RDF2020 – IMPORTANT UPDATE
FORUM TRAINING COURSE PROVISION
Unfortunately, all face-to-face training courses are postponed until further notice. We are watching the situation carefully and will open bookings again once we know it is ok to do so. Meanwhile we will work to find online solutions to enable our learning to continue and we are exploring alternative methods of providing support, discussion and training should this situation continue longer term.
Thank you for your patience and understanding
R&D Community responds to COVID-19
‘These are unprecedented times’; we must each say this, hear this and feel this multiple times a day as events touch each and every one of us. As the news changes and plans evolve there is a constant message from our CMO that is upfront and foremost: the science is central to what we do; research is absolutely critical to finding a solution.
It is extraordinary how the research and evidence community is mobilising in addition to the heroic efforts of our front line clinical colleagues. There are numerous places where the evidence is being collated, for example the Lancet Resources Centre and now the Oxford COVID-19 Evidence Service and many new studies emerging.
What are R&D Offices, Sponsors and R&D Departments doing?
The NHS R&D Forum community is key to ensuring that new and urgent COVID-19 research in the pipeline can happen whilst the implications on the continuation of existing research is actively assessed.
“Practically this is with regards to prioritising studies, releasing research staff to support clinical staff and/or releasing research space to the Trust to manage patients, protocol deviations/USMs in case of a lockdown, mitigation strategies on a study basis, considering whether amendments are required, research team numbers/ delegation and who to contact if the PI is unavailable” as well as actively preparing for new COVID studies coming through. (Research manager)
New rotas and policies are being drafted, emergency meetings are being held, study risk assessments are being conducted, regulatory guidance has been evaluated and staff guidance has been issued. Sponsors, funders and sites are being contacted and discussions held with CI and PIS. Research staff are moving swiftly to support clinical departments wherever they can, however they can and many are setting up new COVID 19 research. Some of the senior R&D leadership are stepping up to support their Trust/CCG operational response.
A selection of policies or staff guidance in-use-examples is provided in the Resources Exchange. You can help to share learning by uploading your tools guidance or assessments that will help others.
What is the NHS R&D Forum doing to support our community?
Members are representing the community at the national stakeholder meeting, chaired by Louise Wood and we are feeding in all intelligence collated. We are sharing practice, communicating any particular challenges, calling for new guidance and collecting examples of tools and resources to support. Our Forum working group members are also holding weekly hangouts to update each other on practice and to check on the well-being of group members and their teams.
If you have something to say, raise or share please do email FAO Kate via firstname.lastname@example.org
- Royal College of Occupational Health
- Health & Care Research Wales
- NHS Research Scotland
We will keep this webpage updated. If you have anything to share please get in touch FAO Kate email@example.com
A massive collective effort
Our CMO, Prof Chris Whitty of course also co-leads the NIHR. The Chief Scientific Advisor Sir Patrick Vallance, spoke at our conference in 2016.
Their support for research is unwavering and so too is the amazing effort and abilities of all our NHS, health and care workforce.
This really is when team science comes into its own.
Thank you for all you are doing
Message from DHSC
Please see below a new message from Dr Louise Wood, dated 26th March 2020.
Please cascade this information to your networks.
The NIHR website has been updated with a statement regarding the introduction of a national process to prioritise COVID-19 research. Please find the page here. Details on the process and the new single point of entry for prioritising COVID-19 studies can be found here.
Research but not as we know it: Managing novel methods in research.
The slides from our symposium are online here.
Using patient data in data-driven healthcare technologies – a blog from Engagement Manager Will Navaie
HRA Engagement Manager, Will Navaie, attended the NHS R&D Forum’s symposium ‘Research but not as we know it’ earlier this month to share key messages on the use of patient data in the development of healthcare technology. Read Will’s blog here
How accessible is research – really?
Click here to read the article written for CHART by Dr Sarah Williams, Associate Director of Research & Improvement.
Short online survey about patient and public involvement in data monitoring committees
Do you know someone who could complete a short online survey about PPI for data monitoring committees for clinical trials? Nuru Noor (a PhD student at the MRC Clinical Trials Unit based at University College London) is undertaking this work as part of a PhD on improving clinical trials. The survey aims to collect the views of patients, carers and family members of people who have taken part in or been involved with RCTs. The survey is here.
