R&D Forum News

R&D Forum News

  • January 2020 Newsletter (1/30/2020)
    Happy 2020 everyone! 
     
     
    With lots of events, group meetings, resources and initiatives in development plus an updated website in the pipeline it is looking exciting for the Forum in 2020. Many members of the health care R&D community contribute their time to making the Forum a vibrant and supportive place for all and we hope you will continue to do so over the coming year.  
     
    If you would like to get involved, create a resource, join a group, or work on something with others, please get in touch FAO Kate via info@rdforum.org.uk. Please also contact Kate if you can help drive any of the initiatives highlighted in this edition of the news. 
     
    Become a Forum Trainer
     
    We are selecting new trainers for Forum courses, in particular the Essentials of NHS Research and Regulatory Ready courses. If you are experienced in NHS R&D management with a broad understanding and you are a great trainer looking for a development opportunity to support others, please get in contact FAO Allyson via info@rdforum.org.uk and for information on all our training courses please click here

    For more information click here. 
     

    Did you know?

    2020 is the international year of the nurse and midwife. 
     

    Sally Humphreys, Research Management Working Group chair, Florence Nightingale Foundation research scholar (and nurse), blogs about the pivotal role nurses and midwives play in research. Read Sally’s blog here.

    Did you read? 

    The Academy of Medical Sciences Report exploring the NHS-academic interface and our Forum response:
     
    The report was published earlier this month by the Academy and calls for improved investment in health research, making 6 recommendations.  With links to a number of associated papers including case studies, a patient round table and an economics analysis for consultant time in research, the report is important to read and is welcomed. Our strategy & leadership working group have issued a response and call for the inclusion of all professional groups across all care settings from the outset. 
     
    The report also explores the value of joint research offices, which is a topic that will be presented and discussed further at the Forum conference in May. 
     
    Link to our response, the report and associated papers here.


    Medical & Dental Pay Scales for Junior Doctors – Write up by Mark Terry, 
    Clinical Research Operations Manager at the Royal Marsden
     
    Last month Mark wrote up his experience of securing funding to support a salary gap between clinical fellows and research fellows in his Trust. You can read his update in his summary paper here. Mark is willing to share his experience in this area. If you would like further information contact mark.terry@rmh.nhs.uk

    Effective delivery of Complex Innovative Design (CID) cancer trials—A consensus statement

    Blagden, S.P., Billingham, L., Brown, L.C. et al. Effective delivery of Complex Innovative Design (CID) cancer trials—A consensus statement. Br J Cancer (2020).
     
    This consensus statement was published earlier this month to improve the conduct, quality and acceptability of oncology CID trials in clinical research but may be applicable to other disease areas. 

    Some of the authors of this paper will be presenting at our Forum symposium in March, where we shall discuss the management of complex studies with adaptive designs such as umbrella trials, platform trials and also data driven technologies.

    Read more here.

    Early Bird Rate extended

    The early bird rate was due to end on 31st January. Although bookings have been flying in, we have received requests from a large number of NHS Trusts who are in the process of setting up new suppliers and raising Purchase Orders. We appreciate that due to the restructure it is taking delegates longer than normal to obtain a PO, so we have taken the decision to extend the early bird rate for two weeks. 

    Click here to book.

    RDF20 programme and list of posters now online

    The Conference Programme is now 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.  Click here to view the programme.

    Forum Symposia – Research not as we know it: Managing novel methods in research
    2nd March 2020: London 
     
     The agenda is live and we are delighted to confirm two new speakers: 
    • Sheuli Porkess, Executive Director Research, Medical & Innovation, the Association of the British Pharmaceutical Industry who will given an industry perspective on the future of clinical research. 
    • Will Navaie, Engagement Manager HRA, will share his thoughts on managing methods for evaluating data driven technologies.
    Innovative real world research designs are likely to become more commonplace for both sites and Sponsors and so we aim to look at how we can build our confidence as a community to ensure they are able to run well in and for the NHS. We shall discuss with industry regulators and hear experience from R&D teams the management of complex studies with adaptive designs such as umbrella trials, platform trials and also data driven technologies. 

    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

    Archiving Master Class
    Date: 29th June
    Location: London
    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

    CRNCC Research Engagement Survey for your completion.

    The engagement of ‘non-research’ NHS staff was clearly identified in our Forum community survey as a critical area requiring further support and development. We have therefore supported the NIHRCRN CC engagement team in sending out a subsequent survey to help establish successful engagement practices and to find out more about the challenges in this area. 

    The survey is distributed in google forms format, which should be accessible to all without a log in. Please email Roger.steel@nihr.ac.uk if you have difficulties accessing it.  

    Access this short survey here

    CHART: An Alliance for Community Trusts Progress update

    In light of the NHS Constitution1 and the Long Term Plan2 emphasising the need for new ways of working, this is an ideal time for Community Trusts to join forces.  The Community is often the NHS component that falls between Acute Trusts and Primary Care and is not well understood which is mainly attributed to its complexity.  Community Trusts are not renowned for their research activity, however many have aspirations to develop and grow.  

    Read more about CHART and an update on their progress here

    Beyond project specific PPI

    The Forum Service Users and Carer Group welcomes a paper exploring a move beyond project specific PPI towards better organisational involvement.

    A recent paper published has highlighted the importance of strategic PPI, which is a key area of work for the Service Users and Carers group of the Forum. The paper “Moving beyond project-specific patient and public involvement in research” explores how patient public involvement moves beyond project-specific activities to become embedded within the wider infrastructure of the organisation. 

    This is an area that the service users group have identified through their extensive personal experience and highlighted to the NIHR and policy makers. The group will continue to work with our partners and the Forum strategy and leadership working group to develop this area of important work. 

    A link to the paper is here 

    Calls from the Community 


    The set-up of social care research: Key issues and barriers from a governance perspective plus a call for resources and good practice
     
    The CRN Coordinating Centre has provided funding to Eastern and Wessex Clinical Research Networks to carry out a piece of work to scope how the Clinical Research Networks can support the set-up of adult social care research. This is being led by Clare Symms, Viv Shaw and Jan Westbury who are looking at the key issues and barriers from a governance perspective and looking to devise potential solutions taking account of what is in place already. 
     
    If anyone knows of resources or practice that work well we would be very interested to know more. Please get in touch in early February and do circulate this information on to colleagues.  
    Contact at CAPCCG.RandDoffice@nhs.net or SNCCG.RandDoffice@nhs.net.

    Further information about the project is available here

    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

    How do you review a study for sponsorship? 
     
    We are collating sponsor assessment SOPS & review processes to help inform our development of some standards following on from the sponsors symposium table talks. Please send anything you have FAO Kate at info@rdforum.org.uk
     
    Example agreements or SOPS for outsourcing site activities
     
    Do you have any examples of agreements or SOPS you have used when outsourcing for site activities? We are collating examples to support guidance in this area.

    SoECAT information or training slides for research teams 

    If you have a developed a slide set or materials you can share that aims to support research teams to understand the SoECAT (what it is, what it is for, and how it affects researchers) please send them to either Kate at info.rdforum.org.uk or Phillip

    Update on #makeitpublic research transparency strategy 
     
    The #Make it Public strategy was agreed, in principle, by the HRA’s Board when it met in December. The Board thanked everyone involved in the consultation and agreed that the strategy had been developed through a robust process. However due to the General Election the Board postponed approval of the strategy. The Board will meet again in early February 2020 to agree the implementation plan. The HRA will make an announcement about strategy after the February Board meeting.

    Pharmacy Assurance process for NHS Sponsors from 1 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 CTIMPs. Further information is available on the HRA website.

    Read more about the process including dates for free workshops here.

    Excess Treatment Costs update
     

    As part of the on going work to improve the ETC system for researchers, new guidance has been published for researchers, study teams and sponsors on completing the Schedule of Events and Cost Attribution Tool (SoECAT) – in addition to specific guidance on how to complete the SoeCAT.
     
    The new national system for paying Excess Treatment Costs was successfully delivered however the ETC Project will continue for the next 18 months with the aim to tackle a number of issues currently faced in delivery the Excess Treatment Cost service, as follows:
    • Improve the current manual transfer of the ETC per patient value and single modelling method in ODP by developing new alternative ETC payment models to ensure payments are made to the intervention site expecting the funding as opposed to the recruitment site currently recorded in CPMS. This will reduce the number of transactions required to transfer funds between various organisations.
    • Improve the current tools used to attribute the costs of non-commercial studies, which currently use the spreadsheet version of the SoECAT by developing an automated version of the SoECAT within CPMS. 
     

    Changes to NIHR costing methodology from 2020/21
     

    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 preparation for the transition to the new system, links to the old Excel tool have now been removed from the NIHR’s website. Make sure you are ready for the big switchover – find out more about the iCT and how to get started here.
     
    We encourage all NHS R&D Departments to proactively work ahead of this deadline and register themselves with group CPMS accounts so that are able to receive new iCT requests from our commercial partners, meaning that negotiation timelines and setup are reduced to a minimum. Since its launch last year, there has been a significant increase in the number of companies using the online system. However the NIHRCRNCC continues to work hard to achieve full usage of the new web-based interactive Costing Tool (iCT) before the old, excel version is discontinued from April 2020.  A number of helpful films about the new iCT are available via the NIHRtv Youtube channel including submission guidance for life sciences industry
     
    If you would like to further understand the advantages to working within the iCT ahead of the 1 April 2020, please contact your regional LCRN Industry Operations Manager or email phillip.good@nihr.ac.uk who will be able to talk you through how the iCT can work to the benefit of your organisation. 

    NIHRCRN CC Staff Update- Associate Director of Nursing and 70@70 Programme Lead role
     
    Clare Meachin has left her seconded role at the CRNCC as the Associate Director of Nursing and Programme Lead for 70@70 (and also her substantive role as Deputy Chief Operating Officer for CRN South London) at the end of November 2019 to take up a post as one of the Directors of Nursing at Portsmouth Hospitals NHS Trust. Dr Sharon Barrett, currently on secondment to the CRNCC, has succeeded Clare as the interim Associate Director of Nursing and 70@70 Programme Director for the coming period.
    Read more here.

    Life sciences Industrial Strategy Update is published

    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. 
     
    Read the update

    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. 
     
    Read the report or listen to an update

    MRC Regulatory Support Centre (MRC-RSC) quarterly news 

    The RSC have published their quarterly round up of all research regulatory news. Download it here.

    New resources in REX this month

    1. The Development of a core competency framework for clinical research staff Merrie Gowie, DanielleWilson, SarahGregory & Louise L.Clark
    2. What does a great lay summary look like Academy of Medical Sciences
    3. Two e-learning modules to explain the regulations and ethics of Research Tissue Banks HRA & HTA
    4. Youtube Video: The ethical, governance & management implications of involving consumers in health research Virginia Minogue & Anne-Laure Donskoy.
    5. Innovative methods e-learning

    View the latest additions to the Resource Exchange here

    Other News, Calls & Funding


    NIHR Podcasts
     
    The NIHR Clinical Research Network issue monthly podcasts.  Hosted by Prof. Allan Gaw, these discussions explore a wide range of topics related to Health Research.  This month we hear from Prof. Martin Rossor on the topic of  ‘Dementia Research’.  Listen here on the NIHR Soundcloud channel.
     
    There is a wealth of previous recordings available here. These include discussion about Primary Care Research (with Prof. Philip Evans);  Research Ethics Committees (with Dr Hugh Davies); Multi-arm, Multi-stage Clinical Trials (with Prof. Allan Hackshaw); and Patient Research Ambassadors (with Helen Cooke).

    Improving Healthcare through Clinical Research – A NIHR Massive Open Online Course (MOOC)
     
    The next presentation of ‘Improving Healthcare through Clinical Research’ starts on the 3rd February.  The course runs for four weeks and new learners can join at any time to learn how medical treatments are discovered, tested and evaluated to improve healthcare for all.
     
    New R&D staff and those interested in a career in Health Research will find this course particularly valuable. You can join this course here

    Be Part of Research

    Read more from the NIHR here.

    NIHR Funding Opportunities 

    Health & Care Research Wales Funding Opportunities

    Latest Jobs

     
    New jobs this month – see here

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

  • NIHR CRN updates – January 2020 (1/27/2020)

    Staff Update- Associate Director of Nursing and 70@70 Programme Lead role 

    Clare Meachin left her seconded role at the CRNCC as the Associate Director of Nursing and Programme Lead for 70@70 (and also her substantive role as Deputy Chief Operating Officer for CRN South London) at the end of November 2019 to take up a post as one of the Directors of Nursing at Portsmouth Hospitals NHS Trust.

    Clare provided invaluable leadership for the development and implementation of the 70@70 Programme since Susan Hamer’s retirement at the end of 2018, and has done outstanding work in engaging with senior stakeholders and nurses and midwives at all levels around the programme.

    Clare said: “After working in clinical research for the past 20 years, and developing the 70@70 programme I see a role as a Director of Nursing, back in an NHS Trust, as a fitting end to my career as a nurse. In all honesty, I will use all I have learnt and understood about research, NHS Engagement and all the many facets of delivery of research in the NHS in the new job. Making connections between clinical priorities, research and evidence-based care will I hope be the foundation of this new role for me…

     I will miss all the amazing people I have met and worked with over the past 20 years – it will be quite a wrench leaving research – but it is all for the right reasons both professionally and personally.

     

    As many of you are aware, the Department of Health and Social Care has agreed to fund a new role of ‘NIHR Director for Nursing and Midwifery’, whose responsibilities include leadership for the 70@70 Programme.  As that role is not scheduled to commence until spring 2020, we are delighted to confirm that Dr Sharon Barrett, currently on secondment to the CRNCC, has succeeded Clare as the interim Associate Director of Nursing and 70@70 Programme Director for the coming period.  Sharon is the Deputy Chief Operating Officer at CRN North Thames but is qualified nurse with a specialist background in cardiovascular medicine.

