February 2020 Newsletter

Date: 2 March 2020

Did you know?

There will be a new way of working from the 1st of April 2020 in relation to the costing of commercial contract research studies. All studies will be costed on the interactive costing tool (iCT). The iCT is the mandated tool. The Excel Spreadsheet tool currently used for costing will no longer be valid for studies submitted from 1st April 2020.

The National Contract Value Review process will not be mandated on 1st April but managed implementation of the process continues with accredited national coordinators undertaking the reviews.

Additional details will be provided through a dedicated bulletin and a webinar for the R & D community on the 24th March 2020. Booking details will be circulated in the coming days.

If you have any questions please do not hesitate to contact England.research@nhs.net

Did you read?

Regulating AI in Health and Care 

This is a blog by Matthew Gould, CEO of NHSX, explaining a recent roundtable of regulators to explore AI and a plan for the future. The blog contains a great explanation of the roles of each organisation in the regulatory landscape.

Read more here.

Three key messages on GDPR and research from Heather Couper at the MRC regulatory support centre.

Heather has written a blog for the UK Tissue Directory and Coordinating Centre exploring GDPR for biobanking with 3 key messages on the regulation for research.

Read her blog here.

Life Sciences Industrial Strategy Update 

Last month we reported that an update on progress made towards the life sciences strategy through the industry sector deal 2 has now been published. Many initiatives, including the recently advertised patient recruitment centres, are flagged in the report.

We will be hearing more about the sector deal from Emma Lowe at our Symposium on the 2nd March. Read the update here

Wellcome Trust research culture survey findings

The Wellcome Trust has published the findings of a large survey exploring how we do research and our research culture. The report calls for change to provide better support for researchers.

The Forum strategy and leadership working group will review the implications at their next meeting on March 11th in London. Read the report here or listen to an update by clicking here.

RDF20 update

Bookings for RDF20 continue to flood in and we are looking forward to a vibrant event.

One of the best features of RDF20 is the variety of the programme which provides delegates with the opportunity to find out more about current topics from expert speakers, attend specialist breakout sessions, learn from the personal development workshop, visit the poster presentations and exhibition stands and share experience with colleagues at the networking opportunities on offer.

Conference hotel rooms availability

One of the benefits of holding RDF20 at such a fantastic venue is the availability of great hotels near the Sage itself. Although both the Crowne Plaza Newcastle and the Jurys Inn Gateshead are now full, we are pleased to say that rooms remain available at the Copthorne Hotel Newcastle and the Jurys Inn Newcastle. We do, however, suggest you book your place at RDF20 soon.

Gala Dinner – limited spaces left

The Conference Gala Dinner and Awards presentation takes place on the evening of Monday 11th May and has proved popular with those booking to attend RDF20.

We strongly recommend that those hoping to attend the Gala Dinner book to do so soon as possible as this event is nearly full.

The Conference Programme and list of posters is available online. Plenary Sessions include:

• Louise Wood CBE
• Dame Jackie Daniel
• Professor Mary Dixon-Woods
• Professor Shaun Treweek
• Professor Chris Whitty
• Professor Clare Bambra

The programme including breakout sessions and a list of posters is now available.

More details and booking

 

Forum Symposia – Research not as we know it: Managing novel methods in research
2nd March 2020: London
Last chance to book
Calling all R&D offices and research management teams…our next Symposium in London on 2nd March will address the effective management of complex innovative trials and data driven technologies. The day will include top speakers from the Medicines and Healthcare products Regulatory Agency, the Department of Health and Social Care, The Health Research Authority and The Association of the British Pharmaceutical Industry (ABPI) Speakers will also represent the NHS R&D Department at Birmingham University Hospitals NHS Trust and the Medical Research Council CTU at UCL. This is a great opportunity for networking and working through your plans for the future with peers. Full details, agenda and booking can be found by clicking here.

