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Brighton & Sussex Medical School

Posts: the EPPiGen project

EPPiGen - posts

Our dedicated posts page features a range of reports, reviews and opinion pieces on topics, events and publications relating to the EPPiGen project.

Keep up-to-date with the latest news and views on the EPPiGEN Twitter page.

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July 2020

Considering Preparedness during a pandemic

4 test tubes marked 1 to 4, 3 are yellow with - marks next to them, one is red with a + mark next to it

Throughout the coronavirus pandemic the Nuffield Council on Bioethics has organised events, and published in-house and guest blogs with the aim of ensuring that social and ethical issues are neither overlooked nor misrepresented. Read more about Nuffield Council on Bioethics events here >

On 24 April 2020, Professor Bobbie Farsides chaired an invitation only NCOB online event entitled ‘Social and Ethical Implications of COVID-19 Immunity Testing’. Participants joined from several countries, representing a cross section of academic and practical disciplines. On the basis of discussions at this meeting NCOB Deputy Director, Dr Peter Mills drafted a detailed briefing note entitled  COVID-19 antibody testing and ‘immunity’ published on the NCOB website on 18 June 2020.

On Thursday 2 July 2020 the NCOB invited Professor Farsides to be on the panel for an open Webinar entitled “Ethical implications of antibody testing and “immunity certification.” Her fellow panellists were Dr Agomoni Ganguli-Mitra, (Lecturer and Chancellor’s Fellow in Bioethics and Global Health Ethics, University of Edinburgh School of Law) and Professor Dr Steffen Augsberg, (Professor of Public Law, University of Giessen). You can watch the webinar in full below. 

 

Nuffield Council on Bioethics Twitter post, Reads: Our latest guest blog from @Ethixbird is an extended version of her presentation from our webinar on COVID19 antibody testing and 'immunity certification'. Read 'The troubling prospect of immunity certificates'

This is a screenshot of NCOB Twitter post on antibody testing.

 

Following on from this event, Professor Farsides was invited to publish a slightly longer version of her talk on the NCOB website under the title “The troubling prospect of immunity certificates”, published on the NCOB website on 9 July 2020.

Participation in these events provided an opportunity to reflect on preparedness in relation to a very different scenario to that focused upon in the main EPPiGEN project. Rather than thinking about preparedness in the context of a politically valued and hopeful transformational project, the pandemic challenges us to think about what we need to know and understand ethically in order to be adequately prepared to deal with threat and potential disaster.  

Professor Farsides’ thesis in this instance was consistent with the meta-ethical approach of the EPPiGEN project which stresses the crucial importance of understanding the contextual facts of the matter as they pertain to particular ethical issues. It also demonstrated the project team’s appreciation of the value of social scientific analysis in ensuring that systemic issues are recognised and given due regard. Finally, working on the issues raised by the NCOB shone a light on the potential for politics and ideology to compete with ethically and scientifically sound judgement, even when government claims to be fully committed to pursuing the public interest and supporting a common good.

June 2020

Evidence presented to the Science and Technology Parliamentary Committee

Dr Tara Clancy, Council Member, Nuffield Council of Bioethics, presented evidence to the Science and Technology Parliamentary Committee on 17 June 2020. The subject was Commercial Genomics, with a focus on the need for government regulation.

Watch the full Commercial Genomics session here >

Microscope magnifcation of COVID-19 virus

April 2020

Uncertainty and anxiety: the ‘responsible public’ in lockdown 

By Shadreck Mwale, 4 April 2020. 

If you want to see the impact of the lockdown, the first thing you will want to do is look outside your window. Listen to the eerie silence in the streets- no moving traffic or people. If you can take your once a day exercise time allowance outdoors, pay attention to how narrow footpaths really are. They are not wide enough for maintaining the two-metre social distance. And you probably have already experienced the awkward greetings on footpaths and pavements.

