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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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(US) A new NIH rule won’t be enough to make clinical research more inclusive – STAT (Louise Aronson | January 2019)0

Posted by Admin in on February 22, 2019
 

A quiet but revolutionary new national health policy goes into effect this week, ushering in changes that could lead to important medical discoveries that benefit most Americans. There’s just one problem. Implementing the change will require that our country’s health researchers make some fundamental changes in how they do business.

The exclusions of some sections of society from clinical trials is not merely a matter of justice (fair access to research opportunities) it can seriously limit the usefulness of the research and conceal problems with the treatment. As populations in the global north are getting older this limitation becomes more significant.  This STAT piece reflects on why the regulatory move by the NIH won’t help.

Under the National Institutes of Health’s new Inclusion Across the Lifespan policy, federally supported medical research must include patients of all relevant ages or explain their exclusion. Since most studies already include adults, and a mandate to include children has existed since 1998, the novelty in this policy is the stipulation that clinical research include people age 65 and older.
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That’s a big group. It currently includes both Donald Trump and Nancy Pelosi, Ruth Bader Ginsberg and Clarence Thomas, as well as the 50 million other older Americans, along with the rest of us who get lucky enough down the road to make it into elderhood.
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Children in Social Research: Do Higher Payments Encourage Participation in Riskier Studies? (Stephanie Taplin, et al | February 2019)0

Posted by Admin in on February 18, 2019
 

Abstract

Full disclosure, columns on the advisory panel for this work, But this is a great paper with disciplinary application.

The MESSI (Managing Ethical Studies on Sensitive Issues) study used hypothetical scenarios, presented via a brief online survey, to explore whether payment amounts influenced Australian children and young people to participate in social research of different sensitivity. They were more likely to participate in the lower sensitivity study than in the higher at all payment levels (A$200 prize draw, no payment, $30, or $100). Offering payments to children and young people increased the likelihood that they would agree to participate in the studies and, in general, the higher the payments, the higher the likelihood of their participating. No evidence of undue influence was detected: payments can be used to increase the participation of children and young people in research without concerns of undue influence on their behavior in the face of relatively risky research. When considering the level of payment, however, the overriding consideration should be the level of risk to the children and young people.
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Keywords
children and adolescent, pediatrics, justice, participant selection, inclusion, recruitment, payment for research participation, research ethics, risks, benefits, and burdens of research, beneficence and nonmaleficence, vignette studies, decision-making capacity, surrogate decision makers, parental consent, child assent, voluntariness, coercion
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Taplin, S., Chalmers, J., Hoban, B., McArthur, M., Moore, T. and Graham, A. (2019) Research Ethics Committees’ Oversight of Biomedical Research in South Africa: A Thematic Analysis of Ethical Issues Raised During Ethics Review of Non-Expedited Protocols. Journal of Empirical Research on Human Research Ethics.
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Whose hearts, livers and lungs are transplanted in China? Origins must be clear in human organ research – The Conversation (Wendy Rogers and Matthew Robertson | February 2019)0

Posted by Admin in on February 14, 2019
 

Scientist He Jiankui’s claimed use of the genetic tool CRISPR to edit the genomes of twin girls led to international condemnation. His actions have focused a spotlight on research ethics – and what the consequences should be when scientists “go rogue”.

The Chinese Academy of Science initially looked into He’s conduct, and a subsequent internal government investigation has allegedly identified multiple violations of state laws. He has now been fired by his university.


Read more: Tension as scientist at centre of CRISPR outrage speaks at genome editing summit


But beyond just this example, what does happen when scientists fail to comply with globally-accepted guidelines for ethical medical research? We examined this issue focusing on published research involving recipients of organ transplants performed in the People’s Republic of China.\

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