News

Spotlighting the sun

NSF Discoveries - 39 min 57 sec ago

Astronomers with the National Science Foundation (NSF)-funded National Optical Astronomy Observatory (NOAO) captured pictures not only of Thursday's partial solar eclipse, but also of the "monster" sized active region or sun spot that has many comparing it to one of a similar size that occurred 11 years ago.

The sun spots were earlier reported by scientists with the NSF-supported National Solar Observatory. According to astronomers Frank Hill and Kiran Jain, "As of Oct ...
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Materials for the next generation of electronics and photovoltaics

NSF Discoveries - 39 min 57 sec ago

MacArthur Fellow develops new uses for carbon nanotubes
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Halting the spread of Ebola: Nigeria a model for quick action, scientists find

NSF Discoveries - 39 min 57 sec ago

Rapid control measures critical to stopping the virus in its tracks
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Designing tomorrow's air traffic control systems

NSF Discoveries - 39 min 57 sec ago

MIT researcher explores algorithmic solutions to make flying more efficient
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Ten things to know about the flowers of fall: Sunflowers

NSF Discoveries - 39 min 57 sec ago

Scientists unfurl common flowers' genetic secrets
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What happens to your brain when your mind is at rest?

NSF Discoveries - 39 min 57 sec ago

Kavli Prize winner recognized as pioneer in research in the development and use of brain imaging techniques
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Geospatial data project puts major issues on the map

NSF Discoveries - 39 min 57 sec ago

Powerful Web-based system let users worldwide predict damaging floods and potential effects of climate change
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Sleeping sands of the Kalahari awaken after more than 10,000 years

NSF Discoveries - 39 min 57 sec ago

Overgrazing leaves desert's red dunes blowing in the African wind
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Making stars

NSF Discoveries - 39 min 57 sec ago

Astronomy program provides tools, support to enhance diversity
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Brown Dog: A search engine for the other 99 percent (of data)

NSF Discoveries - 39 min 57 sec ago

Illinois-led team develops tools to search the unstructured Web
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Advances in computer mobility, connectivity and networks

NSF Discoveries - 39 min 57 sec ago

Researcher develops programs and platforms that will ensure systems work despite power losses and other issues
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Expensive cup o'joe? Blame coffee farm rust fungus

NSF Discoveries - 39 min 57 sec ago

To find answers, scientists study ecological complexity of Mexican, Central American coffee plantations
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How to grow mussels

NSF Discoveries - 39 min 57 sec ago

Researchers optimize growing conditions and practices to improve mussel farming
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Community college project gets students on the STEM path

NSF Discoveries - 39 min 57 sec ago

Undergraduates get involved in research activities as part of teaching mission
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Building the framework for the future of biofuels

NSF Discoveries - 39 min 57 sec ago

Do plant-based fuels offer a realistic reprieve from a fossil-powered future? An ASU engineer examines the full cycle
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Plant-based building materials may boost energy savings

NSF Discoveries - Fri, 2014-10-24 16:45

Insulation for homes of the future may be harvested from fields of kenaf, an alternative to fiberglass
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WHO plans for millions of doses of Ebola vaccine by 2015

Nature Newsblog - Fri, 2014-10-24 15:47

Posted on behalf of Declan Butler.

The World Health Organization (WHO) announced plans on 24 October to produce millions of doses of two experimental Ebola vaccines by the end of 2015.

The Ebola virus has caused about 5,000 deaths in West Africa during the current epidemic.

US National Institute of Allergy and Infectious Disease

Hundreds of thousands of doses should be available to help affected countries  before the end of June, the WHO said at the conclusion of a meeting in Geneva.  Vaccine makers, high-level government representatives, and regulatory and other bodies gathered to discuss the design and timing of planned clinical trials, as well as issues of supply and funding for mass vaccination programmes.

Phase I trials of two vaccine candidates have started, and as many as five additional vaccines could begin testing by 2015, says Marie-Paul Kieny, WHO assistant-director general for health systems and innovation.

As of 19 October, Ebola had infected almost 10,000 people in Sierra Leone, Liberia and Guinea and killed around 5,000 of them, the WHO estimates. The true figures are likely higher, as many cases go unreported. With no end to the epidemic yet in sight,  a working vaccine could be a game-changer.

