Tag: Policy

Philip Hammond, the UK’s chancellor of the exchequer, has promised to underwrite EU research projects after Brexit.

British scientists say they’re relieved by a government promise to guarantee them funding for existing EU research projects, even after the country leaves the European Union. But the reassurance only partly allays concerns about Brexit’s effect on UK science.

The United Kingdom receives billions of euros for research from the European Union, mostly from its €74.8-billion (US$83.6-billion) Horizon 2020 (H2020) programme. June’s referendum vote for the nation to leave the EU left British scientists worried that funding for existing multi-year projects could be yanked away. And the uncertainty led to reports of EU collaborators deciding to drop UK scientists from future grant applications — even though the United Kingdom is still a full member of the EU. Tell Nature: Big or small, we want to hear how Brexit is affecting you

But on 13 August, the government announced that it will step in to pay UK contributions to EU H2020 projects after Brexit, provided that the projects were bid for before the day that the UK leaves the EU (a date which has not yet been fixed). “By underwriting Horizon 2020 funding in this way today, we are again demonstrating the importance we place on maintaining the world leading research that takes place in the UK,” said UK science minister, Jo Johnson.

Other types of EU project were given lesser guarantees. UK recipients of EU ‘structural funds’ (some of which are spent on research infrastructure) are to be assured funding only if they bid for them before an annual address on the nation’s finances known as the ‘Autumn Statement’ — an event that typically takes place in November or December. Still, the promise ensures that, for example, the UK’s University of Manchester can expect to receive £5 million (US$6.4 million) from EU funds for a planned Graphene Engineering Innovation Centre.

“Since the referendum vote, the research community has been struggling with the uncertainty. This provides huge reassurance,” says Sarah Main, director of the Campaign for Science and Engineering (CaSE) in London. The move will also reassure European collaborators, she says.

“This is encouraging news that provides much-needed stability for British universities during the transition period as the UK exits the EU, and provides an important signal to European researchers that they can continue to collaborate with their UK colleagues as they have before,” said Alistair Jarvis, deputy chief executive of the higher-education umbrella group Universities UK in London.

But the campaign group Scientists for EU issued a statement calling the announcement “decidedly underwhelming” and “a confirmation of the bare essentials, but nothing more”. After Brexit, UK scientists may lose the ability to apply for H2020 funding, depending on the terms of the split. And the government has not committed to shoring up those potential lost funds with domestic grants, Scientists for EU pointed out.

“This guarantee alleviates some of the uncertainties about existing and imminent H2020 grants, but does nothing to dispel fears about mobility between the UK and the rest of the EU following Brexit, which is integral to many H2020 schemes, nor does it address longer-term funding issues,” says Paul Crowther, who heads the physics and astronomy department at the University of Sheffield, UK.

Main says that she is still encouraged by the government’s continued support for science. She cites another example of political positive intentions: a letter from UK Prime Minister Theresa May in July to the director of London’s Francis Crick Institute, Paul Nurse, saying that the government was committed to ensuring a positive outcome for UK science. “To be honest, I’m feeling positive,” she says.

Nature doi:10.1038/nature.2016.20434

http://www.nature.com/news/index.html Nature

http://www.nature.com/news/uk-government-gives-brexit-science-funding-guarantee-1.20434 Original web page at Nature

Staff at Canadian university given little guidance on how to mitigate future problems.

These kinds of attacks — holding data hostage — are becoming increasingly common.

The first Patrick Feng knew about a cyberattack on his university was when one of his colleagues told him that her computer had been infected by hackers and rendered unusable.

Feng, who studies technology and sustainability policy at the University of Calgary in Canada, immediately checked the Dropbox folder that he was sharing with that colleague — and found that it, too, had been compromised.

“The hackers had created encrypted copies of all my Dropbox files and deleted the originals,” he says. “And there was a ransom note demanding bitcoin to unlock them.” Bitcoin is an online, anonymous currency, making it an attractive option for cybercriminals.

The attack, which started on 28 May, left many researchers locked out of their data and university e-mail. Most staff and faculty regained access to the school’s networks by 30 May, and e-mail was back up by 6 June.

Feng’s Dropbox folder contained data and draft manuscripts for a research paper that he is writing on innovative ways of teaching research methods to undergraduates, but he wasn’t too concerned. His personal laptop was unaffected, and he asked Dropbox to restore his folder to the last saved version before the attack, which the company was able to do in a couple of days.

Others were not so fortunate. Two of Feng’s colleagues, including the one who had informed him about the hack, had to have the hard drives of their university-issued computers wiped and restored.

A few of the most badly affected faculty and staff have yet to regain full access to their data. But, there is no indication that any personal or school data were released to the public, according to the university. “Research data that was stored on our systems was backed up prior to the attack and remains intact,” says Marina Geronazzo, a university spokesperson.

