Robust regulatory requirements are essential to research, particularly in the field of health and medicine. The approvals procedure acts as a check against misconduct and risk, minimising harm to the participants and organisations involved.
Yet in Australia, many researchers believe the situation has got out of hand. Instead of creating a system which upholds integrity, safety and excellence, they say we have spawned a monstrosity; a Kafkaesque tangle of insensible bureaucratic hurdles, marked by inconsistencies and duplications across institutions and states.
Millions worth of Australian health and medical researchers' time is being wasted, critics contend, with quality research stymied as a result. Amongst the research community, frustrations fester and abound.
One such frustrated individual is Professor Adrian Barnett, a statistician with QUT’s Faculty of Health. He’s been telling politicians about the problem for years, to little avail. In fact, “the last time they tried to change the system, they made it far worse,” he told Campus Review, with the processes for obtaining ethics and governance approval split apart.
In a fresh campaign to remove rigmarole, Barnett has united with four other academics from Bond University and the University of Sydney. Together, they’ve launched an online petition calling for a national inquiry into improving research ethics and governance. Their vision is to implement “national systems with standardised forms that are used by every state and territory health department”, with processes streamlined and efficiency restored.
Barnett will be the first to admit that boring tasks are part and parcel of research work. “If you’re in a lab, you’re doing things over and over again. It’s not CSI,” he laughs. “But this particular boring part is frustrating because it has no value.”
His own team is dealing with such a high volume of approvals paperwork, they actually employ people just to fill out forms. Which is, of course, another drain on limited resources.
“Everybody underestimates how long it takes,” he says.
He recounts a time when a research project of his own looking into winter illness was “partially ruined” after being held up by one signature from a lawyer. There was “nothing controversial” about the study at all, said Barnett. Yet despite beginning the approvals procedure in January, it was July when he was finally able to start talking with patients.
“A lot of them were rightly saying: ‘Winter’s nearly over. You’ve missed the boat’,” Barnett says heavily.
“That study was nowhere near what it could have been.”
In the petition’s comments, signatories have shared their own stories of exasperation and delay.
“For one negligible risk project, there can be numerous ethics applications and site specific assessments, requiring sign-off by CFOs and others in each site of one health jurisdiction,” writes one.
“Doing multinational studies has shown me that Australia’s system is the most inefficient and over regulated,” says another.
While there is a lack of comprehensive data in the area, there is research to support these first-hand accounts.
A 2017 study found that in one negligible-risk project looking into biobank operations across three study sites, researchers spent 60 hours meeting regulatory requirements for a 7.5 hour research activity. One disadvantage to such imbalance, the authors pointed out, was the "clear potential to alienate funding bodies and to reduce community support for research". It also meant that researchers may be inclined to tailor projects in order to move more swiftly through the approvals process, including avoiding or targeting certain sites.
"As a result, multi-site research data could be skewed, and research jurisdictions could lose the potential benefits of locally conducted research, such as clinical trials being undertaken within their population. In more extreme cases, research projects may be deferred or not undertaken," the authors write.
Another paper, this one co-authored by Barnett, looked into the high costs of getting multi-centre research approved. It found that “75 and 90% of time was spent on repeated tasks, respectively, and many time-consuming tasks, such as reformatting documents, did nothing to improve the study design or participant safety”.
Multi-state research projects are a nightmare unto themselves, says Barnett. He confesses the governance nightmare involved has meant he never wants to embark on one again.
“There are whole areas of research that I wouldn’t consider doing because I know the governance process would be just too hard,” he adds.
Others in the science community blanch at the costs of multi-state projects too. They feel the system is designed to exact a penalty from those who’d hope to conduct comprehensive research, leaving valuable lines of enquiry unexplored, and the knowledge base depleted. Barnett agrees that recent science graduates might be dismayed to the point of being disillusioned with the onerous, insensible realities of getting research work off the ground.
Ultimately – given research is a public service – citizens themselves are at a disadvantage.
“The ultimate beneficiaries of health and medical research are patients and those that care for them,” writes petition supporter Janette B. “We need to remember that every day that a clinical research application is delayed in ethics or governance review, the answers (and potentially) patients and clinicians need are delayed. Some patients don't have time to wait.
“If we really want to be patient-centric, then we need to streamline and act as one country, for the benefit of its population.”
Barnett believes we can learn a great deal from international models, many of which are a lot simpler.
“We’re a very risk-averse nation,” he says. “We tend to focus on the slightest thing that could go wrong, and this clouds about the bigger picture.”
He’s received nothing but solidarity since launching the petition. This time, through the mechanism of a national inquiry to bring validity to the chorus of claims, he’s hoping to build enough momentum for meaningful change. And he doesn’t see why support wouldn’t be forthcoming from ethics and governance committees, too.
“There are important ethical issues they have to deal with,” he points out. “Let’s say they have 100 submissions in front of them, and fifty of them have already been read by someone else. If they can reduce their workload, and argue the contentious ethical questions instead, why wouldn’t they?”
The petition, ‘We need a national inquiry to streamline/improve research ethics and governance in Australia’ can be found here.Do you have an idea for a story?
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