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Letters

Towards better health research in Australia — a plea to improve the efficiency of human research ethics committee processes

Sandra C Thompson, Frank M Sanfilippo, Tom G Briffa and Michael S T Hobbs
MJA 2009; 190 (11): 652

To the Editor: Population health and clinical researchers have long endured time-consuming submission of applications for a single study to multiple human research ethics committees (HRECs), which each have their own application forms and processes. Each HREC form collects similar information, with slight variation but much repetition. They invariably differ in emphasis and space provided, precluding a simple cut-and-paste among forms. The resource burden of completing this step in the research process has been highlighted previously.1,2 Rarely does completion of multiple applications add value.

Responding to researchers’ protestations, the Australian Health Ethics Committee developed a National Ethics Application Form (NEAF). An improved version (NEAF2) was released in August 2008, with recommendations it be adopted by ethics committees Australia-wide.3 While some state health departments have embraced the new form and reform processes,4 rationalisation has not occurred in all jurisdictions.

As investigators on a 3-year (2008–2010) study of cardiovascular disease that is funded by the National Health and Medical Research Council (NHMRC) and requires access to hospital records throughout Western Australia, our first ethics application was submitted in November 2007. Sequential preparation and submission to other HRECs led to the requisite approval from all 12 HRECs taking a further 12 months to achieve after the first approval.

Few of these committees accepted an application using NEAF at the time. Adopting the current version of NEAF5 — adding supplementary questions pertinent to each institution (if necessary) — and rationalisation of processes to access public hospital medical records would be enormously more efficient for researchers. Centralised processes could also reduce the impost on HRECs.

Our experience with contrasting requirements of the various HRECs has included different reporting timelines (6–12 months), different reminders to report, different periods of study approval (1–4 years), use of institutional letterhead, requirements for at least one chief investigator to be a staff member of the institution auspicing the HREC, requirements that investigators personally attend the HREC meeting, and differences in whether faxed and digital signatures are accepted. Such differences in requirements and processes are documented,2,6 and inevitably delay substantive research.

This ongoing waste of resources and energy — in processes that distract from quality research but do not enhance ethical integrity — increases the burden on both researchers and members of HRECs. Rationalising and streamlining ethics processes could free resources, allowing greater attention to research monitoring by HRECs and research translation by researchers.

We urge expedited implementation of NEAF2 and further reform. State health departments and affiliated organisations should collaborate to rationalise processes and expedite centralised or reciprocal approvals where appropriate. The bold proposal for a national system to streamline the ethics review process within and across Australian jurisdictions7 will invigorate discussion of overdue reform.

Sandra C Thompson, Associate Professor1Frank M Sanfilippo, Research Fellow2Tom G Briffa, Research Fellow2Michael S T Hobbs, Emeritus Professor2

1 Centre for International Health, Curtin University of Technology, Perth, WA.

2 School of Population Health, University of Western Australia, Perth, WA.

s.thompsonATcurtin.edu.au

  1. Watson LF, Rayner JA, Lumley JM. Hospital ethics approval for a population-based case-control study of very preterm birth. Aust Health Rev 2007; 31: 514-522. <PubMed>
  2. Roberts LM, Bowyer L, Homer CS, Brown MA. Multicentre research: negotiating the ethics approval obstacle course [letter]. Med J Aust 2004; 180: 139. <eMJA full text> <PubMed>
  3. Australian Health Ethics Committee. Canberra: National Health and Medical Research Council, 2008. http://www.nhmrc.gov.au/health_ethics/ahec (accessed Jan 2009).
  4. Fraser HE, Martlew AE, Frew DJ. Model for a single ethical and scientific review of multicentre research in New South Wales. Med J Aust 2007; 187: 7-8. <eMJA full text> <PubMed>
  5. National Ethics Application Form. Canberra: National Health and Medical Research Council, 2008. http://www.nhmrc.gov.au/health_ethics/ahec/neaf (accessed Jan 2009).
  6. Jaffe A, Strachan RE, Williams KJ. Consent in paediatric research: an evaluation of the guidance provided in the 2007 NHMRC National statement on ethical conduct in human research [letter]. Med J Aust 2008; 189: 347-348. <eMJA full text> <PubMed>
  7. Harmonisation of Multi-centre Ethical Review (HoMER). Canberra: National Health and Medical Research Council, 2008. http://www.nhmrc.gov.au/health_ethics/homer/index.htm (accessed Mar 2009).

(Received 18 Jan 2009, accepted 31 Mar 2009)


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