The university is confident that it will be able to restore all data from those back-ups, she says. But the school did pay a ransom of Can$20,000 (US$15,500) for the decryption keys as a precaution. They say it will be used only as a last resort.

This kind of “ransomware” attack is becoming increasingly common, says James Scott, a cybersecurity specialist at the Institute for Critical Infrastructure Technology, a think-tank in Washington DC — and universities are hardly immune. In the United States, the education sector is the third most common target for hackers, after healthcare and retail, he says.

In many cases, the ransom money that hackers can extract from their victims is a secondary goal. “Ransomware is the new DDoS,” Scott says, referring to a Distributed Denial of Service attack, in which a network of infected computers overwhelms a target with more connection requests than it can handle. Hackers use these attacks as a distraction while they steal data, he explains.

City of Calgary police are still searching for the perpetrator. Past incidents, Scott says, make him suspect that Chinese sources may have been involved. The country has allegedly targeted Canadian researchers before. In 2014, the Canadian government accused “Chinese state-sponsored actors” of hacking the National Research Council, a federal research agency headquartered in Ottawa.

It’s a matter of Chinese policy to use espionage to bring their country up to speed, technologically, with the West, says Scott, who is not a part of the investigation. “Universities are a huge target for China because of their advanced research.”

Scott says that universities are particularly vulnerable to cyberattacks because they often have multiple overlapping public and private networks, and staff, faculty members or students with infected devices might connect with any number of them. Many labs also have devices “frankensteined” into their networks that were never intended to be there, which opens up new avenues of attack.

Feng says that aside from requiring everyone to change their passwords, the university has provided little guidance on how researchers can better protect themselves against such attacks in the future. He says that it is up to researchers to be aware of the risks, and to take the proper precautions by automatically backing up their data on external hard drives, or to the cloud. “Even though I teach technology policy, and am aware of these kinds of issues, I still thought it was never going to happen to me,” he says.

Nature doi:10.1038/nature.2016.20111

http://www.nature.com/ Nature

http://www.nature.com/news/ransomware-cyberattack-highlights-vulnerability-of-universities-1.20111  Original web page at Nature

CRISPR, the genome-editing technology that has taken biomedical science by storm, is finally nearing human trials.

On 21 June, an advisory committee at the US National Institutes of Health (NIH) approved a proposal to use CRISPR/Cas9 to help augment cancer therapies that rely on enlisting a patient’s T cells.

“Cell therapies [for cancer] are so promising but the majority of people who get these therapies have a disease that relapses,” says study leader Edward Stadtmauer, a physician at the University of Pennsylvania in Philadelphia. Gene editing could improve such treatments and eliminate some of their vulnerabilities to cancer and the body’s immune system, he says.

This first trial is small and designed to test whether CRISPR is safe for use in people, rather than whether it cures cancer or not. It will be funded by a US$250 million immunotherapy foundation formed in April by former Facebook president Sean Parker. The trial itself does not yet have a budget. The University of Pennsylvania will manufacture the edited cells, and will recruit and treat patients along with centers in California and Texas.

The researchers will remove T cells from 18 patients with melanoma, sarcoma, or myeloma, and perform three CRISPR edits on them. One edit will insert a gene for a protein engineered to detect cancer cells and instruct the T cells to target them, and a second edit removes a natural T cell protein that could interfere with this process. The third is defensive: removing the gene for a protein that identifies the T cells as immune cells and preventing the cancer cells from disabling them. The researchers will then infuse the edited cells back into the patient.

“Last year’s excitement over CRISPR was in anticipation of this,” says Dean Anthony Lee, an immunologist at MD Anderson Cancer Center in Houston and a member of the NIH’s Recombinant DNA Research Advisory Committee (RAC) that reviewed the proposal. CRISPR, he says, makes genome engineering easy enough that such trials can move forward quickly.

The RAC reviews all proposals for human trials involving modified DNA that are conducted in the United States. Stadtmauer’s team will now have to convince US regulators and review boards at their own institutions to allow the trial. Immunologist Carl June from the University of Pennsylvania, who is a science advisor on the project, says it could begin by the end of the year.

Others may not be far behind. Editas Biotechnologies in Cambridge, Massachusetts, for instance, has said that it wants to use CRISPR in a clinical trial for a rare form of blindness as soon as 2017. However, RAC members say they have not yet been approached about reviewing the trial.

While most attention has focused on CRISPR because of its ease of use, the T-cell trial will not be the first test of the efficacy of using gene editing to fight diseases. In 2014, June led a study using a gene-editing system called zinc-finger nuclease.

His group took blood from 12 people with HIV and removed the gene for a protein on T-cells targeted by the virus in the hopes that this would prevent infection of the cells. The results were encouraging, and the technique is now being used in clinical trials for several other applications.

And last week, researchers at Great Ormond Street Hospital for Children in London began a safety study with 10 children using a similar technique called TALENS. Instead of using a patient’s own cells, this system uses T cells from a donor that have been edited to remove genes that would cause the patient’s body to reject them. The gene editing then directs the T cells to attack the cancer and protects the cells from other immunotherapy drugs.

