Category / nhs

National Institute for Health Research publishes latest annual report

The NIHR has published its latest Annual Report highlighting it’s achievements during 2019/2020. You can read more below.


The report celebrates how NIHR funding and support continues to have a lasting impact on our health and social care system. It details our world-class and ground-breaking research that is delivered by the talents and expertise within NIHR and the collaborations and partnerships we have forged. In addition to showcasing the breadth of areas NIHR provides funding and support, over 100 of our major research achievements are featured in the report, organised under the NIHR’s six core workstreams. The report also gives an insight into the shifting focus to COVID-19 research as we came to the end of 2019/20.

You can also access a HTML version of the NIHR Annual Report 2019/2020.

Highlights in this year’s report include:

1. Funding, supporting and delivering high-quality research

At the core of NIHR is a commitment to fund high quality research that benefits the NHS, public health and social care. Our research funding schemes – programmes, units and schools – deliver a coherent programme of response mode and commissioned research. We awarded over £250 million of funding to 310 new projects. Our first-ever dedicated social-care funding call awarded £2.5 million to 12 new projects focused on adult social care.

2. Investing in world-class infrastructure and a skilled delivery workforce

The NIHR’s sustained investment in people, facilities and technology has transformed the health and care system’s ability to translate discoveries into improved treatments and services. This infrastructure supports research funded by NIHR and by our partners. 5,405 research nurses were employed in the CRN, with 43,568 people participating in Good Clinical Practice.

3. Attracting, training and supporting the best researchers

We funded 525 new personal training awards to develop and support the next generation of researchers and leaders. More than 2,300 people were supported by NIHR-funded training awards to develop the skills they need to meet the nation’s health and care needs.

4. Partnering with other public funders, charities and industry

Working successfully with partners in the UK’s world-leading life sciences sector, our Clinical Research Network supported 1,580 industry and commercial studies and 1,738 charity funded studies.

5. Funding applied global health research and training

We supported 8 Research and Innovation for Global Health Transformation (RIGHT) awards, focused on epilepsy, severe and stigmatising skin diseases, and infection related cancers. 13 RIGHT Proposal and Partnership Development Awards (PPDA) on mental health, 17 Global Health Policy and Systems Research (HPSR) programme development awards and 61 Training Leads attended the first NIHR Global Health Research Training Forum.

6. Engaging and involving patients, carers and the public

More than 732,000 participants were recruited by the NIHR Clinical Research Network into health and social care studies. 398 members of the public reviewed 841 funding proposals, and 124 members of the public served on our funding committees and advisory boards.

Read more information about our contribution to research and access previous annual reports.

https://www.nihr.ac.uk/news/nihr-publishes-latest-annual-report/27175 

UK COVID-19 research passes one million participants

Please see below for an update from the National Institute for Health Research.


More than one million participants have now taken part in COVID-19 research across the UK.

NIHR data shows that a total of 1,075,000 participants have taken part in COVID-19 research, across more than 180 studies. Of these, more than 100 studies were funded by the NIHR, amounting to more than £108 million given to dedicated COVID-19 research.

This milestone has been achieved across England, Northern Ireland, Scotland and Wales by members of the public, NHS doctors and nurses, NIHR research staff and researchers, regulators, life science companies, research funders and policy makers.

Their efforts have enabled world-leading research into therapeutics such as dexamethasone and tocilizumab and delivery of the Oxford/AstraZeneca vaccine. Platform studies such as RECOVERYPRINCIPLE and REMAP-CAP have all made a significant contribution to the global understanding of COVID-19.

These discoveries have significantly improved outcomes for people who get the virus, especially those most at risk of becoming severely unwell and hospitalised.

On Monday 15 March, the NIHR and NHS will be launching the #ResearchVsCovid ‘thank you’ campaign to celebrate the efforts of participants, researchers and healthcare professionals for their involvement in COVID-19 research.

The campaign kicks off with a series of video thank yous to participants, researchers and NHS staff. These celebratory videos will feature England’s Chief Medical Officer Prof. Chris Whitty and NHS England Chief Executive, Sir Simon Stevens.

Professor Chris Whitty, Chief Medical Officer for England and co-lead for the National Institute for Health Research (NIHR), said:

“Reaching one million participants in COVID-19 research shows the impressive selflessness of people across the UK who have volunteered to take part. This research has led to vaccines, better treatments and improved care. A huge thank you to everyone who has taken part in, led or enabled the research.

NHS chief executive Sir Simon Stevens said:

“During the darkness of this pandemic, NHS clinical researchers, UK scientists and one million volunteer patients have together helped illuminate a more hopeful path for humanity.