    Sharon has been interim Head of Feasibility and Start Up since May 2019 and leading on a number of key areas such as; the management of feasibility service and the introduction of the new approach to assessing study start up and intra-study variability (HLO9).  She has also supported key projects such as; excess treatment costs, interactive costing tool, confidentiality disclosure agreements and more recently the commercial contract research project.  She has also been involved in discussions around the expansion and engagement within social care and building partnerships with NHS England and Genomics Medicine Service and Genomics England

     

    Contact: lcrn.support@nihr.ac.uk.

     

     

     

  • Pharmacy Assurance process for NHS Sponsors from 1 April 2020 (1/27/2020)

    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 CTIMPs. Further information is available on our website.

    Read more about the process including dates for free workshops below:

    The Health Research Authority (HRA) has an ongoing commitment to streamline research governance and processes. The Pharmacy Assurance process coordinates a standardised single technical pharmacy review for eligible studies across the UK. The completed review can be used by all participating NHS/HSC sites to support local capacity and capability assessments and study set up in their pharmacy departments.

    To support this phase Pharmacy Assurance becoming a component of HRA and HCRW Approval, the HRA is running a series of workshops across England.

    The workshops are free and there will be two sessions running each day. The morning workshops will focus on the changes and implications for pharmacists and pharmacy technicians working in clinical trials. The afternoon sessions will focus on the requirements and implications for NHS sponsors/co-sponsors and R&D/I staff. Please note pharmacy staff attending the morning sessions may be able to use this as evidence towards their Clinical Professional Development (CPD) portfolio.

    Dates

    • February 24, 2020 – London
    • February 25, 2020 – Newcastle 
    • February 26, 2020 – Manchester
    • March 2, 2020 – London
    • March 3, 2020 – Bristol
    • March 4, 2020 – Birmingham

    For further details on the workshop objectives and how to register your attendance, please visit the HRA website. 

  • CHART: An Alliance for Community Trusts (1/27/2020)

    In light of the NHS Constitution1 and the Long Term Plan2 emphasising the need for new ways of working, this is an ideal time for Community Trusts to join forces.  The Community is often the NHS component that falls between Acute Trusts and Primary Care and is not well understood which is mainly attributed to its complexity.  Community Trusts are not renowned for their research activity, however many have aspirations to develop and grow.

    Two years ago six Community Trusts met together for one day to talk about the issues they faced and as a result suggested the formation of an alliance.  This meeting was followed by the launch of the alliance in November 2018 with  58 attendees from 24 organisations.  The launch event hosted by Birmingham Community Healthcare NHS Foundation Trust was supported by presentations from Imogen Shillito  Director of Stakeholder Engagement and Communications at the NIHR Clinical Research Network, Lucy Chatwin Business Manager Academic Health Science Network and Professor Jeremy Kirk Clinical Director for the Clinical Research Network West Midlands.  

    What is CHART?

    CHART is a Community Healthcare Alliance of Research Trusts.  This alliance engages with R&D leaders and research active staff and is intended to be a practical place to:

    • gain support from other CHART organisations as many Community R&D teams are very small and often work part time
    • share best practice
    • network and generate new research or innovation bespoke to Community Trusts
    • present a collective voice to national bodies to influence and support future research within the community setting

    The CHART working group is composed of:

    Christine Burt – Birmingham Community Healthcare NHS Foundation Trust

    Lee Tomlinson  –  Kent Community NHS Foundation Trust

    Helen Vaughan – Sussex Community NHS Foundation Trust

    Elizabeth Allen – Leeds Community NHS Trust

    Rubina Reza – Derby Community NHS Foundation Trust

    New additions to the working group are:

    Joanne Jackson – Kent Community NHS Foundation Trust (Admin Support)

    Sarah Williams  – Solent NHS Trust

    Kathryn Brown – Hounslow and Richmond Community Healthcare NHS Trust

    The primary challenge faced in developing CHART has been the limited capacity of the working group to absorb this additional initiative into their already busy roles. Nevertheless, although progress has been slow, the working group have begun to make signfiicant progress. 

    Completed and on-going activity in this area includes:

    • Analysis of the launch feedback
    • Development of a mailing list
    • Branding and terms of reference
    • Identifying administration resource
    • Exploration of various communication platforms such as the Hospify App or NIHR Google hub – no final decision has yet been made due to the complex nature. Email will be the main communication tool.
    • Development of aims and objectives and action plan
    • Promotion of CHART via poster presentation at R&D Forum 2019
    • Conversations with the Department of Health and Social Care and the Clinical Research Network
    • Attendance at research meetings where Community representation is requested

    Who is CHART For?

    CHART is for any organisation engaged in Community healthcare research.  This will primarily be Community Trusts however we welcome Mental Health Trusts, Primary Care organisations and Acute Trusts with Community activity where research needs to grow.

    How can I join CHART?

    Email: joanne.jackson6@nhs.net to be added to the mailing list

    Twitter: sign up to CHART’s twitter account @CommunityHART

    What are the next steps for CHART?

    Regular articles and information posted on this forum

    Increase CHART engagement by gathering and prioritising your ideas for action

    A CHART event in 2020

    The CHART group are hosting a central CHART meeting on Monday 30th March. It will be held at Aston University conference centre, Birmingham. This event is open to anyone who is engaged in Community healthcare research and there will be an opportunity to discuss community trust research activity with senior staff at CRNCC.

    Our challenge to you today is to ask “How can an alliance be of use to you in your organisation”?  “What do you have to offer”?  “What would you like to learn from others”?  Please mention the Alliance in your organisations and join the CHART coversations on twitter.

    References

    1. https://www.gov.uk/government/publications/the-nhs-constitution-for-england/the-nhs-constitution-for-england
    2. https://www.england.nhs.uk/long-term-plan/
  • Academy of Medical Sciences Report (1/14/2020)

    UK NHS and research leaders say the next ten years could transform the health and wealth of the UK in a new report from the Academy of Medical Sciences 

    Some of the UK’s leaders in medical sciences on 8th January said investment in health research over the next ten years could transform the health of the nation, save more lives and contribute to the wealth of the UK.

    The NHS R&D Forum strategy & leadership group, a strategic body of senior research leaders from across health & care, including some of the country’s most prestigious NHS clinical research organisations, welcomed the report by the Academy of Medical Sciences (AMS), which calls for more investment and better partnerships between the NHS and the UK’s universities for research. The group however stresses the importance of investment in multidisciplinary teams across all care sectors from the outset and welcomes the recommendation of a pilot, to generate evidence to show where additional resource will have the greatest impact and looking more broadly at the barriers to research activity.

    The NHS R&D Forum Leadership and Strategy group said:

    “Clinical research is fundamental to improving the UK’s health and its wealth. The NHS is leading the world in clinical research and our aim is to ensure that NHS patients continue to benefit from the expertise in the UK. The AMS report makes a robust case that investment will be needed to ensure we continue to translate innovations from the research community into new treatments for patients in the next decade.

    “Excellent partnerships between NHS organisations and academic institutions are fundamental to building on current successes. We know that taking part in research both as a patient or as a member of staff has direct benefits on the quality of care the NHS can provide.

    “The AMS report is an important part of setting the agenda for this decade and in identifying that better infrastructure and strong partnerships across all research institutions are essential to future developments. We look forward to working with the Academy on developing these ideas further, which we believe should involve a wide range of professional groups across health and care from the outset and in the pilot, looking broadly at the barriers to participation in research.

    The NHS R&D Forum has been developing a number of initiatives to enable more NHS professionals to get involved in clinical research, one of the key recommendations of the AMS report. Members of the NHS R&D Forum are part of a multi-stakeholder team supporting the development of metrics, as recommended in the report and members are working to influence this for primary care.”

    References and notes

    The AMS report, “Transforming health through innovation: Integrating the NHS and academia”, presents a number of case studies for the effective delivery of clinical research including NHS-academic partnerships for research and innovation in health and care. 

    The report highlights the risk to health and care without improved investment in research capacity and capability and includes six recommendations that aim to ensure research and NHS healthcare are aligned.

    The AMS has also published an associated report on the benefits of enabling every NHS Consultant to carry out research as part of the core duties: ‘Estimate of the economic costs and literature review of the benefits of dedicated research time for Hospital Consultants in the NHS’.

    January 2020

  • December 2019 Newsletter (12/20/2019)

    Season’s Greetings 
     

    The past year has been packed with activity as we increase our connections, our confidence and our impact as a community. In 2020 there is much more to come and as we welcome more groups to form and develop practice, we plan to have lots of outputs to share in Newcastle for RDF20. Don’t forget to get your poster abstracts in by 31st December.
     
    Wishing you all the very best for the festive season ahead.

    Did you read?
     
    ‘All the stars were aligned’? The origins of England’s National Institute for Health Research

    A fascinating historical review of the origins of the NIHR in England, this article is worth a read for context and insight.
     
    Atkinson, P., Sheard, S. & Walley, T. ‘All the stars were aligned’? The origins of England’s National Institute for Health Research. Health Res Policy Sys 17, 95 (2019) doi:10.1186/s12961-019-0491-5 

    Click here to read the full article
     

    Less than two weeks left before the Poster Abstract Submission expires. 

    The deadline for submissions is 31st December so if you or your team would like to present a Poster at the Annual Conference in Newcastle ensure you submit your Poster Abstract before the deadline. 

    Topics should be relevant to the wider R&D community. The Annual NHS R&D Forum is about sharing best practice in R&D within health and social care settings.

    Click here to submit your poster abstract.

    RDF20 will take place in Newcastle from the 10-12 May and we expect over 500 delegates from across health and care research to attend. Please book early to ensure your place and take advantage of the early bird rate that ends on 31st January 2020.

    The Sunday night workshop and networking buffet will take place in the Crowne Plaza Newcastle and the rest of the conference is being held at Sage Gateshead. This year we are giving delegates the option to choose their conference hotel during the booking process. Make sure you read the notes for each hotel and their location before you complete your booking. 

    All the details are available on the conference website. All event enquiries should be directed to RDF20@delegant.co.uk

    Further details and booking

    Research not as we know it: Managing novel methods in research
    2nd March 2020: London 

    Innovative real world research designs are likely to become more commonplace for both sites and sponsors and so we aim to look at how we can build our confidence as a community to ensure they are able to run well in and for the NHS.
     
    Following the success of our recent symposia we have arranged our third event to explore how we can manage novel studies that have complex, real world or novel designs like adaptive and umbrella trials. This symposium has been put together following the Industrial Strategy and Life Sciences Sector Deal 2.
     
    Speakers & topics include: 
     
    Emma Lowe: The Life Sciences Strategy & policy perspective 
    Department of Health & Social Care, Research Policy Senior Manager – Industry Relations & Growth
     
    Dr Kirsty Wydenbach: The MHRA & regulatory perspective 
    Deputy Unit Manager/Senior Medical Assessor 
Clinical Trials Unit, MHRA
     
    Joanne Plumb: A research office perspective 
    Deputy Director of Research Development and Innovation: University Hospitals Birmingham NHS Foundation Trust
     
    Conduct Methodology team: A trial management perspective 
    At MRC CTU at University College London
     
    Facilitated round table discussions will explore topics in depth 
     
    Join 50 colleagues to help prepare for managing the future of research.

    Click here to book

    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

    Archiving Master Class
    Date: 29th June
    Location: London
    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

     LinkedIN group for Non-commercial Sponsors

    Did you know there is a new LinkedIN group for non-commercial Sponsors and R&D office staff?  Connect with your colleagues and peers by joining here

    Representation at meetings this month 

     
    Royal College of Physicians: How to embed research in NHS Trusts of better Patient Care 

    This month group members represented the Forum and the research management, support & leadership community by facilitating a conversation at the Royal College of Physicians: How to embed research in NHS Trusts for better Patient Care. 

    A number of delegates and presenters discussed the benefits of the research effect in NHS organisations and then explored the challenges of how to develop a research culture, professional credibility for research and the time and space to undertake research. Slides from the event are now in our Resources Exchange.

    Dr Rebecca Smith, Chair of the Forum Research Strategy & Leadership Working Group attended for the Forum and was recorded summing up which you can listen to by clicking here.

    The RCP used the event to launch their statement “Benefiting from the ‘research effect’” which sets out how NHS trusts can better support clinicians to become research active. This statement and supporting documents are aimed at supporting Trusts and Chief Executives to benefit from delivering research.

    Read more here.

    The Research Strategy & Leadership Working Group of the Forum continues to support embedding research in a health care setting as a clear theme arising from our community survey analysis. We are working closely with the RCP and the NIHR CRN on work to support R&D management teams in the future and with UKRD colleagues to support being a well-led, research-active organisation. 

    The group met this month and reviewed questions for Louise Wood in January, responses to the Forum community survey and key outputs for 2020. Data sharing was identified as a big hot topic for which we are establishing a task and finish group in the New Year.

    If you are interested in this work please email FAO Kate via info@rdforum.org.uk for more information.

    The Research Management Working Group also met this month and shared updates on activities and challenges. Group member Mark Terry has written up his experience of securing funding to support a salary gap between clinical fellows and research fellows in his Trust, The Royal Marsden. You can read his update in his summary paper: Medical & Dental Pay Scales for Junior Doctors here.

    Mark is willing to share his experience in this area. If you would like further information contact mark.terry@rmh.nhs.u

    The Primary Care & Commissioning Working Group has written to the Department of Health & Social Care about the risk to RCF following CCG mergers

    As CCGs begin to merge the group has identified there may be an impact on RCF funding for CCGS. After exploring the issue and some modeling work by group Chair Clare Symms, the issues are now summarized in a comprehensive paper for colleagues at the Dept. Health & Social Care. 

    If you have something you would like us to share or discuss at these groups or with policy makers, please get in touch via info@rdforum.org.uk

    Calls from the community

    • Do you have any examples of agreements you have used to support home care nurses in CTIMP studies?
    • Non-commercial costing templates

    How do you review a study for sponsorship? 

