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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

The Next Phase of Human Gene-Therapy Oversight – The New England Journal of Medicine (Francis S. Collins and Scott Gottlieb | August 2018)0

Posted by Admin in on October 18, 2018
 

The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) have played key roles in the emergence of safe and effective human gene therapies. Now, we are proposing new efforts to encourage further advances in this rapidly evolving field.

The potential to alter human genes directly was first recognized nearly 50 years ago, around the same time as initial groundbreaking advances were being made in recombinant DNA technology. After intense discussions regarding the ethical, legal, and social implications of this technology, conversations were initiated at the NIH that led to the establishment of the Recombinant DNA Advisory Committee (RAC) in 1974. The RAC’s mission was to advise the NIH director on research that used emerging technologies involving manipulation of nucleic acids — a mission that was eventually expanded to encompass the review and discussion of protocols for gene therapy in humans. In 1990, the FDA oversaw the first U.S. human gene-therapy trial, which involved pediatric patients with adenosine deaminase deficiency and was conducted at the NIH Clinical Center in Bethesda, Maryland.

Although no major safety concerns were initially reported, over the course of the 1990s it became evident that many questions regarding the safety and efficacy of gene therapy remained unanswered. These unknowns were brought into sharp focus in 1999 when Jesse Gelsinger died of a massive immune response during a safety trial of gene therapy for ornithine transcarbamylase deficiency.1 This tragic death led to closer scrutiny of the field, including a greater focus on open dialogue and increased regulatory oversight.

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The Rise of Peer Review: Melinda Baldwin on the History of Refereeing at Scientific Journals and Funding Bodies – Scholarly Kitchen (Robert Harington | September 2018)0

Posted by Admin in on October 17, 2018
 

I  was recently given the opportunity to read a fascinating paper by Melinda Baldwin, (Books Editor at Physics Today magazine, published by the American Institute of Physics), entitled “Scientific Autonomy, Public Accountability, and the Rise of “Peer Review” in the Cold War United States” (Isis, volume 109, number 3, September 2018). Melinda is an accomplished historian of science, with a special emphasis on the cultural and intellectual history of science and scientific communication. Not only is her writing infectiously entertaining, the story itself is new, or at least it is new to me. It turns out that peer reviewing in scientific journals is a relatively recent construct, first emerging in the nineteenth century and not seen as a central part of science until the late twentieth century.

A great piece reflecting on the history of peer review that nicely contextualises current frustrations and future directions. A worthy inclusion in ‘further reading’ lists when speaking about peer review.

Melinda paints a picture of constant change in peer review, which perhaps provides a lesson for us all. Maybe this should be obvious, but there is no status quo in academic publishing, and while we may feel our moment is more important than those that have gone before, or those ahead of us, expectations and models are fluid, be you author, reviewer, publisher, institution, or funder.
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In this interview I ask Melinda to talk about her article, and provide some more personal views on peer review topics of the moment.
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Who Says You Need Permission to Study Yourself? – NEO.LIFE (Emily Mullin | September 2018)0

Posted by Admin in on October 16, 2018
 

Sara Riggare can’t finish her PhD because an ethics committee says she needed their approval first.

For the past six years, Sara Riggare, who has Parkinson’s disease, has been conducting research on herself as part of her PhD at the prestigious Karolinska Institute in Sweden. Using mobile apps, she tracks her symptoms, sleep, and activity.

She’s not unique in doing so: Many people self-monitor with apps and wearable devices like Fitbit and the Apple Watch, a trend spurred by the broader Quantified Self movement, where “lifeloggers” track everything from their blood sugar to their microbiome, and even carry out experiments on themselves.

For the past six years, Sara Riggare, who has Parkinson’s disease, has been conducting research on herself as part of her PhD at the prestigious Karolinska Institute in Sweden. Using mobile apps, she tracks her symptoms, sleep, and activity.

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The “problem” of predatory publishing remains a relatively small one and should not be allowed to defame open access – LSE Impact Blog (Tom Olijhoek and Jon Tennant | September 2018)0

Posted by Admin in on October 15, 2018
 

A recent investigation led by an international group of journalists raised concerns over the scale of the problem of deceptive publishing practices, with many researchers of standing and reputation found to have published in “predatory” journals. However, while the findings of this investigation garnered significant media attention, the robustness of the study itself was not subject to the same scrutiny. To Tom Olijhoek and Jon Tennant, the profile afforded to investigations of this type causes some to overstate the problem of predatory publishing, while often discrediting open access publishing at the same time. The real problem here is one of education around questionable journals, and should not distract from more urgent questions around the shifting scholarly ecosystem.

Writing about the scale of questionable publishing Tom Olijhoekand Jon Tennant suggest the relative scale of the problem isn’t as bad as some science reporters suggest, but that doesn’t mean it’s not having an impact that is concerning. We agree. There are plenty of open access publishers which have high editorial standards and there are some large and supposedly reputable publishers that sometimes feel like they are running an expensive protection racket.

Full disclosure: Tom Olijhoek is Editor-in-Chief of DOAJ and Jon Tennant is the founder of the Open Science MOOC.
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Imagine you want to investigate the quality of restaurants. You know beforehand there are bad restaurants. So you set up your investigation by going to a number of bad restaurants of bad reputation. What do you find? You find that a number of restaurants are really bad, an inevitable conclusion. You even find that people of standing and reputation have visited these restaurants on occasion.
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Would the conclusion here be that all restaurants are bad? Several investigations of this kind have looked into the problem of “predatory” or “questionable” publishers, the most famous being the heavily criticised and deeply flawed “sting operation” by John Bohannon in Science magazine. In science speak, this is called doing an experiment without an appropriate control group, usually sufficient for research to be desk rejected for being fundamentally flawed.

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