How do I create consent or assent documents?
Use the template “TEMPLATE: Biomedical Consent Document (HRP-592)” for Biomedical Research, “TEMPLATE: Social Behavioral Consent Document (HRP-582)” for Social Behavioral Research, or “TEMPLATE: Social Behavioral Consent Document with HIPAA Authorization (HRP-1721)” for Social Behavioral Research requiring a HIPAA Authorization, to create a consent document. Each template consent document contains information that is generally relevant to each type of research.
Ensure that you write the consent document using terms that all potential participants can understand to make an informed decision. You should write the consent forms in lay language at or below an eighth-grade reading level and define complex terms at their first use. See the IRB Office’s Quick Guide for Writing Consent Forms in Lay Language webpage..
Note that all consent documents and summaries for short form consent documents must contain all of the required and additional appropriate elements of informed consent disclosure. Review the “Long Form of Consent Documentation” section in the IRB’s “WORKSHEET: Criteria for Approval (HRP-314)” to ensure that you address these elements. In addition, when using the short form to document consent, you must include the appropriate signature block from one of the template consent documents above on the short form.
The IRB Office recommends that you date the revisions of your consent documents to ensure that you use the most recent version approved by the IRB. The IRB Office also will watermark consent documents with IRB approval and expiration date if applicable.
Include the appropriate signature block from the consent document template in the consent document you submit for review.
Refer to the Guidance on Children as Research Participants, Parental Permission, and Child Assent on consent procedures when working with children. Study teams are encouraged to develop a separate assent document, when appropriate in consideration of the research context, to support the informed consent and assent process. When developing an assent form, please keep in mind the audience you are writing for and ensure the language is understandable to them.