Over the past few months, we have been having a conversation about how we could make ethics review more streamlined and proportionate. We've spoken to people working in research and Research Ethics Committees (RECs) to hear what they think works in the current service and what could work 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.
- Members of the public want us to make better use of committee members’ expertise and time.
Now we want to broaden the conversation, and this consultation is the next phase. Based on what we've heard so far, we've developed some ideas on how we could rethink ethics review, to improve both the application journey and the review itself. Now we want to hear from you!
Take part in the online survey now
- introduce a tool to support researchers to think more ethically
- use ethics review by expert Research Ethics Service staff
- delegate ethics review for studies within a programme of research
We hope to refine the current journey for applications, adopting increasing levels of scrutiny according to the nature of the research and the ethical issues it raises.
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
What is outside the scope of this consultation?
Through this consultation we are 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, such as how Research Ethics Committees make decisions and who makes up their membership.
Your opinion matters
We want to hear from you. Whether you are a member of the public, a current or former Research Ethics Committee member, staff involved in research ethics review, a researcher, research organisation or you’ve taken part in a study, your opinion matters to us.
We want the ideas presented here to spark discussions, to consider how we can continue to improve.
The consultation includes:
Developing our ideas
We have worked closely with an advisory group to help us develop these ideas. We have also gathered informal feedback from a range of interested people. This feedback has allowed us to better understand some of the issues or unintended consequences of our proposals.
One of our initial ideas included ethics review for hospitals and universities conducting research. This idea could have seen the HRA and our partners in Northern Ireland, Scotland and Wales delegate ethics review for certain types of research to institutions who satisfy a specific set of standards. We have decided not to consult on this idea right now. Through informal discussions with institutional representatives, we heard that as research starts to recover from the pandemic, a shift to institutional review could cause disruption and increased workloads for institutions.
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.
At this stage, we are not asking for views about how these ideas might work in practice. After the consultation, we will analyse all the responses and present recommendations to the Research Ethics Service in collaboration with our partners in Northern Ireland, Scotland and Wales. We will then test and pilot any new approaches. We will publish the outcome of our consultation once it closes on 7 October 2022.
Take part in the online survey
Find out about the workshops
We will have a range of workshops and visit existing events with a range of organisations either face to face or online to discuss these ideas. Dates will be published here and advertised via social media.
|Date||Workshop details||Who this workshop is for||How to book a place|
|14/07/22||12.30pm to 3.30pm||Research Ethics Committee members||Email invitations will be sent out to REC members|
|31/08/22||10am to 1pm||Researchers and sponsors||Email email@example.com for invite|