Literature DB >> 33178365

A call for a streamlined ethics review process for multijurisdictional, child health research studies.

Brigitte Lemyre1,2, Jaya P Bodani3,4, Stefani Doucette5, Michael S Dunn6, Deepak Louis7, Luis Monterrosa8, Amit Mukerji9, Georg M Schmölzer10,11, Prakeshkumar Shah12, Balpreet Singh13,14, Jonathan Wong15, Thierry Lacaze-Masmonteil5, Martin Offringa16.   

Abstract

To be time and resource efficient in neonatal research and to answer clinically relevant questions with validity and generalizability, large numbers of infants from multiple hospitals need to be included. Multijurisdictional research in Canada is currently fraught with research ethics review process hurdles that lead to delays, administrative costs, and possibly termination of projects. We describe our experience applying for ethics review to 13 sites in 7 provinces for a project comparing two standard of care therapies for preterm born infants with respiratory distress syndrome. We welcome the current opportunity created by the Institute of Human Development Child and Youth Health and the Institute for Genetics, to collaboratively identify practical solutions that would benefit Canadian researchers, Research Ethics Boards, and children and families.
© The Author(s) 2019. Published by Oxford University Press on behalf of the Canadian Paediatric Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Entities:  

Keywords:  Multicenter research; neonatology; research ethics review

Year:  2019        PMID: 33178365      PMCID: PMC7606166          DOI: 10.1093/pch/pxz160

Source DB:  PubMed          Journal:  Paediatr Child Health        ISSN: 1205-7088            Impact factor:   2.253


  7 in total

1.  Streamlining the ethics review system.

Authors:  Shannon Lough
Journal:  CMAJ       Date:  2015-11-30       Impact factor: 8.262

2.  Research ethics review: do it once and do it well.

Authors:  Paul Hébert; Raphael Saginur
Journal:  CMAJ       Date:  2009-03-17       Impact factor: 8.262

3.  Ethics application protocols for multicentre clinical studies in Canada: A paediatric rheumatology experience.

Authors:  Loren A Matheson; Adam M Huber; Aleasha Warner; Alan M Rosenberg
Journal:  Paediatr Child Health       Date:  2012-06       Impact factor: 2.253

4.  Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective.

Authors:  Hanna Ezzat; Sue Ross; Peter von Dadelszen; Tara Morris; Robert Liston; Laura A Magee
Journal:  BMC Health Serv Res       Date:  2010-07-30       Impact factor: 2.655

5.  Call for a pan-Canadian approach to ethics review in Canada.

Authors:  Stuart G Nicholls; Karine Morin; Laurel Evans; Holly Longstaff
Journal:  CMAJ       Date:  2018-05-07       Impact factor: 8.262

Review 6.  Ethics review of pediatric multi-center drug trials.

Authors:  Allison C Needham; Mufiza Z Kapadia; Martin Offringa
Journal:  Paediatr Drugs       Date:  2015-02       Impact factor: 3.022

7.  Poractant alfa versus bovine lipid extract surfactant for infants 24+0 to 31+6 weeks gestational age: A randomized controlled trial.

Authors:  Brigitte Lemyre; Christoph Fusch; Georg M Schmölzer; Nicole Rouvinez Bouali; Deepti Reddy; Nicholas Barrowman; Nicole Huneault-Purney; Thierry Lacaze-Masmonteil
Journal:  PLoS One       Date:  2017-05-04       Impact factor: 3.240

  7 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.