    We are collating sponsor assessment SOPS & review processes to help inform our development of some standards following on from the sponsors symposium table talks. Please email anything you have to info@rdforum.org.uk

    Excess Treatment Costs: One Year On

    The NHSE&I, DHSC, CRNCC and partners update on progress made around ETCS, one year on from the implementation of new process, R&D Forum newsletter: NIHR CRN updates – December 2019.

    Read the summary 

    There is new guidance on the ETC main page for researchers, study teams and Sponsors on the SoECAT, including guidance on how to complete it. 
     

    NIHR CRN update 

    Research activity/Q3 datacut update

    We’d like to remind colleagues that the NIHR CRN quarter 3 datacut will be fast approaching after the Christmas holidays; Friday January 24th. Please encourage timely LPMS research activity data upload to ensure all activity that has occurred in your organisation will be included in the reporting.

    2019/20 Q3 CCG Excess Treatment Cost payment schedules will be produced using the manually uploaded research activity data and confirmed research activity data via LPMS only. The Q3 CCG Excess Treatment Cost payment schedules will also include 2019/20 Q1 and Q2 confirmed research activity data that had not been confirmed in the previous data cuts.

    Provisional research activity data that is confirmed at a later quarter, i.e. Q1, Q2 and Q3 of 2019/20, will be included in the 2019/20 Q4 CCG ETC payment schedules. For example recruitment activity recorded in CPMS as provisional in Q2 but confirmed in Q4 will be included in the Q4 CCG ETC payment schedules.

    For any questions or further information, please contact your Local Clinical Research Network

    Change in Excess Treatment Cost triage process as of 1st November 2019

    Please note that the management of studies triaged for commissioner ETCs changed on Friday 1st November 2019.

    Triage submissions will continue to be made via a single googleform and will be collated within a single central sheet for processing by the triage team but the triaging team itself, will be based within the NIHR CRNCC and will manage all queries on new triage submissions.

    Please note that there is now only one googleform and that submissions for all potential commissioners should be submitted via this single route.

    Over the coming months the NIHR CRNCC will be assessing the required information, in order to limit the requirement for extended email traffic, and will be endeavouring to improve both the initial googleform and the quality of communications that you may have previously been in receipt of.

    All studies submitted via the googleform, for ETC triage, before 1st November 2019 will be completed, via the original route by NHSE, and will not be managed by the new NIHR CRNCC team. Queries related to all aspects of the ETC process should continue to be routed via the ETC Helpdesk etc.helpdesk@nihr.ac.uk

    National Contract Value Review (NCVR) process: Upcoming appointment of National Coordinators

    In preparation for the introduction of the National Contract Value Review process in April 2020, appointment of National Coordinators, responsible for undertaking the NCVR, will begin in January 2020.

    NHS England and NHS Improvement and NIHR will be writing to R&D Directors at organisations that meet the eligibility criteria, inviting them to be a National Coordinator host site. Host sites will be asked to nominate skilled, experienced individuals from their organisation to undergo training and accreditation to undertake the role of National Coordinator from April 2020.

    The appointment process and criteria for organisations will be published imminently on the NIHR website. Read more here or for more information on the National Coordinator role and appointments process, email: england.research@nhs.net. To find out more about the NCVR and ongoing work to improve study set up for commercial contract research in England, visit the NIHR website.

    New resources in REX this month
     

    Non-Commercial Sponsors Symposium Slide set includes:

    • Diary of a EudraCT user including top tips for anyone uploading results to EudraCT
    • How we sponsor (general): including general introduction, decision making, risk assessment, dealing with the unexpected and root cause analysis.
    • How we sponsor (specialist): ATMPS, Devices, AI & International Sponsorship 
    • Data Sharing 
    • HRA update 

    Benefitting from the Research Effect: (Royal College of Physicians)

    Includes a blog series supporting research in NHS Trusts 

    • RCP event slide set: embedding research in NHS Trusts
    • How District General Hospitals can become more research active: A Trust CEO perspective (Simon Constable FRCP, Chief Executive, Warrington & Halton Teaching Hospitals NHS Foundation Trust) 
    • How Alder Hey hospital enabled research time for healthcare professionals By Louise Shepherd CBE, chief executive, Alder Hey Children’s Hospital.
    • Research adrenaline junkie: how clinical research energised my carer Dr Matthew Brookes, consultant gastroenterologist at the Royal Wolverhampton NHS Trust
    • What are the financial benefits of research in the NHS Pratima Chowdary, professor and consultant of haematology at the Royal Free Haemophilia Centre.

    Protocol Deviations Toolkit (Transcelerate) includes: 

    • Protocol Deviations Process Guide
    • Protocol Deviations Map
    • Protocol Deviations Assessment Plan
    • Protocol Deviations Management Toolkit Webinar 

    Protocol Deviation Reporting: Cutting Through The Ambiguity (article) 
    By Catherine Stewart, clinical sciences group lead, Pfizer, and Laura Galuchie, TransCelerate program lead, Merck

    View the latest additions to the Resource Exchange here

    Other News, Calls & Funding


    The Association of British Pharmaceutical Industry has published its first annual report into clinical trials. 
     
    The report ‘Clinical trials: How the UK is researching medicines of the future’ aims to provide a definitive view of the UK’s domestic research environment and how it compares internationally.
     
    For an overview of the report’s findings click here to read the ABPI blog 

    Does your organisation host NIHR awards?
     

    If so, then the annual Researchfish submission window will open on Monday 3 February 2020 and close at 16:00hrs on Thursday 12 March 2020. 
     
    If your organisation hosts NIHR awards then you need to:
    • Ensure you organisational contact details are up to date in the NHS R&D Forum Directory as we use this as a means of communicating with you regarding the submission;
    • Alert award holders to the submission window in early 2020;
    • Encourage your researchers to begin entering information – an early start will reduce pressure closer to the deadline 
    To find out more details regarding the Researchfish submission please visit our website: www.nihr.ac.uk/researchfish. If you have any remaining questions then the NIHR Evaluation team can be contacted via evaluation@nihr.ac.uk

    NIHR Funding Opportunities 

    Health & Care Research Wales Funding Opportunities

    Latest Jobs

     
    New jobs this month – see here

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

  • Excess Treatment Costs – One Year On (12/17/2019)

    NHSE&I, DHSC, NIHR CRNCC & Partners

    In October 2018, following extensive consultation with stakeholders, a new process for the management of excess treatment costs (ETC) for non-commercial research in the NHS was introduced by NHS England, NIHR Clinical Research Network Coordinating Centre (CRNCC), Department of Health and Social care (DHSC), and Health Research Authority (HRA).  This was a result of continued feedback from stakeholders about their frustration of a system they saw as fragmented.  The previous system for managing ETCs led to researchers having to negotiate ETCs, often with multiple commissioners, with variable arrangements leading to variable responses to requests to support ETCs. This also led to lack of consistency, clarity, and transparency, often contributing to delays in study set-up times.

    In a little over a year of partnership working, a national system has been implemented to address the biggest issues reported by stakeholders: triaging over 100 studies and moving from a system with local variation towards a system that provides consistency of process. In the first six months alone, 146 studies were transitioned into the new system, where CCGs were the responsible commissioner, of which 584 organisations received additional CCG ETC payments over and above the annual thresholds. Great strides have been made in a relatively short time, which has brought:  

    • A legal framework to enable CRNCC and Local Clinical Research Networks (LCRN) to manage the ETCs system.
    • The creation of a single point of access to ETC management via the LCRN.
    • A national pooled budget for CCG allocations managed by CRNCC on behalf of the CCGs.
    • A single national system for ETCs where specialised commissioning is the responsible commissioner.
    • The elimination of local variation in ETC funding arrangements for CCG commissioned studies.
    • Elimination of the need for researchers and providers to negotiate with commissioners.
    • Increased transparency of process and access.
    • Reduction in the administrative burden for providers.

    There is also no need for researchers to agree ETCs with individual participating sites. Provider sites know exactly the level of ETCs that they are expected to fund from the annual threshold – and once they have met this threshold, what additional funding they can expect to receive. For studies falling into Specialised Commissioning, additional financial assurance has been created with support where necessary, and direct payments of ETCs over and above those funded within existing contracts are now provided.

    To promote consistency of costing methodology, the HRA Schedule of Events has been adapted to provide information about study costs.  The new Schedule of Events Cost Attribution Template (SoECAT) uses the best elements of the Activity Capture and Attribution Template that was trialled previously to capture the different costs associated with clinical research and attribute them, according to AcoRD principles. It enables the generation of an average ETC per patient value for a study.

    A transparent system for the assessment of studies with high cost ETCs has also been created and implemented.

    Together these improvements have brought a level of clarity, transparency and predictability to the system that previously did not exist nationwide, but there is more to be done. To date, the focus and priority has been around making changes that would have a positive impact on the most studies. Building on feedback and learning from the first six months of operation, further refinements to ensure the system works well for even more studies are currently in development:

    • Comprehensive ETC guidance early in the new year that brings together all the various guidance issued so far into one place. This guidance will also set out the eligibility criteria for receiving automatic ETC funding and further clarity on the thresholds for ETCs. The guidance will outline the high cost threshold process and include process maps to provide additional clarity to stakeholders who want or need to understand the process.  
    • New SoECAT guidance will be published that explains how a SoECAT is used and when it needs to be completed as well as guidance on completing a SoECAT.
    • For ‘Specialised Commissioning’ studies, guidance will be published, simplifying the process for researchers to find relevant regional specialised commissioning teams and confirm ETC arrangements for studies funded pre-1 October 2018. This guidance will include details of named individuals within Regional Specialised Commissioning teams who will be responsible for handling pre-1 October 2018 study queries. These individuals have already received training to help them deal with such queries.
    • The aim is to work towards making payments directly to the organisations incurring the ETCs, improving the management of studies that do not fit easily into the new system such as cluster studies.
    • Further improvements will be made to the SoECAT forms to will make it easier to complete.
    • Additional improvements to the current tools and systems used for entering study information for ETCs will be made.

    Instilling clarity and predictability into the ETC system has been an ongoing theme in the first year, as feedback and lessons have been gathered, processed, and acted upon.  A system has been put in place where data can be collected and improvements made – based on more robust evidence, something which has not been possible to achieve previously.  However, it is recognised that there are medium and longer-term refinements needed. In the upcoming months and years, further refinements will continue to be made to the ETC process.

    These improvements show an ETC system that is growing from strength to strength – an outcome that not only benefits funders, researchers, providers, and the R&D community, but ultimately benefits the thousands of patients that have participated in research studies up and down the country. A key priority will be to continue to listen to and act on feedback to make ETCs work for everybody.

     

     

     

     

  • November 2019 Newsletter (12/6/2019)
    Did you read…?
     
    Joshi, I., Morley, J.,(eds) (2019). Artificial Intelligence: How to get it right. Putting policy into practice for safe data-driven innovation in health and care. London, United Kingdom: NHSX.
     
    “ This report gives a considered and cohesive overview of the current state of play of data-driven technologies within the health and care system, covering everything from the local research environment to international frameworks in development” (p12 Executive Summary)

    Read more here.
     

    Did you know…?
     
    New UK standards for Public Involvement in research are now available. This work is a final and complete set of standards for everyone doing health and social care research. 
     
    The standards can be used in a variety of ways and are a really useful tool that will help R&D teams assess their involvement practice and plans for improvement. 

    Bookings are now open for RDF20, the 2020 Annual NHS R&D Forum Conference.

    RDF20 will take place in Newcastle from the 10-12 May and we expect over 500 delegates from across health and care research to attend. Please book early to ensure your place and take advantage of the early bird rate that ends on 31st January 2020.

    The Sunday night workshop and networking buffet will take place in the Crowne Plaza Newcastle and the rest of the conference is being held at Sage Gateshead. This year we are giving delegates the option to choose their conference hotel during the booking process. Make sure you read the notes for each hotel and their location before you complete your booking. 

    All the details are available on the conference website. All event enquiries should be directed to RDF20@delegant.co.uk

    Click here for further details

    Research but not as we know it: Managing novel methods in research symposium.

    Date: 2nd March 2020
    Location: London

     
    Following on from the success of our recent symposia we have planned a third event to focus on exploring how we can manage novel studies that have complex or novel designs like adaptive and umbrella trials. This symposium has been put together following the industrial strategy and life sciences sector deal 2.
     
    Adaptive designs are likely to become more commonplace for both sites and sponsors and so we aim to look at how we can build our confidence as a community to ensure they are able to run well in the NHS.
     
    Keynote speakers include: 
     
    Emma Lowe: Department of Health & Social Care, Research Policy Senior Manager – Industry Relations & Growth
     
    Dr Kirsty Wydenbach: 
Deputy Unit Manager / Senior Medical Assessor 
Clinical Trials Unit, MHRA

    Joanne Plumb: Deputy Director of Research Development and Innovation: University Hospitals Birmingham NHS Foundation Trust

    Conduct Methodology team at MRC CTU at University College London
     
    Click here to book

    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

    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

    Forum CDA work

    Ongoing work on the use of Confidentiality Disclosure Agreements in commercial contract research was presented to the Four Nations Contracts Group this month and a plan has been developed to ensure completion in the New Year. We expect to update you about this exciting initiative in the coming weeks. 

    New Forum Contracts group 

    Olivia Chalwin, at the University Hospitals Southampton, has called for new members to join her in forming a new Forum Contract Leads Group. Thank you to those who have been in touch to take this group forward. Olivia can be contacted via info@rdforum.org.uk


     

    New Forum Communications group 

    A small group for R&D communications leads is being formed to support the development of practice in this area. If you are keen to take part email info@rdforum.org.uk 


    Forum Non-Commercial Sponsors Symposium

    120 people attended the 2nd Non-commercial Sponsors Symposium. A mix of important hot topics, sharing practices on how we sponsor, and table talks to help us move sponsorship forward as a community. It was fantastic to have so many NHS, HEI and charity sponsor teams together for the day and this enabled lots of new connections to be made between colleagues. 