In this piece, I reflect on two separate events over the course of two days experiencing uncertainty and anxiety induced by CoVID- 19. As someone whose other half works on the front line in the NHS, I developed a cough. For me, this was an ordinary cough with a simple aetiological cause – ‘allergic reaction – due to spending too much time in a dusty shed one afternoon’. Nevertheless, as Hannah Bradby points out,  times of ‘ordinary’ coughs are long gone. Today, a cough, sniffle or slight headache requires more attention and requires vigilance and strict self-surveillance. This is because among other things, we have to consider ourselves already infected and therefore, should look out for the signs and symptoms. Now post lockdown I am unsure what my cough means for me and my household, and those I may have walked by on my time of exercise outdoors. I wrestled with a number of questions- is this the beginning of the CoVID-19? Is this it? Suffice to say amid all the unknowns, a decision was made, my other half had to work from home that day. Luckily for me, the cough dissipated just as quick as it appeared, was gone, never to return by the following day.  Not that I have stopped feeling paranoid or suspicious of every small change in my body since. The experience left me feeling anxious about how one can tell they have got the virus. How different is it to all symptoms I have felt before?

The following day, I had a telephone conversation with a friend who was returning home after a week away for work. While they were away, one family member had developed a cough- not progressive and with no other symptoms. Having spent time away from home, they were not sure whether to return home or stay away.  Worried they may be taking the infection home or indeed risking catching whatever was brewing in their household.  During this conversation, it was clear that we were both anxious about the current situation. Anxiety was exacerbated by the lack of clarity- both in terms of what constitutes CoVID-19 symptoms and when one has to call for help. Would it not help to test everyone with signs and symptoms to ascertain a condition and dispel the anxiety induced by having a slight cough or headache?  We wondered…..

These experiences brought home the anxiety and uncertainty that the pandemic brings with it. Exemplifying Lupton’s (2012) argument about the moral discourse associated with access to medical services, especially access to emergency services. The moral discourse is evident in the NHS (1997) patients charter which aimed to ‘balance patient’s rights of access to NHS services with their responsibility to use services wisely‘. Therefore, over this period of time, access to Accident and Emergency Services, (including Primary Care) to see one’s GP has required a responsible public- able to assess whether one’s condition is a “real” emergency and wise to avoid wasting valuable time and scarce NHS resources. The need for such individual and public responsibility, the ability to assess their symptoms and decide on an appropriate responsible course of action, has become even more crucial in the current context.  In the digital age, the responsible public is expected to engage and interpret online information, assumed to be accessible to everyone, as well as constant, at times conflicting news headlines, and online symptom trackers and assess whether their symptoms are those of CoVID-19 and take necessary steps.  However, in the context of lack of prior experience or contact with those who may have the condition to draw on as their basis of ‘knowledge’, the responsible public is left uncertain and anxious.

Uncertainty is a complex concept with a cluster of meanings and definitions- here I refer to uncertainty as a state where information about CoVID-19 is insufficient, leading to uncertainty on what the public should do when confronted with what could be the onset of CoVID-19. The point here is not that we should avoid uncertainty. In essence, it is an impossible task, as uncertainty is an inherent part of medicine. Within medicine, uncertain information plays a significant role in promoting autonomy. However, in the current context uncertainty is problematic, and brings to mind  Han et al ‘s classification of uncertainty as it relates to complexity, probabilities and ambiguity in health contexts.

First, uncertainty today results from the complexity of CoVID-19 – its fast infection rate, mortality rate, lack of known treatments and preventative vaccines like other types of flu, never mind that you can be fully contagious and completely asymptomatic! The evolving and varied nature of symptoms experienced by patients across the globe adds to the complexity of CoVID-19. It is confounding both the medical practitioners and politicians, leading to a lack of consensus on what actions are to be taken.  For example what does a lockdown look like and what does it involve? Who and how is it to be enforced?  As such the responsible public is left equally confused and anxious.

Second, uncertainty is borne from the fact that CoVID-19 is also associated with risk probabilities. Medical and policy pronouncements have recently emphasised that specific demographics are more at risk than others of contracting the virus.  Resulting in a relaxed attitude among some demographics who feel they have a low probability of contracting the virus. However, recent news headlines challenge these assumptions with news reports indicating younger and healthier people can contract and die from the CoVID-19. This raises questions about what risk really means in this context, further adding to anxiety public attempting to behave responsibly.

