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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

Guidance and supplementary guidance: Safety monitoring and reporting in clinical trials involving therapeutic goods (Guidance: NHMRC | 2018)0

Posted by Admin in on May 3, 2018
 

The National Statement on Ethical Conduct in Human Research 2007 recognises that sponsors, investigators/researchers, institutions and HRECs all have relevant responsibilities. This Guidance, which replaces the Australian Health Ethics Committee’s 2009 Position Statement, is designed to clarify the responsibilities of all parties in relation to reports of adverse events (AE), including serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs), occurring in clinical trials for which institutions are responsible and for which the Human Research Ethics Committees (HRECs) have reviewed and approved.

This guidance specifically addresses the monitoring, collection and reporting of adverse events and adverse reactions that occur in clinical trials involving investigational medicinal products (IMPs) and investigational medical devices (IMDs) for trials conducted under the Clinical Trial Exemption (CTX) or Clinical Trial Notification (CTN) schemes. The Guidance is also broadly applicable to all clinical trials involving therapeutic goods.

NHMRC has developed the following documents to supplement the Guidance and to provide further advice for non-commercial and commercially-sponsored clinical trials involving therapeutic goods. This supplementary guidance covers the following topics…

Access the guidance material

Evolving friendships and shifting ethical dilemmas: Fieldworkers’ experiences in a short term community based study in Kenya (Papers: Dorcas M. Kamuya, et al | 2013)0

Posted by Admin in on April 29, 2018
 

Abstract

This open access paper is a great read for researchers planning, or research ethics reviewers considering, projects that will involve local field workers.

Fieldworkers (FWs) are community members employed by research teams to support access to participants, address language barriers, and advise on culturally appropriate research conduct. The critical role that FWs play in studies, and the range of practical and ethical dilemmas associated with their involvement, is increasingly recognised. In this paper, we draw on qualitative observation and interview data collected alongside a six month basic science study which involved a team of FWs regularly visiting 47 participating households in their homes. The qualitative study documented how relationships between field workers and research participants were initiated, developed and evolved over the course of the study, the shifting dilemmas FWs faced and how they handled them. Even in this one case study, we see how the complex and evolving relationships between fieldworkers and study participants had important implications for consent processes, access to benefits and mutual understanding and trust. While the precise issues that FWs face are likely to depend on the type of research and the context in which that research is being conducted, we argue that appropriate support for field workers is a key requirement to strengthen ethical research practice and for the long term sustainability of research programmes.

Kamuya, D., Theobald, S.J., Munywoki, P.K., Koech, D., Geissler, W.P. and Molyneux, S.C. (2013) Evolving friendships and shifting ethical dilemmas: Fieldworkers’ experiences in a short term community based study in Kenya. Developing World Bioethics 13(1): 1-9.
Publisher (Open Access): https://onlinelibrary.wiley.com/doi/full/10.1111/dewb.12009

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