Research Administrators have many roles, from providing compliance oversight of research projects before they even begin, to management of projects to ensure they stay on course, both to timetable and budget.
Infonetica is proud to support the essential work of Research Administrators throughout the world, from research-intensive universities, to hospitals and Governmental bodies. We are the market leaders in ethics review management systems. We used the expertise we developed building the system used by the NHS to create a more sophisticated and advanced ethics review system. Ethics Review Manager (Ethics RM) is the powerhouse behind some of the most sophisticated automated ethics review systems in use today, including –
In addition to ethics review, we support research Administrators through ReDA – our fully functional clinical trial management tool. ReDA provides oversight and control for even the most complex multi-site studies from inception to completion. ReDA is incredibly simple to configure to the needs of the project and can be up and running in a matter of hours.
ReDA is currently being used for all NHS portfolio studies in Scotland and Wales – read more about how NHS Research Scotland uses ReDA [here].
All of our products are supported by our Service & Support Desk teams, both in the UK and Australia. Our team of product specialists provide system support for research administrators, allowing them more time to focus on BAU tasks. Our on-boarding process is second to none, with useful train-the-trainer sessions right through to a premium set up where we do all the hard work for you.
I could firmly believe that squirrels are made of jam – however, I do not have the automatic right to be given a global platform on which to broadcast my views. Free speech is great, but not always what its cracked up to be.
As concerns about links between Covid-19 and 5G illustrate, if I were to have a sufficiently large platform, I could convince some of the population of literally anything.
Recent stories in the UK mainstream media suggest that as many as one-third of people in the UK would refuse a coronavirus vaccine. Looking in more detail reveals that 6% would “definitely not” get vaccinated, whereas a further 10% would “probably not.” Not all refusers will be doing so because they think coronavirus a hoax, but it is a surprisingly common belief.
Some people cannot be vaccinated and so, unless they resort to long term isolation, they rely on the rest of the population’s immunity to protect them. Here is a nice article about how herd immunity works.
However, to result in effective herd immunity, a disease like polio requires 80-85% of the population to possess acquired immunity (from past infection or vaccination). Once you look at more infectious diseases like measles, the figure rises to 90-95%.
At the moment, we’re still not sure if coronavirus infection does produce lasting immunity, so those 16% who would be unlikely to be vaccinated start to look really worrying.
There have been some really promising results in vaccine trials already, especially in the UK and US. Over 20 are in clinical trials with a further 140 in earlier development. If you are interested in clinical trials, check out our training [here].
Back in January 2014, I wrote a blog post on Infonetica’s sister website www.whitehalltraining.com about vaginal mesh implants and how they highlight potential weaknesses in medical device testing – you can read it [here]
Now more than 700 women and their families have shared with an enquiry their harrowing experiences with vaginal mesh, pregnancy test Primodos and epilepsy drug sodium valproate.
The chair of the review is Baroness Julia Cumberlege who was reportedly shocked by the “sheer scale” and “intensity of suffering.”
The review looked at –
Having recently presented a webinar on pharmacovigilance, I find these especially shocking. The whole process of tracking and reporting on adverse drug reactions was largely prompted by failures over the use of thalidomide in pregnant women.
Back in the 1960s, there were no effective mechanisms to capture and react to adverse drug reactions – especially once a drug had been launched on the market.
According to the review, hundreds of babies are being born each year to mothers “unaware” of the risks that sodium valproate can pose in pregnancy.
The review has made several recommendations –
It is hard not to blame institutional misogyny for many of these failings.
I really find it hard to believe that the situation would have been the same had the mesh been used to treat prostate cancer, or the drugs used to reduce blood pressure.
Health minister, Nadine Dorries, is apparently “determined” to make changes needed to protect women in the future.
The rather euphemistic term “dual-use research” has been around for some time. It is the name given to research that could just as easily help or harm humanity – for example think of a revolutionary new chemical manufacturing process that could create chemical weapons or fertilizers.
The cliché is the innocent scientist whose radical invention is perverted by the state and used for evil. For those who miss the reference in the title of this post, check out the following video on YouTube – https://youtu.be/QdhwTXwhA4c
The US military’s Defense Advanced Research Projects Agency (Darpa) has been working on rapid diagnosis of germ or chemical warfare poisoning. It has reportedly developed a blood test that could detect Coronavirus as early as 24 hours after infection. This is well before people show symptoms. It is also several days before a carrier is considered capable of spreading it to other people. And around four days faster than current tests could detect the virus.
According to the head of Darpa’s biological technologies office, Dr Brad Ringeisen, it has the potential to be “absolutely a gamechanger”.
But this still leaves the ethical debate about dual-use research. The US National Science Advisory Board for Biosecurity provides advice on regulating “dual-use research of concern.” This is considered to be any life sciences research that could be misapplied to pose a threat to public health and safety, agricultural crops and other plants, animals, the environment or material.
