16 Sept 2016

Ethics process for weight loss surgery data needs slimming

by Anne Crawford

Ethics process for weight loss surgery data needs overhaul, say Monash researchers.

Monash scientists and clinicians setting up an Australia-wide clinical quality registry for bariatric surgery have called for a more streamlined national ethics review process to oversee data collection and retention.

The researchers, at Monash University’s Department of Epidemiology and Preventive Medicine (DEPM) and Central Clinical School (CCS), are establishing the Bariatric Surgery Registry (BSR) to collect data comparing procedures, providers and institutions and to provide feedback to practitioners, aimed at assessing and improving health care in the field.

Bariatric or weight loss surgery, including gastric bypass or gastric bands, is growing in Australia. An estimated 15,000 procedures will be performed this year at a cost of more than $225 million. Yet there are no evidence-based guidelines directing who should be offered the surgery, nor any long-term community data documenting its safety and efficacy in Australia.

“Bariatric surgery is still a relatively new area of surgery,” said Professor Wendy Brown, clinical lead for the BSR and head of CCS's Department of Surgery. “The profession recognized there was a need to monitor and track our outcomes to make sure we are offering our patients effective and safe procedures that are right for them.”

To this end, DEPM, together with the Obesity Surgery Society of Australia and New Zealand, began a national rollout of the Bariatric Surgery Registry in 2014.

The registry collects information on each procedure performed, the devices used, changes in patients’ weight and diabetes status, and adverse events, collecting data primarily from surgeons.

But its rollout has hit snags.

Because the registry tracks and stores identifiable, sensitive health information, protocols require human research ethics committee (HREC) approval to ensure that it complies with the Australian privacy act. HREC review is required for every hospital contributing to the registry: there are currently some 164 hospitals undertaking bariatric surgery in Australia.

The process of gaining ethical approval from all the hospitals has proved expensive and time-consuming. Obtaining even 31.7% of the required approvals for the registry cost more than $180,000 in salaries. To date, 82 hospitals have signed up to the registry with 39 from two big private hospital groups about to join.

“When you go to 164 different ethics committees it becomes quite burdensome because each ethics committee wants to change paragraphs, then the changes have to go back to everyone for their approval,” Professor Brown said.

Professor Brown said that she appreciated Australian privacy laws and the need to seek patients’ permission to hold their information but says this could be done using a more streamlined approach. She said HRECs were typically set up to review research projects rather than quality and safety initiatives.

The researchers called for a new national process for HREC review that could be used by all quality control registries. This would streamline implementation and reduce costs whilst still protecting patients’ privacy.

Examples of such reform could be: having all sites apply to a single national ethics committee that works for quality and safety initiatives, like New Zealand; or implementing specific federal legislation protecting the transfer of information to and from approved clinical quality registries.

The researchers made their call in the September edition of the Medical Journal of Australia. Professor Brown spoke to the MJA in a podcast:  https://www.mja.com.au/multimedia/podcasts

Brown WA, Smith BR, Boglis M, Brown DL, Anderson M, O'Brien PE, McNeil JJ, Caterson ID.
Streamlining ethics review for multisite quality and safety initiatives: national bariatric surgery registry experience. Med J Aust. 2016 Sep 5;205(5):200-1.

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