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Re-thinking Ethics Review - public consultation

About the consultation

Over the past few months, we have been having a conversation about how we could make ethics review more streamlined and proportionate. We have spoken to people working in research and in ethics committees to hear about what they think works in the current service and what could work better. We have also spoken to sponsors (the individual, organisation or partnership that have overall responsibility for a research project).

This is what we heard:

  • 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 have heard so far, we have developed some ideas on how we could re-think ethics review, to improve both the application journey and the review itself. Now we want to hear from you

Our ideas:

  • 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 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 the 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 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 an online survey and public workshops.

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, however at this time we have decided not to consult on this idea. Through informal discussions with institutional representatives, we heard that now is a time of intense work 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 23 September 2022.