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

Abstract

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.

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 Committee‐approved project was then propagated to 125 local Research Ethics Committees, found that while approval times had improved, 67% of changes requested by local Research Ethics Committees were considered non‐local and thus outside their prerogative. Issues also remained around costs to prepare applications and transparency of information for researchers.4 These issues resonate with our experience of NMA in Australia. In 2015, a new Health Research Authority run by the National Health Service and backed by new legislation was introduced in the UK to manage ethics approvals nationally, in a model reform Australia could consider. The Human Heredity and Health in Africa initiative is undertaking the ethics review process for genomic studies across Africa. A recent report on the challenges faced by this initiative suggested that the main barrier to ethics approval is a lack of genomic expertise within ethics committees.5 With increasing international data sharing efforts, internationally compatible solutions to research ethics issues need to be developed. The Global Alliance for Genomics and Health has developed an ethics review recognition policy,6 and Australia could continue to demonstrate leadership internationally if remaining challenges to multijurisdictional research were addressed.