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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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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Make reports of research misconduct public – Nature (C. K. Gunsalus | June 2019)0

Posted by Admin in on June 30, 2019
 

Confronted with bad behaviour, institutions will keep asking the wrong questions until they have to show their working, says C. K. Gunsalus.

During decades as a research-integrity officer, expert witness for misconduct investigations and consultant, I have been inspired — and I have seen inexcusable conduct. Even when investigations are exemplary and findings clear, universities rarely report them publicly. That secrecy perpetuates misbehaviour and breeds mistrust — as evidenced by the ongoing revelations of universities that failed to respond appropriately, sometimes for years, to allegations of sexual misconduct.

Science is fast becoming more transparent. So, too, should institutional practice. Open misconduct reports would create a virtuous circle. Institutions would learn from their own and others’ investigations. Leaders would be more likely to pay attention to reports that are subject to scrutiny. Honest researchers could see that although groundbreaking science is often uncertain, it is qualitatively different from the conduct that leads to misconduct reviews.

We are already seeing such a shift in health care. Last month, a study showed that mortality is lower in UK hospitals in which medical professionals feel that they can talk openly about problems without worrying about repercussions to their careers (V. Toffolutti and D. Stuckler Health Affair. http://doi.org/c6df; 2019). I often find that institutional investigators ask the wrong questions, such as: ‘We don’t have to report this, do we?’, ‘How could anyone think Dr X would do such a thing?’ or (to whistle-blowers) ‘Why would you want to cause trouble for your own research project?’ Investigators pin all the blame on one actor without examining the contributions of co-authors or supervisors of the flawed work. An investigation might stop abruptly if the subject of it resigns. A 2019 paper examining investigations by institutions after the retraction of 12 clinical-trial papers by one research group stated that although investigations lasted for between 8 and 17 months, they did not examine preclinical papers from this group even after receiving detailed, serious concerns about them (A. Grey et al. Res. Integr. Peer Rev. 4, 3; 2019).

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