In research where child assent is being obtained, parental permission is required (unless waived). Parents will sign the Informed Consent Document in two places. One is the signature of consent, and one is an attestation that their child has received a proper explanation covering all points of the assent information sheet and has agreed to participate.
Researchers should carefully consider and propose adequate provisions for obtaining the assent of children prior to their participating in research. The eIRB application should address whether the intended subject population of children would be capable of understanding the nature of their participation in the research, and if so, whether or how assent will be obtained.
Researchers should use the age-appropriate assent templates listed below. Each point should be discussed with the minor in an age appropriate manner and all questions answered by the research team. Agreement to participate should be documented in the research record. Not requiring a written signature does not alleviate the responsibility to appropriately assent minors for study participation. There are assent information sheet templates for both clinical and non-clinical studies for two age groups; Adolescents aged 15 - 17 and Children ages 7 - 14. Assent is not required for children aged 6 and under.
Please note: for studies involving drugs with known teratogenic effects (i.e., category x or like drugs), the adolescent assent should be used for children ages 10-17, and the child assent for those ages 7-9. The adolescent assent will have explicit reproductive risk language, and the child assent will not. Additional instruction is in the assent template.
Researchers conducting studies prior to policy changes may continue using currently approved assent forms and processes for their studies, including obtaining the minor's signature, as approved by the IRB.
New Assent Templates:
Adolescents - Age 15 - 17
Children - Age 7 - 14