Fundamental Process

Adults provide consent to participate in research.

Parents or legal guardians provide permission for their children to participate in research. (Parental permission must be secured before a researcher asks children if they are willing to participate.)

Children provide their assent. (They cannot legally consent.) The absence of dissent does not constitute assent.

How it Works:

There are two fundamental steps in every adult consent, parental permission, and child assent process. A researcher will:

1. Present information that potential subjects need to make a decision about whether to participate in research and give them the opportunity to ask questions. This presentation can take various forms, such as a conversation, a printed document, a screen of information on a computer.

2. Document that the person received the information and agreed to be in the study. Documentation is usually a written form that a subject signs.

Exceptions to the Rule:

Both steps outlined above can be waived by an IRB. For example, when research takes place over the Internet, the requirement to document consent using a signed form may be waived. Some children may not be old enough to provide meaningful assent so it would not be necessary to present them information about the study. There are situations in which documentation may be audio-recorded or filmed, for example, if the subjects are not literate. Details about waivers are provided below.

What is a Child?

Children are persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research will be conducted. Generally, though not always, the age of consent is the age at which minors reach the age of majority and are considered adults. In the United States, state law dictates the age of majority. In most states, the age of majority is 18 and a 17 year old is considered a child when applying the federal regulations for protecting research subjects. (Children younger than 18 years old may become emancipated minors and awarded the rights of adults to consent to research participation.)

The age of majority might be quite different in other countries. It is also possible that a nation may have no legal definition of majority. In such cases researchers will have to rely on community standards.

Exactly the same information that must be provided to adults providing consent.

The primary difference between consent and parental permission is that “you” is replaced by “your child.” For example:

“I will read four vignettes to your child about conflicts that happen on the playground. After each vignette I will ask your child to tell me what goal your child would have if he or she was a child in the vignette.”

“I will record your child’s responses, but not his or her name.”

Yes. For example:

There are no regulations that require specific content in a child assent form or script. However, children need the same kind of information that you would give an adult. For example, they need to know who you are, why you are asking them to be in your study, and what you want them to do. They need to know that they don’t have to be in your study and they need to have the chance to ask questions. They also need to know that their parents have said that it is okay with them if their children want to be in the study.

The assent procedure must be designed for the age and maturity of the children in the study and must be culturally appropriate. This means that you need know quite a bit about the children you will ask to be in your study.

You may need more than one child assent process if you have children of varying ages in your study. For example, you may need a simple oral script for young children and an assent form comparable to an adult consent form for older adolescents.

Yes.

An IRB may decide that child assent is not required because a child is not capable of providing assent.

The regulations offer the following guideline: "In determining whether children are capable of assenting, the IRB should take into account the ages, maturity, and psychological status of the children involved."

Even if children are capable of providing assent, the requirement to secure assent may be waived by an IRB, for example in a cultural context in which children, unlike in the United States, are not expected to make independent decisions about research participation. 

Child Assent

Documentation of child assent is not required by the federal regulations for protecting research subjects. It is appropriate to ask older children, such as high schools students, to sign assent forms. An oral assent process is appropriate for young children and children of any age who cannot read.

Parental Permission

Documentation of parental or guardian permission for children to become research subjects is generally required, although there are exceptions. For example, the requirement to document parental permission may be waived by the IRB if: