Updates
New: Consent, Assent, HIPAA template revisions
Scope: Consent; Parental Permission; Assent; Consent for Emergency Use; Short Form Consent; Short Form Assent; and HIPAA Templates
Some changes have come to the Seattle Children’s research templates noted above.
- New applications should utilize Seattle Children’s template forms, which include all of the latest required language.
- For studies that are currently approved, the Human Subjects Protection Program (HSPP) office will send a checklist of updated form content to all research teams at the time of continuing review (also known as “renewal”).
Below is a summary of the updates you will see in the relevant research templates:
| Type of Change | Reason | Applicability |
| Adding a line for the "time" of many signatures. Need to use the new signature lines included in posted templates. | Required by the Joint Commission | All research studies open to enrollment. |
| Revisions to the consent injury language to clarify that research participants will not waive any rights. | Consistency with the FDA information sheet “A Guide to Informed Consent.” | All research studies open to enrollment where the consent forms contain injury language. |
| Adding a consent statement informing participants that the clinical trial will be listed on ClinicalTrials.gov | Required by FDA. 21 CFR 50.25(c). | Only studies that are required to register with ClinicalTrials.gov. For information, see the Research Tool Kit page on CHILD. |
Now available: Spanish translation of consent form template language
Spanish translations (DOC) of the current consent form template language, to help study teams update any Spanish consent documents.
New: IRB process improvements
Scope: New full review IRB process
Effective Date: September 1, 2010 — Date that new forms and processes are required
Key Improvements:
- Pre-review replaced by consultations with HSPP analysts
- Redesigned application forms
- Improved tools and templates provided
These improvements are expected to streamline the review process by eliminating the re-work inherent in pre-review and getting studies to the IRB review phase more quickly. Consultations will take place in person or via telephone prior to application submission. The purpose is to provide education and guidance to researchers. IRB submissions will now need to be in final, complete form as they will not receive a pre-review. To support this change, the IRB-ITHS Application and supporting documents have been redesigned to provide greater clarity and transparency as well as to better support investigators in the review process. Taken together, these improvements are designed to enable researchers to initiate the IRB process more effectively and to increase the efficiency of the process.
Please see the following for more detailed information:
Application Process for New Studies
Planning a new research study? Follow our step-by-step application process.
Contact Us
If you have any questions about the application process, please contact the Human Subjects Protection Program for assistance.
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FAQs
- Does my research require IRB approval?
- What happens after I submit my IRB application?
- What if there are changes to my study after I receive IRB approval?
- How do I renew or close a study?
- What if my research involves other sites besides Children’s, many with their own IRB?
- View all FAQs