Category / Research Ethics

Health Research Authority UPDATE: undergraduate and master’s research projects

New eligibility criteria from 1 September 2021

The HRA and the devolved administrations, supported by the Wessex Institute at the University of Southampton, have reviewed their approach to study approval for student research.

The review aimed to ensure students have the best learning experience of health and social care research, and to reduce the time that the HRA, DAs and NHS Research Ethics Committees (RECs) spend advising on and reviewing student applications.

In March 2020 the HRA paused student research approvals to create capacity for urgent COVID-19 research. Now, from 1 September 2021, they are introducing new eligibility criteria for standalone student research.

The new criteria mean that some master’s level students will be able to apply for ethics review and HRA/HCRW Approval or devolved administration equivalent. Standalone research at undergraduate level that requires ethics review and/or HRA/HCRW Approval (or devolved administration equivalent) cannot take place. Arrangements for doctoral research remain unchanged. Full details are in table one – permitted student research table. They have also made it clear when students are able to take the role of Chief Investigator, see table two – which type of students may act as Chief Investigator.

It is possible for students to learn about health and social care research without completing standalone projects. Looking at other ways to build skills and experience better reflects modern research and emphasises team science. View the video of the HRA event ‘Exploring good practice in Student Research’ to hear from course leaders about how successful these alternative approaches have been (registration is required to view) or read the HRA website for further information and ideas https://www.hra.nhs.uk/student-research/.

The HRA are giving notice now so that course leaders and students have time to prepare for the new arrangements, including ensuring that any changes to institutional policies and procedures are made.

If you have any queries about the eligibility criteria, please contact queries@hra.nhs.uk or swignall@bournemouth.ac.uk

Free online course – Improving Healthcare Through Clinical Research

Interested in clinical research and what’s involved? Are you contemplating a career in healthcare or the life sciences, or, do you want to find out more about the role of clinical research in improving healthcare?

If you’ve answered yes to any of the above questions, then why not sign up to FutureLearn’s Improving Healthcare Through Clinical Research course?

The course has been developed by the University of Leeds and is be available from Monday 24th May, via this link.

It is completely free and all online, lasting 4 weeks.

This course has been certified by the CPD Certification Service as conforming to continuing professional development principles. By completing the course you will have achieved 16 hours of CPD time.

Remember – support is on offer at BU if you are thinking of introducing your research ideas into the NHS – email the Research Ethics mailbox, and take a look at the Clinical Governance website.

NIHR welcomes new vision for the Future of UK Clinical Research Delivery

The National Institute of Health Research (NIHR) and partner organisations across the health research ecosystem have welcomed the publication of a bold and ambitious vision for the future of clinical research delivery in the UK.

This UK-wide vision sets out the ambition to create a patient-centred, pro-innovation and data-enabled clinical research environment, which empowers everyone across the health service to participate in delivering research and enables people across the country to take part in research that is of relevance to them.

The vision has been developed through the cross-sector Recovery, Resilience and Growth programme, with NIHR working alongside the NHS, regulators, medical research charities, life sciences industry, the UK government and devolved administrations.

You can read more here.

NIHR virtual event – Equality, diversity and inclusion in applied health and social care research

The NIHR Research Design Service South East is hosting an event to discuss and explore what is meant by equality, diversity and inclusion in research and the importance of thinking about it when planning your health or social care research project.

Professor Kamlesh Khunti, Director of the NIHR Applied Research Collaborations East Midlands and Centre for BME Health, will talk about his recent research on COVID-19 in ethnic minority populations. Dr Esther Mukuka will talk about her new role as the Head of Equality, Diversity and Inclusion at the NIHR, and the increasing emphasis being put on those that apply for any NIHR funding to demonstrate their commitment to equality, diversity and inclusion and a healthy research culture more generally.

The presentations will be followed by informal workshops to look at different case studies demonstrating the application of equality, diversity and inclusion principles in research.

The event is open to anyone with an interest in applied health and social care research.

