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Original research
Informed consent and assent guide for paediatric clinical trials in Europe
  1. Pirkko Lepola1,
  2. Maxine Kindred2,
  3. Viviana Giannuzzi3,
  4. Heidi Glosli4,
  5. Martine Dehlinger-Kremer5,
  6. Harris Dalrymple5,
  7. David Neubauer6,
  8. Geraldine B Boylan7,
  9. Jean Conway8,
  10. Jo Dewhurst5,
  11. Diane Hoffman9
  1. 1 University of Helsinki and Helsinki University Hospital, Department of Children and Adolescents, Helsinki, Finland
  2. 2 Portfolio Delivery Operations, Janssen Research & Development, High Wycombe, Buckinghamshire, UK
  3. 3 Research Department, Fondazione per la Ricerca Farmacologica Gianni Benzi onlus, Bari, Italy
  4. 4 Paediatric Clinical Trial Ward, Oslo University Hospital, Oslo, Norway
  5. 5 Center for Pediatric Clinical Developmen, ICON plc, Dublin, Ireland
  6. 6 Department of Child, Adolesecent & Developmental Neurology, University Medical Centre Ljubljana, Children's Hospital Ljubljana, Ljubljana, Slovenia
  7. 7 Department of Paediatrics and Child Health, Neonatal Brain Research Group, Cork University Maternity Hospital, Cork, Ireland
  8. 8 Department of Paediatrics & Child Health, University College Cork, Cork, Ireland
  9. 9 Retired from work, Janssen Research and Development LLC, Raritan, New Jersey, USA
  1. Correspondence to Mrs Pirkko Lepola, University of Helsinki and Helsinki University Hospital, Department of Children and Adolescents, 00029 Helsinki, Finland; pirkko.lepola{at}hus.fi

Abstract

Objective Clinical 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.

Methods Current 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.

Results A 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%.

Conclusion The 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.

  • ethics
  • therapeutics

Data availability statement

Data are available in a public, open access repository. All data are publicly available via Enpr-EMA website: https://www.ema.europa.eu/en/documents/other/assent/informed-consent-guidance-paediatric-clinical-trials-medicinal-products-europe_en.pdf.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/archdischild-2021-322798

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    Data availability statement

    Data are available in a public, open access repository. All data are publicly available via Enpr-EMA website: https://www.ema.europa.eu/en/documents/other/assent/informed-consent-guidance-paediatric-clinical-trials-medicinal-products-europe_en.pdf.

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    Footnotes

    • Contributors Literature search and guide document table design was done by PL, MK, VG, HG, MD-K, HD, DN, GBB, JC, JD and DH. Data figures and tables to the article were done by PL. Data interpretation, writing and approval of final version were done by all authors. Guarantor: Pirkko Lepola (PL)

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests PL is the Chair of the Coordinating Group of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), and all authors have been members of the ad hoc Enpr-EMA Ethics Working Group during this work.

    • Provenance and peer review Not commissioned; externally peer reviewed.