Involving children and young people in paediatric research
Children and young people can help set research priorities, shape trial design and develop the information their peers receive. Meaningful involvement gives them understandable information, freedom to express their views, influence over decisions and feedback on what their contribution achieved.
Purpose and rights
Children are not small adults, so clinical trials need to be designed for them and with them. Young patient advocates can help improve trial design, including questions such as suitable formulations for different diseases and age groups. Improving paediatric medicines requires a continuing social commitment from the stakeholders involved. Co-partnership with young people is increasingly recognised as improving clinical research's relevance.
The UN Convention on the Rights of the Child recognises children's right to express their views freely in matters affecting their lives, including healthcare. Young people are active participants in research rather than passive recipients. Participation includes being informed, having a voice and making decisions together, while retaining the choice not to express an opinion.
Empowerment and informed decision-making
Empowerment gives young people relevant information, understanding of a healthcare issue and a sense of authority to make decisions. Engagement is their motivation to participate in decisions, supported by a strong partnership with professionals and language tailored to their maturity. Making health decisions takes practice and information; becoming informed and speaking up helps young people learn to express their views.
Informed decision-making is especially relevant for preschoolers, schoolchildren and adolescents, and involves four aspects:
- Information: allow time to receive understandable information.
- Voice: provide opportunities to express viewpoints freely.
- Influence: explain what the outcome of involvement in research will be so that young people feel genuinely engaged.
- Feedback: explain the final result of their involvement, closing the decision-making loop.
Young persons advisory groups
Young persons advisory groups bring together young people with or without a disease and may also include parents or carers. Living with the disease gives members experience of what action is needed, so disease experience is sometimes a membership requirement. Members have a strong motivation for science and health research and receive specific training to provide advice, feedback and perspectives on projects, research and health policies. Their work serves young people's interests first, alongside those of researchers and industry.
Groups have formed across the world to advocate for young people's health, engage and empower trial participants and families facing an unfamiliar process, and advise researchers and industry on maintaining a child-centred approach throughout a study.
Contributions across the study
Advisory groups can set research priorities and identify unmet needs, beginning with design and planning and continuing through dissemination. In consultative work, stakeholders ask which research questions and unmet needs justify a study. Collaborative work can involve organising awareness campaigns or producing educational materials, while interviews and surveys offer other ways to gather feedback.
Outputs can include input on or revision of clinical-study documents and information for other young trial participants, as well as co-created guidance. In a Council of Europe guide-development project, an advisory group used a survey to suggest improvements and help finalise guidance for healthcare professionals and others working in paediatric trials. The group also created a video with young people for their peers, explaining the importance of research involvement and having a say.