campusreview.com.au
‘Millions wasted’
Call for a national inquiry to streamline
research approvals.
By Kate Prendergast
R
obust 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 of dollars’ worth of health and medical researchers’ time
is being wasted, critics contend, with quality research stymied as a
result. Among the research community, frustrations fester.
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.
policy & reform
“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, Barnett says. Yet despite beginning the approvals
procedure in April, 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’,” he says heavily.
While there is a lack of comprehensive data in the area, there
is research to support Barnett’s view. 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
might 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 wrote.
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 per cent 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 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.
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 the
bigger picture.”
He’s received nothing but solidarity since launching the petition.
This time, through 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
50 have already been read by someone else. If they can reduce their
workload and argue the contentious ethical questions instead, why
wouldn’t they?” ■
13