Multicentre research: negotiating the ethics approval obstacle course
Author: Kerry J Breen
Published online: 18 October 2004
Kerry J Breen
Chair, Australian Health Ethics Committee, National Health and Medical Research Council, PO Box 9848, Canberra, ACT 2601. kerrybreenATaccess.net.au
Comment: It is correct that the National Health and Medical Research Council’s National statement on ethical conduct in research involving humans1 (paragraph 3.4) does not say that other sites should accept ethics review of a research proposal from another human research ethics committee (HREC). However, the national statement is written to permit and encourage this, but not to enforce it.
Dickson’s letter also raises the issue of the terms of reference of HRECs. He alludes to an additional role — as gatekeeper of an institution’s resources — which some may feel is beyond the domain of HRECs. The national statement provides the framework for the composition and role of HRECs in their work of ethical review, but does not prevent an institution from asking its committee to also be the steward of access to resources regularly used (eg, medical records, pathology laboratories). The national statement requires an institution to set out the terms of reference for its HREC, “including the scope of its responsibilities” (paragraph 2.2). The prime function of HRECs is to make recommendations about whether a research proposal is ethical, but the final approval about whether the research can proceed rests with each individual institution.
Thus, there is more to getting approval for a research proposal than just the ethical review.
References
- NHMRC. National statement on ethical conduct in research involving humans. Canberra: NHMRC; 1999. Available at: www.nhmrc.gov.au/publications/synopses/e35syn.htm (accessed Sep 2004).
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