Assent means a minor’s (e.g., child, youth, adolescent under the age of 18) affirmative agreement to participate in research (45 CFR 46.402(b)). To assent, the minor must actively show a willingness to participate in the research and not just comply with directions to participate.

A researcher working with preschool children recently visited my office. She was looking for suggestions on how to determine assent with young study participants. After obtaining parent permission to work with the child, I suggested she consider the following approaches: 

1. Observe the child’s typical behavior
2. Ensure the verbal assent script is age-appropriate 
3. Pay attention to the child’s verbal and nonverbal behaviors when reciting the verbal assent script
4. Ask if the child understands
5. Pause and compare the child’s responses to typical behavior  
6. Evaluate if the child is showing signs of distraction (e.g., fidgeting), discomfort (e.g., frowning), boredom (e.g., yawning), or confusion (e.g., furrowed eyebrows)
7. Respond to the child’s needs and wants (e.g., repeat information, take a break, or stop)
8. Respect the child’s decision to continue or stop the study
9. Repeat study procedures or stop the study entirely if the child wants to withdraw
10. Confirm the child understands the next steps (e.g., either the study will continue or stop)
11. Double-Check the child understands the next step (e.g., offer verbal and visual assenting options, such as “red light, yellow light, green light”)
12. Document the child’s assent

The assent process is an ongoing, respectful, and interactive conversation between the researcher and the child, young adult, or adult lacking the capacity to give informed consent. Researchers should ensure each individual understands the research study and what participation will involve.

— Dr. Myra Luna Lucero