Understanding Assent in Children's Healthcare
When a child is asked to take part in medical research or treatment, the process involves more than just a parent's signature. Informed assent—a child's affirmative agreement to participate—represents a crucial ethical practice that respects children as individuals with evolving autonomy 1 6 .
International ethical standards recognize that minors have the right to be heard and to have their opinions taken into consideration, progressively according to their age, maturity, and discernment 1 .
Assent is fundamentally different from consent. While informed consent is the legally valid permission obtained from adults or legally authorized representatives, assent is the affirmative agreement from someone who cannot provide legally binding consent, such as a minor 6 9 .
The core purpose of assent is not to transfer decision-making authority to the child, but to respect their developing capacity for self-determination 1 .
Information must be presented in a way the child can understand, using language, examples, and concepts suited to their age and cognitive ability 7 .
A common question in both research and clinical settings is: at what age should we begin seeking a child's assent? While regulations don't specify an exact age, most guidelines suggest around age 7 as when children begin to be capable of providing meaningful assent 1 2 .
Children in this age range may have limited ability to fully comprehend research complexities but should be consulted about participation. The focus should be on conveying an accurate picture of what the actual experience will be like using familiar examples 7 .
Adolescents typically have longer attention spans, larger vocabularies, and better reasoning abilities. The assent procedure for this group should include information similar to what would be provided to adults, but written in age-appropriate ways 7 .
Even children younger than 7 can benefit from developmentally appropriate involvement. For preschool children (ages 3-6), visual representations like smiley or frowny faces may help interpret willingness 7 .
A crucial study published in the Journal of Adolescent Health aimed to better understand perspectives of adolescent research participants and their parents about assent and parental permission 3 .
Researchers conducted structured interviews with 177 adolescent-parent pairs from the NIH Clinical Center and Seattle Children's Hospital 3 .
The findings provided unprecedented insight into how assent processes are actually experienced by families:
| Aspect of Decision-Making | Teen Perspective | Parent Perspective |
|---|---|---|
| Preferred Decision Model | Normally made decision together with parents | Normally made decision together with teen |
| Satisfaction with Process | 95% satisfied with learning process | Generally satisfied with process |
| Information Desired | Less detail about goals, procedures, risks | Wanted more information about all aspects |
| Pressure to Participate | 25% reported pressure from parents or staff | Not reported as significant issue |
| Signature Preference | Only 2% preferred not to sign consent form | Not specifically addressed |
Perhaps the most concerning finding was that about 25% of teens reported feeling pressure to enroll in research 3 . This pressure came not only from parents or relatives but also from doctors, nurses, and research teams.
Effective assent requires careful attention to how information is communicated to children. The Teachers College Institutional Review Board provides compelling examples of how to translate standard consent language into terms children can understand:
| Standard Consent Language | Youth-Friendly Assent Language |
|---|---|
| "This study is being done to determine how student organization skills and study habits affect their grades." | "We are trying to learn about how students study." |
| "Your participation is voluntary. You can leave the study at any time..." | "You do not have to be in this study if you do not want to. Nothing bad will happen to you if you say no..." |
| "The principal researcher will keep all written materials locked... All information... will be held strictly confidential..." | "I will keep the information I collect safe and secure. I will not share information that has your name on it..." |
| "You might feel embarrassed to share personal information. You do not have to answer any questions..." | "You could feel uncomfortable, afraid, lonely, or hurt. It is okay for you to not answer a question." |
A rapid systematic review published in BMC Medical Research Methodology analyzed interventions designed to improve comprehension in assent processes . The review examined 19 studies from seven countries comprising 2,805 participants .
| Intervention Type | Examples | Effectiveness |
|---|---|---|
| Enhanced Paper Forms | Simplified text, illustrations, Q&A format, comics | Mixed results; some studies showed significant improvement while others found no difference |
| Multimedia Approaches | Videos, interactive computer programs, avatar dialogues | Generally positive results, especially with interactive exercises |
| Process Improvements | Interspersed questions, separate parent-teen sessions | Positive effects for interspersed questions; separate sessions helped older teens |
| Visual Aids | Pie charts to explain probabilities | Pie charts were easiest for children to understand |
The review concluded that while some interventions show promise, improving assent comprehension is an under-researched area with limited reliable evidence . However, the findings suggest that multi-modal approaches—combining clear language, visual aids, and interactive check-ins—likely work best.
An essential aspect of meaningful assent is respecting a child's dissent—their objection to participation 6 . Even children who are too immature to provide full assent may be able to register an expression of disapproval 6 .
A child's dissent carries substantial weight and requires a lesser level of understanding than assent 6 .
There are exceptional circumstances where overriding dissent might be justified, such as when an intervention offers direct benefit that is important to the child's health and is available only in the research context 6 .
Researchers and clinicians should be attentive to both verbal and non-verbal cues of dissent:
Children who understand what will happen to them and feel some control over the process typically experience less fear and anxiety 1 .
Involvement in decision-making provides children with practice in making important decisions, contributing to their developing autonomy 6 .
Meaningful assent ensures that children are not merely subjects of research but respected participants whose perspectives matter.
Collaborative decision-making that includes both parent permission and child assent supports family-centered care 1 .
As one bioethicist suggests, we might better think of assent as "developmentally appropriate involvement in decision making" rather than just a procedural requirement 6 . This shift in perspective emphasizes the ongoing conversation and respect for the child's developing personhood rather than merely obtaining a signature on a form.
The evolution of assent practices continues as researchers develop more effective ways to involve children in decisions about their healthcare and research participation. The growing recognition that children have the right to be heard in matters affecting them represents a significant shift toward more ethical, respectful, and patient-centered care for all ages.
As the evidence base grows, we can expect more refined approaches to communicating with children about complex medical concepts, more nuanced understanding of how children develop decision-making capacity, and more meaningful ways to include even very young children in decisions about their bodies and experiences.
What remains clear is that the fundamental principle of respect for persons applies to individuals of all ages—and that listening to a child's voice, whether saying "yes" or "no," is an essential practice that honors their dignity and developing autonomy.