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Attention: New applications for IRB review on or after January 21, 2019 must meet the requirements of the revised Common Rule. (See below)

 

Navigate to a type of submission to see details about what and how to submit to the IRB.

 

Common Rule Compliance

The federal regulations for the protection of human subjects known as the Common Rule have been revised, with a compliance date of January 21, 2019. The regulatory changes will only impact new federally funded studies that receive initial review by the Fred Hutch IRB on or after that date.

The IRO has prepared numerous revised policies and forms that will affect all submissions. Some forms were pre-released in November. Prior versions are no longer accepted for these forms:

  • Application for Review Interventional Research
  • Application for Review Observational Research
  • Application for Review Human Specimens or Data Research
  • Participating Site Application
  • Exempt Checklist
  • Waiver of Consent Supplement

Revised policies, consent templates, and some additional form updates are now available. To view the version and date changes, click here.

If you have any questions about these changes, please reach out to our office at iro@fredhutch.org. To view the revised 2018 Requirements directly, visit https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html.

Milestone Date

New Application versions pre-released

Nov 19, 2018

Submission deadline for New Apps under pre-2018 Common Rule

Dec 24, 2018

Last IRB meeting dedicated to New Apps under pre-2018 Common Rule

Jan 9, 2019

2018 Common Rule compliance date

Jan 21, 2019

Will the regulation changes affect my existing approved studies?

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No. Studies that received IRB approval before January 21, 2019, will continue under the prior Common Rule requirements. Fred Hutch does not currently plan to transition existing studies to the revised regulations.

What if my study is "in-flight"?

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Disapproved Studies:

If your study was disapproved by the IRB before January 21, 2019, you must re-submit on the new versions of the forms (in addition to addressing the IRB requirements as outlined in your IRB result letter).

Studies Approved with Minor Modifications:

Studies that were approved with minor modifications before January 21, 2019 are considered approved under the “Pre-2018 Requirements” of the Common Rule. You do not need to resubmit on the new versions of the forms. You only need to address the IRB requirements outlined in the IRB result letter.

What if my study is FDA-regulated?

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FDA regulations have not changed. If you are submitting new research that is also federally funded, the revised regulations impact you.

What if the IRB requests a de novo new application?

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For older studies, the IRB occasionally requests a de novo new application submission, to ensure compliance with current regulations and policies. If your de novo application will be reviewed by the IRB after January 21, 2019, the research must switch to the “2018 Requirements” of the revised Common Rule.

What do “Pre-2018 Requirements ” and “2018 Requirements ” mean?

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The initial effective date of the revised Common Rule was in 2018. Therefore, even though final compliance date is January 21, 2019, the regulations  refer to “Pre-2018 Requirements” and “2018 Requirements.” Fred Hutch has adopted this terminology for consistency with published regulations and guidance.


 

CTMS and Changes to IRB Processes

OnCore CTMS is live for all study teams as of September 17, 2018. All submissions to the Fred Hutch / Cancer Consortium IRB must be sent via email to IRBinbox@fredhutch.org. This replaces all prior submission methods (paper and email routing to CRS), regardless of study type.

If you have any questions regarding the IRB submission process, please contact iro@fredhutch.org. For general questions regarding the CTMS project, please contact ctmspm@uw.edu.

  • New Applications may only be submitted after full Scientific Review Committee (SRC) approval (if applicable).
  • Email submissions to IRBinbox@fredhutch.org should include all documents as Word or PDF attachments.
  • At minimum, individual document attachments are required for the following: IRB form under review (e.g., new application, continuing review report, etc.), protocol, protocol synopsis, each consent form, HIPAA authorization, and each IB. Please do not send a single PDF scan of all submission documents.
  • Please name your attachments with readily understandable file names (such as “protocol,” “patient consent”, “donor consent” etc.) and include version dates for all documents.
  • Consent forms should include both a version and date.
  • Fred Hutch IRO will return all IRB approvals to the PI and IRO Contact via email. You will no longer receive paper copies of approved documents.  The following documents will be emailed to you as attached PDF packets:
    • 00000_IRB Forms and Supplements
    • 00000_Protocol
    • 00000_Protocol Synopsis
    • 00000_Consent  (separate scan for each consent)
    • 00000_HIPAA Authorization
    • 00000_IB  (separate scan for each IB)    
    • 00000_Other Study Documents
  • All study teams are responsible for maintaining Word versions of IRB-approved documents to be used for future revisions.  We are unable to provide these to you.
  • Fred Hutch IRO will send renewal notice emails directly to study teams.