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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

(UK) Misconduct allegations push psychology hero off his pedestal – Science (Cathleen O’Grady | July 2020)0

Posted by Admin in on July 28, 2020
 

One of Anthony Pelosi’s most ambitious projects was on the back burner for more than 2 decades. In the early 1990s, Pelosi, a psychiatrist at Priory Hospital Glasgow, published two extensive critiques of the work of Hans Eysenck, a giant of 20th century psychology. Eysenck’s papers contained questionable data and results so dramatic they beggared belief, Pelosi concluded. His critiques, and those by several others, were widely discussed in the field, but never led to formal investigations. Buried by the demands of clinical practice, research, and a young family, Pelosi never found the time to continue his effort. No one, he says, “picked up the baton.”

The far reach of this misconduct and the absurdness of Eysenck’s claims shouldn’t distract us from an important point: Renown doesn’t make research misconduct impossible.

More than a quarter-century later, Eysenck, who was celebrated for his theories of personality and individual differences, is finally falling from his pedestal. Last week, the International Journal of Social Psychiatry and the Journal of the Royal Society of Medicine issued expressions of concern for seven of his papers. Other journals have issued 64 such statements, as well as 14 retractions, over the past 6 months.
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The renewed scrutiny comes in the wake of an inquiry by King’s College London (KCL), where Eysenck was a psychology professor from 1955 to 1983 at what was then the Institute of Psychiatry. But Pelosi and others argue KCL failed to include many of Eysenck’s other papers that also deserve a more thorough investigation in light of his lasting influence on the literature.
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The Hong Kong Principles for assessing researchers: Fostering research integrity (Papers: David Moher, et al | July 2020)0

Posted by Admin in on July 27, 2020
 

Abstract
For knowledge to benefit research and society, it must be trustworthy. Trustworthy research is robust, rigorous, and transparent at all stages of design, execution, and reporting. Assessment of researchers still rarely includes considerations related to trustworthiness, rigor, and transparency. We have developed the Hong Kong Principles (HKPs) as part of the 6th World Conference on Research Integrity with a specific focus on the need to drive research improvement through ensuring that researchers are explicitly recognized and rewarded for behaviors that strengthen research integrity. We present five principles: responsible research practices; transparent reporting; open science (open research); valuing a diversity of types of research; and recognizing all contributions to research and scholarly activity. For each principle, we provide a rationale for its inclusion and provide examples where these principles are already being adopted.

Moher, D., Bouter, L., Kleinert, S., Glasziou, P., Sham, M.H., Barbour, V., Foeger, N. & Dirnagl, U. (2020) The Hong Kong Principles for assessing researchers: Fostering research integrity. PLoS Biol 18(7): e3000737. https://doi.org/10.1371/journal.pbio.3000737
Publisher (Open Access): https://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.3000737

(Australia) Why did a journal suddenly retract a 45-year-old paper over lack of informed consent? – Retraction Watch (Adam Marcus | July 2020)0

Posted by Admin in on July 26, 2020
 

A journal has retracted a 45-year-old case study over concerns that the authors had failed to obtain proper informed consent from the family they’d described.

Part of good governance is recognising when a tough position is just silly. Not too long ago, AHEC took a stance that cell lines, for instance, could still be used even though consent was not a routine part of the process 30+ years ago. There has to be a balance between respect and common sense. In this instance, no one would have noticed if it hadn’t been retracted. Perhaps it should highlight the need to have routine mechanisms in place for consent for case series.

The article, “Stickler syndrome report of a second Australian family,” appeared in Pediatric Radiology, a Springer Nature title, in 1975. The first author was Kazimierz Kozlowski, a prominent radiologist who was born in Poland and worked in the United States and Australia, where he studied skeletal diseases in children.
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Stickler syndrome is an inherited disorder marked by defects in the skeleton, eyes and other organ systems. The condition affects roughly one in 7,500 babies in the United States, although the true incidence may be somewhat higher because some cases are mild enough to go undiagnosed.
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According to the retraction notice:

The Editors have retracted this article [1] as is it is not clear whether parental consent was provided for publication of the images and case. Given the age of the article we have been unable to verify this, therefore the article is no longer available online in order to protect the privacy of the individual. Both authors agree to this retraction.

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Characteristics of registered clinical trials assessing treatments for COVID-19: a cross-sectional analysis (Papers: Hemalkumar B Mehta, et al | June 2020)0

Posted by Admin in on July 25, 2020
 

Abstract
Objectives The coronavirus disease 2019 (COVID-19) pandemic has prompted many initiatives to identify safe and efficacious treatments, yet little is known regarding where early efforts have focused. We aimed to characterise registered clinical trials assessing drugs or plasma treatments for COVID-19.

Design, setting and participants
Cross-sectional analysis of clinical trials for the treatment of COVID-19 that were registered in the USA or in countries contributing to the WHO’s International Clinical Trials Registry Platform. Relevant trial entries of drugs or plasma were downloaded on 26 March 2020, deduplicated, verified with reviews of major medical journals and WHO websites and independently analysed by two reviewers.

Main outcome(s)
Trial intervention, sponsorship, critical design elements and specified outcomes

Results Overall
201 clinical trials were registered for testing the therapeutic benefits of 92 drugs or plasma, including 64 in monotherapy and 28 different combinations. Only eight (8.7%) products or combinations involved new molecular entities. The other test therapies had a wide range of prior medical uses, including as antivirals, antimalarials, immunosuppressants and oncology treatments. In 152 trials (75.7%), patients were randomised to treatment or comparator, including 55 trials with some form of blinding and 97 open-label studies. The 49 (24.4%) of trials without a randomised design included 29 single armed studies and 20 trials with some comparison group. Most trial designs featured multiple endpoints. Clinical endpoints were identified in 134 (66.7%) of trials and included COVID-19 symptoms, death, recovery, required intensive care and hospital discharge. Clinical scales were being used in 33 (16.4%) trials, most often measures of oxygenation and critical illness. Surrogate endpoints or biomarkers were studied in 88 (42.3%) of trials, primarily assays of viral load. Although the trials were initiated in more than 17 countries or regions, 100 (49.8%) were registered in China and 78 (37.8%) in the USA. Registered trials increased rapidly, with the number of registered trials doubling from 1 March to 26 March 2020.

Conclusions
While accelerating morbidity and mortality from the COVID-19 pandemic has been paralleled by early and rapid clinical investigation, many trials lack features to optimise their scientific value. Global coordination and increased funding of high-quality research may help to maximise scientific progress in rapidly discovering safe and effective treatments.

Ehrhardt, S., Moore, T.J., Segal, J.B. & G Alexander, G.C. (2020) Characteristics of registered clinical trials assessing treatments for COVID-19: a cross-sectional analysis. BMJ Open doi: 10.1136/bmjopen-2020-039978

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