Informed consent and assent guide for paediatric clinical trials in Europe

Abstract

ObjectiveClinical trial sponsors spend considerable resources preparing informed consent (IC) and assent documentation for multinational paediatric clinical trial applications in Europe due to the limited and dispersed patient populations, the variation of national legal and ethical requirements, and the lack of detailed guidance. The aim of this study was to design new easy-to-use guide publicly available on European Medicines Agency’s, Enpr-EMA website for all stakeholders.MethodsCurrent EU legal, ethical and regulatory guidance for paediatric clinical trials were collated, analysed and divided into 30 subject elements in two tables. The European Network of Young Person’s Advisory Group reviewed the data and provided specific comments. A three-level recommendation using ‘traffic light’ symbols was designed for four age groups of children, according to relevance and the requirements.ResultsA single guide document includes two tables: (1) general information and (2) trial-specific information. In the age group of 6–9 years old, 92% of the trial-specific subject elements can be or should be included in the IC discussion. Even in the youngest possible age group (2–5 years old children), the number of elements considered was, on average, 52%.ConclusionThe EU Clinical Trial Regulation (2014) does not contain specific requirements exclusively for paediatric clinical trials. This work is the first to extensively collate all the current legal, regulatory and ethical documentation on the IC process, together with input from adolescents. This guide may increase the ethical standards in paediatric clinical trials.

PedCRIN tool for the biosamples management in pediatric clinical trials

“…Table 1 shows the list of points to be considered. They are intended to be customized according to the patient age and understanding, as shown in a recently published guide on informed consent and assent in pediatric trials in Europe 10 …”

“…They are intended to be customized according to the patient age and understanding, as shown in a recently published guide on informed consent and assent in pediatric trials in Europe. 10 T A B L E 2 Minimizing harm and maximizing welfare: technical, ethical, and methodological measures (Topic 2).…”

“…In pediatric trials, children should participate in the informed consent and assent process according to their age and understanding, receiving age-appropriate information about what will happen in the study. [7][8][9][10] The EU General Data Protection Regulation (GDPR) 11 with its guidelines 12 has endorsed and strengthened the need for informed consent that is required by the Helsinki Declaration, 13 Good Clinical Practice (GCP) guidelines, 14 and other relevant provisions. 15 When seeking consent, the use, storage, and possible future use of material should be explained.…”

The proxy dilemma: Informed consent in paediatric clinical research ‐ a case study of Thailand

“…As Lepola et al (2016) reveal in their comparative study of 27 European countries, 66 there are considerable differences in national legal requirements on informed consent and assent, which can often lead to considerable time and resources being spent on reconciling regulatory differences in multicentre clinical trials. 67 Lepola et al (2021) have developed an 'Informed Consent and Assent Guide' as a tool to enhance ethical standards of informed consent practice and engender common practices for informed consent in multinational clinical paediatric trials. Whether such a tool could be developed and implemented in LMICs remains questionable.…”

What information and the extent of information to be provided in an informed assent/consent form of pediatric drug trials

“…For child assent, such issues are even more challenging, with no explicit guidelines clearly outlining the scope of what would be considered necessary information to be provided in an informed assent form (IAF) [10][11][12]. The responsibility for defining what constitutes adequate information in an IAF generally resides with the institutional review board (IRB)/independent ethics committee (IEC), resulting in disparities in IAF requirements across different IRBs/IECs [13].…”