We've been working together to make ethics review more innovative, efficient and trusted. Find out how Think Ethics began.
- Research ethics review: why it matters
- Listening to views about the current service
- Testing new approaches to ethics review
- Research ethics review for the future
- Differentiated, proportionate review methods
- Better participant information
- The right committee meeting format for a diverse membership
- Streamlined documentation for REC review
- More consistent REC review
- Working with others to agree the improvements
- Partners in the Devolved Administrations
- Meet the members of our Ethics Review Advisory Group
Research ethics review: why it matters
Independent research ethics review ensures that the rights and wellbeing of people taking part are at the heart of all research. It reassures the public that health and social care research is designed and carried out in a way which responds to their needs, enables them to make informed choices about whether to take part and ensures they are treated fairly.
The review, carried out by Research Ethics Committee (RECs), applies to all types of research in the NHS or in social care (with very few exceptions), which involve people, their tissue or their data, regardless of who is funding the research or which institution is leading it. RECs also review studies which test medicines in human subjects for the first time. Whilst the goal is to facilitate and enable high-quality research, it retains a crucial independence from the research team and sponsor. Research Ethics Committees operate according to the principles set out in the Declaration of Helsinki, first published by the World Medical Association in 1964.
RECs and the service that supports them have evolved over the decades since the declaration was published. Today in the UK, research ethics review is carried out through a network of 84 RECs across the UK, coordinated by the Health Research Authority (HRA) and our devolved administration equivalents and underpinned by a single application portal and common standards and processes.
The people who sit on RECs bring a range of professional and lived experience to the review of research. They give their time for free and provide a vital service to research teams and the people who take part in studies.
Listening to views about the current service
We heard the views of REC members, patients, researchers and life sciences companies about what aspects of research ethics review work well and what could be improved. We have also analysed our service to understand where ethics review adds most value, to be more helpful to researchers and, ultimately, to enable patient-centred, ethical research to start as quickly as possible.
During our listening exercise, we’ve heard that:
Researchers and research sponsors:
- value research ethics review because it provides independent scrutiny of their work, building public confidence in research. They also value the space it provides to discuss the ethical issues and receive helpful feedback
- welcome the continuation of virtual meetings used during the pandemic, to enable them to attend REC meetings
- would like to see a reduction in the volume and complexity of information they need to submit for review. And they would like the review to be more focussed, highlighting essential improvements and doing so in a consistent way across committees.
Patients and participants:
- value research ethics for the independent assurance it provides. It can strengthen the relationship between researchers and participants and helps to ensure that study information is clear
- would like to see a greater focus on ensuring patient and public involvement in the design and management of research, improved participant information and a greater focus on including a wider range of people in research studies.
- are rightly proud of the contribution they make to high-quality research
- would welcome a reduction in the volume of documentation they review
- would welcome review of the appropriate balance between protecting participants in research and enabling autonomy.
The feedback we have received so far has allowed us to identify key areas for change.
Testing new approaches to ethics review
We tested new ways of carrying out ethics review outside of the COVID-19 pandemic response service. Back in January 2021, the HRA and partners in Wales, Scotland and Northern Ireland opened a pilot to test a fast-track ethics review service for non-COVID Phase 1 and global clinical trials. The key features of the service were:
- a dedicated fast-track Research Ethics Committee (REC)
- a paid committee chair
- committee members drawn from a panel of existing members, rather than a set committee membership
- dedicated approvals staff
- shortened timelines between submission and REC meeting and between REC meeting and outcome.
The pilot service aimed to carry out research ethics review within 15 days of submission (not including time taken by applicants to respond to requests for further information), saving 50% on standard timelines for studies of this type.
