Peer-reviewed article
Developing a prospective ethical governance framework for a discrete choice experiment involving children aged 6-12 years: the PREF-ANX Kids study.
Martins Esteves I, Pestana-Santos M, Sampaio F, Reis Santos M ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This paper describes the development of an ethical governance framework for conducting discrete choice experiments (a research method) with children aged 6-12 years. The framework addresses ethical challenges specific to this research methodology, including cognitive demand, emotional distress, and data protection. The paper outlines planned procedures across four domains but does not evaluate any intervention affecting child well-being; it is methodological guidance for researchers rather than an assessment of child outcomes or interventions.
Key points
- The framework identifies six ethical challenges specific to DCEs with children: sustained cognitive demand, emotional distress, assent under clinical stress, parental influence, clinician-researcher role conflict, and personal data processing
- Four operational domains are proposed: relational participation, cognitive and emotional safeguarding, reflexive professional responsibility, and privacy stewardship
- The framework has not yet been implemented or empirically evaluated
- Trade-offs between competing ethical and methodological priorities are made explicit
- Future refinement should incorporate co-design with children and families
Limitations
This paper describes a prospective framework that has not been implemented or tested, so it cannot demonstrate whether the proposed procedures actually protect children or maintain data quality in practice. No children or families were involved in developing the framework, which the authors acknowledge as a limitation.
Abstract
Background Discrete choice experiments (DCEs) are quantitative preference-elicitation methods, developed largely within health economics, in which participants choose repeatedly between hypothetical scenarios composed of systematically varied attributes. Their growing use with children supports children's right to be heard in decisions affecting their care, yet it also raises ethical challenges that general paediatric research ethics guidance does not address in operational detail: sustained cognitive demand, potential emotional distress, assent that can blur under clinical stress, parental influence, clinician-researcher role conflict, and the processing of children's personal data. Methods We developed a prospective ethical governance framework during the preparatory phase of the PREF-ANX Kids study (Preferences for Preoperative Anxiety Management in Children), a planned multicentre DCE examining preferences for nursing interventions to manage preoperative anxiety among children aged 6-12 years undergoing elective surgery in Portuguese public hospitals, their parents, and healthcare professionals. Development combined a pragmatic, non-systematic synthesis of ethical, regulatory, and methodological guidance with iterative structured discussion within an interdisciplinary team. No formal consensus method was applied, and no children or families were involved in development; we identify this as a limitation. Framework The framework comprises four domains operating across the research lifecycle: relational participation, cognitive and emotional safeguarding, reflexive professional responsibility, and privacy stewardship. For each domain it specifies planned procedures (continuous assent and dissent monitoring, adapted task burden, structured reflexive documentation, and a prospective data protection impact assessment) together with their normative justification, and it distinguishes elements specific to PREF-ANX Kids from elements potentially adaptable to other paediatric DCEs. Trade-offs between competing ethical and methodological priorities are made explicit rather than resolved silently. Conclusions The framework is prospective: it has not yet been implemented or empirically evaluated, and no claims of demonstrated effectiveness are made. It is intended to support transparent ethical planning of DCEs involving children aged 6-12 years and will be assessed during the PREF-ANX Kids study. Future refinement should incorporate co-design with children and families and empirical evaluation of feasibility, acceptability, participant experience, and data quality.