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Assent in paediatric research: theoretical and practical considerations
1Department of Clinical Bioethics, The NIH Clinical Center, Building 10, Room 1C118, Bethesda, MD 20892, USA. dwendler@nih.gov
Insights
Children aged 14 and older should provide assent for research participation. Their dissent must always be respected, even when research offers potential clinical benefits.
Area of Science:
- Pediatric research ethics
- Child assent and consent
Background:
- Global guidelines mandate child assent in research.
- Lack of clear guidance for review committees on implementing assent and waivers.
- Need to define child capacity for assent and conditions for waiving assent.
Purpose of the Study:
- To argue for the importance of respecting children's decision-making capacity in research.
- To propose an age threshold for child assent based on developmental understanding.
- To emphasize the ethical imperative of respecting children's sustained dissent.
Main Methods:
- Analysis of existing data on child cognitive development and research comprehension.
- Ethical argumentation regarding children's autonomy and protection from harm.
- Review of current guidelines and ethical considerations for assent waivers.
Main Results:
- Children capable of understanding research can provide assent, typically developing around age 14.
- Sustained dissent from all children, regardless of assent capacity, should be respected.
- Assent requirements may be waived for research with significant clinical benefit, but dissent must still be honored.
Conclusions:
- An age of 14 is proposed as a practical threshold for assent capacity in research.
- Children's sustained dissent is a critical ethical consideration that should always be respected.
- Balancing research benefits with children's autonomy requires careful ethical deliberation and clear guidelines.
Abstract:
Guidelines around the world require children to provide assent for their participation in most research studies. Yet, little further guidance is provided on how review committees should implement this requirement, including which children are capable of providing assent and when the requirement for assent may be waived on the grounds that the research offers participating children the potential for important clinical benefit. The present paper argues that the assent requirement is supported by the importance of allowing children who are capable to make their own decisions. This suggests children are capable of assent when they become able to understand the research in question. While development varies across individual children, existing data suggest most children develop this ability by approximately age 14. Until instruments are developed to assess the assent capacity of individual children, this age should be used as the threshold for assent. In addition, the importance of protecting children from harm suggests that the sustained dissent of all children, including those who are unable to provide assent, should be respected. While the assent requirement may be waived when research participation offers the potential for important medical benefit that is unavailable outside the research context, analysis suggests that children's sustained dissent should be respected in all cases.
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