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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Common Rule revisions: Comparing changes in US and Singaporean research regulations – CentresBLOG (Owen Schaefer | January 2017)0

Posted by Admin in on February 5, 2017

While Singapore will see a new regulatory regime for research as the Human Biomedical Research Act (HBRA) comes into force, the US has undergone one of the most major revisions to its own ‘Common Rule’ regulating research in decades. Interestingly, the new Common Rule overall relaxes restrictions on various aspects of research in the US. In this post I’ll briefly summarise some of the big takeaways, and draw some comparisons to the HBRA.

Softening in the face of Public Comment

The previous draft of the revised Common Rule had several provisions that did not make it into the final draft due to strong public backlash during the comment period. Most prominently: the draft would have required broad consent for research on de-identified biological samples. Researchers reacted very negatively, stating that this would significantly interfere with important biomedical research without providing significant additional protection to participants (as the main risks are informational). Patient groups were in agreement, concerned that innovative treatments would be delayed due to excessive bureaucratic regulation. The requirement was scrapped, and broad consent is now only required for research on identifiable samples.

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How fake peer review happens: An impersonated reviewer speaks – Retraction Watch (Alison McCook | November 2016)0

Posted by Admin in on February 3, 2017

Earlier this month, BioMed Central and Springer announced that they were retracting nearly 60 papers for a host of related issues, including manipulating the peer-review process. Recently, we were contacted by one of the reviewers who was impersonated by some of the authors of the retracted papers.

The scientist wants to remain anonymous, but provided us with emails that supported his version of events.

In case you need a refresher on the “events” that took place: The two publishers recently pulled 58 papers from authors mostly based in Iran, citing evidence of plagiarism, and manipulating the peer-review process and allocating authorship positions inappropriately.

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Students ‘given dose equivalent to 300 coffees’ in botched test – The Guardian (Matthew Taylor | January 2017)0

Posted by Admin in on January 31, 2017

Northumbria University fined £400,000 after researchers gave students 100 times intended amount of caffeine

This horrifying (and almost tragic) case highlights why research ethics reviewers ask who will conduct various components of a project and their expertise to do so or the supervision/training they will receive. The importance of this is not limited to biomedical research but is more acute when their is significant potential for serious harm.

A university has been fined £400,000 after two students were left fighting for their lives after they were accidentally given the equivalent of 300 cups of coffee in a botched experiment.
Northumbria University told Newcastle crown court it was “deeply, genuinely sorry” after sports science students Alex Rossetto and Luke Parkin were each given the massive dose of caffeine. They were admitted to intensive care for dialysis after the calculation error led to violent side-effects.
Prosecutor Adam Farrer told the court the overdose “could easily have been fatal”. Peter Smith, defending, said the university wished to “emphasise that they take the welfare of their students and staff seriously”.
The students had volunteered to take part in a test in March 2015 aimed at measuring the effect of caffeine on exercise. They were given 30g of caffeine instead of 0.3g, Farrer said.

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Dopey dupe retractions: How publisher error hurts researchers – Retraction Watch (Ivan Oransky | December 2016)0

Posted by Admin in on January 30, 2017

Not all retractions result from researchers’ mistakes — we have an entire category of posts known as “publisher errors,” in which publishers mistakenly post a paper, through no fault of the authors. Yet, those retractions can become a black mark on authors’ record. Our co-founder Ivan Oransky and Adam Etkin, Executive Editor at Springer Publishing Co (unrelated to Springer Nature) propose a new system in the latest issue of the International Society of Managing & Technical Editors newsletter, reprinted with permission below.

Given the serious impacts retractions can have upon the reputations and careers of researchers it is time to call ‘publisher errors’ something other than a retraction. We thought this worth worth circulating if only for the line ‘If it walks like a duck and quacks like a duck, don’t call it a vulture’.

Imagine you’re a researcher who is one of 10 candidates being considered for tenure, or a promotion, or perhaps a new job which would significantly advance your career. Now imagine that those making this decision eliminate you as a candidate without even an interview because your record shows you’ve had a paper retracted. But in this particular case, what the decision makers may not be aware of is that the paper was not retracted because you made an honest mistake—which, if you came forward about it, really shouldn’t be a black mark anyway—or even because you did something unethical. It was retracted due to publisher error. Like Han Solo and/or Lando Calrissian, you’d find yourself in utter disbelief while saying “It’s not my fault!”— and you’d be right.

Retraction Watch has reported on several “retractions” that were the result of publisher error. Usually this comes in the form of duplicate publication. Perhaps an unedited version was published due to an administrative miscommunication. Maybe a production glitch caused the same paper to appear in consecutive issues of the same journal. Possibly a journal was transferring the article to another journal produced by the same publishing house and inadvertently published it in both journals. Then there are a few cases in which a journal rejected an article, published it anyway, and then retracted it.

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