Establishing a global regulatory floor for children's decisions about participation in clinical research.

Autor: Joffe S; Department of Medical Ethics and Health Policy, Perelman School of Medicine, Philadelphia, PA, USA. joffes@upenn.edu.; The Division of Oncology, Children's Hospital of Philadelphia, Philadelphia, PA, USA. joffes@upenn.edu., Allen AJ; Eli Lilly and Company (retired), Indianapolis, IN, USA., Davis JM; Department of Pediatrics and Tufts Clinical and Translational Research Institute, Tufts Medical Center, Boston, MA, USA., Koppelman E; Multi-Regional Clinical Trials Center, Brigham and Women's Hospital and Harvard, Boston, MA, USA., Kornetsky SZ; Clinical Research Compliance, Boston Children's Hospital, Boston, MA, USA., Ku GMV; Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium., Miller VA; Division of Adolescent Medicine, Children's Hospital of Philadelphia, Philadelphia, PA, USA., Preston J; National Institute for Health Research Alder Hey Clinical Research Facility, Department of Women's and Children's Health, Institute of Life Course and Medical Sciences, Institute in the Park, Alder Hey Children's National Health Service Foundation Trust, Liverpool, UK., Shah LD; Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA., Bierer BE; Multi-Regional Clinical Trials Center, Brigham and Women's Hospital and Harvard, Boston, MA, USA.; Division of Global Health Equity, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Jazyk: angličtina
Zdroj: Pediatric research [Pediatr Res] 2023 Aug; Vol. 94 (2), pp. 462-465. Date of Electronic Publication: 2023 Jan 28.
DOI: 10.1038/s41390-023-02483-8
Abstrakt: Background: Enrolling children in clinical trials typically requires parental or guardian permission and, when appropriate, child assent. Aligning requirements across jurisdictions would facilitate multisite pediatric trials. Guidance from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is the best candidate for a global standard but would benefit from additional specification.
Methods: Ethical analysis of ICH guidance for permission and assent for pediatric trials, with recommendations for clarification.
Results: ICH guidance regarding permission and assent would be enhanced by additional detail in the following areas: (1) what information should be provided to parents, guardians, and children considering a trial, and how that information should be provided; (2) the definition of "assent," the criteria for when assent should be required, and the need to include children in discussions even when assent is not mandated; (3) criteria for requiring children's signatures indicating agreement; (4) greater specificity regarding children's right to decline or withdraw; and (5) clarification of when children's wish to decline or withdraw from participation may be overridden and of what the overriding process should entail.
Conclusion: ICH guidance provides a global standard for decision making regarding children's participation in trials. Several clarifications would facilitate the conduct of multinational pediatric research.
Impact: Enrolling children in clinical trials requires the permission of a parent/guardian ± the assent of the minor. Differing global regulatory requirements for enrolling children complicate the conduct of multicenter and multinational trials. The authors identify points of ambiguity and/or contradiction in the International Council for Harmonization guidelines and offer recommendations for a common ethical platform for conducting global pediatric research.
(© 2023. The Author(s), under exclusive licence to the International Pediatric Research Foundation, Inc.)
Databáze: MEDLINE
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