During the pilot phase, between January and March 2021, we found that:
- there is demand for fast-track ethics review. Satisfaction with the service was high and some applicants would be willing to pay for an accelerated service. However, integration with the wider approvals service and the UK regulatory system is important
- the service benefits companies, making the UK more competitive and enabling quicker patient access to medicines
- a swift review is possible: the median review time (not including the time taken for applicants to respond to enquiries) was 14 days
- REC members were, in the main, very satisfied with being part of the fast-track service, despite the turnaround times being significantly shorter.
Accordingly, the HRA now offers Fast Track review for global clinical trials and studies that are in the early stages of testing medicines, known as Phase I
Research ethics review for the future
Researchers often talk about ‘getting ethics approval’, as part of the process they need to go through before their study can begin. Use of this shorthand in a complicated and sometimes lengthy process is understandable, but it suggests a view that researchers see ethics review as a hurdle to get over, rather than an opportunity to help make their research reflect the needs of participants and the wider patient population.
We know that researchers value ethics review, but although many will have good intent, they may not rigorously consider ethical issues from the very beginning of planning their research. We want to avoid research ethics as being seen as a check done by a committee, but instead as a way of thinking which can be used throughout the research, but which is enhanced by REC review.
One of the ways this can be done effectively is by involving patients, service users and the public in research studies. Public involvement in research means research that is done with or by the public, not to, about or for them. It means that patients or other people with relevant experience contribute to how research is designed, conducted and disseminated. Involving people with relevant lived experience in the design and development of research can improve its quality and relevance.
At its heart, our work to improve research ethics review is about embedding ethical thinking throughout research, as well as to improve the public understanding of ethics, so the public can be more involved and hold us to account. That’s why we have called it ‘Think Ethics’. We aim to design a research ethics review service which further enables thinking ethically – starting long before and finishing long after review by an ethics committee.
The analysis and feedback received so far have led us to focus on the following areas for change:
- differentiated, proportionate review methods
- better participant information
- a better experience for REC members
- more consistent REC review.
We think this approach will derive more benefits:
- public, patients, participants and applicants feel protected and reassured
- participants are better informed about the studies they join and have a better experience in taking part in research studies
- researchers applying for ethics review have a clear route of review for different types of research and each research study is reviewed in a way that suits the ethical issues it raises
- research ethics review is more focused, consistent and makes good use of the skills and experience of REC members
- the involvement of patients and the public in the design, conduct and dissemination of research is ‘business as usual’, not an optional extra
- international companies choose the UK as their preferred place to do research.
Differentiated, proportionate review methods
The health and social care research reviewed by ethics committees across the UK is enormously varied; using a range of research methods, involving different types of participants and testing many different interventions across numerous disease areas. Some raise minimal ethical issues, whilst others require careful review to ensure the dignity, rights and autonomy of participants are protected.
To reflect this, we offer three types of review:
- full REC Review – providing committee review of studies with a median timeline of 26 days
- Proportionate Review – providing a light-touch review of studies outside of a committee which raise no material ethical issues with a median timeline of 19 days
- Fast-Track Review – an expedited review, currently available to Clinical Trials of Investigational Medicinal Products (CTIMPs).
We know that prioritisation works and that not all research studies raise the same type or complexity of ethical issues. The current approach to differentiated review methods is welcomed. However, we could improve them and go further.
As part of Think Ethics we have reviewed methods including review at a REC meeting, light-touch review and, building on feedback from researchers, the possibility of self-assessment by researchers and sponsors. We want to ensure that REC members’ time is focussed where it adds most value, reducing the work pressure on them and reducing bureaucracy for studies with few or no ethical issues.
Better participant information
People who are invited to take part in a research study need clear, accessible information about the study so that they can decide whether or not to join. Whilst many study teams produce excellent participant information developed in partnership with people and communities, RECs still see participant information that is lengthy, complex and inaccessible to many people.
Most studies are not given a favourable opinion at first review and around 40% of those are the result of problems in the information and consent documentation. This is often because the participant information is not good enough, but there is also some inconsistency in the changes that RECs ask research teams to make. This creates additional work for applicants, RECs and staff and extends the timeline to the final outcome.
