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

Author:

Lemyre Brigitte12ORCID,Bodani Jaya P34,Doucette Stefani5,Dunn Michael S6,Louis Deepak7,Monterrosa Luis8,Mukerji Amit9,Schmölzer Georg M1011,Shah Prakeshkumar12,Singh Balpreet1314,Wong Jonathan15ORCID,Lacaze-Masmonteil Thierry5,Offringa Martin16

Affiliation:

1. Division of Neonatology, Children’s Hospital of Eastern Ontario, Ottawa

2. Department of Pediatrics, University of Ottawa, Ottawa

3. Department of Pediatrics Regina General Hospital, Saskatchewan Health Authority, Regina

4. Department of Pediatrics, College of Medicine, University of Saskatchewan, Regina

5. Department of Paediatrics, Cumming School of Medicine, University of Calgary, Calgary

6. Department of Newborn and Developmental Paediatrics, Sunnybrook Health Sciences Center, Toronto

7. Department of Paediatrics and Child Health, Max Rady Faculty of Medicine, University of Manitoba, Winnipeg

8. Department of Pediatrics, Division of Neonatology, Dalhousie University, Saint-John

9. Division of Neonatology, McMaster University, Hamilton

10. Centre for the Studies of Asphyxia and Resuscitation, Neonatal Research Unit, Royal Alexandra Hospital, Edmonton, Alberta

11. Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta

12. Department of Pediatrics, Mount Sinai Hospital and University of Toronto, Toronto

13. Division of Neonatal-Perinatal Medicine, IWK Health Center, Halifax

14. Department of Pediatrics, Dalhousie University, Halifax

15. Department of Pediatrics, BC University of British Columbia, Vancouver

16. Division of Neonatology, The Hospital for Sick Children, Toronto

Abstract

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.

Publisher

Oxford University Press (OUP)

Subject

Pediatrics, Perinatology, and Child Health

Reference7 articles.

1. Poractant alfa versus bovine lipid extract surfactant for infants 24 + 0 to 31 + 6 weeks gestational age: A randomized controlled trial;Lemyre;PLoS One,2017

2. Ethics review of pediatric multi-center drug trials;Needham;Paediatr Drugs,2015

3. Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: The investigator’s perspective;Ezzat;BMC Health Serv Res,2010

4. Ethics application protocols for multicentre clinical studies in Canada: A paediatric rheumatology experience;Matheson;Paediatr Child Health,2012

5. Research ethics review: Do it once, do it well;Hebert;CMAJ.,2009

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