Time to connect the dots in ethics approval


By Amanda Sheppeard

31 Mar 2016

A disjointed and complicated approach to ethics approval and research governance is deterring researchers from potentially ground-breaking work, says a leading South Australian rheumatologist and academic.

Professor Catherine Hill, staff specialist at the Queen Elizabeth and Royal Adelaide Hospitals, Clinical Professor at the University of Adelaide and Chair of the South Australian Medicines Evaluation Panel, said the there was an urgent need to simplify, homogenise and nationalise the human ethics approval process for non-clinical trial studies.

Any national standard must be mutually accepted across all states and territories to reduce the burden of administration and allow researchers to get on with the job, she said.

“I think patients would be really surprised if they knew what sort of hoops we had to jump through just to get a study going,” she told the limbic. “It doesn’t encourage people into research – it is a deterrent.”

Professor Hill was commenting on an observational study she co-authored that was published in the Australasian Medical Journal.

The study observed the processes involved in establishing a nationwide study to investigate the molecular aetiology of Giant Cell Arteritis (GCA).

Study researchers hit a roadblock recruiting people to the genetic study, so they decided to take a different approach and try to access some of the 2500 specimens from biopsies taken from patients with GCA and archived at pathology centres around the country.

Tissue samples would then be used for DNA testing and examination. GCA is a rare but severe illness that targets elderly patients and can cause blindness and stroke without treatment. The only current treatment available is corticosteroids.

But the process of gaining the relevant approvals proved to be a major headache, especially as the specimens were stored in different states.

Researchers were required to submit numerous ethics and research governance applications to cover each individual storage site, and “significant discrepancy was noted with regard to the practices of these committees across the country”, they found.

The whole process took a year, and for ophthalmologist Dr Elisabeth De Smit, who was leading the study as part of her PhD, countless hours of administration and communication with committees.

“Over the period she was doing this she sent 5000 emails (relating to the ethics and governance approvals process),” Professor Hill said. “I’ve got to say she deserves her PhD for persistence if nothing else. I think the inconsistencies were the most frustrating.”

The good news is that the study is now proceeding, and she is hopeful that it might lead to better treatment alternatives.

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