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 twoversions (long and short) of most of the following documents. Short versions containall questions with links to Investigator Help sections and Regulatory/Policy Backgroundsections. Long versions contain all of the same material in the documents, but withoutthe functional links, which makes the documents longer.

IRB-ITHS Application

  • IRB-ITHS Application(short) (DOC) - revised April 3, 2015
  • IRB-ITHS Application(long) (DOC) - revised April 3, 2015
    • This application is used for new studies that do not qualify for other IRBapplication forms (Exempt Form, etc.) and for studies utilizing the Pediatric Clinical Research Center. This document is primarily aimed at gathering information for theregulatory findings the IRB must make. This application is required forthese new study submissions and should be submitted with the Local ImplementationPlan (LIP) and any relevant supplements.
     

Local Implementation Plan

  • Local Implementation Plan(short) (DOC) - revised April 3, 2015
  • Local ImplementationPlan (long) (DOC) - revised April 3, 2015
    • This form is required for new full-review study submissions and shouldbe submitted with the IRB-ITHS Application and any relevant supplements. Thepurpose of this document is to provide a summary of how your study will beimplemented at Children's. The LIP is considered a "living" document that shouldbe updated and submitted to the IRB with each modification or renewal thatinvolves change to the LIP.
     

Supplements

  • These are supplements to the IRB-ITHS Application and are required for newfull-review study submissions only if applicable to the study. Supplementsallow customization of application submissions for differing types of studies. Forexample, only researchers who are submitting a study involving banking ofdata/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

  • 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 ordata for future research (which constitutes "banking"). The futureresearch could include research performed by other investigators; it could alsoinclude research performed by the same investigators in the future.
     

Specimens and Radiation Supplement

Coordinating Centers Supplement

  • Coordinating CentersSupplement (DOC)
    • Complete this supplement if Seattle Children's is to be the coordinating center for amulti-center study. Definition of coordinating center: An institution,department or center that agrees to be responsible for the conduct oradministrative/coordinating functions of a multicenter study.
     

Drugs, Devices and Biologics Supplement

Pediatric Clinical Research Center (PCRC) Services

  • PCRC Services Application Form
    • This form will automatically determine if a data safety monitoring plan (DSMP) is required. The following documents are required when filling out the form:
      • Final IRB approval and IRB application
      • Final IRB-stamped consent/assent and HIPAA forms
      • Study protocol
    • Email the PCRC with questions.

Special Populations Supplement

  • Special PopulationsSupplement (short) (DOC)
  • Special PopulationsSupplement (long) (DOC)
    • Complete this supplement if you wish to enroll members of a specialpopulation listed below in your research:
      • Wards/foster children
      • Neonates
      • Pregnant women and fetuses
      • Prisoners
      • Persons with diminished decision-making capacity/mentally disabledpersons
      • Economically or educationally disadvantaged persons
       
    • Note: Because children are so frequently participants inresearch at Seattle Children's, theregulatory requirements for enrolling childrenhave been incorporated into the main IRB-ITHS Application. TheInstitutionalReview Board (IRB) needs to make specific, additional regulatory findings forinclusion of these special populations in research.
     

Other Application Forms

  • IRBExpedited Review Application for Existing and Confidential Data, Records orSpecimens – revised June 5, 2015 (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 IRBApprovalNEW – revised March 1, 2013 (DOC)
    • The revised application includes all of the following categories fordetermination: Not Research; Research, but Not Involving Human Subjects; ExemptHuman Subjects Research; and Non-Engagement in Human Subjects Research.
     
  • Compassionate Use DeviceForm (DOC) – NEW
    • Use this form for compassionate uses of devices. Compassionate use allowsaccess to investigational devices for patients who do not meet the requirementsfor inclusion in a clinical investigation but for whom the treating physicianbelieves the device may provide a benefit in treating and/or diagnosing theirdisease or condition.
     
  • PedCIRB Facilitated IRBReview Application - New Study (DOC)
    • Hematology/Oncology researchers may use this form to ask the Children's IRBto rely on the NCI Pediatric Central IRB (PedCIRB) for a new protocol.