IRB Application Forms
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; and
- 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
- IRB-ITHS Application (short) (DOC) – revised 4-10-12
- IRB-ITHS Application (long) (DOC) – revised 4-10-12
- 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 4-10-12
- Local Implementation Plan (long) (DOC) – revised 4-10-12
- 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 Seattle 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.
Supplements
- 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
- Banking Supplement (short) (DOC)
- Banking Supplement (long) (DOC)
- 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 Seattle 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 multi-center study.
Genome-Wide Association Studies Supplement
- Genome-Wide Association Studies Supplement (short) (DOC)
- Genome-Wide Association Studies Supplement (long) (DOC)
- Complete this supplement for new studies involving the proposed submission of genotype/phenotype/other data into Genome-Wide Association Studies (GWAS) repositories governed by NIH GWAS policy or NDAR policy (e.g., dbGaP). Researchers should check with the funding agency if unsure whether such NIH policies apply. This supplement is also applicable to ongoing or completed studies that are now seeking certification for submission to such repositories.
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
- Neonates
- Pregnant women and fetuses
- Prisoners
- Persons with diminished decision-making capacity/mentally disabled persons
- Economically or educationally disadvantaged persons
- Note: Since children are so frequently participants in research at Seattle 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.
- IRB Expedited Review Application for Existing and Confidential Data, Records or Specimens — revised 2-27-09 (DOC)
New Revised Form — Required for Submissions as of April 1, 2009- 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 — revised 1-30-12 (DOC)
- 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)
- Use this form to renew ongoing studies or to close an existing study.
- The IRB sends out status reports to the principal investigator two to three 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.
- Below is a checklist of recent changes to the Seattle Children’s template language. Please review it and incorporate the applicable language into your consent/assent/HIPAA forms before submitting the materials for continuing review. All changes should be tracked in Microsoft Word to facilitate IRB review.
- Pregnancy testing language should be revised if pregnancy testing is described in the current consent form. (See Section 8 of template consent and the language resource text; if the study uses a separate assent form, then add pregnancy language from the template assent.)
- Statement that research information will go into the medical record should be added, if appropriate (see Section 11 of template consent).
- Research-related injury language should be revised (see Section 13 of template consent).
- Payment tracking language should be added if applicable (see Section 14 of template consent). The payment tracking language relates to ORF Policy 4.
- Statement about ClinicalTrials.gov should be added if applicable (see Section 15 of template consent). For information, see the Research Tool Kit page on CHILD.
- Time of signature needs to be added for many signatures. Need to use the new signature lines included in posted templates (see Section 17 of template consent; see last section of template assent; see permission section of HIPAA authorization.)
- All consent/assent templates and HIPAA templates are available on our website.
- IRB Status Report: Research Using Existing and Confidential Data, Records or Specimens — revised 10-16-08 (DOC)
- Use this form to renew or close research using existing and confidential records, data or specimens.
- 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 Seattle Children's IRB to rely on the NCI Pediatric Central IRB (PedCIRB) for a new protocol.