Although CRISPR is easier to use than these other techniques, and better able to edit multiple genes at once, June says the challenge will be a propensity for “off-target” effects. These are instances in which the system cuts or mutates unintended parts of the genome. And despite precautions, the immune system could still attack the edited cells.

During the RAC meeting, one of the committee’s greatest concerns was a potential conflict-of-interest. Among other financial involvements, June has ties to the pharmaceutical company Novartis, holds patents on T-cell technologies, and could potentially stand to benefit from the success of this trial. June declined to give details as to the exact nature of his conflict of interest, but says that his university is taking steps to manage it, such as preventing him from being involved in selecting patients.

Several RAC reviewers suggested that the University of Pennsylvania not be allowed to recruit patients at all and to leave it to other institutions: this language did not make it into their final approval.

However, the RAC members say they are being extra careful with this study. “Penn has a very extensive conflict and has a history,” says Laurie Zoloth, a bioethicist at Northwestern University in Evanston, Illinois. Looming over the discussion is the name Jesse Gelsinger, who died at age 18 while participating in an early gene therapy trial conducted by researchers at the University of Pennsylvania in 1999.

Subsequent investigation found numerous problems with the study, including unreported animal data on the therapy’s ill-effects and the fact that the investigators had a financial stake in the study’s outcome.

The incident is generally considered to have set gene therapy back by decades. “Any first use in humans we have to be extraordinarily careful,” Zoloth says. So a lot is riding on this trial.

But Mildred Cho, a bioethicist at Stanford University in California and a RAC member, says that safety work in animals for a new therapy will only take researchers so far. “Often we have to take the leap of faith.”

Nature doi:10.1038/nature.2016.20137

http://www.nature.com/ Nature

http://www.nature.com/news/index.html  Original web page at Nature

Future of science uncertain after referendum result. It was the result that most scientists didn’t want. The United Kingdom’s vote to leave the European Union has plunged it into political and economic uncertainty — and left researchers worried over the future of their funding and collaborations, the UK’s participation in major European research programmes, and the freedom of movement and employment status of thousands of scientists.

Many researchers in the UK expressed shock and dismay as the result of the 23 June referendum — with 52% of people voting in favour of ‘Brexit’ to 48% against — sank in.

“This is a poor outcome for British science and so is bad for Britain,” Paul Nurse, the head of the Francis Crick Institute in London and a Nobel-prizewinning geneticist, told journalists. “British scientists will have to work hard in the future to counter the isolationism of Brexit if our science is to continue to thrive,” he said.

The messy and protracted process of negotiating a UK departure from the EU means that it may not become clear for years how science is affected. Politicians campaigning for a UK divorced from the EU had pledged before the vote that universities and scientists in the country would not lose out. But immediate concerns for researchers revolve around funding: UK universities currently get around 16% of their research funding, and 15% of their staff, from the EU.

“This is going to be very damaging,” says Jonathan Butterworth, a physicist at University College London who works on the ATLAS experiment at the Large Hadron Collider near Geneva, Switzerland. Another urgent worry, he says, is for students and postdocs from elsewhere in Europe at universities in England, Wales, Scotland and Northern Ireland. “We need strong statements that the level of research and education funding that was coming though the EU will be guaranteed,” he adds.

Jamie Martin, an advocate for the UK’s exit from the EU and a former special adviser to the pro-Brexit politician Michael Gove, said that he would offer “total reassurance” to worried scientists. Although most academic groups had lobbied for the UK to remain in the EU, Martin says that “the good news for them is that the people at the top of the Vote Leave campaign share their instincts on science”. This includes being open to skilled people from outside the UK and understanding the importance of continued funding, he says.

Researchers fear that if the UK leaves the EU, the country could lose access to the bloc’s research programmes, including the Horizon 2020 programme of research grants. The UK currently hosts more EU-funded holders of grants under the European Research Council than any other member state.

Being outside the EU would not automatically rule out the UK’s involvement in EU research programmes. Horizon 2020, for instance, has association agreements with 15 other countries, which gives them equal rights to participation as EU member states in return for a negotiated financial contribution. But associate membership may not be possible for the UK if it moves to restrict the free movement of people.

Swiss scientists, for example, experienced numerous problems when a referendum in that country to restrict the freedom of movement of people from Croatia across its borders led to its researchers being cut out of Horizon 2020 programmes. (A patched-up deal whereby Switzerland’s government is paying for individual Swiss scientists to take part in research programmes is an interim measure that currently holds only until February 2017.)

Before the vote, a report from Digital Science (a consultancy in London operated by the Holtzbrinck Publishing Group, which also has a share in Nature’s publisher), estimated that the UK could lose £1 billion (US$1.4 billion) in science funding each year if the government did not make up the shortfall in EU-linked research funds.

