August 2020 Newsletter
Date: 28 August 2020
Did you read?
My pandemic experience – redeployment, crisis leadership and meeting the challenge head on
This is a new, honest and insightful blog posted on the Forum website by Dr Rebecca Smith about her experience of leading for the Trust, outside of the R&D department. Becca is Deputy Director Research, R&I North Bristol NHS Trust and our NHS R&D Forum Strategy & Leadership Group Co-Chair. Read the blog here
Our Shared Practice Bulletin 2
Our second shared practice bulletin published in early August to share initiatives undertaken by NHS R&D departments during the COVID-19 pandemic. Examples cover vaccine trials, onsite monitoring solutions, priority setting partnerships and research undertaken by R&D management teams themselves. All examples include the contact details of the contributing R&D team. Download the bulletin here
Did you know?
The Interim NHS People Plan, developed collaboratively with national leaders and partners, sets a vision for how people working in the NHS will be supported to deliver care and identifies the actions NHSE&I will take to help them. Read the people plan here
R&D Forum Virtual Classrooms
Our recent virtual classrooms have had great feedback and so we are pleased to open two more courses for bookings. These are a great opportunity to take some well-earned time to develop, connect with peers and work through everyday challenges.
Each course is interactive and a workbook will be sent to your office or home address. Certificates are emailed on completion.
Some members have been in touch asking if we can host group bookings virtually and this is possible depending on availability of our trainers, numbers and dates so do get in touch to discuss further.
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.
Further details and booking can be found by clicking on the button below.
Essentials of NHS Research
Virtual classroom 16th & 17th November
This course is designed for any role at all levels when new to a health care R&D department. The course might also be of interest to colleagues in industry, academia and the third sector that would like to better understand managing NHS Research. Updated material includes a whole new look package of essentials for anyone looking for a complete overview of NHS R&D management.
Further details and booking can be found by clicking on the button below.
HAVE YOUR SAY
Joint Monitoring Survey: Summary of Responses
The Forum and UKRD jointly surveyed the community in July to determine the proportion of sites allowing on-site monitoring as well as the enablers and barriers for this activity.
100 responses were received of which 70% were Acute Trusts. Responses were also received from Mental Health, Community, CCGs and included Scotland and Wales.
- 80% reported that they had received requests for on-site monitoring
- 40% were allowing on-site monitoring, 50% were not allowing 10% were n/a
- Available space for lone working or social distancing; available space in Covid-cold space, non-clinical space or off-site.
- One monitor at a time, usual PPE/distancing
- Monitor tested few days before visit, usual PPE/distancing, monitor to repost any symptoms in next 7 days.
- Questionnaire prior to visit, temperature on arrival and declaration re; no symptoms
- Position letter available giving rules for access and system of permissions.
- Dedicated space with PC, video for conversations with staff, dedicated staff ‘runner’ for notes/other documentation. Documents quarantined for 72 hours and space/PC cleaned before and after visit.
- Prior phone call to minimise time on-site.
- Each visit risk-assessed, monitoring only allowed where absolutely necessary.
- Limited to interventional studies where on-site monitoring essential.
- No paper notes; screen sharing only – needs all resources in one place and dedicated R&D staff member for duration
- Many departments finding that compliance with systems results in very significant increase in work for R&D.
Barriers
- Lack of space and ability to distance.
- Trust ‘blanket ban’ on external visitors.
- Local ‘lockdown’.
- Lack of staff on site due to home-working, shielding, lack of space to distance.
- R&D in University building currently closed to staff and public.
- Scottish Government guidelines prevent on-site monitoring.
- Staff anxiety about external visitors, need individual risk assessment for returning staff.
- Concerns about monitors using public transport (eg flights from SouthEast to North/Scotland).
- No agreed approach for multi-Trust alliance
- Viewed as inappropriate to allow external visitors when clinical services not fully open.
Other comments
- Want sponsors to develop better remote and screen sharing options.
- Disclaimer so employer and employee accept risk and agree Trust process.
- Would like shared guidance from other Trusts.
- Would like national guidance eg from NHS R&D Forum/ HRA.
- When staff still not allowed on site unreasonable to allow monitors.
- Who is responsible for training on PPE/procedures etc?
