Guidance

Assent of Children in Research

IRBMED
Apr 12, 2013 10:15 am

The IRBMED has developed an assent template for researchers to use in developing an assent document appropriate for children ages 10 to 14. It is available here. Below are frequently asked questions about assent. More information is available here.

  • Why must IRBs and researchers consider assent?

    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 §46.408 & 21 § 50.55

     

  • What is assent?

    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’s authority to say “No” to participating in research. 45 CFR 46.402(b), 21 CFR 50.3(n)

  • What is an assent process?

    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 is not identical to the consent process. Parents retain responsibility to protect the child from risks. The assent should focus on elements important 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.

  • What if the parent and child disagree?

    “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, even if his or her parents or guardian have granted permission, the child’s decision prevails,” HHS Office of Human Research Protections (OHRP).

  • How does the IRB determine when children are capable to assent?

    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 guidelines that the IRB and researchers may use to determine whether to require assent.

     

  • When can the IRB waive assent?

    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. (NCI)
    • 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
  • How do researchers communicate assent plans to the IRB?

    In section 10.2.2., 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).

     

    Original 8/29/08

    Updated 4/12/2013

Questions?

Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)
2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.

Edited By: bpsea@umich.edu
Last Updated: January 23, 2019 1:00 PM