New Applications for Review

Relevant IRB policies/procedures:

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

[all IRB policies/procedures]

The Application for Review was updated effective January 1, 2014.  Previous version(s) of the application form will be accepted until March 31, 2014.

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.

All application forms, display the icon to indicated additional documentation is required to be attached.

The forms also display a  icon when additional help and instruction is available for the particular question.  Additional help information for all forms can be found here - IRB Forms - Instructions and Help

Versions of the Application for Review:

   

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) and/or Clinical Investigator's Meeting (CIM). 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 or CRScustomerservice@fhcrc.org.

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.

IND/IDE If you need assistance in determining whether your study requires an IND or IDE, please contact Regulatory Affairs at RegulatoryAffairs@fhcrc.org or 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 Seattle Children's website to download the form. 

Accessing Medical Records at UW or Seattle Children's: In addition to IRB review, studies that will access medical records at the University of Washington (UW) or Seattle Children's must obtain a confidentiality agreement prior to accessing UW or Seattle Children's medical records.  Note: If you are accessing medical records at UW or Seattle Children's your application will not qualify for exemption category 4. 

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.

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.

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..

   

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.

Please submit the documents in the following suggested order:

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 FHCRC Protocol Office, approved documents will be returned to the CRS Protocol Review Coordinator. 

Note: All New applications require scientific review and sign-off 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.

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.

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