A case study evaluation of ethics review systems for multicentre clinical trials

To the Editor: Hicks and colleagues presented a study contrasting the ethics review system in two multicentre trials.1 They concluded that the introduction of a centralised ethics review process in New South Wales did not reduce the overall time taken to receive approval, but did help to reduce the time and resources involved in preparing applications.

We are establishing a multicentre trial to prospectively evaluate and refine a model to predict patient outcomes after endovascular aortic aneurysm repair.2 This will involve collaboration between vascular surgeons at over 40 sites throughout Australia, one site in the United Kingdom and six sites in New Zealand.

We, along with Hicks and colleagues, have experienced difficulty in establishing our multicentre trial. Multiple individual ethics applications have been submitted to human research ethics committees (HRECs) throughout Australia. The National Ethics Application Form (NEAF) was created to minimise inconsistencies and reduce the time and resources required when submitting ethics applications to multiple HRECs. Although the NEAF was designed to increase efficiency and quality,3 in reality it has done little to facilitate the submission process. It has been useful in NSW and Queensland, which have processes to allow the review of multicentre trials, but few HRECs in other Australian states accept the entire form, and often they have their own specific requirements. This has resulted in increased costs and time, as well as different interpretations of the trial protocol — effects that Hicks and colleagues found were reduced with a centralised ethics system.

We are at least 9 months behind schedule in establishing our trial after having submitted over 25 individual applications. This has resulted in substantial losses in patient recruitment and research time. Other researchers have also reported on the excessive time and resources required to submit ethics applications.4

Like Hicks and colleagues (and no doubt other researchers), we are advocates of the Harmonisation of Multi-centre Ethical Review (HoMER) initiative.5 This national system would allow single ethics review that would be recognised by all institutions participating in a collaborative research project, without re-review by their institutional HREC.

It is uncertain how many HRECs will adopt the HoMER initiative, but we remain optimistic that HoMER can solve problems that the NEAF has not. Central coordination of the ethics review process may help standardise documentation, as demonstrated by Hicks and colleagues, but clearly other factors, such as the time required for approval, need to be addressed.