Sign up online

https://www.nihr.ac.uk/events/equality-diversity-and-inclusion-in-applied-health-and-social-care-research/27216?utm_source=newsletter-fs&utm_medium=email&utm_campaign=fs-2021-04

UK government sets out bold vision for the future of clinical research delivery

Patients, clinicians and researchers across the whole of the UK are set to benefit from the ambitious vision for the future of clinical research delivery according to this press release from the UK Government.

The plan includes:

  • Strengthening the UK’s renowned research expertise as a world-leader in designing and delivering research
  • An ambitious vision to unlock the true potential of research putting patients and NHS at its heart
  • Using the lessons from COVID-19 to build back better, the government will create a patient-centred, pro-innovation and digitally-enabled research environment.

Saving and improving lives: the future of UK clinical research delivery, published on March 23rd was developed by the UK government and devolved administrations. The policy paper sets out how they will deliver faster, more efficient and more innovative research – from the streamlining of costing, contracting and approvals processes to the Health Research Authority’s rapid ethics review pilot, which aims to halve the time to provide a final opinion for research applications.

Using best practice, it is hoped that participating in research will become more accessible, increasing diversity and allowing more people across the whole of the UK to take part. They will work with Centres of Excellence, such as the Centre for BME Health in Leicester, and there will be more support for research in more diverse and under-served communities and innovative approaches.

The NHS will be encouraged to put delivery of research at the heart of everything they do, making it an essential and rewarding part of effective patient care. This included building a culture across the NHS and all health and care settings that is positive about research, where all staff feel empowered and supported to take part in clinical research delivery as part of their job.

The vision is built around 5 key themes:

  1. Clinical research embedded in the NHS: to create a research-positive culture in which all health and care staff feel empowered to support and participate in clinical research as part of their job.
  2. Patient-centred research: to make access and participation in research as easy as possible for everyone across the UK, including rural, diverse and under-served populations.
  3. Streamlined, efficient and innovative research: so the UK is seen as the best place in the world to conduct fast, efficient and cutting-edge clinical research.
  4. Research enabled by data and digital tools: to ensure the UK has the most advanced and data-enabled clinical research environment in the world, building on our unique data assets to improve health and care.
  5. A sustainable and supported research workforce: which offers rewarding opportunities and exciting careers for all healthcare and research staff of all professional backgrounds – across both commercial and non-commercial research.

The vision reflects the ambition of all 4 UK governments and has been developed through a broad cross-sector approach involving NHS, medical research charities, life sciences industry and academia. Continued collaboration across sectors and organisations will ensure the key action areas will be delivered.


Remember – support is on offer at BU if you are thinking of introducing your research ideas into the NHS – email the Research Ethics mailbox, and take a look at the Research Governance and Integrity website.

National Institute for Health Research publishes latest annual report

The NIHR has published its latest Annual Report highlighting it’s achievements during 2019/2020. You can read more below.


The report celebrates how NIHR funding and support continues to have a lasting impact on our health and social care system. It details our world-class and ground-breaking research that is delivered by the talents and expertise within NIHR and the collaborations and partnerships we have forged. In addition to showcasing the breadth of areas NIHR provides funding and support, over 100 of our major research achievements are featured in the report, organised under the NIHR’s six core workstreams. The report also gives an insight into the shifting focus to COVID-19 research as we came to the end of 2019/20.

You can also access a HTML version of the NIHR Annual Report 2019/2020.

Highlights in this year’s report include:

1. Funding, supporting and delivering high-quality research

At the core of NIHR is a commitment to fund high quality research that benefits the NHS, public health and social care. Our research funding schemes – programmes, units and schools – deliver a coherent programme of response mode and commissioned research. We awarded over £250 million of funding to 310 new projects. Our first-ever dedicated social-care funding call awarded £2.5 million to 12 new projects focused on adult social care.

2. Investing in world-class infrastructure and a skilled delivery workforce

The NIHR’s sustained investment in people, facilities and technology has transformed the health and care system’s ability to translate discoveries into improved treatments and services. This infrastructure supports research funded by NIHR and by our partners. 5,405 research nurses were employed in the CRN, with 43,568 people participating in Good Clinical Practice.