Researchers have already begun to call for the UK to maintain science funding and to welcome researchers from abroad. “Any failure to maintain the free exchange of people and ideas between the UK and the international community including Europe could seriously harm UK science,” said the head of the Royal Society in London, Venkatraman Ramakrishnan, a Nobel-prizewinning structural biologist.

And Julia Goodfellow, president of the umbrella group Universities UK, which had campaigned against a leave vote, said that her group’s “first priority” would be to try to convince the government that EU staff and students should be allowed to continue studying in the country.

Brexit “creates opportunities for science”, says Martin — such as possible increases in science funding, repealing EU rules that some say hamper research, and the possibility that controlling unskilled migration could in turn mean more scope for increased migration of skilled workers, such as scientists. “Now what it’s about is scientists lobbying to get these changes,” he adds.

In a tweet this morning, science minister Jo Johnson, a supporter of the UK remaining in the EU and the brother of the prominent ‘leave’ campaigner Boris Johnson, simply said: “Big decision. Let’s make it work.”

Nature doi:10.1038/nature.2016.20153

http://www.nature.com/news/index.html Nature

http://www.nature.com/news/researchers-reeling-as-uk-votes-to-leave-eu-1.20153  Original web page at Nature

In today’s Science, the Global Alliance for Genomics and Health (GA4GH) calls for a federated data ecosystem for sharing genomic and clinical data. The authorship, which includes Richard Durbin, Julia Wilson, Stephen Keenan, and David Lloyd of the Wellcome Trust, as well as a diverse team of international leaders in academia, research, medicine, and industry, argues that a common framework of principles, protocols, and interoperable technical systems are necessary to enable responsible and effective data sharing.

GA4GH was established in 2013 to bring the community together to build the tools and establish the standards necessary to achieve that goal. Today, it counts more than 400 organizations and more than 700 individuals in its membership, which spans more than 70 countries. “These stakeholders are working together across traditional boundaries to create the common framework that will allow us to make best use of the millions of genome sequences that currently sit in siloed databases around the globe,” says Peter Goodhand, GA4GH Executive Director and a member of the author group.

“We are at a critical time for genomic data interpretation,” said Richard Durbin of the Wellcome Trust Sanger Institute in the UK, and co-chair of the GA4GH Data Working Group. “We know from the international research that led human genome sequencing that the key to understanding individual genetic differences is to compare them to data from other people. But the scaling up of genomics for clinical use is being carried out by organisations that do not necessarily have the traditions or mechanisms in place to carry out the necessary sharing. We must establish trusted systems to enable safe mutual clinical benefit via effective data exchange.”

To date, GA4GH has created a toolkit of diverse products, including the Genomics API, which allows disparate technology services to exchange genotypic and phenotypic data, as well as the Framework for Responsible Sharing of Genomic and Health Related Data, which outlines the basic principles and core elements for responsible data sharing. GA4GH has also catalyzed the development of three data sharing projects which aim to illustrate the value of sharing data in real world contexts. These consist of (i) an open-ended approach to sharing data across the Internet (the Beacon Project), (ii) an international collaboration among breast cancer genetics experts (the BRCA Challenge), and (iii) a peer-to-peer network of clinicians (Matchmaker Exchange).

In addition to outlining successes, the paper notes a variety of remaining challenges to sharing data across national and institutional boundaries. For example, the membership is currently working on solutions to secure data access while maximizing the scope of information that can be shared, to create tools that are flexible enough to be readily implemented in different knowledge domains, and to establish sustainable funding models that support data curation, hosting, and computation.

“Private funders and national governments will need to be involved on some level to support these activities so that clinicians and scientists may access as much free, curated data as possible,” says Mike Stratton, Director of the Wellcome Trust Sanger Institute, CEO of the Wellcome Genome Campus, and a member of the GA4GH Strategic Advisory Board. “The Sanger Institute has supported the Global Alliance since its inception as we are committed to helping researchers and clinicians access and freely share the genomic and related health data they need to transform human health.”

https://www.sciencedaily.com/  Science Daily

https://www.sciencedaily.com/releases/2016/06/160609151209.htm Original web page at Science Daily

There is no shortage of optimism about the scientific potential of CRISPR–Cas9, a technique that can precisely alter the genomes of everything from wheat to elephants. But there is a great deal of confusion over who will benefit financially from its use.

On 10 March, the US Patent and Trademark Office (USPTO) will begin an investigation into who deserves the patent on using CRISPR–Cas9 to edit genes. This ‘patent interference’ could determine who profits from CRISPR in coming years.

Already, companies have sprung up to take advantage of the technique in agriculture, industrial biotechnology and the treatment of human diseases. One firm, Editas Medicine in Cambridge, Massachusetts, raised US$94 million when it went public on 2 February, even though it does not expect to enter clinical trials until 2017.

Nature takes a look at what the interference proceeding entails and what it could mean for the fate of CRISPR–Cas9.

