Assent

The regulations define when assent of children will be required and when it can be waived. The IRB can waive the requirement for assent if either:

• some or all of the children will not be capable; or
• under some circumstances, when the study holds out the prospect for direct benefit that is important to the health or well-being of children, and is available only in the context of research; or
• the research meets the same requirements as waiver of consent.

If you want the IRB to waive assent for some or all participants, you need to describe this in your protocol and specify the conditions for the waiver. If there is no waiver, you must obtain assent from the children.

According to 45 CFR 46.408(b) and 21 CFR 50.55(e), the IRB might decide that permission from one parent is enough for certain types of research. However, for other types of research, you need permission from both parents unless specific exceptions apply. At NIH sites, if parents share joint legal custody, both must give permission unless exceptions are met.

45 CFR 46.408(c) allows the IRB to waive parental permission if it’s not reasonable for the research, if there is another way to protect the children. This is often used for studies involving teenagers but can also apply to younger children who are abused or neglected. For teenagers, assent is usually enough. For younger children, you might need someone else, like an advocate, to protect them. This provision doesn’t apply to FDA-regulated research.

The documentation requirements for parental permission under 45 CFR 46.408(d) and 21 CFR 50.55(f) are the same as for consent of adult subjects.

The IRB recognizes that the abilities and needs of children vary widely, so investigators, when obtaining assent from a minor, should provide study information in a format tailored to the child that is in front of them. When creating your plan for obtaining assent, consider the following guidelines:

1. Tailor Information to the Child: Provide study information in a way that suits the child’s age and understanding. Recognize that children's abilities and needs can vary widely.
2. Submit a Proposal: In your protocol, describe which age groups can give assent, and which cannot. This should depend on the research type, complexity, and the children involved. Even if children are too young to give formal assent, explain the research in a way they can understand.
3. Use Age-Appropriate Forms: At the NIH, the IRB prefers that you create written assent forms suitable for the child's age. Use the provided template for children around a certain age (fill in the specific age range). There are no strict rules about what must be included in an assent document, so only include relevant information. Write the form in simple language to ensure it is easy for the children to read and understand.
4. Reading Level Considerations: Aim to write the regular consent document at about an 8th-grade reading level. For older children (specify age or grade), you might use the regular consent form as their assent document, as they can read and understand it.

By following these steps, you can ensure that the process of obtaining assent from child participants is clear, appropriate, and respectful of their developmental stages.