    All presentation slides are now available on our website and we have set up a new Forum LinkedIN non-commercial Sponsors community group to keep the conversations flowing. 

    Download the slides here


     

    New Forum LinkedIN non-commercial sponsors community group 

    This is a closed group just for individuals working in sponsor teams or R&D offices that are looking to act as sponsor. The purpose is to facilitate more conversations around sponsorship, to share experience and expertise, and to address challenges together. If you are interested and keen to virtually connect with others who work in sponsorship email info@rdforum.org.uk for more information.


     

    Meetings coming up in December

    5th December: RCP/NIHR CRN CC/R&D Forum teleconference
    5th December: ETC feedback teleconference
    10th December: Research Strategy & Leadership Working Group
    11th December: Research Management Working Group 
    12th December: Learning & development Oversight Group 
    13th December: RDF20 Programme Content Group 

    If you have something you would like us to share or discuss at these groups or with policy makers, please get in touch via info@rdforum.org.uk


    Calls from the community

    • Do you have any examples of agreements used to support home care nurses in CTIMP studies?
    • Non-commercial costing templates
    • Archiving processes and procedures 

    If so then please email them to info@rdforum.org.uk 

    Resource Exchange

     
    New resources in REX this month include:

    There are lots of new resources in REX following our symposia.

    Thank you to the MRC Regulatory Support Centre for collating the following data sharing resources:
    • Registries to Aid Discoverability
    • Content Anonymisation
    • Using a Trusted Research Environment 
    • Preparing Data Quality Assurance and Standards  
    National Contract Value Review Webinar slideset 

    The slides from the recent webinars were issued last month and can be found here. Please refer to slides 12 and 13, which outline what Phase 2 of the project means for your organisation. 

    View the latest additions to the Resource Exchange here

    Other News, Calls & Funding


    Does your organisation host NIHR awards?
     
    If so, then the annual Researchfish submission window will open on Monday 3 February 2020 and close at 16:00hrs on Thursday 12 March 2020. 
     
    In the current economic climate it is vital that funders have the ability to demonstrate the impact that the research they fund makes, and the NIHR is no different in this space. The NIHR uses the information submitted to Researchfish on research outputs, outcomes and impacts to understand the impact of its research and monitor progress. These data also support the NIHR in its case for continued investment in applied health research, responding to requests for information, and the building of impact case studies. 
     
    If your organisation hosts NIHR awards then you need to:
    • Ensure you organisational contact details are up to date in the NHS R&D Forum Directory as we use this as a means of communicating with you regarding the submission;
    • Alert award holders to the submission window in early 2020; 
    • Encourage your researchers to begin entering information – an early start will reduce pressure closer to the deadline
    To find out more details regarding the Researchfish submission please visit our website: www.nihr.ac.uk/researchfish. If you have any remaining questions then the NIHR Evaluation team can be contacted via evaluation@nihr.ac.uk
     
    NIHR Funding Opportunities

    Health and Care Research Wales Funding

    New R&D staff are unaware of the NHS R&D Forum & Resources Exchange
     

    Feedback received through the community survey and at recent symposia suggests R&D staff are unaware of the NHS R&D Forum including all the resources, help and opportunities that are available. This may be particularly true for staff members who are new in post or new to NHS R&D.
     
    The Forum is not just for management and governance staff, it is the home for all individuals working in, with and for providers and commissioners of health and care at all levels and in all types of organisations across the UK. We are a diverse community and we believe that it is our strength to come together as an inclusive network. There are lots of ways to get involved to seek help or just to share with colleagues.
     
    Please promote the Forum to your colleagues and take part, you can sign up here

    Latest Jobs

     
    New jobs this month – see here

    Please submit your latest vacancies and we will also tweet them out. 

  • Non-commercial sponsors symposium slides (11/27/2019)

    Over 100 delegates attended the non-commercial sponsors symposium which was held in Birmingham on Tuesday 19th November.

    The slides from this event can be found here.

    Supporting information from the session on “How do we conduct risk assessments” can be found here.

  • National Improvement Plan for the delivery of the Study Support Service (11/1/2019)

    The Clinical Research Network Study Support Service helps researchers and the life sciences industry plan, setup and deliver high quality research to time and target to the benefit of NHS patients and the public. These services are available for all studies eligible for our support, regardless of location, study type, study size, therapy or research area – whether a study is medical, diagnostic, pharmaceutical or biotech. We offer a flexible package of support across the clinical study life-cycle. Our offer includes a range of practical services to support study placement, set-up, and delivery monitoring to enable recruitment to agreed time and target.

    The CRN has been formally providing these services for almost five years now; since 1 July 2016 this has been under the nation-wide branding of the Study Support Service. View this short video that describes the Study Support Service.

    In the 2018/19 the CRN undertook a national improvement project for the Study Support Service focusing on the needs of commercial customers. View their video summarising the key outcomes from the 2018-2019 Improvement Plan.

    In 2019-2020 they are focusing on a further four areas for improvement. These are described in this short video.

  • NEW NIHR campaign – Your Path in Research (11/1/2019)

    Evidence shows that research active trusts have improved outcomes for patients, as well as improved staff morale, recruitment and retention. To support improved patient outcomes there is a need for health and care professionals to become more involved in research and expand their knowledge. The NIHR has recently announced the start of an exciting new campaign, Your Path in Research, which aims to inspire healthcare professionals to get more involved in research.

    Your Path in Research recognises that everyone providing or supporting care in the NHS uses clinical research, but not everyone is aware of how to incorporate it on a daily basis.

    This new campaign will give health and care professionals an opportunity to learn more about the research that can directly impact their everyday work, by highlighting a variety of ways they can take their first or next step in their research career.  Follow the campaign and get involved via NIHR social media channels.

     

     

     

  • NEW Free Online Course ‘What is Health Research?’ (11/1/2019)

    The National Institute for Health Research (NIHR) Clinical Research Network (CRN) has launched a new online course ‘What is Health Research?’

    The course is a Massive Open Online Course, or MOOC, and has been been designed in collaboration with the University of Leeds Digital Education Service and Futurelearn.

    Learners will discover how research is improving health care; find out what’s involved in health research, bust the common myths surrounding health research and explore ways to get involved and how people. They will hear from people who have taken part in research, learn why they volunteered and the difference it can make.

    John Castledine, Head of Learning and Development at NIHR CRN, said:

     “We are very excited to launch our new online course ‘What is Health Research?’. Everyone should be given both the opportunity to take part in research and to make decisions, which are right for them when choosing whether or not to join a study.

    “Education is a very powerful tool and the online format of this course ensures everyone can have access to great learning and the insights we have collected from research participants, patients, the public and researchers. Learning about health research has never been easier.”

    The course lasts three weeks and learners can complete the course at their own pace.

    ‘What is Health Research?’ starts on the 11 November.

    Sign up here https://www.futurelearn.com/courses/what-is-health-research

     

  • National Contract Value Review process update (11/1/2019)

    A new, standardised, national approach to costing and contracting for commercial contract research (CCR) is being introduced across NHS sites in England to improve consistency and reduce unnecessary delays to study set-up.

    The new arrangements will introduce greater certainty for NHS providers and industry. The scope of the new arrangements includes multi-site studies and excludes phase 1, phase 2a, ATIMPS and primary care studies at this stage.

    The National Contract Value Review process brings together three key elements to improve commercial contract research set-up:

    1. Mandated use of an unmodified model site agreement and standard costing methodology from 1 October 2018 including the use of the new interactive Costing Tool (iCT) from June 2019
    2. Establishing standards for nationally defining and allocating commercial study resource and procedure requirements
    3. Introduction of a national coordinator role responsible for completing the National Contract Value Review for the study, ensuring that NHS providers recover all justified costs associated with delivering a commercial research study

    A phased approach to implementation of the new process will be adopted to allow the model to be refined and tested with the engagement of stakeholders.

    • Phase 1 February – June 2019 – complete.
      • The first phase focused on understanding the intra-study variability in study costs and resource allocation across organisations to inform training requirements and National Coordinator models.
    • Phase 2 & 3 July 2019 – April 2020 – in process
      • The aim of phases 2 and 3 is to further test and refine the National Contract Value Review process using live studies. Study stakeholders will be closely supported by CRN staff, to ensure the process runs smoothly, collecting feedback which will shape the final process and the national coordinator role.
      • All 34 NHS organisations involved in phase 1 have been invited to continue into phase 2. The first wave of training has been provided to volunteer National Coordinators from R&D teams, with further training sessions for R&D teams and Industry delivered throughout this period.

     

     

     

     

  • Forum activity during October (11/1/2019)

    This month representatives of the NHS R&D Forum:

    • Held embedding research through strategy, leadership & culture symposium.
    • Developed the first draft of the updated Forum website
    • Input into NIHR Well-led guide
    • Took part in MHRA/HRA/Forum teleconference about home care nurses and contractual agreements with PI site & supporting solutions
    • Provided Primary Care feedback on ETCs and the SoECAT to NHSE&I
    • Drafted a letter to DHSC on the impact of CCGs merger on RCF funding for CCGS
    • Represented Research Management at National ATMP infrastructure & governance group
    • Reviewed a document developed by the RCP
    • Attended a workshop for the HRA
    • Took part in NHSE ETC feedback group
    • Attended CCR project advisory group & suggested webinars
    • Held group meetings for Evidence for commissioning, conference planning, service users and carers, Primary care & Commissioning, & non-commercial sponsors groups.
    • Presented at HRA champions
    • Presented the NHS R&D Forum CDA guide, joint position statement and tools taken to 4 nations contracting group and agreed next steps
    • Initiated the set up of a contracts community of practice and lead group. If you are a contracts manager and interested in this group please contact Olivia Chalwin via info@rdforum.org.uk

     

     

     

  • Slides from 2019 Embedding Research Symposia (10/29/2019)

    Over 50 delegates attended the 2nd Embedding Research Symposia on 9th October in London.

    Presentation sides are available to download here

  • Changes to NIHR costing methodology from 2020/21 (10/29/2019)

    From April 2020, the NIHR’s online interactive Costing Tool (iCT) will be the only system available for industry costing submissions for new studies. There will be no further Excel templates produced after this time. Make sure you’re ready for the big switchover – find out more about the iCT and how to get started here.

    We encourage all NHS R&D Departments to pro-actively work ahead of this deadline and register themselves with group CPMS accounts so that are able to receive new iCT requests from our commercial partners, meaning that negotiation timelines and setup are reduced to a minimum. If you would like to understand further advantages to working within the iCT ahead of the 1st April 2020 then please contact phillip.good@nihr.ac.uk who will be able to talk you through how the iCT can work to the benefit of your organisation.

  • New report shows clinical research improves health of UK economy and NHS (10/29/2019)

    The value of clinical research to the NHS, the UK economy and jobs market has been evaluated in a new report, which provides an assessment of the economic impact of the NIHR Clinical Research Network’s (NIHR CRN) activities to support clinical research in England. The report, produced by KPMG and commissioned by the NIHR CRN, covers the financial period 2016/17 to 2018/19 and shows that over this period, clinical research supported by the NIHR CRN generated an estimated £8bn of gross value added (GVA) and 47,467 full time equivalent (FTE) jobs for the UK. Read more.

  • MRC regulatory support centre quarterly update (10/29/2019)

    Download the quarterly update of regulatory research news from the MRC regulatory support centre here. Members of the team will be joining the non-commercial Sponsors symposium to discuss data sharing.  

  • Be Part of Research can promote your study to thousands of potential participants (10/8/2019)

    The NIHR launched its Be Part of Research service back in May this year. Designed for the public, it makes information about research available to anyone who wants it. With a simplified navigation, improved search and filtering facility, and the ability to feedback on the usefulness of study information, the website builds on the success of the UK Clinical Trials Gateway (UKCTG), which has been delivered by NIHR for a number of years.

    Like UKCTG, the study data on the Be Part of Research site is refreshed weekly and comes directly from two databases, ISRCTN (International Standard Randomised Controlled Trial Number) Registry and ClinicalTrials.gov. There is no other way to list your trial or study on Be Part of Research. Studies funded by the NIHR or listed on the NIHR Clinical Research Network’s Portfolio of studies are not automatically added to Be Part of Research.

    The site already receives tens of thousands of visits each month, and we have ambitious plans to grow this. The service is a great opportunity for your study to be seen by members of the public who are keen to participate in research.

    How can you add your study?

    • If your study is registered with ISRCTN or clinicaltrials.gov then your study information will be automatically added to our studies list, with details refreshed once a week.
    • Members of the public will be able to find this information and get in touch with you if they’re interested in taking part. It’s crucial that study information, including site and contact details are always up-to-date on the source registries.
    • We can’t block studies being added from the source registries, so if the public shouldn’t put themselves forward, please make this clear in your summary on ISRCTN and clinical trials.gov, to avoid unwanted contacts to your team and to avoid disappointing volunteers.

    Read more about how to add your study.

    Can you promote the service?

    Yes, absolutely! We’ve made our promotional materials available for anyone to order. Materials include:

    • Posters and leaflets for public and health care professionals
    • New leaflet for researchers – which explains how researchers can add their study to the service
    • Slides for TV screens at events and in waiting rooms

    Visit www.nihrresources.co.uk to order printed materials, or contact the team to request the digital assets. Email bepartofresearch@nihr.ac.uk. Full details of the materials available are listed at the end of this post.

    Most materials are free, although a cost for postage and packaging will be incurred. Alternatively, materials are available to download should you wish to print them locally.

