June 2022 Newsletter
Date: 1 July 2022
Welcome to the Forum June 2022 Newsletter
This week the Government has published The Future of UK Clinical Research Delivery: 2022-2025 Implementation Plan, click here to read more.
In March 2021, the 10 year vision: Saving and Improving Lives: The Future of UK Clinical Research Delivery was published followed in June 2021 by the Phase 1 Implementation Plan setting out the steps that would progress the vision in 2021 to 2022.
This Phase 2 plan summarises the progress made so far and the actions planned over the next 3 years, from 2022 to 2025, ensuring we make the progress necessary to achieve the vision in full by 2031. The plan has been developed by the cross-sector UK Clinical Research RRG Programme in consultation with stakeholders from across the clinical research ecosystem including your Forum.
Best Regards,
Maria Palmer
Director, NHS R&D Forum
The Forum ICS and Research Symposium – 13th October, Leeds
The programme will include presentations from senior leaders and national stakeholders to share the direction of research for ICS’s, Research Governance and Research Delivery. There will also be many opportunities to discuss and share your progress in ICB and your challenges.
With speakers from NHSE, DHSC , HRA , NIHR
Bookings to open shortly
Monthly Forum Working Group Update
Hello my name is Rachel Illingworth and I’m Head of Research and Evidence at NHS Nottingham and Nottinghamshire CCG, which from 1st July will be NHS Nottingham and Nottinghamshire Integrated Care Board (ICB) and I chair the NHS R&D Forum Evidence for Commissioning Group.
We formed as a community of practice in 2018 and now meet virtually every quarter. The group is made up of a wide range of individuals from a variety of organisations who all have a remit to support and enable commissioners to find and use evidence from research and other types of evidence including evaluation, to inform the commissioning cycle. The group includes R&D Leads, Library and Knowledge Specialists and Senior Managers working in CCGs, CSUs (commissioning support units), a University, NHS England and Improvement, Health Education England, NIHR Centre for Engagement and Dissemination, NIHR CRN Coordinating Centre and the UK Health Security Agency.
The aim of the group is to provide support, share learning, best practice and to work together as champions, advocates and influencers in this field.
Current priority areas include:
- Transition to Integrated Care Systems (ICSs) and Integrated Care Boards (ICBs)
- Developing evidence and evaluation capacity and capability in CCGs / ICBs
- Evidence repositories for sharing evidence reviews and evaluation reports
We are keen to hear from Forum members about work happening in CCGs and ICSs in relation to evidence informed commissioning, topics we might be able help with, plus new members are always welcome please write to us via the main R&D Forum email address. Thank you.
#Red4Research 2022
Thank you for supporting research.
Call for Trainers
The NHS R&D Forum is seeking applicants for the following roles within our training programme. Please note that at the moment all courses are being run online, but we do hope to return to face to face training in the future, so applicants should be prepared to travel.
Course Leader for “Finance in the R&D Office”
A course leader should have at least 2 years experience in the subject matter as well as considerable training and facilitation experience. You will be expected to put together, manage and lead a reference group to develop the course materials within an agreed timeframe, as well as helping to recruit trainers as required. Course leaders in general also act as trainers, but this is not required.
The UKRDFM will be leading a workshop on Friday 15th July at the CRF Network national conference in Bournemouth, to discuss the finance guidance. They’re hoping a course leader will be in place by then and will be able to attend the workshop. But please apply if you’re interested , even if you are not able to attend this event.
Medical Devices Course
We need two or three NHS representative(s) to be part of the reference group to develop the Medical Devices course. This will involve working with the course leader to develop the course materials and ensure that they are suitable for attendees who are either part of the NHS or work with the NHS on medical device studies.
For more information on the roles and the courses and for application forms, please contact allyson@rdforum.org.uk
Essentials of NHS Research (4 places remaining)
5th & 6th September
The updated material includes a whole new look package of essentials for anyone looking for a complete overview of NHS R&D management.
This is a two day course. The first day covers the overall research landscape and the legislation and regulations that govern it, as well as the various aspects of research management and governance. Day two concentrates more on the design, development and management of a research project, as well as looking at wider issues of leadership and strategy. The course is a mixture of traditional trainer presentation with interactive activities and discussions.
Regulatory Inspection Ready
12th September
This one-day course is aimed at those who deliver research in a healthcare setting either in a Sponsor team or as a Host, and that maybe subject to regulatory inspection. Preparation for Inspection is critical but compliance driven from preparation rather than from quality systems can lead to poor practice and Inspection findings.
Archiving Masterclass
10th October
An excellent course providing expert insights in the practicalities of research archiving procedures.
End of study procedures are the domain of both the NHS and the Sponsor and so if you are a named archivist or just need to understand more about how to firm up your procedures then you should consider this one-day event.
Local Capacity and Capability for Research
17th October – Save the date, bookings opening soon
A one-day course designed to provide an understanding of the requirements of an NHS organisation when determining whether to take part in a particular research study as a host. It explains the principles of good study set up, the information required by the R&D office and where it can be obtained. It introduces delegates to the various systems and documents associated with research and also provides some guidance on developing relationships with key support departments and stakeholders within an NHS organisation.
Essentials of Research Sponsorship
7th November – Save the date, bookings opening soon
This course is designed to provide the essentials to become and/or improve the management of clinical research as a sponsor. A one day course that will provide an opportunity to develop skills and gain knowledge in the underlying principles of sponsorship. The course covers widely accepted concepts that not only directly apply to sponsorship but are transferable to other areas of the research industry.
RDF 2022 Events Schedule
To view what else we have planned for the rest of the year, please click below. Courses up to March are only available to book right now, but we will open the booking pages for April & May, events in due course.