The challenging ethical question is finding an acceptable trade-off between the benefits created by legitimate uses of dual-use research and the potential harms of misuse.
If you are interested in the ethical debate about dual-use science, the following article is a good read – “Defining dual-use research: When scientific advances can both help and hurt humanity.”
Professor Adrian Hill leads the Oxford team who were one of the front runners in the race to develop a successful vaccine. His team’s vaccine, ChAdOx1 nCoV-19, looks extremely promising. Prof Hill said a few month’s back that he felt there was an 80% chance it could form the basis of an effective vaccine by September.
So why is he now saying that there is only a 50% chance of having any result at all?
The reason is that it’s becoming increasingly hard to recruit the 10,000 adults and children the study needs. As he told the Daily Telegraph –
“it’s not a race against the other guys. It’s a race against the virus disappearing, and against time.”
Hill’s team is working with AstraZeneca to develop the vaccine, and the UK government has already signed up for up to 100 million doses.
Just last month, AstraZeneca were hoping for answers on vaccine efficacy in June or July. It now seems the process could take far longer, unless transmission rates stay high.
Falling transmission rates may seem like a good thing, but those who fall into the category of extremely vulnerable, really need a viable alternative to solitary confinement.
One way out of the mire is to intentionally infect healthy volunteers with a weakened version of Covid-19. These so-called “human challenge studies” (HCS) are somewhat controversial – especially as some of the participants would, by design, receive a placebo followed by the virus.
This does seem to be somewhat stretching the 3rd principle of GCP – that the rights, safety and wellbeing of the trial subject is more important than the interests of science or society.
In April, the US FDA was sent a letter from 35 US Representatives urging it to take nothing off the table in searching for a Covid-19 treatment – including HCS. They see no inherent ethical problem in HCS, believing the benefits outweigh the risks.
The US vaccine expert, Stanley Plotkin, and New York University bioethicist, Arthur Caplan, argue for HCS in upcoming article for the journal, Vaccine. They argue that if the normal process is followed it –
“…normally takes months to years, during which SARS-2 will infect and possibly kill millions.”
They see human challenge trials as a way of speeding things up.
Infonetica provides online medical research training, so we’ve had our share of conversations with companies whose research programmes have been massively disrupted. However, you can’t just pause some trials without serious consequences.
A recent article in the journal, Science, highlighted the case of US HIV prevention trials that are still going on albeit with some creative measures.
“…study teams have bought and shipped protective equipment to personnel at clinical trial sites, secured special permits where necessary for trial participants to leave their homes for medical visits, and arranged their private transportation to avoid public buses.”Clinical trials press on for conditions other than COVID-19. Will the pandemic’s effects sneak into their data? Science, 6th May 2020
It went on to suggest that the effect of the pandemic on mental health should be factored into the equation too.
The primary aim of GCP is to protect patients and to do what is in their best interests. Clearly just stopping treatments isn’t in most patient’s best interests.
In the UK, patients receiving treatment for auto-immune conditions are automatically considered high risk and advised to “shield” – effectively being advised to go into isolation apart from medical intervention. But there are inconsistencies even in this approach – for example, patients with untreatable auto-immune conditions, are not currently being told to shield.
The key problem, as I see it, is that all good science involves controlling a limited number of variables so you can measure the effect of change. However, this assumes that the other variables remain fixed. During the pandemic, the situation is so massively divorced from “normal” that there is a real risk of findings being un-reproducible in a post-Covid world.
I’ve already mentioned the effect of the pandemic on mental health, but what about the reduced likelihood of being exposed to pathogens (important in the HIV trial), changes to diet, changes to exercise levels etc?
The list goes on…
On the one hand we have US President Donald Trump – who applies the quick-fix logic of a businessman surrounded by staff to handle details. Sometimes suggesting weird, off the wall things can be just what’s needed to boost innovation. As long as people don’t then take matters into their own hands and try swallowing bleach because they think the President suggested it!
On the other hand, we have the tried and tested approach of Good Clinical Practice and rigorous double-blinded trials. These are the bedrock of medical research and represent the safest way forward. However, double blinds become problematic where there is no “standard” treatment to compare with a test drug.
Doctors at the sharp end of pandemics like Covid-19 are faced with a stark choice – try something they think might work or carry on trying to support the patient until the recover. Some of the earliest Covid-19 patients in China, were given the anti-retroviral drug, lopinavir–pitonavir, and the rheumatoid arthritis drug, Actemra (tocilizumab).
The important point here, is that the drugs were controlled and the patients observed. There are no placebos in the true sense – the control group were given ventilation and other support but not specific control drugs.
