Shaping standards globally - a blog by Janet Messer, HRA Director of Approvals

The UK is one of the best places in the world to do health and social care research and fundamental to that is our effective ethics approval system.

Last month I attended a workshop in Brussels with leading experts from around the world to collaborate and share learning on the ethical issues of human challenge studies.

One type of human challenge study is called a human infection model, where healthy volunteers are intentionally given an infection in a safe and controlled environment. These types of studies are used to test vaccines or treatments for infections.

Intentionally infecting a healthy person raises lots of ethical issues so effective ethics review is really important for this type of research to take place in a way that people can trust. A world-leading Covid-19 human challenge study was recently conducted in the UK, so we have lots of learnings to share.

The workshop brought together researchers, healthcare professionals and research ethics experts who were all involved in conducting or reviewing human challenge studies.

I attended the event with Dr Simon Kolstoe, Research Ethics Committee Chair, who provided the ethics committee viewpoint, and Dr Chris Chiu, who led the Imperial College London Covid-19 human challenge study. We were invited because the UK is the only country that was able to run Covid-19 human challenge research.

My role was to explain how the UK’s research ethics review system is organised and how we approached the review of the Covid-19 human challenge studies.

All challenge clinical trials taking place in the UK need to be reviewed by a Research Ethics Committee, who give an opinion on whether the research is ethical and fair.

The UK is a world leader in supporting new ways to do research safely and ethically, so it was great to share the UK’s expertise in this field of research, and to demonstrate how our research ethics review is coordinated to provide a robust and effective review of these complex, and innovative studies.

In the case of the Covid 19 human challenge research, this involved convening a specialist Research Ethics Committee made up of experienced members from around the UK, some of whom had reviewed other challenge studies before.

Our approach was recognised by the World Health Organisation as a model of good practice for ‘ethics review of novel, complex and sensitive study designs’.

During the conference, I also discussed the importance of public involvement to inform our approach so that we can earn people’s trust in the way that the research will be done and the ethics review of this.

This is really important if we want to increase the diversity of people taking part in research because it can ensure that research is designed in ways that make it easier to take part and that everyone can be confident to take part because they know that ethics review will have considered their best interests. Health and social care research should be done with and for everyone to meet the needs of the whole population.

While the HRA is a UK based organisation, research is global, and a lot of research takes place across multiple countries.

By sharing learning globally, we can help shape more safe and ethical research worldwide.

With the UK’s strong research ethics system, and our role as one of the main organisations in the UK coordinating this important work, we can help shape standards globally that benefit everyone involved in health and social care research, no matter where they live.