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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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Read the rest of this discussion piece

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.

Read the rest of this discussion piece

Scientific misconduct at an elite medical institute: The role of competing institutional logics and fragmented control (Papers: Christian Berggren and Solmaz Filiz Karabag | April 2018)0

Posted by Admin in on May 8, 2018
 

Abstract
The incidence of revealed fraud and dishonesty in academia is on the rise, and so is the number of studies seeking to explain scientific misconduct. This paper builds on the concepts of competing logics and institutional fields to analyze a serious case of medical and scientific misconduct at a leading research institute, Karolinska in Sweden, home to the Nobel Prize in Medicine.

The Paolo Macchiarini/Karolinska case highlights an uncomfortable reality: the speed, response and consequences of research misconduct by star researchers is often shaped by a powerful institution conflict of interest. The consequences can be dire. Of course the institutional impacts of being deemed later to be reticent to act are often worse. The internal processes for reflecting on the bona fides of an allegation and the institution’s social responsibility/risks need to be rethought. We have included links to the earlier items about this case.

By distinguishing between a market-oriented, a medical and an academic logic, the study analyzes how various actors − executives, research leaders, co-authors, journal editors, medical doctors, science bloggers, investigative journalists and documentary filmmakers − sustained or tried to expose the misconduct. Despite repeated warnings from patient-responsible doctors and external academic reviewers, Karolinska protected the surgeon, Paolo Macchiarini, until a documentary film at the Swedish national public TV exposed the fraud which led to public inquiries and proposals for a new national ethics legislation.
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The analysis illustrates the power of a market-oriented logic focused on brand and image at the research institute and at a leading journal, but also the perseverance of the logics of scientific scrutiny and medical care among practicing doctors and independent academics although the carriers of these logics were less well organized than the carriers of the market-oriented logic. Furthermore, the analysis shows the problem of fragmented control in the academic institutional field. The discussion of remedies compares the Karolinska case, where media actors were instrumental in sanctioning the perpetrators, with a similar instance of medical misconduct at Duke in the US where the government agency (ORI) intervened and shows the limitations of both types of actors. The conclusion highlights the importance of studying misconduct management and institution-building in different fields to develop effective remedies.
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Keywords
Institutional logics, Institutional actors, Scientific misconduct, Retraction, Academic dishonesty, Fragmented control.
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Berggren, C. and S. F. Karabag (2018). “Scientific misconduct at an elite medical institute: The role of competing institutional logics and fragmented control.” Research Policy.
Publisher: https://www.sciencedirect.com/science/article/pii/S0048733318300817

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