01 · The Question
Should a six-year-old and a sixteen-year-old receive the same research explanation?
Probably not. Imagine explaining a blood draw to a six-year-old using the phrase “venipuncture for biospecimen collection.” Technically accurate, perhaps. Communicatively successful, probably not.
Now imagine giving a 16-year-old only a brightly illustrated sheet saying, “We want to learn about your health. You can help us if you want.” That may be understandable, but it could be far too superficial for an adolescent capable of engaging with the research in considerably greater depth.
Developmentally appropriate assent therefore requires more than making every sentence shorter. Researchers need to adjust how information is explained while preserving an accurate account of what participation actually involves.
03 · What You Need to Know
Developmentally appropriate does not mean merely simplifying vocabulary
Start with what the child needs to understand about the experience
For children whose developmental level limits their ability to comprehend the full nature of research but who can still be meaningfully consulted, OHRP suggests focusing on an accurate picture of what participation is likely to be like.
That may include what will happen, where it will happen, approximately how long it will take, whether anything may hurt or feel uncomfortable, what the child will be asked to do, and whether the child has a meaningful choice about participation.
This approach reflects the purpose of assent. The researcher is not trying to turn a young child into a miniature research-methodologist. The aim is to give the child enough understandable information to participate meaningfully in the decision.
There is no universal script for each birthday
Ages can help researchers anticipate developmental differences, but they should not be treated as precise cognitive boundaries. The ability to meaningfully assent does not begin at one universal age, and children of the same age may differ in maturity, literacy, communication, prior experience, and understanding.
Consequently, age bands are best treated as practical design guides rather than rigid psychological classifications. The IRB or research ethics committee may also impose specific institutional requirements for particular participant groups.
For younger children, make the experience concrete
Young children may understand immediate, observable experiences more readily than abstract concepts. Explanations can therefore focus on what the child will see, hear, do, or feel.
Instead of saying, “A biospecimen will be collected for laboratory analysis,” a researcher might explain that a trained person will take a small amount of blood from the child's arm with a needle and describe honestly whether it may hurt. Instead of discussing “study duration,” explain how long today's activity will take using a comparison the child can understand when appropriate.
Concrete language should remain accurate. Researchers should not promise “this won't hurt” merely because that sounds reassuring if discomfort is reasonably possible.
For school-age children, explain both the activities and the choice
As children become better able to understand sequences, reasons, and choices, the explanation can include more about why the research is being conducted and what participation requires.
A school-age child may be able to understand that researchers are trying to answer a question, that joining the study is different from ordinary schoolwork or clinical care, that certain activities will happen because of the research, and that the child's own agreement matters when assent is required.
Researchers should still use ordinary language and explain unfamiliar terms. More information is useful only if the child can make sense of it.
For adolescents, do not oversimplify merely because they are minors
OHRP specifically advises that when adolescents have a capacity to understand similar to adults, the assent procedure should include information similar to what would be provided for adult informed consent or parental permission.
This may include a fuller explanation of the study's purpose, procedures, duration, foreseeable risks or discomforts, potential benefits, alternatives when relevant, confidentiality, voluntary participation, and the ability to stop participating, subject to the applicable protocol and legal framework.
An adolescent capable of discussing these issues should not receive an artificially juvenile explanation merely because the document is called an assent form.
| Developmental situation |
Communication emphasis |
Possible approach |
| Younger child with limited abstract understanding |
Concrete experience |
Explain what will happen, who will be there, how long it will take, and what may feel uncomfortable. |
| School-age child able to understand reasons and sequences |
Experience plus purpose and choice |
Explain what the researchers are trying to learn, what the child will do, and that the child's agreement matters when assent is sought. |
| Older child with increasing abstract understanding |
More complete study information |
Discuss procedures, foreseeable risks, potential benefits, confidentiality, and voluntariness in increasingly detailed terms. |
| Adolescent with adult-like understanding |
Information approaching adult consent |
Provide information similar in substance to adult informed consent or parental permission, expressed clearly and appropriately. |
Use ordinary words without making the explanation misleading
OHRP recommends replacing technical terminology with ordinary language where possible. “Taking blood from your arm with a needle,” for example, may communicate more effectively than “venipuncture.”
Plain language does not require removing every scientific term. Sometimes a term matters and should be introduced, but it can be defined immediately in words the child understands.
The test is functional: after hearing the explanation, does the child have a reasonable understanding of what the research experience will involve?
Adapt the presentation, not only the words
Developmental adaptation can involve more than rewriting sentences. Depending on the child and study, researchers may use conversation, pictures, diagrams, demonstrations, short videos, electronic materials, or other communication methods approved for the research.
Electronic methods can also be used for pediatric assent. Joint OHRP and FDA guidance emphasizes that the method used should not impede the child's ability to assent and that the language and presentation must remain understandable to the child.