Third, CoVID-19 uncertainty results from vague available information. There is paucity of information on symptoms or what course of action the responsible public has to take when they suspect they have symptoms. Even more unclear is when to call 111, 999 or when hospitalisation must be sought -illustrated in increasing sobering recent news media reports of people dying in self isolation, possibly their attempt at acting responsibly.

As Han et al observe, the issue with these forms of Uncertainty is that they lead to harms -such as anxiety and sadly, according to media reports, death in self isolation, and consequently undermines autonomy for the public to behave responsibly. Clearly what the public needs to act responsibly, is clear guidelines on what actions are to be taken when, where and how while acknowledging the uncertainty in such guidelines. Whether it is social distancinglength or frequency of exercise, what to do when symptoms emerge, at what point to call for help and where this help should be sought. The current flux in information on the C0VID-19 lockdown makes a responsible public anxious. Quite where this leaves universal healthcare systems, both now, and post pandemic, is difficult or impossible to say.

Microscope magnifcation of COVID-19 virus

February 2020

Creating Health and Wellbeing: Through Creative Endeavour(s)

5 February 2020

Dr Shadreck Mwale (BSMS) working with colleagues, Dr Jo Hope and Dr Chris Allen (both at the University of Southampton) organised a BSA South Coast Medical Sociology regional symposium 'Creating Health and Wellbeing: through creative endeavours' which took place on 5 February 2020. The University of Southampton hosted the event. The symposium brought together two researchers and a community worker to discuss Public Patient Involvement in Public Health and research. 

 Creating Health and wellbeing through creative Endeavours report >

October 2019

Professor Anneke Lucassen gives evidence to committee

The EPPiGEN Project Co-Principal Investigator, Professor Anneke Lucassen, from the University of Southampton, gave evidence at the Science and Technology Select committee about the risks of direct-to-consumer (DTC) testing on 15 October 2019. 

Watch the full session below.

Watch the DTC testing session in full  >

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June 2019

Symposium - Ethical Quandaries: Blurred Boundaries and Transformations in Genomic Medicine

On 11 June 2019, The EPPiGEN project, in collaboration with the British Sociological Association (BSA) Medical Sociology South Coast study group held a symposium at Brighton and Sussex Medical School.  The BSA Medical Sociology South study group is part of a diverse range of regional study groups supported and funded by the BSA. The South Coast Study group is convened by Dr Chris Allen (University of Southampton) and Dr Shadreck Mwale (BSMS). 

The symposium’s theme was ethical issues associated with the emergence and increasing use of genetic and genomic medicine. The speakers for the event were Professor Kate O’Riordan (University of Sussex), Dr Gabby Samuel (Kings' College London) and Associate Professor Dr Felicity Boardman (University of Warwick). The meeting was well attended, with many attendees coming largely from the South East and London regions, but also two international delegates, from Austria and Malta.

Professor Kate O’Riordan opened the session with a paper titled Scientists, publics and genetically edited humans in the media. The paper explored the media coverage of CRISPR-Cas9 in 2013 and the aftermath of the announcement of the use of CRISPR in embryo research in the UK, and the 2018 announcement of live births in China using the same technique. The paper focused on media representation of prominent scientific figures of Dr Kathy Niakan (UK) and Dr He Jiankui (China), highlighting how both scientists and global publics are constructed as potential obstacles to, or supporters of, the use of CRISPR.

Dr Gabby Samuel followed with a paper 100,000 Genomes Project (100 KGP): a case study of “ethical quandaries” emerging from genomic medicine. The presentation traced the development of the 100kGP and its role of laying the ground for the current rollout of a genomic medicine service in the NHS. A fascinating component of the paper was how ethics are understood and enacted by various institutions involved in the delivery of the project. The paper concluded by raising questions about what constitutes ethical research in these settings and how ethical practices in genomic medicine can be nurtured during the mainstreaming process. 

Dr Felicity Boardman’s presented the paper Living with the genome: disability, impairment and suffering in a genomic age. Dr Boardman made a call for including data referring to patient experience in the design and delivery of genomic medicine. She offered particularly compelling data supporting a patient-focused account of the concepts of "seriousness' and ‘suffering' and how to incorporate them in genomic practice.

