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Portrait of Titti Mattsson. Photo.

Titti Mattsson

Professor

Portrait of Titti Mattsson. Photo.

Concordance of International Regulation of Pediatric Health Research

Author

  • Mark A. Rothstein
  • Dimitri Patrinos
  • Kyle B. Brothers
  • Ellen Wright Clayton
  • Yann Joly
  • Ma'n H. Zawati
  • Pamela Andanda
  • Thalia Arawi
  • Mireya Castañeda
  • Don Chalmers
  • Haidan Chen
  • Mohammed Ghaly
  • Ryoko Hatanaka
  • Aart C. Hendriks
  • Calvin W.L. Ho
  • Jane Kaye
  • Dorota Krekora-Zając
  • Won Bok Lee
  • Titti Mattsson
  • Pilar Nicolás
  • Obiajulu Nnamuchi
  • Emmanuelle Rial-Sebbag
  • Gil Siegal
  • Jane M. Wathuta
  • Bartha Maria Knoppers
Show all

Summary, in English

Objective: To assess the comparability of international ethics principles and practices used in regulating pediatric research as a first step in determining whether reciprocal deference for international ethics review is feasible. Prior studies by the authors focused on other aspects of international health research, such as biobanks and direct-to-participant genomic research. The unique nature of pediatric research and its distinctive regulation by many countries warranted a separate study. Study design: A representative sample of 21 countries was selected, with geographical, ethnic, cultural, political, and economic diversity. A leading expert on pediatric research ethics and law was selected to summarize the ethics review of pediatric research in each country. To ensure the comparability of the responses, a 5-part summary of pediatric research ethics principles in the US was developed by the investigators and distributed to all country representatives. The international experts were asked to assess and describe whether principles in their country and the US were congruent. Results were obtained and compiled in the spring and summer of 2022. Results: Some of the countries varied in their conceptualization or description of one or more ethical principles for pediatric research, but overall, the countries in the study demonstrated a fundamental concordance. Conclusions: Similar regulation of pediatric research in 21 countries suggests that international reciprocity is a viable strategy.

Department/s

  • LU Profile Area: Proactive Ageing
  • Health Law
  • Department of Law

Publishing year

2023

Language

English

Publication/Series

Journal of Pediatrics

Volume

260

Issue

September

Document type

Journal article

Publisher

Academic Press

Topic

  • Pediatrics

Keywords

  • adequacy
  • assent
  • children
  • consent
  • ethics
  • research

Status

Published

Research group

  • Health Law

ISBN/ISSN/Other

  • ISSN: 0022-3476