Concordance of International Regulation of Pediatric Health Research

J Pediatr. 2023 Sep;260:113524. doi: 10.1016/j.jpeds.2023.113524. Epub 2023 May 26.


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.

Keywords: adequacy; assent; children; consent; ethics; research.

MeSH terms

  • Biological Specimen Banks*
  • Child
  • Ethics, Research*
  • Humans
  • Informed Consent
  • Research Personnel