We raise awareness and tackle issues with key decision makers and stakeholders. All position statements will be kept under review.
Animals in research
Like all members of the Association of Medical Research Charities (AMRC), Fight for Sight endorse the 3Rs principle to replace the use of live animals unless absolutely necessary, reduce the number of live animals used in research and refine procedures to make the use of animals in research as humane as possible.
As a member of the AMRC, Fight for Sight supports the use of animals in research if there is no viable alternative. We actively review this position, mindful that new technologies aim to develop alternatives to reduce and eventually replace animal models. Currently, we think the use of animals is a necessary part of the research process to advance our understanding of disease and aid in the development of new treatments for eye conditions.
Fight for Sight’s terms and conditions states that researchers must adopt best practice in the use of animals in research, and as such we support the ARRIVE (Animal Research: Reporting of In Vivo Experiments) guidelines which are intended to improve the reporting of the use of animals in medical research.
Bio-banking is both the storing and making available of biological samples for use in research. This has been the single most important change in recent times to support research into human diseases, including eye conditions.
The UK Bio-bank is a collaboration between the Wellcome Trust, MRC, British Heart Foundation and the Scottish Government. It recruited 500,000 people for biological samples aged 40-69 in 2006-2010. Eye research has been specifically boosted by the collection of 100,000 eye measures (such as retinal photographs) as part of the UK Bio-bank.
Fight for Sight acknowledges that the UK Bio-bank is an important resource for eye researchers to better understand eye conditions. Fight for Sight welcomed the announcement that all 500,000 people in the UK Bio-bank will have their DNA sequenced. This will help provide an even richer data source for researchers to better understand the contribution of genetics, environment and lifestyle in disease development.
Charity Research Support Fund
The Charity Research Support Fund (CRSF) is a block grant to universities. In England, it has been allocated by Research England, under UK Research and Innovation (UKRI), as part of the QR (quality-related) funding it awards to universities since April 2018. Its purpose is to fund the indirect costs of research such as utilities and overheads. This makes the best use of supporter donations as they go to funding the direct costs of medical research. The 3 other national higher education funding bodies each administer a charity support element as part of the QR funding they administer to universities.
Fight for Sight acknowledges that the CRSF is vital to ensure that we can fund innovative sight saving research. The CRSF was increased in 2018 to £204 million. This is the first increase in the CRSF since it was fixed at £198 million in 2010.
Fight for Sight welcomed this increase in the CRSF and we would like to see the CRSF rise year on year in line with inflation.
Clinical trials are research studies involving patients, which compare a new or different type of therapy or intervention against currently available treatments, or look at ways to prevent illnesses e.g. through testing a new vaccine.
New drugs or treatments currently must go through clinical trials to fully understand the risks and benefits of a new approach. Trials aim to test the safety and clinical effectiveness of new therapeutics or interventions for patients. A new treatment is not always better, and trials are therefore very important to find out whether one treatment is safer and more effective than another, or if it is just as good.
Fight for Sight fully acknowledges the vital role of clinical trials in bringing new treatments to patients in our fight against sight loss. We provide some funding for small clinical trials via grant funding schemes to improve the evidence base for therapeutic approaches.
Genome editing describes a group of techniques used to alter the DNA sequences in living cells. DNA from a genome can be precisely replaced or removed using “molecular scissors” at a particular sequence which is then repaired by the cell causing an ‘edit’ to occur. This technique can be used to remove mutations in DNA that can cause disease. Genome editing can improve our understanding of the role of specific genes involved in disease, as well as being used to develop novel therapies.
There are two major technique groupings. The first of these are processes which use engineered nucleases, while the second uses recombinant Adeno-Associated Viruses (rAVV). Most current research focuses on engineered nucleases, with the most promising technique so far being CRISPR-Cas9 developed in 2012.The CRISPR-Cas9 protein works by cutting the DNA of a cell in a specific place. When the cell repairs the damage, a few DNA letters get changed at this spot, an effect that can be exploited to disable genes.
CRISPR-Cas9 has a number of potential risks and benefits. Its primary benefits over other genome editing techniques is that it is a relatively simple and efficient system. It has made genome editing faster, cheaper and more accurate. CRISPR-Cas9 has lots of promise, but it is not without its disadvantages, such as the Cas9 enzyme occasionally cutting the DNA sequence in the wrong place that may lead to problems.
