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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

A Star Surgeon Left a Trail of Dead Patients—and His Whistleblowers Were Punished – LeapsMag (Eve Herold | October 2018)0

Posted by Admin in on February 22, 2019
 

[Editor’s Note: This is the first comprehensive account of the whistleblowers’ side of a scandal that rocked the most hallowed halls in science – the same establishment that just last week awarded the Nobel Prize in Medicine. This still-unfolding saga is a cautionary tale about corruption, hype, and power that raises profound questions about how to uphold integrity in scientific research.]

When the world-famous Karolinska Institutet (KI) in Stockholm hired Dr. Paolo Macchiarini, he was considered a star surgeon and groundbreaking stem cell researcher. Handsome, charming and charismatic, Macchiarini was known as a trailblazer in a field that holds hope for curing a vast array of diseases.

This horrifying case will be depressingly familiar for New Zealand readers, because it could easily be described as Sweden’s v own ‘unfortunate experiment’

He claimed that he was regenerating human windpipes by seeding plastic scaffolds with stem cells from the patient’s own bone marrow—a holy grail in medicine because the body will not reject its own cells. For patients who had trouble breathing due to advanced illness, a trachea made of their own cells would be a game-changer. Supposedly, the bone marrow cells repopulated the synthetic scaffolds with functioning, mucus-secreting epithelial cells, creating a new trachea that would become integrated into the patient’s respiratory system as a living, breathing part. Macchiarini said as much in a dazzling presentation to his new colleagues at Karolinska, which is home to the Nobel Assembly – the body that has awarded the Nobel Prizes in Physiology or Medicine since 1901.
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Karl-Henrik Grinnemo was a young cardiothoracic surgeon and researcher at Karolinska in 2010, when Macchiarini was hired. “He gave a fantastic presentation with lots of animation and everyone was impressed,” Grinnemo says of his first encounter with Macchiarini. Grinnemo’s own work focused on heart and aortic valve regeneration, also in the field of stem cell research. He and his colleagues were to help establish an interdisciplinary umbrella organization, under Macchiarini’s leadership, called the Advanced Center for Translational Regenerative Medicine, which would aim to deliver cures from Karolinska’s world-class laboratories to the bedsides of patients in desperate need.
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Oft-quoted paper on spread of fake news turns out to be…fake news – Retraction Watch (Adam Marcus | January 2019)0

Posted by Admin in on February 20, 2019
 

The authors of an much-ballyhooed 2017 paper about the spread of fake news on social media have retracted their article after finding that they’d botched their analysis.

Sometimes the irony of a forced retraction is too delicious to ignore. The story is also a painful reminder of why researchers need to triple check the data and analysis, then check it again. The career damage retractions, even self retractions, is too serious to risk.

The paper, “Limited individual attention and online virality of low-quality information,” presented an argument for why bogus facts seem to gain so much traction on sites such as Facebook. According to the researchers — — from Shanghai Institute of Technology, Indiana University and Yahoo — the key was in the sheer volume of bad information, which swamps the brain’s ability to discern the real from the merely plausible or even the downright ridiculous, competing with limited attention spans and time.
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As they reported:
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Our main finding is that survival of the fittest is far from a foregone conclusion where information is concerned.
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Cloning monkeys for research puts humans on a slippery ethical slope – The Conversation (David Hunter | February 2019)0

Posted by Admin in on February 17, 2019
 

Scientists have many tools at their disposal to study, manipulate and copy genes.

We don’t ordinarily include animal ethics items in the newsroom/Resource Library (this is the third such item out of 1300+ entries), primarily because we feel ill-equipped to comments on such matters, and we are not ordinarily proponents of slippery slope arguments, but David Hunter’s comments here are well made and worthy of consideration.

Now it appears researchers at the Institute of Neuroscience in Shanghai, China, have combined techniques to produce a world first: gene edited, cloned macaque monkeys (Macaca fascicularis).
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Qiang Sun, a senior researcher in the project and Director of ION’s Nonhuman Primate Research Facility explains:
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We believe that this approach of cloning gene-edited monkeys could be used to generate a variety of monkey models for gene-based diseases, including many brain diseases, as well as immune and metabolic disorders and cancer.
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Wake-up call from Hong Kong – Science (Victor J. Dzau, et al | December 2018)0

Posted by Admin in on February 12, 2019
 

The Second International Summit on Human Genome Editing, held in Hong Kong last month, was rocked by the revelation from a researcher from Shenzhen that twins were born whose healthy embryonic genomes had been edited to confer resistance to HIV. Despite widespread condemnation by the summit organizing committee, world scientific academies, and prominent scientific leaders that such research was “deeply disturbing” and “irresponsible,” and the launch of an investigation in China into the researcher’s actions, it is apparent that the ability to use CRISPR-Cas9 to edit the human genome has outpaced nascent efforts by the scientific and medical communities to confront the complex ethical and governance issues that they raise. The current guidelines and principles on human germline genome editing are based on sound scientific and ethical principles. However, this case highlights the urgent need to accelerate efforts to reach international agreement upon more specific criteria and standards that have to be met before human germline editing would be deemed permissible.

“We need…broad agreement on…criteria for human germline genome editing research…”

Together, we call upon international academies to quickly convene international experts and stakeholders to produce an expedited report that will inform the development of these criteria and standards to which all genome editing in human embryos for reproductive purposes must conform, and to engage scientific bodies around the world in this effort. The United States National Academies are willing to lead in this endeavor. Academies are well-positioned to convene needed international expertise and to help foster broad scientific consensus on the responsible pursuit of human genome editing research and clinical applications. We strongly believe that international consensus on such standards is important to avoid the potential for researchers to rationalize the justification or seek out convenient locales for conducting dangerous and unethical experimentation. The establishment of international scientific standards is not intended to substitute for national regulation but could inform such regulation.

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