Prospective Ethical Governance Framework Proposed for Paediatric Discrete Choice Experiments

Researchers developing the PREF-ANX Kids study have introduced a prospective ethical governance framework to safeguard children aged 6 to 12 years during discrete choice experiments in perioperative healthcare settings. Published in BMC Medical Ethics, the methodological paper outlines a structured model developed during the preparatory phase of a planned multicentre study in Portuguese public hospitals. Rather than reporting empirical trial findings or claiming clinical outcomes, the team presents a pre-implementation model designed to resolve ethical tensions before participant recruitment begins. Discrete choice experiments have expanded from health economics into clinical paediatrics to quantify how patients weigh alternative healthcare options by presenting repeated choices between hypothetical scenarios with varied attributes. While preference elicitation honours children’s rights under the United Nations Convention on the Rights of the Child to express views on matters affecting their care, standard paediatric research guidelines fail to address the operational complexities that emerge when vulnerable young surgical patients face repeated decision tasks.

The PREF-ANX Kids framework responds to six intersecting ethical challenges that arise when eliciting preferences from paediatric cohorts in hospital environments. First, the authors highlight the substantial cognitive burden of discrete choice experiments, where evaluating complex trade-offs across multiple shifting attributes can outpace developmental capacity and induce fatigue. Second, perioperative settings introduce emotional distress, as scenarios involving surgery, parental separation, or pain are presented to children already experiencing acute preoperative anxiety. Third, researchers emphasize the fragility of paediatric assent, noting that parental consent cannot guarantee ongoing willingness from a child whose initial compliance may degrade into fatigued submission. Fourth, parental presence introduces relational dynamics that can transition from comfort into undue influence, potentially displacing the child’s authentic voice. Fifth, dual clinician-researcher positioning creates authority conflicts, where families may conflate discretionary research with clinical care. Finally, data protection demands specialized stewardship because young children cannot fully appraise the long-term implications of processing their personal and health data.

Conducted within a doctoral nursing research programme, the framework governs the planned PREF-ANX Kids multicentre study, which examines how children aged 6 to 12, their parents, and healthcare professionals prioritize nursing interventions for managing preoperative anxiety before elective surgery. To establish the framework, an interdisciplinary team with expertise in paediatric nursing, perioperative care, nursing ethics, clinical supervision, and health economics across Portugal and Sweden integrated three foundational sources. They synthesized international ethical and regulatory guidance, including the Declaration of Helsinki, Council for International Organizations of Medical Sciences guidelines, the United Nations Convention on the Rights of the Child, the General Data Protection Regulation, and Portuguese Law 58/2019. This synthesis was paired with discrete choice experiment methodology standards and refined through iterative deliberations among the research team. Formal ethical approval for the protocol has been granted by the Ethics Committee of ULS Matosinhos, with additional institutional reviews underway, while participant recruitment and data collection remain entirely prospective.

At the core of the governance architecture are four interactive domains operating across five lifecycle stages: design, piloting, recruitment, data collection, and dissemination. The first domain, relational participation, treats assent not as an isolated administrative event, but as an ongoing relational process monitored across every task. The protocol establishes an unambiguous decision rule: a child’s dissent, whether communicated verbally or through non-verbal resistance, overrides parental permission. The authors justify this absolute priority by noting that in research lacking direct therapeutic benefit, children’s expressed will must carry decisive moral weight because no clinical advantage exists to counterbalance their objection. Furthermore, recognizing that dependent children rarely voice explicit objections, researchers must monitor subtle behavioural indicators such as repeated hesitation, withdrawal, disengagement, and inconsistent responding. If reluctance emerges, the session terminates immediately. Crucially, preference responses collected prior to termination will be excluded from analysis and permanently destroyed, preventing the subordination of the child’s autonomy to research convenience.

Within this relational model, parental presence is recognized as a developmentally appropriate source of security for children facing clinical uncertainty, rather than an inherent barrier. Children participating in the PREF-ANX Kids arm may elect to have a parent or trusted caregiver present throughout the session for emotional support. However, the governance framework establishes guardrails to distinguish legitimate reassurance from impermissible interference, such as caregivers answering on the child’s behalf, prompting selections, or urging continuation despite visible exhaustion. When interference occurs, researchers must redirect attention respectfully to the child, ensuring the young participant’s genuine perspective dictates whether the interview proceeds. In addition, the framework mandates age-differentiated assent procedures, recognizing developmental disparities between children aged approximately 6 to 8 years and those aged 9 to 12 years. Communication protocols tailor explanations of voluntariness, task quantity, procedural duration, and data handling so younger children receive accessible concrete explanations while older children receive more comprehensive descriptions of confidentiality.

The second domain, cognitive and emotional safeguarding, addresses task architecture to keep cognitive demands within proportional developmental thresholds. To protect young participants from exhaustion in stressful hospital surroundings, the research team instituted an eight-task ceiling for children, representing a marked reduction compared to adult discrete choice experiment protocols. This conservative threshold was chosen pragmatically based on paediatric literature and will undergo empirical testing and possible downward adjustment during pilot phases. Every individual choice task will incorporate an explicit opt-out alternative, ensuring no child feels forced to select an unpalatable hypothetical scenario. To accommodate broad cognitive variance, the team designed simplified attribute descriptions, colour-coding schemes, pictorial supports, and age-tailored visual illustrations, accompanied by verbal scaffolding for younger participants and autonomous completion options for older cohorts. Blocking and partial-profile designs distribute cognitive complexity across tasks, ensuring experimental tasks do not overwhelm working memory or distort preference expressions.

