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Ethics and compliance hurdles in conducting multicentre low-risk research

Merin V Pariyadan, Elizabeth D Hotham, Sean Turner and Sanjay Garg
Med J Aust 2015; 203 (8): 324-325. || doi: 10.5694/mja15.00537

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.

  • Merin V Pariyadan1
  • Elizabeth D Hotham1
  • Sean Turner2
  • Sanjay Garg1

  • 1 University of South Australia, Adelaide, SA
  • 2 Women's and Children's Hospital, Adelaide, SA

Correspondence: libby.hotham@unisa.edu.au

Competing interests:

No relevant disclosures.

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