One patent claim comes from a team led by molecular biologist Jennifer Doudna at the University of California, Berkeley, and microbiologist Emmanuelle Charpentier, now at Umeå University in Sweden and the Max Planck Institute for Infection Biology in Berlin. They published a 2012 paper demonstrating that the Cas9 enzyme can be directed to cut specific sites in isolated DNA (M. Jinek et al. Science 337, 816–821; 2012), and initiated their patent application on 25 May 2012.

Another team, led by Feng Zhang at the Broad Institute of MIT and Harvard in Cambridge, Massachusetts, published a 2013 paper demonstrating the application of CRISPR–Cas9 in mammalian cells (L. Cong et al. Science 339, 819–823; 2013). Zhang’s team began a patent application on 12 December 2012.

Although the Berkeley team filed first, the Broad team submitted its application to an expedited review programme, and was awarded the patent in April 2014. The Berkeley team then requested a patent interference against the initial Broad patent plus 11 related Broad patents. On 11 January, the USPTO granted Berkeley’s request.

A relic from the past. Until a few years ago, the United States awarded patents to those who could show that they were the first to invent, rather than simply the first to file the patent. Under that system, when competing inventors claimed to have created the same invention first, the USPTO declared an interference proceeding to determine which deserved the patent.

The United States switched to a first-to-file system in March 2013. But several key CRISPR–Cas9 patents were filed before the change.

A panel of three USPTO patent judges will hear evidence from both sides to establish which team invented the application of CRISPR–Cas9 for gene editing. Much of the action will be carried out over the telephone or through written documents. But there will probably be some oral arguments, and these could include testimony from the academic inventors.

Patent interferences can be highly technical, says John Conley, a legal scholar at the University of North Carolina in Chapel Hill. “It’s hard for me to cite anything more convoluted in the law than this,” he says. “It’s mind-boggling.” The USPTO panel will probably try to determine not only which team was the first to use CRISPR–Cas9 for gene editing, but which conceived of the invention first.

The process could be messy. During the era of ‘first-to-invent’ patents, some companies kept ‘inventor’s notebooks’: when someone at the firm thought of a new invention, they were to write it down in the notebook and have the entry notarized in case it came into play during future patent disputes. Few academic labs go to such lengths.

The law that did away with the United States’ first-to-file policy also introduced changes intended to expedite interferences. But a verdict on the CRISPR patents could still be months, or even years, away. And given the high financial stakes, many expect the losing party to appeal against the USPTO interference decision, further dragging out the process.

Not necessarily. In its filings to the Securities and Exchange Commission, Editas Medicine highlighted a potential interference claim by a Seoul company called ToolGen. Having multiple interferences over the same patent is rare, says Conley, but possible.

The Broad and MIT team also fast-tracked several of its applications at the European Patent Office (EPO), and has been awarded several patents so far. Doudna’s single application is pending.

Although the EPO does not have an interference process, outside parties can formally object to a patent. By 11 November 2015, the deadline for objections to the Broad’s first European CRISPR–Cas9 patent, nine parties had come forward — launching an opposition procedure that can take years to resolve.

Once that process is finished, participants can appeal. This adds another four or five years to the clock, says Michael Roberts, a partner at the intellectual-property law firm Reddie & Grose in Cambridge, UK. For this reason, Roberts believes that it will be several years before there is clarity on the earliest CRISPR–Cas9 patents in Europe.

Nature 531, 149 (10 March 2016) doi:10.1038/531149a

http://www.nature.com/news/index.html  Nature

http://www.nature.com/news/how-the-us-crispr-patent-probe-will-play-out-1.19519  Original web page at Nature

The World Organisation for Animal Health (OIE) has evaluated the quality of national animal health systems, including Veterinary Services, in more than 130 countries.

More than 110 of the countries evaluated – mainly developing and emerging countries – do not yet have relevant legislation concerning appropriate conditions for the importation, manufacture, distribution and use of veterinary products, including antimicrobials. In some cases, legislation is totally non-existent. Where it does exist it is very often not properly applied because of lack of public funds for the implementation of controls.

In such countries, antimicrobials are usually freely available to anyone, directly or indirectly, without restriction. Worse still, they circulate as normal goods and are often adulterated (dosage less than that mentioned on the packaging, different molecule or complete placebo). Thousands of tonnes of adulterated antimicrobials destined for use in animals are circulating worldwide (and the same is true of antimicrobials for human use).

Unfortunately, the use of antimicrobials in animals by untrained personnel is not confined to developing and emerging countries. In a significant number of Member Countries of the Organisation for Economic Co-operation and Development (OECD), it is easy to acquire antimicrobials, particularly via the internet, and many farmers do so. Some of these countries still allow the use of some antimicrobials on fruit trees to control certain bacterial diseases, as well as the incorporation of some antimicrobials into animal feed as growth promoters or for other non-therapeutic purposes. Political action, for example by the G8 countries or the World Trade Organization, could hope to persuade countries in this category to change these practices, estimated by many credible scientists as risky.