3. Attracting, training and supporting the best researchers

We funded 525 new personal training awards to develop and support the next generation of researchers and leaders. More than 2,300 people were supported by NIHR-funded training awards to develop the skills they need to meet the nation’s health and care needs.

4. Partnering with other public funders, charities and industry

Working successfully with partners in the UK’s world-leading life sciences sector, our Clinical Research Network supported 1,580 industry and commercial studies and 1,738 charity funded studies.

5. Funding applied global health research and training

We supported 8 Research and Innovation for Global Health Transformation (RIGHT) awards, focused on epilepsy, severe and stigmatising skin diseases, and infection related cancers. 13 RIGHT Proposal and Partnership Development Awards (PPDA) on mental health, 17 Global Health Policy and Systems Research (HPSR) programme development awards and 61 Training Leads attended the first NIHR Global Health Research Training Forum.

6. Engaging and involving patients, carers and the public

More than 732,000 participants were recruited by the NIHR Clinical Research Network into health and social care studies. 398 members of the public reviewed 841 funding proposals, and 124 members of the public served on our funding committees and advisory boards.

Read more information about our contribution to research and access previous annual reports.

https://www.nihr.ac.uk/news/nihr-publishes-latest-annual-report/27175 

Health Research Authority UPDATE: undergraduate and master’s research projects

Please see below for a further update from the HRA on Master’s and undergraduate research. Any queries or concerns please email Suzy Wignall, Clinical Governance Advisor.

Update on student research – new eligibility criteria from 1 September 2021

The HRA and the devolved administrations, supported by the Wessex Institute at the University of Southampton, have reviewed their approach to study approval for student research.
The review aimed to ensure students have the best learning experience of health and social care research, and to reduce the time that the HRA, DAs and NHS Research Ethics Committees (RECs) spend advising on and reviewing student applications.

In March 2020 we paused student research approvals to create capacity for urgent COVID-19 research. Now, from 1 September 2021, we are introducing new eligibility criteria for standalone student research.


New critera

The new criteria mean that some Master’s level students will be able to apply for ethics review and HRA/HCRW Approval or devolved administration equivalent. Standalone research at undergraduate level that requires ethics review and/or HRA/HCRW Approval (or devolved administration equivalent) cannot take place. Arrangements for doctoral research remain unchanged.

Full details are in table one – permitted student research table. We’ve also made it clear when students are able to take the role of Chief Investigator, see table two – which type of students may act as Chief Investigator?


Alternative ways of learning about health and social care research

It is possible for students to learn about health and social care research without completing standalone projects. Looking at other ways to build skills and experience better reflects modern research and emphasises team science. View the video of our event ‘Exploring good practice in Student Research’ to hear from course leaders about how successful these alternative approaches have been (registration is required to view) or read our website for further information and ideas: https://www.hra.nhs.uk/student-research/.


Queries

If you have any queries about the eligibility criteria, please contact queries@hra.nhs.uk.

Clinical Governance RKEDF sessions

As part of the RKEDF Academics and Researchers can book onto the following sessions, either as a one-to-one meeting or a bespoke team session:

Please contact Suzy Wignall, Clinical Governance Advisor if you are interested in any of these sessions.

Meet members of the Research Ethics Panels

This morning we meet members from the Social Sciences & Humanities Research Ethics Panel (SSH REP).

Dr Parisa Gilani, Senior Lecturer in HR and OB, BUBS
I joined the Social Sciences and Humanities Ethics Panel in November 2019 as the departmental representative for People and Organisations (BUBS). As an Early Career Researcher I welcomed the opportunity to actively contribute towards the research community and meet and learn from knowledgeable colleagues across the university. I had also attended a number of SSH Ethics Panels as a researcher and found the experience to be a positive and rewarding one that enhanced the quality of research projects I had been involved in.

I joined the Panel at an interesting time – with the Pandemic hitting just a few short months after joining. I only had the pleasure of meeting my fellow Panel members in person once before we switched to virtual working. The current situation has also challenged our way of thinking about research in the current context. A lot of our recent discussions have focussed on researcher and participant safety and formulating suitable ethical protocols for online forms of data collection – particularly the use of Zoom and Microsoft Teams.

