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  1. Requirements of informed consent beyond a signature
  2. Assent as an addition to, not a substitute for, parental permission
  3. Adaptation of assent to developmental stage

Academy · Regulatory Affairs · Informed consent vs assent

Informed Consent Versus Assent: Distinct Requirements for Paediatric Research Participation

Assent is not a simplified consent form for children but a structurally different requirement, obtained alongside the permission of a parent or guardian rather than in place of it. This article examines the requirements of informed consent and paediatric assent under ICH guidance.

Pubrica AcademyWritten by a research ethics consultant Reviewed bya regulatory affairs consultant Published10 October 2026 Last checked10 October 2026 Reading time6 minutes Sources2 peer-reviewed

Informed consent is the voluntary, informed agreement of a competent individual to participate in research, given after disclosure of the study's purpose, procedures, risks and benefits. Assent is a minor's affirmative agreement to participate, sought in addition to (not instead of) a parent or guardian's informed permission, reflecting the child's evolving capacity to understand and express a preference.

Learning objectives

  • What valid informed consent requires beyond a signature.
  • Why assent is distinct from, and additional to, parental permission.
  • Why the content and format of an assent process should be adapted to the child's developmental stage.

Common misconceptions

  • “A signed consent form is sufficient evidence that informed consent was properly obtained.” Under ICH Good Clinical Practice guidance, informed consent requires an ongoing process of disclosure and understanding, in which the purpose, procedures, risks, benefits and alternatives are communicated in a manner the participant can comprehend and agreement is voluntary; the act of signing a document is not sufficient, and a signature without genuine understanding does not constitute valid informed consent.
  • “If a parent gives informed permission for a child to participate in research, the child’s own agreement is a formality.” ICH E11, the guideline on paediatric clinical investigations, treats a child’s assent as a substantive, age-appropriate requirement that reflects the child’s evolving capacity to understand and express a view, to be obtained in addition to parental permission wherever the child is developmentally capable. A child’s dissent, even when a parent has consented, is generally expected to be respected except in specific, limited circumstances, such as research offering the prospect of direct benefit that is otherwise unavailable.

ICH Good Clinical Practice guidance describes informed consent as a process by which a participant voluntarily confirms willingness to take part in a trial, after being informed of all aspects relevant to that decision, with consent documented by means of a signed and dated form1. The guideline frames the signed document as evidence of the process, not the process itself; genuine comprehension of the purpose, procedures, risks, benefits and voluntary nature of participation is the substantive requirement, which is why consent is increasingly treated as an ongoing dialogue rather than a single event at enrolment.

Assent as an addition to, not a substitute for, parental permission

ICH E11 addresses paediatric research specifically, requiring that a parent or legal guardian's informed permission be obtained, and additionally that the child's assent be sought wherever the child has the developmental capacity to provide it2. Assent and parental permission are two separate requirements, not a single combined one; a study is not ethically authorised for a capable child’s participation on parental permission alone if that child’s own assent has not also been sought.

Adaptation of assent to developmental stage

ICH E11 recognises that children’s capacity to understand research concepts varies substantially by age and development, and expects the assent process (the language used, the information conveyed and the format of the discussion) to be adapted accordingly, rather than a single standard document being used across all ages2. A young child's assent may be a simple, age-appropriate verbal agreement; an adolescent's assent process more closely resembles adult informed consent in depth and format.

Key points

Informed consent is a process of disclosure and understanding rather than a signature alone. A child’s assent is a separate requirement, additional to parental permission, that reflects the child’s evolving capacity, and the assent process should be adapted to the child’s developmental stage rather than following a single standard format.

Practical application

  1. Consent should be treated as an ongoing process rather than a single signature event. Re-confirmation of understanding should be built into longer studies, particularly where new information emerges.
  2. Both parental permission and the child’s assent should be obtained and documented separately. Parental permission should not be regarded as sufficient on its own for a developmentally capable child.
  3. Assent materials should be adapted to the specific age range enrolled. Age-appropriate assent materials (language, format and length) should be developed rather than a single document used across all paediatric ages.

There is no single universal age threshold; ICH E11 and most ethics committees expect assent to be sought once a child has the cognitive and emotional capacity to understand the research and express a preference, commonly treated as beginning around age 7, with the specific threshold often set by the local ethics committee.

Generally, a child's dissent should be respected, except in narrow circumstances such as research that offers the prospect of direct benefit not available outside the study, and such exceptions should be clearly justified and reviewed by the ethics committee.

Not necessarily; a genuinely age-appropriate assent process may require an entirely different format (verbal discussion, picture-based materials, shorter sessions) rather than a shortened version of the adult consent document.

References

Every source above is a peer-reviewed article, a publisher’s record of one, or a standard issued by the body that owns it. Each carries the date it was last read. Where a standard moves, this article is revised rather than left up with a note.

How to cite this article

Pick your referencing style and copy it. Your university or target journal may vary the punctuation — check its guide if it has one.

Pubrica Academy. (2026, October 10). Informed Consent Versus Assent: Distinct Requirements for Paediatric Research Participation. Pubrica. https://pubrica.com/academy/concepts-definitions/informed-consent-vs-assent/

This article is written to be learned from. Cite it if you are referring to what it says; if you are using the evidence behind it, cite the sources listed above instead.

Consent/assent process check

This checklist applies to the design of a study’s consent and assent process.

[ ] Consent treated as an ongoing process, with re-confirmation built in for longer studies
[ ] Parental/guardian permission and child's assent documented separately, where applicable
[ ] Assent materials adapted to the specific age range enrolled
[ ] Process for respecting a child's dissent defined, including any narrow exceptions
[ ] Ethics committee's specific age threshold for assent confirmed and followed

Pubrica AcademyWritten and maintained by Pubrica’s subject matter experts. Articles are revised when the underlying standards change, and each article states the date on which it was last reviewed.

How Pubrica can help

Pubrica assists in designing age-appropriate assent materials alongside the informed consent process, aligned with ICH E11, the expectations of the relevant ethics committee and the applicable ICH E6(R3) Good Clinical Practice guidance and local regulatory requirements.

Submit an enquiry Get your consent and assent materials reviewed

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