Meet the Support Organisation: Health Research Authority

The NHS Innovation Service brings together 12 world-class expert support organisations, working in partnership to help innovators navigate the health and care system, speeding up access to support.

In our Meet the Support Organisation series, we’ll meet the people and teams who are part of the service, helping to turn great ideas into real-world impact.

Each profile introduces one of our partner organisations - exploring who they are, how they support innovation, and their advice for anyone looking to make a difference through the NHS.

1. Who are you, what is your role and what is your involvement with the NHS Innovation Service?

My name is Ashley Totenhofer and I am the Regulatory Performance and Innovation Manager at the Health Research Authority (HRA). I have worked for the HRA and its predecessor organisation since 2011in a variety of different roles.

The team I currently lead interacts with innovators via the NHS Innovation Service and provides advice about what regulatory approvals might be needed for a project and how to obtain these. These approvals include an ethical opinion from an NHS Research Ethics Committee (REC), support from the Confidentiality Advisory Group for the use of identifiable data without consent, HRA and Health and Care Research Wales (HCRW) Approval, approval from the MHRA if the study involves a medical device or investigational medicinal product, Administration of Radioactive Substances Advisory Committee (ARSAC) Approval, and others.

Whilst we don’t help with sponsorship or funding for their desired research project, we can also signpost innovators to potential sources of funding or to organisations that might be able to help with sponsorship.

2. What is your organisation’s role in supporting health innovation? What specific expertise do you individually bring to the NHS Innovation Service?

The team I lead is in the approvals operations division of the HRA approvals service– this means they are used to managing research applications through the approval process, and guiding researchers when they’re unsure of the approvals needed or how to progress through the system. We are therefore ideally placed to support innovators who are also unsure of where to go or how to proceed with getting the relevant research approvals for their project or idea.

3. How do you/your organisation help innovators navigate the NHS and bring their ideas to life?

The HRA’s vision is for high-quality health and social care research that people can trust, that improves people’s health and wellbeing. Innovators are key to this. Without innovators bringing new ideas to the table, there would be less research happening in many important areas. And without research showing the benefits of innovations, it’s unlikely an innovation will be a success in the NHS, as the research provides the evidence that the innovation is an improvement on the current system.

At the moment, we’re receiving a lot of referrals for innovations considering the use of Large Language Models to speed up processes in the NHS. For this type of project, our guidance generally focuses on signposting innovators to the relevant guidance as often they are at a very early stage in the process. However, if they can come back to us with a more developed plan (or initially approach us at a later stage in the development of the project) we are able to guide them through the research application process, which supports them to proceed with a research proposal.

4. Can you share an example of a successful innovation you’ve supported via the NHS Innovation Service?

Since our role is primarily an advisory one, we often only need to interact with an innovator once to offer guidance on what they need to do next. One such example is a proposal for an ‘AI-Driven Oral Biosensor for Real-Time Adaptive Neuro-Support’. The innovators initially approached us as they were unsure if they needed any regulatory approvals and if they did, how to obtain then. We helped them to establish that it would need a favourable opinion from an NHS REC and guide them through the application process. We also guided the innovators to an appropriate NHS organisation to support their application.

5. What’s your one piece of advice for innovators looking to work with the NHS?

To really think about the people who will potentially be using the new product or service you are proposing, and factor this into any study you design, As well as the conditions of their involvement, the information you provide is really important. We have guidance on participant information quality standards on the HRA website.