Waiver of Assent

The regulations for waiver of assent are contained in Subpart D which enumerates the special protections for children in research. There are three ways in which the IRB can waive assent for some or all of the subjects.

45 CFR 46.408: Requirements for permission by parents or guardians and for assent by children

(a) In addition to the determinations required under other applicable sections of this subpart, 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. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances in which consent may be waived in accord with #46.116 of Subpart A.

Waiver of Assent for FDA-regulated Studies

21 CFR 50.55: Requirements for permission by parents or guardians and for assent by children

(c) The assent of the children is not a necessary condition for proceeding with the clinical investigation if the IRB determines:

  1. That the capability of some or all of the children is so limited that they cannot reasonably be consulted,

    or

  2. That the intervention or procedure involved in the clinical investigation holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the clinical investigation.

Waiver of Assent Criteria

Some or all of the children aren't capable of providing assent:

  • Per Emory policy, if the child is younger than 6 years old, assent is not required. If the child is 6 to 10 years old — must obtain subject's verbal assent, unless a waiver is deemed appropriate. Likewise, if a child is 11 to 17 years old you must obtain subject's signature on the assent form to document assent, unless approved to waive.

  • The research may be complicated or the subject population may have limitations which make the likelihood that they can comprehend the research sufficiently to provide assent. In that case, a waiver may be appropriate.

Research is approved under 21 CFR 50.52 or 45 CFR 46.405:

The research (1) holds out the prospect for direct benefit to the child, (2) the benefit is important for the child's health and (3) the benefit is only available in the research. This usually means that the investigational agent(s) are only available in the context of the research.

  • All three conditions must be met;

  • This is a common scenario for clinical trials of investigational drugs or devices for life-threatening conditions such as treatment of cancer;

  • The IRB will generally but not always require assent for a Phase 1 oncology trial. The prospect for direct benefit is often quite a bit less than for a Phase 3 trial and there are generally alternatives outside of the trial. However, there are situations where the trials in adults or other Phase I trials in children demonstrate substantial likelihood of clinical benefit which provides a basis for waiver of assent.

The research meets the criteria for Waiver of Consent under 45 CFR 46.116(d)

  • Waiver of assent may be requested along with waiver of consent. The most frequent example for this waiver is for studies that are limited to the retrospective review of records.

  • Waiver of assent may also be requested in situations where consent (parental permission) will be obtained. For example, it may not be practicable for the investigator to obtain the assent of the child for a telephone survey.