Public conversations about ethics review – a blog by Louise Vale, HRA public contributor

In June the HRA published a report, commissioned as part of our Think Ethics work, which is looking at how we can improve research ethics review to be more innovative and efficient. The report follows a series of workshops earlier this year where members of the public were invited to discuss ethics review and who is trusted to ensure ethics in research. Our public contributors, Lynn Laidlaw, Dolapo Ogunleye and Louise Vale, observed these workshops and read the report on key findings. Here Louise gives her personal response to the report.

During the workshops I was impressed by how quickly members of the public got to grips with ethical issues, even if they had not been involved in health research before. This was reflected in the report, where their voices were very clear. I would like to highlight some of their ideas and suggestions.

Who identifies research priorities?

The workshop participants were keen for research priorities to be identified by the public and patients, rather than by government, industry and academia. I think this is such an important issue. Sometimes patients and researchers have the same priorities, but this doesn’t happen automatically. One participant mentioned a project where patient involvement had changed the research focus from life expectancy to quality of life. I have also seen research priorities shift significantly when patients and members of the public are asked what is important to them. In a charity researching spinal injury, projects initially focused on recovering the ability to walk. After consultation this changed, because people with spinal injury said that improvements in bladder and bowel control would make more difference to their quality of life. I think it’s important to remember that not all patient voices are equal. Some are less able to lobby for support or express their needs, and as a result their conditions may be overlooked for research. I would like to see some mechanisms in place to ensure fairer resource allocation between different health conditions and groups.

Moral, political and economic implications of research

Workshop participants also said they would like ethics review to take account of the moral, political and economic implications of research. I agree that we should all be looking at the big picture. This is about the risks, costs and potential benefits of the research.

I have Long Covid, a disabling condition which now affects so many people of working age that it is impacting on the economy. The Bank of England raised concerns about the record number of people leaving the workforce due to long-term illness in its May evidence session with the Treasury Committee. In July, the Institute for Fiscal Studies reported on the impact of Long Covid on individual incomes, which it estimated at £1.5 billion so far. Long Covid is a new condition and research is in relatively early stages. The economic cost of the illness is part of the context for the research.

Monitoring of research

Participants felt that ethics review and monitoring should continue throughout a research project. The main ethics review takes place before the start of the project. Project teams have to report any changes to their plans after that, as well as any serious adverse events that happen during the study. They also submit annual reports throughout the project.

The message from the workshop participants was that they expected ethics review to be a continuous process throughout the project, to ensure public trust. I think continuous ethics monitoring is an interesting idea and maybe it will become feasible with developments in technology.

One very good suggestion from the workshops was that an independent person should be appointed for each research project, so that people taking part would have someone to contact outside the research team if they had any ethical concerns. I understand that participants sometimes contact the Research Ethics Committee that approved their project with queries and concerns. On reflection, I think it would also be helpful for public contributors to have an independent person to contact, because we often have to deal with ethical issues on our projects. It's great that conversations about this are already underway.

Raising the profile of the HRA

All participants were keen for HRA and other research bodies to raise their public profile. They agreed that if members of the public had known more about research ethics and regulation before the pandemic, they would have had more confidence in the vaccines. This is a clear invitation to everyone involved in research to reach out to new public audiences.