Through Think Ethics, we are working with research participants, researchers and REC members to improve participant information and ensure that review of this information by a REC is consistent and proportionate. Good public involvement in the development of participant information is central to this.
The right committee meeting format for a diverse membership
The use of virtual committee meetings during the pandemic has enabled greater attendance by applicants, made co-opting committee members more straight forward, and has opened up the possibility of becoming a REC member to a wider group of people for whom attendance at a face-to-face meeting would be difficult. However, we know that REC members value the sense of community that their committee provides and benefit from the times that they are able to meet and work together in person.
Through the Think Ethics programme, we have designed a committee format which takes advantage of virtual working but retains the sense of community within and between RECs which is so important. This will be aided by different forms of learning and opportunities for REC members to come together outside of a formal REC meeting.
Streamlined documentation for REC review
REC members often observe that the information provided in response to IRAS questions and in study documentation takes many hours to review and the information can be repetitive. They report that it is hard to know what is most important to focus on and what can be checked by staff.
In the next stages of Think Ethics programme, we will review and make improvements to research ethics questions for applicants and ensuring REC members review only the information required for ethics review.
More coherent REC review
Whilst RECs use the same approach to considering ethical issues and work within standard operating procedures, there will always be some natural variation in how they make decisions. In some areas, however, this variation is experienced as being too wide, leading to a frustrating experience for applicants, and, potentially, rates for provisional and favourable opinions at first review that differ in a way that is not justified. .
Through the Think Ethics programme’s Ethics in Focus project, we're working with REC members to determine what level of variation is appropriate, including learning from the examples of good practice in individual RECs and the experience of the fast-track REC and consider how good practice can be spread across the service.
Working with others to agree the improvements
Research ethics review affects many people: participants in research projects; patients and the public who have an interest in research and its findings; Research Ethics Committee members and the staff who support them; researchers and research sponsors and funding bodies. To design changes which meet the needs and expectations of these stakeholders, we will work in an open and consultative way, listening to their perspectives and experiences, whether though standing groups, workshops or more in-depth research.
We work closely with organisations in Wales, Northern Ireland and Scotland who support Research Ethics Committees and have established a Think Ethics Advisory Group, chaired by Professor Andrew George, a Non-Executive Director on the HRA Board.
Our advisory group gives advice based on their lived and professional experience. It includes academics, commercial sponsor organisations, REC members and Public Involvement Network members. It also includes our devolved administration partners.
Partners in the Devolved Administrations
Health and Care Research Wales / Welsh Government
Health and Social Care Research and Development, Northern Ireland
NHS Research Scotland / Chief Scientist Office
Meet the members of our Ethics Review Advisory Group
The group includes researchers, research organisations, ethics committee members, patients and the public.
Professor Andrew George (Chair), Non Executive Director at the HRA
'In addition to being a NED at the HRA, I have a strong interest in education and am on the board of Health Education England and chair of two Colleges. I am Chair of Imperial College Health Partners, who are responsible for fostering health innovation in North West London, and am on the board of Surrey Borders Partnership NHS Foundation Trust. I am an executive coach. My academic background is in immunology. I chaired the Hammersmith Hospital Research Ethics Committee for a decade and was Chair of the National Research Ethics Advisors’ Panel.
Sue Harrison MBE, REC Vice Chair, acting Chair Berkshire B, lay plus member
'I have been a lay plus REC member since 2011 so I must enjoy it! Recent events such as the EU exit and the COVID-19 pandemic have really highlighted the value of the first class research being carried out in the UK. I welcomed the opportunity to join the advisory group to help improve the efficacy and efficiency of our reviews and meetings, but also ensure that it is a rewarding experience for everyone involved. This will help to ensure that the UK maintains and improves its competitiveness in life sciences.'