Screening Log Guidelines – (SLoG) project
Norwich Clinical Trials Unit have been awarded NIHR funding to look at a potential standardised model for screening data: who should be included and which data should be collected.
One aspect of this work is already underway, collecting views from those using screening logs via a survey, to understand current practice and shape the next stage of the project.
Further to this initial survey, we would like to engage with as many stakeholders as possible and use the Delphi Method to define and refine some national guidance on the use of screening logs, and hopefully produce an agreed screening log template.
As screening logs are relevant to lots of trials taking place within the NHS, we wonder whether there are any forum members who would like to participate in the Delphi rounds?
Researcher Guidance for Public Health ETC
Managing Excess Treatment Costs (ETC) for Research into Public Health and Social Care Interventions Commissioned by Non-NHS Organisations in England only.
Overview
The Department of Health and Social Care (DHSC) and NIHR are piloting interim arrangements to support non-NHS excess treatment costs for research into public health and social care (non-NHS intervention costs). This replaces the previous arrangements for supporting public health intervention costs managed by Public Health England (PHE).
Whilst it is expected that as a matter of principle the organisation responsible for commissioning the service being researched should pay intervention costs or provide equivalent resources, where this has not been possible public health and social care research studies funded by non-commercial funders may be eligible for support from DHSC.
Researchers who are undertaking research in public health and/or social care in England that is funded commercially and who are seeking funding for excess treatment costs (ETCs) should contact interventioncostenquiries@dhsc.gov.uk in the first instance.
Excess treatment costs: Payment thresholds lowered for NHS trusts
NHS trusts delivering non-commercial clinical research will benefit from additional funding to deliver studies across England – following a financial policy change lowering the point at which trusts can claim back research excess treatment costs.
Excess treatment costs (ETC) are the costs incurred by NHS trusts and care providers involved in delivering research, when the treatments given as part of delivering studies are more expensive than the care/treatment that the participants would have normally received.
NHS England and NHS Improvement’s national NHS Clinical Commissioning Group (CCG) ETC payment system, which is managed by the National Institute for Health and Care Research (NIHR), applies a contribution threshold to NHS secondary care sites for claiming back the excess treatment costs they incur while delivering studies. NHS sites are required to surpass this threshold before any ETC payments can be made.
Addressing the challenges to conducting trials involving adults lacking capacity to consent – Key findings and recommendations from CONSULT-ENABLE Study
The Centre for Trials Research has recently published a paper exploring the barriers and facilitators to conducting trials involving adults lacking capacity to consent (CONSULT-ENABLE Study), which also made a series of recommendations for funders, regulators, RECs, researchers and research delivery teams.
Survey on addition Information Governance reviews by organisation participating in research studies
HRA and HCRW are undertaking a survey to understand where and why additional Information Governance reviews are undertaken by organisations participating in HRA and HCRW Approved research. They aim to understand:
- Where these additional reviews duplicate reviews already undertaken as part of HRA and HCRW Approval and should therefore cease;
- Where our own review criteria and processes should be modified to provide additional assurances to participating organisations, and;
- Where our guidance would benefit from greater clarity, particularly on which assurances participating organisations should be taking from HRA and HCRW Approval and where local organisations still need to make local assessments and arrangements.
They ask for a response to the following from each NHS research support function (e.g. R&D, R&I Office or equivalent), no later than 5 July. This survey is intended to be completed by the RD function, not the DPO or Information Governance Lead.
Find out more and complete the survey here
New LCRN Geographical Configuration post 31st March 2024
From April 2024, the 15 current Local Clinical Research Networks (LCRNs) will be replaced by 12 NIHR Regional Research Delivery Networks (RRDNs), each mapped onto the NHS England Regional Office boundaries and those of the Integrated Care Systems (ICSs) operating within the regions, also coterminous with most local authority boundaries.
This will provide even more focus on regional collaboration, influence and development with the local NHS and care system, to meet the needs of people within a region, while facilitating joint working with the NHS and ICSs. The NIHR Research Delivery Network will be led by the leaders of the RRDNs together with the National Coordinating Centre and DHSC.
New NIHR Infrastructure Competition Announcement: Research Support Service
A new NIHR Infrastructure open competition, which will be launched in August 2022, incorporating facets of the current NIHR Research Design Service (RDS) and NIHR Clinical Trial Units (CTUs).
Building on the success of the RDS and CTUs funding schemes, the NIHR will be launching a new, open competition to fund NIHR Research Support Service (RSS). The NIHR RSS scheme will replace both the NIHR RDS and NIHR CTU Support Funding programme, but importantly, will incorporate and retain the remits of each scheme, collectively forming a national community providing expert research design, methodological support, advice, and collaboration throughout the pre- and post-application/research conduct. The current NIHR RDS and NIHR CTU Support Funding nomenclatures will be discontinued from September 2023.
NIHR Publishes Latest Annual Report
The NIHR has published its latest annual report highlighting its milestones and achievements during 2020/21 – a year like no other. The report celebrates how NIHR responded to the COVID-19 pandemic while continuing to fund and support world-class and ground-breaking research.
Writing in the forward to the report, Professor Chris Whitty and Dr Louise Wood, state: “During a year in which our lives were dominated by the global COVID-19 pandemic, NIHR played a central role in underpinning the nation’s scientific response, benefiting patients in the UK and globally.”
NIHR Updates
- CCG ETC National Payment System and ETC Helpdesk
- New Director of Science, Research and Evidence will help lead NIHR
- Research reset update
- How the NIHR mobilised and adapted the UK research landscape to deliver COVID-19 studies
- Be part of the NIHR Research podcast series
- NIHR Awards Update
Contacting the R&D Forum
As a reminder, should you need to contact the Forum the best way is via email which is info@rdforum.org.uk
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