Welcome to HRA Latest, I’m pleased to be able to share the latest updates for all those working or involved in health and social care research.

We’re delighted to announce our first Make it Public conference, on 3 and 4 November. As part of the conference we’ll be showcasing case studies from across the UK to highlight good practice and the impact of making research more visible. Keep reading to find out how to tell us about great examples you’d like to share.

There’s also more news for researchers and sponsors using combined review. Our new streamlined service will be the only way to apply for new Clinical Trials of Investigational Medicinal Products (CTIMPs) in the UK from January 2022.

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

Karen Williams, Deputy Chief Executive and Deputy Director of Finance, Procurement and Estates.

Make it Public annual conference We’re excited to announce our first research transparency conference, taking place on 3 and 4 November. Invitations to the conference will be sent out in the next few weeks. We’ve worked closely with our partners and will be showcasing best practice in transparency in health and social care research. Dr Naho Yamazaki, Head of Policy and Engagement at the HRA, announced the conference. Watch the video Want to tell us about a great study? To highlight good practice and the impact of making research more visible, we’re still looking for case-studies of excellent transparency practice under any of the four pillars of our Make it Public strategy: registering research studies reporting results informing participants sharing study data and tissue Tell us about your study

Reviewing the worlds first COVID-19 challenge study Our specialist Research Ethics Committee (REC) was set up to evaluate the world’s first COVID-19 human infection challenge study. We brought together uniquely qualified experts and lay members to consider the ethical issues of this ground breaking-research. The committee has written about how they considered the balance between benefits and harms in a new blog in the Journal of Medical Ethics Read the blog

COVID-19 - COPI notice In April 2020 the former Secretary of State for Health and Social Care issued a general notice under the Health Service Control of Patient Information (COPI) Regulations 2002 to support the response to COVID-19. This notice, which applies only in England and Wales, allows NHS Trusts, Local Authorities, and others to process confidential patient information (CPI) without consent for COVID-19 public health, surveillance, and research purposes. The former Secretary of State was committed to ensuring that those working for the health and care sector continue to have the data they need to respond to COVID-19. The COPI notice is due to expire in September 2021 and there is a review underway exploring whether to extend beyond this date. If you need to process CPI beyond the COPI notice, please consider preparing for transitioning to support under Regulation 5 (‘Section 251’ support) through an application to CAG. For further information please contact cag@hra.nhs.uk Read NHSX info governance FAQs

Supporting researchers and sponsors using combined review From January 2022, combined review with the MHRA will be the only way to apply for new Clinical Trials of Investigational Medicinal Products (CTIMPs) in the UK.    Combined review brings together a single application for both Clinical Trial Authorisation and REC opinion and approval is delivered together.  There’s also an option of a fast-track ethics review for certain types of study.   You’re advised to start using the system now, and to help we’ve refreshed our web pages with all the latest information, including step-by-step guidance.    Read more about combined review

Tackling maternal health challenges

The Association of the British Pharmaceutical Industry (ABPI) has set up a Maternal Health Project Group to address the lack of licensed medicines and treatments designed and researched for use in pregnancy and breastfeeding.

The aim is to make sure patients and health care providers are more informed about any decisions they may need to make. The group is using the combined expertise of patients, healthcare agencies and experts, including the HRA, to make progress in key areas,

If you are a patient or a member from industry and you think you could help, the ABPI MHPG needs you! Please contact Belen (bgranellvillen@abpi.org.uk) at the ABPI for more information.

Read more about the key areas and work of the group

Use of GP data - what is shared, why it is needed and how is it protected NHS Digital (NHSD) has paused the roll-out of the General Practice Data for Planning and Research (GPDPR) to listen to patients, health care professionals and the public following concerns raised about how the data will be used and whether the public has sufficient information. Elizabeth Bohm, our Head of Data and AI Policy has written a blog about why GP data is important for research and how it is protected. Read the blog

Operational news

Data transfers from across the EU and UK

UK businesses and other organisations will be able to receive personal data from the EU and EEA without having to put additional arrangements in place thanks to an adequacy decision announced last month.

The decision is for four years but may be reviewed during that time.

No action is required by sponsors or participating sites.

Piloting a coordinated review for medical devices

We’re working with the Medicines and Healthcare products Regulatory Agency (MHRA) to develop and test a coordinated submission and review process for applications of medical device clinical investigations.

The process involves a coordinated review of applications to the MHRA and REC to improve efficiency, streamline approval and reduce approval time.

We’re looking for researchers who intend to carry out a clinical investigation for medical devices to help us test the new process.

If you’re interested, email devices.regulatory@mhra.gov.uk before making an application

We share updates like these in our operational news bulletin HRA Now. Sign up to receive important updates via our website here