Assent of Children in Research

Federal regulations require, “The IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent.” The IRB must make the determination for each protocol that includes children. The IRB must require child assent unless it can be appropriately waived. 45 CFR 46.408 & 21 CFR 50.55

“Assent” means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. This means the child must actively show his or her willingness to participate in the research, rather than just complying with directions to participate and not resisting in any way. A child has authority to say “No” to participating in research. 45 CFR 46.402(b), 21 CFR 50.3(n)

It is a reasonable effort to enable the child to understand, to the degree they are capable, what their participation in research would involve. It does not constitute a consent process and may involve different procedural elements. Parents retain responsibility to protect the child from risks. The assent should focus on elements relevant to the child (e.g. pain, time). Foremost, when assent is required by the IRB, parents and researchers must adhere to the child’s decision.

“If a child is capable of assent and the IRB requires that assent be sought, it must be obtained before the child can participate in the research activity. Thus, if the child dissents from participating in research or does not provide a sufficiently affirmative agreement, even if his or her parents or guardian have granted permission, the child’s decision prevails,” HHS Office of Human Research Protections (OHRP): Frequently Asked Questions: Children in Research

Regulations direct IRBs to consider:

• Age and maturity of the children
• Psychological state of the children
• Nature of the proposed research activity

Regulations give IRBs flexibility in deciding which children an investigator must assent. A judgment may be made for all children to be involved in research under a particular protocol, or for each child. The IRB’s outcome should be suited/delineated for the study at hand.

Click here for a table showing common IRB determinations whether to require assent, based on the age of the participant and whether the study offers the prospect of direct benefit.

There are 3 waiver options:

1. Capabilities of some or all children is so limited they cannot be consulted.

2. Study offers important benefit unavailable outside of the research.

• When the study offers a treatment that is thought to be a better option than those currently available, or it offers the only alternative.
• Criterion of ‘potential direct benefit’ is not sufficient to grant this waiver.

3. Assent can also be waived under the same criteria as a consent waiver:

• the study is minimal risk
• subjects’ rights and welfare aren’t adversely affected
• assent is not practicable (for reasons other than children’s capabilities)
• if the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable form
• when appropriate, the subjects will be provided pertinent information

In section 10.2, eResearch prompts researchers to describe the process to seek and obtain informed assent for children and
parental consent/permission (e.g., setting, timing, personnel involved, arrangements for answering
subject questions before and after the consent is signed).