Our earlier blog posts highlighted the irony of numerous ethical reviews for the same research project, which makes us wonder about the validity of multiple opinions, besides creating huge administrative burdens and wasted time and costs for the researcher as well as the ethics committees themselves. This is especially the case in studies that evaluate service quality, interventions and outcomes, as they are required to follow patients across several hospitals, health services, local health districts and across jurisdictions, and call for utilizing data from different data collections.
Obtaining ethics approvals for such ‘multi-centre’ health research continues to be an onerous exercise for researchers, as they navigate the varying, and sometimes inconsistent requirements of multiple HRECS for the same project. One recent study described an Australian multi-centre project in which the cost of ethics approvals alone accounted for 38% of the project budget. For a study involving 50 centres the mean cost per site was $6960. In the same study, 75% of time was estimated to have been spent on repeated tasks as well as tasks that were time-intensive, such as re-formatting documents that “did nothing to improve study design or participant safety.” This is just one example of a reality that the health and medical research sector has been dealing with for over two decades.
Researchers expressed such frustrations in a 1996 report to the then Federal Minister of Health, claiming that the ethics approval processes existed in isolation from one another, increasing workloads for both researchers and ethics committees.
In light of this, the report made several recommendations including:
• need for improved communication and cooperative arrangements between ethics committees;
• acceptance by ethics committees of a single assessment of the scientific and safety/privacy aspects of a proposal
• encouragement of administrative consistency among ethics committees
Yet, ten years later many of the same issues remained and upon the request of the Australian Health Ministers' Advisory Council (AHMAC), in 2006 the NHMRC established a project called the national harmonisation of multi-centre ethical review (HoMER). Now called the National Approach to Single Ethical Review of Multi-centre Research, this policy works towards enabling the recognition of a single ethics and scientific review of multi-centre human research within and/or across Australian jurisdictions. The National Mutual Acceptance (NMA) scheme, is a result of this policy.
National Mutual Acceptance of scientific and ethical review of multi-centre human research
The NMA is a Memorandum of Understanding (MoU) whereby the ethics review for a research proposal accepted by one HREC is mutually accepted by the all other institutions participating in the multi-centre research. The NMA requires that Institutional HREC conducting the single review be certified under the NHMRC National Certification Scheme, and also be a Certified Reviewing HREC under the NMA scheme. Although initially limited to clinical trials, the scope of the MoU now extends to all human research. With its development in 2013, the MoU was signed by health departments of three states (Victoria, South Australia and Queensland, and New South Wales), with the Australian Capital Territory joining in 2016, and Western Australia in 2017.
So what does this mean for researchers?
While NMA is technically in place, unfortunately, we still have a long way to go for a nationally consistent, transparent, and coordinated scientific and ethical review process. While the NMA is a step in the right direction, researchers are still far from accessing a ‘one-stop-shop’ for gaining ethics approval for their projects.
- The NMA still does not cover all jurisdictions, nor all types of research. For example, it excludes projects that seek access to state-wide datasets. The long list of research types excluded from the NMA, for each state and territory can be found here. Researchers working in these NMA-excluded areas, still need to follow jurisdiction specific requirements – which could be multiple depending on the scope of their research.
- In terms of processes and documentation too there are exceptions. Although researchers can apply using NHMRC’s online HREA (Human Research Ethics Application), they are required to complete additional state specific modules, if they have research components in Victoria and Western Australia.
- Of course, given the nature of the fragmented health system, the NMA does not automatically extend to institutions outside the public health system, such as private health organisations or private universities. Unless previously agreed upon, neither do these entities necessarily accept the review of a NHMRC-certified HREC.
- Finally, even among public health organisations, none of these enabling processes such as the National Certification Scheme is mandatory. Researchers are still required to contact individual institutions and their ethics committees and their readiness to accept the NMA.
Getting down to brass-tacks
In the 2017 review of Data Availability and Use, the Productivity Commission again highlighted the need for and value of streamlining ethics approval processes, providing recommendations that echo those from twenty years ago. In particular, these recommendations address the realities, risks and rewards of multi-centre research and the need for a system that supports these projects in a uniform, efficient and transparent manner.
HRECs hold the important role of weighing public benefits of research against the potential risks. Ethics review outcomes need to be the same irrespective which HREC processes the application. Therefore, a successful system of single ethics review relies on the key principle of ‘trust’ between different HRECs. For trust to exist, there needs to be confidence that all ethics committees have sufficient knowledge and skills to evaluate the projects, in a reliable way that is also replicable.
The Population Health Research Network (PHRN) has identified this need, and offer specialised training to HRECs to review data-linkage research. However, such training for HRECS should not be optional, and neither limited to specialised types of research.
We require leadership and cooperation from the sector to address these important issues so that another twenty years don’t whittle away as we wait for a single transparent process.