First clinical trials underway

The two vaccines whose production will be increased are already in early stage testing in healthy volunteers. One is a chimpanzee adenovirus vaccine containing a surface Ebola protein (ChAd3), developed by the US National Institute of Allergy and Infectious Diseases and drug giant GlaxoSmithKline. It is being tested in the United States, the United Kingdom and Mali.

The other is a recombinant vesicular stomatitis virus (rVSV) vaccine, developed by the Public Health Agency of Canada and licensed to NewLink Genetics in Ames, Iowa. It is being tested in the United States, with plans to start trials soon in Europe and Africa.

These phase 1 trials will assess the vaccines’ safety and whether they elicit levels of immune response that have been shown to confer protection in non-human primates. The trials will also assess the dose needed to generate sufficient immune response, which in turn helps determine how quickly manufacturers can produce doses.

A third candidate is a two-vaccine regimen: one developed by US pharmaceutical company Johnson and Johnson and the US National Institute of Allergy and Infectious Diseases, and another by Bavarian Nordic, a biotechnology company based in Denmark. It will begin phase 1 testing in the United States and Europe in January. Johnson and Johnson announced on 22 October that it would spend up to US$200 million to fast track the vaccine’s development; it plans to produce more than a million doses in 2015, with 250,000 available by May.

Advanced testing

The first phase II and III trials, to test efficacy as well as safety, are set to start in Liberia in December and  in Sierra Leone in January.  The current plan is to test both the GSK and NewLink vaccines simultaneously, but that could change depending on the results of the ongoing phase I trials. Data from the phase II and III tests is expected by April, Kieny says.

The ‘three-arm’ Liberia trial would test and compare the safety and effectiveness of the two vaccines against each other and a placebo. Each vaccine would be tested on 10,000 subjects, with an equal number of subjects given placebo. This allows researchers to obtain quick, reliable data on how well the vaccines work.

A  ‘stepped-wedge’ randomized trial in Sierra Leone would give subjects vaccine sequentially, with no group given a placebo. This is useful for testing products that are expected to benefit patients, and products that are in short supply.

No trial design has yet been fixed for Guinea, where a lack of infrastructure has precluded early testing. If the Liberia and Sierra Leone trials show that the vaccines works and is safe, subsequent trials in Guinea would be used to answer follow-up questions.

Ethical and practical considerations

The Sierra Leone trial will enrol at least 8,000 healthcare workers, and other frontline responders, such as ambulance drivers and burial workers. The Liberia trial might included healthcare workers, but these would not be the primary study population, Kieny says.

Any decision to give a placebo to healthcare and other frontline workers will be controversial; many consider it to be unethical, given these individuals’ work caring for Ebola patients, and the risks that they face in doing so.

Mass vaccinations are usually only carried out after years of trials to accumulate full safety and efficacy data. The proposed timeline for Ebola vaccine development is therefore unprecedented.

If existing public-health interventions used to control Ebola outbreaks begin to slow the epidemic, the  need for mass vaccination will lessen, Kieny says. But if the epidemic continues to expand, the WHO could consider expanding vaccination programmes.

In the meantime, the WHO and its partners are considering how best to engage with communities to prepare for vaccination programmes. Another issue is simply determining how to keep vaccine cool enough — -80 degrees Celsius — to maintain its efficacy. This will require specialised fridges and the establishment of cold supply chains to affected areas.

Also to be determined : who will pay for mass vaccination. Kieny says simply that “money will not be an issue”. Aid groups and governments have begun to pledge support for such efforts.  Médecins Sans Frontières (MSF) has said that it will create a fund for Ebola vaccination, while the European Union has committed €200 million. The GAVI vaccine alliance, the main sponsor of routine vaccinations in low-income countries, is also looking at how it could bring its vast resources and experience to the table. It will put a plan to its board in December as to what role it could play in any Ebola mass vaccination.

Categories: General, News

US research ethics agency upholds decision on informed consent

Nature Newsblog - Fri, 2014-10-24 13:32

United States regulators are standing by their decision that parents were not properly informed of the risks of a clinical trial in which premature babies received different levels of oxygen supplementation.

