As of March 1, 2016, all work – new applications, modifications, renewals, etc. – will need to be submitted to the IRB via Click unless otherwise directed by the HSPP staff. The items available here are for use with the legacy system only. Do not upload these documents into Click, or you will be asked to withdraw your submission and re-submit using Click documents. Updated materials needed for use with Click IRB submissions are available in the Click Library. For a complete listing of the documents available in the Library, view the Click Document List (XLSX).
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 August 2017
- 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 August 2017
- 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.
When using the short form consent process for any legacy IRB studies, please use the appropriate Short Form Consent Cover Sheet, Short Form Consent Form, and Short Form Assent (if necessary).
Note that if your study was initiated in the Click IRB electronic system, you should refer to the short form consent and assent forms that appear on the Click IRB Resources page. If you have any questions about which short forms to use, please email the IRB.
- Information Sheet (DOC), revised June 2017
- Developed for when you are requesting to get consent without a signature requirement (waiver of documentation of consent). This form will serve as an information sheet for participating subjects and has all of the elements of consent, but the researcher and the participant are not required to sign the form. This is typically used for minimal risk research for which written consent is not required outside of the research context (e.g. survey studies).