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Welcome to HRA Latest!
I’m pleased to be able to share this month’s updates for all those working or involved in health and social care research.
Our Chair, Professor Sir Terence Stephenson, provides reassurance about the COVID vaccine roll-out and reflects on the role of the HRA. There’s also news about our newly appointed non-executive director. More on this, and all of our stories, below.
Don’t forget, for regular updates and the latest news, you can follow us on Twitter @HRA_Latest.
Teresa Allen, Chief Executive
Vaccine review and reassurance
The Medicine and Healthcare products Regulatory Agency (MHRA) has approved a COVID-19 vaccine for roll-out in the UK starting next week. The MHRA concluded that the Pfizer BioNTech vaccine met its strict standards of safety, quality and effectiveness.
As he fronts a new government campaign to reassure the public about vaccine development, our Chair Professor Sir Terence Stephenson reflects on the role of the HRA in the race from lab to jab.
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MedCity chief executive Neelam Patel joins the HRA as Non-Executive Director
Neelam Patel, the Chief Executive of MedCity, has been appointed to join the HRA Board. Neelam, who previously worked for the National Institute of Health Research (NIHR) and has a diverse history of private and public sector experience, will join us as non-executive director in April next year.
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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.
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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.
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We've updated our 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.
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Save the date: public involvement in a pandemic report launch
In May we worked with 56 partner organisations to establish the UK COVID-19 public involvement matching service to support public involvement in urgent COVID-19 research.
We've reviewed what we've learned this year about public involvement in research during a public health crisis, and will share our findings in a report shortly. The launch of the report will be on Wednesday 13 January 2021,11am-12:30pm, via Zoom. The event will be open to everyone, and we'd love to see you there - please save the date in your diaries and we'll provide further details soon.
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Our London office address is changing
The address for our London office is changing on 1 January 2021.
Our London office is relocating from Skipton House to Redman Place in Stratford, to form a government hub with four other Arms Length Bodies of the Department of Health and Social Care.
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Guidance updates this month
New guidance on preparing for UK Transition
Updated guidance on amendments to COVID-19 studies
Updated guidance on Clinical Negligence Scheme for General Practice
Updated guidance on data protection impact assessments
MHRA guidance for on-site access to Electronic Health Records by sponsor representatives in clinical trials
Researchers and REC members - share your views on research design and risk to participants
Can you spare 10 minutes to complete a short survey looking at whether there’s a perceived relationship between research design and risk to research participants?
The survey closes on Friday 18 December 2020 and all responses will be anonymous.
NIHR's new INCLUDE project to help researchers make trials more inclusive
Many groups – such as women, older people and ethnic minorities – are under-served in clinical trials. An NIHR project aims to ensure that health research includes the people who most need it.
The innovations in clinical trial design and delivery for the under-served (INCLUDE) project was set up in 2017 to increase the inclusion of under-served groups in research.
The INCLUDE team has gathered information from literature reviews, surveys and workshops; and outlined the key characteristics of under-served groups and identified barriers to taking part in research. These findings have been used to produce the INCLUDE roadmap, which makes recommendations to researchers for improving access to clinical research for under-served groups.
Building resilience into clinical trial design and conduct during the pandemic
The MHRA has published new guidance for sponsors to help support resilient clinical trials during the ongoing COVID-19 pandemic.
This blog explains more about trial flexibilities and why they’re so important.
ACRO creates new framework to advance decentralised clinical trials (DCTs)
In October 2019, ACRO established the Decentralized Clinical Trials (DCT) Working Party to examine the barriers to adoption of DCTs and create quality-based principles and tools to facilitate implementation of decentralized clinical trials. In September 2020, ACRO released a paper to provide an overview of key issues in the decentralization of clinical trials and to introduce two DCT tools.
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