Concordance of International Regulation of Pediatric Health Research

Document Type

Article

Publication Title

Journal of Pediatrics

Publication Date

2023

ISSN

0022-3476

Page Number

113524

Keywords

adequacy, assent, children consent, ethics, research

Disciplines

Health Law and Policy | Law

Abstract

International, multi-site, pediatric health research has shown great promise by vastly increasing the amount and heterogeneity of biospecimens and clinical records. However, considerable impediments are created by the significant costs and delays associated with obtaining regulatory approval in numerous countries, which is often complicated by varying and sometimes opaque research ethics standards and procedures. Although it is unlikely that the global community could reach consensus on a single set of research ethics policies and procedures, voluntary policy pronouncements by countries agreeing to defer to the approval of research ethics bodies in other countries might be a way forward.

Deference is only feasible where countries have existing research ethics policies and procedures that are generally comparable, even if not identical. Unique protections for minors as vulnerable research participants date to the Declaration of Helsinki (1964) and more recently to the guiding principles of the Council for International Organizations of Medical Sciences (2016).

The Convention on the Rights of the Child, adopted by the United Nations in 1989, has been ratified by 196 nations; the US is a signatory but has not ratified it. The health and welfare of children, as expressed in “the best interests of the child,” is a primary consideration in any decision concerning them (art. 3). Also important are the right “to be heard in accordance with the age and maturity of the child” (art. 12), and the right to “the enjoyment of the highest attainable standard of health” (art. 24). No specific provision addresses biomedical research.

The influence of these international guidelines suggests that countries around the world might have adopted policies on pediatric research sufficient to support voluntary agreements to defer to research ethics review from another country. To assess the future viability of such an approach, we studied the equivalence of pediatric research ethics review in 21 diverse countries.

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