Professional Learning & Development

A Practical Application of Monitoring in a Health Care Setting
Date: 2nd & 3rd March 2020
Location: Bristol
Further details and booking

Local Capacity & Capability for Research
Date: 20th March
Location: London
Further details and booking

AcoRD Master Class
Date: 25th June
Location: London
Further details and booking

Archiving Master Class
Date: 29th June
Location: London
Further details and booking

Regulatory Inspection Ready
Date; 9th July
Location: Birmingham
Further details and booking

Forum courses ‘in-house’ 

All courses on the Forum programme can be tailored to serve local needs and settings. If you would like a course delivered in your organisation please contact info@rdforum.org.uk

 

Forum Round Up

January and February saw working group meetings and discussions with key policy makers, including Dr. Louise Wood. Read more about our work this month and all our meetings coming up here.

Meetings coming up in March

Meetings coming up in March

2&3 March: Applied Monitoring Training Course
2nd March: Novel Methods Symposium
4th March: NIHR CRP launch event
5th March: RCP, NIHR, NHS R&D Forum Teleconference
11th March: Strategy & Leadership Working Group Meeting
13th March: Commercial Costing Reference Group
16th March: HRA Project Board
18th March: North West R&D Managers Meeting
19th March: Research Management Working Group Meeting
20th March: Capacity & Capability Training Course
24th March: CCR webinar for the R&D community
26th March: ETC Feedback group
30 March: CHART meeting
1st April: Evidence for Commissioning all day meeting

Forum to coordinate a response to UKRI open access policy consultation 

UK Research and Innovation (UKRI) has announced a nine week consultation to inform their proposed Open Access policy and we will be co-ordinating a response from the Forum across all of our working groups.

Open Access aims to make the published findings of publicly-funded research freely available online as soon as possible, in ways that will maximise re-use.  The consultation launched on 13 February 2020 and closes at noon on 17 April 2020. The consultation is open to all individuals with an interest in research and innovation.

The findings of the consultation will support the exploration of open access issues across the UK Government.

If you have a comment you wish to raise via the Forum you can send them FAO Kate via info@rdforum.org.uk

You can participate in the UKRI review directly by clicking here.

Calls from the Community 

CHART National Community Alliance Event 30th March
Conference Aston: Aston University, Aston St, Birmingham B4 7ETHere is an exciting opportunity for researchers from Community Trusts and colleagues engaged in research in out of hospital care settings to come together.

Agenda and further details are here.  Kate our Forum manager will be speaking about the Forum on the day.

Are you setting up new trial recruitment sites?Thousands of trials are done every year and all of them need to recruit participants.  Setting up trial sites to support this recruitment takes time, effort and money.  Despite all this, not all trial sites go on to recruit as hoped.  What would help is a way to predict whether a site would be a “good” recruitment site.

The Estimating Site Performance–2 project (ESP2) aims to test a tool that might help.  The project aims to include experiences from across the globe, which will ensure that the findings and recommendations that follow are globally relevant. Read more here.

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

Feed in: Be Part of Research Website Development Priorities

The NIHR CRNCC is collecting feedback on the Be Part of Research Website to help inform the future development of the site.

Read more here and find out how you can feed in and help to shape the next version.

Request for Trust Policies or Guidance for reimbursing PPI contributors during research grants

Do you have a Trust Policy or guidance document for reimbursing patients and public contributors for PPI activities that happen during the development of research grants; examples might include a Trust’s recommendations for reimbursement, Trust policy on how payments can be made,  the responsibilities of different staff groups etc. We are also interested to know if you have any Trust limits on reimbursement for PPI activities that are ‘costed’ into grant applications; for example, members of the public who are part of Trial Steering Groups etc. Please respond FAO Lucy Wasinski via Info@rdforum.org.uk

CQC well led inspections: Trust R&D teams, what supporting information do you need?

Members of our groups continue to work with the National partnership that is supporting the inclusion of research in CQC well-led inspections. The partnership has fed back to CQC inspectors on the experience of Trusts and would now like to support Trusts and R&D staff further. To help us provide information that will be of most use please email your thoughts on what you would like to see FAO Kate and Ashley via info@rdforum.org.uk

All email addresses at the HRA will have changed by March 2020

The change is happening in phases throughout February 2020, and all addresses will have changed by March 2020.Staff email addresses will be standardised as firstname.lastname@hra.nhs.uk. 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.

