Bureaucracy a barrier to building clinical registries


By Geir O'Rourke

22 May 2023

Prof. David Celermajer

The barriers thrown up by institutional bureaucracies are jeopardising Australia’s ability to establish clinical registries, as well as the country’s global research competitiveness, it is being warned.

Researchers from the Congenital Heart Alliance of Australia and New Zealand (CHAANZ) say their recent experience highlights an “urgent” need for a radical reduction in red tape, with some institutions taking months to approve data sharing with a congenital heart disease registry they were setting up in 2020 and 2021.

Funded with a Medical Research Futures Fund (MRFF) grant awarded in June 2020, there were full time staff at the University of Sydney devoted to putting together the registry and obtaining approval from 11 participating institutions from around the country.

Despite this, it was not until April 2021 that the team were able to execute a multi-institutional agreement  and obtain ethics and governance approvals with all 11 participating organisations – a full 283 days of work.

From there, time to site governance approvals ranged from nine days to nearly 10 months at one institution, the team led by Professor David Celermajer reported in Australian Health Review (link here).

“Our documented experience demonstrates that the processes involved in achieving multi-site ethics and governance approval for nationally projects is in urgent need of reform,” they wrote.

“The effect that a few outlier institutions had on the timeline of our project was substantial and the only available course of action was to send further follow-up communications that had negligible influence on expediting review times.”

Just one part of the process – developing and signing the multi-institutional agreement, required the sending of 214 emails in total, the team said. And some 71 emails were sent to just one of the institutions to get it over the line.

Additionally, the number of requested points of additional information ranged from zero to 31 queries, they added.

“Although the lead human research ethics committee (HREC) had provided approval for a waiver of consent for retrospective data collection, one governance office required submission of further documentation regarding this, requesting statements from the lead HREC specifying it was granted under a specific section of the National Statement,” they wrote.

“Site specific requests such as this, questioning the decisions of the lead HREC, caused numerous time delays and increased administrative burden on the lead HREC.”

One factor that appeared to have a major impact on red tape was the fact that some institutions had different ethics management systems to the lead HREC.

These generally required more documentation and created duplication and a “far greater burden” on administrative staff, according to the team.

Suggestions for reducing unnecessary delays in future registries

As a result, a single ethics management system should be adopted nationally, with a central portal for all applications and fulfilling monitoring requirements, they said.

Another idea was for a national body to be set up to expedite multi-institution agreements and governance approvals.

This could be taken on by the NHMRC or Department of Health and would accelerate the process and ensure accountability from the various institutions’ governance offices which was currently lacking, the authors said.

Additionally, a standardised set of documents should be required for all site-specific assessments, to streamline the number of documents required and eliminate jurisdictional differences, they suggested.

The team concluded: “In summary, this paper demonstrates an inefficient system which lacks key accountabilities.”

“The result of this is a high administrative burden and delays to project commencement. Repeated publications highlighting this have not resulted in systems change.”

“The inefficient practices documented here and by others highlight the need for more centralised systems in place to manage research. By streamlining the processes involved, researchers can redirect their focus and funding to achieving their research aims.”

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