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

Is it right to cut corners in the search for a coronavirus cure? – The Guardian (Julian Savulescu | March 2020)0

Posted by Admin in on March 26, 2020
 

Vaccine and drug trials are slow, to account for safety. But in a pandemic time isn’t just money – it’s lives

The race is on to find a treatment for coronavirus. This race is split between two approaches: the trialling of pre-existing drugs used for similar diseases, and the hunt for a vaccine. In both instances, important ethical decisions must be made. Is it OK to reassign a treatment that comes with side-effects? And with thousands dying from coronavirus every day, is it acceptable to cut corners in the search for a vaccine?

We are really living through something that six months ago would have been a decidedly hypothetical bioethics vignette.   In the midst of a pandemic, how do you weigh lost and impacted lives when thinking about Phases I, II and III trials for a vaccine or cure?  We plan to write something about this for the subscribers’ area.  We have included links to 14 related items.
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You may also like to watch this special TED discussion: https://www.ted.com/talks/bill…

Last Friday, the World Health Organization announced the launch of Solidarity, a worldwide trial of the four most promising candidate treatments for Covid-19: remdesivir, an antiretroviral treatment for Ebola; chloroquine and hydroxychloroquine, both antimalarials; ritonavir, an HIV treatment; and interferon, a treatment for hepatitis C. Both Kaiser Permanente Washington Research Institute in Seattle and China’s Academy of Military Medical Sciences last week announced the start of human trials for new possible vaccines. Around 30 other research groups worldwide are working on vaccines.
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But the WHO estimates that a vaccine won’t be ready until June 2021. There are requirements that have to be observed. The gold standard for this kind of research is the clinical trial – administering the vaccine to a large number of people in controlled conditions and measuring its effect. Usually scientists wait 14 months to monitor effectiveness and possible side-effects – which is why we may have to wait until next summer. Coronavirus vaccine trials face the following dilemma: we need treatment quickly but we also need to know it will work. The worst outcome for the medical industry would be a vaccine that either did not work or, worse, was harmful or had side-effects. Globally, faith in vaccines is already at an all-time low.
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Clinical trials: how to make informed consent more ethical – The Conversation (Jeremy Howick | February 2020)0

Posted by Admin in on February 19, 2020
 

It has been illegal to treat humans like guinea pigs since the Nuremberg trials, in which Nazi doctors were punished for doing unspeakable things to prisoners. These days, we have to explain the experiment to the people taking part in trials for new treatments and get their permission (their “informed consent”).

A fascinating discussion and useful suggestions.

Specifically, we have to tell them about the risks of taking part. So in a trial of a new drug, we have to tell patients about all the possible side-effects. In ethical geek-speak, we have to preserve patients’ autonomy by giving them enough information to make an autonomous decision. Which is fine, up to a point.
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It is also an ethical requirement to avoid unnecessarily harming patients. A recent study published in the BMJ Journal for Medical Ethics shows that the relatively recent discovery of so-called nocebo effects – a result of the patient’s expectation that the treatment will harm them – means that harm is being done by the way we inform patients about the trial in which they are taking part.
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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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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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