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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

The Dying Scientist and his Rogue Vaccine Trial – Wired (Amanda Schaffer | May 2018)0

Posted by Admin in on June 18, 2018
 

Bill Halford was convinced he’d found a miracle cure, but he was running out of time to prove it. So he teamed up with a Hollywood executive and recruited a band of desperate patients.

IN A PHOTO from 2009, Bill Halford, who was then 40 years old, looks like a schoolboy who hasn’t quite grown into his big ears. He wears an ill-fitting red shirt tucked into belted khakis; his jawline is square and his eyes are full of wonder. The picture was taken at Southern Illinois University, where he was a respected professor. A few years before, he had made a significant discovery—one that would determine the course of his life.

Halford, a microbiologist, had taken an interest in the peculiar nature of herpes—how it lies dormant in the nervous system and reactivates to cause disease. Herpes is one of the most pervasive viral infections in the world, sometimes causing painful genital blisters, and it has frustrated scientists attempting to find a cure. But in 2007, Halford realized that a weakened form of the virus he’d been studying might serve as a vaccine. He designed an experiment in which he inoculated mice with this variant, then exposed them to the wild-type form of the virus. In 2011 he published the results: Virtually all the mice survived. By contrast, animals that were not injected with his vaccine died in large numbers. It was promising science.

That same year, however, Halford became seriously ill. At first he thought he had a sinus infection, but it turned out to be a rare and aggressive form of cancer, sinonasal undifferentiated carcinoma. Halford was 42 years old at the time, with two teenage children. He underwent chemotherapy and radiation followed by surgery, but he was told that the form of cancer he had did not usually stay at bay for long. Halford had always been determined—“a 90-hours-a-week sort of researcher,” as his wife, Melanie Halford, puts it. The cancer diagnosis only seemed to harden his focus. Others had tried, and failed, to develop a herpes vaccine, but Halford was convinced that his method—using a live, attenuated form of the virus—would succeed. He would use whatever time he had left to show he was right.

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Why all randomised controlled trials produce biased results (Papers: Alexander Krauss | March 2018)0

Posted by Admin in on June 7, 2018
 

Abstract

Background: Randomised controlled trials (RCTs) are commonly viewed as the best research method to inform public health and social policy. Usually they are thought of as providing the most rigorous evidence of a treatment’s effectiveness without strong assumptions, biases and limitations.

Objective: This is the first study to examine that hypothesis by assessing the 10 most cited RCT studies worldwide.

Data sources: These 10 RCT studies with the highest number of citations in any journal (up to June 2016) were identified by searching Scopus (the largest database of peer-reviewed journals).

Results: This study shows that these world-leading RCTs that have influenced policy produce biased results by illustrating that participants’ background traits that affect outcomes are often poorly distributed between trial groups, that the trials often neglect alternative factors contributing to their main reported outcome and, among many other issues, that the trials are often only partially blinded or unblinded. The study here also identifies a number of novel and important assumptions, biases and limitations not yet thoroughly discussed in existing studies that arise when designing, implementing and analysing trials.

Conclusions: Researchers and policymakers need to become better aware of the broader set of assumptions, biases and limitations in trials. Journals need to also begin requiring researchers to outline them in their studies. We need to furthermore better use RCTs together with other research methods.

Key messages

  • RCTs face a range of strong assumptions, biases and limitations that have not yet all been thoroughly discussed in the literature.
  • This study assesses the 10 most cited RCTs worldwide and shows that trials inevitably produce bias.
  • Trials involve complex processes – from randomising, blinding and controlling, to implementing treatments, monitoring participants etc. – that require many decisions and steps at different levels that bring their own assumptions and degree of bias to results.

Keywords: Randomised controlled trial, RCT, reproducibility crisis, replication crisis, bias, statistical bias, evidence-based medicine, evidence-based practice, reproducibility of results, clinical medicine, research design

Krauss, A. (2018) Why all randomised controlled trials produce biased results. Annals of Medicine. 50:4, 312-322, DOI: 10.1080/07853890.2018.1453233
Publisher (Open Access): https://www.tandfonline.com/doi/full/10.1080/07853890.2018.1453233

Implementing the Tri-Council Policy on Ethical Research Involving Indigenous Peoples in Canada: So, How’s That Going in Mi’kma’ki? (Carla Moore | April 2017)0

Posted by Admin in on May 22, 2018
 

Abstract
The 2010 edition of the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans introduced a new chapter, titled “Research Involving the First Nations, Inuit and Métis Peoples of Canada.” The goal of our study was to explore how this chapter is being implemented in research involving Mi’kmaw communities in Nova Scotia. Qualitative data from four groups—health researchers, research ethics board representatives, financial services administrators, and Mi’kmaw community health directors—revealed that while the chapter is useful in navigating this ethical space, there is room for improvement. The challenges they encountered were not insurmountable; with political will from the academy and with guidance from Indigenous community health and research leaders solutions to these barriers can be achieved.

Moore, C. , Castleden, H. E. , Tirone, S. , Martin, D. (2017). Implementing the Tri-Council Policy on Ethical Research Involving Indigenous Peoples in Canada: So, How’s That Going in Mi’kma’ki?. The International Indigenous Policy Journal, 8(2) . Retrieved from: http://ir.lib.uwo.ca/iipj/vol8/iss2/4 DOI: 10.18584/iipj.2017.8.2.4
Publisher (Open Access): https://ir.lib.uwo.ca/iipj/vol8/iss2/4/

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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