Assent / Informed Consent Guidance for Paediatric Clinical Trials with Medicinal Products in Europe

The Enpr-EMA Assent / Informed Consent Guidance for Paediatric Clinical Trials with Medicinal Products in Europe provides practical recommendations to support the development of informed consent and assent processes for clinical trials involving children and adolescents. Developed by the Ethics Working Group of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), with support from the European Young Persons Advisory Group Network (eYPAGnet), the guidance aims to promote high-quality, ethical paediatric clinical research by supporting appropriate involvement of children and families in trial participation decisions.

The guidance provides recommendations on the elements that should be considered when preparing consent and assent documentation across different paediatric age groups, including general trial information, study-specific information, communication approaches, and considerations related to children's ability to understand and participate in decision-making. It supports researchers in developing materials that are appropriate to the child's age, maturity and developmental stage, while ensuring that parental or legal representative consent requirements are appropriately addressed.

This resource is particularly relevant for paediatric rare disease clinical trials, where children and families are often required to make complex decisions about participation in studies involving investigational treatments, limited treatment options and significant unmet medical needs. Rare disease trials frequently involve small populations, multinational recruitment and long-term participation, making clear communication, trust-building and ethically appropriate consent processes essential for successful study implementation.

Although developed within the European regulatory context, the principles described in the guidance are broadly applicable to paediatric clinical research internationally. The emphasis on child-centred communication, meaningful assent, family involvement and respect for children's rights can support the planning and conduct of paediatric rare disease trials across different healthcare and regulatory settings.