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Assent is not consent
  1. Amanda Sibley1,
  2. Mark Sheehan2,
  3. Andrew J Pollard1
  1. 1Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK
  2. 2The Ethox Centre, University of Oxford, Oxford, UK
  1. Correspondence to Amanda Sibley, MPH, Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine, Department of Paediatrics, University of Oxford, Churchill Hospital, Oxford OX3 7LJ, UK; amanda.sibley{at}


A recent article from Archives of Disease in Childhood outlined problems with the act of gaining child assent for research participation. However the arguments used in the article are incomplete or misguided. Rather than being harmful, assent should be seen as an ethically-appropriate way in which we can engage with the child about his participation in research. While additional clarification of the concept of assent is needed, the child's family context can provide us with a valuable guide to the way we involve him in the decision-making process.

  • Autonomy
  • informed consent
  • minors/parental consent
  • public health ethics
  • family
  • cloning
  • virtue theory and bioethics
  • resource allocation/ priority setting
  • artificial reproduction
  • biotechnology
  • paediatrics
  • medical ethics
  • newborns and minors
  • allowing minors to die
  • donation/procurement of organs/tissues
  • prolongation of life and euthanasia
  • quality/value of life/personhood

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Baines, in an article published in Archives of Disease in Childhood, has provided a perspective on the problems associated with child assent for research participation, specifically that assent can actually cause harm.1 However, the arguments to support his claim are misguided.

His statement that ‘if consent is the authority to proceed, then assent has no role’ presumes that assent is a non-binding form of consent. The purpose of an assent process is not to provide a second consent but to allow the child to have an appropriate level of involvement in the decision-making process about something that affects him.

Baines also worries that the assent process has the potential to miss the competent child. However, if anything, the process of engaging with the child through gaining his assent in an ability-appropriate way would make it more likely for the researcher to be attentive to the child's cognitive abilities and therefore more likely to recognise his competence.

Furthermore, Baines claims that focusing on assent can lead to a failure to distinguish research on adults from research on children, thus potentially exposing children to greater research risks. However, regardless of whether a minor assents or consents, such research needs ethics committee approval. Furthermore, existing guidelines, used by those responsible for ethical review, emphasise that research on minors must be necessary, provide a potential health benefit and have minimal risk,2–4 directing a lower risk for research involving children than adults.

We wholeheartedly agree that the concept of assent warrants further discussion and clarification. The definition, purpose or scope of assent (like the interpretation of dissent) remains woefully ill-defined. Yet, rather than feeling compelled to fulfil another regulatory requirement, we urge investigators to view assent as an opportunity to engage with the child about their participation in research, showing respect for their developing autonomy and self-worth. While children are not considered to have the necessary emotional and cognitive capacities to give fully informed consent,5 6 it is ethically appropriate that we should allow the child to take part in the decision-making process regarding his research participation at the relevant level, even if we rely ultimately on the parent's consent.

In one of his arguments against assent, Baines unwittingly points to the key to how we can revise the assent process to better satisfy these goals. He argues that the act of seeking a child's assent may lead to tensions within the family, which may harm the parents' relationship with their child. While this seems a clear exaggeration, the family context is, we suggest, crucial to consider in any interaction with a paediatric research participant. It is precisely the routine familial tensions and the way they are negotiated within the family context that can provide a valuable guide to the way in which children should be involved in decisions about their research participation.7 8


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  • Linked article 100242.

  • Funding AS and MS receive funding from the Department of Health's NIHR Oxford Biomedical Research Centre. AJP is a Jenner Investigator and James Martin Senior Fellow.

  • Competing interests None.

  • Provenance and peer review Commissioned; internally peer reviewed.

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