Please use this identifier to cite or link to this item: https://repository.monashhealth.org/monashhealthjspui/handle/1/52776
Conference/Presentation Title: Beyond the protocol: navigating ethics and governance in the multisite QASC Australasia trial.
Authors: Dale S.;Fasugba O.;Coughlan K.;Saheb S.;McInnes E.;Cadilhac D.A.;Cheung N.W.;Hill K.;Page K.;Menendez E.S.;Neal E.;Pollnow V.;Slark J.;Ranta A.;Gilder E.;Levi C.;Grimshaw J.M.;Middleton S.
Monash Health Department(s): Monash University - School of Clinical Sciences at Monash Health
Institution: (Dale, Fasugba, Coughlan, Saheb, McInnes, Middleton) Nursing Research Institute, St Vincent's Health Network Sydney, St Vincent's Hospital Melbourne and Australian Catholic University, Sydney, NSW, Australia
(Dale, Fasugba, Coughlan, Saheb, McInnes, Middleton) School of Nursing, Midwifery and Paramedicine, Australian Catholic University, Sydney, NSW, Australia
(Cadilhac) Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Melbourne, VIC, Australia
(Cheung) Centre for Diabetes and Endocrinology Research, Westmead Hospital and University of Sydney, Sydney, NSW, Australia
(Hill) Stroke Foundation, Sydney, NSW, Australia
(Page, Pollnow) St Vincent's Health Network Sydney, Sydney, NSW, Australia
(Menendez) Vall d'Hebron Hospital Universitari, Barcelona, Catalonia, Spain
(Neal) Prince of Wales Hospital, Randwick, NSW, Australia
(Slark, Gilder) School of Nursing, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand
(Ranta) Department of Medicine, University of Otago, Wellington, New Zealand
(Ranta) Department of Neurology, Wellington Hospital, Wellington, New Zealand
(Levi) John Hunter Hospital, Newcastle, NSW, Australia
(Levi) Department of Medicine, University of Newcastle, Newcastle, NSW, Australia
(Grimshaw) Department of Medicine, University of Ottawa, Ottawa, ON, Canada
(Grimshaw) Methodological and Implementation Research Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada
Presentation/Conference Date: 13-Nov-2024
Copyright year: 2024
Publication information: Cerebrovascular Diseases. Conference: Asia Pacific Stroke Conference 2024 Combined Australian and New Zealand Stroke Organisation Transcending Borders. Adelaide, SA Australia. 53(Supplement 1) (pp 153), 2024. Date of Publication: 2024.
Journal: Cerebrovascular Diseases
Abstract: Background: Multicentre studies require ethics and governance approvals from individual sites with the potential for duplication and costly delays. Aim(s): To describe the ethics and governance approval processes for a multicentre international stroke randomised controlled trial (QASC Australasia Trial). Findings were compared to our previous Australian multicentre T3 Trial. Method(s): Prospective, descriptive analysis (November 2021 - April 2024) for Australian sites. Result(s): We required lead ethics approval from NSW (n=1), ethics approvals from Western Australia (n=1) and Northern Territory (n=2), with n=52 individual site governance applications. Lead ethics took 4.3 weeks (median), requiring one revision; all three ethics approvals took 1.6 weeks (median) (range: 0.6- 4.3 weeks). Median time for 45 governance approvals was 13.1 weeks (range: 0.9-54.3 weeks) excluding 6 sites awaiting approval (median 51.9 weeks, range: 12-72.6 weeks to-date). Median time for Clinical Trials Research Agreement execution (n=45 sites) was 7.4 weeks (range: 0.9-44.4 weeks). The 2012-2014 T3 Trial processes were longer: lead ethics took 10 weeks (median); all five ethics approvals took 6 weeks (median) (range: 3-10 weeks); 21 governance approvals took 16 weeks (median) (range: 7-28 weeks). According to the recommended 8.6-week timeframe1, ethics review time was met for all applications but exceeded in 68.9% (n=31/45) of governance applications. Conclusion(s): While there are notable improvements in obtaining ethics approval, the governance process for multicentre studies continues to be time consuming, contributing to delays in translation of research into practice. It is hoped the National One Stop Shop initiative will eradicate delays and better utilise scarce research resources.
Conference Name: Asia Pacific Stroke Conference 2024 Combined Australian and New Zealand Stroke Organisation Transcending Borders
Conference Start Date: 2024-09-25
Conference End Date: 2023-09-01
Conference Location: Adelaide, SA, Australia
DOI: http://monash.idm.oclc.org/login?url=https://dx.doi.org/10.1159/000541320
URI: https://repository.monashhealth.org/monashhealthjspui/handle/1/52776
Type: Conference Abstract
Subjects: cerebrovascular accident
Appears in Collections:Conferences

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