“Thanks to their remarkable and selfless work, they have made unique and decisive contributions to therapies and vaccines for our shared global fight against Covid-19. It is amazing to consider that more than one million people in this country who have selflessly volunteered to participate in our research will themselves help save over a million lives worldwide.”

Find out more about the COVID-19 research people have helped to make happen.

https://www.nihr.ac.uk/news/uk-covid-19-research-passes-one-million-participants/27215?utm_source=twitter-research&utm_medium=social&utm_campaign=covid&utm_content=1millionnews

Health Research Authority UPDATE: undergraduate and master’s research projects

Please see below for a further update from the HRA on Master’s and undergraduate research. Any queries or concerns please email Suzy Wignall, Clinical Governance Advisor.

Update on student research – new eligibility criteria from 1 September 2021

The HRA and the devolved administrations, supported by the Wessex Institute at the University of Southampton, have reviewed their approach to study approval for student research.
The review aimed to ensure students have the best learning experience of health and social care research, and to reduce the time that the HRA, DAs and NHS Research Ethics Committees (RECs) spend advising on and reviewing student applications.

In March 2020 we paused student research approvals to create capacity for urgent COVID-19 research. Now, from 1 September 2021, we are introducing new eligibility criteria for standalone student research.


New critera

The new criteria mean that some Master’s level students will be able to apply for ethics review and HRA/HCRW Approval or devolved administration equivalent. Standalone research at undergraduate level that requires ethics review and/or HRA/HCRW Approval (or devolved administration equivalent) cannot take place. Arrangements for doctoral research remain unchanged.

Full details are in table one – permitted student research table. We’ve also made it clear when students are able to take the role of Chief Investigator, see table two – which type of students may act as Chief Investigator?


Alternative ways of learning about health and social care research

It is possible for students to learn about health and social care research without completing standalone projects. Looking at other ways to build skills and experience better reflects modern research and emphasises team science. View the video of our event ‘Exploring good practice in Student Research’ to hear from course leaders about how successful these alternative approaches have been (registration is required to view) or read our website for further information and ideas: https://www.hra.nhs.uk/student-research/.


Queries

If you have any queries about the eligibility criteria, please contact queries@hra.nhs.uk.

Clinical Governance RKEDF sessions

As part of the RKEDF Academics and Researchers can book onto the following sessions, either as a one-to-one meeting or a bespoke team session:

Please contact Suzy Wignall, Clinical Governance Advisor if you are interested in any of these sessions.

NIHR issues final update on implementation of the Restart Framework

The NIHR published a Framework on 21 May 2020 – when the NHS started to restore routine clinical services – to support the restarting of research paused due to COVID-19. Developed in partnership with multiple stakeholders and the devolved nations, the Framework provides a flexible structure for local decision-making.

You can read the latest and final update here.

Integrated Research Application System (IRAS) – survey open

IRAS, the Integrated Research Application System, is changing.

The Health Research Authority wants to hear from people who’ve used the system about how it should look in the future.

A short anonymous survey https://www.surveymonkey.co.uk/r/5B5X95H is available until 24th February 2021.

Department of Health and Social Care statement on prioritisation of research studies

Please find below a statement from the Department of Health & Social Care. Please bear this in mind when in correspondence with NHS Trusts and if planning a clinical research study.
If you have any queries, please contact Suzy Wignall, Clinical Governance Advisor, in the first instance.


Statement from DHSC 

We recognise that at the current time those working in many NHS sites are under huge pressure as the number of COVID-19 cases and admissions to hospitals continue to rise and frontline clinical staff are unable to work due to sickness.

While we have a small number of proven treatments and vaccines for COVID-19, more are needed to reduce transmission, reduce the number of patients that require hospitalisation and to improve outcomes for those that do. It is therefore critical that at this challenging time we continue to recruit participants to our urgent public health (UPH) studies. As such I am writing to confirm that the current levels of prioritisation for research studies, set out within the Restart Framework still apply, as follows:

  • Level 1a (Top Priority) – COVID-19 UPH vaccine and prophylactic studies (as prioritised by the Vaccines Task Force and agreed by Jonathan Van-Tam, deputy CMO) and platform therapeutics trials (currently RECOVERY/RECOVERY +; PRINCIPLE; REMAP CAP).
  • Level 1b – Other COVID-19 UPH studies
  • Level 2 – Studies where the research protocol includes an urgent treatment or intervention without which patients could come to harm. These might be studies that provide access to potentially life preserving or life-extending treatment not otherwise available to the patient.
  • Level 3 – All other studies (including COVID-19 studies not in Level 1a or 1b).

