The ethics approval process for multisite research studies in Australia: changes sought by the Australian Genomics initiative

Matilda A Haas, Tiffany F Boughtwood and Michael CJ Quinn, on behalf of Australian Genomics
Med J Aust 2019; 211 (10): . || doi: 10.5694/mja2.50397
Published online: 18 November 2019

Australian Genomics is calling for a change in research ethics and governance frameworks

Australian Genomics is a national initiative building evidence to ensure the effective implementation of genomic medicine into Australian health care ( 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 site‐specific assessment (SSA) requirements, review time, personnel costs, and causes of delay.

  • Matilda A Haas1,2
  • Tiffany F Boughtwood1,2
  • Michael CJ Quinn2,3
  • on behalf of Australian Genomics

  • 1 Murdoch Children's Research Institute, Melbourne, VIC
  • 2 Australian Genomics Health Alliance, Melbourne, VIC
  • 3 Genetic Health Queensland, Royal Brisbane and Women's Hospital, Brisbane, QLD


The Australian Genomics Health Alliance is funded by a National Health and Medical Research Council grant (Grant Reference No. 1113531) and the Australian Government's Medical Research Future Fund. Members of the Australian Genomics Health Alliance who also supported and contributed to the publication of this work: Andrea M Belcher, Peta Phillips, Zornitza Stark, Adam Jaffe, Christopher Barnett, Julie McGaughran, Christopher Semsarian, Richard J Leventer, Katherine Howell, Andrew J Mallett, Aron Chakera, Chirag Patel, Cathy Quinlan, Amali Mallawaarachchi, Tony Roscioli, Kristi Jones, Matthew Cook, David R Thorburn, Paul J Lockhart, Cas Simons, Sebastian Lunke, Denise Howting, Clara Gaff, Deborah White, Marcel Dinger, Stephen Fox, Nigel Laing, Jozef Gecz, Ingrid E Scheffer, John Christodoulou, Andrew Sinclair and Kathryn N North. We thank Nikolajs Zeps and Craig Willers for their insightful comments on the manuscript.

Competing interests:

No relevant disclosures.


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