Concordance of International Regulation of Pediatric Health Research
(2023) In Journal of Pediatrics 260(September).- 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... (More)
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.
(Less)
- author
- Rothstein, Mark A.
; Patrinos, Dimitri
; Brothers, Kyle B.
; Clayton, Ellen Wright
; Joly, Yann
; Zawati, Ma'n H.
; Andanda, Pamela
; Arawi, Thalia
; Castañeda, Mireya
; Chalmers, Don
; Chen, Haidan
; Ghaly, Mohammed
; Hatanaka, Ryoko
; Hendriks, Aart C.
; Ho, Calvin W.L.
; Kaye, Jane
; Krekora-Zając, Dorota
; Lee, Won Bok
; Mattsson, Titti
LU
; Nicolás, Pilar
; Nnamuchi, Obiajulu
; Rial-Sebbag, Emmanuelle
; Siegal, Gil
; Wathuta, Jane M.
and Knoppers, Bartha Maria
(Less) - organization
- publishing date
- 2023
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- adequacy, assent, children, consent, ethics, research
- in
- Journal of Pediatrics
- volume
- 260
- issue
- September
- article number
- 113524
- publisher
- Academic Press
- external identifiers
-
- scopus:85162239307
- pmid:37245625
- scopus:85162239307
- ISSN
- 0022-3476
- DOI
- 10.1016/j.jpeds.2023.113524
- language
- English
- LU publication?
- yes
- id
- b864ed33-c799-4ffe-a25b-fa9f1893c4e0
- date added to LUP
- 2023-06-27 11:27:22
- date last changed
- 2024-04-19 23:18:46
@article{b864ed33-c799-4ffe-a25b-fa9f1893c4e0,
abstract = {{<p>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.</p>}},
author = {{Rothstein, Mark A. and Patrinos, Dimitri and Brothers, Kyle B. and Clayton, Ellen Wright and Joly, Yann and Zawati, Ma'n H. and Andanda, Pamela and Arawi, Thalia and Castañeda, Mireya and Chalmers, Don and Chen, Haidan and Ghaly, Mohammed and Hatanaka, Ryoko and Hendriks, Aart C. and Ho, Calvin W.L. and Kaye, Jane and Krekora-Zając, Dorota and Lee, Won Bok and Mattsson, Titti and Nicolás, Pilar and Nnamuchi, Obiajulu and Rial-Sebbag, Emmanuelle and Siegal, Gil and Wathuta, Jane M. and Knoppers, Bartha Maria}},
issn = {{0022-3476}},
keywords = {{adequacy; assent; children; consent; ethics; research}},
language = {{eng}},
number = {{September}},
publisher = {{Academic Press}},
series = {{Journal of Pediatrics}},
title = {{Concordance of International Regulation of Pediatric Health Research}},
url = {{http://dx.doi.org/10.1016/j.jpeds.2023.113524}},
doi = {{10.1016/j.jpeds.2023.113524}},
volume = {{260}},
year = {{2023}},
}