Marie Bardsley, REC lay member
‘I have a PhD in neurochemistry followed by three postdoctoral fellowships in Trinity College, Dublin, Southampton University and Cambridge University where I also taught undergraduates and postgraduate courses in biochemistry and pharmacology. Subsequently I was a commissioning editor of medical publications for Elsevier in the Netherlands. I was appointed manager of academic medical journals for WB Saunders in London. These jobs both involved international travel to visit research groups engaged in emerging fields of medical research. In 2000 I started by own virtual company publishing academic medical journals online. This company now supports other companies. Apart from REC activities, I worked as a data manager in Bart’s Health Emergency Department (ED). The role was part of Emergency Department (ED) Youth Crime data sharing initiative, funded by the Department of Health (TKAP). The initiative aimed to map crime and engage with local community safety partners using data gathered from emergency departments.’
Oliver Matias, MPhil/PhD student at City, University of London and REC member
‘I have sat on the East Midlands - Nottingham 1 REC for almost four and a half years now. I have previously worked in clinical trials and have also worked in research and healthcare more broadly and studied as part of my degrees. I have taken part in clinical research as a patient/participant before. I’m currently undertaking Mitra studies (Buddhism) of which ethics is one of the 'Theefold Path.’
Dan Mace, lay plus REC member
‘I have seven years’ experience as lay plus member of a regular REC and recently of the fast track REC. I’m also a member of the local Health Watch and, until recently, spent 12 years as a Citizens Advice volunteer.’
Dr Nicola Williams, Director of Support and Delivery, Health and Care Research Wales
‘I have over 25 years of experience in NHS research, previously as a researcher in primary care and public engagements and then as Director of Research and Development in an acute trust. I am now responsible for ensuring efficient, effective and high-quality research support and delivery across NHS Wales.’
Dr Joanne Doleman, Senior Research Governance manager at Wellcome Sanger Institute and REC lay member
‘I have been a REC member for almost four years and I additionally was a research scientist for many years running human intervention studies. In my role as governance manager, I act both as a sponsors’ contact and additionally support researchers in their applications through NHS REC and HRA review.’
Professor Nalin Thakkar, Vice President, Professor of Molecular Pathology, Consultant Histopathologist, The University of Manchester
‘I have significant experience of research ethics and delivery of the NHS research ethics service having served previously as Chair of the university REC, Vice-Chair of an NHS REC, National Research Ethics Advisor, and as a Non-Executive Director of the HRA. In my university role, I am the executive lead for research governance (including sponsor responsibilities), ethics and integrity.’
Rasha Al-Lamee, Clinical Senior Lecturer and Consultant Cardiologist, Imperial College London and Imperial College Healthcare NHS Trust
'I am a clinical trialist with expertise in placebo-controlled trials of interventional procedures. I am co-lead of the cardiovascular theme of the Imperial NIHR BRC, NIHR CRN cardiovascular speciality lead for North West London and a public and patient involvement/engagement theme champion at the National Heart and Lung Institute.'
Lynn Laidlaw, Public Contributor/Research participant/Patient researcher
'I live with a rare disease and multiple long-term conditions. I am an experienced public contributor and have recently been funded, as part of a team, to do a piece of patient led research.'
Susan Kohlhaas, Director of Research, Alzheimer’s Research UK
'I am the Director of Research at Alzheimer’s Research UK which is a major funder of dementia research in the UK. I have worked for over a decade in the charity sector working closely with the academic community and industry to support research from concept to completion. It’s great to be part of this group that aims to streamline the HRA processes and support more research that can ultimately benefit patients.'
Thomas Smith, Life Sciences Public Engagement Specialist, ProPatient
'I am a public engagement specialist, combining experience of policy, clinical research and media representation to emphasise that meaningful patient engagement is the key to sustainable innovation in healthcare. I am a member of the European Health Parliament and a European Patients’ Academy on Therapeutic Innovation (EUPAT) Fellow, and an internationally-recognised consultant operating with patient organisations all over Europe.'