Gene editing of non-reproductive cells is regulated by the Human Tissue Authority (HTA) while the gene editing of reproductive cells is regulated by the Human Fertilisation and Embryology Authority (HFEA). All genome editing related research funded by Fight for Sight abides by the regulations of these authorities.
Fight for Sight supports genome editing research in ophthalmology. Genome editing has the potential to significantly progress our understanding of key disease mechanisms, as well as the development of new therapies for people with sight loss. Fight for Sight has funded genome editing research based on competitive peer review.
Gene therapy is providing a growing focus in the environment of eye research. It is an exciting area of new science with the potential to benefit people living with sight loss. The nature of this research aims to provide treatments to correct or replace gene abnormalities.
Inherited genetic conditions that lead to sight loss, currently have no treatments available, but early indications of gene therapy highlight the potential to halt the progression and possibly improve sight for people with inherited eye diseases. As with other new areas of research, its potential needs to be balanced with adequate safeguards.
Fight for Sight supports the funding of research to increase knowledge and development of gene therapy, as well as expanding the expertise required to deliver such treatments and after-care.
Improving access to treatments for patients with eye conditions
In the UK, before a new intervention is made available for patients, it must first receive a licence from the European Medicines Agency (EMA). In some European countries such as Germany, the intervention is made available to patients immediately, where as in other countries, including the UK, they have an additional process before being made available.
Organisations such as the National Institute for Health and Care Excellence (NICE), NHS England, the All Wales Medicines Strategy Group (AWMSG) and the Scottish Medicines Consortium (SMC) appraise medicines, devices and surgical interventions, which can then be accessed by patients on the NHS.
These are made available by assessing a number of criteria, such as clinical efficacy and cost-effectiveness compared to treatment options that are currently on the market. Treatments that are approved for use must be made available for patients within three months of final approval by NICE. The SMC recommendations are not mandatory.
This process from initial market authorisation to patients having access to these new interventions can take over two years. Additionally, health is a devolved issue within the UK that results in different processes of reimbursement in different home nations. This can lead to inequity of access for treatments for people within the home nations.
At Fight for Sight, we want to ensure that people living with any sight-threatening condition can gain access to treatments and interventions that improve their quality of life based on clinical need, irrespective of where they live within the UK.
We will respond and engage with individual NICE appraisals where there is evidence that it will improve patients’ lives by representing the viewpoint of patients. We will work with clinicians and examine scientific evidence and comment only on the clinical value of an intervention and the benefits that it could bring to patients.
Fight for Sight will look to work with others to influence the improvement of the assessment and reimbursement processes for new interventions in the long term.
Increasing availability of donor eyes for corneal transplant and eye research
Fight for Sight was instrumental in setting up the UK Corneal Transplant Service (now a part of NHS Blood and Transplant) in 1983. Since then, approximately 80,000 corneas have been donated for transplant. The Human Tissue Authority (HTA) regulates and licenses organisations that store human tissue and organs for medical research. Currently in England, Scotland and Northern Ireland, patients that wish for their tissues and organs to be used for transplant or research must actively give their consent for their tissue to be used.
The Human Transplantation (Wales) Act 2013 for the first time in the UK introduced a “deemed consent” or “soft opt-out” (the family may refuse donation) option for organ transplantation. England and Scotland are currently considering a change to their organ donation system to a “soft opt-out” system as well.
In Wales, since the Human Transplantation Act came into effect on 1 December 2015, there has been an initial rise and then a fall in corneal donation. It is perhaps too early to say if the change in the law has had a positive or negative affect on donation rates. However, since the introduction of an opt-out system, the overall donor pool has increased by 179% (1). An increase in the donor pool should theoretically also bring down the gap between supply and demand of corneas as well.
There is a shortage of donor eyes for transplantation. In 2016/17 there was a deficit of 892 corneas for transplant (2). Nine out of ten donors in the UK restricted their corneas being donated, and we know that there is also a lack of ocular tissue for medical research as well. This statistic underlies the huge barriers to ensuring enough eyes are donated within the UK. More needs to be done within the UK to change this through awareness raising of the importance of helping restore someone’s sight and contributing to medical science.