From 2005-2009, the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) trial randomly assigned 1,316 premature babies to receive one of two levels of oxygen supplementation in an effort to test which level was best. Though the lower level was associated with increased risk of brain damage and possibly death, and the higher level with blindness, the study leaders said that they did not disclose these risks to parents because all ranges of oxygen used in the trial were considered to be within the medically appropriate range at the time.

The study was supported by the US National Institutes of Health (NIH). On 7 March, 2013, the US Office of Human Research Protections (OHRP) issued a letter determining that the trial investigators had not adequately informed parents about the risks to their babies in the SUPPORT trial. The NIH and many researchers disputed the decision, arguing that it would impede “comparative effectiveness research” studies that are designed to test the best use of approved interventions. Parents of children in the trial, however, and others supported the OHRP’s determination that parents hadn’t received adequate information. The two sides clashed at a meeting convened by NIH and OHRP in August 2013.

Today, 24 October 2014, the OHRP has issued guidance reiterating and clarifying its position on what types of risks must be disclosed to study subjects in comparative effectiveness research studies such as SUPPORT. The agency has determined that risks of the intervention must be disclosed to study participants even if the risks are considered acceptable according to current medical guidelines, if the study intends to evaluate these risks and if the patients’ risks will change when they enroll in the study.

The OHRP said that even though both the low and high levels of oxygen supplementation were considered within the acceptable range, “the key issue is that the treatment and possible risks infants were exposed to in the research were different from the treatment and possible risks they would have been exposed to if they had not been in the trial.”

“[F]or the great majority of infants in the trial, it is likely that their participation altered the level of oxygen they received compared to what they would have received had they not participated,” the OHRP added.

The agency said further that if a trial is designed to compare the risks of potential side effects of a treatment already in use, then the risks are “reasonably foreseeable” and that prospective study participants should be made aware of it.

“If a specific risk has been identified as significant enough that it is important for the Federal government to spend taxpayer money to better understand the extent or nature of that risk, then that risk is one that prospective subjects should be made aware of so that they can decide if they want to be exposed to it,” OHRP said.

The guidance is open to comments until 24 December.

Categories: General, News

Western Australia abandons shark cull

Nature Newsblog - Fri, 2014-10-24 10:47

Western Australia Premier Colin Barnett

Government of Western Australia

The state of Western Australia is abandoning a controversial shark-culling programme, but has also gained the right to deploy deadly baited lines for animals that pose an “imminent threat”.

The programme, run by the state government off several Western Australian beaches, had been heavily criticised by scientists when it was announced in 2013. It was due to run until 2017, and had caught at least 170 sharks using hooks suspended from drums moored to the seafloor.

In September the state’s own Environmental Protection Agency halted it. State Premier Colin Barnett then applied to the national government for permission to resume it, but today he announced that his government had ended that effort. “We have withdrawn the application after reaching agreement with the Commonwealth which enables us to take immediate action when there is an imminent threat,” said Barnett.

Under an agreement with the national government, Western Australia will be able to kill sharks in future to deal with a shark that has attacked or with one that it thinks poses a threat. Protocols for how this would happen are now in development.

This apparent concession from the national government has drawn some concern from those celebrating the end of the cull.

“I remain concerned that drum lines could be used in some instances as part of emergency measures and particularly that this could occur without Federal approval,” said Rachel Siewert, the marine spokeswoman for the Australian Greens, in a statement.

The Western Australia cull is also drawing renewed attention to the long-standing cull in Queensland, which continues unabated.

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National Agricultural Library has joined the BHL.

Ernst Mayr Library Facebook - Thu, 2014-10-23 07:04
National Agricultural Library has joined the BHL.


Timeline Photos
We're pleased to announce that the @[108879087298:274:U.S. Department of Agriculture] National Agricultural Library (NAL) has joined BHL! http://ow.ly/CYQkk Alongside many other BHL members, NAL is actively digitizing seed and nursery catalogs for BHL. Browse the collection: http://biodiversitylibrary.org/browse/collection/seedcatalogs This image from Illustrated Book of Gardening, 1899, digitized by NAL: http://biodiversitylibrary.org/page/45964165
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