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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 CommissionAll 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.govRequired 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: Oaths of Confidentiality are no longer required

Oaths of Confidentiality of any kind (including Recruitment) are no longer required to be submitted to the IRB. 

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 
 

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