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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.
There’s news about the specially trained Research Ethics Committee we’ve set up to be ready to review COVID-19 human infection challenge vaccine studies. You can read 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
Ethics review of COVID-19 human infection challenge vaccine studies
The first COVID-19 human infection challenge vaccine study in the world is planned for the UK. This type of study involves deliberately infecting healthy volunteers after they have had a vaccine. It can be a quicker way to see if a vaccine is effective than waiting for enough people to be naturally exposed to the virus.
We’ve established a specially trained Research Ethics Committee to review this research. You can find out more about challenge studies, and how we will review a COVID-19 human infection challenge vaccine study, on our website.
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Join a Research Ethics Committee
We’re recruiting Research Ethics Committee members. We want people who are passionate about health and social care research, particularly registered healthcare professionals and retired doctors, to join us. Our committees meet online regularly to review research studies to ensure they’re ethical and fair. It’s a rewarding role that offers the opportunity to develop, both professionally and personally, and stay up to date on the latest developments in research
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Update on health and social care research projects for educational purposes
We are currently not reviewing applications for individual undergraduate and master’s student research. This will remain the case until September 2021.
The decision is in line with national priorities for NHS/HSC to support COVID-19 studies and the restart of clinical trials, and recognises the continuing pressure of the COVID-19 pandemic. We have published information about other ways in which students can gain experience of health and social care research.
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New Chief Digital Transformation Officer to help transform digital research systems
We have appointed a new Chief Digital Transformation Officer to lead our digital and technology functions.
Kurt Weideling will help transform the HRA’s digital research systems in support of our ambitious priorities for research in the UK.
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Transparent health research - what's in it for the public
Earlier this year, we launched our Make it Public research transparency strategy to make sure that information about all health and social care research is made publicly available to benefit patients, researchers and policy makers.
In a new blog, Derek Stewart, patient advocate and member of the HRA research transparency strategy group, has shared his reflections on the involvement of public and patients in the development of this work.
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Consent is only possible in a relationship
It is vital to gain fully informed consent from participants in health and social care research.
‘Think of it as an ongoing dialogue that goes from initial discussions through to letting people know what the research project found’.
HRA Non-Executive Director, Professor Andrew George, writes about informed consent in health and social care research.
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Removal of commercial organisation information document
The commercial organisation information document was initially introduced across the UK with the implementation of the UK Local Information Pack in June 2019. Following feedback from stakeholders, it has been agreed across the four nations that the commercial Organisation Information Document will no longer be used as part of study set up from Thursday 12 November 2020.
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Cutting edge treatments to be fast-tracked to patients through international collaborations
The UK will be joining two initiatives bringing together some of the world’s leading regulators to allow pharmaceutical companies to submit medicines to be reviewed by several countries at the same time, pooling resources and allowing patients to benefit from earlier access.
The MHRA will join Project Orbis, focusing on cutting-edge cancer treatment, and the Access Consortium, which aims to help secure faster patient access to high quality, safe and effective medicines.
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NIHR CRN portfolio application form to be discontinued
From early November, the Portfolio Application Form (PAF) will no longer be required to apply for NIHR Clinical Research Network (CRN) support, and the option to create a PAF will be removed from the Integrated Research Application System (IRAS) as of 5 November 2020.
Applications to be considered for NIHR CRN support should still be made by selecting ‘yes’ to question 5b of the IRAS project filter through IRAS, or where HRA Approval is not required, through the relevant Local Clinical Research Network.
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