Visual materials should clarify rather than decorate. A cheerful cartoon needle that makes a potentially painful procedure appear painless may be child-friendly in appearance while being ethically poor communication.
Check understanding rather than assuming readability equals comprehension
Researchers should create opportunities for children to ask questions and should pay attention to whether the child actually understands the central features of participation.
This need not become an intimidating oral examination. Simple conversational prompts can reveal much more than asking, “Do you understand?” A researcher might ask the child to describe what they think will happen or what they could do if they no longer wanted to continue.
The purpose is to identify misunderstanding and explain again, not to make the child earn the right to participate by passing a quiz.
Language and culture also matter
Age-appropriate wording is not necessarily understandable wording if the child does not speak the language fluently or the explanation relies on unfamiliar cultural assumptions. Communication should account for the participant's language and relevant communication needs in addition to developmental level.
Researchers should follow applicable IRB requirements for translated materials, interpreters, and assent procedures involving participants who use languages other than the research team's primary language.
Do not confuse a shorter explanation with permission to omit consequential information
Developmental adaptation involves selecting and presenting information in a form the child can understand. It should not become a convenient reason to conceal an unpleasant procedure, meaningful discomfort, or other information necessary for the child to appreciate what participation will actually be like.
The appropriate depth will vary. The commitment to an accurate description should not.
Watch Out
“Child-friendly” should never mean deceptively reassuring. If a procedure may hurt, cause embarrassment, require repeated visits, or involve another experience important to the child's decision, explain it truthfully in terms the child can understand.
04 · A Practical Example
One research procedure, three different explanations
Hypothetical Example
Explaining a research blood draw across developmental levels
Suppose a study requires one small blood sample solely for research purposes. The core fact does not change: blood will be taken with a needle, and the procedure may cause brief pain or discomfort. What changes is how much detail the child can meaningfully use.
Younger child
“We would like to take a little bit of blood from your arm. A nurse will clean your arm and use a small needle. It might hurt or pinch for a little while. You can ask us questions before we start.”
Older school-age child
“One part of the study involves taking a small amount of blood from your arm so the research team can study it. A nurse will clean the area and use a needle. You may feel a pinch or some soreness. We can explain each step before it happens.”
Adolescent
“The study includes one blood draw for research analysis. A trained member of the team will collect the sample from a vein in your arm. Possible effects include brief pain, bruising, light-headedness, or discomfort. We can explain how the sample will be used and what information will be collected from it.”
These are illustrative rather than universal scripts. The exact information should reflect the actual protocol, its risks, the child's abilities, and the IRB-approved assent process.
Notice what does not change across the examples: none disguises the needle, pretends that discomfort is impossible, or tells the child only what would make participation sound attractive. Developmental adaptation changes the communication, not the underlying facts.
06 · What This Means for You
Design the explanation around the children you will actually recruit
Do not begin by writing one assent form and then trimming words until its readability score looks sufficiently low. Begin with the participant population and the actual research experience.
A simple decision framework
If children have limited capacity for abstract concepts
Prioritize concrete descriptions of what will happen, how long it will take, and what they may experience.
If children can understand reasons, sequences, and choices
Add understandable explanations of why the research is happening, what participation requires, and what choices they have.
If older children can engage with more complex information
Increase the detail concerning procedures, risks, potential benefits, confidentiality, and voluntariness as appropriate.
If adolescents demonstrate adult-like understanding
Provide information similar in substance to adult informed consent or parental permission while maintaining the appropriate assent framework.
If the age range is broad
Consider more than one communication approach or assent document rather than forcing all participants into a single developmental level.
Your protocol should explain how information will be adapted, particularly when the study recruits children across substantially different developmental stages. The IRB should be able to see not only what researchers intend to tell children but why the communication is appropriate for the proposed population.
Also plan for children who communicate differently from the assumptions built into a standard written form. An inability to engage with one format does not necessarily establish an inability to assent.
Finally, make room for an actual response. Assent is not a lecture delivered to a child before adults proceed with a decision already made. If the child is capable of assent, the explanation should culminate in a genuine opportunity to agree or decline. When a child does not verbally refuse but clearly appears unwilling to participate, researchers should not use the absence of the word “no” as evidence that the communication process succeeded.
07 · A Quick Checklist
Before explaining a study to a child, check the communication
Before using an assent explanation, check:
Identify what the child needs to understand about the actual experience of participation.
Match the level of detail to developmental ability rather than chronological age alone.
Replace unnecessary technical terminology with accurate ordinary language.
Describe relevant pain, discomfort, inconvenience, or other experiences honestly rather than making them sound harmless.
Give older children and adolescents enough information for the level of understanding they actually possess.
Consider language, literacy, communication needs, and appropriate presentation formats in addition to age.
Provide opportunities for questions and use conversational methods to identify important misunderstandings.
Verify that all assent materials and procedures follow the IRB or research ethics committee's approved approach.