Federal guidelines (45 CFR 46.408) require that in addition to obtaining parental permission for children to participate in research studies, assent must also be obtained from minors when the IRB determines that a child is capable of providing assent. The IRB requires that one of the following methods be used in obtaining child assent:
- Use a parental consent document that also includes a child assent statement
When using the combined-document method, the assent statement should be written in age-appropriate language, addressing what the child is being asked to do and the rights of the child not to take part in the study. The parental consent section of the document should contain a signature line for the parent or legally authorized representative (LAR), and the assent section of the document should contain a line on which the child signs. Click here for a sample of this type of document.
- Use a parental consent document and separate child assent document
When a separate assent document is utilized, the researcher should ensure that the name of the consenting parent appears on the assent that is signed by the minor (as surnames may differ). The links below provide samples of assent written in age-appropriate language.
Researchers are required to obtain parental permission prior to obtaining child assent, and minors are not required to take part in a study for which a parent has given consent. All questions regarding use of assent should be directed to firstname.lastname@example.org or to the IRB Administrator at (678) 797-2268.