    Tell us what you think

    We’re really keen to hear feedback on how what people think of the site or how it can be best used to help more people participate in research.  Email us at bepartofresearch@nihr.ac.uk

    Full list of promotional materials:

    Printed materials

    • Leaflets for public
    • Leaflets for parents, children and young adults
    • Easy read leaflets
    • Leaflets for healthcare professionals
    • Leaflets for researchers
    • A3 posters
    • A4 posters
    • Exhibition banners (Please note cost: £120 per banner)

    Digital materials include:

  • Five Patient Recruitment Centres: Important opportunity for NHS Trusts and NHS Foundations Trusts in England (10/8/2019)

    On Friday the NIHR CRN released a competition looking for hosts for five Patient Recruitment Centres (PRCs). This is a unique opportunity to be at the forefront of a key development for delivering late-phase commercial research in England.

    The expectation is a single NHS organisation will bid to host one of five PRCs across England.  Each Centre will operate on a national franchise-like model, using predefined standard operating procedures and technology (NIHR Hub) to enable a digital first approach to undertake late-phase commercial research.  A consistent approach to centre operations, including costing contracting and R&D approval, will facilitate the rapid set-up of studies.

    The application process is in two stages: 

    Timeline for Stage 1 questionnaire submission (SOQ): 

    • Deadline for clarification questions relating to the SOQ is by 12.00 PM on 21 October 2019
    • All SOQ applications must be submitted, via email only to prc@nihr.ac.uk by 12.00 PM on 25 October 2019

    Further information is available at the PRC website here

    Please contact prc@nihr.ac.uk if you have any queries at all about the PRC programme.

  • MHRA & TechUK: Face to face meeting for EHR vendors (10/4/2019)

    The MHRA have confirmed they will be holding a face-face meeting with EHR suppliers, hosted by techUK, on Monday 28th October

    Please note this event is not for R&D departments directly but we would appreciate your help to promote the invitation to any suppliers of electronic health records in both primary and secondary care (including commercial and non-commercial developers).  

    The Medicines & Healthcare products Regulatory Agency (MHRA) and techUK would like to invite electronic health record suppliers to a digital discussion on the importance of these systems in ensuring the UK remains as a global leader in clinical trials. Having held an initial positive first steps telecon with some providers back on 3 September, a commitment was made to continuing this conversation in person to enable all to talk in more detail about the requirements of electronic health records under the clinical trials legislation, and how we can best work together to meet those requirements within systems already implemented and in use, as well as those in development.

    For further information about this event please follow the link below. 
     
     
  • Consultation on Draft Scope and Standards for Clinical Research Practitioners (9/25/2019)
    In early 2018, the Department of Health gave approval for the NIHR Clinical Research Network (CRN) to develop the professional identity of Clinical Research Practitioners (CRPs) in a staged approach. In collaboration with the Academy for Healthcare Science (AHCS), the CRP Directory was launched in September 2018 and over 500 CRPs are now publicly listed. 
     
    Documentation has been developed through serial iteration involving a range of key stakeholders, including CRPs, other health and care professionals and senior managers and leaders within organisations. Draft Scope of Practice for CRPs and Draft Standards of Proficiency for CRPs are now available for your review and feedback on whether these are fit for purpose. These documents are accompanied by a short position paper on the initiative.  Please access the documentation and supporting resources here: https://nihr.ahcs.ac.uk/consultation-on-crp-accredited-registration/
     
    Your response to this consultation is valuable and will contribute to shaping the introduction of accredited registration for CRPs.  A linked Feedback Form will remain open for responses until 27th September, 2019.
  • GDPR & Transparency Wording for All Sponsors (9/25/2019)

    The recommended GDPR wording for Participant Information Sheets for data transparency has been updated and issued by the HRA; this is particularly relevant to all Sponsorship Teams. 

    Summary of the revisions to the transparency wording are:

    A single set of wording covering both commercial and non- commercial sponsors comprising of:

    • Summary information to be included in PIS.
    • Wording for generic leaflet, to be provided alongside the PIS.

    What does the revision in text means for sponsors?

    • Sponsors do not need to update wording if they have previously included GDPR wording.
    • The revised wording is available for new studies, although the old revised wording can be accepted.
    • If sponsors (commercial) have alternative sponsor level wording in place they may continue to use it.
    • If a commercial sponsor does not wish to use the revised wording and do not have agreed wording, this should be sent to approvalprogramme@nhs.net.
    • Non-standard wording from non-commercial sponsors should continue to be assessed as part of the study wide review.

    Please also see the following link: https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/data-protection-and-information-governance/gdpr-guidance/templates/transparency-wording-for-all-sponsors/ 

     

  • DHSC contingency planning webinars (9/20/2019)

    The Department of Health and Social Care (DHSC) will be running four of webinars, kindly hosted by the Association of the British Pharmaceutical Industry (ABPI), to update on our contingency planning to assure continuity of supply for clinical trials and investigations in the event we leave the EU with a ‘no deal’. This will also be an opportunity for you to ask questions and raise any concerns you have as we approach 31st October.

    You can register to attend one of the webinars by following the links below:

    They will be open to all stakeholders, as well as members of the ABPI. 

    We would like to take this opportunity to thank you for your continuing support. Many sponsors of clinical trials and investigations have responded to our two recent requests for information via and short survey and spreadsheet of trials/investigations to review. We hugely appreciate your efforts, which have provided us with invaluable assistance towards our no deal contingency planning. If you have not yet responded, we would be extremely grateful if you could complete both requests as soon as possible and return them to clinicaltrialssurveyreturns@dhsc.gov.uk If you have not received these requests, please let us know and we will resend the relevant information.

    If you have any questions about continuity of supply of clinical trials in general, please email DHSC at ctcontingencyplanning@dhsc.gov.uk.

  • Recent Forum Activities: (9/20/2019)

    In addition to the consultation responses on PIC and Transparency and the community survey, the following work has been ongoing over the summer.

    Members of the Executive committee met with Dr Louise Wood, Director of research & Evidence at DHSC, to share updates from the Forum and to discuss priorities, which we shall take to our working groups. A teleconference was held with Lindsey Hughes Deputy Director of Research at NHS England and NHS Improvement and updates on the CCR project were discussed. You can read more about the CCR project in the policy update.

    Written feedback was provided to the Royal College of Physicians to help shape their ongoing support for research in NHS organisations and input was given to the CRN NHS Engagement team working to prepare NHS Trusts on being a well-led research active organisation.

    Forum Executive group member Virginia Minogue, and Bill Wells from Oxford Health NHS Foundation Trust, published a blog in the BMJopinion following their work on research waste “Patients and the public are essential to reducing research waste”

    AcoRD training was delivered to Wales and much planning took place for our ongoing professional development programme. Members worked with the MHRA to consider contracts being used for homecare nurses, and attended the MHRA GCP non-commercial symposium, with great insights from inspectors and networking opportunities; the slides are now in the resources exchange.

    The Forum was represented at the multi-stakeholder non-commercial costings group, CCR advisory group, HRA Sponsors reference group and UKRD/ Forum R&D finance workstream. The Forum research management working group met and discussed a number of hot topics including their work programme and impact. The evidence workstream is planning a one day face to face meeting and work has begun on improvements to the Forum website

    If you would like to get involved or you have something you would like members to share with stakeholders please get in touch with Kate via info@rdforum.org.uk

  • Updated guidance for Ionising Radiation (9/20/2019)

    The Health Research Authority has worked with its Four Nations Radiation Assurance Working Group, which includes MPEs, CREs, and the ARSAC, to update guidance in IRAS regarding ionising radiation. Most of the guidance is aimed at applicants, but some is also useful for sites, which participate in research.

    The question specific guidance on the IRAS project filter page has been updated on the questions “Does the study involve the use of any ionising radiation?” and “Does the study involve exposure to radioactive materials?”. It now gives examples of some of the most common ionising and non-ionising procedures used in research applications. This should help applicants to identify how to answer these questions; answering “yes” to them leads to various additional questions in Part B Section 3 of IRAS being made available. 

    There is also updated guidance about how to identify whether ionising radiation procedures in an application would be considered as research exposures, and therefore will assist applicants in completing the project filter page correctly. The new guidance is available on the Help section of IRAS.

    Research ethics committee staff and the lead nation’s coordinating function may use the above guidance to check that the IRAS project filter page has been completed correctly.

    The question specific guidance in Part B Section 3 of IRAS has also been updated, including:

    • Confirmation that Lead MPEs need to be registered with the RPA2000;
    • Clarification that the maximum number of ionising radiation exposures conducted in the study should be listed in this section;
    • Clarification on how to proceed with completing this section of IRAS if an application is being processed through Radiation Assurance

    Please note that you need to be logged in to IRAS in an application to see any of the question specific guidance.

     

  • A new measure from NIHR CRN for ‘Study Set Up’ (9/20/2019)

    For information: by Sharon Barret, Head of Feasibility & Start Up , NIHR CRN CC

    To ensure that the NIHR CRN continues to focus on improving performance and reducing the time taken for study site set-up for NIHR CRN Portfolio studies a new HLO will be introduced in 2019/20 which will measure and aim to reduce the intra-study variability in set up times.

    The CRN CC undertook a “review and refresh” of the HLOs as part of its Annual Business Plan for 2018/19. This project included an extensive survey to elicit the views of LCRN Partnership Group members, LCRN Host Organisations, LCRN Patients and Public Involvement and Engagement (PPIE) Leads, and CRN National Specialty Leads. Over 400 individuals participated in the consultation.  The proposal to DHSC was to retain most current HLOs, with some changes in wording for clarity, and to withdraw some HLOs.

    The HLOs proposed for withdrawal were:

    • HLO 4 – Reduce the time taken for eligible studies to achieve set up in the NHS
    • HLO 5 – Reduce the time taken to recruit first participant into NIHR CRN Portfolio studies.DHSC accepted other changes but advised that it was not content for the removal of the above HLOs and that CRN CC should reconsider their withdrawal.  A new proposal was drawn up, put forward and agreed.

    From April 2019, HLO 4 & 5, are no longer being reported.  A new NIHR CRN measure will focus on reducing the time taken for study site set up from “Date Site Selected” to “Date First Participant Recruited” at each site. These data points were used to calculate previous HLOs are available as part of minimum data set in CPMS/LPMS. 

    This will now be identified as HLO 9.  This metric will allow CRN CC to determine the level of impact NIHR CRN has on this ‘combined measure’ of consistency of study start up, including recruitment of the first participant at site. 

    For 2019/20, a new introductory target of a 5% reduction was introduced and a national medianaverage time for study set up based on figures for set-up performance in FY 2018/19.   This means that LCRNs will be expected to, focus on intra-study variabilityin 2019/20, and meeting the national targets.

    Dr Sharon Barrett (CRN CC Head of Feasibility and Start Up) stated; “In real terms, what we are aiming for is to acknowledge the sites who are in a position to set studies up and recruit the first patient in a timely fashion but also the sharing of best practice to allow other sites across the country to mitigate any challenges which may arise at their respective sites during set up” (see figure)

    Data gathered by LPMS’s will capture both study and site level to allow LCRNs to performance manage their respective partner organisations in improving performance. This will happen alongside the PID reporting that is expected for NHS organisations.

    Contact: Sharon Barrett (Head of Feasibility and Start Up) sharon.barrett@nihr.ac.uk

  • Multiple Sclerosis (MS) Society Survey (9/6/2019)

    The objective of the ‘expert consortium for progression in Multiple Sclerosis (MS) clinical trials’, set up in 2017 is to design and deliver an efficient clinical trials platform to speed up the development of new treatments to slow (and ultimately stop) the progression of MS. The consortium was commissioned with building on the success of the UK MS Clinical trials network. With the help of the STOP-MS appeal the MS society plans to invest £100 million in MS research over the next 10 years.

    The consortium was split into two broad strategy groups, “Treatment Selection” and “Trial design and delivery strategy”. The “Trial design and delivery strategy group” were tasked with:
    • designing a scalable infrastructure platform that can deliver efficient MS trials
    • proposing a trial design that can be run through the platform.

    This “Trial design and delivery strategy group” was further broken down into 3 linked working groups:
    1. “Infrastructure Working Group”. To design UK wide recruitment and trial delivery infrastructure
    2. “Trial Design Working Group”. To generate a menu of design options for running efficient, scalable and flexible clinical trials
    3. “Outcome Measures Working Group”. To develop list of primary and secondary outcome measures with focus on potential interim measures, horizon scanning, development and validation of emerging and future measures

    One of the objectives of the Infrastructure Working Group is to develop a comprehensive plan for tackling barriers to recruitment, scalability, incentivisation, collaboration and consultation with NIHR Clinical Research Network (CRN) and Local Clinical Research Network (LCRN)); the “Recruitment and Engagement Strategy”

    We are therefore now scoping out the opinion of both R&D departments and MS study team on our proposed Recruitment and Engagement Strategy. We do hope that you will be able to spend 10-15 minutes completed the enclosed survey and forwarding it to as many of your R&D colleagues who it may be relevant to.

    Please could you respond to the survey by the 13th September 2019.

    Complete the survey here

  • HRA Radiation Assurance Phase 3 reviewer recruitment open (9/4/2019)

    Following the success of Phases 1 and 2 of Radiation Assurance, the HRA are inviting further Medical Physics Experts (MPEs) and Clinical Radiation Experts (CREs) to become registered reviewers in preparation for the launch of Phase 3. Their previous phases accepted studies involving cardiology, rheumatology and neurology, as well as all oncology studies taking place in the NHS.

    During Phase 3, all other studies involving ionising radiation taking place in the NHS will be accepted. This will be the final phase of rollout prior to Radiation Assurance being integrated as part of HRA and HCRW Approval.

    As the HRA is widening their study acceptance criteria, they are strongly encouraging CREs and MPEs with the relevant experience to register to review applications through Radiation Assurance. Applications from CREs are particularly welcomed. Benefits to being CREs and MPEs registered with the HRA include:

    • supporting research taking place in the NHS;
    • undertaking a professional role supporting a UK-wide process
    • contributing to improved healthcare in the UK.
    • training on the Radiation Assurance process;
    • their employer being provided with a standardised fee of £500 + VAT for new study reviews and £250 + VAT for amendment reviews (England, Northern Ireland and Wales only. Separate arrangements apply for reviewers based in Scotland);
    • CREs registered with the Royal College of Radiologists being able to claim one CPD point for every review they complete through Radiation Assurance.

