Concordance of International Regulation of Pediatric Health Research
Copyright © 2023 Elsevier Inc. All rights reserved..
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.
Medienart: |
E-Artikel |
---|
Erscheinungsjahr: |
2023 |
---|---|
Erschienen: |
2023 |
Enthalten in: |
Zur Gesamtaufnahme - volume:260 |
---|---|
Enthalten in: |
The Journal of pediatrics - 260(2023) vom: 26. Sept., Seite 113524 |
Sprache: |
Englisch |
---|
Beteiligte Personen: |
Rothstein, Mark A [VerfasserIn] |
---|
Links: |
---|
Themen: |
---|
Anmerkungen: |
Date Completed 11.09.2023 Date Revised 13.09.2023 published: Print-Electronic Citation Status MEDLINE |
---|
doi: |
10.1016/j.jpeds.2023.113524 |
---|
funding: |
|
---|---|
Förderinstitution / Projekttitel: |
|
PPN (Katalog-ID): |
NLM35747841X |
---|
LEADER | 01000naa a22002652 4500 | ||
---|---|---|---|
001 | NLM35747841X | ||
003 | DE-627 | ||
005 | 20231226072658.0 | ||
007 | cr uuu---uuuuu | ||
008 | 231226s2023 xx |||||o 00| ||eng c | ||
024 | 7 | |a 10.1016/j.jpeds.2023.113524 |2 doi | |
028 | 5 | 2 | |a pubmed24n1191.xml |
035 | |a (DE-627)NLM35747841X | ||
035 | |a (NLM)37245625 | ||
035 | |a (PII)S0022-3476(23)00372-4 | ||
040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
041 | |a eng | ||
100 | 1 | |a Rothstein, Mark A |e verfasserin |4 aut | |
245 | 1 | 0 | |a Concordance of International Regulation of Pediatric Health Research |
264 | 1 | |c 2023 | |
336 | |a Text |b txt |2 rdacontent | ||
337 | |a ƒaComputermedien |b c |2 rdamedia | ||
338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
500 | |a Date Completed 11.09.2023 | ||
500 | |a Date Revised 13.09.2023 | ||
500 | |a published: Print-Electronic | ||
500 | |a Citation Status MEDLINE | ||
520 | |a Copyright © 2023 Elsevier Inc. All rights reserved. | ||
520 | |a 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 | ||
520 | |a 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 | ||
520 | |a 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 | ||
520 | |a CONCLUSIONS: Similar regulation of pediatric research in 21 countries suggests that international reciprocity is a viable strategy | ||
650 | 4 | |a Journal Article | |
650 | 4 | |a adequacy | |
650 | 4 | |a assent | |
650 | 4 | |a children | |
650 | 4 | |a consent | |
650 | 4 | |a ethics | |
650 | 4 | |a research | |
700 | 1 | |a Patrinos, Dimitri |e verfasserin |4 aut | |
700 | 1 | |a Brothers, Kyle B |e verfasserin |4 aut | |
700 | 1 | |a Clayton, Ellen Wright |e verfasserin |4 aut | |
700 | 1 | |a Joly, Yann |e verfasserin |4 aut | |
700 | 1 | |a Zawati, Ma'n H |e verfasserin |4 aut | |
700 | 1 | |a Andanda, Pamela |e verfasserin |4 aut | |
700 | 1 | |a Arawi, Thalia |e verfasserin |4 aut | |
700 | 1 | |a Castañeda, Mireya |e verfasserin |4 aut | |
700 | 1 | |a Chalmers, Don |e verfasserin |4 aut | |
700 | 1 | |a Chen, Haidan |e verfasserin |4 aut | |
700 | 1 | |a Ghaly, Mohammed |e verfasserin |4 aut | |
700 | 1 | |a Hatanaka, Ryoko |e verfasserin |4 aut | |
700 | 1 | |a Hendriks, Aart C |e verfasserin |4 aut | |
700 | 1 | |a Ho, Calvin W L |e verfasserin |4 aut | |
700 | 1 | |a Kaye, Jane |e verfasserin |4 aut | |
700 | 1 | |a Krekora-Zając, Dorota |e verfasserin |4 aut | |
700 | 1 | |a Lee, Won Bok |e verfasserin |4 aut | |
700 | 1 | |a Mattsson, Titti |e verfasserin |4 aut | |
700 | 1 | |a Nicolás, Pilar |e verfasserin |4 aut | |
700 | 1 | |a Nnamuchi, Obiajulu |e verfasserin |4 aut | |
700 | 1 | |a Rial-Sebbag, Emmanuelle |e verfasserin |4 aut | |
700 | 1 | |a Siegal, Gil |e verfasserin |4 aut | |
700 | 1 | |a Wathuta, Jane M |e verfasserin |4 aut | |
700 | 1 | |a Knoppers, Bartha Maria |e verfasserin |4 aut | |
773 | 0 | 8 | |i Enthalten in |t The Journal of pediatrics |d 1945 |g 260(2023) vom: 26. Sept., Seite 113524 |w (DE-627)NLM000019003 |x 1097-6833 |7 nnns |
773 | 1 | 8 | |g volume:260 |g year:2023 |g day:26 |g month:09 |g pages:113524 |
856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.jpeds.2023.113524 |3 Volltext |
912 | |a GBV_USEFLAG_A | ||
912 | |a GBV_NLM | ||
951 | |a AR | ||
952 | |d 260 |j 2023 |b 26 |c 09 |h 113524 |