IRB Application Forms

IRB-ITHS Application (DOC 514KB)

This application is used for new studies requiring IRB review (that do not qualify for using other IRB applications) and for studies utilizing the pediatric Clinical Research Center (CRC) at Children's or using resources of the Institute of Translational Health Sciences (ITHS).

At the end of the application there are instructions on how to submit the application for review by the IRB. Please refer to the IRB application process for new studies when you are completing the form, particularly if you are a first time user.

Information and instructions about the ITHS submission process and the Clinical Research Center Network (CRCN) Scientific Review (formerly the SAC Review) can be found on the ITHS web site at: http://www.iths.org/ResearchResources/Applications/. Note: Protocols that have undergone prior scientific review by a pre-approved external scientific review committee do not require additional review by the CRCN Scientific Review Committee. Detailed information and a listing of the current ITHS approved external peer scientific review committees can be found on the ITHS website link listed above.

IRB Expedited Review Application - For Existing and Confidential Data, Records or Specimens (DOC 293KB)

For research using existing (i.e., on the shelf at the time of IRB review) confidential records, data or specimens.

This form contains all information to be compliant with federal privacy rules (HIPAA) and Washington State law. Instructions are included within the form.

Application for Exempt Review Status (DOC 36KB)

For research that may qualify for exempt review (as defined in the federal regulations). The definitions of exempt review categories are described on page one of the form.

IRB Status Report (DOC 117KB)

Use this form to renew ongoing studies or to close an existing study.

The IRB sends out status reports to the principal investigator 2-3 months before the study is due to expire. The report includes instructions on how to complete the form.

The information sheet Renewing or Closing a Study is a good resource.

IRB Status Report - Research Using Existing and Confidential Data, Records, or Specimens (DOC 101KB)

Use this form to renew or close research using existing and confidential records, data or specimens.