Contains Nonbinding Recommendations
parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal
responsibility for the care and custody of the child (21 CFR 50.55(e)(2)).
76
The general requirements for informed consent, found in 21 CFR 50.20, 21 CFR 50.25 and 21 CFR
50.27, apply to parental permission (21 CFR 50.55(e)-(f)). When obtaining parental permission, in the
event the parents of a child do not understand English, the parental permission must be obtained and
documented in language that is understandable to the parents (21 CFR 50.20). The child who will be
participating in the research should not be used as an interpreter for the parent, even if the child is fluent
in English and may be able to assent. Similarly, if child assent is required, the information given to the
child should be in language that is understandable to the child.
“Assent” means a child’s affirmative agreement to take part in a clinical investigation, not just the failure
to object (21 CFR 50.3(n)). Child assent, when appropriate, and parental (or guardian) permission taken
together meet the ethical requirement to obtain informed consent. Absent a waiver of the assent
requirement (21 CFR 50.55(d)), the IRB must determine that there are adequate provisions for soliciting
the assent of children when, in the IRB’s judgment, the children are capable of providing assent (21 CFR
50.55(a)). In deciding whether children are capable of providing assent, the IRB must consider the ages,
maturity, and psychological state of the children to be involved in the clinical investigation (21 CFR
50.55(b)).
77
A child does not need to fully understand the clinical investigation in order to provide assent,
provided the child is capable of understanding the interventions and the related procedures. For example,
a child may be able to understand and provide assent if the child understands and agrees to the
interventions and/or procedures in the trial (e.g., drawing a blood sample for a test), even though the child
may not be capable of understanding a randomized clinical trial.
An IRB may determine that assent is not necessary or may waive the assent requirement in certain
situations (21 CFR 50.55(c) and (d)). For example, the assent of children is not a necessary condition for
proceeding with a clinical investigation if the IRB determines 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 (21 CFR
50.55(c)(2)). Also, the IRB may waive the assent requirement for children capable of assenting if the IRB
finds and documents that the clinical investigation involves no more than minimal risk to the subjects; the
waiver will not adversely affect the rights and welfare of the subjects; the clinical investigation could not
practicably be carried out without the waiver; and, when appropriate, the subjects will be provided with
76
For additional discussion on what is meant by “not reasonably available,” see the Secretary’s Advisory
Committee on Human Research Protections (SACHRP) recommendations at
https://www.hhs.gov/ohrp/sachrp-
committee/recommendations/attachment-d-november-13-2018/indes.html.
77
FDA recognizes that IRBs may adopt procedures setting an age below which children are presumed incapable of
providing assent.