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.
It wouldn’t be the first time – remember, the “five a day” rule designed to encourage us to eat more fruit and vegetables? Well, the “five” was not chosen for scientific reasons. It was picked, because the government considered it a simple and achievable target for the UK public (Australia went for a “Go for 2 & 5” rule, maybe they’re better at maths that the British).
If an infection is airborne, increasing separation clearly reduces risks. However, nothing is quite so simple.
US Centers for Disease Control and Prevention have advised that flu can spread up to 6 feet (1.8 meters). This seems in line with UK recommendations and yet the US stance is the rather vague “put distance between yourself and other people.”
The World health Organisation recommends keeping a distance of at least 1 m.
Was 2 meters picked in the UK because it was felt that people here would be less likely to wear face masks? Again, Australians were given different guidance – they plumped for 1.5 meters (maybe Australians are better at measuring as well as maths).
This is the tricky balancing act that governments need to carry out. As social and economic factors come into play, the purely medical advice may not necessarily be the best way to go.
However, recent reports have shown that the general level of trust in the population is at an all-time low. Trust in everything from newspapers and broadcast news to friends and neighbours. Perhaps as a side-effect of isolation, views are polarising and we’re getting better at shutting out facts that don’t reinforce our beliefs.
If the ongoing review of the two-meter rule does result in a reduction of the “safe” distance, will the public follow it? Will they suspect it is being done for the right reasons?
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.
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!
Italy recently introduced a new law following a 10 fold increase in the number of children contracting measles in April 2017, compared to the previous year. Known as the Lorenzin law, children must now receive 10 mandatory vaccines covering various diseases before attending school. Children aged 6 and under will be excluded from nursery and kindergarten without proof of vaccination. Older children won’t be banned from school but their parents risk receiving a €500 fine if they send their children to school without the appropriate vaccinations.
This controversial law comes in a bid to raise the country’s plummeting vaccination rates from below 80% to the World Health Organization’s target of 95%. This latter figure represents the percentage of people that need to be vaccinated in order to protect the population as a whole and prevent outbreaks of contagious diseases. A vaccination rate of 95% should provide “herd immunity”. This term is based on the belief that if enough people in a population are vaccinated, the remaining minority will in turn be protected.
Being too young, having a weakened immune system or being allergic to ingredients contained in a vaccination are all reasons why certain members of a population may be unable to receive vaccinations. It is these people who rely on herd immunity to avoid otherwise preventable infectious diseases. However, are these grounds substantial enough to impose mandatory vaccinations on the rest of the population?
An increasing number of parents would argue that they are not. These members of the growing anti-vaccination movement are reluctant to have their children vaccinated for fear that it will result in unwanted, and potentially fatal, side effects. As a result, they often strongly believe that whether their children are vaccinated or not is their decision, and should not be determined by the government.
Furthermore, there are certain members of the population that may wish to withhold from receiving vaccinations for religious reasons. The use of animal-derived gelatine and human fetus tissue pose the largest concerns here. Imposing mandatory vaccinations on these individuals could go against deeply embedded religious beliefs and remove their sense of autonomy.
With all of these various stances in mind, the ethical implications of mandatory vaccinations is certainly open for debate. Whatever your beliefs are, it should be remembered that the decision to get vaccinated or not is one that has consequences for the rest of the population.
This article is the second part of a two part series on the anti-vaccination movement. To read the first instalment please click here.
Here at Infonetica we have been developing systems to manage the ethical review process for over ten years. With the ethics debate widening, our Ethics Review Manager (ERM) software can manage the processing of ethical decisions for a wide range of organisations.
Originally discovered by a researcher from Osaka University in 1987, gene editing could potentially be used to eliminate heritable diseases through deleting or changing certain coding in embryos. However, the technology involved in this editing is still in the experimental stages, and as such is currently banned in most countries. There is a fear that the changes in DNA could be passed on to future generations, with unpredictable side-effects.
It appears as though these fears are about to be put to the test for the first time in history, as a scientist in China has recently claimed to have produced the world’s first genetically-edited babies. This is yet to be verified, however, if confirmed it could have immense ethical and moral implications.
He Jiankui, a professor from The Southern University of Science and Technology in Shenzhen, is claiming to have edited embryos for seven couples during fertility treatment. According to him, one pregnancy has resulted from this so far.
Jiankui revealed that all of the men in his experiment had HIV while all of the women did not. However, the fathers’ infections are deeply suppressed thanks to standard HIV medicines. Simple methods exist to prevent them from infecting their offspring.
The existence of these treatments mean that the scientist’s intervention was not aimed at preventing HIV transmission. Instead, he hoped to provide the offspring with protection against the disease, reducing their chances of contracting it during their lifetime.
This breakthrough intervention has raised many ethical questions.
Experts worry that we won’t know the full consequences of this gene editing until we can study future generations of the offspring concerned. Even if the editing works perfectly, people without normal genes may be at a greater risk of contracting other viruses.
Ethical questions have also been raised regarding consent. With the consent forms referring to the experiment as an Aids Vaccine Development Programme it is likely that the participants were not made fully aware of the potential risks of the study.
What is particularly shocking is the fact that Jiankui’s work remained a secret for so long. He did not register the clinical trial with Chinese authorities until November, long after the study had begun.
As a country that has been at the forefront of gene editing for several years, China has failed to update its regulations at the same pace, to reflect the risk of gene editing. A 2003 ‘ethics guidance’ document bans the use of research embryos for reproduction. However, the punishments for violations of this regulation remain unspecified.
While China have declared He Jiankui’s work a violation of their law, the incident serves to highlight a concerning gap in their ethical review processing.
“First, they are bred specifically for the programme and then 25% of them don’t make the grade – those pups then have to be rehomed. And they are going into a system which is already bursting full of dogs that need to find a new home, so that’s overloading the rehoming problem.”
Ms Webster went on to assert that guide dogs should be phased out, as the animals are unable to consent to work. She appreciated that the blind need to be guided but believes ‘the future of that is technology’.
However, with no technological advancements in the guiding of blind people on the horizon, how ethical is the practice of guide dogs?
The answer is very ethical, at least according to The Guide Dogs for the Blind Association.
This guide dog training charity explain that the training process is fun, as it is centred on reward-based training methods. This method uses praise when dogs successfully complete a task. Dogs always have the choice to take part.
On the rare occasion where a dog appears to not suit the guiding role, they are identified by the trainers who then work to find an appropriate alternative path for them. Commenting on this process, a spokesperson for the charity explained:
“We have a fantastic relationships with the UK’s other assistance dog charities, so we work with them to find jobs for these dogs as other types of assistance dogs for those who need them, or our dogs have also become sniffer dogs for police forces. Where we can’t find an alternative working role for our dogs, we find them loving homes – often with the dog’s puppy walker, or with another of our dog-focused volunteers.”
The charity’s website explains that they work with owners to determine the right time for a guide dog to retire – usually at around the age of 8. They then give the owner the option to keep the retired guide dog and begin training with a replacement guide dog. If this is not appropriate then they can either nominate someone suitable to rehome the retired guide dog, or the dog can be rehomed through the charity’s formal rehoming process.
With almost 5,000 guide dog owners currently residing in the UK, it is clear that the need for guide dogs isn’t going anywhere anytime soon. However, this debate certainly generated some food for thought.