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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.

Our next virtual classroom is the AcoRD master class, which will run online on the 21st October. Please note that this is for experienced staff and is not a basics course. The course materials are currently being updated to include the triage process and are delivered by experienced AcoRD specialists who are Forum trainers.
Please promote this opportunity to those in Sponsor offices, funding teams or LCRNs who are proficient in AcoRD attribution but who need some extra insights into the latest policy and more complex study scenarios, including the triage process.
A workbook will be sent to your home or office address.

Book Here.

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:

  1. Decreased commercial income.
  2. Unfunded research costs for UPH studies.
  3. Decreased charity income and future unfunded grant extensions.
  4. 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?

Some members are in the middle of creating local e-consent processes and would like to hear from anyone who is in the same position and/or who has already implemented them. If you are interested in getting together to discuss approaches then please get in touch via info@rdforum.org.uk
Do you e-archive successfully? 

Members are I’m keen to get in touch with other Trusts who have implemented electronic archiving to see whether it is practical in their organisation. If you have any experience of systems to share please email via info@rdforum.org.uk and we will put you in touch.
Shared practice bulletin v2 
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 

DHSC has identified a number of issues with the costing, attribution and funding of COVID-19 studies.  Consequently it has asked all funders to ensure that current COVID-19 study applications that have not yet been contracted or the grant awarded have been correctly costed and attributed.  Funders may require a SoECAT to be completed for awards made in principle prior to finalising grants/contract to facilitate this process.
DHSC has also asked funders to ensure that any new COVID-19 applications are supported by a SOECAT where one would usually be required so that costing and attribution issues are picked up and resolved at the funding stage.
NIHR Q&A funding pages updated  

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.

Updated guidance on ETCs related to COVID 19
For all COVID-19 studies, including studies categorised as Urgent Public Health Research (UPH) studies should continue to adhere to the standard processes and mechanism for ETC attribution, costing and validation by completing a Schedule of Events Cost Attribution Template (SOECAT) as per usual practice.
ETC payments for these studies will be also be made in accordance with the arrangements of the national ETC system.
For studies where CCGs are the responsible commissioner, ETC payments for COVID-19 studies will be subject to provider thresholds where applicable.
Due to the disruption arising from COVID-19 as well as enhancements that we are making to the payments process, all CCG Excess Treatment Cost (ETC) payments made by Local Clinical Research Networks (LCRNs) will be suspended until at least Quarter 2 of the financial year 2020/21. Note: This includes payments to both primary and secondary care providers.
For studies where NHS E/I Specialised Commissioning is the responsible commissioner, ETC payments will be subject to specialised commissioning national finance team’s assurance review, and will take into consideration block funding arrangements that are in place to support funding flows during the COVID-19 pandemic.
The news item can also be found here on the NIHR website 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)

View the latest additions to the Resource Exchange here

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.

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