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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.
This month find out how clinical trial regulation is changing for the better. Our combined review service is available now and will become the only way to apply for new drug trials from January 2022. There’s important information about new eligibility requirements for student research, and an update on our research transparency work.
As always, for regular updates and the latest news, you can follow us on Twitter @HRA_Latest.
Matt Westmore, Chief Executive
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New eligibility criteria for student research from 1 September 2021
We’re introducing new eligibility criteria for the review of student research from 1 September 2021. Applying across the UK, the changes are the result of the review, supported by the Wessex Institute at the University of Southampton, to ensure students gain the best learning experience of health and social care research.
To help course leaders to prepare for change and to share good practice, the Association of Research Managers and Administrators (ARMA) and the NHS R&D Forum are hosting a round table discussion on Tuesday 29 June 2021 along with our Chief Executive, Matt Westmore.
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 Clinical trial regulation is changing for the better
We’ve been working with the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health Research (NIHR) and our partners in the devolved administrations to provide a more streamlined and efficient service for new drug trials. Combined review is already benefiting sponsors, contract research organisations and researchers submitting applications for review of clinical trials of investigational medicinal products (or CTIMPs). This service will become the only way to apply by January 2022.
Combined review uses a new improved part of IRAS. We’d like to thank everyone who has been helping us to develop this service.
 Fast-track ethics review: 50% faster
Our fast-track ethics review aims to provide an ethics opinion for global clinical trials and first-in-human studies of medicines in half the time of a usual review. An expert committee provides a consistent and efficient approval process and in return, we expect fast-track studies to be high quality, and to have involved the public in their design.
We are now working to incorporate the fast-track ethics review into the combined review with MHRA for certain types of study. Please ask the combined review team about fast-track ethics review within the combined review. We currently have committee slots available for June.
#MakeItPublic leading the way in research transparency
Last summer we launched #MakeItPublic our strategy to ensure that trusted information from health and social care research studies is publicly available for the benefit of all.
We are changing the way we work to help to make research transparency easy, make research transparency the norm and make information public; and we are looking at how we can support the wider research community to do the same. We've already improved our research summaries page to make it easier to find out about research studies approved by our Research Ethics Committees.
Our Chief Executive, Matt Westmore, has recorded a short video restating our commitment to research transparency and letting people know they can expect to see more from #MakeItPublic over the next few weeks.
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New Ethics Review Advisory Group meets for the first time
Our new Ethics Review Advisory Group met for the first time on Friday 21 May.
The advisory group, which is chaired by our non-executive director Professor Andrew George, will be giving advice and input into the Ethics Review Programme, led by Juliet Tizzard, Director of Policy and Partnerships.
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Increase in clinical trials registration
A recent look at clinical trials reviewed by our Research Ethics Committees has revealed that 88% have been registered on a publicly accessible database. This increased from 81% in the 2019 review and 84% in the 2020 review. Phase one studies showed the highest rate of registration at 94%.
While the increase is good news, our Make it Public research transparency strategy sets out our vision that 100% of all clinical trials be registered. It is important because it helps to avoid duplication of effort and foster collaboration. It is also a condition of the Research Ethics Committee (REC) favourable opinion.
This type of audit helps us to see how many studies are meeting the requirement, where we can offer support and, in the future, may decide where we need to take further action.
We have published our latest Clinical Trial Registration Audit Report on our website. The 2021 report audited clinical trials that received a favourable opinion (FO) between January and June 2019.
Researching magic mushrooms – a BBC 2 documentary
A study approved by our Brent Research Ethics Committee has been the focus of a BBC2 documentary, The Psychedelic Drug Trial, which aired on Wednesday 19 May.
The film crew followed researchers from Imperial College London, looking at whether magic mushroom compound, psilocybin, performs as well as antidepressant in small study.
You can watch the documentary and read a blog by Dr Simon Kolstoe, who is a Senior Lecturer in Evidence Based Healthcare at the University of Portsmouth, about the ethics of carrying out health research involving Class A drugs. Simon chairs our Hampshire A REC but was not involved in the review of the study.
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News from across UK research |
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Researcher Roadshow: Fundamentals of using routinely collected healthcare data in research
The NIHR Research Design Service, and partners, is running a Researcher Roadshow on 28 June 11am - 2pm.
Featuring experts from Health Data Research UK, MRC Regulatory Support Centre, the University of Leeds and NHS Digital, the roadshow is aimed at researchers who want to understand more about the fundamentals of using routinely collected healthcare data for research.
It is free to attend and you can find more information or sign up here.
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