated IRB forms.
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:
- verify the migrated data are accurate with your records
- upload currently approved documents into Hutch IRB to complete the record (similar to today’s Continuing Review process)
Study team member data for migrated studies only included the PI and the Primary Contact (“IRO Contact”). Therefore, you will also need to consider the following steps for studies migrated to Hutch IRB:
- 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.
For migrated studies that do not undergo continuing review, you have until March 28, 2024 to complete the migrated record.