Continuation Review Report

Relevant IRB policies/procedures:

  • Continuing Review (Policy 2.2) [pdf]

[all IRB policies/procedures]

    

Why is continuing review required?

DHHS regulation 45CFR46.109(e) requires that the IRB review human subjects research at intervals appropriate to the degree of risk, but not less than once per year.

To ensure that all studies are reviewed and approved on an annual basis, the IRO will send you a reminder notice through interoffice mail several weeks before your CRR is due.

   

How are Approval Dates Calculated?

FHCRC IRB maintains a "fixed anniversary date" whenever possible when conducting continuing review of research after the initial review. This means the expiration date of your study will be on the same month and day each year. There are situations when a study's anniversary date might be reset. The following examples illustrate the calculation done at the time of Continuing Review:

  1. If the continuing review report is approved with or without modifications within 30 days of the current "approval through date", the anniversary date stays fixed and the new "approval through date" is one full year from the prior year's "approval through date". For instance, if a study is currently approved from 10/20/2011 through 10/20/2012 and the IRB conducts continuing review and approves the study for another year on 10/5/12, the new approval period is 10/20/2012 through 10/20/2013. The "document release date" is either the IRB meeting "agenda date" if the continuing review was approved as submitted; or the "signature date" if the continuing review was approved with minor modifications which needed subsequent confirmation of completion by the IRB Chair or designee or via expedited review.
  2. If the continuing review report is approved with or without modifications outside of 30 days prior to the current “approval through date”, the anniversary date is reset and the new “approval through date” is one full year from the “agenda date”.  For example, if a study is currently approved from 10/20/2011 through 10/20/2012 and the IRB conducts continuing review and approves the study for another year on 9/5/2012, the anniversary date is reset and the new approval period is 9/5/2012 through 9/5/2013. The “document release date” is the either the IRB meeting “agenda date” if the continuing review was approved as submitted; or the “signature date” if the continuing review was approved with minor modifications which needed subsequent confirmation of completion by the IRB Chair or designee or via expedited review

The IRB will generally approve studies for one year.  However, there are instances where the IRB may approve a study for a shorter time period.  If the IRB approves a study for less than one year, the anniversary date will be reset.  

    

General Submission Instructions

    

Full Review and Minimal Risk Expedited Review

Please submit the following original document 

     

Exempt Review

Please submit the following original documents:

  • A New Application will need to be reviewed and approved every 5 years.  A CRR form is not required.

    

Cooperative Review Studies

Please submit the following original documents:

  • Cooperative Review Auth Agreement CRR Cover Page [download Word doc]
  • Approved (signed, with current dates of approval) copy of the offsite's continuation review/status report 
  • Current approved version of the Protocol or Activity Plan (only if modified in the last approval period)
  • Current approved version of the Consent Form(s) (only if modified in the last approval period)

 

IRB Authorization Agreement (when FHCRC is relying on an offsite institution for IRB review    

Please submit the following original documents:

  • Cooperative Review Auth Agreement CRR Cover Page [download Word doc]
  • Approved (signed, with current dates of approval) copy of the offsite's continuation review/status report 
  • Current approved version of the Protocol or Activity Plan (only if modified in the last approval period)
  • Current approved version of the Consent Form(s) (only if modified in the last approval period)
  • Current approved version of the participant materials (e.g. approach letters, questionnaires, advertisements, etc (only if modified in the last approval period)

    Questions regarding continuing review requirements for IRB Authorization Agreements, please contact Lori Lodzinski at (206) 667-4976 or llodzins@fhcrc.org.

    

IRB Certification of Approvals

Multi-center studies are required to submit Certification of Approvals for performance sites they coordinate at the time of CRR.  The CRR form will prompt for an updated Multi-Center Supplment when applicable. 

  • Update the Multi-Center Supplement and include with CRR. 
  • The approval document from the performance site.  The approval document can be submitted in one of two ways:          

1.  An Assurance Identification/IRB Certification/Declaration of Exemption (formerlycalled Optional Form 310) can be completed by the performance site's IRB; 

Blank Assurance Identification/IRB Certification/Declaration of Exemption Form

2.  The approval document from the performance site's human subjects (IRB) office which includes the following:

    • Protocol number or institution's identification number (e.g. IRB number)
    • Title of the protocol
    • Offsite Principal Investigator's name
    • Performance site's FWA and IRB #s
    • Review Date and approval dates
    • Type of Review (e.g., Full or Expedited) 

Questions regarding continuing review requirements for IRB Certification of Approvals, please contact Lori Lodzinski at (206) 667-4976 or llodzins@fhcrc.org.

    

Other Considerations

  • UW/FHCRC Cancer Consortium:  If you have questions regarding the Cancer Consortium IRB and/or the submission process, please go to www.cancerconsortium.org.
  • Clinical Research Division (CRD) Study:  If you are conducting a CRD or UW/FHCRC Cancer Consortium study, the Protocol Office will email you all appropriate forms and current study documents, and submit your documents to the IRB.
  • Closing a study?:  If you are reporting a "Closure", a CRR that includes a final summary is required. If the study was never activated (i.e., no subjects entered), you may indicate this on the CRR.

[instructions on how to close a study or terminate an IRB Authorization Agreement / Individual Investigator Agreement]

  • If any documents, such as consent forms use acronyms, please be sure to spell each acronym completely when first using them. For example, Institutional Review Board (IRB).
  • Once the application receives final approval, the IRO will forward one copy of the approved documents to the Contact person.

 

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