July 2020 Newsletter
Date: 30 July 2020
Did you read?
Research leadership – you’ve got to work at and beyond the boundaries
Last month we shared the following blog from Dr Nick McNally
Managing Director UCL/UCLH Research and Chief Operating Officer for the NIHR biomedical research centre at UCLH)
Read it again here
Did you know?
The UK Research & Development Road Map is published
The government has published UK research & development roadmap to set out the UK vision and ambition for science, research and innovation.
Download the road map here
AcORD Masterclass now open for bookings
Virtual classroom 21st October.
HAVE YOUR SAY
Routes of feedback
We continue to collate your comments, feedback and thoughts in order to route them through to the DHSC, appropriate individual or organisation. Forum representatives attend a number of stakeholder groups and also invite policy makers and regulators to attend our quarterly working group meetings.
Recent feedback has been routed through to:
- The NIHR RESTART advisory meetings, led by William van’t Hoff,
- Monthly ETC meetings and DHSC non-commercial costings group, led by Trudi Simmons
- The NIHR speciality primary care industry group
- HRA study set up board, led by Janet Messer
- Direct to DHSC via Louise Wood, Trudi Simmons and Mark Toal
Themes of recent feedback
- How hard teams are working
- Underfunding or undercosting of studies
- Retention of R&D staff
- Impact of COVID on Clinical academic pathways
- Challenges of vaccines study delivery including: Recruitment of the BAME community to vaccine studies & over recruiting
- SIREN study practicalities
- Sustainability (see the finance impact statement below)
- Practicalities of on site regulatory inspection and audit.
You can continue to feed in your comments and insights via our website here.
Finance Impact Statement submitted to DHSC
A statement on the financial impact of Covid19 on R&D in the UK has been submitted to the Department of Health & Social Care on behalf of the NHS R&D Forum and UKRD.
UK R&D finance Managers Group was established to support the NHS wider community to address concerns relating to the potential NHS research departments financial deficit due to COVID-19. The task and finish group undertook a rapid survey within the R&D leadership and finance communities. Responses were received from around 50 NHS organisations of which 90% reported concerns of major financial risks associated with the research response to COVID-19.
From this survey and further conversations within the R&D community, the group have identified that whilst there is some concern around NIHR funding, the main concerns for NHS R&D departments and their respective organisations relate to:
- Decreased commercial income.
- Unfunded research costs for UPH studies.
- Decreased charity income and future unfunded grant extensions.
- COVID19 Vaccine Trials
The paper aims to set out the reasons for concern, assess the impact and proposes recommendations for consideration by DHSC. It concludes that a significant proportion, possibly as much as 40%, of the UKs clinical research infrastructure is funded by non-NIHR core funding streams and urgent action is required. Failure to address the issues will result in significant and rapid loss of highly skilled workforce and infrastructure.
The task and finish group comprised of representatives from the following organisations: University Hospital Southampton, East and North Hertfordshire NHS Trust, Newcastle upon Tyne Hospitals NHS Foundation Trust, University Hospitals of Leicester NHS Trust, Oxford Health NHS Foundation Trust, Guys and St Thomas NHS Foundation Trust and University Hospitals of Derby & Burton NHS Foundation Trust. Thanks to all participants for their valuable contribution.
DOWNLOAD THE IMPACT STATEMENT HERE
AROUND THE FORUM
Are you developing e-consent processes?
Our next Shared practice guide v2 coming soon. If you would like to be included please email info@rdforum.org.uk
The Health Research Authority (HRA) in association with the devolved administrations, has launched its new research transparency strategy.
feedback from DHSC
The COVID-19 pandemic has highlighted the importance of sharing information about research taking place – to understand the virus and find the tests, treatments and vaccines – so that results can inform best quality care and preventive measures. This also means researchers do not duplicate efforts and can build on each other’s work while the public can see what research is going on.
Now, following a public consultation, the HRA’s Make it Public strategy has been launched. The strategy aims to deliver lasting change by making transparency easy, making it the norm and making information public.
The HRA is beginning work to implement the new strategy, starting with clear guidance for researchers and sponsors, an enhanced monitoring programme to ensure public reporting and informing study participants and, in the future, introducing sanctions into the research approvals process.
