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

Exempting low-risk health and medical research from ethics reviews: comparing Australia, the United Kingdom, the United States and the Netherlands (Papers: Anna Mae Scott, et al | January 2020)0

Posted by Admin in on April 1, 2020
 

Abstract

Background
Disproportionate regulation of health and medical research contributes to research waste. Better understanding of exemptions of research from ethics review in different jurisdictions may help to guide modification of review processes and reduce research waste. Our aim was to identify examples of low-risk human health and medical research exempt from ethics reviews in Australia, the United Kingdom, the United States and the Netherlands.

Methods
We examined documents providing national guidance on research ethics in each country, including those authored by the National Health and Medical Research Council (Australia), National Health Service (United Kingdom), the Office for Human Research Protections (United States) and the Central Committee on Research Involving Humans (the Netherlands). Examples and types of research projects exempt from ethics reviews were identified, and similar examples and types were grouped together.

Results
Nine categories of research were exempt from ethics reviews across the four countries; these were existing data or specimen, questionnaire or survey, interview, post-marketing study, evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, audit and service evaluation, and other exemptions. Existing non-identifiable data and specimens were exempt in all countries. Four categories – evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, and audit and service evaluation – were exempted by one country each. The remaining categories were exempted by two or three countries.

Conclusions
Examples and types of research exempt from research ethics reviews varied considerably. Given the considerable costs and burdens on researchers and ethics committees, it would be worthwhile to develop and provide clearer guidance on exemptions, illustrated with examples, with transparent underpinning rationales.

Scott, A.M., Kolstoe, S., Ploem, M.C., Hammatt, Z. & Glasziou, P.  (2020) Exempting low-risk health and medical research from ethics reviews: comparing Australia, the United Kingdom, the United States and the Netherlands. Health Research Policy and Systems. 18(11). https://doi.org/10.1186/s12961-019-0520-4
Publisher (Open Access): https://health-policy-systems.biomedcentral.com/articles/10.1186/s12961-019-0520-4

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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Read the rest of this discussion piece

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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