ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)
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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Disgraced surgeon is still publishing on stem cell therapies – Science (Matt Warren | April 2018)0

Posted by Admin in on May 19, 2018
 

Paolo Macchiarini, an Italian surgeon, has been fired from two institutions and faces the retraction of many of his papers after findings of scientific misconduct and ethical lapses in his research—yet this hasn’t prevented him from publishing again in a peer-reviewed journal. Despite his circumstances, Macchiarini appears as senior author on a paper published last month investigating the viability of artificial esophagi “seeded” with stem cells, work that appears strikingly similar to the plastic trachea transplants that ultimately left most of his patients dead. The journal’s editor says he was unaware of Macchiarini’s history before publishing the study.

“I’m really surprised,” says cardiothoracic surgeon Karl-Henrik Grinnemo, one of the whistle-blowers who exposed Macchiarini’s misconduct at the Karolinska Institute (KI) in Stockholm. “I can’t understand how a serious editorial board can accept manuscripts from this guy.”

Macchiarini was once heralded as a pioneer of regenerative medicine because of his experimental transplants of artificial tracheas that supposedly developed into functional organs when seeded with a patient’s stem cells. But his career came crashing down after the Swedish documentary Experimenten showed the poor outcomes of his patients, all but one of whom have now died. (The lone survivor was able to have his implant removed.) Macchiarini was subsequently fired from KI, both the university and a national ethics board found him guilty of scientific misconduct in several papers, and Swedish authorities are now considering whether to reopen a criminal case against him.

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(US) FDA Launches Criminal Investigation Into Unauthorized Herpes Vaccine Research – KHN (Marisa Taylor | April 2018)0

Posted by Admin in on May 15, 2018
 

The Food and Drug Administration has launched a criminal investigation into research by a Southern Illinois University professor who injected people with his unauthorized herpes vaccine, Kaiser Health News has learned.

SIU professor William Halford, who died in June, injected participants with his experimental herpes vaccine in St. Kitts and Nevis in 2016 and in Illinois hotel rooms in 2013 without safety oversight that is routinely performed by the FDA or an institutional review board.

According to four people with knowledge about the inquiry, the FDA’s Office of Criminal Investigations is looking into whether anyone from SIU or Halford’s former company, Rational Vaccines, violated FDA regulations by helping Halford conduct unauthorized research. The probe is also looking at anyone else outside the company or university who might have been complicit, according to the sources who asked not to be identified because of the sensitivity of the matter.

Canada sued over years of alleged experimentation on indigenous people – The Guardian (Ashifa Kassam | May 2018)0

Posted by Admin in on May 12, 2018
 

Class-action suit filed on behalf of thousands of people allegedly subjected to medical tests without consent in the mid-20th century

A class action lawsuit has been filed in a Canadian court on behalf of the thousands of indigenous people alleged to have been unwittingly subjected to medical experiments without their consent.

We will be following this case with revulsion. Were the allegations to be proven it wouldn’t only be an opportunity for justice, reconciliation and healing in Canada it will also probably prompt serious consideration for First Peoples around the world

Filed this month in a courtroom in the province of Saskatchewan, the lawsuit holds the federal government responsible for experiments allegedly carried out on reserves and in residential schools between the 1930s and 1950s.
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The suit also accuses the Canadian government of a long history of “discriminatory and inadequate medical care” at Indian hospitals and sanatoriums – key components of a segregated healthcare system that operated across the country from 1945 into the early 1980s.
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“This strikes me as so atrocious that there ought to be punitive and exemplary damages awarded, in addition to compensation,” said Tony Merchant, whose Merchant Law Group filed the class action.
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How We Found Sources for Our Research Misconduct Story — And How You Can Help Us Find More – ProPublica Illinois (Jodi S. Cohen | April 2018)0

Posted by Admin in on May 10, 2018
 

Privacy rules were an obstacle to finding participants in Dr Mani Pavuluri’s lithium studies, but we got around them.

This is a salutary story, not only in terms of modifying a project in the way described in the story (going from 13-16 year old kids to children around 10 or younger), but also the degree that social media can enable the identification of research participants whose identities were supposedly protected

This story was first published in ProPublica Illinois’ weekly newsletter. Sign up for that here.

A story we published yesterday revealed how the University of Illinois at Chicago recently had to repay the federal government $3.1 million after the National Institute of Mental Health determined one of the school’s star faculty members violated grant protocols — and put vulnerable kids at risk.

UIC child psychiatrist Mani Pavuluri had received the grant funds from NIMH to study how the powerful drug lithium affects the brain functions of adolescents with bipolar disorder. But she violated several guidelines, including enrolling children younger than 10 in the trial though it was supposed to only include 13- to 16-year-olds.

UIC was at fault, too. It failed to properly oversee her work, according to NIMH.

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