Application Form for Full Review

(Activities involving More than Minimal Risk)

For all activities that do not qualify as either exempt or minimal risk, an application for Full Review must be submitted to the Institutional Review Office (IRO).

The application comprises two documents, the Protocol Disposition Form and the Application for Review. Additional documents may be required, depending on the activity.

• Protocol Disposition Form [download Word doc] updated November 16, 2009 
• Instructions for completing Protocol Disposition Form p.2 [download PDF] updated February 05, 2007
• Application for Review [download Word doc] updated November 16, 2009 
• Additional documents
  • Prisoner Certification Checklist for Investigator [download Word doc] updated 01-14-08
  • Cancer Surveillance System (CSS) [download Word doc] posted August 01, 2007
  • Certificate of Translation [download Word doc]
  • Waiver of Consent Supplement [download Word doc] posted November 16, 2009
  • Dataset Submission Supplement for NIH GWAS and Other Central Genetic Data Repositories [download Word doc]  posted November 16, 2009
  • Statistical Center Supplement [download Word doc] updated November 16, 2009 
  • Coordinating Center Operations Form [download Word doc] updated November 16, 2009 
  • International Research Performance Site Assessment [download Word doc] updated November 16, 2009 
  • HIPAA Supplement [download Word doc] updated November 16, 2009 
  • Repository, Registry or Databank Form [download Word doc] posted August 01, 2007
  • UW Confidentiality Agreement [access UW Confidentiality Agreement]
  • Seattle Children's Oath of Confidentiality [download Word doc]
  • Funding Source Supplement [download Word doc] updated November 16, 2009 

Special Considerations

If the application submitted for review includes documents that are incomplete (e.g., questionnaires and/or data collection forms), you must submit, at a minimum, a draft consent form(s) and a memo stating that submitted documents are incomplete. No human subject may be enrolled in the study until subsequent Full Review and approval by the IRB has occurred. Continue with the Instructions for Submission (see below) to the IRB.

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

Accessing Medical Records from UW or Seattle Children's: — Studies that will access medical records from the University of Washington (UW) or Seattle Children's and have a waiver of consent must complete the confidentiality agreement of the appropriate institution after receiving IRB approval from FHCRC. UW PIs submitting an UW Consortium application must also submit this form.

Note: It is the PI's responsibility to obtain the signature from the respective institution's human subjects department and to submit the signed confidentiality agreement form to the FHCRC's IRB.

• UW Confidentiality Agreement Form — Please contact the University of Washington Human Subjects Division at (206) 543-0098 with any questions regarding this document.
• Seattle Children's Oath of Confidentiality Form — Please contact Seattle Chilren's IRB at (206) 987-7820 with any questions regarding this document.

Cancer Surveillance System (CSS): — Studies that involve the use of identifiable Cancer Surveillance System (CSS) data (e.g., data with names, addresses, SSNs, other identifiers) to recruit CSS patients must complete and submit the CSS Case Subject Recruitment Method Form [download Word doc] to access such data.

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's website.

Clinical intervention: Studies involving clinical intervention may receive review by Scientific Review Committee (SRC) and/or Clinical Investigator's Meeting (CIM). If you need assistance in determing whether your study requires review by either of these two Committees, please contact the Protocol Office at (206) 667-4520 or protocol@fhcrc.org.

Depositing data to any Genome Wide Association Studies (GWAS) or other genetic information research repository - must complete and submit the Dataset Submission Supplement for NIH GWAS and Other Central Genetic Data Repositories. 

IND/IDE — If you need assistance in determining whether your study requires an IND or IDE, please contact Victoria (Tory) Lakes, Regulatory Affairs Manager at (206) 667-1367 or visit the Research Trials website.

University of Washington Cancer Consortium studies: — Questions regarding the Cancer Consortium IRB and/or the submission process, please go to www.cancerconsortium.org.

Additionally, investigators submitting a UW Cancer Consortium application must submit the completed UW/CC coversheet and Review Authorization form.

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.

Instructions for Submission to IRB

Submit ORIGINAL DOCUMENTS ONLY.

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

Please submit the documents in following suggested order:

• Protocol Disposition Form
• Application for Review
• Scientific Review Committee (SRC) Minutes (if applicable)
• Protocol Synopsis (if applicable)
• Protocol/Activity Plan and/or entire Grant Application
• DHHS-approved protocol (complete) if one exists
• Questionnaires, subject completed data collection forms, logs
• Cancer Surveillance System (CSS) Case Subject Recruitment Method Supplement (if applicable)
• Letter of Support from CSS or Gatekeeper of Repository, Registry or Data Bank
• Letters of Approach/Recruitment
• Prisoner Certification Checklist for Investigator
• Consents
• DHHS-approved sample consent document (if one exists)
• Waiver of Consent Supplement
• 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 Office of 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 distriubtion plan
• Sample Collection Data/Case Report Form(s)
• Sample Pre-Screening Instruction Collection Form
• UW or Seattle Children's Confidentiality Agreement (if applicable)
• 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 Contact Person.

Note: All New applications require scientific review and sign-off on the Protocol Disposition Form by either the Associate Director or the Department Head. Most Clinical Division Applications must first be routed through the Protocol Office. Please contact the Protocol Office at (206) 667-4520 if there are any questions.

Your application may be word processed, as long as the format is followed, or you may type the information into the form. To select a box, double click on the and select "checked" in the "default value" box and click "ok".

These materials should be submitted along with, or prior to, submission of a funding proposal for Institutional Review sign-off of the funding proposal, unless the grant qualifies for "Just In Time" Review. If any documents use acronyms, please be sure to spell each acronym completely when first using them. For example, Institutional Review Board (IRB).

View a current listing of the IRB submission deadlines and meeting dates.

Please contact the IRO if you have any questions regarding this paperwork. We are prepared to assist anyone who may need advice. Your cooperation in all of these matters is much appreciated and helps to process your materials more rapidly.