One of the things I have most enjoyed about being an SSH REP member is having the opportunity to learn about the exciting, innovative and important research that goes on across BU – outside of my own discipline. Every month I’m blown away by the innovative research projects that I have the pleasure of reading about. Many of these address current challenges such as the Covid Pandemic, well-being and links to the UN Sustainability goals.

Over the last few months we have changed the way we review Ethics documents that come to the Panel. Each research project is now assigned a lead reviewer and a secondary reviewer, which allows us the space and capacity to really delve into each project we are assigned to in-depth.

Working with fellow Panel members has also enhanced the quality of the Ethics documents I produce and enabled me to further support my own students as they embark on the Ethics process. Sometimes Ethics is seen as a tick box exercise, but if anything being a part of this Panel over the last year has reinforced to me the important role that Ethics plays in ensuring our physical and psychological safety, that of our participants and in strengthening the quality of research.

Finally, there is sometimes apprehension experienced over being asked to present research at Ethics Panels, however I can safely say that we are all a very supportive group of people, who strive to provide proportionate, consistent and high quality of research across the University. I have personally thoroughly enjoyed being part of the Panel. So if you are submitting your Ethics documentation – good luck and we hope to see you at a Panel soon!

Dr Osi Okwilagwe, Lecturer in Strategy, BUBS

A few years ago, whilst fresh out of my PhD journey and as a new member of staff, I joined the SSH REP. As an Early Career Researcher, I was indeed new to the world of research ethics and was especially pleased to be offered a place by Dr Sean Beer who was Panel chair at the time. In my four years on the role and currently working with a new Panel chaired by Prof Jonathan Parker, I have come to appreciate how large the industry of research is and how important it is for the members of the SSH REP to have a real interest in supporting Social Sciences & Humanities research at BU and in protecting potential participants’ interests – to give their opinion on whether the research methodology is ethical and fair. For me it has been an eye opener working with senior and more experienced colleagues reviewing each month an array of ethics checklists submitted by staff and postgraduate research students, all who conduct very interesting research.

I suppose when people think about ethical research, they think of rules for distinguishing between what is considered acceptable and unacceptable behaviour – right from wrong! Submitting ethics checklists for an ethics review or attending an interview with the Panel for a submission assessed as above minimal risk is really not daunting contrary to popular opinion. The SSH REP understands the sometimes complex issues involved in reaching ethical decisions; bear in mind that the Panel’s aim is to promote and facilitate research at BU. Staff and postgraduate research students who submit their ethics checklist should also not despair if the feedback from the Panel entails a long list of suggestions or amendments, as the role of the SSH REP is to ensure that all research carried out, is conducted to the highest possible ethical standards for research and to provides support to staff and students planning research projects. The mixed experiences and backgrounds of members that make up the Panel allow for wide perspectives as possible. Panel members take a robust approach to the consideration of risk and benefits of a research project. Each member brings their own valuable perspective, knowledge, and experience, as well as concern of the ethics checklist submitted for a particular research project to the Panel’s deliberations. Hence, the feedback given are usually suggestions for researchers to take on board to amend the ethics checklist or to improve the participant’s information sheet; invariably helping towards increasing the likelihood of participant recruitment and of generating quality and publishable research results.

The invaluable experience I have gained from reviewing submissions and working with the SSH REP, has allowed me to appreciate the diverse nature of research carried out by our colleagues at BU and has also ingrained in me that as researchers, a key duty is to promote ethical research.

Here are 3 top tips I like to share when considering making an ethics checklist submission:

1. If researchers are new to research, do ask for help, perhaps from a more experienced colleague/supervisor or send an email to the Research ethics team with any questions.

2. Complete the ethics checklist carefully and read the guidance on the documents to be submitted along with the checklist.

3. Spend a considerable amount of time on the Participant Information Sheet; the adequacy of consent is important. So do identify any contentious issues there may be in conducting the research.

Meet members of the Research Ethics Panels

On Monday we focussed on the work of the Research Ethics Panel and yesterday we heard from Dr Orlanda Harvey who visited the Social Sciences & Humanities Research Panel as part of her PhD journey.