In a notable methodological shift, the framework repurposes conventional econometric quality checks to serve direct safeguarding functions. In standard discrete choice experiments, embedded dominance tests—which present two choices where one alternative is logically superior across every attribute—are used solely to detect poor data quality or irrational respondent choices. Under the PREF-ANX Kids framework, failing a dominance test is treated primarily as a critical signal of incomprehension, fatigue, or disengagement. When a child fails an embedded dominance test, researchers must pause the experiment immediately, conduct a structured comfort check, offer clarifying explanations, provide an optional rest break, or propose session discontinuation, rather than mechanically discarding data post hoc. Session facilitators will undergo uniform cross-site training to identify specific behavioural indicators, including prolonged response latencies, repeated questions, inconsistent interaction with pictorial aids, and visible frustration. Above all, the governance structure establishes that clinical care permanently supersedes research activities, requiring experimental sessions to yield, be rescheduled, or be abandoned whenever clinical preparations arise.

The third domain, reflexive professional responsibility, tackles ethical hazards associated with clinician-researchers embedded within paediatric healthcare units. While clinical familiarity allows investigators to interpret paediatric cues with greater sensitivity, dual positioning risks introducing coercive authority dynamics, as families may feel compelled to participate to secure clinical goodwill. The PREF-ANX Kids framework mandates that recruitment and initial assent discussions be handled by neutral investigators uninvolved in the child’s direct clinical treatment whenever staffing allows. For smaller settings where complete operational separation cannot be achieved, the framework institutes structured reflexive research memos completed immediately after every data collection session. Guided by standardized prompts, investigators record perceived authority dynamics, moments of researcher-directed reassurance seeking, instances of parental pressure, and difficulties encountered in separating clinical duties from investigative objectives. These reflexive records are evaluated during formal supervision sessions with senior doctoral mentors, establishing an operational pathway where recurring relational friction triggers procedural reviews or formal protocol amendments submitted to ethics committees.

The fourth domain, privacy stewardship, enforces institutional safeguards grounded in European data protection principles and Portuguese Law 58/2019, operationalized through a prospective Data Protection Impact Assessment. The framework separates consent for research participation from consent for personal data processing, ensuring participants understand the independent nature of each authorization. To protect personal information, data will be pseudonymised at the point of collection, with decoding keys encrypted and housed under strict role-based access controls within Portuguese public servers. Under this localized arrangement, individual-level pseudonymised files remain exclusively in Portugal, while international collaborators in Sweden receive only fully anonymised, aggregated analytical summaries, thereby preventing cross-border transfer of personal records. Irreversible anonymisation occurs only after dataset finalisation, preserving the child’s right to withdraw data during initial phases while acknowledging that withdrawal becomes impossible once datasets are permanently de-identified. The authors openly acknowledge that these protective measures involve tangible methodological trade-offs: restricting task counts limits statistical power, prioritizing dissent reduces sample completeness, and destroying partial data eliminates traditional attrition analyses.

In their discussion, the authors emphasize the framework’s prospective nature as a primary limitation, reiterating that no empirical feasibility, participant acceptability, or data quality assessments have yet been conducted. Furthermore, the development process was conducted entirely by adult professionals without direct co-design involvement from children, parents, or public involvement representatives, an omission the team identifies as a substantive limitation that could embed adult assumptions about acceptable paediatric burden. The research team plans to address this through participatory co-design and qualitative evaluations of participant experiences during the upcoming PREF-ANX Kids study. The authors categorize the framework’s components into three distinct transferability tiers: study-specific operational parameters, such as the eight-task maximum and Portuguese data localisation; potentially adaptable procedures, including continuous assent monitoring and repurposing dominance tests as safety triggers; and universally transferable principles, specifically the binding authority of paediatric dissent in non-beneficial research and the priority of clinical care. Ultimately, the framework serves as an open, prospective benchmark to foster transparent methodological planning across paediatric discrete choice experiments.

Subject of Research: Prospective ethical governance framework for paediatric discrete choice experiments

Article Title: Developing a prospective ethical governance framework for a discrete choice experiment involving children aged 6–12 years: the PREF-ANX Kids study

Article References: Martins Esteves, I., Pestana-Santos, M., Sampaio, F., & Reis Santos, M. (2026). Developing a prospective ethical governance framework for a discrete choice experiment involving children aged 6–12 years: the PREF-ANX Kids study. BMC Medical Ethics, 27(1), Article 204. https://doi.org/10.1186/s12910-026-01565-6

Image Credits: AI Generated

DOI: 10.1186/s12910-026-01565-6

Keywords: paediatric research ethics, discrete choice experiments, PREF-ANX Kids, child assent, health economics, preoperative anxiety, research governance, data protection, Developing, prospective, ethical, governance