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

Flying Blind – the Australian Health Data Series: Human Research Ethics Committees (HRECs) (Nadia Levin | September 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 our previous blog, The Ethics Quagmire: Case Studies you might have read the case study by Kathy Tannous concerning the difficulties she has faced getting ethics approval from three ethics committees. But are there problems closer to home for researchers, in their own institutions, even when only one HREC is involved? We think so. But the solution may also lie with these institutions, in the better application of existing guidelines. We explain how below.

A set of three reports that make useful observations about health data management/sharing, research ethics review and the operation of HRECs.

Earlier this year, the Productivity Commission handed the Australian Government its report on Data Availability and Use and Research Australia is working with the Taskforce within the Prime Minister’s Department who is developing the Government’s response. A particular area of focus for us, as the national peak body for the medical research pipeline, is the Productivity Commission’s recommendations on Human Research Ethics Committees (HRECs).
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HRECs are responsible for providing ethics approval for most publicly funded human research in Australia that involves people; the research can’t proceed without it. This includes research as diverse as a clinical trial, where patients are receiving experimental new medications and treatments, to surveys and research using existing datasets- the types of data based research considered by the Productivity Commission.
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Read the rest of this discussion piece

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.

Read the rest of this discussion piece

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Friday afternoon’s funny – Peril ahead?0

Posted by Admin in on February 14, 2020
 

Cartoon by Don Mayne www.researchcartoons.com

Do you feel your project is coasting along well, perhaps recruitment/data collection is progressing faster than anticipated?  Scrutinise what’s coming up with regard to human research ethics and research integrity, because an awful peril may be thundering toward you.

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