This approach has been followed in other pandemics, and The WHO’s Covid-19 trials are not double-blind because they argued that they needed to balance rigor with speed.
We all know the story of the tortoise and the hare. Rushing full tilt into drug testing can actually delay things according to Rebecca Li, executive director of the Multi-regional Clinical Trial Center at Harvard University.
She points out that the vast majority of experimental drugs do not succeed. Without properly reviewed and planned trials, researchers risk going down rabbit holes and wasting valuable research effort. It is hard not to get carried along by the overriding sense of urgency that is gripping the healthcare sector, but this does not mean ethics should go out of the window.
Sure, rely on the most efficient ethical review tools at your disposal to reduce wasted time but don’t throw the baby out with the bathwater. If you can find ways to speed up peer view processes for example – use them!
Like everyone, we at Infonetica want to help assist in the current Covid-19 crisis. Tissue Auditor is already being used to help UK Covid-19 testing so we are making it more widely available.
Our tissue tracking software, Tissue Auditor is being used by two major testing sites in the UK to manage samples and we have decided to make it available for ANY organisation working on Covid-19 testing or research free of charge.
Our system offers these benefits –
• web-based – no time-consuming installation and can be used on virtually any device.
• single sign on – so staff can use their existing login credentials.
• works with RFID tags, or 1D/2D barcodes
• full audit history from sample creation to destruction.
• keeps all documents in one place for easy cross-referencing.
If your organisation might benefit from Tissue Auditor or if you could pass this message on to any of your contacts who may – that would be great.
Email: email@example.com for more information.
However, the anti-vaccination movement has been growing in recent years. The World Health Organization (WHO) now list it as one of the top 10 potential threats to global health in 2019.
The dangerous implications of this growing vaccine hesitancy can be clearly seen in the Philippines. Earlier this year an outbreak of the highly contagious measles virus infected over 8,000 people. More than 130 of these died, and sadly many of them were children.
This measles outbreak arose in response to complications related to a dengue vaccination, Dengvaxia. Developed by a French drugs manufacturer, the vaccine reportedly offered protection against the potentially fatal mosquito-borne disease, Dengue Fever. In an attempt to mitigate the disease, Philippine authorities provided over 800,000 children with the vaccination in 2016. However, a year later it was revealed that this vaccination could potentially worsen the deadly disease in those who had not previously been exposed to the virus. This side effect unfortunately resulted in 14 deaths.
The immense effect that this scare has had on the country is highlighted by the rapidly decreasing immunisation rate, falling from 75% in 2016 to just 60% in 2017. This decrease makes potentially fatal outbreaks of otherwise preventable diseases ever more likely.
Unfortunately the Philippines is not the only country to experience the negative implications of the anti-vaccination movement first hand. It was recently reported that there has been a measles outbreak in Hackney, London. As a result local parents are being urged to keep their children’s vaccinations up to date.
The increasing frequency of these outbreaks across the world highlights the negative impact that vaccine hesitancy is having on a global scale. Unfortunately more and more lives will be put at risk if the anti-vaccination movement continues to grow at its current rate.
This article is the first in a two part series on the anti-vaccination movement. To read the second installment please click here.
If you are interested in learning more about protecting yourself in the event of an outbreak, then take a look at our infection prevention and control course.
If you are interested in learning more about protecting yourself in the event of an outbreak, then take a look at our infection prevention and control course.
The annual flu season is upon us and many of us get vaccinated against prevalent strains of influenza, identified from the southern hemisphere’s winter. Flu is caused by a virus that has the ability to mutate quickly, regularly leading to new strains and the possibility of outbreaks each year.
What flu researchers are hoping for is a vaccination that could combat all strains of the virus, to reduce, or even eliminate, the need for yearly vaccinations. Up until now, such a solution has proved elusive, but recent research published in Science suggests the answer could lie with llamas!
Whilst humans produce large antibodies that attack flu antigens directly, llamas produce much smaller antibodies that target harder to reach areas of the virus. Areas that don’t mutate regularly. Researchers at the Scripps Institute in California examined the numerous antibodies present in llama blood, finding four that could potentially fight flu in humans. These four antibodies were effective on all but one of the sixty variations of flu they were tested on.
Yet what’s especially interesting about the research, is its possible application. The research suggests that an effective delivery method could use gene therapy. This would be particularly beneficial for the elderly, as traditional vaccinations become less effective as the efficiency of the immune system declines. The use of gene therapy could mean targeted cells can immediately produce the desired antibodies of their own accord.
Whilst the initial results are encouraging, the study is still ongoing. If upcoming human trials are successful, then the goal of producing a vaccine that would be effective for multiple seasons, might not be so far off. But as research continues, the question remains are we doing enough to protect the most vulnerable in society, from what can be a deadly illness.
To learn more, take a look at our Infection Prevention and Control course!