Requirements and special considerations for drug trials with children across six jurisdictions: 2. Ethics review in the regulatory approval process.


Stewart, Breanne, Lepola, Pirkko, Egger, Gunter F, Ali, Fahimeda, Allen, Albert J, Croker, Alysha K, Davidson, Andrew J, Dicks, Pamela, Faust, Saul N ORCID: 0000-0003-3410-7642, Green, Dionna et al (show 14 more authors) (2025) Requirements and special considerations for drug trials with children across six jurisdictions: 2. Ethics review in the regulatory approval process. Frontiers in medicine, 12. 1539787-. ISSN 2296-858X, 2296-858X

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Abstract

<h4>Background</h4>Conducting clinical drug trials (CTs) with children presents several challenges. A major challenge is the need to enroll participants at multiple sites across different jurisdictions. Recruiting the required number of children within a reasonable timeframe requires the study to be reviewed by Research Ethics Boards (REB) or Institutional Review Boards (IRB) at multiple sites across various jurisdictions. This work, undertaken by the Working Group (WG) on International Collaborations at the European Network of Pediatric Research at the European Medicines Agency (Enpr-EMA) aims to describe the research ethics review requirements including any pediatric specific requirements, as well as current or upcoming changes across six jurisdictions - the European Union (EU), United Kingdom (UK), United States of America (USA), Canada, Japan, and Australia.<h4>Methods</h4>An open questionnaire developed by the WG and directed at both the Competent Authorities (CA) and the national pediatric clinical trial networks arranged by jurisdictions.<h4>Results</h4>A synopsis of the current regulatory requirements covers centralized versus independent review, comparisons between investigator initiated and industry sponsored clinical trials, timelines, review board members requirements and the consenting/assent process for clinical trial (CT) applications, application submission processes and application requirements for each of the six jurisdictions. It also describes changes currently or soon to be implemented in some jurisdictions.<h4>Conclusion</h4>This environmental scan highlights the differences in ethics review for CTs in pediatric medicine development across six jurisdictions. While there is a growing trend for centralized ethics review, it is not universally permitted due to institutional, state/provincial, or national policies. Even where central review is allowed, local review may still be required for vulnerable populations like children. Harmonized and centralized ethics reviews offer advantages such as expert pediatric reviewers and efficient and consistent evaluations.

Item Type: Article
Uncontrolled Keywords: clinical trials, institutional review board, pediatrics, regulatory science, research ethics committee, research ethics review
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences
Depositing User: Symplectic Admin
Date Deposited: 26 Mar 2025 10:51
Last Modified: 07 Aug 2025 08:25
DOI: 10.3389/fmed.2025.1539787
Open Access URL: https://doi.org/10.3389/fmed.2025.1539787
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URI: https://livrepository.liverpool.ac.uk/id/eprint/3191048
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