Today you get to meet some of its members with the focus on the Science, Technology & Health Research Ethics Panel (STH REP).

 

Dr Liam Wignall (Psychology Department)

My research explores different aspects of sex and sexuality, looking at sexual identities and the experiences of non-heterosexuals; changing sexual practices, including during COVID-19kink activities and the changing role of the internet. Given my research interests on the often personal topic of sexuality, I am keenly aware of the need to consider the ethical implications of any research conducted. I have sat on numerous ethics panels and had fascinating discussions about my research and the ethical considerations. This has ranged from thinking about the wording of the questions and how participants may perceive them, to making sure I think of my own safety when collecting data in the field. These discussions forced me to think about how I conduct research and providing justifications for each step, ultimately improving my studies.

I became a member of the panel so that I could offer the same advice to others when they were conducting research, asking other researchers the same questions that I was once asked: “What precautions have you taken should things go wrong?”; “How are you protecting yourself when conducting research on a sensitive topic?”; “Do participants know what will happen to their data?” Often when conducting research, we can become so focused on one aspect of the project that it’s helpful for others to ask these questions – I see this as one of the jobs of the ethics panel.

The principal role of the STH REP is to ensure that all research is conducted in an ethical way, following principles and procedures set out by BU and associated bodies (e.g., British Psychological Society). I see my role on the panel as encouraging researchers to consider how they can follow these guidelines to conduct great research. Ethics is not about preventing research from being done, it’s thinking about how good research can be done in an ethical way.

On a personal note, it’s also amazing to see the range of research projects being conducted at Bournemouth University. Being on the panel allows me to chat with colleagues across the faculty and ask them about their research. As a panel, we have had ethical discussions relating to how technology can improve the lives of people with physical disabilities; the intricacies of how dating profiles are used; and how to explain research to children to ascertain consent. Three-hour meetings can just fly by…

Dr. Sofia Meacham (Senior Lecturer in Computing Department of Computing and Informatics)

“Why did I become a member?”

I became a member of the STH REP three years ago through my strong interest on the subject as part of my own research. Specifically, ethical considerations for Artificial Intelligence decision making and their acceptance from scientific and wider community was the matter that I came across first in my research. This raised an interest in how the two worlds: technical achievement and ethical considerations can be combined and the challenges arising from this combination can be overcome. Finding a community of like-minded academics from several fields was obviously the next step to progress this interest, get accustomed with BU’s processes on the matter and contribute through my previous knowledge on technical and ethical matters. Last but not least, ethics has been an integral part of my education from an early stage such as primary school through ancient Greek philosophy and family traditions.

“What do you like about being a member?”

After becoming a member and although the participation is voluntarily, I enjoyed every aspect of it. Without exaggeration, I have been given the option to reduce my workload by stepping down which I have rejected! Being a member, the panel discussions once a month provide a multi-disciplinary approach opening my personal horizons and patterns of thought. There is a democratic handling of all opinions and there is not a single meeting that was not beneficial and enjoyable. Although the panel meetings are taking place with a pleasant environment, the responsibility that the committee has to academia and the society is being taken very seriously.

Last but not least, I would like to emphasize that ethical considerations are of increasing importance in todays rapid technological and other developments. Academia should play integral role to ensure that research developments are performed in alignment with ethical considerations and STH REP is an excellent place within our BU academic community.

Thank you Liam and Sofia!

Tomorrow you get to meet members from the Social Sciences & Humanities Research Ethics Panel

What it’s like to attend a Research Ethics Panel …. A PGR’s account

Undertaking Research – Facing the BU Ethics Panel

By Orlanda Harvey

When you start your PhD journey, one of the first hurdles that you face is gaining Ethical Approval for your study. This can be a very daunting concept at the beginning, as it is often a complete unknown, or it was for me, as this was the first time I had to go through the process. Looking back now; from the very comfortable vantage point of having achieved my doctorate, it is easy to forget the anxiety and mystique surrounding this process. Questions such as: What happens if I do not get approval? dominated my thoughts. I was one of the lucky ones, for although I was seeking approval to investigate people’s experiences of using substances (In this case Anabolic Androgenic Steroids) which would mean I would have to face the BU panel, I did not need NHS ethical approval. Sitting in an office (the joy of life pre-Covid) alongside peers who were facing that experience made me very thankful, for small mercies, as although the BU process feels as if it takes a long time comparatively, with hindsight it is efficient. This, however, does not mean to say that I did not experience a few bumps in the road.