HRA Pharmacy Assurance process for NHS Sponsors of CTIMPS in England and Wales from April 2020
From 01 April 2020, NHS sponsors and co-sponsors of Phase I-III oncology CTIMPs and Phase III non-oncology CTIMPs will be expected to submit their studies for review through the Pharmacy Assurance process, specifically the Self-managed route. Non-NHS sponsors can still submit through Pharmacy Assurance; we remain open to the aforementioned. The HRA now want NHS sponsors in England and Wales to adopt this process from April for all Phase I-III oncology and all Phase III non-oncology CTIMPs. Further information is available on the HRA website.

NIHR Clinical Research Network appoints new Chief Executive
Dr William van’t Hoff has been appointed as the next Chief Executive of the National Institute for Health Research (NIHR) Clinical Research Network (CRN). He will take up post full time from 1 April 2020, replacing Dr Jonathan Sheffield OBE who retires on 31 March. As Chief Executive, William will lead the Network and oversee the delivery of its strategy to increase opportunities for people across the country to take part in clinical research.
Dr William van’t Hoff is an experienced paediatrician, having worked as a Consultant Paediatric Nephrologist at Great Ormond Street Hospital for Children NHS Foundation Trust (GOSH) since 1996. He is also currently the NIHR CRN’s Clinical Director for NHS Engagement, and Director of the NIHR GOSH Clinical Research Facility (CRF). He will be leaving his long term posts at Great Ormond Street Hospital to concentrate on his new role as Chief Executive of the NIHR CRN.
Prof Chris Whitty, DHSC Chief Scientific Adviser and co-lead of the NIHR, said: “I’m very pleased that Dr William van’t Hoff has been appointed Chief Executive of the NIHR Clinical Research Network. His wealth of experience as a front-line NHS clinician and clinical research leader will prove a real asset – not just for NIHR – but for patients and the public across the country.”
Dr Maria Palmer, Director of the Forum said: “ On behalf of the Forum I would like to extend our congratulations to William in securing this new and important role. We look forward to continuing our work together to ensure all health and care organisations and non-commercial Sponsors are supported to embed relevant and high quality research for patient and public benefit”

Read more on the NIHR website.

Clinical Research Network Annual Datacut:  5pm on Friday 24th April 2020

Please note that all High Level Objective reporting will be based on confirmed 2019/2020 research activity data only. This includes manually uploaded activity data and research activity data provided through LPMS which has been confirmed in CPMS by the study team representative.

Please continue to encourage staff recruiting participants in your organisations to record them in LPMS in near real time. If you have any Chief Investigators within your Trust, encouraging and supporting them to complete confirmation of activity provided by all participating sites in CPMS will ensure the activity will be included in the year end reporting and, where applicable, Excess Treatment Costs can be paid.
If you notice any out of date information on a study record (for example the record indicates the study is in set up when it has opened to recruitment), or if you are informed of a change (for example an extension), please highlight this to your LCRN,  including relevant details. This will enable the LCRN to update the CPMS study record and ensure our reporting reflects accurate and up to date information.
The NIHR CRN CC appreciate the introduction of this new way of working has been a significant change for everyone involved, and would like to thank you for all your hard work. If you have any queries, or if there is any assistance the CRN can provide in the lead up to the year end datacut, please contact your Local Clinical Research Network contacts.

Excess Treatment Costs (ETC) update

1. Launch of the Excess Treatment Cost Google site
A new Google site has been launched for the national Excess Treatment Cost (ETC) service to help provide the operational processes and policies of the new NHS Excess Treatment Costs service in one central repository. This does not replace the ETC dedicated webpage on the NIHR website and should act as a supplement.

