Concordance of International Regulation of Pediatric Health Research - 08/09/23

Doi : 10.1016/j.jpeds.2023.113524

Mark A. Rothstein, JD ^1,^⁎ , Dimitri Patrinos, JD ², Kyle B. Brothers, MD, PhD ³, Ellen Wright Clayton, MD, JD ⁴, Yann Joly, PhD ², Ma'n H. Zawati, PhD ², Pamela Andanda, PhD ⁵, Thalia Arawi, PhD ⁶, Mireya Castañeda, PhD ⁷, Don Chalmers, LLM ⁸, Haidan Chen, PhD ⁹, Mohammed Ghaly, PhD ¹⁰, Ryoko Hatanaka, PhD ¹¹, Aart C. Hendriks, PhD ¹², Calvin W.L. Ho, JSD ¹³, Jane Kaye, DPhil ¹⁴, Dorota Krekora-Zając, PhD ¹⁵, Won Bok Lee, MD, SJD ¹⁶, Titti Mattsson, PhD ¹⁷, Pilar Nicolás, PhD ¹⁸, Obiajulu Nnamuchi, SJD ¹⁹, Emmanuelle Rial-Sebbag, PhD ²⁰, Gil Siegal, MD, SJD ²¹, Jane M. Wathuta, PhD ²², Bartha Maria Knoppers, PhD ²³
¹ Louis D. Brandeis School of Law, University of Louisville, Rancho Santa Fe, CA
² Centre of Genomics and Policy, McGill University, Montreal, QC, Canada
³ Department of Pediatrics, University of Louisville School of Medicine, Louisville, KY
⁴ Center for Biomedical Ethics and Society, Vanderbilt University, Nashville, TN
⁵ School of Law, University of the Witwatersrand, Johannesburg, South Africa
⁶ Faculty of Medicine, American University of Beirut, Beirut, Lebanon
⁷ Institute of Higher Studies Monterrey, National Autonomous University of Mexico, Mexico City, Mexico
⁸ School of Law, University of Tasmania, Hobart, Tasmania, Australia
⁹ School of Health Humanities, Peking University, Beijing, China
¹⁰ College of Islamic Studies, Hamad Bin Khalifa University, Doha, Qatar
¹¹ Shobi University, Kawagoe, Saitama, Japan
¹² Institute for Public Law, Leiden University, Leiden, The Netherlands
¹³ Centre for Medical Ethics and Law, Faculty of Law, University of Hong Kong, Hong Kong
¹⁴ Centre for Law, Health & Emerging Technologies, Faculty of Law, University of Oxford, Oxford, United Kingdom
¹⁵ Institute of Civil Law, University of Warsaw, Warsaw, Poland
¹⁶ Ewha Law School, Ewha Womans University, Seoul, South Korea
¹⁷ Faculty of Law, Lund University, Lund, Sweden
¹⁸ Faculty of Law, University of the Basque Country, Vizcaya, Spain
¹⁹ Center for Bioethics and Human Rights, Faculty of Law, University of Nigeria, Nsukka, Enugu State, Nigeria
²⁰ French Institute for Health and Medical Research, Toulouse, France
²¹ Faculty of Law, Ono Academic College, Kiryat Ono, Israel
²² Strathmore University Law School, Nairobi, Kenya
²³ Centre of Genomics and Policy, McGill University, Montreal, QC, Canada

^∗Reprint requests: Mark A. Rothstein, JD, Louis D. Brandeis School of Law, University of Louisville, 3787 Via Vuelta, Rancho Santa Fe, CA 92091.Louis D. Brandeis School of LawUniversity of Louisville3787 Via VueltaRancho Santa FeCA92091

Abstract

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.

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Keywords : adequacy, assent, children, consent, ethics, research

Plan

Methods

Results

Capacity to Consent

Consent/Permission/Assent

Best Interests of the Child

Assent by Children

Greater Protection for Children in Research

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Article 113524- septembre 2023 Retour au numéro

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Concordance of International Regulation of Pediatric Health Research - 08/09/23

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