The key to success for me was advice from my Supervisory Team to ensure that I took time to get all my ducks in a row prior to submission and to take the time to prepare all my information sheets and paperwork. This was valuable as there were no changes required to my initial submission, and it went straight through to the panel. I had also looked at the panel meeting deadlines so that I could plan for my submission date and sought advice from the Research Development and Support (Governance) Team to clarify a few points. Going through the online documentation felt a little bureaucratic and at times repetitive but it was very straightforward and easy to use. It certainly made the write up of the ethics and methodology element chapters of the Thesis easier; as one of my supervisors is prone to say, no writing, when it relates to your study, is ever wasted (thank you Edwin).

The panel meeting itself was an interesting experience, for although my supervisor was there to support me (thank you Margarete) it was very clear that the focus was on me and my plans for the research, so all the questions were directed my way. At first, I was apprehensive but actually the experience turned out to be quite enjoyable. After all, at that point I was incredibly enthusiastic about my project and these people wanted me to talk about it! I later learnt to treasure such moments. The questions they asked came from a place of curiosity, and it was not long into the meeting before I realised that they were interested in supporting the research and were ensuring that I had considered key ethical points. If I am totally honest there was only one question that I found a little left field, but you are never going to agree with everything.

It was not all plain sailing, I did pass the panel but still had the email with, a few minor amendments needed. However, these were easily resolved, added clarity to the participant information sheets and could be covered by just replying with the amendments to the panel chair. Overall, the whole experience was beneficial to both my development as a researcher, and my understanding of the ethics challenges.  The positive comments from the panel also proved to be a bolster to my confidence at that early stage in my PhD Journey.

A final unexpected outcome was that, as a result of going through the checklist I had to consider if my population was vulnerable, as people who use illicit drugs are quite often are given this label as a de-facto result of their drug use. This was interesting as although they were using drugs that although not illegal, they do fall into a grey area of the law and was something that we discussed at Panel. This made me think more deeply about the population as a whole, and as a result ended up in me writing a short paper, which was published on the ethics of using AAS and the perceived vulnerability of this group: ‘Shades of Grey’: The Ethics of Social Work Practice in Relation to Un-prescribed Anabolic Androgenic Steroid Use,  which, brings me back to Edwin’s sage advice: nothing you write should ever be wasted 🙂

The role of the Research Ethics Panels at BU

Since 2014, the Social Sciences & Humanities (SSH) and Science, Technology & Health (STH) Research Ethics Panels have reviewed and continue to review ethics checklists submitted by staff and postgraduate research students (above minimal risk only). Their role is to review the ethical aspects of the study to facilitate high quality, safe research practice.  This may be involve a light-touch process if the research is deemed low risk, or it may include an interview with the Panel if it is assessed as above minimal risk.

When first established, the Panels were chaired by Dr Sean Beer (SSH REP) and the late Prof Holger Schutkowski (STH REP) who worked hard to establish the process we have today.  The current Panel Chairs are Profs Jonathan Parker (SSH REP) and Sam Porter (STH REP) who picked up the reins in February 2019 to continue and champion the work of the Panels and who work tirelessly to support our research community.

The Chairs are assisted by Deputy Chairs, Prof Richard Berger (SSH REP) and Dr Jayne Caudwell (STH REP) and academics colleagues from across BU and representatives from Professional Services and independent lay members.  Together, members have a wide range of experience and expertise.  This allows the Panel to provide well structured, consistent and balanced opinions when considering the ethical viability of projects submitted for review.

Support for the panels is provided Sarah Bell (SSH REP), who is the University’s Research Governance Advisor, and Suzy Wignall (STH REP), who is the Clinical Governance Advisor. They are happy to answer any queries that you may have.