New measures set out in the strategy – will improve transparency and openness in health and social care studies, by:
- Expecting researchers to plan how they will let research participants know about the findings of the study from the beginning
- Introducing additional monitoring to check that researchers are reporting results and to collect information about study findings
- Making information on individual research projects – and their transparency performance – available to the public
- Introducing a system to consider past transparency performance when reviewing new studies for approval and in the future introducing sanctions
Read the strategy and find more information at www.hra.nhs.uk/makeitpublic
Costing feedback from DHSC
The Q&A pages on the impact of COVID-19 on research funded or supported by NIHR were updated on the 13th July, to include guidance on PPE and the redeployment of research staff to the NHS during COVID-19. Read more here.
NIHR Update
NHS COVID-19 vaccine research registry
The NHS COVID-19 Vaccine research registry will help people across the UK sign up for information on the new COVID-19 vaccine studies.
The registry has been developed as part of the UK Government’s Vaccine Taskforce, in partnership with the National Institute for Health Research (NIHR), NHS Digital, and the Northern Ireland, Scottish and Welsh Governments. We are also collaborating with ZOE, the company behind the Covid-19 symptom study who have 3.5 million UK users of their app, to work together to enrol their volunteers onto vaccine trials. It will help large numbers of peoplebe recruited into the studies over the coming months, potentially leading to an effective vaccine being identified and made available to the UK public against coronavirus earlier. Read more about how it works here.
Data and Business Intelligence
We are delighted to say study-site status information, provided through LPMS, is now available in the ‘Covid-19 impact on CRN portfolio’ app in the Open Data Platform (ODP). You can find it in the ‘Study Site Restart Summary’ tab. Using filters you can see the proportion of study sites which are open to recruitment, paused to recruitment due to pandemic etc in a certain LCRN, specialty, etc. We appreciate that data quality in both CPMS and LPMS has been impacted by the pressures of the Covid pandemic and are actively working to improve this. This is a first iteration of the app and further improvements will be made. If you have any questions or suggestions, please contact your Local Clinical Research Network in the first instance or click the ‘Provide feedback’ button in ODP.
National visibility of study site status information
A piece of work is under way to visualise study site status information recorded by sites in LPMS at a national level through ODP. This will enable the CRN and stakeholders to monitor on an ongoing basis how many sites in a particular study; LCRN, specialty etc are recruiting, suspended due to COVID, closed due to COVID etc. Further information and guidance on where to access this information will follow in due course. If you have any questions or suggestions, please contact your Local Clinical Research Network Business Intelligence team or email the CRN Coordinating Centre Business Intelligence team on inforequest@nihr.ac.uk
Innovation in Trial Design and Study Delivery – Joint NIHR & HRA Podcast Series
The clinical research landscape is changing and clinical trials are evolving to find new, faster and more efficient ways to bring new treatments to patients. Over the coming months NIHR are collaborating with HRA and the ECMC to publish a series of podcasts focusing on innovation in trial design and delivery. The podcasts were originally produced in response to recommendations made in a published paper; Effective delivery of Complex Innovative Design (CID) cancer trials- a consensus statement, published by the ECMC, NIHR, HRA and partners in the British Journal of Cancer. They are designed for anyone with an interest in complex or innovative trials. They feature a range of experts including experienced researchers, patients, an ethic committee chair and members of the HRA.
New resources in REX this month
The NHS R&D Forum Resource Exchange (REX) is a searchable, categorised set of resources and case studies submitted by members of the Forum community. To submit a resource for consideration for inclusion in REX please click here.
You will find the following new resources in REX this month.
Nottingham University Hospitals NHS Trust.
Verbal Consent (Rec approved script)
Cambridge CRF
External Monitoring Visits (working document)
Cambridge CRF
Code of conduct for research participant home visits (working document):
East & North Hertfordshire NHS Trust
Supporting grassroots innovation (article)
Latest Jobs
Research Funding Officer, St. George’s University of London
Click here for further details
Research Integrity, Ethics and Governance Administrator (AWERB, Sponsorship and RKEC), University of Sussex
Click here for further details
HRA Head of Approvals Operations
Click here for further details
Research Fellow, Leeds & York Partnership NHS Foundation Trust
Click here for further details
Senior Monitor, University of Birmingham
Click here for further details
Please submit your latest vacancies and we will also tweet them out.