In the area of preventing antimicrobial resistance in animals (and its potential benefits for public health), although some countries and regions are already very cautious, the adoption of effective provisions by the rest of the world is likely to be long, difficult and controversial, not to say illusory.

Unfortunately, globalisation of the food trade, coupled with traditional and medical tourism, enable (and will continue to enable) existing or future resistant bacteria to colonise the entire planet with ease, regardless of any preventive measures implemented locally.

How can we face this important challenge?

The OIE trains national Focal Points appointed by its Member Countries and forms networks to enable them to develop and modernise legislation on the production, importation, distribution and use of veterinary products, as well as to carry out such tasks as monitoring the consumption of antimicrobials, because very little is yet known about actual volumes used in the 180 Member Countries involved in the OIE veterinary legislation support programme.

OIE Member Countries adopt international standards on the prudent use of antimicrobial agents and on the harmonisation of the risk assessments that they undertake to implement. International cooperation in the form of development aid is crucial to helping developing countries, and even emerging countries, to apply these standards, especially since, in the short term, animal production is expected to grow by more than 50% owing to increasing use of intensive production systems in these countries.

The OIE also recommends policies to introduce minimum geographical coverage by veterinarians so as to ensure animal health surveillance, using this network to guarantee the early detection of potential epizootics (including zoonoses such as animal influenza) and a rapid response to contain outbreaks at source. Such a network can also improve the general health of animals by allowing the judicious and proper limited use of antimicrobials. The network’s existence and sustainability is partly dependent on revenues from services provided by veterinarians, many to mainly poor customers in the isolated or deprived areas where they work, which are home to the numerous animals to be monitored. These revenues come mainly from the delivery of products, including antimicrobials, which veterinarians administer directly to the animals. This can raise a potential conflict of interest that needs to be addressed. It is why our organisation provides

Standards and programmes to improve the quality of veterinary education worldwide, including in the fields of microbiology, pharmacology and ethics. A standard on the design and functioning of national and regional Veterinary Statutory Bodies empowered by the law and by State delegation of the necessary powers to oversee qualifications, ethical standards and professional excellence, as well as to expel anyone whose conduct is improper.

While some countries have decoupled prescription from delivery for certain veterinary drugs, including antimicrobials, this may pose logistical problems of responsiveness to diseases, particularly at the farm level, and may facilitate illegal practices (direct and uncontrolled self-supply and intervention of unscrupulous and ignorant individuals, mainly via the internet). The risks associated with these practices may have consequences that are much more serious than any irregularities in drug prescription or delivery by veterinarians, which are much easier to control and prevent. Several countries that have implemented decoupling have seen an increase in the general consumption of antimicrobials (according to those in a position to assess such consumption). It is worth noting that the human consumption of antimicrobials continues to grow despite the fact that decoupling of drug prescription and delivery is widespread in human medicine.

It appears that measures to limit the emergence of resistance in animals, including managing and limiting globally what are deemed to be the riskiest practices, (including the use of antimicrobial agents in plant production), should be made a global priority, including in developed countries.

http://www.oie.int/en  OIE

http://www.oie.int/en/for-the-media/editorials/detail/article/risks-associated-with-the-use-of-antimicrobials-in-animals-worldwide/  Original web page at OIE

An organization that distributes a large slice of the national science budget to English universities each year will face the axe, if a UK government proposal gains political support.

In a consultation document which may presage a wider shake-up to the way science is funded in the UK, the government suggests scrapping the Higher Education Funding Council for England (HEFCE), which doles out around £1.6 billion ($2.4 billion) for research annually to universities.

The document, published by the department for Business, Innovation, and Skills (BIS) on 6 November, makes it clear that other organizations would take up HEFCE’s responsibilities, although exactly how remains an open question.

Even if the idea never comes to pass, it suggests the government is not shy of suggesting radical changes to the British science funding landscape.

That is likely to heighten the concerns of UK scientists who are already braced for a government-wide spending review, scheduled for 25 November, which it is feared may lead to cuts to the science budget.

And the proposal comes as researchers await the results of a separate review into the future of the seven UK agencies who distribute the rest of the nation’s science budget: the research councils.

The UK science budget is distributed in two ways. HEFCE hands out a grant to universities each year for both research and teaching (allocated on the basis of an audit of university research quality), while the research councils invite researchers to compete for grants.

The consultation document emphasizes that if HEFCE were scrapped, this would not mean an end to this ‘dual support’ system. But it suggests that a single body might in future encompass the functions of both HEFCE and the research councils, with assurances that the two types of funding remain separate.

It is unclear how that would affect the status of the research councils, which are currently independent entities but might not be if they fell under a new umbrella body. Asked whether such a move might constitute a merger of the research councils, a spokeswoman for BIS told Nature that the design of the future research system remains “all up for consultation”. Impact of UK research revealed in 7,000 case studies.