Dr Mark Sheehan, Oxford Biomedical Research Centre Ethics Fellow, Ethox Centre, University of Oxford
'I am a philosopher by training and have worked on issues in research ethics and governance for about 20 years. This has involved research in ethics and delivering training to researchers and REC members about research ethics. I have been a National Research Ethics Advisor since 2012.'
Linda Cartwright, expert REC member and alternate Vice Chair
I am an expert member and Alternate Vice Chair of Oxford C REC. I have a medical background with particular experience of health protection and microbiology.
Dr Nicole Mather, Non Executive Director of the HRA and Wellcome Sanger Centre
'I lead IBM’s Life Sciences consulting team in the UK, which brings world-leading business, technology and digital capabilities to innovative pharma and growing SMEs. IBM deploys deep expertise enabling digital reinvention, bringing leading capabilities across digital strategy, analytics, cognitive technologies and cloud technology solutions. As Director of the Office for Life Sciences, I have shaped the UK ecosystem and health data environment and led for UK government on the development of the Life Sciences Industrial Strategy and first Sector deal, focusing on the creation of new UK industries in the UK such as Genomics, Digital Health and early diagnosis. Before IBM, I worked at Deloitte and AT Kearney, providing strategy consulting across Health and Life Sciences from Big Pharma and Med Tech to SMEs and national policy. I am a Non Executive Director of the Wellcome Sanger Centre and the Health Research Authority and hold a DPhil, MSc and MA from the University of Oxford.'
Chris Cannaby, Senior Clinical Operations Manager, MSD UK
'I’ve worked in clinical research for almost 20 years, starting off filing one page application forms in an R&D office and then seeing the gradual, though exponential increase in hoops and obstacles to deliver studies in the NHS in roles with the Clinical Research Network, NHS set up and delivery teams, R&D management, and latterly within the HRA and pharma. My main goal in that time has been to support people that want to do effective, high quality, safe research deliver their studies, and to work to start the decrease in those hoops and obstacles.'
Jonathan Fennelly-Barnwell, Deputy Director Approvals Service at the HRA
'I have been at the HRA since 2011, having joined the National Research Ethics Service as a regional manager, then leading the newly formed HRA’s collaboration and development work. Before this, my career was primarily in public health, mental health services and service development.
My academic interests are medical ethics and law, and particularly their relationship with change. I am currently a doctoral candidate at the London School of Hygiene and Tropical Medicine, researching ethics and legal embodiment in public health policy. I am the HRA’s Caldicott Guardian, responsible for making sure that people’s private health and care information is used properly.'
Professor Mary Dixon-Woods, Director of THIS Institute, University of Cambridge
‘This initiative to align systems, processes and values relating to research ethics with what the system is seeking to achieve will be hugely valuable. I am particularly impressed with the emphasis on respect for participants is the guiding principle and with the drive for clarity, consistency and smooth processes.’
Bryan R Deane MA, PhD, dipM Director, New Medicines & Data Policy ABPI (Association Of The British Pharmaceutical Industry)
'I have a degree in Pharmacology and a PhD in Neuropathology, and over 25 years’ experience in the pharmaceutical industry. This covered development and launch of new medicines in a variety of therapy areas including infectious diseases, diabetes, respiratory and oncology, and a wide range of countries and regions. I joined the the ABPI (Association Of The British Pharmaceutical Industry) in May 2018, covering all aspects of New Medicines discovery, development and manufacturing including a focus on AMR, vaccines, advanced therapies, and harnessing health data. I’d like to see as many patients as possible have the opportunity to take part in clinical research, that research is relevant to improving patient outcomes and the patient experience and that the results of research are available, accessible and understandable.'
Other Ethics Review Advisory Group members
|Helen Lewis-White||North Bristol NHS Trust|
|Jo Rycroft-Malone||National Institute for Healthcare Research (NIHR)|
|To be confirmed||National Institute for Healthcare Research (NIHR)|