Literature DB >> 23730169

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

Loren A Matheson1, Adam M Huber, Aleasha Warner, Alan M Rosenberg.   

Abstract

INTRODUCTION: Individual institutions govern research ethics applications and each must administer and regulate their own protocols. Variations in ethics review procedures and expectations among centres impose impediments to efficiently conducting multicentre studies.
METHODS: Observations relating to preparing multisite ethics documents for a study conducted by Canadian paediatric rheumatology investigators are described. Research ethics applications from the 12 participating centres were compared.
RESULTS: Although the applications were similar in their content, they differed in their formatting. All applications shared a commitment to ensuring that the study conformed to exemplary ethical standards.
CONCLUSIONS: There is wide variation in the multicentre clinical study ethics application process at the institutional level. Considering the common fundamental elements required by all ethics review boards, the present study conceptualized introducing a discipline-specific uniform ethics application process acceptable to all Canadian research ethics boards. This may be a more efficient strategy that could help lessen the burden of collaborative research.

Keywords:  Ethics; Multicentre studies; Paediatrics; Rheumatology

Year:  2012        PMID: 23730169      PMCID: PMC3380748     

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


  16 in total

1.  Variation in institutional review board responses to a standard protocol for a multicenter clinical trial.

Authors:  T O Stair; C R Reed; M S Radeos; G Koski; C A Camargo
Journal:  Acad Emerg Med       Date:  2001-06       Impact factor: 3.451

2.  Introduction to special issue of Accountability in Research on the review and approval of biomedical research proposals: a call for a centralized national human research protections system.

Authors:  Howard Mann; Adil E Shamoo
Journal:  Account Res       Date:  2006 Jan-Mar       Impact factor: 2.622

3.  Ethics review of multi-centre clinical trials in Canada.

Authors:  Michael E Enzle; Rodney Schmaltz
Journal:  Health Law Rev       Date:  2005

Review 4.  Differences between research ethics committees.

Authors:  Sarah J L Edwards; Tracey Stone; Teresa Swift
Journal:  Int J Technol Assess Health Care       Date:  2007       Impact factor: 2.188

5.  Harmonisation of ethics committees' practice in 10 European countries.

Authors:  R Hernandez; M Cooney; C Dualé; M Gálvez; S Gaynor; G Kardos; C Kubiak; S Mihaylov; J Pleiner; G Ruberto; N Sanz; M Skoog; P Souri; C O Stiller; A Strenge-Hesse; A Vas; D Winter; X Carné
Journal:  J Med Ethics       Date:  2009-11       Impact factor: 2.903

Review 6.  Regulation of clinical research and bioethics in Portugal.

Authors:  Fatima Lampreia Carvalho
Journal:  Bioethics       Date:  2007-06       Impact factor: 1.898

7.  Ethics approval for a national postal survey: recent experience.

Authors:  C Middle; A Johnson; T Petty; L Sims; A Macfarlane
Journal:  BMJ       Date:  1995-09-09

8.  What do research ethics committees say about applications to conduct research involving children?

Authors:  E Angell; H Biggs; F Gahleitner; M Dixon-Woods
Journal:  Arch Dis Child       Date:  2010-06-23       Impact factor: 3.791

9.  Breaking the camel's back: multicenter clinical trials and local institutional review boards.

Authors:  W J Burman; R R Reves; D L Cohn; R T Schooley
Journal:  Ann Intern Med       Date:  2001-01-16       Impact factor: 25.391

10.  The Ontario cancer research ethics board: a central REB that works.

Authors:  M R Chaddah
Journal:  Curr Oncol       Date:  2008-01       Impact factor: 3.677

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  4 in total

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

Authors:  Brigitte Lemyre; Jaya P Bodani; Stefani Doucette; Michael S Dunn; Deepak Louis; Luis Monterrosa; Amit Mukerji; Georg M Schmölzer; Prakeshkumar Shah; Balpreet Singh; Jonathan Wong; Thierry Lacaze-Masmonteil; Martin Offringa
Journal:  Paediatr Child Health       Date:  2019-12-19       Impact factor: 2.253

Review 2.  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

Review 3.  Ethical standards for medical research in the Israeli military - review of the changes in the last decade.

Authors:  Ayal Hassidim; Raeed Kayouf; Nirit Yavnai; Naomi Panush; David Dagan; Tarif Bader; Michael Hartal
Journal:  Isr J Health Policy Res       Date:  2016-12-01

4.  Emerging issues in paediatric health research consent forms in Canada: working towards best practices.

Authors:  Edward S Dove; Denise Avard; Lee Black; Bartha M Knoppers
Journal:  BMC Med Ethics       Date:  2013-01-30       Impact factor: 2.652

  4 in total

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