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The ethics approval process for multisite research studies in Australia: changes sought by the Australian Genomics initiative
Author(s) -
Haas Matilda A,
Boughtwood Tiffany F,
Quinn Michael CJ
Publication year - 2019
Publication title -
medical journal of australia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.904
H-Index - 131
eISSN - 1326-5377
pISSN - 0025-729X
DOI - 10.5694/mja2.50397
Subject(s) - process (computing) , library science , ethics committee , political science , engineering ethics , research ethics , engineering , computer science , public administration , operating system
Australian Genomics is a national initiative building evidence to ensure the effective implementation of genomic medicine into Australian health care (www.austr alian genom ics.org. au). The research program is embedded in clinical practice, with 5000 patients with rare diseases and cancers being prospectively recruited for genomic testing into clinical flagship projects through 31 hospitals across Australia (Box 1). Achieving national recruitment will ensure that the clinical, diagnostic and research pathways are developed through the infrastructure and workforce in each jurisdiction. We initiated the research ethics and governance approval process for our multisite human research project, which was eligible for single ethical review by one Human Research Ethics Committee under the Australian National Mutual Acceptance (NMA) framework (Box 2), and recorded details relating to our experience in navigating the research ethics and governance system. This included any sitespecific assessment (SSA) requirements, review time, personnel costs, and causes of delay. When NMA was introduced, it was envisaged that the reform would consolidate a nationalised ethics review system.1 Internationally, Australia’s NMA ethics review process has been lauded as a streamlined system, leading the way for other countries.2,3 In the United States and Canada, the institutional review board system requires researchers to apply to each institution in a multicentre study. Researchers report little harmonisation in application requirements, considerable expense and time to prepare applications, and a lack of consistency in institutional review board response to projects in multicentre studies.2 However, Canada and the US have initiated single multisite review systems. Implementation in Canada will be relevant to Australia’s situation, as they share a similar federated model of government. Until recently, in the United Kingdom, multicentre studies were served by Research Ethics Committees, with local Research Ethics Committees charged with subsequently reviewing projects for local issues. Three years after the introduction of this system in 1997, one study, in which a multicentre Research Ethics