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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Breakthrough Gene Therapy Clinical Trial is the World’s First That Aims to Reverse 20 Years of Aging in Humans – CISION (Osvaldo R. Martinez-Clark | November 2019)0

Posted by Admin in on November 28, 2019
 

This is the world’s first IRB-approved clinical trial aimed at reversing aging by at least 20 years; it is also the world’s most expensive pay-to-play trial with a one million price tag to enroll.

This isn’t a human research ethics vignette/scenario, but could very easily be used as the basis for a discussion with researchers, research ethics reviewers, research ethics advisers, or research office staff about:
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  1. Pay-to-play clinical trials
  2. Appropriate recruitment materials
  3. The use of ethics approval as a sales tool
  4. The conduct of trials in another country

MANHATTAN, Kan., Nov. 21, 2019 /PRNewswire/ — Libella Gene Therapeutics, LLC (“Libella”) announces an institutional review board (IRB)-approved pay-to-play clinical trial in Colombia (South America) using gene therapy that aims to treat and ultimately cure aging. This could lead to Libella offering the world’s only treatment to cure and reverse aging by 20 years.
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Under Libella’s pay-to-play model, trial participants will be enrolled in their country of origin after paying $1 million. Participants will travel to Colombia to sign their informed consent and to receive the Libella gene therapy under a strictly controlled hospital environment.
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Traditionally, aging has been viewed as a natural process. This view has shifted, and now scientists believe that aging should be seen as a disease. The research in this field has led to the belief that the kingpin of aging in humans is the shortening of our telomeres.
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Telomeres are the body’s biological clock. Every time a cell divides, telomeres shorten, and our cells become less efficient at dividing again. This is why we age. A significant number of scientific peer-reviewed studies have confirmed this. Some of these studies have shown actual age reversal in every way imaginable simply by lengthening telomeres.
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Holiday funny – Potential participant duped0

Posted by Admin in on November 28, 2019
 

Cartoon by Don Mayne www.researchcartoons.com

Thanks Giving isn’t a holiday in Australasia and animal ethics really isn’t our thing, but we thought this Don Mayne cartoon was a chance to reflect on two ethical challenges in human research:
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(i) Purporting to recruit participants for a research project when your motives are otherwise – which is potentially a merit & integrity and respect problem; and
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(ii) Having a research topic and recruitment strategy that don’t match.
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Which will almost certainly lead to participant complaints.

(Australia) Skin cancer doctor in hot water after papers retracted – The Age (Liam Mannix and Tom Cowie | November 2019)0

Posted by Admin in on November 24, 2019
 

For most, sailing the Mediterranean on a luxury cruise ship is a relaxing escape. But skin cancer expert Professor Anthony Dixon was working. And a storm was about to hit the credibility of his research.

Over the 12-day cruise, the professor spent nine hours teaching doctors and nurses how to recognise skin cancer. A prominent educator, Professor Dixon has trained dozens of health professionals in his methods, many of them on cruise ships.

But two of his journal articles were about to be retracted after complaints from other cancer experts that they contained factual errors. Such retractions are considered rare and necessary to prevent inaccurate information being available to other practitioners.

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The female problem: how male bias in medical trials ruined women’s health – The Guardian (Gabrielle Jackson | November 2019)0

Posted by Admin in on November 14, 2019
 

Centuries of female exclusion has meant women’s diseases are often missed, misdiagnosed or remain a total mystery

From the earliest days of medicine, women have been considered inferior versions of men. In On the Generation of Animals, the Greek philosopher Aristotle characterised a female as a mutilated male, and this belief has persisted in western medical culture.

The historical, and continued, exclusion of women from clinical trials is a significant problem that really hasn’t been addressed by drives by granting bodies.  Similar exclusion tends to be the experience of people whose first language isn’t English, people living with a disability and First Nation peoples. Researchers and research ethics review bodies can play an important role in addressing this major problem.

“For much of documented history, women have been excluded from medical and science knowledge production, so essentially we’ve ended up with a healthcare system, among other things in society, that has been made by men for men,” Dr Kate Young, a public health researcher at Monash University in Australia, tells me.
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Young’s research has uncovered how doctors fill knowledge gaps with hysteria narratives. This is particularly prevalent when women keep returning to the doctor, stubbornly refusing to be saved.
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“The historical hysteria discourse was most often endorsed when discussing ‘difficult’ women, referring to those for whom treatment was not helpful or who held a perception of their disease alternative to their clinician,” Young wrote in a research paper published in the journal Feminism & Psychology.

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