Vaccine review and reassurance, fast-track ethics review pilot and more

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NHS Health Research Authority

HRA Latest – 3 December 2020

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

Professor Sir Terence Stephenson, Chair of the HRA

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.

Read more

Nealam Patel, Chief Executive of MedCity

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.

Read more

Fast track pilot image - multiple blue arrows moving to the right

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

Several systems combined into one streamlined approach

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.

Circle of white arrows joined together, ending in an orange arrow pointing forwards

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.

Read more

Public involvement - two jigsaw puzzle pieces made up of people, slotting together

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. 


MRI scans

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

Yellow lorry with we are moving written on the side

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.

Read more

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 

News from across UK Research

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.

Read more 

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.

Read more 

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.

Read more

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.

Read more