    Information on how to apply to become a registered reviewer is available on the HRA’s website. The launch date for Phase 3 will be confirmed as soon as they have enough reviewers registered to provide a continued good service.

    Organisations which sponsor research should use this opportunity to ensure that Radiation Assurance fees are included in their grant applications. Further information on calculating how much Radiation Assurance costs is available in the Payments Framework Guidance on the HRA website.

    If you have any queries please contact the technical assurance team at hra.radiationassurance@nhs.net.

     

     

  • July Newsletter 2019 (8/2/2019)

    Did you read…?
    The notes and slides from the MRC data anonymisation workshop, held in May. They can all be found here
     
    Did you know?
    The NIHR website has been updated and therefore some links to key items will have moved. For example: all ETC information is now accessed via the new link and so you may wish to update some of your bookmarks. Please report any broken links you find in the Resources Exchange and we will fix them. 

    There is a new helpdesk email address to help manage ETC queries.

    The Forum Symposia Series  

    These one-day events connect members of our community to share practice on a specific theme.

     

    Embedding research through strategy, leadership & culture

    October 9th: London

    Embedded research is key to being a well-led NHS organisation and enabling this is the primary role of an NHS R&D function.

    We are delighted to release the programme and speakers including Prof Martin Marshall and Dr Sarah Ball. Prof Marshall is Chair Elect Royal College of GPs and Professor of Healthcare Improvement at UCL in the Department of Primary Care and Population Health. Dr Ball is Senior Analyst RAND Europe and Cambridge Centre for Health Services Research (CCSHR) and is co-author of the rapid evidence review for THIS institute on NHS engagement in research.

    Please note this small symposium has limited places only and with fantastic speakers confirmed, places are filling up fast. 

    Further details & booking

    Non-commercial Sponsors Symposium
    November 19th: Birmingham NEC

    We are creating an exciting programme for this Symposia event that builds on previous years learning. Juliet Tizzard, Health Research Authority, will be speaking as part of a morning plenary session. The day will involve a mix of keynote and community presentations, roundtable discussions with stakeholders and group working.

    Further details & booking

    Research not as we know it: Managing novel methods in research 
    2 March 2020: London

    If you are interested in talking at this symposium about the practical management of innovative study designs then please contact us via info@rdforum.org.uk

    Further details & booking

    Professional Learning & Development

    A practical application of monitoring in a health care setting
    Date: 30 September – 1st October 2019 
    Location: Birmingham NEC

    This course is aimed at individuals and organisations that deliver non-commercial research in a healthcare setting. It explores the application of monitoring as a quality assurance tool, focuses on skills for monitoring and provides an understanding of risk-based monitoring in order to ensure high quality research in the NHS.

    This is a practical two-day course delivered by experienced monitors who work in the NHS. Sessions include slide presentations but are primarily practical and interactive. An essential workbook will be provided to all delegates.

    Book Now

    Essentials of NHS research 
    Date: 4th – 5th November 2019
    Location: Birmingham

    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 or just for those who need to keep updated.

    This course was previously known as ‘Research the Basics’ but evaluation feedback consistently told us that it wasn’t really basic. Updated material includes a whole new look package of essentials for anyone looking for a complete overview of NHS R&D management.

    Book Now

    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

    Our Forum response to the PIC consultation 

    Our Forum response to the consultation “Incentivising NHS organisations to act as PICs in research” has been submitted to the NIHR CRN for inclusion in their report to the DHSC.

    Thank you to all who sent in considered views. We received 80 responses to the survey and held a teleconference with working group members to formulate our response. We also received emails and discussed in various group meetings.

    Read the Forum Response here

    Forum Community SHORT Survey: Finding out your needs 

    We have launched a very short community survey to hear about your issues, challenges, priorities and needs. It is very quick and easy to complete. Please complete this to help us work and share things that are most relevant to you. We will find UK-wide solutions, seek out support and work on resources to help.

    We will also feedback to policy makers all the things you would like us to say and share the findings with you and therefore will be asking you on a regular basis to let us know.

    Complete the Forum Community Survey

    Activities this month 

    This month we held our quarterly service user and carers group meeting where we discussed co-applicancy, changes to the landscape, the Forum PIC response and our priorities for PPI across Forum workstreams.

    We held the Forum Executive Group meeting, which looks at the strategic progress and governance of the Forum as an organisation. At the meeting we discussed developing group structures and setting work plans for the four key themes, a review of progress and all activities, finance and our plans for ongoing conversations with the group chairs. All working groups will be reviewing their contributions to the Forum themes during 2019-2020.

    Forum Members attended the HRA champions and HRA external learning reference group meetings, where the transparency strategy and learning for data driven technologies were discussed.

    Forum trainer Allyson Bailey delivered 2 separate Capacity and Capability training days to Welsh R&D staff, and chaired the learning and development oversight group teleconference.

    The Forum learning & development oversight group worked on applications for new trainers, and discussed a framework for professionalising the workforce. Following an application process we are pleased to welcome Karen Eade, Head of R&D at James Paget, as a new Forum trainer for Local Capacity & Capability Review. The AcoRD training team is working hard on content for a course in Northern Ireland and Wales and will be ready to open a new date for England shortly.

    We responded to the PIC incentivisation survey, feedback on ETCs and CQC inspection and developed the symposium agendas.

    Feedback to the CQC 

    A teleconference was held with the CQC, NIHR CRNCC and members of the community who have experienced a CQC well led inspection since research was included, in October 2018. The feedback received was really valued and will form part of an ongoing conversation, which we will continue to share with you. The following has been shared with us as a result of some queries raised by the Forum working group members:

    NIHR CRN Well Led Champions 

    The CRN is identifying Well Led Champions for each LCRN team and we have been made aware of some concerns about this. These are not new positions but a voluntary responsibility added to an existing post internal to each LCRN. Their role is to link with all LCRN staff to ensure they are up to date and fully aware of the Well Led context as it applies to research and defined by the CQC. The Champions are supported nationally by the CRN CC’s NHS Engagement team, which has been working closely with the CQC and partners to improve the profile of research in the NHS. For the CRN this internal champion function is important to well informed support and collaboration in normal interaction with NHS Trusts.

    Network champions should therefore support the Trust R&D function, as partner organisations. The Trust R&D function continues in its remit to enable the organisation to be well-led through embedded research and in preparation for CQC inspection. We will continue to work together as national partners in the sharing of good practice in this regard. All resources can be found via keyword search CQC in the Forum Resources Exchange

    Meetings coming up in August

    In between the summer holidays Forum meetings this month include:

    1st August: RDF20 Programme Content Group TC
    2nd August: Non-commercial Sponsors Group Symposia planning
    2nd August: AcoRD Masterclass Northern Ireland
    12th August: Forum meeting with Louise Wood
    15th August: ETC feedback group
    22nd August: CCR advisory group

    Meeting with Louise Wood

    Members of the Forum are meeting with Louise Wood, Director of Science, and Research & Evidence at the Dept., Health & Social Care on the 12th August. Any responses we have received to the Forum survey in time for the meeting will help to inform our conversation with her.

     


    Calls from the community

    R&D structures/organograms

    Members have asked for examples of varying structures/organograms for R&D and we would like to include examples in the resources exchange. If you have them ready to share please send into us at info@rdforum.org.uk

    Please send any shared learning around the following top topics:

    • Moving funds across organisations for ETCS
    • Research in Primary Care Networks/Integrated Care Systems
    • Electronic archiving
    • MHRA lab inspections
    • Sponsoring phase 1 studies
    • Making the case for research to the Trust

    A vendor assessment tool for GMP of Phase 1 CTIMP 

    A Trust Sponsor is looking to select a vendor for the manufacturer of an IMP in a Phase 1 CTIMP and needs reassurance of good manufacturing practice. If you are able to help please email info@rdforum.org.uk

    We are collating experiences and resources on any of these topics and so if you have anything to share of benefit to others please get in touch via info@rdforum.org.uk

    NEW group to support Forum communications

    Are you in an R&D office or department in a communications role and interested in helping the Forum communications strategy?

    We are looking to set up a Forum expert communications group to support and inform all the Forum communications. We will meet virtually by teleconference in the first instance but we may hold an occasional face-to-face meeting. We envisage the group will also act as an important community of practice and support for those who are in this role.

    If you are interested in joining this new group and can commit to helping us shape our Communications Strategy, please contact us at info@rdforum.org.uk

    A place is available for a member from a Primary Care R&D office to join the Primary Care & Commissioning working group 

    The primary care & commissioning working group have a place for one other R&D manager or member of the workforce from a Primary Care Research Office. If you are interested and can commit to attending our meetings in London please contact group chair Clare.symms@nhs.net with an outline of your role and interest.

    Read all the latest regulatory news and updates in the MRC Regulatory Support Centre quarterly newsletter

    The quarterly newsletter can be found here

    New transparency strategy for research

    The Health Research Authority (HRA) in association with the devolved administrations, has launched a consultation on research transparency
     
    The Forum will be submitting a response in order to help develop this important strategy, which will have implications for researchers, sponsors, funders, patients and the public. 
     
    Any considerations for this response can be emailed to info@rdforum.org.uk

    Contributions can also be made directly to HRA via an online survey, or as part of a series of face-to-face workshops in Manchester, London, Belfast, Cardiff and Edinburgh, and more information is available here The consultation will run for 12 weeks until September 2019.
     
    This is an important piece of work so do feed in and #makeitpublic.

     
    ETC thresholds – letter to Directors of Finance 
     
    A letter has been sent to Provider Trust Directors of Finance, confirming the ETC thresholds for the coming year. Please find the letter here

    Resource Exchange

    New resources in REX this month include:

    • NIHR Health Services Research toolkit: A new toolkit to support researchers deliver high quality health services research  
    • HRA tissue banks FAQ
    • Updated radiation guidance from HRA 
    • Nuffield Council Bioethics Briefing: Patient access to experimental treatments
    • Nuffield Council Bioethics Briefing: Medical Implants 
    • Deming, data and observational studies (article)
    • A guide to reporting protocols of pilot & feasibility trials 
    • Development and evaluation of decision aids for people considering taking part in a clinical trial: a conceptual framework (article)
    • MHRA blog: Electronic Health Records


    View the latest additions to the Resource Exchange here

    New NHS trust tops clinical research league table for first time in 8 years 

    Congratulations to Guy’s and St Thomas’ NHS Foundation Trust for topping the CNR league tables for the first time this year and to all the organisations who have made great progress this year. Full details can be found here
     
    We are delighted that Kate Blake, Director of R&D Strategy at Guys will form part of a panel discussion at our embedding symposium in October. 
     
    Congratulations to the 15 ARCs awarded £135 million 
     
    Congratulations to all the 15 new ARCS who have been awarded a share of the £135 million investment funds recently announced  
     
    In July 2019, the NIHR announced a £135 million investment in 15 new NIHR Applied Research Collaborations (ARCs), to support applied health and care research that responds to, and meets, the needs of local populations and local health and care systems. The 15 ARCs are listed here
     
    NIHR Funding Opportunities

    Health and Care Research Wales Funding Opportunities

  • New toolkit launched to support delivery of health services research (7/5/2019)

    The NIHR has launched a new toolkit for researchers, to help them deliver the high quality health services research that the NHS needs.

    The Health Services Research (HSR) Toolkit is a national resource which brings together ideas, guidance and support in one place.

    Health services research is critical for an NHS that is effective, efficient and centred on patient need. The HSR Toolkit has been launched by the NIHR Clinical Research Network, which supports a wide range of research studies that focus on improving the quality, accessibility and organisation of health services.

    The new toolkit is designed to help researchers navigate the challenges of delivering good quality health services research and support them to deliver their health services research studies successfully.

  • Your opportunity to feedback on your experience of CQC Well Led Inspections : clinical research (7/2/2019)
    As you will by now be aware, clinical research is now included as part of the CQC’s Well Led Inspections of Trusts. It is important to understand how the inspections are going so the CQC, NHS R&D, and NIHR CRN have agreed to work together to gather feedback. We would each like to see that these inspections have a useful impact on how well research is integrated in the work of all Trusts, and assist the CQC in reviewing the approach for optimal effect. 
     
    To achieve this we are holding an initial teleconference on the morning of 19th July for those who have experienced a Well Led Inspection in your Trust since the new research elements were published in the Well Led Framework in October 2018. It will be an opportunity discuss your experience and observations directly with colleagues in other Trusts as well as representatives of CQC, NHS R&D and NIHR CRN.   
     
    If you are interested, available and have experienced a recent Well Led inspection please click here to register to take part. We will then send you joining details. If you are unavailable to join the teleconference please use the registration form to leave some of your observations  based on your experience.
     
    The CQC is particularly interested to know details such as:
    • Who inspectors talked to in the Trust.
    • Your perceptions of the knowledge and skills of the inspection team with regard research.
    • Whether you recognised the findings for research in the inspection report and whether these were useful.
     
    Please click here to register to take part.
     
  • Department of Health and Social Care: EU Exit Update (7/2/2019)

    Please see a Joint Written Ministerial Statement from David Lidington MP here outlining the steps being taken by government around freight capacity procurement in the event the UK exits the EU without a deal on 31st October.
     
    Also find below correspondence from DHSC Commercial Director Steve Oldfield sent to suppliers of medicines and medical devices and clinical consumables. This communication provides additional information that you might find useful, including guidance around securing additional freight capacity, warehousing and the National Supply and Disruption Response. Please note that for clinical trial supplies, our position has not change since our communication of 26th March: 
     
    Organisations running clinical trials and clinical investigations in the UK should consider their supply chains for supplies (including Investigational Medicinal Products, devices/in-vitro diagnostics devices, advanced therapy medicinal products, radioisotopes and other clinical consumables) to ensure appropriate arrangements are in place to assure supplies in the event of any possible border delays.
     
