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The path to reducing duplication of human research ethics review in Australia
Abstract
The expansion of collaborative and data-intensive multicentre international research has intensified the need to reassess current national ethics review systems to ensure they both protect research participants and facilitate ethical research. Regarding the latter aim, this means ensuring that systems do not create unnecessary review barriers that may delay or even prevent important, ethical research. Australia and other jurisdictions recently have been revising their ethics review procedures and guidelines. However, many Australian Human Research Ethics Committees (HRECs) continue to undertake a full review of each research project undertaken at their home institution, irrespective of whether the project is stand-alone or multicentre. Australia has been addressing duplication in ethics review, but this remains a work-in-progress. Structural barriers created by state-based approaches to legislation and ethics review exacerbate the problem in the Australian context. Harmonisation of ethical review has not enjoyed sufficient resourcing or political support and moves ahead at a glacial pace. International cooperation and harmonisation of protocols through initiatives like the Global Alliance for Genomics and Health (GA4GH) provide a clear impetus to accelerate ethics review reform that aims to reduce duplicated review and recognise the equivalency of review of multi-centre research projects by another research ethics committee.
... These state-based schemes have been accompanied by efforts by the NHMRC to facilitate shared reviews at the national level. To this end, the National Approach to Single Ethical Review of Multi-Centre Research (formerly Harmonisation of Multi-Centre Ethical Review, HoMER) was implemented in 2007 (Johns et al. 2017). A central component of this scheme is national certification of participating institutions and their HRECs based on an independent assessment by the NHMRC (Australian Government National Health and Medical Research Council 2018b). ...
... Eight (61%) accepted the application using the NHMRC standard form, while the remainder required a customised form. The time taken to complete all submissions, including revisions and further communication, amounted to 74.5 working days, with an estimated overall cost of $60,471 (Johns et al. 2017). Other studies report similar experiences (De Smit et al. 2016;White et al. 2016;Rush et al. 2017). ...
The regulation of genomic data sharing in Australia is a confusing mix of common law, legislation, ethical guidelines, and codes of practice. Beyond privacy laws, which only apply to genomic data that meets the definition of personal information, the key regulatory lever is the National Health and Medical Research Council (NHMRC) National Statement for Ethical Conduct in Human Research (“National Statement”) (2007). Compliance with the National Statement is a requirement for institutions to apply to the NHMRC for funding, and includes—among other things—requirements for review of most genomic research by Human Research Ethics Committees. The sections of the National Statement specifying requirements for research with human genomic data are currently under review, including proposed new requirements addressing the return of genetic research findings and oversight of transfer agreements. Ensuring the willingness of Australians to donate their genomic information and participate in medical research will require clarification and harmonisation of the applicable regulatory framework, along with reforms to ensure that these regulations reflect the conditions necessary to promote ongoing public trust in researchers and institutions.
Before 1950 the practice of medicine was based largely on observations of outcomes in one individual or in small groups of patients. With the development of the randomized controlled trial (RCT) around the middle of the 20th century, medicine was rapidly transformed, as inferences increasingly were made on the basis of this experimental method.1 The first of these trials were conducted mainly to investigate infectious diseases. Because large effects were expected (e.g., a reduction in mortality rate or disease outcomes by greater than half), small trials were sufficient and could often be conducted by a single investigator. However, for most chronic diseases (e.g., cardiovascular disease or cancer) treatments are likely to have at best only a moderately beneficial effect (although potential harm from treatments could be much larger). This realization transformed RCTs and led to the conduct of large, multicentre trials often involving tens of thousands of subjects.2 Such trials have provided conclusive evidence for the efficacy, lack of efficacy or harm of numerous therapies in many diseases;3 as such, they have led to the widespread use of proven effective treatments, which has prevented several tens of millions of premature deaths and much suffering. RCTs and their resulting discoveries should probably rank among the most important milestones in the history of medicine.