Professor Bobbie Farsides brought the symposium to a close by bringing together key messages from the presentations. She highlighted how, though the papers were drawing on different topics, each speaker highlighted the significance of ethics in genetics and genomic medicine, and therefore the need to be ethically as well as scientifically prepared. 

The reception of the delegates was encouraging as speakers and delegates continued discussing the issues raised by the talks during a networking session. One delegate commented: "The fact that I flew in to attend [the symposium] shows that we need such fora for such topics". 

The EPPiGEN project will continue to collaborate with others to provide space for rigorous academic debates about ethics associated with genomic medicine.

Digital image of a blue translucent chain with 0s and 1s on the chain links

April 2019

Ipsos MORI - ‘A public dialogue on genomic medicine: time for a new social contract?’ 

On the 25 April 2019, Ipsos MORI published a report titled ‘A public dialogue on genomic medicine: time for a new social contract?.’ The report was commissioned by Genomics England and co-funded by Sciencewise an arm of UK Research and Innovation that supports public dialogue on scientific and technological issues. The idea of “social contract” in genomic medicine can be traced back to the work of some members of the EPPiGEN Research Team. Professor Anneke Lucassen (EPPiGEN Co-PI), and EPPiGEN Project Collaborators Professors Michael Parker and Sir Jonathan Montgomery contributed a co-authored chapter in the Chief Medical Officer’s (CMO) (2016) report ‘generation genome’. They argued that “if the potential benefits of genomics are to be realised, there is a need for a rethinking of the wider ‘social contract’ for medical practice and research in the UK.” By social contract, they refer to the principles of mutual responsibilities espoused in the NHS constitution in which patients, the public and staff are bound together by a set of reciprocal rights and obligations in order for the service to be effective, efficient and to operate fairly for mutual benefit. The NHS constitution “recognises that each party has important rights that must be respected, but also that each owes each other responsibilities…” The NHS constitution “… is thus the expression of a form of ‘social contract’ which aims to bring the highest levels of human knowledge and skill to save lives and improve health” (Lucassen, Montgomery and Parker 2016;3). In addition, their work accentuates the challenges genomic medicine poses to the existing ‘social contract’ on issues of public involvement, patient consent, information sharing and the amount of personal data the health service will have to store. (For details on these issues see chapter 16 of the CMO (2016) Report). It is good to see this work gaining traction in the debates about a future genomic medicine service in the NHS.

The Ipsos MORI report was based on a series of public dialogue events involving members of the public to discuss their concerns, aspirations about as well as to capture public interest and acceptance of the significance of genomic medicine in the health service.  The report found that ‘genomic medicine may change public expectations around donating their data; and that clinicians and researchers will need to be equipped with ‘genomic literacy’ to support patients and donors and explain the ever-closer relationship between research and clinical care. The ways that medical charities, research organisations, and industry work with the NHS, and the importance of basic biological research, will also need to be better explained.’ The report also highlights the significance of the principles and values underpinning the NHS as an institution, in which the public, patients and NHS staff are bound together in mutual responsibility to make the NHS work effectively and equitably. The report reveals that ‘although participants were unfamiliar with the terminology around this ‘social contract’, they had very clear perceptions of how the NHS works and the ‘contract’ between the service and patients.’

It is good to see Professor Michael Parker in his capacity as a board member of Genomics England interviewed among others by Genomics England in their response to the report. Professor Parker is quoted stating that the Ipsos MORI report “highlights the crucial role that ethics and participant engagement play in establishing and maintaining public trust in genomics. It is essential reading for everyone with an interest in genomic and data-driven medicine. It presents the results of an inclusive and thorough process of public dialogue and makes a vital contribution to ongoing discussions about genomic medicine. It reveals that the relationship between the NHS, patients, and the public is currently understood in terms of three core values: reciprocity, altruism, and solidarity…

Through its research, the EPPiGEN Project will be interested in tracking the extent to which the idea of “social contract” resonates with healthcare professionals and the public and how its conceptions by various interested parties shape the future of an integrated genomic medicine service in the NHS.