Moving HEFCE’s research functions into the research councils “sounds like a stupid idea to me,” says Kieron Flanagan, a science-policy researcher at Manchester Business School. “If you’ve accepted the principle that we maintain the dual support system, it doesn’t make sense to put both aspects of that in the same hands”.

Ultimately, the BIS document says, any decision would be guided by responses to the consultation – which can be received until January 2016 – and by the results of the review into the research councils, which is being led by Nobel-prizewinning geneticist Paul Nurse, the president of London’s Royal Society. Given HEFCE’s legal status, scrapping it would also require the approval of Parliament.

In the light of Nurse’s review, and a perceived drive by BIS secretary Sajid Javid to reduce the numbers of the department’s partner agencies, researchers had already been speculating before today’s consultation document whether the research councils might be merged.

But Flanagan also thinks that merging the research councils to create a giant agency would be a mistake. The agencies already share some back-office functions, and any further merging would bring marginal gains but sizeable risks, he adds. “I don’t think there’s any example of a large, successful research system that has a single, science funding body.

These are not the only ideas explored in the BIS proposal. Another option is to create a new body to replace the research-related functions of HEFCE (whose teaching-related and regulatory responsibilities would be taken up by a different organisation, the Office for Students). Flanagan and others wonder whether BIS might itself hand out research money, although this is not an option flagged in the consultation document.

The proposal is clear that scrapping HEFCE would not mean scrapping the UK’s university research audit, known as the Research Excellence Framework. However, in the future the government will look to reduce the burden of the audit, potentially by making greater use of metrics, it says. A future audit might also try to limit costs by discouraging the “industries” which it says some institutions create around the exercise, such as carrying out multiple mock assessments and bringing in external consultants.

More widely, the BIS consultation is designed to refocus the UK university system on teaching. The Office for Students would, for example, take responsibility of a new Teaching Excellence Framework, which will judge university’s teaching performance against measures such as student satisfaction and graduate job prospects. In the future, universities’ ability to increase the tuition fees they charge in line with inflation will be tied to “high quality teaching”, the document adds.

Nature doi:10.1038/nature.2015.18743

http://www.nature.com/news/index.html  Nature

http://www.nature.com/news/uk-government-proposes-scrapping-major-universities-funder-1.18743   Original web page at Nature

Scientists hope new rules could spur stem cell research in China. Chinese stem-cell scientists have welcomed long-awaited measures that, state media claim, will rein in rogue use of stem cells in clinics while allowing research.

The measures — announced on 21 August by China’s National Health and Family Planning Commission through state media — offer a straightforward path towards clinical studies, researchers told Nature. But some also warn that the measures do not have the teeth needed to stop clinics offering unproven and unapproved treatments.

For years, clinics around China have been ignoring government regulations and warnings from the scientific community, offering desperate patients costly and, according to experts, probably ineffective treatments. These were often labelled as clinical trials as a cover to charge patients. Other countries have experienced similar problems.

In January 2012, the government took stock of the situation. It implemented a ban on unapproved stem-cell therapies and a temporary moratorium on new clinical trials, promising to establish a clear framework for future trials. Since then, however, many rogue stem-cell clinics have continued to operate, while stem-cell scientists with valid research agendas have waited for a way to move forward

Qi Zhou, a stem-cell and cloning scientist at the Chinese Academy of Sciences (CAS) Institute of Zoology in Beijing, has been waiting for the guidelines so he can move his research from animal models to humans. In unpublished work, his team has already implanted dopamine-producing neurons derived from stem cells into monkeys that have been chemically induced to show symptoms similar to those of Parkinson’s disease. The monkeys have shown some improvement, and he now hopes to try the treatment on humans. “I think it’s time, time to start doing some clinical research,” he says

Jianwu Dai, a regenerative-medicine specialist at the CAS Institute of Genetics and Developmental Biology in Beijing, hopes to implant a small collagen scaffold seeded with stem cells into humans to try to repair spinal-cord injuries. His team has treated some 25 people using the scaffold seeded with mononuclear cells, a type of blood cell taken from bone marrow, and Dai says he has seen some improvements. But he thinks that neural stem cells derived from embryonic stem cells will deliver better results

The new measures outline requirements for such studies, including obtaining patients’ informed consent and using clinical-grade stem cells that have been approved by an independent body. They say that stem-cell clinical studies can be carried out only at authorized hospitals, and they forbid the hospitals from charging recipients or advertising. Researchers who want to do pilot studies, such as Zhou and Dai, will need to register with the health ministry with documentation showing that there are sufficient animal studies to support trials in humans and that they are using certified cell lines verified by independent evaluation

The penalties for breaking the rules are not yet clear, although a senior health-ministry official has pledged to use them to clean up the stem-cell field in China

Zhou does worry that rogue clinics will continue to offer completely untested treatments. “Some hospitals, some companies won’t care. They do what they want,” he says.

