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How Will the New ‘Fred Hutchinson Cancer Center’ Impact the IRB/IACUC Processes?

Fred Hutchinson Cancer Research Center (Fred Hutch) plans to merge with its longtime clinical affiliate, Seattle Cancer Care Alliance (SCCA) to form the new Fred Hutchinson Cancer Center (FHCC), effective April 1, 2022.

The IRO has received several questions asking about any anticipated impacts to approved IRB and IACUC studies if the proposed FHCC merger moves forward. Answers to the most frequently asked questions have been added to the OSR FHCC Transition Management FAQ in a new IRO section. Additionally, study teams can submit any merger-related questions for the IRO using a button on OSR’s transition management page. Below you can find the most current FAQs related to IRO activities:

 

 

 

Will approved consent forms and other participant-facing study materials need to be revised to reference the institution’s new name by April 1?

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No. Approved study materials do not need to be immediately updated. These materials can be revised at the time of the next Modification or Continuing Review after the merger closes. The IRO will release revised consent form templates and forms to reflect the new legal name.

Will there be any changes to the human or animal subject assurance numbers?

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No. The IRO has confirmed with both the Office for Human Research Protections (OHRP) and the Office of Laboratory Animal Welfare (OLAW) that the federalwide assurance (FWA) number and OLAW assurance number will remain the same.

Will reliance agreements need to be updated to reflect the new legal name?

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Generally, no. The IRO is working with the Office of General Counsel to notify all organizations with existing reliance agreements of the legal name change.

Will a new Funding Verification and Activation Form (FVAF) be required for existing awards novating to FHCC?

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No. An FVAF will not be required solely due to the funding novation process.

Does the IRO need to be notified about changes to the project IDs associated with an approved IRB File?

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Revisions to the project ID(s), and any other administrative updates, can be reported with the study’s next Continuing Review Report on the Funding Source Supplement. A separate Modification is not required if there are no changes to the scope of work. For studies not required to submit Continuing Review Reports, please incorporate these administrative updates into a future Modification.

Does the IRO need to be notified about changes to the project IDs associated with an approved IACUC protocol?

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Revisions to the project ID(s), and any other administrative updates, can be updated at the time of the protocol’s next Amendment or Triennial review in Hutch IACUC. A separate Amendment is not necessary if there are no changes to the scope of work.

Is there any impact to Department of Defense (DOD) awards that have IRB or IACUC approvals from HRPO or ACURO, respectively?

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The IRO will notify HRPO and ACURO about the change in legal name on behalf of all Fred Hutch investigators with active DOD awards. No additional action should be required by the study teams.


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