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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

(JAP) Japanese stem cell fraud leads to a new retraction – Retraction Watch (Adam Marcus | January 2019)0

Posted by Admin in on February 23, 2019
 

Last March, we reported on the retraction of a 2017 paper in Stem Cell Reports by Kohei Yamamizu and colleagues for widespread fabrication of figures. Turns out the problems were at least five years older than that.

Yamamizu had received a pink slip from his institution, the Center for iPS Cell Research and Application (CiRA), which had put the blame for the misconduct squarely on his shoulders. (The director of the institute, Nobel winner Shinya Yamanaka, also took some of the blame in a public statement in which he said he bore “a strong responsibility for not having prevented research misconduct at our institute.”)

Yamamizu has a new retraction, but this time’s a bit different. Here’s the notice for the paper, “Protein Kinase A Determines Timing of Early Differentiation through Epigenetic Regulation with G9,” which appeared in Cell Stem Cell in June 2012 (Yamanaka was not a co-author on either study).  Although the statement acknowledges the internal investigation, it doesn’t mention misconduct or name Yamamizu:

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(US) Overdue: a US advisory board for research integrity – Nature (C. K. Gunsalus, et al | February 2019)0

Posted by Admin in on February 23, 2019
 

Research needs an authoritative forum to hash out collective problems, argue C. K. Gunsalus, Marcia K. McNutt and colleagues

When it comes to fostering rigour and scientific integrity, US research institutions are stuck. Working out best practice is far from straightforward, and faculty members can be resistant to top-down directives. So, on a day-to-day basis, the conventions that research groups have for documenting methods and results, conducting analyses and allocating credit are often less than optimal. At worst, they can encourage dishonesty and scandal. For example, in April 2017, Brigham and Women’s Hospital in Boston, Massachusetts, and its health-care network agreed to pay US$10 million to settle fraud allegations in stem-cell research funding. (Researchers contest who is at fault.) The hospital has requested retractions of more than 30 papers, and a clinical trial involving more than 100 participants has been paused while data are reviewed. Resources that might have brought better medical care have been squandered.

Calls in the US for a Research Policy Board (RPB) describe an approach that warrants serious consideration in Australasian countries. It has the potential to address problems that have haunted governments and frustrated institutions, researchers and research offices.

Building a culture of quality and integrity requires conversations across the scientific enterprise. Science is a complex ecosystem of funders, journals, academic administrators, scientific societies and researchers — the latter group including principal investigators, staff scientists, postdocs and graduate students. The interests of each group conflict as often as they overlap, and interactions tend to be stratified and constrained. Institutional presidents sit on working groups with each other but not with research-integrity officers. These officers attend conferences with each other, but not with faculty advisers and bench scientists. Journal editors meet scientists and other editors, but not institutional officers, on whom they rely for investigation when concerns about manuscripts arise.
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In the United States, a fractured, inefficient, inconsistent system has built up over the past 70 years to protect research quality and integrity. Separate and sometimes overlapping mechanisms focus on distinct areas, such as oversight of trial participants and animal subjects, data management, financial transactions and declarations of interest.
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Learning lessons from the Paolo Macchiarini case – Horizons (Matthias Egger | December 2018)0

Posted by Admin in on February 23, 2019
 

Independent bodies – not universities – should investigate suspicions of scientific misconduct, says Matthias Egger.

I was sitting next to Agneta Bladh, the chair of the Swedish Research Council, when the conversation over dinner turned to the case of Paolo Macchiarini. You may have heard of the Swiss-born, Italian ‘star surgeon’, who after several investigations was found guilty of scientific misconduct in June 2018 and dismissed from the Karolinska Institutet near Stockholm.

Food for thought for those of us who reside in countries (e.g. Australia and New Zealand) where universities/research institutions conduct their own research misconduct investigations (with the perceived conflicts of interest that raises)

Briefly, Macchiarini had become famous in regenerative medicine for using synthetic scaffolds seeded with patients’ stem cells in trachea transplants. The Lancet, which published several of his papers, praised him as someone who crosses frontiers to innovate, ominously citing the poet T. S. Eliot: “only those who risk going too far can possibly find out how far one can go”.
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The story makes sobering reading. All three patients who received a transplant in Sweden died. Macchiarini was cleared of research misconduct in 2015, with The Lancet defending him in an editorial. Events came to a head a year later after the nationwide screening of a series (‘The Experiments’) by filmmaker Bosse Lindquist, which provoked a massive response and a crisis of confidence at the Karolinska Institutet. A slew of resignations followed: the Vice-Chancellor, the dean of research and the chair of the university board, and investigations were re-opened. In June 2018, the University found Macchiarini and six others guilty of scientific misconduct, and The Lancet retracted two of his papers.
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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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