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IRB Consent and Assent Forms

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IRB Consent and Assent Forms

Note: Research teams are expected to use the relevant Seattle Children’s templates provided here for all new studies. Forms that do not conform to these templates will only be approved if the IRB finds that the research team has provided a compelling reason for the use of such forms. Thus, research teams should provide this information to the IRB with their new study submissions.

  • Consent, Assent and Parental Permission Template (DOC), revised February 5, 2013
    • This template provides the essential skeleton for building a consent, assent and parental permission form for your study. The template contains all the required elements of consent and required institutional language and meets readability standards for 8th-grade reading level or lower. It is also recommended that the research team utilize the Language Resource Text for assistance with wording for commonly used concepts and terms. 
  • Assent Form Template (DOC), revised February 5, 2013
    • Developed for young people (7 to 13 years of age) who can read. This template will assist you in developing simple written assent forms for young people you present with the option of research.
  • Parental Permission Only Template (DOC), revised February 5, 2013
    • This template is similar to the Consent, Assent and Parental Permission Template. It can be used when 1) the parents/guardians are the only person(s) presented the option of having their child participate in a study, or 2) assent is required but can best be documented by use of the Assent Form Template. The Parental Permission Only Template should not be used when assent for those 14 years or older will be documented on the same form as parental permission or if there is a potential to have participants 18 years or older.
  • Parent Participant Consent Addendum (DOC)
    • This addendum is for research teams who are asking parents to participate in the research by providing medical history, filling out certain types of questionnaires/surveys, or providing blood or urine samples (note: DNA testing is not eligible). You may need a separate consent form for parents depending on what their participation would entail.
  • Language Resource Text (DOC), revised August 9, 2013
    • The Language Resource Text is meant to work with the templates, providing language below the 8th-grade reading level for commonly used concepts and terms. It is a resource for language that you can incorporate into study documents as needed based on the specifics of your study.
  • Spanish Translation of Consent Form Template Language (DOC), revised May 29, 2012
    • Spanish translations of the current consent form template language, to help study teams update any Spanish consent documents.
  • Glossary Resource (DOC)
    • A list of plain-language alternatives for hundreds of words typically used in medical and research settings. This is a resource for language that you can incorporate into study documents as needed based on the specifics of your study.
  • Short Form Consent Cover Sheet – For Use with Language Minorities (Limited- or Non-English-Speaking Families) (PDF), revised July 10, 2009
    • To be provided with the Short Form Consent.
    • The short form consent cover sheet has been translated into the following languages:
  • Short Form – Consent for Use with Language Minorities (Limited- or Non-English-Speaking Families) (DOC), revised May 12, 2011
    • Developed for situations where you did not anticipate recruiting families who do not speak English, and there is not sufficient time to obtain a certified translation of the approved English consent form.
    • The short form consent has been translated into the following languages:
  • Short Form – Assent for Use with Language Minorities (Limited- or Non-English-Speaking Families) (DOC), revised May 12, 2011
    • Developed for younger children (7 to 13 years of age) who can read to be used in situations where you did not anticipate recruiting families who do not speak English, and there is not sufficient time to obtain a certified translation of the approved English assent form.
    • The short form assent has been translated into the following languages:
  • Emergency Use Consent Form Template (DOC), revised November 2012
    • Use this template to prepare a consent form for use in emergency situations, i.e., a life-threatening situation for which no standard acceptable treatment is available, and there is not sufficient time to obtain IRB review and approval.
    • The FDA allows one emergency use of an investigational drug, biological product or medical device without prospective IRB approval.
    • See Emergency Use of Investigational Drugs, Biologics or Medical Devices (PDF) for details on emergency use approval.

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