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A call for a national inquiry into the burden of research ethics and governance

 


Adrian Barnett, Queensland University of Technology

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Do we need a national inquiry into the burden of research ethics and governance in health and medical research Australia? Many Australian researchers would cry “yes!” because they have repeatedly experienced application systems that are time-consuming and illogical.

I have never met a researcher who did not think that ethics and research integrity wasn’t vitally important, but many current application systems have more to do with risk aversion than the safety of patients or the public.

This risk aversion means that millions of dollars worth of Australian researchers’ time is being wasted on submitting the same forms to multiple ethical review committees. For example, getting approvals for our group’s low-risk survey of nurses in 50 hospitals cost an estimated $348,000 in staff time and delayed the study by six months (Barnett et al 2016).

Another Australian study of 60 nationwide hospitals spent an estimated $264,000 on approvals and the researchers’ experienced puzzling variations in submission requirements and decisions about the study’s level of risk (Clay-Williams et al 2018).

Another Australian study found that the time taken to complete the ethics and governance forms for a negligible risk study took eight times longer than the actual research (Rush et al 2018).

These are not isolated experiences and the current processes are driving researchers crazy. In our recent one-day meeting on improving research quality, we asked attendees to vote on the changes most needed to improve research and reduce research waste. The idea of a national inquiry into ethics and governance was voted fourth highest out of 21 policies (the full survey results are available here).

What should a national inquiry consider? The primary question should be: why can’t we have a national system? A national system that has standardised forms and is used by every state and territory health department. A national system that covers all types of research, not just clinical trials.

An inquiry into ethics processes could have been part of the Chubb inquiry (had Labor won the election) that promised a root-and-branch examination of Australia’s overall research framework and to “ensure that Australia maintains its international competitive advantage”. Other countries use simpler approval processes and we hamper our ability to conduct research by tying up researchers in wasteful knots of unnecessary paperwork.

A national inquiry should engage with the people doing the hard work of reviewing applications on ethics committees. These people should also welcome a streamlined system that cuts-out the requirement for them to review already reviewed applications, giving them more time to focus on important ethical considerations.

Researchers should also acknowledge that some delays and duplication are their own fault. A key problem is that ethics applications can be so badly written that committee members cannot judge the ethical implications of the study.

Australian researchers want a system that improves and facilities their research, not one that puts “virtually insurmountable and costly barriers in place” (Clay-Williams et al 2018). We want a “tailored and harmonised” system (Rush et al 2018).

Many researchers have been talking about the need for change for over a decade, but have seen only small improvements and plenty of backwards steps too. A national inquiry would cost time and money, but the potential long-term savings to researchers and the public from this important reform could be enormous.

Declaration of conflicts of interest: Adrian Barnett receives funding from the National Health and Medical Research Council.

References

  • Rush, A., Ling, R., Carpenter, J. E., Carter, C., Searles, A., & Byrne, J. A. (2018). Research governance review of a negligible-risk research project: Too much of a good thing? Research Ethics, 14(3), 1–12. https://doi.org/10.1177/1747016117739937
  • Clay-Williams, R., Taylor, N. & Braithwaite, J. (2018) Potential solutions to improve the governance of multicentre health services research. Med J Aust; 208 (4): doi: 10.5694/mja16.01268
  • Barnett, A. G., Campbell, M. J., Campbell, Shield, C., Farrington, A., Hall, L., Page, K., Gardner, A., Mitchell, B.G. & Graves, N. (2016) The high costs of getting ethical and site-specific approvals for multi-centre research. Research Integrity and Peer Review 1:16 https://doi.org/10.1186/s41073-016-0023-6

This post may be cited as:
Barnett, A. G. (22  May 2019) A call for a national inquiry into the burden of research ethics and governance. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/a-call-for-a-national-inquiry-into-the-burden-of-research-ethics-and-governance

Comment: can a national enquiry lead to change?

When I first read Adrian Barnett’s research ethics monthly item advocating a national enquiry into research ethics and governance reviews of human research, I confess to with actions of déjà vu and despair. As someone who has been involved in research ethics for more than 25 years, my first thoughts were ‘Haven’t we known this for a long time. And if we have, why do we need to spend money on a national enquiry to find out what we already know?’ A little more reflection has led to a more sober response.

The revolutionary changes in approval mechanisms for clinical drug trials in Australia with the introduction of the CTN and CTX schemes in 1992, the globalisation and corporate consolidation in the pharmaceutical industry, understanding of the nature of disease and need for larger research populations and the expansion and expertise of Australia’s clinical research workforce that, together, from the 1990s rapidly increased the number of clinical trials that needed to be conducted on numerous sites.

Australia’s responses commenced with ‘a streamlined national approach to scientific and ethics review of multicentre health and medical research in Australia: issues and options’ (commonly referred to as the Frommer report) in September 2006 and progressed through the development of the harmonisation of multi-centre ethics review (HoMER) initiative, the certification program for designated human research ethics committees administered by the National Health and Medical Research Council (NHMRC) and the more recent emergence of the national mutual acceptance scheme.

Despite this activity, discontent remains. Although there may be no need for a national enquiry to establish that a wide degree of discontent exists, what is probably lacking is a detailed understanding of the sources and causes of that discontent. If an enquiry could reliably identify these, it may open a clear pathway and perhaps even a mandate for them to be resolved. However, even if an enquiry appeared to offer a mandate, the recurrent issue that has plagued all attempts to improve ethics and governance review remains: who has, or most important, who can act on, that mandate? Unlike single jurisdictions like New Zealand and the United Kingdom, Australia’s federal structure with its State and Territory differences inevitably complicates and perhaps dooms all attempts to establish a truly national system – the promising proposals of the 2006 Frommer report had to travel the circuitous route of the Australian Health Ministers Advisory Council, (AHMAC) the COAG Health Council, to the National health and Medical research Council (NHMRC) – and so on.

Australia needs to find a better way to progress the findings of such an enquiry.



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