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News and updates from HRA
Date: 18 December 2020
Prof Matt Westmore to become new CEO of the HRA
Congratulations to Professor Matthew Westmore for becoming the new CEO of the HRA. We are delighted that Prof Westmore will take up the excellent legacy left by Teresa Allen. The NHS R&D Forum has worked with Prof Westmore in the past exploring how we best add value to research at an organisational level and we look forward to continuing to do so as he takes on this new and important role.
Call for NHS CTIMP sponsors to join Combined Ways of Working pilot in 2021
Has your organisation got any Clinical Trials of Medicinal Products (CTIMPs) planned in 2021?
Our Combined Ways of Working (CWoW) pilot is now accepting expressions of interest from new applicants looking to submit in 2021. We are particularly keen to hear from NHS sponsors.
Read more
https://www.hra.nhs.uk/about-us/news-updates/call-nhs-ctimp-sponsors-join-combined-ways-working-pilot-2021/
Fast-track ethics review pilot opens in January
A new fast-track research ethics review pilot is opening in January. The pilot will test a rapid research ethics review for global clinical and phase I trials for any disease area.
The pilot – which will run between 4 January and 30 March 2021 – will test whether the HRA, on behalf of the UK, can establish a sustainable model for providing rapid research ethics review.
It builds on our work providing fast-track ethics review for COVID-19 research.
Read more
https://www.hra.nhs.uk/about-us/news-updates/fast-track-ethics-review-pilot-opens-january/
Updated amendment tool on IRAS
After launching our online amendment tool on the Integrated Research Application Service (IRAS) earlier this year, we’ve been listening to feedback and have made some refinements
Read more
https://www.hra.nhs.uk/about-us/news-updates/weve-updated-our-amendment-tool-on-iras/
Technical Assurances update: MPE/CRE review procedure and generic risk statement
Thanks to the support of the Four Nations Radiation Assurance Working Party and various stakeholders, we have released updated Medical Physics Expert and Clinical Radiation Expert review procedures and amended Generic Risk Statements for radiation.
Read more
https://www.hra.nhs.uk/about-us/news-updates/technical-assurances-update-mpecre-review-procedure-and-generic-risk-statement/
Updated guidance for health and social care researchers at the end of the transition period.
The United Kingdom left the European Union on 31 January 2020. The Transition Period comes to an end on 31 December 2020 and this page sets out what Sponsors will need to do from 1 January 2021. Where relevant, we will also signpost to guidance from other relevant organisations.
Read more
https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/guidance-health-and-social-care-researchers-end-transition-period/
Updated guidance on Data Protection Impact Assessments
The following guidance has been jointly developed by the HRA and the Medicines and Healthcare products Regulatory Agency (MHRA), in consultation with the Information Commissioner’s Office (ICO), on behalf of the UK.
This guidance is for sponsors, contract research organisations (CROs) and participating NHS organisations when considering management of personal data processed for the purpose of healthcare research. It provides advice relating to data protection impact assessments (DPIAs).
Read more:
https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/data-protection-and-information-governance/gdpr-guidance/what-law-says/data-privacy-impact-assessments/
Updated guidance on amendments to COVID 19 studies
This guidance is for sponsors, sites and researchers who need to make changes to an existing study to manage the impact of COVID-19. The arrangements described are designed to ensure that changes (known as amendments) can be made quickly whilst subject to the appropriate oversight to protect the interests of participants.
MHRA has published information for CTIMPs and for Medical Devices on its website.
The Human Tissue Authority has published information regarding COVID-19 for HTA Licenced establishments on its website.
Read more here
https://www.hra.nhs.uk/covid-19-research/covid-19-guidance-sponsors-sites-and-researchers/