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Ethics and compliance hurdles in conducting multicentre low-risk research

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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’…