New Applications

This page covers the following information:

Versions of the IRB Application
IRB Supplements
Special Considerations for All Applications
How to Submit Your Application to the IRB

Versions of the IRB Application

IRB Application
External IRB Supplement

Two different versions of the IRB Application exist. Research in which there will be interaction with subjects will use IRB Application (Contact). Research which only consists of obtaining and using data or specimens from some source other than the participants will use IRB Application (No Contact). Choose the version of the IRB Application which best fits the type of research you are conducting. The application forms will guide you to what type of IRB review you will need.

• IRB Application (Contact)
  Use this form if you will interact with subjects, such as for an interventional study with blood draws, a web-based survey, telephone interviews, focus groups, etc.

• IRB Application (No Contact)
  Use this form ONLY if the research consists of obtaining and using data or specimens from some source other than the participants (for example, it is a medical records review project or a study on leftover biospecimens).

• Not Human Research Determination
  Use this form to request a determination of Not Human Research.

• External IRB Supplement
  If Fred Hutch is engaged in the research, use this form to request authorization from the Fred Hutch IRO to rely on an external IRB (any IRB other than the Fred Hutch IRB).

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IRB Supplements

Additional forms and supplements which may be required as directed in the Application form.

• Children Supplement
  
• Consent Supplement
• Department of Defense Supplement
• Device Supplement
• Drug Supplement
• HIPAA Supplement
• Exempt Form
• Expedited Review Form
• Genomic Data Sharing Supplement
• International Research Performance Site Assessment Supplement
• Multi-Center Supplement
• Prisoner Certification Checklist for Investigator
• Repository or Registry Supplement

Forms and supplements can be found in Forms Central.

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Special Considerations for All Applications

Interventional studies involving cancer or relating to cancer: These studies may need review by the Cancer Consortium's Scientific Review Committee (SRC). If you need assistance in determining whether your study requires review by SRC, please contact Clinical Research Support at 206.667.4520.

University of Washington Cancer Consortium studies: For questions about whether Fred Hutch is the right IRB, refer to Selecting the Right IRB. Additionally, UW investigators submitting an application to the Fred Hutch Cancer Consortium IRB must first request authorization from UW HSD to rely on the Fred Hutch IRB.  UW investigators can complete the REQUEST: External IRB Review form to initiate this request through UW.

Seattle Children’s: For questions about whether Fred Hutch is the right IRB, refer to Selecting the Right IRB. Additionally, when Seattle Children’s is an institution engaged in the research, the investigator must include an Acknowledgement of Reliance on an External IRB Letter from Seattle Children’s with the submission to the Fred Hutch IRB.  Seattle Children’s investigators can initiate this request by making an External IRB submission in the Seattle Children’s Click IRB system.

Accessing Protected Health Information (PHI) from Seattle Children's: Studies accessing/using/creating/sharing PHI from Seattle Children's must submit a Seattle Children's HIPAA form.  Please go to the Seattle Children's website to download the form.

IND/IDE: If you need assistance in determining whether your study requires an IND or IDE, please contact Regulatory Affairs at RegulatoryAffairs@fredhutch.org or 206.667.4520.

Certificate of Confidentiality: Studies collecting information that if disclosed, could have negative consequences to the participants' financial statuses, employability, insurability or reputation, a Certificate of Confidentiality issued by the National Institutes of Health (NIH) may be required. For more information about Certificate of Confidentiality, please go to the NIH website.

Radiation Safety Review Requirements: If your study involves radiation procedures, please go to the Radiation Safety Review webpage to determine whether Radiation Safety Committee review is required.

Institutional Biosafety Review Requirements: If your study involves the introduction of recombinant DNA or RNA into humans, the application will automatically undergo Full Review and Institutional Biosafety Review will be required.

Note about non-faculty members (non-Professors) as PIs: According to the Fred Hutch Human Research Protections Program (HRPP), the President & Director (or designee) and the Institutional Official must approve any requests for non-faculty members (non-professors) to serve as the Principal Investigator of a Fred Hutch study involving human subjects. The IRO will initiate the permissions request for any non-faculty PI’s, but may cause some delays in processing.

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How to Submit Your Application to the IRB

Log in to Hutch IRB and click the "Create" button, selecting "Create New Study." Complete the study SmartForms and attach all requested documents, including the IRB Application and any IRB Supplements as prompted by the IRB Application form.

It is recommended that you keep a complete set of the documents submitted to the IRB for your records.

The following is a list of potential attachments (not including IRB Supplements) that may be necessary if relevant to the submission:

• IRB Application
  
• Scientific Review Committee (SRC) Approval (if applicable)
  
• Protocol
• Questionnaires, participant-facing data collection forms, logs, surveys
  
• Letters of Approach/Recruitment
  
• Consent(s)
• Scripts used for oral consent
• DSMB Charter
  
• Certificate of Confidentiality (if applicable)
  
• Recruitment web pages and risk assessment report from the Information Security Officer
• Institutional Biosafety Committee (IBC) approval documents
  
• Radiation Safety Committee Review approval documents
  
• Investigator Brochure (if applicable), package insert, drug booklet or information sheet supplied by the drug company (sponsor)
  
• FDA letter with the IND/IDE assignment number and PI confirmation letter or documentation of FDA approval from the sponsor
  
• Analysis of IND Exempt requirement

After IRB Review, the IRB will provide you with a written decision via Hutch IRB indicating the IRB determination: Approval, Modifications Required to Secure Approval, Deferral, or Disapproval.

Helpful Resources to Submit Your Application to the IRB:

• List of IRB Meeting Dates
• Create and Submit a Study: Online Video

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