Abstract
BACKGROUND AND 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.
Original language | English |
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Pages (from-to) | 1051-5 |
Number of pages | 5 |
Journal | Respirology (Carlton, Vic.) |
Volume | 14 |
Issue number | 7 |
DOIs | |
Publication status | Published - Sept 2009 |
Keywords
- Australia
- Biomedical Research
- Ethics, Research
- Humans
- Multicenter Studies as Topic
- National Health Programs