    A story has also been published on Gov.uk, which includes links to the Written Ministerial Statement and letter to suppliers.
     
    Please also find below a letter from Stephen Hammond, Minister of State for Health at the Department of Health and Social Care (DHSC), sent to all MPs and Peers.
     
    The letter provides further detail on DHSC plans to support the continuity of medicines, medical products and clinical trial supplies into the UK in the event of a no-deal exit

    We appreciate that you may also receive these communications via another route, in which case we apologise for any inconvenience.  
     
    If you have any further questions, please contact ctcontingencyplanning@dhsc.gov.uk.

  • New NHS trust tops clinical research league table for first time in 8 years (7/2/2019)
    For the first time in eight years a new trust has topped the NIHR Clinical Research Network Research Activity League Table for the highest number of studies. Guy’s and St Thomas’ NHS Foundation Trust undertook the most clinical research studies with 567 supported studies during 2018/19. To improve future treatments and care for patients, the trust is supporting a wide range of studies from eczema prevention in newborns to better understanding outcomes for people with sepsis.

    The league table is published by the NIHR Clinical Research Network each year and provides a picture of research activity across all NHS trusts and CCG regions in England. The table data includes how much clinical research is happening, where, in what types of trusts, and involving how many patients.

    2018/19 has been a record breaking year for clinical research across England, with a total of 870,250 participants taking part in NIHR Clinical Research Network supported studies – the highest number on record with an increase of 140,000 more than in 2017/18. Last year more than 6,000 studies were supported by the NIHR Clinical Research Network and 50% of NHS trusts and 61% of CCG regions increased the number of studies that were available to patients.

    Jonathan Sheffield, Chief Executive Officer of the NIHR Clinical Research Network says:

    “It’s been a fantastic year for health and care research across England, with 100% of trusts supporting research studies, providing patients with more opportunities than ever before to take part in vital research which improves future treatment and care.  

    “There’s a growing body of evidence which suggests that research-active hospitals have lower mortality rates, and better patient outcomes, so the NIHR Clinical Research Network will continue to work closely with NHS organisations to ensure that research continues to be offered to people as part of quality patient care.  

    “The number of patients taking part in research this year is a significant step towards meeting the NHS Long Term Plan, of one million people being registered as interested in taking part in research by 2024. I would like to congratulate Guy’s and St Thomas’ for topping the table this year, and also thank all those hard working, NHS staff across the country, supporting the delivery of research on top of their other clinical duties. We couldn’t achieve these results without you.”

    Cambridge University Hospitals NHS Foundation Trust has achieved the biggest increase in the number of studies available to patients to participate in, with an increase of 68 studies bringing their total number to 466. 

    In line with NIHR Clinical Research Network priorities, to bring easier access to research opportunities for patients where they live, Pennine Acute Hospitals NHS Trust tops the table for the number of patients recruited into studies, with 37,122 patients recruited in 2018/19.

    See the results of your local trust or CCG region by visiting: 
  • June Newsletter 2019 (6/30/2019)

    Did you read…? 

    The Forum Review May 18-19 detailing all the work achieved by our members. This review outlines all our groups and their chairs 

    Click here for further information

    Did you know?

    The NHS R&D Forum exists to empower the workforce to enable high value, quality research and development to improve health and care.

    Are all your team signed up? Join the community here

    Forum Symposia Series – Bookings now open

    Back by popular demand the Symposia are running again to connect members of the community in key topics of interest and to enable the ongoing sharing of practice. 

    Embedding research through strategy, leadership & culture
    9th October 2019London

    Further details

    Non-commercial sponsors
    19th November 2019Birmingham NEC

    Further details 

    Research not as we know it: Managing novel methods in research
    2nd March 2020, London 

    Further details

    Professional Learning & Development

    A practical application of monitoring in a health care setting
    Date: 30 September – 1st October 2019 

    Location: Birmingham NEC

    This course is aimed at individuals and organisations that deliver non-commercial research in a healthcare setting. It explores the application of monitoring as a quality assurance tool, focuses on skills for monitoring and provides an understanding of risk-based monitoring in order to ensure high quality research in the NHS.

    This is a practical two-day course delivered by experienced monitors who work in the NHS. Sessions include slide presentations but are primarily practical and interactive. An essential workbook will be provided to all delegates.

    Click here for further information & 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

    PIC consultation 

    Thank you for all the responses to the PIC consultation in response to the Industry Sector Deal 2. We received a fantastic number and will be submitting a Forum-wide response to the NIHR CRN CC shortly. A copy will be posted on the Forum website. The survey is now closed.

    Click here for further information

    Working groups

    Three of our working groups met this month. As well as hearing from partner organisations and commenting on current topics, we participated in a short workshop to discuss PIC activities. The group members also shared their existing challenges and discussed their group priorities & aims. We will update on this as they develop. 

    Some of the topics discussed included primary care networks, electronic archiving, MHRA lab inspections, integrated care systems, non-NHS sites, research management research, sponsoring phase 1 studies, and making the case for research to the trust.

    We are collating experiences and resources on any of these topics and so if you have anything to share of benefit to others please get in touch via info@rdforum.org.uk

    A new ambition for cross sector collaboration with the life sciences industry: NHS Confederation & ABPI roundtable 

    Professor Phillip Smith, Associate Director of R&D at East & North Herts was privileged to attend a round table event to discuss future partnerships between the NHS and life sciences industry.

    NHS Confederation and the ABPI have now published a report of this meeting with the aim of starting a wider conversation. The report highlights both hard and soft barriers to collaboration and calls for action around key areas including (1) leadership & culture, (2) building trust and (3) planning for success including better articulating health challenges.

    Click here for further information

    NHS England Commercial Contract Research Advisory Group 

    Members of the Forum took part in the first CCR advisory group meeting. This group is formed to ensure that the commercial contract research community has the opportunity to offer expertise, advice and scrutiny to the project. As part of this group members are charged with collating, representing and cascading information on the agenda, which we will do via Forum news. 

    A place is available for a member from a Primary Care R&D office to join the Primary Care & Commissioning working group 

    The primary care & commissioning Working Group have a place for one other R&D manager or member of the workforce from a Primary Care Research Office. If you are interested and can commit to attending our meetings in London please contact group chair Clare.symms@nhs.net with an outline of your role and interest. 

    Join the Programme Content Group for RDF20

    Join the RDF20 Programme Content Group and help us to develop another fantastic programme for Newcastle. Duties include regular teleconferences, setting the scope of the sessions, speaker selection and review of oral & poster abstracts. If you would like to join please contact the programme chair Dr Nicky Williams via info@rdforum.org.uk

    Non-commercial sponsorship – expressions of interest to speak

    Do you have an innovative, interesting or pragmatic and proportionate approach to Sponsorship that you would like to share at our next Sponsors symposium on the 19th November in Birmingham? If so the non-commercial Sponsors group is keen to hear from you.

    Click here to submit a short expression of interest to speak by 5pm July 18th

    Have your say: New transparency strategy for research

    The Health Research Authority (HRA) in association with the devolved administrations, has launched a consultation on research transparency

    The Forum will be submitting a response in order to help develop this important strategy, which will have implications for researchers, sponsors, funders, patients and the public. Any considerations for this response can be emailed to info@rdforum.org.uk.

    Contributions can also be made directly to HRA via an online survey, or as part of a series of face-to-face workshops in Manchester, London, Belfast, Cardiff and Edinburgh, and more information is available at www.hra.nhs.uk/makeitpublic. The consultation will run for 12 weeks until September 2019.

    This is an important piece of work so do feed in and #makeitpublic. 

    Calls from the community

    Call for tools to support research in non-NHS sites 

    The Primary Care & Commissioning Group would like to receive any tools for supporting the set up and management of research in non-NHS sites and so please send them to group chair clare.symms@nhs.net

    Archiving resources

    We have added more links to the resources exchange but we need more practical tools and examples. Please send any updated archiving resources to us for inclusion. This includes SOPs, workflows, retention schedules, policies, experience of e-archiving and job descriptions. Please send to info@rdforum.org.uk or upload directly.

    Vendor assessment tool for GMP of Phase 1 CTIMP 

    A Trust Sponsor is looking to select a vendor for the manufacturer of an IMP in a Phase 1 CTIMP and needs reassurance of good manufacturing practice. If you are able to help please email info@rdforum.org.uk

    MRC Data Anonymisation Workshop Outputs 

    Notes & slides from a brilliant workshop by the MRC Regulatory Support Centre exploring data anonymisation are now available to download here. Members of the Forum will continue to feed into this work. 

    Click here to access the notes and slides.
     
    Model Participant Identification Centre (PIC) Agreements 
     
    Model Participant Identification Centre (PIC) agreements have now been published and are available on IRAS Help-alongside guidance.
     
    PICs are NHS/HSC organisations that identify potential research participants. They are not research sites and should not be treated in the same way as research sites.

    What contracting arrangements should be put in place with NHS/HSC PICs?
     
    
NHS/HSC PICs should be set up by through a sub-contracting arrangement with the participating NHS/HSC organisation that the PIC supports using the appropriate model agreement:


    MHRA breaches report 2018
     
    The metrics report for breaches of GCP reported to the MHRA in 2018 has been published here

    New ETC helpdesk email address

    There is a new help desk email address to help manage ETC queries. The help desk email address is etc.helpdesk@nihr.ac.uk and is now live to use. 
     
    The helpdesk will allow the CRNCC to track and resolve enquiries more efficiently and it is important you send queries through so that they can be captured. This inbox should now be used for all ETC enquiries, rather than the Study Support Service inbox supportmystudy@nihr.ac.uk
     
    New interactive costing tool for industry (iCT)
     
    NIHR has launched a new web-based costing tool for industry – which will enable faster and more efficient costing and contracting between the life sciences sector and the NHS during the study set-up phase.

    The new interactive Costing Tool (iCT) is now available as a module within CPMS – NIHR’s research activity data management system. It includes a number of major improvements over the previous Excel-based version of the costing template.  Read more
     
    Important please read: 
    Please note that NHS Trusts or their delegated costing authorities (for harmonised locations) MUST ensure that their costing teams are registered on CPMS (as individuals or Group emails) to use the iCT. In cases where they are not, the CRN will be unable to allocate studies to those organisations and they will be unable to review the study costings
     

    Research Participant Experience Report

     
    The NIHR has published the annual Research Participant Experience Report 2018/2019 with recommendations for future practice at study, Sponsor and organisational level.

    Click here for further information
     
    Be part of research website 
     
    Clinical Trials Gateway has been rebuilt to make it easier for everyone to use. It is now called ‘Be part of research”. Please promote widely and feed in to make sure it continues to develop usefully.  
     
    Click here for further information
     
    Professor Chris Whitty appointed England CMO and UK CMA
     

    Professor Chris Whitty will become the new Chief Medical Officer for England and the UK government’s Chief Medical Advisor. He will take up this post later in the year retaining the Research & Development Portfolio for the Dept. Health 


    Click here for further information

    Dr Louise Wood awarded in the Queen’s Birthday Honours 

    Congratulations to Dr Louise Wood, Director of Science Research & Evidence at the Department of Health & Social Care who was awarded a CBE in the Queen’s Birthday Honours this year.
     
    Click here for further information
     

    Many resources, links and tools were shared at the conference. Please remember to submit them for others to see You can submit them directly here

    View the latest additions to the Resource Exchange here 

    Royal College of Physicians and Clinical Research Network Awards

    The National Institute for Health Research (NIHR) Clinical Research Network and the Royal College of Physicians (the College) joint awards programme is now open for entry. The awards recognise outstanding contributions of NHS consultants and trainees who are active in research.
     
    Click here for further information
     
    NIHR Funding Opportunities 

    Health and Care Research Wales Funding Opportunities 

    Latest Jobs

     View the latest jobs online – see here.

    Please submit your latest vacancies and we will also tweet them out. 
     

  • Have your say: New transparency strategy for research (6/20/2019)

    The Health Research Authority (HRA) in association with the devolved administrations, has launched a consultation on research transparency

    The Forum will be submitting a response in order to help develop this important strategy, which will have implications for Researchers, sponsors, funders, patients and the public. Any considerations for this response can be emailed to info@rdforum.org.uk.

    Contributions can also be made directly to HRA via an online survey, or as part of a series of face-to-face workshops in Manchester, London, Belfast, Cardiff and Edinburgh, and more information is available at www.hra.nhs.uk/makeitpublic. The consultation will run for 12 weeks until September 2019.

    This is an important piece of work so do feed in and #makeitpublic.

  • MRC Data Anonymisation Workshop Outputs (6/20/2019)

    Notes & slides from a brilliant workshop by the MRC Regulatory Support Centre exploring data anonymisation are now available to download here. Members of the Forum will continue to feed into this work. 

  • New ETC helpdesk email address (6/17/2019)

    There is a new helpdesk email address to help manage ETC queries.
    The help desk email address is etc.helpdesk@nihr.ac.uk and is now live to use. The helpdesk will allow the CRNCC to track and resolve enquiries more efficiently and it is important you send queries through so that they can be captured. This inbox should now be used for all ETC enquiries, rather than the Study Support Service inbox supportmystudy@nihr.ac.uk

  • Call for views: Recognising and incentivising the NHS to act as Participant Identification Centres (6/12/2019)

    The Forum has been asked to submit a response to the above call and following a short workshop we would now like your views to inform it. This is a very short survey with only 2 questions and so please do submit them by close of business on Friday 21st June. The Forum working groups will then review and submit a Forum-wide response. 

    To take part in the survey click here

  • May Newsletter 2019 (6/3/2019)

    2019 NHS R&D Forum Annual Conference 

    An amazing conference with nearly 600 members of the community gathered together to share and learn. A first evening of networking with Acadami Wales put us in a happy place, looking at how to overcome our learned behaviours to know that happiness breed’s success and not the other way around. 

