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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

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

Research, Ethics And Risk In The Authoritarian Field (Books: Marlies Glasius, et al | 2018)0

Posted by Admin in on May 6, 2018
 

Abstract
In this introduction to Research, Ethics and Risk in the Authoritarian Field, we explain why and how we wrote this book, who we are, what the ‘authoritarian field’ means for us, and who may find this book useful. By recording our joint experiences in very different authori- tarian contexts systematically and succinctly, comparing and contrasting them, and drawing lessons, we aim to give other researchers a framework, so they will not need to start from scratch as we did. It is not the absence of free and fair elections, or repression, that most prominently affects our fieldwork in authoritarian contexts, but the arbitrariness of authoritarian rule, and the uncertainty it results in for us and the people in our fieldwork environment.

Keywords
Authoritarianism, Field research, Reflection, Uncertainty, Qualitative research, Fieldwork methods

Glasius, M., de Lange, M. Bartman, J. Dalmasso, E. Lv, A. Sordi, A.D. Michaelsen, M. Ruijgrok, K.(2017). Research, Ethics and Risk in the Authoritarian Field, Springer International Publishing
Publisher (Open Access): https://link.springer.com/content/pdf/10.1007%2F978-3-319-68966-1.pdf

Contents

1 Introduction
Why This Book
Who We Are
What Is the Authoritarian Field?
How We Experience Authoritarianism
Beyond ‘Westerners’ and ‘Locals’
How We Wrote This Book
Who This Book Is For
References

2 Entering the Field
Ethics Procedures
Gaining Entry: Permits and Visas
Constrained Choices
Not So Dangerous
And Yet It Can Be Dangerous
Assessing Risk in Advance
Going the Anthropologist Way
Encountering the Security Apparatus
Data Security Trade-Offs
Chapter Conclusion: Planning Ahead and Accepting Risk
References

3 Learning the Red Lines
Hard Red Lines
Fluid Lines
Depoliticizing the Research
Wording
Getting Locals to Vet Your Wording
Behaviors
Shifting Red Lines—Closures
Shifting Red Lines—Openings
Chapter Conclusion: Navigating the Red Lines
References

4 Building and Maintaining Relations in the Field
Building Connections
Local Collaborators
Refusals
Testing the Waters
Work with What You Have
Where to Meet
Triangulation, Not Confrontation
Sensitive Information
Being Manipulated
Doing Things in Return
Chapter Conclusion: Patience, Trust, and Recognition
References

5 Mental Impact
Targeted Surveillance
Stress, Fear, and Paranoia
Betrayal and Disenchantment
Hard Stories
The Field Stays with Us
Attending to and Coping with Mental Impact
Pressure to Get Results
Positive Mental Impact
Chapter Conclusion: Talk About It
Reference

6 Writing It Up
The Call for Transparency
Interviews with ‘Ordinary People’
Interviews with ‘Expert Informants’
Interviews with ‘Spokespersons’
Protective Practices
Off-the-Record Information
Anonymity vs. Transparency
Transparency About Our Practices, Not Our Respondents
A Culture of Controlled Sharing
Archiving Our Transcripts
Writing, Dissemination, and Future Access
Chapter Conclusion: Shifting the Transparency Debate
References

Dos and Don’ts in the Authoritarian Field

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