I would also like to take this opportunity to remind you of the NIHR guidance for a second wave of covid 19 activity (https://www.nihr.ac.uk/documents/nihr-guidance-for-a-second-wave-of-covid-19-activity/25837).This guidance still applies and, as outlined, states that the deployment of staff funded through an NIHR Infrastructure award or funded by the NIHR Clinical Research Network (CRN) to front line duties should only occur in exceptional circumstances.

The deployment of clinical academic staff should be undertaken within the guidelines issued by a working group convened by the UK Clinical Academic Training Forum and the Conference of Postgraduate Medical  Deans of the UK. Where NHS Trusts consider they need to redeploy staff to support the frontline this should only be done to support clinical activity during the emergency phase of the pandemic and we would expect them to return to their R&D roles as soon as possible, once the pressures on the system reduce.

As indicated by the Restart Framework, at the current time, we need to continue prioritise our support for the most urgent COVID-19 research as part of the response to tackle the pandemic. At the same time we need to ensure we continue to try and maintain support to deliver non-COVID studies currently open on the portfolio, particularly those within Level 2. A system-wide Recovery, Resilience and Growth programme has been established which brings together the key partners across the clinical research ecosystem to ensure the UK is well-positioned to take a coordinated national approach to achieving the recovery of the UK’s clinical research delivery and restore a full, diverse and active research portfolio as soon as practicable.

HRA UPDATE: guidance on undergraduate and master’s research projects

At the beginning of August an update was released by the Health Research Authority with regard to the review of clinical research by undergraduate and master’s students.

The HRA have released a further update – please see below. If you have any queries or concerns please contact Suzy Wignall, Clinical Governance Advisor in Research Development & Support.

Back in March the Health Research Authority and devolved administrations announced the decision to stop reviewing applications for individual undergraduate and master’s student projects until further notice while we prioritised the urgent review of COVID-19 studies. This was also due to the significant pressure on the NHS/HSC, limiting its ability to participate in research studies unrelated to COVID-19.

The pause on health and social care research projects for educational purposes has now been extended until September 2021. This decision is in line with national priorities for NHS/HSC to support COVID-19 studies and the restart of clinical trials and studies as well as the continuing pressure of the COVID-19 pandemic. This decision has been taken in collaboration with partners in the devolved administrations.

We are not reviewing applications for individual undergraduate and master’s student research projects until September 2021.

Any students with approved studies are reminded to check with the relevant NHS/HSC organisations locally about whether or not their projects may continue.

We have published information about other ways in which students can gain experience of health and social care research and have tips on our website.

We are committed to engaging our stakeholders as part of the development of ongoing guidelines for student research.

To receive updates about student research, please email communications@hra.nhs.uk to sign up.

HRA UPDATE: guidance on undergraduate and master’s research projects

Please see below for an update from the Health Research Authority surrounding the review of undergraduate and master’s research projects.

‘Back in March the HRA and devolved administrations announced we had decided to stop reviewing applications for individual undergraduate and master’s student projects until further notice while we prioritised the urgent review of COVID-19 studies. This was also due to the significant pressure on the NHS/HSC, limiting its ability to participate in research studies unrelated to COVID-19.

As the lockdown eases, we wanted to update students, supervisors and HEIs on our current position in relation to student research and ethics review. For now, our existing position of not reviewing applications for individual undergraduate and master’s student projects will remain in place. This means that any student project requiring approvals will not be able to proceed. Any students with approved studies are reminded to check with the relevant NHS/HSC organisations locally about whether or not their projects may continue.

In the autumn we will publish our proposed new guidelines for student research for consultation in use. Students, research supervisors and HEIs will be invited to share their opinions and help shape our framework.

You can find more information on our current position on our website: https://www.hra.nhs.uk/planning-and-improving-research/research-planning/student-research/

HRA launch new ‘Make It Public’ strategy

The Health Research Authority have launched a new strategy to ensure information about all health and social care research – including COVID-19 research – is made publicly available to benefit patients, researchers and policy makers. The new strategy aims to build on this good practice and make it easy for researchers to be transparent about their work.

You can read the announcement here.

For further information on the strategy itself you can take a look at the dedicated page on the HRA website.

 

Wessex reaches over 200,000 participants in clinical research

Over 200,000 participants have joined research studies supported by the National Institute for Health Research (NIHR) Clinical Research Network (CRN) Wessex in the last five years, according to latest figures published by the NIHR CRN.

The NIHR CRN’s 2019/20 annual statistics show that 37,067 participants took part in NIHR CRN Wessex supported research studies in the last financial year, taking the CRN Wessex participant total for the last five years to 222,042.

