The background to Think Ethics

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:

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.

Other Ethics Review Advisory Group members

• Ethics Review Advisory Group terms of reference