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

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 (www.australiangenomics.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 site‐specific assessment (SSA) requirements, review time, personnel costs, and causes of delay.