When Do Children or Adolescents Need Both Assent and Parental Permission?

When do you need both the parent's permission and the child's agreement?

Suppose a parent signs the paperwork allowing a 14-year-old to join your study. The adolescent understands what participation involves and is capable of making a meaningful choice. Can you enroll them immediately, or must the adolescent also agree?

In many studies involving children, the answer is that both decisions matter. The parent or guardian provides permission, while a child who is capable of assent affirmatively agrees to participate. Neither should automatically be treated as a substitute for the other.

But “always get both” is also too simple. Whether both are required depends on applicable law and regulations, the child's capacity to assent, the nature of the research, and any determinations or waivers made by the institutional review board (IRB) or research ethics committee.

Both are generally needed when parental permission is required and the child can assent

Think of assent and parental permission as two separate requirements

Parental permission and child assent answer different questions

In research involving children, parental permission and child assent should not be collapsed into one decision. Parental permission is the agreement of a parent or guardian to the child's participation. Assent is the child's affirmative agreement to participate when the child is capable of providing it.

The distinction matters because a parent's authorization does not tell you whether the child wants to participate. Likewise, a child's willingness does not ordinarily give the researcher the legal authorization that parental permission provides when such permission is required.

Understanding the underlying difference between assent and legally effective consent is therefore the starting point.

Under HHS rules, capable children generally should be asked for assent

For research covered by the U.S. Department of Health and Human Services regulations for children, the IRB must determine that adequate provisions are made for soliciting children's assent when, in the IRB's judgment, the children are capable of providing it.

The IRB considers the children's ages, maturity, and psychological state. It may make a general determination for children included in a protocol or determine capacity individually when appropriate.

This means that researchers should not independently decide that assent is unnecessary merely because obtaining it would complicate recruitment. Nor should they assume that every child is capable of assent simply because the protocol includes an assent form. The question of whether a child can meaningfully assent requires a capacity judgment rather than a signature alone.

Parental permission is ordinarily also required

Under HHS Subpart D, when parental permission has not been waived, adequate provisions must be made to obtain permission from each child's parents or guardian in accordance with the applicable regulatory category.

The number of parents whose permission is required can differ according to the category of research. For research approvable under 45 CFR 46.404 or 46.405, the IRB may determine that permission from one parent is sufficient. For research under 45 CFR 46.406 or 46.407, permission generally must be obtained from both parents unless one parent is deceased, unknown, incompetent, not reasonably available, or only one parent has legal responsibility for the child's care and custody.

That distinction is easy to miss. “Parental permission required” does not necessarily tell you whether one or two parents must provide it.

An exception to assent does not automatically waive parental permission

This is one of the most important distinctions for protocol design. Assent and parental permission are separate requirements with separate regulatory pathways.

Under HHS regulations, an IRB may determine that assent is not a necessary condition when the capability of some or all of the children is so limited that they cannot reasonably be consulted. The regulations also identify circumstances involving an intervention or procedure that offers an important prospect of direct benefit and is available only in the research context. Assent may additionally be waived when the applicable requirements for waiver of consent are satisfied.

None of those determinations automatically means that parental permission disappears. Researchers still need to establish whether parental permission is required.

A waiver of parental permission does not automatically waive assent

The reverse is equally important. An IRB may, under specified circumstances, waive parental or guardian permission. HHS regulations include provisions for situations in which parental permission is not a reasonable requirement for protecting the child subjects, such as certain research involving neglected or abused children, provided appropriate protections are substituted and the waiver is consistent with applicable law.

If parental permission is waived, however, a capable child's assent may still be required. The detailed conditions for waiving parental permission in research with minors therefore need to be considered independently from the assent determination.

Sensitive adolescent research may require particular care

Some studies involve topics for which requiring parental involvement may itself create ethical, scientific, or practical difficulties. Research concerning abuse, sexual health, substance use, mental health, homelessness, or other sensitive circumstances can raise especially difficult questions.

That does not give investigators a general license to omit parental permission. Rather, researchers should determine whether applicable law and regulations permit a waiver and present the justification and alternative protections to the reviewing IRB or ethics committee. The analysis of sensitive adolescent research where parental permission may create risk requires careful attention to both participant protection and legal requirements.

The two decisions do not necessarily have to occur in a fixed order

HHS regulations do not prescribe a universal sequence in which parental permission and child assent must be obtained. OHRP explains that IRBs have discretion to determine an appropriate order for the research context.

Parental permission will often be sought first, particularly in research involving more than minimal risk. In some minimal-risk settings, however, it may be reasonable to ask whether a child is interested before approaching the parent. For example, a school-based study might first identify students who wish to participate and then seek permission from their parents.

If parental permission is required and has not been waived, the child cannot be enrolled merely because assent was obtained first.

Both decisions should remain meaningful

Obtaining two signatures is not the objective. The parent needs sufficient information to make an informed decision about allowing participation, while the child needs an explanation suited to their ability to understand and decide.

A single adult-oriented form handed to both parent and child may therefore be inadequate even when both eventually sign it. The communication used to seek assent should reflect the child's developmental abilities. Researchers may need to adapt how the research is explained to children of different ages while preserving the accuracy of the information.

When both decisions are needed before enrollment

Now suppose the parent gives permission but the adolescent says, “I don't want to do the interview.” If the IRB requires the adolescent's assent and no applicable exception or waiver applies, parental permission alone does not satisfy the enrollment requirements.

Conversely, suppose the adolescent enthusiastically agrees but the parent declines permission. If parental permission is required and has not been waived, the adolescent's assent alone is insufficient. The specific implications of a situation in which the child wants to participate but the parent refuses should therefore not be confused with the reverse situation.

Common mistakes about needing both assent and permission

Determine each requirement separately before recruitment begins

When designing a study involving minors, avoid asking only, “Do I need consent?” Break the enrollment process into separate questions about legal authority, parental or guardian permission, and child assent.

Your protocol should make these decisions explicit. It should describe who will provide permission, which participants will be asked for assent, how capacity will be approached, what information each person will receive, how agreement will be documented when required, and what happens when parent and child disagree.

That final possibility should not be left to the research assistant standing in front of the family on recruitment day. If a capable child refuses despite parental permission, the protocol should already establish how the research team will respond to a child's refusal when the parent has given permission.

Before enrolling a child, verify both sides of the decision

Frequently asked questions about assent and parental permission

Neither decision automatically substitutes for the other

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