One of the biggest barriers to successful donation is family refusal in the UK’s current opt-in system, which could also be an issue within a soft opt-out system. NHS Blood and Transplant (NHSBT) estimate that more than three families a week were saying no to organ donation, in 2016 the consent rate from families stood at 62% (3).
Fight for Sight supports a move to an opt-out organ donation system, as evidence shows that this can improve donation rates by increasing the donor pool. However, evidence from countries such as Spain, which has one of the highest rate of donation in the world, suggests a cultural shift and an investment in an infrastructure to support increased donation is key to improving donation rates and not just a change in the legal system.
Fight for Sight urge members of the public to join the organ register and not restrict the donation of their eyes. Increasing the number of donations is crucial to ensuring that that people that need corneal tissue can regain their vision. We would also urge members of the public to give consent for their eyes to be used for research as they are crucial for new scientific breakthroughs that can help end sight loss.
1. Organ Donation house of commons research briefing
2. Figures provided by NHS Blood and Transplant
3. NHSBT press release, September 2016
Open Access research
Open Access is the process of making research freely and widely available in academic journals. Fight for Sight believes that research being open access maximises the impact of research and benefits the wider research community as well as patients.
There are two routes to making research open access:
- Green Access - The final peer reviewed article is deposited in an electronic depository. Access to the research output can be granted either immediately or after an embargo period
- Gold Access – The final peer reviewed article is published in a way that allows immediate access to everyone free of charge.
We support and encourage researchers to make their research open access. Fight for Sight’s grant terms and conditions allow researchers to apply for open access and dissemination costs within their grant application.
Patient data in research
The use of NHS data has a number of benefits for research. It can help researchers better understand the causes of disease, improve diagnosis and help develop new treatments and a better understanding of prevention. This is important for people living with sight loss as for many conditions we do not know enough about what causes them and how to treat them effectively.
We recognise however, that despite safeguards and measures of confidentiality that not everyone would like their data to be used for research purposes and that there are concerns about trust and confidence about how their information is collected, stored and shared.
It is essential that the public and patients are able to make informed choices about sharing their personal health information. Fight for Sight supported the introduction of the national patient data opt-out in 2018 for patients to opt-out of their identifiable NHS data being used outside of their direct healthcare if they so wish.
Stem cell research
Sight loss occurs when one or more components of the eye are damaged or stop working properly. Stem cells may be of use to replace the damaged cells in the eye.
While we recognise that there are alternative perspectives on stem cell based research Fight for Sight believes that this area has the potential to transform the way in which we respond to sight loss – providing treatments for many of today’s incurable eye diseases and conditions.
Stem cell research and therapy is subject to strict regulation through the Human Fertilisation and Embryo Authority (HFEA) and within this framework of regulation Fight for Sight supports research projects that involve the use of embryonic, non-embryonic (adult) and animal stem cells. We do not and would not support unregulated use and marketing of unproven stem cell treatments.
Fight for Sight believes that continued research into the use and potential of stem cells is essential to enhance our knowledge and understanding and take us closer to ending sight loss.
Working with industry
Fight for Sight is committed to sound ethical collaboration with commercial and corporate partners in the interest of people affected by sight loss and blindness. We receive support from a range of companies including pharmaceutical and medical devices companies, as part of a diverse fundraising strategy.
We recognise the importance of working with all stakeholders to ensure we do our best to meet the needs of our beneficiaries and their families. However, the views of the charity are always reached independently and are based on informed and balanced evidence, ensuring that these companies do not impact or influence our strategic direction.
This policy provides clear guidance about how Fight for Sight works with pharmaceutical and medical devices companies, and follows the code of fundraising practices as detailed by the Institute of Fundraising.
- Under no circumstances will companies influence the charity’s strategy, policy, activities or actions either explicitly or implicitly.
- Every charity and industry collaboration will be assessed and agreed on an individual basis according to the charity’s internal corporate policy.
- The charity recognises that pharmaceutical and medical devices company partners must follow The Association of the British Pharmaceutical Industry (ABPI) Code of Practice. The charity is aware of these guidelines and will ensure that both parties in any agreement work to fulfil these obligations.