- It would be helpful to know what guidance sponsors are giving monitors to avoid mixed messages.
- Could there be a small local monitoring team to do on-site monitoring for multiple sponsors?
Revision to the 7 existing Caldicott Principles: National Data Guardian for Health & Social Care (NDG) consultation.
Deadline 3rd September
- The National Data Guardian for Health and Social Care (NDG) is seeking views on proposed revisions to the seven existing Caldicott Principles and the extension of the Caldicott Principles to include an additional principle which makes clear that patients’ and service users’ expectations must be considered and informed when confidential information is used.
- We think these proposals are of interest to the research community and wanted to inform you of the consultation in case you, or your organisation, wanted to put in a response. Our Forum groups will consider a response on behalf of the community.
The link to the consultation survey can be found here
This link will also take you to a background document, which may helpful in responding to the survey. The closing date for the consultation is midday 3rd September.
NEW RCP report published challenges the equity of undertaking research across clinical teams and call for a highly visible R&D function.
Research for all? An analysis of clinical participation in research.
The RCP has published a report following a survey of their members that shows unequal access to research participation by women, rural physicians and those from BAME backgrounds. They also call for NHS organisations to support a highly visible R&D function.
The action plan at the end makes a number of recommendations including that:
- NHS trusts should support a highly visible R&D function that clearly explains the different ways clinicians can become involved in research and what support is available
- R&D departments and royal colleges should work collaboratively to disseminate examples of good practice, to ensure that learning and best practice on how to increase research activity in the NHS is shared
- NHS trusts must do more to publicise research focused mentoring schemes, especially to those underrepresented in research such as women and people from BAME backgrounds
- To support those who feel they do not have the knowledge or skills to participate in research, royal colleges, education bodies, NIHR and trusts should work to provide alternative routes into research – for example through credentialing schemes
Representatives of the NHS R&D Forum continue to work with RCP and the NIHR CRN on their work in this area and includes the establishment of a new Forum for cross-sector oversight to integrate research activity into care, which will meet for the first time on the 8th of October.
NIHR Update
The letter states that now there is less workforce pressure, it should be the default position that every eligible patient is offered enrolment into a trial and that hospitals should be aiming to recruit 60% of these eligible patients.
The five senior doctors – including NIHR co-lead and Chief Medical Officer for England Prof. Chris Whitty – begin the letter by thanking NHS trust staff for their hard work in providing clinical care for COVID-19 patients and supporting research into COVID-19. Read more about this and access the letter here
Please find links to the latest news items and case studies from our Local Clinical Research Networks.
For any queries please contact the Workforce Development Lead in your Local Clinical Research Network.
ETC Payments 2020/21 Q1 and Q2
As previously announced, phase II of the Excess Treatment Cost (ETC) project is underway meaning the method of paying CCG ETCs will be transitioned to a payment model that best suits the study rather than automatically paying the recruiting site. To ensure we transition all existing and new studies with applicable CCG ETCs to the new payment models, the 2020/21 Q1 CCG ETC payments made via the LCRNs have been suspended until after the 2020/21 Q2 data cut. Therefore the 2020/21 Q1 and Q2 payments will be combined into one payment run.
We have recently been advised that DHSC will be implementing a new payments system in mid-December 2020. The CRNCC and DHSC will make every effort to ensure the combined Q1 and Q2 payments are made to the LCRNs by the end of November 2020. However, if this is not possible, these payments will be delayed until January 2021. The CRNCC will issue the CCG ETC payment schedules as normal so LCRNs and provider organisations will know what payment can be expected.
Further updates will be provided in the coming weeks, ahead of the launch of the new payments process.
Contact: ETC Helpdesk etc.helpdesk@nihr.ac.uk.
Over 100,000 volunteers now registered for COVID-19 vaccine trials
As the number of people registered to take part in COVID-19 vaccine trials has now topped 100,000, we are encouraging others to follow their lead to help speed up efforts to discover safe and effective vaccines.
The NHS Covid-19 vaccine research registry will help large numbers of people to be recruited into the trials over the coming months, potentially leading to effective vaccines being identified and made available to the UK public against coronavirus earlier. It 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.
To enable large-scale vaccine studies to take place across the UK, the aim is to get as many people as possible signed up by October. The register can be accessed at www.nhs.uk/researchcontact (continue reading the article on the NIHR website).