Logo for Eppigen Ipsos MORI - multicoloured squares arranged around a circle

BACKGROUND IMAGE FOR PANEL

March 2019

Qualitative Health Research Network (QHRN) Conference

Report by Dr Shadreck Mwale, 30 March.

I attended the 4th QHRN conference on the 21-22 March in London. The QHRN conference is a biannual event whose aim is to provide space for the dissemination of qualitative or mixed-method research in health, illness and care. The QHRN is based at the University College London (UCL), and is described on their website as "a cross-faculty and transdisciplinary initiative to support the use and development of qualitative research in health, illness and care". The aim of the network is "to encourage an intellectually dynamic yet supportive atmosphere for debate and discussion that examines the place of qualitative research in contemporary health research, its core concepts and methods." 

The theme for this year's QHRN conference was "Crafting the Future of Qualitative Health Research in a Changing World". This two-day event brought together researchers from a range of disciplines such as Sociology, Psychology, Medicine and Nursing, among others. It also included policymakers, practitioners and service users.

Day one offered a choice of four workshops.

  1. An introduction to Rapid Qualitative Research,
  2. Introducing Longitudinal Qualitative Research: The craft of research Through Time
  3. An introduction to Ethnographic Research Practice in Healthcare and
  4. Introducing Qualitative Analysis Software

I attended the Longitudinal Qualitative Research workshop run by Emeritus Professor Bren Neale (University of Leeds). The workshop was very informative, particularly on the design and conduct of longitudinal qualitative research. Using a very engaging participatory approach, Professor Neale challenged participants to consider the significance of time to understanding experiences of health and illness, and how time is central in the design and conduct of longitudinal research.

Day two was a more traditional conference format with presentations of wide-ranging research from the UK and across the globe. The opening Plenary by Professor Glenn Roberts (King's College London) challenged delegates to think of designing and implementing participatory qualitative research that brings about beneficial change in the organisation and delivery of healthcare. 

The conference had three parallel sessions. A session I was keen to attend because of the observational element in our project was the “Ethnographic Encounters”. The session consisted of four presentations. Monica Leverton’s (University College London) paper on the nature of care for people living with dementia using observations opened the session. Caroline Robitaille (University of Montreal, Canada) followed with a paper on doing ethnographic research using web-based tools. Then, Eugenia Brage (University of Buenos Aires, Argentina) presented a paper on the therapeutic journeys of childhood cancer patients in Argentina. Amit Desai (Kings College London) brought the session to a close with a paper on “Evolving ethnographic sensibilities” which explored the challenges of conducting ethnographic research in contexts where randomised controlled clinical trials are the modus operandi.

While the presenters researched different geographical and socio-political contexts, together their papers provided useful insights into the practicalities and role of ethnographic research in health while raising questions about what constitutes "real" ethnographic research.

Professor Virginia Braun (University of Auckland, New Zealand) closed the conference with a symposium on ‘story completion’ as a new innovative research approach in qualitative health research. As a project with a strong interest in methodological innovations, it was interesting to reflect on whether Professor Braun’s approach might help shed light on our interest in ethical preparedness.

For more details see QHRN

BACKGROUND IMAGE FOR PANEL

February 2019

Getting started: reflections on setting up a complex qualitative research project involving NHS staff 

Ethical Preparedness in Genomic Medicine (EPPiGEN) is a major £1.2 million Wellcome Trust Collaborative Award project run by Brighton and Sussex Medical School and University of Southampton. The EPPiGEN project aims to examine the concept of ethical preparedness in the context of genomic medicine as genomics is becoming embedded within the UK healthcare system. The project examines how the promises and challenges of genomic medicine are understood and experienced by those providing and engaging with the service.

Work Package One of the EPPiGEN Project, organised and conducted by researchers from Brighton and Sussex Medical School, focuses on experiences and perceptions of healthcare professionals whose practice will be affected by the mainstreaming of genomic medicine. This qualitative research project, involving informal observations, semi- structured in-depth interviews and Ethical Discussion Groups*, recruiting healthcare professionals working in Primary and Secondary Care settings across the Kent Surrey and Sussex (KSS) region. Before commencing the research, identification and negotiation of access to study sites, and sponsorship and governance approvals had to be in place. This is where the Clinical Research Network (CRN) comes in. 

