Through 2022 we have been continuing conversations about how we could make ethics review more streamlined and proportionate. We've spoken to members of the public, people working in research and members of Research Ethics Committees (RECs) to hear what they think works in the current service and what could work even better. We've also spoken to sponsors (the individual, organisation or partnership that have overall responsibility for a research project).
We heard that:
- some researchers and sponsors feel there are unnecessary barriers and burdens in ethics review, leading to added bureaucracy and longer review timelines
- some committee members feel their workload is too heavy and time consuming and does not always focus on ethics issues
- members of the public want us to make better use of committee members’ expertise and time.
We wanted to broaden the conversation, and a consultation with a series of surveys were the next phase. Based on what we'd heard so far, we developed some ideas on how we could rethink ethics review, to improve both the application journey and the review itself.
Our ideas that we discussed and surveyed people about were:
- introduce a tool to support researchers to think more ethically from initial research idea, to the conduct of the study and beyond
- use ethics review by expert Research Ethics Service staff
- delegate ethics review, under predetermined conditions, for studies within a programme of research to institutions running those programmes.
Making sure good quality research happen means the NHS can benefit from trustworthy evidence. The dedicated people who sit on Research Ethics Committees will continue to be central to this aim. For studies which are higher risk and have more significant ethical issues, a committee will always be the most appropriate method of review. Those studies include:
- clinical trials of medicines (known as CTIMPs) and medical devices
- studies involving adults who are not able to consent for themselves
- studies using additional ionising radiation (X-rays and CT scans for example) to routine clinical care
- studies involving people in some residential care homes and social care settings.
Our ideas will help RECs be able to focus their previous time as volunteers on more ethically complex studies. Tools to help researchers maintain focus on ethics throughout study development, will also help their institutions review the ethics of their studies, which is what already happens in many cases such as with university research ethics committees. These, and using expert staff to review certain studies under specific conditions to be further defied, will also allow REC time to be dedicated to more complex studies, and any studies which are required by law to have REC review.
What was outside the scope of this consultation?
Through this consultation we were not proposing changes to other research reviews such as governance and legal assessment or reviews by other bodies or changes to the application portal, IRAS. Nor are we asking about changes which are being considered later in Think Ethics or other national work, such as how Research Ethics Committees make decisions and who makes up their membership.
After the consultation
These ideas have the potential to change ethics review in the UK. We want to be sure that the benefits of change outweigh the risks and that we have thought through all the likely consequences.
During the public conversation, we did not ask for views about how these ideas might work in practice – we wanted to test the concepts with people, and better understand possible benefits and risks across the research system, with a view to undertaking detailed operational planning once it was clear which ideas our stakeholders think should be progressed. After the online survey and workshop period, we are analysing all the responses. We will publish the outcome of our conversation, and will present recommendations to the Research Ethics Service in collaboration with our partners in Northern Ireland, Scotland and Wales. We will then develop detailed pilots to test new ways of working in 2023, after which detailed, evidenced recommendations for national changes to research ethics review will be considered by the HRA and our partners in Northern Ireland, Scotland and Wales.