Going through the process of an ethics review shouldn’t be a tick box exercise that is forgotten about once a favourable opinion is secured.  This isn’t what the process is about.  Ethical issues can occur at any time throughout the life cycle of a research project – when recruiting participants, in process of analysing data, in the reporting of research results.  Your ethics review is a living document that should be referred to and updated as and when appropriate.

Members are approachable should you have questions before you submit an ethics checklist and there is plenty of guidance available via the research governance & integrity website.  Never think you are alone in the process.  We are here to help and be a source of support throughout the life cycle of your research project.

NIHR issues final update on implementation of the Restart Framework

The NIHR published a Framework on 21 May 2020 – when the NHS started to restore routine clinical services – to support the restarting of research paused due to COVID-19. Developed in partnership with multiple stakeholders and the devolved nations, the Framework provides a flexible structure for local decision-making.

You can read the latest and final update here.

Integrated Research Application System (IRAS) – survey open

IRAS, the Integrated Research Application System, is changing.

The Health Research Authority wants to hear from people who’ve used the system about how it should look in the future.

A short anonymous survey https://www.surveymonkey.co.uk/r/5B5X95H is available until 24th February 2021.

Department of Health and Social Care statement on prioritisation of research studies

Please find below a statement from the Department of Health & Social Care. Please bear this in mind when in correspondence with NHS Trusts and if planning a clinical research study.
If you have any queries, please contact Suzy Wignall, Clinical Governance Advisor, in the first instance.


Statement from DHSC 

We recognise that at the current time those working in many NHS sites are under huge pressure as the number of COVID-19 cases and admissions to hospitals continue to rise and frontline clinical staff are unable to work due to sickness.

While we have a small number of proven treatments and vaccines for COVID-19, more are needed to reduce transmission, reduce the number of patients that require hospitalisation and to improve outcomes for those that do. It is therefore critical that at this challenging time we continue to recruit participants to our urgent public health (UPH) studies. As such I am writing to confirm that the current levels of prioritisation for research studies, set out within the Restart Framework still apply, as follows:

  • Level 1a (Top Priority) – COVID-19 UPH vaccine and prophylactic studies (as prioritised by the Vaccines Task Force and agreed by Jonathan Van-Tam, deputy CMO) and platform therapeutics trials (currently RECOVERY/RECOVERY +; PRINCIPLE; REMAP CAP).
  • Level 1b – Other COVID-19 UPH studies
  • Level 2 – Studies where the research protocol includes an urgent treatment or intervention without which patients could come to harm. These might be studies that provide access to potentially life preserving or life-extending treatment not otherwise available to the patient.
  • Level 3 – All other studies (including COVID-19 studies not in Level 1a or 1b).

I would also like to take this opportunity to remind you of the NIHR guidance for a second wave of covid 19 activity (https://www.nihr.ac.uk/documents/nihr-guidance-for-a-second-wave-of-covid-19-activity/25837).This guidance still applies and, as outlined, states that the deployment of staff funded through an NIHR Infrastructure award or funded by the NIHR Clinical Research Network (CRN) to front line duties should only occur in exceptional circumstances.

The deployment of clinical academic staff should be undertaken within the guidelines issued by a working group convened by the UK Clinical Academic Training Forum and the Conference of Postgraduate Medical  Deans of the UK. Where NHS Trusts consider they need to redeploy staff to support the frontline this should only be done to support clinical activity during the emergency phase of the pandemic and we would expect them to return to their R&D roles as soon as possible, once the pressures on the system reduce.

As indicated by the Restart Framework, at the current time, we need to continue prioritise our support for the most urgent COVID-19 research as part of the response to tackle the pandemic. At the same time we need to ensure we continue to try and maintain support to deliver non-COVID studies currently open on the portfolio, particularly those within Level 2. A system-wide Recovery, Resilience and Growth programme has been established which brings together the key partners across the clinical research ecosystem to ensure the UK is well-positioned to take a coordinated national approach to achieving the recovery of the UK’s clinical research delivery and restore a full, diverse and active research portfolio as soon as practicable.