The NIHR website gives a good account of the work of the CRN. The KSS CRN is one of 15 local Clinical Research Networks ‘that cover the length and breadth of England. The CRN enables high-quality health and care research in England by meeting the costs of additional staff, facilities, equipment and support services so that research is not subsidised with funding that has been provided for health and care treatments and service. The CRN also provides a vast range of national and local resources and activities that support health and care organisations, staff, and patients and service users to be research active, such as specialist training, information systems to manage and report research, patient and public involvement and engagement initiatives, and communications expertise.’ 

In addition, ‘at the heart of CRN activities is the NIHR CRN Portfolio of studies. This consists of high-quality clinical research studies that are eligible for consideration for support from the CRN in England… research activity (recruitment) data from the NIHR CRN Portfolio is used to inform the allocation of NHS infrastructure for research (including NHS Service Support Costs) and supports the performance management of the Clinical Research Network’ (see CRN).  

Designing a study, negotiating access and obtaining governance approvals for research in the NHS is a complex process, particularly if you are not familiar with the system.  However, we were fortunate to receive invaluable support and guidance from several people and organisations as we worked to get our first major EPPiGEN project up and running. These include Nicky Perry (Operations Manager Brighton and Sussex Clinical Trials Unit), our local Clinical Research Network (CRN), specifically, Dr Helen Membrey (Research Delivery Manager (CRNKSS)), Deirdre Callahan (Project Coordinator (CRNKSS) and the University of Sussex Research Sponsorship Committee.

*EDGs are a hybrid falling between a traditional focus group and a discussion that would be facilitated in a philosophy seminar. Participants do not merely express opinions but are encouraged to challenge others and be challenged in return.

So, what have we learned so far about preparing to do research in the NHS from working with the CRN:

They are not just about clinical trials

The CRN can support and facilitate a wide-range of research including social science research in the NHS. They provide support for all funded research that attempts‘to derive generalisable or transferable new knowledge to answer or refine relevant questions with scientifically sound methods’ Support is provided regardless of the study type or research funder (see NIHR). Staff also have practical knowledge about the NHS ethics application process.

Feedback on the research design 

As an externally funded project the methodology of our research had to be well worked out in advance to ensure it was competitive, and thus we did not require the support of the NIHR Research Design Service (RDS). However, CRN KSS was very helpful in introducing knowledge and understanding of the local environment and the impact that might have on our proposed methodology. While the researcher retains methodological control, having feedback on the design was useful not only in preparing us for what to expect in the field but also reflecting on the suitability of our methodological approach and what adjustments could be made to our approach before commencing fieldwork.

Guidance on the documents 

The CRN provided clear advice on what documents were needed for the HRA/IRAS application process relevant to our project. This is particularly helpful to a social science researcher as some of the documentation and related check lists relate much more obviously to clinical trials than to the sort of qualitative research intervention we were planning. For example, the checklist requires a dossier of the Investigational Medicinal Product (IMP) and templates of delegation logs both of which relate only to clinical trials. From the outset, the CRN were interested in looking at appropriate documents to accompany the application. They provided useful feedback on the contents of the participant information sheet and consent form among others to ensure they were fit for purpose.

Negotiating access

Gaining access to NHS sites for research can be challenging particularly for those working outside the sector. To make negotiating access relatively easy, it is imperative that research aims are clear, this helps the CRN ensure you are matched with sites and individuals who would have an interest/fulfil your recruitment criteria. For example, our research is interested in recruiting healthcare professionals working in Paediatrics, Oncology and Diabetes, the CRN matched us with sites delivering research or care in these specialties. Having the CRN introduce us to possible contacts on each site proved extremely valuable when negotiating access to research sites.

Having a contact

Particularly at the beginning of the project, it was helpful to have a named contact to consult for advice as the research got under way. 

For social researchers venturing into the NHS to conduct research, working with your local CRN could transform the experience from an overwhelming task to something much more manageable. As we prepare for the next phase of the research process, we are excited and confident knowing that whatever challenges we may face there is support from our local CRN.