Informed Assent Form Template for the United States

An Informed Assent Form is a specialized legal document you'll need when conducting research involving minor participants under 18 years of age. Unlike standard informed consent forms designed for adults, this document uses age-appropriate language to help children and adolescents understand what participation in your research study involves. You must obtain both the minor's assent and parental permission to legally include young participants in most research studies.

When do you need this document?

You need an Informed Assent Form whenever your research study involves participants under 18 years old. This applies to academic research, clinical trials, psychological studies, educational research, and medical device testing. If you're conducting a study at a university, hospital, or research institution that involves collecting data from minors through surveys, interviews, medical procedures, or behavioral observations, you must use this form. The document becomes particularly crucial in pediatric clinical trials, school-based research programs, and developmental psychology studies where children's participation is essential to the research objectives.

Key legal considerations

Your Informed Assent Form must clearly explain the study purpose, procedures, duration, and any potential risks or benefits in language appropriate for the child's age and maturity level. You need to emphasize that participation is completely voluntary and that the minor can withdraw at any time without penalty. The form should address confidentiality protections, including how the child's information will be stored and shared. You must also explain any compensation or incentives offered for participation. Remember that assent is not legally binding consent – you still need separate parental permission forms. The document must be approved by your institution's Institutional Review Board (IRB) before use, and you may need different versions for different age groups within your study population.

Legal requirements in United States

Under federal regulations 45 CFR 46 (the Common Rule) and 21 CFR 50, you must obtain informed assent from minors capable of providing it, typically children 7 years and older, though IRBs may set different age thresholds. The form must comply with HIPAA Privacy Rule requirements if you're collecting health information. Your research institution's IRB will determine the specific assent requirements based on the research risk level, participant age range, and study nature. Some states have additional requirements regarding the age of assent or specific protections for minors in research. FDA-regulated studies involving children must follow additional FDA guidance on pediatric research. The form language must be appropriate for the target age group, and you may need to create multiple versions for different developmental stages within your participant population.