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Help us write guidance to embed public involvement in the design and conduct of clinical trials

Last updated on 28 Apr 2023

Have you got experience of public involvement in a range of different types of clinical trials? Could you join a group that advises on guidance about public involvement for researchers?

The Medicines and Healthcare products Regulatory Agency (MHRA) and the Department of Health in Northern Ireland, working closely with the HRA, consulted on a set of proposals to update, improve and strengthen the UK legislation that underpins the regulation of clinical trials. Having analysed over 2000 responses received, they are now taking forward legislation to reform of the UK clinical trials regulatory framework that will:

  • ensure patients and their safety are at the focus of all clinical trials and bring the benefits of clinical trials to everyone
  • create a proportionate and flexible regulatory environment
  • cement the UK as a destination for international trials
  • provide a framework that is streamlined, agile and responsive to innovation

The term clinical trial relates to projects which aim to find out more about an illness, condition, treatment, therapy, or care by directly involving people.

The people taking part choose to follow a treatment plan and to provide information about themselves. The information collected is used to make decisions to improve treatments, therapies, and care for people more generally.

Clinical trials

  • actively involve people and are focused on improving health and care
  • usually the people taking part are patients, but not always
  • often happen in a hospital or GP setting but also occur in other places, for example in the community or people’s homes
  • may ask people to take a new treatment, use a device or be cared for in a certain way, or may ask people to provide information about the care they usually have.

The Health Research Authority (HRA) is one of a few organisations that work together in the UK to regulate and approve different aspects of health and social care research. Our vision is for high quality health and social care research today, which improves everyone’s health and wellbeing tomorrow. We help realise this by making it easy to do research that people can trust.

There is more information about the HRA’s role on our website.

The MHRA regulates medicines, medical devices and blood for transfusion in the UK. They put patients first in everything they do, right across the lifecycle of the products they regulate. They rigorously use science and data to inform their decisions, enable medical innovation and to make sure that medicines and healthcare products available in the UK are safe and effective.

There’s more information about the MHRA’s role on their website.

What's the activity?

We are looking for four people who have experience of public involvement in clinical trials, to work online alongside a group of researchers, sponsors and members of staff from HRA and MHRA.

Together, you will form a ‘working group’, which will be responsible for:

  • reading draft guidance and feeding back on the relevance, usefulness, and clarity of the guidance
  • identifying which people with different points of view might be missing from the group, and helping us decide who else could feed back on drafts
  • planning how to share and promote the guidance so it is received and read by people it affects

We would value your input for about six months at first with monthly meetings between May and October to develop the guidance.

Following the writing of the guidance there will be another two meetings. The meeting will be first to discuss implementing the legislation and promoting the guidance. The second one will be when we have published the guidance, at this point we would like to meet with you again to give you an update on progress and reflect on the process of working together.

What will be involved?

The group will work online via Zoom. They will meet around once a month and communicate via email.

The guidance itself will be written in plain language so it is not essential to be familiar with legal jargon. However, it is important to have experience in the design and conduct of a range of clinical trials.

The work will involve reading, writing, and reviewing many different versions of the same paper, and referring to other guidance. There will be flexibility in when you do work that can be conducted offline, and we will make sure that we provide you with sufficient time between meetings to ensure that you are able to participate fully.

Meeting dates will be decided once the group has been established. We will try to make sure that these meetings are at times that mean everyone can attend. This might mean that we have some daytime meetings and some early evening meetings. It will not be a problem if you cannot attend every meeting. The group will be large enough that if one or two people are unable to attend a meeting, it should not impact on the work.

What difference will it make and how will I know?

Providing clear guidance about involvement that can be applied to every type of clinical trial and every phase of research will support researchers to involve people with lived experience more often and in more meaningful ways.

We will publish the guidance on our website, and we will update you following its publication as to how it is being received and used.

Jim Elliott will keep in touch with you and let you know what is happening with this work.

What support will I receive?

You point of contact for this work will be Jim Elliott, Public Involvement Lead for the HRA. Before the ‘working group’ starts, Jim will brief you on the project and facilitate a discussion about how to work well together. A member of the HRA team will be available after meetings should anything difficult come up for you.

Once selected, we will invite you to share your access and support needs and any reasonable adjustments required. We will keep this information confidential. With your permission, we will share it with the HRA and MHRA staff you work with.

What skills or experience do I need to take part?

For this work, we need to hear from people with a range of experiences of public involvement in the design and conduct of multiple clinical trials. We will select a group of people to ensure we have the broadest range of experience represented.

We are interested in hearing from people who have experience being involved in planning and conducting different phases of clinical trials, clinical trials in a range of different disease areas, and in different types of trial designs.

When applying please let us know about your involvement in up to five different clinical trials, providing the information listed in the ‘How do I apply?’ section below for each trial you want to tell us about. If you have been involved in more than five trials, please tell us about ones that cover a range of different types of design or disease areas. Please also tell us how many trials you have been involved in overall and over what time period that has been.

We are committed to creating an inclusive workplace that promotes and values diversity. We know from experience that different ideas, perspectives and backgrounds create stronger, more creative ways of working, that help us to achieve the ambitions in our strategy. We welcome applications which represent the rich diversity of our community: age, disability, gender identity and expression, ethnicity, impairment, neurodiversity, religion or belief, sex, sexual orientation, and other diverse life experience such as being a carer, level of education, living in a deprived and / or rural area, and socio-economic background.

How do I apply?

To apply, contact the the public involvement team by emailing by Wednesday 10 May 2023. Please put ‘Involvement Guidance’ in the subject line.

Please tell us about your experience of involvement in up to five clinical trials, and please provide us with the details in the list below for each trial:

  1. the name of the trial
  2. the type of trial (for example see: Types of clinical trials | Cancer Research UK)
  3. the phase of trial you were involved in (see Phases of clinical trials | Cancer Research UK)
  4. the disease area
  5. the year (or years) of your involvement (for example 2018 to 2020)
  6. a brief description of your involvement (no more than 100 words)
  7. whether you were involved as an individual or as part of a patient group
  8. if part of a patient group, the name of that group

You can do this by sending in a voice recording or video of up to two minutes per trial or by writing up to 200 words per trial in an email or word document. If you send in a voice recording or video, we will transcribe these into a document for scoring.

Please don't send us a general CV as an application. It's very important that you tell us about these eight different items for each trial, for us to be able to select a group of people with a good range of different experiences.

If you have any questions, or anything is unclear, you can call the public involvement team on 0207 104 8161.

How will you decide who will be involved?

We will remove your name from your application. One member of the HRA staff and one member of MHRA staff will score what you have written about each trial under the eight headings. We will select a group of people to ensure we have the broadest range of experience represented, so that we can bring together a group with the diverse range of experience that this work needs.

Please note that in addition to being part of this working group, there will be opportunities for anyone with an interest to comment on the draft guidance before it is finalised.

Will I receive payment?

In line with our policy, we can offer a fee of £75 per meeting to cover preparation, taking part in the meeting and feeding back on the notes.

Additional work undertaken by group members requested by us will be reimbursed according to our payments policy.

Will my expenses be covered?

Yes. It is our policy to reimburse reasonable expenses incurred. For example, arranging for travel, additional childcare, or for a carer or personal assistant. We offer a £5 contribution towards any incidental expenses incurred by attending online meetings.

Who do I contact for further information?

Please contact Jim Elliott Public Involvement Lead or Barbara Molony-Oates, Public Involvement Manager on or on 0207 104 8110 if you have any questions.

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