ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)
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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Friday afternoon’s funny – Reasons for refusal0

Posted by Admin in on February 21, 2020
 

Cartoon by Don Mayne www.researchcartoons.com
Full-size image for printing (right mouse click and save file)

In all seriousness, there may be much to be learned from having a mechanism to explore why people decide not to participate in a project.  Of course they must be free not to provide their reasons.

Flying Blind – the Australian Health Data Series: Ethics Reviews, Trust and Mutual Acceptance (Divya Ramachandran | January 2018)0

Posted by Admin in on February 17, 2020
 

Flying Blind is a series of three reports dedicated to uncovering the acute levels of data fragmentation existing at all levels of Australia’s health landscape.

Our earlier blog posts highlighted the irony of numerous ethical reviews for the same research project, which makes us wonder about the validity of multiple opinions, besides creating huge administrative burdens and wasted time and costs for the researcher as well as the ethics committees themselves. This is especially the case in studies that evaluate service quality, interventions and outcomes, as they are required to follow patients across several hospitals, health services, local health districts and across jurisdictions, and call for utilizing data from different data collections.

Obtaining ethics approvals for such ‘multi-centre’ health research continues to be an onerous exercise for researchers, as they navigate the varying, and sometimes inconsistent requirements of multiple HRECS for the same project.  One recent study described an Australian multi-centre project in which the cost of ethics approvals alone accounted for 38% of the project budget. For a study involving 50 centres the mean cost per site was $6960. In the same study, 75% of time was estimated to have been spent on repeated tasks as well as tasks that were time-intensive, such as re-formatting documents that “did nothing to improve study design or participant safety.” This is just one example of a reality that the health and medical research sector has been dealing with for over two decades.

Researchers expressed such frustrations in a 1996 report to the then Federal Minister of Health, claiming that the ethics approval processes existed in isolation from one another, increasing workloads for both researchers and ethics committees.

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Flying Blind – the Australian Health Data Series: The Ethics Quagmire: Case Studies (Uma Srinivasan | August 2017)0

Posted by Admin in on February 17, 2020
 

Flying Blind is a series of three reports dedicated to uncovering the acute levels of data fragmentation existing at all levels of Australia’s health landscape.

In Flying Blind 2, we have been highlighting the tortuous route of the researcher’s journey, as they negotiate the ethics processes and the myriad data sources required for their research. In the next few blogs, Australian health and medical researchers who have been through the journey, present real-life case studies and  back-of-the-envelope calculations of what it takes to identify existing data sets and negotiating the ethics processes, to link the data sets to support their research.

What is sad for Australian health research is that these numbers do not reflect reseachers’ time spent in actually performing research!

We hope the case studies will shine a light on the complexities and the lack of efficiency and transparency around tapping into de-identified pre-existing administrative data sets from multiple states and federal health data sources.

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‘Evidence-Based Medicine’ and the Expulsion of Peter Gøtzsche – Medscape (Daniel Kolitz | December 2019)0

Posted by Admin in on February 13, 2020
 

FOR EIGHT MONTHS in 1975, Peter Gøtzsche recalls driving around Denmark misleading doctors about a new, more expensive type of penicillin. He was 25 years old, with master’s degrees in biology and chemistry. As a pharmaceutical representative for the Sweden-based Astra Group, he was tasked with promoting Globacillin, which was said to be more effective than regular penicillin. At the time, Gøtzsche says he did not know that the claims he was making on behalf of his employer were not backed by high-quality evidence.

Gøtzsche stayed in the pharmaceutical industry for another eight years, writing brochures, strategizing ad campaigns, and, eventually, presiding over clinical trials. It was here that disillusionment set in. Gøtzsche — in his telling, still a principled naïf — would watch with dismay as his superiors twisted or suppressed any unflattering trial results. Increasingly distraught, Gøtzsche began pursuing a medical degree, leaving the industry for good in 1983.

His medical thesis, titled “Bias in Double-Blind Trials,” examined the claims of 244 reports of clinical trials for non-steroidal anti-inflammatory drugs, a group that includes ibuprofen and aspirin. Gøtzsche’s writing strongly critiqued the marketing practices of his former employer, Astra-Syntex, pointing out that no good evidence existed for their claim that the higher the dose, the better the effect.

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