National Contract Value Review Process – Update from the Project Implementation Team
As you will be aware, a decision that no new research studies would be going through other than those related to the COVID19 effort was followed last week by an official statement from the Department of Health and Social Care prioritising COVID-19 research and frontline care (https://www.nihr.ac.uk/news/dhsc-issues-guidance-on-the-impact-on-covid-19-on-research-funded-or-supported-by-nihr/24469).
After consultation with the leadership within NHS England and NHS Improvement and NIHR, the Governance Group for the National Contract Value Review implementation met on 12th March and decided to pause this process with immediate effect.
What does the ‘pause’ mean?
We will not progress with a national contract review on any new studies that require validation. Commercial contract research studies will be validated by the LCRNs as per previous mechanisms
What happens to the roll out of the interactive Costing Tool (iCT)?
The mandated use of the interactive Costing Tool will continue as planned. From 1st April, 2020, all new Commercial Contract Research should be costed using the interactive Costing Tool. Resources are available to support its use on the NIHR website. (https://www.nihr.ac.uk/documents/interactive-costing-tool-ict-getting-started/12170.)
Accreditation for nominated National Coordinators:
The online accreditation platform will remain open for nominated National Coordinators to undertake accreditation should they wish. Please note, however, there is no deadline for completing this while other activities must take priority.
Most face-to-face training for nominated National Coordinators has been completed. When the project resumes, anyone who has been unable to attend will get the chance to take part in further sessions and the training day.
Training for industry representatives and participating sites will be organised and invitations sent out when implementation can recommence.
Three engagement webinars have been organised on the 24th March, 2nd April and 6th April for nominated National Coordinators, wider R & D community and Industry representatives. These will share information on the pausing of implementation and give invitees an opportunity to clarify any questions they may have. Please note these are not mandatory and invitees may choose to attend any or none of them if other activities take priority
We will continue to review the situation and, in line with advice and guidance from senior leadership within NHS England and NHS Improvement and NIHR, will announce when implementation will recommence in consultation with stakeholders.
Contact the project team if you have any questions firstname.lastname@example.org
RCF allocations for 2020-21
RCF allocations for 2020-21 are based on an overall RCF budget of £57m, which is in line with the figure derived when using the weightings and 2017 qualifying income used in the scenarios shared previously with organisations following the 2018 RCF review.
All addresses will have changed by March 2020.Staff email addresses will be standardised as email@example.com. A full list of contact email addresses for Research Ethics Committees is now available.
If you use an @nhs.net email address to contact someone at the HRA after they have moved to their new email address, you will receive a response containing their new details but your email won’t be automatically forwarded.
If you are unsure which contact information to use for the individual or service you require, please contact our mainline on 020 797 22545 or use our contact form.
New resources in REX this month
COVID resources and examples in practice (also key word search COVID-19)
e-Source Readiness Assessment (eSRA) – updated v2020
The eClinical Forum, a non-commercial, non-profit global organization with over 45 organizations active in clinical research, has established criteria to allow compliant use of EHR data in clinical trials. Their eSource Readiness Assessment (eSRA) checklist has been created with sponsors and research sites to simplify the self-assessment of EHR system use in clinical research. It is a standardized approach and free of charge. It allows sites to reuse their assessment across all their clinical trial sponsors. It provides all users (clinical research sponsors, CROs, sites, regulators, technology vendors) with the ease of a common assessment that is solely based on regulatory guidance. eSRA has already been used in several thousand sites worldwide since 2016. The 2020 version has been updated based on regulatory guidance issued during 2019.
Many valuable resources are available for free download.
View the latest additions to the Resource Exchange here
Other News, Calls & Funding
Be Part of Research Update
Be Part of Research service aims to make information about taking part in research available to anyone and already receives tens of thousands of visits each month and we have ambitious plans to grow.
We have identified a number of development priorities and are currently scoping plans for phase three of the services development, which will begin in April 2020. These include:
- Additional study feeds – We are reviewing the study feeds to ensure that we have as close to a complete picture of all recruiting clinical studies. We are aware that this is an issue and is a priority for us to fix.
- NHS Login – the delivery of NHS login for the service which will allow a more personalised approach to using Be Part of Research and work is currently underway to deliver this.
- User journey approach – the team are currently undertaking user experience research to help understand more about our audience and what they need from us to inform future developments and content.