Application for Expedited Review — Minimal Risk Activities

Carefully evaluate whether your protocol qualifies as a minimal risk activity. Conditions for qualifications can be found on the Expedited Review Checklist (Minimal Risk). (If your protocol does not qualify as a minimal risk or exempt activity, it must undergo full review.)

• Expedited Review Checklist (Word, 38KB)

Special Considerations

If the application submitted for review includes documents that are incomplete (i.e., 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 review and approval of the new application including all documents by the IRB has occurred.

Cancer Surveillance System (CSS) —Studies involving medical record review or database linkage, must complete and submit the CSS Waiver Request Form to access such data.

• CSS Case Subject Recruitment Method Form (Word)

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 institition after receiving IRB approval from FHCRC. UW PIs submitting a 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) 549-0098 with any questions regarding this document.
• Seattle Children's Oath of Confidentiality Form— Please contact Seattle Children's IRB at (206) 987-3930 with any questions regarding this document.

Gene Therapy Trials — All activities involving Gene Therapy must undergo full review.

Research not Involving Human Subjects — If your research involves only nonidentifiable specimens or data, it may be considered Research not Involving Human Subjects. If so, submit the Flow Chart to Determine Not Human Subjects Research or Human Subjects Research and Protocol Disposition Form only.

Instructions for Submission to IRB

Complete the Protocol Disposition Form, the Expedited Review Checklist and the Application for Review.

To select a box, double click on the and select "checked" in the "default value" box and click "ok".

• Protocol Disposition Form Updated November 16, 2009
• Expedited Review Checklist (Word, 38KB)
• Application for Review Updated November 16, 2009
• Funding Source Supplement Updated November 16, 2009

The IRB requires ONLY the ORIGINAL DOCUMENTS for processing your IRB application. 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. The original documents include the following, as applicable in the suggested order:

• Protocol Disposition Form
• Application for Review and Expedited Review Checklist
• Protocol (optional; depends on activity)
• Consent Form (not always required)
• Flyers/Advertisements
• Approach Letters
• Questionnaires
• Cancer Surveillance System (CSS) Recruitment Case Subject Recruitment Method Form (if applicable)
• HIPAA Supplement (if applicable)
• UW or Seattle Children's Confidentiality Agreement (if applicable)
• Funding Source Document (FSD)

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.

Your application may be word processed, as long as the format is followed, or you may type the information into the form. These materials should be submitted along with, or prior to, submission of a grant application for Institutional Review sign-off of the grant, 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).

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.

Once the application receives final approval, the IRO will forward one copy of the stamped documents to the Contact Person.