Patients from 100% of NHS trusts across the Wessex region, which covers Hampshire, Dorset, south Wiltshire and the Isle of Wight, took part in research, demonstrating the opportunities for people to participate, wherever they live and work.

You can read the full article here.

A number of BU-sponsored clinical studies have contributed to this figure, so if you have your own research idea and wish to branch out into the NHS, please get in touch.

NIHR stands by Black Lives Matter

The National Institute for Health Research have recently published their statement in support of the Black Lives Matter movement.

The NIHR recognise the problem of racism and structural barriers to minority communities in the research system and have vowed to do more to change this, both in the research landscape and their own organisation.

You can read the statement here.

Free online course! – Improving Healthcare Through Clinical Research

Interested in clinical research and what’s involved? Are you contemplating a career in healthcare or the life sciences, or, do you want to find out more about the role of clinical research in improving healthcare?

If you’ve answered yes to any of the above questions, then why not sign up to FutureLearn’s Improving Healthcare Through Clinical Research course?

The course has been developed by the University of Leeds and is be available from Monday 29th June, via this link.

It is completely free and all online, lasting 4 weeks.

This course has been certified by the CPD Certification Service as conforming to continuing professional development principles. By completing the course you will have achieved 16 hours of CPD time.

Remember – support is on offer at BU if you are thinking of introducing your research ideas into the NHS – email the Research Ethics mailbox, and take a look at the Clinical Governance blog.

HRA announcement – Amendment Tool now live

Please see below for a recent update from the Health Research Authority with regard to a new amendment tool and the online submission of amendments.

If you have any queries please email Suzy Wignall in Research Development & Support.


Online submission of amendments and a new amendment tool is now live across the UK, as of today Tuesday 2 June 2020.

These new processes for handling amendments are part of our ongoing Research Systems programme to improve services for applicants.

  • The amendment tool is designed to simplify the amendment process for applicants and
  • The ability to submit amendments online means that applicants can track the submission history of amendments.

From 2 June, all applicants making an amendment to project-based research will need to complete the amendment tool and submit their amendment online. The tool replaces the Notification of Substantial Amendment (NoSA) and Non-Substantial Amendment forms. Amendments to Research Tissue Banks and Research Databases will also be submitted online from this date.

To help with these changes, we have now published:

For queries on how to complete the tool, questions on the results from the tool, once complete or how to submit your amendment online, please contact amendments@hra.nhs.uk

Amendment Tool

The new amendment tool should be used for all project-based research including amendments being made under the COVID-19 fast-track process, from 2 June. (Research Tissue Banks and Research Databases will continue to use the IRAS generated substantial amendment forms.)

The tool categorises the amendment and provides tailored guidance on how to submit. It will identify any review bodies the amendment needs to be sent to, based on the changes that are being made to the study. It also provides detailed information about the amendment to participating sites.

The Notice of Substantial Amendment/annex 2 form can be generated by completing the tool. This version of the form can then be submitted to the REC and the MHRA (as required) when making a substantial amendment to a trial.

The amendment tool is based in Excel, but in the longer term we plan to fully integrate the tool functionality into IRAS.

The introduction of the amendment tool may require changes to Sponsor’s quality system (e.g. SOPs, guidance documents and templates etc.). Organisations should do this in accordance with the new process in good time. Given the additional demands placed across the healthcare research systems at this time, the MHRA has confirmed that it will adopt a pragmatic approach during inspection.

Submitting amendments online

Once you have completed the amendment tool, you should follow the submission guidance provided in the submission guidance tab of the tool. If the amendment needs to be submitted, then the amendment tool, together with all the supporting documents, should be uploaded into a new part of IRAS and submitted using the online system.

For amendments to Research Tissue Banks and Research Databases the IRAS substantial amendment form should be submitted online in place of the amendment tool.

Applicants will need to set up a new login and password for the new part of IRAS. We are sharing a login process with NIHR systems for the new parts of IRAS that provide online booking, the Combined Ways of Working (CWoW) pilot, and this new amendment system. If you already have a login for any NIHR system or one of these new parts of IRAS you can use the same details. If you do not already have a login for those systems, you will need to set up a new login and password as guided by the system.

Once you have logged in, applications will need to input the IRAS ID for the study as well as some other information regarding the study and amendment, some of which will need to be copied directly from the tool itself. Applicants can upload documents including a pdf of the tool itself. The system will issue an email to confirm the amendment has been submitted.

HRA announcement – Amendment Tool and Guidance now available

Please see below for a recent update from the Health Research Authority with regard to a new amendment tool and the online submission of amendments.

If you have any queries please email Suzy Wignall in Research Development & Support.