INCLUDE Guidance
Following discussions with key stakeholders, ongoing research and hosting a series of events, the NIHR Clinical Research Network (CRN) INCLUDE steering group are delighted to have developed the following:
NIHR CRN INCLUDE Guidance (General)
NIHR CRN INCLUDE Guidance (COVID-19 specific)
Both now available to download here.
The INCLUDE guidance has been designed to be used in conjunction with research, particularly in the early stages of setting-up. The guidance aims to get research teams thinking about ways of making health research more inclusive and to ensure under-served cohorts are more fairly represented in health research.
What will I find in the INCLUDE Guidance?
This guidance summarises what an under-served group is, provides a roadmap suggesting intervention points to improve inclusion, examples of under-served groups and example barriers to inclusion. It then offers a suggested framework of questions to guide the deliberations of funders, researchers and delivery teams as they design and assess clinical research proposals, and ends with examples of good practice and other resources to guide teams seeking to engage with, and improve inclusion of, under-served groups in clinical research.
You will note that the second INCLUDE guidance document is COVID-19 specific. This guidance has been tailored to specifically meet the needs of COVID-19 research.
Find out more about INCLUDE
To find out more about INCLUDE, please take a look at the NIHR CRN INCLUDE Project Summary which provides information to date on the INCLUDE project. Take a look at our new INCLUDE website for additional resources, information about partners and much more.
For enquiries or more information about INCLUDE, please contact Eleanor Anderson (NIHR CRN Project Coordinator) on eleanor.anderson@nihr.ac.uk.
HRA
Call for CAG members
Data has the potential to transform our understanding of healthcare and our Confidential Advisory Group (CAG) sits at the heart of this in England and Wales. The HRA are looking for volunteer lay members to join their work and support this data revolution. Read more here
Update on decision to pause reviewing applications for undergraduate and master’s student projects during the COVID-19 pandemic
In March 2020, the HRA and devolved administrations announced their decision to stop reviewing applications for individual undergraduate and master’s student projects until further notice, while they prioritised the urgent review of COVID-19 studies. This was also due to the significant pressure on the NHS/HSC, limiting their ability to participate in research studies, which were unrelated to COVID-19.
For now, the existing position of not reviewing applications for individual undergraduate and master’s student projects remains in place. This means that any student project requiring approvals will not be able to proceed.
In the autumn they will publish our new guidelines for student research for consultation. Students, research supervisors and HEIs will be invited to share their opinions and help shape our framework.
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.
You will find the following new resources in REX this month.
View the latest additions to the Resource Exchange here
UKCRC: Monitoring Advances Including Consent; Learning from COVID-19 Trials and Other Trials Running in UKCRC Registered Clinical Trials Units During the COVID-19 Pandemic
Click here to access this resource
Royal National Orthopaedic Hospital: Positioning statement – on site Monitoring during COVID-19
Royal Papworth Hospital: On Site Monitoring Letter
Health Foundation: QI made simple
Health Foundation: Able to improve Summary Report
To submit a resource for consideration for inclusion in REX please click here.
Effective trial planning and design of Complex Innovative Design (CID) trials – Joint NIHR HRA & ECMC Programme Office 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. The NIHR have collaborated with HRA and the ECMC to publish a series of podcasts focusing on innovation in trial design and delivery.
Wednesday 19 August sees the latest podcast release in the CID suite of podcasts from the NIHR, HRA and the ECMC. Will Navaie, Engagement Manager at the Health Research Authority discusses Complex Innovative Design trials from the HRA’s perspective.
All previous releases can be found on Soundcloud here. All of the podcasts links are also available on NIHR learn here with the additional opportunity for discussion.
Latest Jobs
To view the latest job vacancies displayed on our website please click here
Independent OSCHR Board member to represent the NHS sector
Further details can be found by clicking on the link below and scrolling to the DHSC boards and committees vacancies section. The closing date for applications is midday on 8th September 2020 Click here for further details
Head of research finance and research finance policy manager positions at DHSC following the retirement of Trudi Symmons.
Closing date is 2nd of September
Research Finance Policy Manager
Please submit your latest vacancies and we will also tweet them out.
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