Ethics and compliance hurdles in conducting multicentre low-risk research

It is over 10 years since Roberts and colleagues1 highlighted difficulties in conducting research across multiple sites. However, the process still remains complex. Our study involved a retrospective data review (2012–2013) across multiple Australian public hospital pharmacy departments to identify the extent of compounding of pharmaceutical products at each site. With no requirement for patient participation (or for patient health details), the project was classified as low or negligible risk. The only participants involved were pharmacists who were provided with the opportunity to raise any concerns related to compounding practices. Ethics approval was obtained from the host university, and from a South Australian hospital site. Despite this, the pathway to gaining ethics approval from the other public hospitals involved multiple procedures.

Gaining ethics approval at one ethics committee involves effort, but in multicentre research projects, the effort is multiplied with non-concordant approval requirements. Extensive paperwork, the need for a local contact person at each site and the delay in obtaining signatures from departmental heads were the major issues, despite utilising the researchers’ professional networks. Human research ethics committee (HREC) meeting schedules varied from 1 to 2 months, with little flexibility to accept proposals if an agenda was full.

After 6 months’ work, we received approval from seven of the 10 HRECs approached. However, one pharmacy department subsequently refused involvement. A summary of major concerns encountered at the six sites at which the research was conducted is shown in the Box.

Delays, repetition of effort, variation in ethics committees’ requirements and inconsistent compliance processes have been previously recognised1 and the role of ethics committees in directing institutional research has been debated by researchers.1-3 These concerns and the often extensive period of time taken to obtain ethics approvals are likely to discourage researchers from conducting multicentre studies, hindering valuable research. The National Ethics Application Form, National Approach to Single Ethical Review of Multi-centre Research, and National Mutual Acceptance of ethical and scientific review for multi-centre clinical trials, have been recently introduced to reduce these hurdles; this has certainly streamlined — at least potentially — the process of the ethics review. It would be useful if a similar streamlined process for site-specific assessment could also be introduced, leading to a once-only approval process for multisite research. However, with separate governance requirements (including legal compliance, data storage and insurance) at each site and in different states across Australia,4,5 this seems to be still a tantalisingly long way off.