Research Ethics Monthly
ISSN 2206-2483
Think of, and treat, consent as a powerful and complex verb, not a strictly defined and constrained noun
November 29, 2021
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The notion of consent and the expectation researchers will seek the prior consent of participants has a long history in human research ethics.
It has been a feature of many of the most infamous ethical Breakers commerce stamps and scandals.
Consequently, it has become a baked in feature of most of the guidelines on human research ethics.
But is that a good thing?
The typical approach to consent in human research doesn’t really work for a number of circumstances, research designs or potential how to participant pools.
Long strict guidelines can compound the error and can risk alienating researchers.
A more nuanced approach that provides guidance on necessary features of consent material can be more helpful than template consent materials.
This is exactly the kind of approach that this called for by the National Statement in Australia
Expertise in ethics, research ethics or review?
November 29, 2021
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In this terrific and thoughtful post, Colin Thomson AM, a Senior Adviser to AHRECS, reflects on what we mean when we talk about expertise i the context of Human Research Ethics Review.
Do we mean expertise in ethics, research ethics or ethics review or a combination?
Do they fit together seamlessly and easily or is there an incongruence?
He frames these matters, when talking about research ethics committee members and research ethics reviewers across ten important categories.
He then suggests ten tests that could be usefully applied to evaluate the quality of review feedback.
How your institution’s research ethics committee and its review feedback fare if judged against this criteria?
Is it time they had some professional development? Does the Committee’s standard operating procedures need to be updated?
This is a valuable read for research ethics committee Chairs, Secretaries and members.
HREC and AEC Workshops in Perth
October 25, 2021
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AHRECS is conducting Human Research Ethics and Animal Ethics workshops in Perth in November.
Wed 3 November 2021 – Animal Ethics workshop
The theme this year focuses on managing large groups of animals such as in laboratories, farms and in the wild. Researchers are adept at managing animals, but when the numbers become very large things can become ethically complex. For instance, how are the 3R principles being met?[iv] Further, when there is overlap between research and the management of a farm or when research is focused on the needs of wildlife the ethical complexities of managing animals as part of research can increase. What are the key issues an AEC needs to focus on and how is this best approached? Expert speakers will address these issues covering the ethical considerations of integrating research into large farm operations, the ethical issues of undertaking environmental research involving large numbers of animals, and a panel of experts will discuss the ethical issues encountered when managing large laboratory projects involving animals.
Wed 17 November – Human Ethics workshop
The theme this year focuses on “what I wish I knew before I started”. It is not uncommon for research to raise ethical questions that were not…
Unnatural justice: Public allegations could cause significant harm to vital clinical trial activity
October 25, 2021
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In this thought-provoking post, Nik Zeps (a consultant with AHRECS and a partner at Chrysalis) discusses the serious harm (in terms of reputation and career, as well as lost useful lines of inquiry) when there are complaints that allege ethical problems with clinical research.
These relate to situations where the clinical research is evaluating different kinds of intervention, where the evidence for the ‘accepted’ treatment might not be clear.
A misunderstanding of such research designs and a visceral reaction to apparent breaches aren’t helpful.
When such allegations are made, the researchers are rarely afforded an opportunity to respond and explain. If they were, one assumes that the manner could be easily cleared up.
We are embarrassed to admit in our own reporting of the cited case we really didn’t grasp the realities of what occurred or called out the very emotive reaction.
When it comes to the approach to human research ethics, did we buy London Bridge thinking it was Tower Bridge?
September 21, 2021
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In this post, two experienced research ethics officers risk being decried as heretics by reflecting upon the justifications that are used for the current Human Research Ethics arrangements in countries around the world.
They use the sale of London Bridge in the Sixties and the urban myth that the US millionaire who bought it thought he was buying Tower Bridge, to ask, given the time, effort and resources expended on research ethics review, are we getting what we paid for?
There are genuine benefits that can flow from a well-conducted review process and they do justify the existence of those processes, but we should stop claiming those processes safeguard us against the criminal, unethical and reckless behaviour of the past.
They don’t and we should stop claiming in our professional development activities and resource material they do.
Regulation of human epigenetic editing: ensuring international frameworks for governing Human Genome Editing don’t impede vital medical research
August 31, 2021
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In this thoughtful post, Nik Zeps reflects on human genome manipulation in medical research, the ethical guidance in Australia and internationally.
He discusses CRISPR and the furore in 2018 around the ‘genetically modified babies’ in China.
Nik then discusses the degree to which the COVID-19 pandemic has pushed discussions about human genetic manipulation off the media radar.
Nevertheless, there have been important international discussions about the topic, including a new WHO Framework. This topic was recently discussed in a paper by Zeps, Lysaght et al. 2021.
The situation might position the WHO as a major player in the international discussion about human genetic manipulation.
Why resourcing practice is a better option for institutions than policing compliance
July 25, 2021
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In this post, Dr Gary Allen (one of the senior consultants at AHRECS) discusses why resourcing reflective practice is a more reliable and effective/constructive way to manage institutional risk than fixating on compliance and using an enforcement and sanctions approach.
Approaching the serious risks from within the frame of resourcing practice treats the role of research ethics as being to facilitate research, rather than being an impediment to research.
This embeds research ethics as being a component of the design and conduct of quality research, not as something external to research.
Systems that promote ethical design and conduct, are also investments in quality research
Gary has worked in the human research ethics field since 1997. He has worked with committees in Australia, Canada, New Zealand, the UK and Vietnam. He Chaired the Committee that drafted the new Chapter 3.1 of the National Statement on Ethical Conduct in Human Research.
Internal Human Research Ethics annual reporting
June 28, 2021
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In this post Gary discusses the components of a good internal report from a research ethics committee to the governing body of the host institution.
Such reports should be produced annually.
A constructive report should provide a snapshot of the committee during the reported period.
The report should cover specific matters that are optional and strategic in nature.
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