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To the Editor: We are writing to add our wholehearted support to the plea made by Carapetis et al1 for a simplified ethical approval process for multicentre studies.
We are conducting two national case-controlled studies of cancer in Australia, funded by grants from the National Institutes of Health and the Department of Defense in the United States, as well as the National Health and Medical Research Council (NHMRC). Our ability to achieve full population coverage was a major competitive advantage in terms of securing international funding. However, to realise this objective, we have spent more than a year obtaining ethics approval from the myriad institutions controlling access to patients and the public.
We have been required to make more than 60 separate ethics applications, lodging about 550 copies of the proposal (a total of 40 000 sheets) at a cost of more than $7000 for paper and printing alone. When labour is included the cost of the initial submissions escalates to $16 000 (excluding substantial investigator time). Other costs include the extraordinary requirement of one ethics committee in Victoria that an investigator from Queensland personally attend a 10-minute interview at which no substantive issues were raised.
The ethical benefit of this investment must be questioned when the majority of changes required by committees have dealt with minor issues such as grammatical style that have little to do with patient protection. Inevitably, such directives are inconsistent across institutions. It is thus impossible to comply with all requests while maintaining a standard set of study documents.
These problems are accentuated for the increasing number of Australian researchers relying on overseas funding. For example, regulatory authorities in the United States insist that all ethics committees reviewing US-funded projects involving humans must have US federal approval to do so. In our experience, few Australian hospital ethics committees have this approval. Therefore, in addition to fulfilling standard institutional ethics requirements, we have also had to help several committees go through the lengthy process of securing US accreditation simply to approve our study!
For all the above reasons, we strongly believe that Australian researchers and patients would be best served by a single national ethics committee for large multicentre studies. This would also reduce the enormous burden currently placed on the individual committees. In the meantime, we thank Breen and Hacker2 for their reminder to institutional ethics committees that the NHMRC national statement "empowers ethics committees to minimise unnecessary duplication".
Queensland Institute of Medical Research, Royal Brisbane Hospital, Brisbane, QLD.
David C Whiteman, MB BS(Hons), PhD, Peter Doherty Research Fellow; Penelope M Webb, MA, DPhil, Research Fellow; David M Purdie, BSc(Hons), MMedSci, PhD, Biostatistician; Adèle C Green, MB BS(Hons), PhD, Deputy Director.Correspondence: Dr David C Whiteman, Queensland Institute of Medical Research, Royal Brisbane Hospital, PO Royal Brisbane Hospital, Brisbane, QLD 4029. davewATqimr.edu.au
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©The Medical Journal of Australia 2003 www.mja.com.au PRINT ISSN: 0025-729X ONLINE ISSN: 1326-5377