- As a member of the AMRC, the charity will apply working with industry principles in line with the AMRC recommendations of independence, integrity and transparency, outlined in AMRC (2014) An Essential Partnership: A guide for charities working with industry.
- In accordance with the principles of the Data Protection Act 1998, the charity will not, under any circumstances, disclose any confidential information regarding its supporters to any companies.
- The charity is committed to being open about our Trustees’ and Senior Management Team’s relationship with companies. The charity maintains a Register of Interests and Trustees and Senior Management Team are required to declare any interests they hold in external companies. The Register of Interests is held in order to identify and manage any potential conflicts of interest.
- The charity will make public all partnerships with the pharmaceutical and medical devices companies through our website.
- Income from pharmaceutical and medical devices companies will be clearly disclosed in our Annual Report.
- A written agreement is drawn up at the beginning of each new partnership with any company and each partnership will be monitored and evaluated.
- The charity will be open and honest in response to any public or media enquiry concerning relationships with corporate partners.
For more information, please contact Fight for Sight’s Corporate Partnerships Manager on 020 7264 3900.
The application of genomics in the diagnosis and treatment of patients with eye conditions
A genome is the complete set of DNA and genes that is found within the nucleus of each cell. It includes all of the instructions for making the proteins that maintain an organism. Genomics is a branch of science that considers the structure, function, mapping, and editing of genomes.
Genomic sequencing is a tool that allows the code of a person’s DNA to be read, increasingly this is being used to better understand the mechanism of disease. The technology has become increasingly cheaper and more accessible. Genome sequencing has led to a greater understanding of the causes of sight-threatening conditions.
The Government established Genomics England in 2013, tasking the organisation with sequencing 100,000 genomes from patients and their families living with cancers and rare diseases. A significant number of patients with sight loss and their families were sequenced and ophthalmology has been a vital part of the project. Building on the 100,000 genomes project, in October 2018, the NHS launched the Genomics Medicine Service (GMS) the first such service in the world to imbed genomics within a health system with the ambition to sequence 5 million genomes by 2022.
UK Biobank is a significant health resource that has 500,000 participants. It was established with the aim of improving the prevention, diagnosis and treatment of a wide range of serious and life-threatening illnesses, including eye conditions. Earlier this year, UK Biobank announced a major initiative to sequence the full genomes of 50,000 UK Biobank volunteer participants. This initiative together with that of Genomics England will improve our understanding of many diseases, including a number of eye conditions.
Genomics is a rapidly developing area of science that has the ability to transform the way in which people with eye conditions are diagnosed and treated. Fight for Sight supports the implementation of genomics and the linking of genomic and clinical data, as it will help us better understand and treat many eye conditions. This will lead to more accurate and timely diagnosis, with improved identification of genomic biomarkers that can result in more personalised therapies and better care options for people living with sight loss.
Data-driven technologiesData-driven technologies is a term used to include developing areas such as Artificial Intelligence (AI) and Machine Learning (ML). The use of AI and ML is rapidly being adopted in a number of areas including health.
These technologies have massive potential as a clinical support and/or decision- making tool for the prevention and diagnosis of different conditions, as well as identifying therapeutic targets. The processing power of current AI technology means that they can increasingly provide insights that humans are not able to do.
The eye is an easily accessible part of the human physiology. It can act as a window to the brain through the optic nerve and the vasculature at the back of the eye, and can provide insights across other condition areas such as diabetes, stroke and cardiovascular disease (CVD). There have been a number of pilot studies which have shown the potential for AI analysis of retinal imaging to accurately diagnose and prevent a number of chronic conditions.
Fight for Sight supports these technologies, as they have the potential to radically improve the prevention, diagnosis and treatment of eye conditions. Using the eye as a model, retinal image analysis can support the prevention and diagnosis of systemic conditions. Algorithms analyse huge amounts of data to provide accurate diagnosis and identifying preventative interventions based on disease risk.
Patient data is a valuable resource. Our existing position statement on patient data in research, clearly articulates our views on patients being empowered and informed about sharing their data for the wider benefit of vision research.
Fight for Sight continues to support ongoing work on issues such as regulation, data ethics and data quality which are important to realise the benefits of AI for vision research.