What difference is public involvement making to the HRA’s work? Writing guidance on public involvement in the design and conduct of phase 1 healthy volunteer studies

Last updated on 30 Apr 2024

We have been working with the Medicines and Healthcare products Regulatory Agency (MHRA) and the Department of Health in Northern Ireland to write guidance on public involvement in clinical trials. The guidance will support the introduction of new legislation on clinical trials in the UK.

​Clinical research aims to find out more about an illness, condition, treatment, therapy, or care. This sort of research may ask people to take part by testing a new treatment, using a device or by being cared for in a certain way. It may also ask them to provide information about the care they usually have.

​Public involvement means that patients or other people with relevant experience contribute to planning, carrying out and sharing the results of research. This helps make sure research is relevant, well communicated and that people have a good experience when taking part.

​Following a survey, we learnt that there is a lot of guidance about public involvement. But there is not much guidance specific to public involvement in phase 1 healthy volunteer studies. There are usually four phases of clinical trials. Phase 1 is usually the first time the treatment or product is tested in humans. It usually aims to learn about what happens to the treatment in the body, and side effects. People who take part in these studies do not have the condition being studied or any significant health problems. They are referred to as healthy volunteers. Participation of healthy volunteers in phase 1 clinical trials is essential for the successful development of new and better treatments.

​Chris, an experienced volunteer, and Dami Odunlami, HRA Public Involvement Manager, reflect on how they have worked together on this project.

How has public involvement informed and influenced this work? 

Photograph of Damilola Odunlami.jpg

The writing group included people working for commercial organisations that design and run phase 1 studies, chairs of some of the HRA’s Research Ethics Committees (RECs) and members of staff from HRA and MHRA. But of course, we couldn’t write guidance without the perspective of people who have volunteered to take part in phase 1 studies.

​As a group, we discussed:

  • ​high-level guidance on what ‘public involvement’ means for Phase 1 healthy volunteer studies
  • ​expectations and requirements for public involvement as part of the approval processes of the HRA through its RECs
  • ​the variations and limitations on what is reasonable and proportional for each study
  • ​how to share and promote the guidance so it is received and read by people it affects

I was very pleased to be asked to contribute to this project. As a very experienced volunteer, I felt that I should be able to contribute something of value to the group. Specifically, from the perspective of someone who must be informed adequately to make a decision to participate in phase 1 clinical studies.

​I raised a couple of very precise details that I hope will now be considered. These points will help volunteers through the screening process.

​This would also help the financial efficiency of the organisation operating the clinical study, and indeed the sponsor. Further to this, it would help retain new volunteers. And more generally it will improve volunteer selection and retention.


​What’s gone well, and what hasn’t gone well?

It has been very interesting to hear the very different considerations of how healthy volunteers can help to review and improve study information and processes. It was interesting to learn how strongly members of the writing group truly do feel about this subject.

Photograph of Damilola Odunlami.jpg

Some challenges we faced was the need to be mindful of any possible barriers to sponsors when producing the guidance so that we can remain a great place to conduct high-quality research and continue to attract study sponsors to the UK whilst also meeting public involvement requirements as set out by the HRA. Hopefully, we will have achieved that when the guidance is published.


​What have you learnt?  

It has been very pleasing to learn that the HRA, MHRA and other organisations truly want to closely monitor informed consent.

​Communication is very important so that volunteers can have all the necessary details, to make a decision that will be right for them. It’s also important not to deliver an overwhelming and difficult body of information. This could put people off taking part in a study.

​This project is a gathering of different perspectives. It includes professionals as well as the volunteers who actually take part in phase 1 research and make all of this research viable and sustainable.

​Perhaps the most difficult aspect of this collective exercise has been finding a time and day that is convenient for everyone to meet at the same time!

Photograph of Damilola Odunlami.jpg

We can achieve more when we have the right people at the table. We would not have been able to produce this guidance without the contribution of everyone involved with the writing group.


To find out more about how public involvement shapes the HRA’s work, take a look at previous issues of our newsletter.

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