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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Scandal-weary Swedish government takes over research-fraud investigations – Nature (Holly Else | July 2019)0

Posted by Admin in on July 26, 2019
 

The Research Misconduct Board is one of the first national agencies tasked with investigating serious research misconduct.

Bruised by a string of high-profile scientific-misconduct cases, Sweden has laid the legislative groundwork for a government agency that will handle all allegations of serious research misconduct. The country follows in the footsteps of neighbouring Denmark, which created the world’s first such agency in 2017.

The Swedish investigative body is a positive move, which is worth emulating by other countries.  It should be complemented by a commitment to genuinely supporting a culture of practice (with nationally co-ordinated professional development and symposia).

Proponents say that handling research-misconduct investigations centrally should ensure equal, impartial treatment. But others say the move will divert resources and attention away from less serious breaches that universities will continue to deal with in-house and which, they argue, cumulatively do more damage than some more serious misdemeanours.
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The way in which Swedish research institutes handle allegations of research misconduct has come under fire in recent years — thanks in part to the case of trachea surgeon Paolo Macchiarini. Macchiarini had been accused of misconduct relating to trials of an experimental trachea-transplant method, in which some patients died. On three occasions in 2015, the prestigious Karolinska Institute in Stockholm cleared him, but independent investigations commissioned by the Karolinska later found that he had committed misconduct. A 2016 independent commission concluded that the institute’s procedures were flawed.
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Journal Publishes Concern About Study Using Forced Organ Donation – Medscape (Diana Swift | June 2019)0

Posted by Admin in on July 21, 2019
 

The Clinical Journal of the American Society of Nephrology (CJASN) recently issued an “Expression of Concern” regarding a 2008 article on renal allograft recipients written by Chinese researchers.

The Expression of Concern stems from an Australian report published online in February in BMJ Open, which urged the repudiation by English-language journals of more than 445 studies involving 85,477 organ transplants done in China. The reason? Many of the organs used were likely forcibly harvested from Chinese prisoners of conscience, such as practitioners of Falun Gong, Uyghurs, Tibetans, and underground Christians.

“We reached out for clarification of the organ source to the senior authors, but one was deceased and the other had left the institution where the research was done,” said CJASN Editor-in-Chief Rajnish Mehrotra, MD, MBBS, a professor of medicine at the David Geffen School of Medicine at University of California Los Angeles.

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Montenegro just made plagiarism illegal. What does it hope to achieve? – Retraction Watch (Mico Tatalovic | March 2019)0

Posted by Admin in on July 13, 2019
 

The parliament of Montenegro, a small country in the southeast of Europe, approved a law on academic integrity earlier this month that effectively criminalizes plagiarism, self-plagiarism and donation of authorship. We spoke to Mubera Kurpejović, director of higher education at the country’s Ministry of Education, explains why the law was needed and what they hope it will achieve.

Why did Montenegro need such a law, given that no other country in the region has anything similar? 

Adoption of the Law on Academic Integrity is an affirmation of the state’s determination to deal with integrity in a quality manner and thus influence citizens’ awareness of this important issue, as well as their awareness of the harmfulness of the violation of academic integrity. The recommendation to adopt a special law on this came out of a feasibility study on a customized system for the prevention of plagiarism in Montenegro.

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Not Reporting Results of a Clinical Trial Is Academic Misconduct – ACP (Editorial | Joshua D. Wallach, MS, PhD; Harlan M. Krumholz, MD, SM | May 2019)0

Posted by Admin in on July 3, 2019
 

Failure to report the results of clinical trials threatens the public’s trust in research and the integrity of the medical literature, and should be considered academic misconduct at the individual and institutional levels. According to the ethical principles for research outlined in the Declaration of Helsinki, researchers “have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports” (1). When participants volunteer to take part in clinical trials, and expose themselves to interventions with unknown safety and efficacy profiles, they have a tacit assumption, based on trust, that the evidence generated will inform clinical science (2). Health care providers and medical societies, who are responsible for evaluating and synthesizing evidence and filling the gap between research and practice, need for investigators to fully report their results in a timely manner. The utility of the diligent search for truth in the medical literature depends on its completeness. However, when research findings are not consistently disseminated, the literature provides a skewed view of the science, which may bias reviews of the evidence.

During the past 2 decades, efforts have been increasing to promote the reporting of clinical trial results. After the creation of ClinicalTrials.gov, a public registration database, the United States moved to establish consequences of not reporting clinical trial results. In particular, the U.S. Food and Drug Administration Amendments Act (FDAAA) of 2007 created legal requirements for certain intervention studies of FDA-regulated…

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