Does a Child Have to Sign an Assent Form?

If a child assents to research, must they sign something?

You have explained your study to a child, answered their questions, and received a clear, affirmative “yes.” Do you now need the child's signature before participation can begin?

Not necessarily. Researchers sometimes treat a signed assent form as though it were the defining feature of child assent. It is not. The child's affirmative agreement and the documentation of that agreement are related but separate matters.

Whether a signature is required depends on the applicable regulatory framework and, importantly, the determination of the institutional review board (IRB) or research ethics committee overseeing the study.

A signature is not universally required for child assent

Obtaining assent and documenting assent are different things

Assent is the child's affirmative agreement, not the signature

Under the U.S. Department of Health and Human Services regulations, assent means a child's affirmative agreement to participate in research. Mere failure to object does not count as assent.

Nothing in that definition requires a signature. A child can sign a piece of paper without meaningfully agreeing, while another child can clearly and meaningfully agree without being able to write their name.

The starting point is therefore the difference between assent and legally effective informed consent. Assent is a process through which a capable child is given an appropriate opportunity to understand and express a choice. Documentation records that process when documentation is required.

HHS regulations leave assent documentation to the IRB

OHRP states explicitly that HHS regulations do not require documentation of assent. Instead, the IRB has discretion to determine the appropriate manner, if any, of documenting child assent.

The IRB should consider factors such as the child's age, maturity, and degree of literacy. It may require a signed assent document, permit another form of documentation, or determine that documenting assent is not warranted.

This means researchers should not create a universal signature requirement simply because their study involves children. Equally, investigators should not decide on their own to omit a signature when the IRB-approved protocol requires one.

A written assent form may make sense for adolescents

For adolescents whose understanding approaches that expected of adults, a written assent document may be entirely appropriate. OHRP indicates that when adolescents participate in research for which a consent form would have been used had they been adults, using a similar form to document assent will generally be appropriate.

The form should still reflect the adolescent's legal and ethical role in the decision. Calling the document an assent form does not turn the adolescent's agreement into legally effective informed consent when the adolescent cannot legally provide such consent.

Researchers should also remember that adolescents may need substantially more information than younger children. The assent process should correspond to what they are capable of understanding, not merely to the fact that the document is labeled “assent.”

Younger children may need a different approach

A written signature can become particularly artificial with children who cannot yet read or who have limited writing ability. OHRP advises that when young children cannot read, any documentation should take a form appropriate for recording that assent occurred.

For example, an IRB-approved procedure might allow a researcher to document in the study record that the child received an age-appropriate explanation and affirmatively agreed. The exact method should follow the approved protocol rather than an investigator's improvised substitute.

The underlying question is whether the child can meaningfully assent. Capacity for assent does not begin at one universal age, nor is it determined by whether a child can sign their name.

Verbal assent can be meaningful assent

If permitted by the IRB-approved procedure, a child's verbal agreement may constitute assent. The important element is affirmative agreement following an appropriate assent process.

HHS guidance does not impose a regulatory requirement to document that verbal assent was obtained, although an IRB or institution may require documentation for a particular study. Researchers should therefore distinguish what federal regulations require from what their own IRB, institution, sponsor, or jurisdiction requires.

An electronic assent process may also be possible

Assent does not have to be confined to paper. Joint OHRP and FDA guidance explains that electronic informed consent methods may be used to obtain pediatric assent when assent is required.

The method should not interfere with the child's ability to assent, and the language and presentation still need to be understandable to the child. If documentation is required, the IRB determines how assent should be documented. In FDA-regulated research, electronic signature and identity-verification requirements may introduce additional practical considerations.

The assent form does not need to reproduce an adult consent form

HHS regulations do not prescribe a fixed set of elements that every child assent document must contain. The IRB has flexibility to determine what information is appropriate for the children and research involved.

That flexibility should not be interpreted as permission to hide important information. Rather, researchers should communicate what the child can meaningfully understand about the research experience. For younger children, this may emphasize what will happen, how long participation will take, and whether anything may hurt or feel uncomfortable. Adolescents capable of adult-like understanding should generally receive substantially more complete information.

How this information is presented should therefore follow the child's developmental abilities. Researchers may need to explain the research differently to children of different ages even within the same study.

The appropriate documentation can change with the participant

The six-year-old's assent is not inherently weaker because it lacks the child's signature. Likewise, the 16-year-old's signature is not sufficient by itself. In both cases, the meaningful interaction comes first; documentation records what the approved process requires.

Common mistakes about assent forms and signatures

Choose documentation only after designing the assent process

When preparing a protocol, start with the child rather than the signature line. Determine which participants are capable of assent, what they need to understand, how the information should be communicated, and how they can express affirmative agreement. Then determine how the IRB expects that agreement to be documented.

Whatever method is approved, remember that assent may coexist with parental or guardian permission. A child's signed assent form does not replace required parental permission, just as a parent's signature does not establish the child's assent.

The protocol should also explain what happens if the child declines to sign or otherwise indicates unwillingness. A signature requirement should never become a mechanism for pressuring a reluctant child into participation. Where assent is required, the child's actual decision remains the central issue.

Before creating an assent signature line, check what is actually required

Frequently asked questions about signing assent forms

The signature records assent; it does not create it

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