Welcome to HRA Latest, and this month’s updates for all those working or involved in health and social care research.
We’re pleased to report on improvements to streamline the way that we and the Medicines and Healthcare products Regulatory Agency (MHRA) review clinical trials of investigational medicinal products (CTIMPs). The new combined review, which from 1 January 2022 will become the way all new CTIMPs are reviewed, means that studies can be managed from start to finish in IRAS. You can read more below.
We’ve introduced new eligibility criteria for student research this week. It aims to ensure students have the best learning experience of health and social care research and to maximise the time students spend getting a broad appreciation of modern, team-based research.
We also have an update on our work as part of the multi-agency advice service for artificial intelligence (AI) in healthcare, which sees us working with the National Institute for Health and Care Excellence (NICE), MHRA and the Care Quality Commission (CQC) to help developers and adopters of AI and other data-driven technologies.
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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Combined review reaches important milestone
We’re pleased to announce that those using combined review for CTIMPs can now manage studies from end-to-end through IRAS. This improvement that mean sponsors and applicants using the service will now be able to manage amendments, safety reporting, end of trial notification and submission of summary results through IRAS.
Combined review is delivered in collaboration with our partners at the MHRA and brings together the Clinical Trial Authorisation and Research Ethics Committee (REC) opinion for CTIMPs – one application, one co-ordinated review, one decision. As it will become the only way to apply from 1 January 2022, sponsors, Clinical Trial Units (CTUs) and Contract Research Organisations (CROs) are advised to use the service for any new CTIMP applications over the coming months.
This development is part of a wider improvement programme for IRAS that will deliver further new developments for CTIMPs and other study types. If you are planning to make an application via combined review for the first time, contact our team for support by emailing cwow@hra.nhs.uk.
New student research eligibility criteria – live from 1 September
New eligibility criteria for standalone student research went live this week (1 September 2021). These changes are designed to ensure students' experience of research reflects how modern health and social care research is conducted.
The new criteria encourage innovative approaches to student research like group research, mock RECs or shadowing a range of people in an existing project.
The changes mean some master’s students will now be eligible to apply for approval to carry out their research.
To help students plan their research, we have created a new student research toolkit. The toolkit has been designed to pull together the resources a student will need to understand what approvals are required and whether they are eligible to carry out their research in the UK. It contains links to existing decision tools, as well as some new ones developed especially for students.
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Planned new advice service for AI in healthcare
The HRA is part of a multi-agency advisory service (MAAS) collaboration to create the world’s first cross-regulatory advisory service for developers and adopters of AI and other data-driven technologies in healthcare.
Working alongside NICE, the MHRA and the CQC, the HRA will help provide transparent and clear arrangements on regulation and access for researchers, innovators and healthcare providers working with AI technologies.
The MAAS will offer a single platform for advice and guidance, working for innovators and adopters to help them understand what must be done and when. It will also develop regulations to provide a clear set of rules around the evidence and safety standards innovators need to meet when developing technologies like AI.
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Involving pregnant people in research
A new study funded by the Department of Health and Social Care is looking at the best coronavirus vaccine dose interval for pregnant people. The Preg-CoV study, led by St George’s, University of London, aims to develop evidence-based guidelines on the use of vaccines during pregnancy.
Pharmacist and lecturer, Michael Pettit, has blogged for us on the difficult choices caused by a lack of data about the use of vaccines and other medicines during pregnancy, and why it’s important to involve pregnant people in clinical trials. A REC vice-chair, Michael is also part of a group of representatives from the HRA is working with the Association of the British Pharmaceutical Industry looking at ways to address the lack of licensed medicines and treatments designed and researched for use in pregnancy.
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Make it Public conference
Our first research transparency conference will take place virtually on the afternoons of 3 and 4 November 2021.
We’ve worked closely with our partners and will be showcasing best practice in transparency in health and social care research.
Details about the conference will be sent out later in the month, so mark the dates in your calendar.
You can register your interest and ask questions by emailing research.transparency@hra.nhs.uk.
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