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 – Captain Placebo0

Posted by Admin in on June 25, 2020
 

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

Members of research ethics review bodies and ethics officers need to be careful they don’t slip into a superhero mindset.  You aren’t battling evil or protecting hapless participants from dangerous research.  Such thinking will turn you into the worst stereotype of someone involved in research ethics review.  Instead, we must strive to facilitate ethical research through constructive feedback and collegiate support.

Is Research Ethics Committee review of most clinical trials fundamentally broken? – BMJ Blog (Mark Yarborough | June 2020)0

Posted by Admin in on June 22, 2020
 

Imagine that you suffered from a fatal neurodegenerative disorder like Alzheimers or ALS, or that you had a serious chronic condition like hypertension or heart disease. Imagine further that you were asked to participate in a clinical trial related to your disease. Finally, imagine that the person recruiting you into the trial reassured you that the study had been vetted by a research ethics committee (REC) tasked with protecting your welfare, rights, and interests.

For more than a century combined, we have chaired, served on, supported, written about and consulted on/for research ethics committees.  And we have served on NHMRC committees.  So it will not come as a complete surprise that we don’t entirely agree with this provocative piece.  But it does raise issues worthy of sober and informed discussion.

 

Of course, countless people in these exact same circumstances routinely get recruited into REC-approved trials. While many or perhaps even most of them may have never heard of RECs and the role they play in clinical research, they nevertheless are likely to implicitly trust that the trials they are being recruited into are both important and ethical to conduct. Such trust should be warranted since that is what REC approval is meant to certify.
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But does REC approval reliably certify this? I suspect that many readers of this journal believe that they do and thus rarely if ever truly ponder the question. I know this used to be true for me, in large part due to my own personal experiences working on RECs and seeing the hard work and dedication of committee members and staff. Today, though, I am convinced that the question is one of the most central ones there is in research ethics. After all, the trustworthiness of the clinical research endeavour is in large part a direct outcome of the strength of the accountability measures in place to support it and REC review is at the heart of those accountability measures.

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Vulnerability in human research (Papers: Ian J. Pieper & Colin J. H. Thomson AM | April 2020)0

Posted by Admin in on April 29, 2020
 

Abstract
The conduct of prior ethics review of human research projects helps to protect vulnerable groups or populations from potential negative impacts of research. Contemporary considerations in human research considers the concept of vulnerability in terms of access to research opportunities, impacts on the consenting process, selection bias, and the generalisability of results. Recent work questions the validity of using enumerated lists as a check box approach to protect research participants from exploitation. Through the use of broad categories to treat cohorts of human research participants as homogenous classes and label some participants as vulnerable merely because they are members of a particular class, some ethics reviewers have used the National Statement on Ethical Conduct in Human Research to strip individuals of their “ethical equality”. Labelling people as vulnerable does not help researchers or human research ethics committee members develop an understanding of the complexities of applying the principles of respect and of justice in ethical decision-making. Conversely, defining specific cohorts of research participants as needing nuanced ethical consideration, due to their vulnerable nature, may imply that other population groups need not be considered vulnerable. We contend that this assumption is erroneous. This paper explores the way that human research ethics guidance documents treat vulnerability within the Australian context and draws on contemporary discussion to focus an alternative perspective based on the principles in the National Statement on Ethical Conduct in Human Research for researchers and human research ethics committee members to consider.

Keywords
Vulnerability, Human Research Ethics, Human Research Ethics Committee (HREC), IRB

Pieper, I.J., Thomson, C.J.H. (2020) Vulnerability in human research. Monash Bioethics Review. https://link.springer.com/article/10.1007/s40592-020-00110-4

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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