Researchers fed up with project delays due to red tape are encouraged to sign a petition calling for a more streamlined national approach to ethics and governance approvals.
The petition says “Millions of dollars worth of Australian health and medical researchers’ time is being wasted on: submitting the same forms to multiple review committees; or submitting forms for negligible risk research that should not need formal oversight.”
It said excessive paperwork slows collaborative research projects and clinical trials, and in some cases may even prevent research from taking place.
One of the instigators of the petition, biostatistician Professor Adrian Barnett told the limbic every researcher has a “horror story”.
“Colleagues have had a number of studies where the ethics has taken longer than the actual research,” he said.
“We had a project – just doing a survey across 50 hospitals – and the ethics approvals delayed the project by 17 months and cost us $348,000.”
“Researchers are giving up on projects before they have even started. Now that causes harm.”
He said the hidden harms associated with research delays or research not even being conducted had to be weighed against the very small risk of harms associated with a research project.
Professor Barnett, from the Institute of Health and Biomedical Innovation at QUT, said many other countries do not have the levels of checking that Australia does.
“… and it is really slowing us down. Certainly the easier areas to fix are the low to negligible risk projects. In the US, they have a self-certification system and we could switch to that system. The most litigious nation on the planet uses a self-certification system.”
He said many of the low risk projects being delayed were secondary data analysis, surveys of hospital staff asking non-confronting questions, or projects using economic and accounting data.
“There is useful red tape but I would put these firmly in the category of not useful red tape.”
“In the past, different groups of us have published papers on this which is useful but doesn’t really get anywhere.”
“The idea now, is…we’ve got the papers, we’ve got the data, let’s bring it to the politicians’ attention and see if we can convince them that this needs to be looked at.”
He said the team had recently met with a staff member from MP Karen Andrews office and have been invited to submit an executive brief on the issue.
“It would be nice to get action. Clinical researchers are extremely busy and shouldn’t be doing extremely repetitive forms when they could actually be doing research or clinical work. It’s a very poor use of their time.”
Support for the petition:
“The time spent on applications far outweighs the time spent on research. Clinical staff are now reluctant to be involved because of the administrative demands, and it is not realistic to have junior staff involved because the admin period is longer than their rotations with departments. We have research ideas on par with our international colleagues – they start, finish and publish while we are still undertaking ethics applications, compiling documents, waiting for HREC assessments and answering administrative questions.” Belinda S.
“It’s unethical to waste time, funding and effort on administrative busywork where there is clearly no or minimal risk to participants. Our current system violates its own principles and needs a total overhaul. A single national system and a single source of research conduct guidelines is needed. Our country is too small to fragment research across the states however differing state legislation makes navigating national approvals a nightmare.” Name withheld.
“There is a huge amount of time and money wasted on meticulous examination and critique of ethical approval applications that should never need to be lodged. A prime example is non-interventional observations of medication usage patterns and treatment outcomes in hospitals and aged care. This issue consumes time and money that should be used to support research, not to retard it.” Chris A.