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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.”