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

 

Common Rule Compliance

ALERT

New versions of six IRB application forms have been pre-released to accommodate new or de novo applications that will be reviewed by the IRB on or after January 21, 2019.

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

You can access the forms here, or on their individual forms pages. Please plan ahead and use the correct versions of the forms.  

Note:  If a New Application (on the current version) is submitted and disapproved, and the issues are not able to be resolved for approval before January 21, 2019, then the application would need to be redone on the pre-released version of the New Application (because of the need for compliance with the new Common Rule after that date).

Milestone Date

New Application versions pre-released

Nov 19, 2018

Submission deadline for New Apps under pre-2018 Common Rule (on current New App versions)

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

 

CTMS and Changes to IRB Processes


T1G2

OnCore CTMS is going live for Target 1 Group 2 (T1G2) on September 17, 2018.  This includes everyone who did not switch to OnCore in July.  The Fred Hutch Institutional Review Office (IRO) would like to share the following related announcements. Refer to the project page to see who is in which target group.

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.

High-level summary:   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.

Dates:

Monday, September 10:

  • T1G2 study teams will start submitting all Continuing Review Reports (CRRs), Modification Forms, and reportable events for Fred Hutch IRB review directly to IRBinbox@fredhutch.org  (instead of submitting hard copies or emailing to submissions@fredhutch.org) 

Monday, September 17:

  • T1G2 study teams will start submitting all New Applications for Fred Hutch IRB review directly to IRBinbox@fredhutch.org (instead of submitting hard copies or emailing to submissions@fredhutch.org) 
    • New Applications may only be submitted after full Scientific Review Committee (SRC) approval (if applicable) and after division signature is obtained.

Additional details:

  • For a list of division approval designees and additional details on obtaining division approval click here. Some Divisions may wish to provide approval via email in lieu of an ink signature; a sample email template acceptable to the IRO can be found here.
    • PHS will be moving to approval of applications via email. Further information will be provided by the division before the September 17th start date.
  • Email submissions to the IRBinbox should include all documents as Word or PDF attachments.
  • Please name your attachments with readily understandable file names (such as “protocol,” “patient consent”, “donor consent” etc.) and include version dates for all documents.
  • 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.

 



T1G1

The OnCore CTMS go-live date for Target 1 Group 1 (T1G1) was July 16, 2018. The Fred Hutch IRB Office would like to share the following key announcements regarding changes to the IRB processes for T1G1 study teams. Refer to the project page to see who is in which target group.

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.

Dates:

Monday, July 9:

  • T1G1 study teams began submitting Continuing Review Reports (CRRs), Research Modification Forms, and reportable events for Fred Hutch IRB review directly to IRBinbox@fredhutch.org instead of submitting to submissions@fredhutch.org
  • T1G1 study teams began submitting IRB CRRs separately from DSMC submissions

Monday, July 16:

  • T1G1 study teams began submitting New Applications for Fred Hutch IRB review directly to us at IRBinbox@fredhutch.org instead of submitting to submissions@fredhutch.org
    • New Applications may only be submitted after full SRC approval (if applicable) and division signatures are obtained.
    • Division approval designees for Fred Hutch IRB applications can be found here. A template for obtaining approval via email in lieu of a signature can be found here. Note: T1G1 study teams must submit email approval electronically, not in hardcopy.
  • Fred Hutch IRO will send IRB approvals to the PI and IRO Contact via email. The following documents will be attached as PDF packets. You will no longer receive paper copies of approved documents.
    • 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
  • T1G1 study teams will be responsible for maintaining Word versions of IRB-approved documents to be used for future revisions.
  • Fred Hutch IRO will send renewal notice emails directly to study teams.