Volume 181 - Issue 8
Multicentre research: negotiating the ethics approval obstacle course
Author: Martin B Van Der Weyden
Med J Aust 2004; 181 (8): 459-461. || doi: 10.5694/j.1326-5377.2004.tb06387.x
Published online: 18 October 2004
Published online: 18 October 2004
Martin B Van Der Weyden
Editor, The Medical Journal of Australia, Locked Bag 3030, Strawberry Hills, NSW 2012. medjaustATampco.com.au
Comment: The distress conveyed by Maxwell and Kaye is the latest in a litany of concerns and complaints to the Journal over recent years about the workings of ethics committees.1
At the centre of the protests is the perceived tardiness and inefficiency of human research ethics committees (HRECs) in Australia.2,3
But the past decade has also seen reform. The National Health and Medical Research Council (NHMRC) has clarified the relationship between research and quality assurance and when quality assurance proposals require ethical scrutiny.4 Furthermore, the NHMRC’s National statement on ethical conduct in research involving humans is clear in its advice that HRECs must establish working procedures that include “timely consideration and review of research protocols”, and it also outlines procedures for expediting review of minimal-risk research.5
On multicentre research, the statement is also clear, stressing the need to minimise unnecessary duplication in review of such research, and calling for “prompt and efficient consideration of multi-centre research protocols” and adoption of “other administrative procedures to accelerate timely consideration and avoid unnecessary duplication”.5
With such clear enunciations, what could go wrong? But, as Maxwell and Kaye attest, things do go wrong. It seems that either the NHMRC recommendations have yet to be translated into reality or the “silo” mentality of HRECs is deeply ingrained. The time may well have arrived to consider performance indicators for HRECs, or even an accreditation process.
After all, clinical research and quality assurance should not be at the mercy of inefficient HRECs.
References
- Jamrozik K. Ethics committees: is the tail wagging the dog? Med J Aust 1992; 157: 636-637.
- Lowenthal RM. Outdated ethical review system impedes important research [letter]. Med J Aust 1999; 171: 51. CHDHICFC
- Roberts LM, Bowyer L, Homer CS, Brown MA. Multicentre research: negotiating the ethics approval obstacle course [letter]. Med J Aust 2004; 180: 139. CHDJBJEB
- National Health and Medical Research Council. When does quality assurance in healthcare require independent ethical review? Canberra: NHMRC, 2003. Available at: www.nhmrc.gov.au/publications/pdf/e46.pdf (accessed Sep 2004).
- National Health and Medical Research Council. National statement on ethical conduct in research involving humans. 1999. Available at: www.nhmrc.gov.au/publications/pdf/e35.pdf (accessed Aug 2004).