title: Multi-centre research in Australia: analysis of a recent National Health and Medical Research Council-funded project.
abstract: OBJECTIVE
  Human research ethics committees provide essential review of research projects to ensure the ethical conduct of human research. Several recent reports have highlighted a complex process for successful application for human research ethics committee approval, particularly for multi-centre studies. Limited resources are available for the execution of human clinical research in Australia and around the world.
  
  
  METHODS
  This report overviews the process of ethics approval for a National Health and Medical Research Council-funded multi-centre study in Australia, focussing on the time and resource implications of such applications in 2007 and 2008.
  
  
  RESULTS
  Applications were submitted to 16 hospital and two university human research ethics committees. The total time to gain final approval from each committee ranged between 13 and 77 days (median = 46 days); the entire process took 16 months to complete and the research officer's time was estimated to cost $A34 143.
  
  
  CONCLUSIONS
  Obstacles to timely human research ethics committee approval are reviewed, including recent, planned and potential initiatives that could improve the ethics approval of multi-centre research.
authors.affiliation: School of Medicine, University of Queensland, Brisbane, QLD, Australia. tim_kidd@health.qld.gov.au
authors.forename: Timothy J
authors.initials: TJ
authors.lastname: Kidd
authors.forename: Guy B
authors.initials: GB
authors.lastname: Marks
authors.forename: Peter T P
authors.initials: PT
authors.lastname: Bye
authors.forename: Claire E
authors.initials: CE
authors.lastname: Wainwright
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Robinson
authors.forename: Barbara R
authors.initials: BR
authors.lastname: Rose
authors.forename: Colin
authors.initials: C
authors.lastname: Harbour
authors.forename: Scott C
authors.initials: SC
authors.lastname: Bell
mesh_terms: D001315:Australia; D035843:Biomedical Research / Q000191:economics / Q000941:ethics*; D032984:Ethics, Research; D006801:Humans; D015337:Multicenter Studies as Topic / Q000191:economics / Q000941:ethics / Q000639:trends; D009313:National Health Programs / Q000191:economics / Q000941:ethics / Q000639:trends*