Online submission of amendments and a new amendment tool will go live across the UK on Tuesday 2 June 2020.

These new processes for handling amendments are part of our ongoing Research Systems programme to improve services for applicants.

  • The amendment tool is designed to simplify the amendment process for applicants and
  • The ability to submit amendments online means that applicants can track the submission history of amendments.

From 2 June, all applicants making an amendment to project-based research will need to complete the amendment tool and submit their amendment online. The tool replaces the Notification of Substantial Amendment (NoSA) and Non-Substantial Amendment forms. Amendments to Research Tissue Banks and Research Databases will also be submitted online from this date.

To help with these changes, we have now published:

For queries on how to complete the tool, questions on the results from the tool, once complete or how to submit your amendment online, please contact amendments@hra.nhs.uk

Amendment Tool

The new amendment tool should be used for all project-based research including amendments being made under the COVID-19 fast-track process, from 2 June. (Research Tissue Banks and Research Databases will continue to use the IRAS generated substantial amendment forms.)

The tool categorises the amendment and provides tailored guidance on how to submit. It will identify any review bodies the amendment needs to be sent to, based on the changes that are being made to the study. It also provides detailed information about the amendment to participating sites.

The Notice of Substantial Amendment/annex 2 form can be generated by completing the tool. This version of the form can then be submitted to the REC and the MHRA (as required) when making a substantial amendment to a trial.

The amendment tool is based in Excel, but in the longer term we plan to fully integrate the tool functionality into IRAS.

The introduction of the amendment tool may require changes to Sponsor’s quality system (e.g. SOPs, guidance documents and templates etc.). Organisations should do this in accordance with the new process in good time. Given the additional demands placed across the healthcare research systems at this time, the MHRA has confirmed that it will adopt a pragmatic approach during inspection.

Submitting amendments online

Once you have completed the amendment tool, you should follow the submission guidance provided in the submission guidance tab of the tool. If the amendment needs to be submitted, then the amendment tool, together with all the supporting documents, should be uploaded into a new part of IRAS and submitted using the online system.

For amendments to Research Tissue Banks and Research Databases the IRAS substantial amendment form should be submitted online in place of the amendment tool.

Applicants will need to set up a new login and password for the new part of IRAS. We are sharing a login process with NIHR systems for the new parts of IRAS that provide online booking, the Combined Ways of Working (CWoW) pilot, and this new amendment system. If you already have a login for any NIHR system or one of these new parts of IRAS you can use the same details. If you do not already have a login for those systems, you will need to set up a new login and password as guided by the system.

Once you have logged in, applications will need to input the IRAS ID for the study as well as some other information regarding the study and amendment, some of which will need to be copied directly from the tool itself. Applicants can upload documents including a pdf of the tool itself. The system will issue an email to confirm the amendment has been submitted.

New online booking service for IRAS – goes live Tuesday 19th May

Please see below for an update from the Health Research Authority with regard to the new system for booking in applications.

Any queries please get in touch with Suzy Wignall, Clinical Governance Advisor.


A new online booking service will be rolled out for IRAS studies on Tuesday 19 May – replacing the current Central Booking Service (CBS) telephone line. This is part of our ongoing Research Systems programme of work to improve our services for applicants.

Applicants submitting research projects through IRAS will no longer need to call the Central Booking Service to book a Research Ethics Committee, or to enable IRAS Form submission. Instead applicants will access the new online booking service via IRAS to book their application for review. The service is quick and easy to use and, unlike the current Central Booking Service, will be available 24 hours a day, seven days a week, making it easier for research applicants. If you need help and support with the new system you can call 0207 104 8008 between 8.30am and 4.30pm Monday to Friday.

In order to make use of this new functionality, applicants will be directed to a new part of IRAS which hosts the online booking service. A separate login will be required, but support will be provided. You will need to set up a new login and password for this area unless you already have a login for a NIHR system or as part of the Combined Ways of Working pilot (CWoW) pilot. In this case you can use your existing log in details.

Applicants will need to answer a series of questions online before being able to book a slot. This directs the applicant to the appropriate REC. The questions will be familiar to anyone who has used the CBS. Once you have completed your online REC booking, you will still need to electronically submit your application in IRAS using the normal process.

Applicants making contact about fast-track COVID-19 studies, should continue to follow our current guidance or email fast.track@hra.nhs.uk, DO NOT use the online booking service. 

The work to build the online booking service began before the current COVID-19 pandemic. It is being rolled out now so that the system can support research applicants with non-COVID-19 studies.

Training and guidance will be available via the IRAS website. You can also watch a short video to see how to use the online booking service.