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HRA Latest - 24 June 2021

Welcome to HRA Latest, and this month’s updates for all those working or involved in health and social care research.

As NHSX launches its strategy to build understanding of how data is used, we talk about the protections in place for patient data – you can read more below. 

You can also find out how combined review is improving our service for drug trials, and we have a #Red4Research roundup. It was great to see so many of you joining in last week!

As always, for regular updates and the latest news, you can follow us on Twitter @HRA_Latest.

Matt Westmore, Chief Executive

The Future of UK Clinical Research Delivery

The HRA is supporting a new UK-wide plan to make it faster and easier to conduct research in the UK, enabling more patients to be involved in, and benefit from, research of relevance to them.

The Future of Clinical Research Delivery plan aims to empower everyone across the health service to participate in delivering research, and enable people across the country to take part in research.

Health data collection and use – why it’s important and how it is protected

The use of patient data in research is in the public eye at present. The NHS Data Strategy, published this week, aims to build understanding on how data is used and allow patients more control over their data. And NHS Digital’s General Practice Data for Planning and Research (GPDPR) aims to allow the collection of patient data from GPs for planning and research. As you may have seen, we welcomed the decision to delay the implementation of GPDPR while NHS Digital takes time to engage with patients, health care professionals and the public.

There are many organisations – ‘data guardians’ – that enable and safeguard the use of patient data in research. And it can be hard to understand who does what. We’ve brought together information on why this data is important to research and the organisations that safeguard your data.

Make It Public Work is continuing to deliver our Make It Public strategy. The plan we published in our strategy last summer has been delayed by the ongoing pandemic, but we are still working to ensure trusted information from health and social care research studies is publicly available for the benefit of all. We will publish an updated implementation timeline next month.  This year we will hold our first transparency conference and publish our first annual transparency report, bringing together examples of best practice and likeminded professionals, patients and the public who are committed to transparency in research. Look out for more information and the dates for our conference in the coming weeks. If you have any questions or would like to sign up to receive the latest updates about our transparency work, please get in touch at research.transparency@hra.nhs.uk

Combined Review and Fast-Track: Improving the process of applying for new drug trials

Combined review will be the only way to apply for clinical trials of investigational medicinal products (CTIMPs) from January 2022. The streamlined approvals service for both Clinical Trial Authorisation and Research Ethics Committee (REC) opinion  is now open to all sponsors and researchers for CTIMPs and we’re encouraging them to get ready for the change and set up accounts in the new part of IRAS.

We’re always looking to improve the system, and applicants using combined review can now book REC meetings online. We’ve also accepted our first fast-track ethics combined review application.

A fast-track committee provides a consistent and efficient approval process in roughly half the time of a usual review. In return, we expect fast-track studies to be high quality, and to have involved the public in their design.

If you would like to talk to us about fast-track ethics review within combined review, please contact the combined review team 

Update on data sharing with the EU

European Union member states have agreed that standards for the protection of personal data in the UK are sufficiently high that such information can continue to flow between the EU and the UK. You can read more about this in our technical bulletin, HRA Now

#Red4Research roundup Last Friday we went #Red4Research.The HRA was proud to join the NHS R&D Forum, other regulators, NHS trusts, charities and national bodies to recognise the incredible work that has gone into making COVID-19 research happen. We gave our thanks to all involved in research, shared what we’d learnt over the course of the pandemic and highlighted the important contributions of REC and CAG members, patients and the public Our staff donned red and shared pictures to show their support, while both staff and volunteers were featured as #Red4Research case studies.

NICE recommendations on shared decision making

The National Institute for Health and Care Excellence (NICE) has issued new recommendations on shared decision making between service users and healthcare professionals.

Shared decision making is a collaborative process that involves a person and their healthcare professional working together to reach a joint decision about care.

NICE has collaborated with Keele University to develop a learning package, aimed at healthcare professionals, to help with implementing these recommendations.

News from across UK research

Best Research for Best Health – the next chapter

It has been 15 years since the publication of Best Research for Best Health, the document that underpinned the creation of the National Institute for Health Research (NIHR). Now the NIHR has published Best Research for Best Health: The Next Chapter on its website. It sets out the NIHR’s operational priorities today and into the future.