Assent in paediatric research: theoretical and practical considerations

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.