New Applications

Relevant IRB Policies/Procedures

• New Application (Policy 2.1)
  
• Determining when Activities are Research Involving Human Research Participants (Policy 1.14)
  
• Investigational New Drugs (IND), Biologics and Investigational Device Exemptions (IDE) (Policy 1.13)
  
• Risks To Research Participants (Policy 1.7)
  

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

Different versions of the application form exist with three specific research types in mind. There are three flavors of the Application for Review; Interventional, Observational, Human Specimen and Data Research (No Subject Contact). Choose the version of the Application for Review 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 as represented by the bands below.

Additional documents may be required, depending on the activity. The application form will prompt for these additional documents to be attached as part of the application package for the IRB to review.

Versions of the Application for Review

Applications for Review
External IRB Cover Sheet - New Application

• Application for Review - Interventional Research
  Use for research involving a research intervention with the intent to change the participant. Research involving a clinical intervention, behavioral interventions, dietary interventions, or any other interaction with a living participant with the intent to change their biomedical condition or behavior should use this form.

• Application for Review - Observational Research
  Use for research involving interactions with a living participant for the purpose of collecting biospecimens or information from the participant with no intent to change them. Biospecimen collection, survey research, long term follow-up, observational research, and other biospecimen/information gathering involving an interaction with a living participant should use this form. 

NOTE: If the collection of biospecimens or information also involves an intervention, use the Interventional Research version of the IRB application.

• Application for Review - Human Specimens or Data (No Participant Contact) Research
  Use for research projects involving human specimens or data where the scope of the research project does not involve interacting with a living participant. Examples include: 
  • Ancillary studies involving specimens or data collected under another research protocol
  • Repositories and coordinating centers with no participant interactions
  • Research involving non-commercially available de-identified specimens/data/cell lines derived from a human
  • Any other activity involving human specimens or data where there is no interaction with the human

NOTE: If the collection of data or specimens also involves interaction with a human, use the Observational or Interventional version of the IRB application.

• External IRB Cover Sheet - New Application
  Use when research is being submitted to an external IRB for review.  Submit this form to the IRO prior to the formal submission with the external IRB.

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Additional Forms

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

• Funding Source Supplement
  
• Multi-Center Supplement Form
  
• Waiver of Consent Supplement
  
• HIPAA Supplement and Waiver of Authorization
  
• Expedited Review Checklist for Minimal Risk Activity
  
• Exempt Checklist
  
• Human Subjects Research Detemination
  
• Children Supplement
  
• Department of Defense Supplement
  
• Device Supplement
  
• Genomic Data Sharing Supplement
  
• International Performance Site Assessment Supplement
  
• Prisoner Certification Checklist for Investigator
  
• Repository, Registry or Databank Form
  
• Statistical Center Supplement

Forms and supplements can be found in Forms Central.

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Special Considerations for All Applications

Clinical intervention involving cancer or relating to cancer: Studies involving clinical intervention may need review by Scientific Review Committee (SRC). If you need assistance in determining whether your study requires review by either of these two Committees, please contact Clinical Research Support at 206.667.4520.

University of Washington Cancer Consortium studies: For questions regarding the Cancer Consortium IRB and/or the submission process, please go to the Cancer Consortium website. Additionally, investigators submitting a UW Cancer Consortium application 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 regarding the Cancer Consortium IRB and/or the submission process, please go to the Cancer Consortium website.  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.

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

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.

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.

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How to Submit Your Application to the IRB

Submit original documents only.

All documents must be single-sided. Please do not use staples. It is recommended that you keep a complete set of the documents submitted to the IRB for your records.

• Application for Review
  
• Scientific Review Committee (SRC) Minutes (if applicable)
  
• Protocol Synopsis (if applicable)
  
• Protocol/Activity Plan and/or entire Grant Application
  
• Questionnaires, subject completed data collection forms, logs
  
• Letters of Approach/Recruitment
  
• Consent(s)
  
• Waiver of Consent Supplement
  
• Prisoner Certification Checklist for Investigator
  
• De-briefing procedures
  
• Scripts used for oral consent
  
• Translated documents in the non-English language and certification of translation
  
• DSMB Charter
  
• Certificate of Confidentiality (if applicable)
  
• Web pages and Risk Assessment from the Information Security Officer
  
• Coordinating Center Operations Supplement
  
• Statistical Center Supplement
  
• International Research Performance Site Assessment Supplement
  
• HIPAA Supplement Form, if applicable
  
• Repository, Registry or Databank Form
  
• Dataset Submission Supplement for NIH GWAS and Other Central Genetic Data Repositories
  
• Institutional Biosafety Committee (IBC) approval documents
  
• Written assurance document from the General Counsel regarding Radiation Safety Committee Review
  
• Investigator Brochure (if applicable), 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
  
• Approval Letter from the FHCRC Regulatory Affairs Department for IDE device control and distribution plan
  
• Collection Data/Case Report Form(s) completed by participants
  
• Sample Pre-Screening Instruction Collection Form
  
• Other pertinent information
  
• Funding Source Document(s) (FSD)

Once the application receives final approval, the IRO will forward one copy of the stamped approved documents to the person identified on the application as the Contact Person.  For research managed through the Fred Hutch Clinical Research Support, approved documents will be returned to the CRS Protocol Review Coordinator.