For New Full-Review Study Submissions
Minimum submission requirements (effective starting September 1, 2010):
- IRB-ITHS CRCN Application
- Applicable supplements (if any) to the application
- Local Implementation Plan
Please see descriptions of these documents below. Note: there are two versions (long and short) of most of the following documents. Short versions contain all questions with links to Investigator Help sections and Regulatory/Policy Background sections. Long versions contain all of the same material in the documents, but without the functional links, which makes the documents longer.
- IRB-ITHS Application (short) (DOC) – revised March 3, 2014
- IRB-ITHS Application (long) (DOC) – revised March 3, 2014
- This application is used for new studies that do not qualify for other IRB application forms (Exempt Form, etc.) and for studies utilizing the ITHS PCRCN resources. This document is primarily aimed at gathering information for the regulatory findings the IRB must make. This application is required for these new study submissions and should be submitted with the Local Implementation Plan (LIP) and any relevant supplements.
Local Implementation Plan
- Local Implementation Plan (short) (DOC) – revised April 10, 2012
- Local Implementation Plan (long) (DOC) – revised April 10, 2012
- This form is required for new full-review study submissions and should be submitted with the IRB-ITHS Application and any relevant supplements. The purpose of this document is to provide a summary of how your study will be implemented at Children's. The LIP is considered a "living" document that should be updated and submitted to the IRB with each modification or renewal that involves change to the LIP.
- These are supplements to the IRB-ITHS Application and are required for new full-review study submissions only if applicable to the study. Supplements allow customization of application submissions for differing types of studies. For example, only researchers who are submitting a study involving banking of data/specimens for future research would need to complete the Banking Supplement. Please review the information provided below (and in the supplements themselves) regarding when particular supplements are needed.
- Banking Supplement (short) (DOC) – revised April 2, 2014
- Banking Supplement (long) (DOC) – revised April 2, 2014
- Complete this supplement if your study will involve storage of specimens or data for future research (which constitutes "banking"). The future research could include research performed by other investigators; it could also include research performed by the same investigators in the future.
Specimens and Radiation Supplement
Coordinating Centers Supplement
- Coordinating Centers Supplement (DOC)
- Complete this supplement if Children's is to be the coordinating center for a multi-center study. Definition of coordinating center: An institution, department or center that agrees to be responsible for the conduct or administrative/coordinating functions of a multicenter study.
Drugs, Devices and Biologics Supplement
ITHS CRCN Services Supplement
Special Populations Supplement
- Special Populations Supplement (short) (DOC)
- Special Populations Supplement (long) (DOC)
- Complete this supplement if you wish to enroll members of a special population listed below in your research:
- Wards/foster children
- Pregnant women and fetuses
- Persons with diminished decision-making capacity/mentally disabled persons
- Economically or educationally disadvantaged persons
- Note: Because children are so frequently participants in research at Children's, the regulatory requirements for enrolling children have been incorporated into the main IRB-ITHS Application. The Institutional Review Board (IRB) needs to make specific, additional regulatory findings for inclusion of these special populations in research.
Other Application Forms
- IRB Expedited Review Application for Existing and Confidential Data, Records or Specimens – revised October 23, 2012 (DOC)
- 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 Determination or Other Status Not Requiring IRB Approval – NEW – revised March 1, 2013 (DOC)
- The revised application includes all of the following categories for determination: Not Research; Research, but Not Involving Human Subjects; Exempt Human Subjects Research; and Non-Engagement in Human Subjects Research.
- Compassionate Use Device Form (DOC) – NEW
- Use this form for compassionate uses of devices. Compassionate use allows access to investigational devices for patients who do not meet the requirements for inclusion in a clinical investigation but for whom the treating physician believes the device may provide a benefit in treating and/or diagnosing their disease or condition.
- PedCIRB Facilitated IRB Review Application – New Study (DOC)
- Hematology/Oncology researchers may use this form to ask the Children's IRB to rely on the NCI Pediatric Central IRB (PedCIRB) for a new protocol.