Question:

For a pediatric trial, at what age would you recommend the use of an assent form?
– Project Manager, Device Company

Response:

The federal regulations require child assent unless it can be appropriately waived, or if capability of some or all the children is so limited that they cannot reasonably be consulted.

The regulations do not provide a set age threshold for assent and leaves it up to the IRB to decide whether to require an assent form; so, the requirement for assent forms and documentation of assent may vary across IRBs.

Assent requires that participants have at least a basic understanding of what might be asked of them, and what might happen. For that reason, WCG IRB recommends providing a simple assent information sheet that explains the research to older children and adolescents and a simple oral script for younger children.

Whether you use an assent discussion, information sheet, or assent form, you should still include the basic elements of consent; and, the information should be appropriate to the child’s maturity and cognitive level. You may also consider different assent processes for different age groups of children.

If you decide to use a form, the FDA and OHRP offer the following guidance on the question of signature documentation of assent:

“Does FDA require the signature of children on informed consent documents?

“As indicated above, researchers may seek assent of children of various ages. Older children may be well acquainted with signing documents through prior experience with testing, licensing and/or other procedures normally encountered in their lives. Signing a form to give their assent for research would not be perceived as unusual and would be reasonable. Younger children, however, may never have had the experience of signing a document. For these children requiring a signature may not be appropriate, and some other technique to verify assent could be used. For example, a third party may verify, by signature, that the assent of the child was obtained.”

Source: Institutional Review Boards Frequently Asked Questions, FDA

The Office for Human Research Protections notes that:

“…the IRB has the discretion to decide what form of documentation is required for a study; but offers the following as guidance: “If adolescents are involved in research where a consent form would have been used if the subjects were adults, it would generally be appropriate to use a similar form to document an adolescent’s assent. If young children are involved who are as yet unable to read, documentation should take a form that is appropriate for the purpose of recording that assent took place. The IRB may also decide that documentation of assent is not warranted.”

Source: Research with Children FAQs, The Office for Human Research Protections