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Institutional Approval: All New Applications require scientific review and sign-off by either the Division Director, Department Chair, or designee prior to submitting to the IRB. For a list of Directors and Designees that may provide this Institutional Approval, please see the document above.
Email approval by the Division Director, Department Chair, or designee is also acceptable in lieu of a signature on the New Application form. Refer to the Institutional Approval Email Template Form IRB Applications for verbiage to be used in the email approval.
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.
Additional forms and supplements which may be required as directed in the Application form.
Forms and supplements can be found in Forms Central.
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: 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 submit the completed UW/CC coversheet and Review Authorization form.
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.
Accessing Medical Records at UW: In addition to IRB review, studies that will access medical records at the University of Washington (UW) must obtain a confidentiality agreement prior to accessing UW medical records. It is the PI's responsibility to obtain the required agreement from UW Human Subjects Division. Note: If you are accessing medical records at UW or Seattle Children's your application will not qualify for exemption category 4.
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.
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.
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.
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.