Douglas Sipp, who researches stem-cell policy at the RIKEN Center for Developmental Biology in Kobe, Japan, says that the mechanism laid out for clinical studies looks pretty similar to those in other countries, and more rigorous than some. But he worries that the measures might not apply to military hospitals, or to private clinics affiliated with military hospitals, which have in the past fallen outside health-ministry jurisdiction in China.

“In principle, I applaud any efforts to rein in practice of predatory clinics that take advantage of patients. But the fact that these new rules do not appear to have penalties leaves open the question of how effective they will be,” says Sipp. “I have seen China crack down on stem-cell clinics at least twice in the past, and the results were inconclusive.”

Nature doi:10.1038/nature.2015.18252

http://www.nature.com/news/index.html  Natur

http://www.nature.com/news/china-announces-stem-cell-rules-1.18252  Original web page at Nature

While transparency, openness and reproducibility are readily recognized as vital features of science and embraced by scientists as a norm and value in their work, a growing body of evidence suggests that those qualities are not necessarily evident today. Scientists have now announced guidelines to further strengthen transparency and reproducibility practices in science research reporting.

An international group of academic leaders, journal editors and funding-agency representatives and disciplinary leaders, including Rick Wilson, the Herbert S. Autrey Chair of Political Science and professor of statistics and psychology at Rice University, has announced guidelines to further strengthen transparency and reproducibility practices in science research reporting. The group, the Transparency and Openness Promotion (TOP) Committee at the Center for Open Science in Charlottesville, Va., outlined its new guidelines in a story published in this week’s edition of the journal Science.

While transparency, openness and reproducibility are readily recognized as vital features of science and embraced by scientists as a norm and value in their work, a growing body of evidence suggests that those qualities are not necessarily evident today.

“A likely culprit for this disconnect is an academic reward system that insufficiently incentivizes open practices,” Wilson said. “In the present reward system, the emphasis on innovation undermines practices that support openness. Too often, publication requirements — whether actual or perceived — fail to encourage transparent, open and reproducible science.”

TOP’s objective is to translate scientific norms and values into concrete actions and change the current incentive structures to drive researchers’ behavior toward more openness. “We know the disciplines differ in what is emphasized, so we sought to produce guidelines that focus on what is shared across disciplines,” Wilson said.

Each of eight standards has three levels of adoption in the TOP guidelines; each moves scientific communication toward greater openness, according to the article in Science. These standards are modular, facilitating adoption in whole or in part. However, they also complement each other; commitment to one standard may facilitate adoption of others.

The standards include citation standards for journals, data transparency, analytic methods (code) transparency, research materials transparency, design and analysis transparency, preregistration of studies, preregistration of analysis plans and replication.

Two standards reward researchers for the time and effort they have spent engaging in open practices. Citation standards extend current article citation norms to data, code and research materials. Regular and rigorous citation of these materials credits them as original intellectual contributions. Replication standards recognize the value of replication for independent verification of research results and identify the conditions under which replication studies will be published in the journal.

Four of the standards describe what openness means across the scientific process so that research can be reproduced and evaluated. Reproducibility increases confidence in findings and also allows scholars to learn more about what results mean. Design standards increase transparency about the research process and reduce vague or incomplete reporting of the methodology. Standards for research materials encourage the provision of all elements of that methodology, and data-sharing standards give authors an incentive to make data available in trusted repositories.

The final two standards address the values resulting from preregistration. Standards for preregistration of studies facilitate the discovery of research, even unpublished research, by ensuring that the existence of the study is recorded in a public registry. Preregistrations of analysis plans certify the distinction between confirmatory and exploratory research, or what is also called hypothesis-testing versus hypothesis-generating research. Making the distinction between confirmatory and exploratory methods transparent can enhance reproducibility.

“The guidelines are sensitive to concerns by both journals and researchers,” Wilson said. “For example, we encourage journals to state exceptions to sharing because of ethical issues, intellectual property concerns or availability of necessary resources. We encourage journals to pick and choose among the different levels and standards in order to define what they expect of the researchers.

“We acknowledge the variation in evolving norms about research transparency. Depending on the discipline or publishing format, some of the standards may not be relevant for a journal. Journal and publisher decisions can be based on many factors — including their readiness to adopt modest to stronger transparency standards for authors, internal journal operations and disciplinary norms and expectations,” Wilson said.

The present version of the guidelines is not the last word on standards for openness in science, according to the report. “As with any research enterprise, the available empirical evidence will expand with application and use of these guidelines,” the TOP Committee wrote. “To reflect this evolutionary process, the guidelines are accompanied by a version number and will be improved as experience with them accumulates.”

http://www.sciencedaily.com/  Science Daily

http://www.sciencedaily.com/releases/2015/06/150625161429.htm  Original web page at Science Daily