2. ETC payments use confirmed recruitment activity data only

The quarter 3 (Q3) ETC payment schedules will continue to use manually uploaded and confirmed research activity data from within CPMS. The ETC payments will continue to exclude provisional recruitment data. The Q3 CCG ETC payment schedules will also include 2019/20 Q1 and Q2 confirmed research activity data that had not been confirmed in previous NIHR CRN data cuts.

It is important to note that retrospective ETC payments for recruitment activity either uploaded or confirmed after the 2019/20 NIHR CRN Q4 data cut (24 April 2020) will not be paid as per the ETC payment principles.

3. ETC Provider Threshold justification

We are aware from feedback that there is a misunderstanding amongst some stakeholders around the justification for Excess Treatment Cost thresholds.
To clarify, the justification for provider thresholds is:

• Providers are making savings through undertaking research / ETC savings
• Providers are saving on the admin burden from previous arrangements

Please note that members of the Forum groups join feedback calls to NHS England and Improvement, the Department of Health & Social Care and the NIHR everymonth. Therefore if you have something to raise please contact Kate via info@rdforum.org.uk

Interactive Costing Tool (iCT) update: full switch over April 1st

From April 2020, the NIHR’s online interactive Costing Tool (iCT) will be the only system available for industry costing submissions for new studies.

In readiness for 1 April full switch over to ICT if you have yet to use the new online iCT and need assistance, please contact the industry operations manager at your Local Clinical Research Network (LCRN) – who will be able to provide support and guidance. NIHR Local Clinical Research Networks (CRNs) have been provided with a readiness framework to support R&D teams in the transition to the new online interactive costing tool (iCT). This framework will enable LCRNs to support local sites and industry partners in their preparations for the use of the iCT.

New resources in REX this month

Bath Research & Development: Non-NHS Research Approval Policy
For non-NHS research active organisations to ensure compliance with the UK research policy framework.

Evaluation of digital health products: Public Health England
Resources from Public Health England to help anyone developing or running a digital health product to conduct an evaluation

CAHPR Research Practitioner Framework
A Research Practitioner’s Framework to support practitioners, managers, educators and leaders to review and plan practitioner roles, activity and support systems within a range of practice settings.

Read more here.

View the latest additions to the Resource Exchange here

Other News, Calls & Funding

NIHR Health Research Futures Podcast A new Health Research Futures podcast, from Professor Julie Lovegrove, focusing on nutritional research, is due for public release on the 20th of February. The podcast will be accessible, after this date, through the following link: https://soundcloud.com/nihr/prof-julie-lovegrove-and-nutritional-research?in=nihr/sets/health-research-futures

Free Online Course ‘What is Health Research?’

We are pleased to announce that the Massive Open Online Course ‘What is Health Research?’ will be starting again on the 16 March.

Over the course of three weeks, which you can do at your own pace, a variety of topics will be covered. You can learn about different types of research, how people are kept safe during research, and what you can expect if you volunteer to take part in research. Most importantly you will hear from people have taken part in research, learn why they volunteered and what difference it made.

Anyone can take this course, so if you have ever wondered what it’s like to take part in research, or other ways you can get involved in helping to be a champion of research, this course is for you!

Please share the link below with family and friends, and help us to spread the word online by retweeting

Starting on the 16 March, follow this link to sign up https://www.futurelearn.com/courses/what-is-health-research

NIHR Funding Opportunities 

Health & Care Research Wales Funding Opportunities

Latest Jobs

Senior Research Manager in Social Care Research

NIHR are advertising for a senior research manager in their social care research portfolio, which is expanding and is set to expand further. A chance to facilitate and shape the social care research agenda across the UK. The link to the advert is here – Ben Morgan is very happy to have informal discussions with anyone interested

Clinical Director for NHS Engagement 

NIHR CRNCC is appointing a new clinical director and strategic lead for NHS engagement. This is a high profile national role closing 4th March.  Details are here

Please submit your latest vacancies and we will also tweet them out.
all planned in Q1 & Q2.

New jobs this month – see here

Please submit your latest vacancies and we will also post on Twitter.

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