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Relevant IRB Policies and Procedures

If Fred Hutch is engaged in a multi-site research study, follow the submission instructions below:

Submission Instructions for Multi-Site Studies

When Fred Hutch is the IRB of Record

  1. Complete the appropriate IRB Application (Contact, No Contact, Not Human Research Determination). List in the application any Cancer Consortium sites engaged in the research study.

  2. Ensure reliance agreements are executed for non-Cancer Consortium participating sites to rely on Fred Hutch. See reliance agreement steps when Fred Hutch is the sIRB.

  3. After the study application (master file) is approved, submit a Participating Site Supplement for each participating site that is outside the Cancer Consortium. The Fred Hutch IRB will assess the qualifications of the site and the site investigator using the information provided in the participating site application, and by obtaining local context review as needed (in general, from all sites outside Washington, and from non-Cancer Consortium sites in Washington depending on familiarity to the Fred Hutch IRB).
When Fred Hutch is the IRB of record, participating sites outside the Cancer Consortium now submitted on the Participating Site Application instead of the Multi-Center Supplement.
Simplified application process for participating sites - New forms must be used by Sept 1

When Fred Hutch Relies on an External IRB

In certain cases, the Fred Hutch PI may send research to an external IRB for review. The Fred Hutch PI is responsible for still satisfying all institutional requirements prior to submitting the application to the external IRB, including but not limited to:

  • He/She and his/her staff have appropriate training
  • Ancillary reviews are complete (e.g., radiation safety committee, scientific review committee, etc.)

The IRO will perform a quality check on outgoing applications, and ensure institutional requirements are met. To submit to an external IRB: 

  1. Prepare the external IRB's submission application.

  2. Ensure a reliance agreement is executed to allow Fred Hutch to rely on the external IRB. See reliance agreement steps when Fred Hutch relies on an institution's IRB or when Fred Hutch relies on an independent IRB.

  3. Submit the External IRB Supplement and the prepared external IRB application to the IRO. 

  4. When the IRO sends an endorsement to proceed with external IRB review, submit the application to the external IRB.

Approval Documents from the External IRB

An additional step occurs after IRB review. Once approval is obtained, send all IRB approval documents to the IRO. This ensures the IRO has record of research being conducted at Fred Hutch, has a copy of the current protocol and consent form, and helps us address study participants' concerns and issues when needed.

Upon each continuing review at the external IRB, the Fred Hutch investigator is also to send those approval documents to the IRO. Please refer to continuing review.