Revised Assent Process
As of October 2012, the SLU IRB no longer requires written documentation from children for the assent process. 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.
See Guidelines for Studies Including Minors.
Researchers should begin using the new SLU age-appropriate assent information sheets 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.
For studies that pre-date this policy change: Researchers may continue using the currently approved assent form and process for the study, including obtaining the minor's signature if it was required. If the decision is made to change the assent process to match the current policy, an amendment should be submitted in eIRB that changes the information on the consent and assent forms.
New Assent Templates:
Adolescents - Age 15 - 17
Children - Age 7 - 14