    A mix of wonderful powerful plenary sessions took us immediately into why we are all doing the job we do. An impassioned call from Jess Mills made in memory of her mother Dame Tessa Jowell for us all to work together towards adaptive personalised treatment and care equally accessible to all. Louise Wood and Professor Sir Jonathan Montgomery followed, bringing not only the policy and regulatory perspectives but also shared stories and thoughtful insights into why we are all committed to improving the impact of research for our loved ones and “creating the evidence to enable people to be born well, live well and die well”.

    Fantastic presentations on future policy, strategic aims and enablers of good research got us thinking about making research easier and more transparent with Juliet Tizzard, Andrew Lotery and Indra Joshi taking us firmly from the comfort of our RCTS into the possible world of AI; everyone was transfixed by the potential for future patients. The first day was rounded off with a real treat, listening to the extraordinary career of Dame Fiona Caldicott sharing her leadership challenges and tips, in conversation with Prof Sir Jonathan Montgomery. 

    As always the presentations from R&D teams across the UK stimulated much discussion and thank you to everyone who submitted abstracts for sharing. 

    There are too many highlights and people to thank to share here but you can read all the presentations online, follow insights on Twitter at #RDF19 and view all the photos too.

    At the very end of Day 2 Philip Darbyshire entertained us with a high-energy call to action and a striking closing remark that has been evident throughout the conference and subsequent events since, including international clinical trials day and the #whywedoresearch tweetfest. “There is an awful lot of support for research in health across the UK” and we are lucky for it. Thank you all for your contribution.”

    Congratulations to all award winners – see who are they are here

    Forum Review 19

    We are pleased to publish the Forum Review 2019, sharing all the hard work and commitment of member’s activities throughout the year. 

    Our work together involves service users and carers and is undertaken in the following themes:

    1Research strategy, leadership & culture: for the NHS, patients, health & care
    2Managing research well: for quality research
    3: Enabling high value, impactful R&D: for evidence & improvement
    4: Professionalisation & value of the workforce: for our community

    Read the full Review here

    Forum Symposia Series – new dates announced

    Back by popular demand the Symposia are running again to connect members of the community in key topics of interest and to enable the ongoing sharing of practice. We will open bookings shortly for:

    Embedding Research a Healthcare Setting 9th October 2019, London

    Non-Commercial Sponsors 19th November 2019Birmingham NEC

    Research not as we know it: Managing novel methods in Research
    2nd March 2020, London 

    Keep an eye on the Forum website where bookings will open soon

    Professional Learning & Development

    Places still available on the following courses running in June. 

    Archiving Masterclass 13th June, London 

    An excellent course providing expert insight into the practicalities of research archiving procedures. Developed to support Research management teams with their processes for archiving this course is for anyone who has responsibility for archiving research in their organisation. Whether you are a named archivist or part of a team with delegated responsibility we hope that you will find this course useful. As with all Forum activities it is also a valuable opportunity to meet with your colleagues from across the country to discuss challenges and solutions.

    Click here for further information & booking

    Local Capacity and Capability for Research 24th June, London 
     
    Understand the requirements of an NHS organisation when determining whether to take part in a particular research study as a host. This course 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.
     
    The first half of the day concentrates on making delegates familiar with process. The second half is spent putting everything into practice working through an example study.
     
    Click here for further information & booking

    Regulatory Inspection Ready 25th June, London

    This 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.

    Click here for further information & 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

    This month members are:

    • Supporting work around amendments, testing developments with the HRA 
    • Supporting learning from CQC inspection 
    • Hearing about the work of the RCP
    • Presenting at meetings, delivering training and developing our symposia 
    • Continuing to drive our work on CDAs, Sponsorship and adding value in research 
    • Reviewing the strategic landscape and considering our priorities as a workforce and for research. 

    If you have something to contribute please get in touch via info@rdforum.org.uk

    Monthly meetings coming up
    This month Forum members  are attending or running the following meetings on behalf of the Community. 

    5th June: Forum Primary Care & Commissioning Working Group
    5th June: Forum Evidence for Commissioning Group 
    5th June: Commercial clinical operations group (cCOG)
    6th June: Forum Research Management Working Group
    13th June: Forum Learning & Development Oversight Group TC
    14th June: Informal Learning Group (HRA, NIHRCRN, MRC, NHS R&D FORUM)
    20th June: Excess Treatment Costs Feedback Group
    21st June: Commercial Contract Research Advisory Group 
    26th June: Forum Research Strategy & Leadership Working Group 

    Contact info@rdforum.org.uk if you have something you would like them to feedback or include on the agenda for discussion with stakeholders 

    Survey reveals NHS research & innovation priorities 

    The AHSN network, NHS England and the NIHR have published the results of a survey to look at NHS research & innovation priorities. This is an important read and a fundamental enabling role for Research management and leadership teams.

    Click here for further information

    Details of the new UK Local Information Pack: to be launched 5th June

    A UK Local Information Packwill be introduced on the 5 June 2019 to support the set-up of NHS / HSC research in the UKResearchers working with NHS / HSC organisations across England, Northern Ireland, Scotland and Wales will benefit from a consistent package to support study set-up and delivery across the UK.

    Read more about the pack including llnks to the new Organisational Information Document here.

    RCP launches “Delivering research for all: expectations and aspirations for the NHS in England”

    The RCP has launched the statement ‘delivering research for all: expectations and aspirations for the NHS in England’. 

    Click here for further information

    This statement follows previous work, including our joint publication ‘Research for all. Best practice in research management’ which you can read here. Members of the Forum shall be working with the RCP to support them in this work in order to enable NHS organisations to embed research well. 

    Launch of new interactive costing tool for Industry

    The NIHR has launched a new web-based costing tool for industry – which will enable faster and more efficient costing and contracting between the life sciences sector and the NHS during the study set-up phase. The new interactive Costing Tool (iCT) is now available as a module within CPMS – NIHR’s research activity data management system. It includes a number of major improvements over the previous Excel-based version of the costing template. 

    Click here for further information

    Roll out of Single Contract Review Process

    Use of the NIHR’s new interactive Costing Tool (iCT) underpins rollout of the single contract review process for commercial contract research, which is being led by NHS England and NHS Improvement, in partnership with NIHR and the Health Research Authority. The first phase of implementation is now underway, with multiple volunteer national coordinators from participating sites conducting an enhanced validation on a single study. 

    Click here for further information

    Resource Exchange

    Many resources, links and tools were shared at the conference. Please remember to submit them for others to see! You can submit them directly here

    View the latest additions to the Resource Exchange here

    #whywedoresearch Tweetfest 2019 & ICTD

    The fantastic #whywedoresearch Tweetfest has been covering 2 weeks worth of brilliant topics all exploring why or how we do research. Follow the conversations on twitter and see all the great work undertaken by other R&D departments and organisations for International clinical Trials day. #ICTD
     
    Clinical Academic Research Partnerships 

    This scheme provides a new flexible route for research-qualified NHS consultants to increase their research skills and experience. See here for funding available. 
     


    Calls from the R&D Community


    NIHR Funding Opportunities 

    Health & Care Research Wales Funding Opportunities 
     
    CI training
     
    Do members have specific training packages in place for new Chief Investigators or research fellows acting in support? Do you use particular trainers/course providers? Please contact Mark.Terry@rmh.nhs.uk with any insights or examples for collation 
     
    Recommendations for SOPs review
     
    Do members have any recommendations for individuals, consultancy or companies who might provide a SOPS update and gap analysis? Please contact info@rdforum.org.uk with any names, contact details and experience.

    Latest Jobs

    View the latest jobs online – see here.

    Please submit your latest vacancies and we will also tweet them out. 

  • Research Participant Experience Report (5/30/2019)

    “The NIHR has published the annual Research Participant Experience Report 2018/2019 with recommendations for future practice at study, Sponsor and organisational level”

  • UK Local Information Pack (5/30/2019)

    Implementation of the UK Local Information Pack is confirmed for the 5 June 2019. It will be important to remember that from this date an Organisation Information Document will replace the current Statement of Activitiesused in England and Wales and the Site Specific Information form, used in Northern Ireland and Scotland.  From this date the Statement of Activities and Site Specific Information form will no longer be in use. The Organisational Information Document will be required as part of the UK Local Information Pack for commercial and non-commercial research.

    Researchers working with NHS/HSC organisations across England, Northern Ireland, Scotland and Wales will benefit from a consistent package to support study set-up and delivery across the UK.  Guidance and information is provided in IRAS Help and some explanatory questions and answers are available on the Four Nations Compatibility project web page. Delegations Logs:  Following feedback we have clarified the use of the delegation log studies.

    Delegation Logs are required for all interventional studies requiring a local Principal Investigator. Sponsor will need to indicate if this is being provided with the UK Local Information Pack or if this is being provided at a later date i.e following Site Initial Visit. The Q&As have been updated with regard to this.   Further webinars will be held on 30 May at the following times 9.15am, 11.00am, 13.00pm and 14.30pm. To register sign on here

  • Launch of new interactive costing tool for industry (5/23/2019)

    The NIHR has launched a new web-based costing tool for industry – which will enable faster and more efficient costing and contracting between the life sciences sector and the NHS during the study set-up phase. The new interactive Costing Tool (iCT) is now available as a module within CPMS – NIHR’s research activity data management system. It includes a number of major improvements over the previous Excel-based version of the costing template. 

    Click here for further information

  • Survey reveals NHS research & innovation priorities (5/9/2019)
    Survey reveals NHS research & innovation priorities 
    The AHSN network, NHS England and the NIHR have published the results of a survey to look at NHS research & innovation priorities. This is an important read and a fundamental enabling role for Research management and leadership teams.

    Read more here:

    https://www.ahsnnetwork.com/nhs-research-innovation-priorities/

  • April Newsletter 2019 (5/2/2019)

    Did you read…?
     
    CQC Inspection and Well-Led Research in NHS Trusts

    A briefing about the outputs from the work to establish research markers in CQC inspection was published last month for the NHS R&D Forum and Members will continue to support this so please do continue to share your experiences via info@rdforum.org.uk

    Click here for further information: https://spark.adobe.com/page/msDL652NBVBM0/ 
       
    Forum Top Tips for EudraCT Reporting 

    All Sponsors of CTIMPS are legally required to report the end of study summary on EudraCT. The Research Management working group issued its top tips for Sponsors and R&D offices to help work through these reporting obligations. 
    Tips were collated by the group and expertly pulled together in an infographic by the chair Sally Humphreys. 

    Click here for further information:http://www.rdforum.nhs.uk/content/wp content/uploads/2019/03/EudraCT-Twitter.pdf

    The VICTOR tool: Visible impact of research. 

    The first version of the VICTOR impact tool is complete and available for anyone to use to demonstrate the impact of being research active. Jo Cooke and Research Fellows Nat Jones and Judith Holliday (Head of Research and Innovation Mid Yorkshire Hospitals NHS Trust) have lead the development of VICTOR 

    Read more from Judith here: http://www.rdforum.nhs.uk/content/2019/03/25/new-tool-support-making-visible-impact-research-victor/

    RDF19: Join the Community

    We are pleased to announce that Jess Mills, daughter of the late Dame Tessa Jowell, will be presenting as part of Plenary Session 1 giving the Patient Perspective on ‘why we’re here’.

     

    Jess Mills is CEO and Co-Founder of ACT For Cancer – The Tessa Jowell Movement For Change and is on the Executive Leadership of the Tessa Jowell Brain Cancer Mission.  ACT for Cancer has been created to deliver Tessa’s legacy, by delivering the most cutting edge, personalised treatment and care through the NHS to all cancer patients currently facing an ‘untreatable’ cancer diagnosis.

    Jess is joined in the session by Louise Wood (DHSC) who will be giving the Policy Perspective and is followed by Teresa Allen (HRA) who will be representing the Regulators Perspective. 

    Forum Round Up

    A few highlights from the Forum groups this month:

    • We’ve delivered the applied monitoring course to the Wessex region, data management in a health care setting, essentials of NHS research and the first AcoRD masterclass in London, which was a great success thanks to a great training team. New dates for AcoRD will be available soon. 
    • The Forum service users and carers group met and discussed the reach of the Forum guidance for public involvement and co-applicancy. The authors will be presenting in a session at the conference if you want to hear more. Click here to view the RDF19 Programme and book for this session: https://www.annualrdforum.org.uk/rdf19-session-detail/?id=1963&key=k40lx 
    • The Forum leadership team met with the chairs of all the working groups to build better links between the groups and to review Forum structures. We discussed what works well, what needs improvement, and made progress towards some immediate actions. It was agreed that we should continue the conversation together and improve the visibility of all who contribute. If you have ideas about how the Forum works seek out our leadership team at the conference or email info@rdforum.org.uk

    Monthly meetings coming up:

    This month Forum members are attending the following meetings on behalf of the community. 
     
    Contact info@rdforum.org.uk if you have something you would like them to feedback

    25 April: HRA Champions Meeting
    25 April: Excess Treatment Costs Feedback Group 
    25 April: MRC Workshop – Safe Sharing of Research Data
    29 April: HRA Non-commercial Sponsors Reference Group
    2 May:  DHSC Non-Commercial Costings Meeting 
    7 May: MHRA Stakeholders Meeting 
    16 May: HRA External Learning Group

    Calls from the community

    Manufacturing vendor checklist or audit forms

    Does anyone have a very detailed manufacturing vendor checklist or audit form that is more in-depth that the ones currently on the resources exchange? If so please email them to info@rdforum.org.uk

    Safety monitoring content experts – do you have particular expertise in safety monitoring for all study types and experience as a research Sponsor, CTU or other, such that you feel confident to join a reference group on this topic? If so please contact gail.melvin@uhl-tr.nhs.uk

    Professional Learning & Development

     
    AnchorArchiving Masterclass
    13th June, London 
    £330 No Vat 

    An excellent course providing expert insight into the practicalities of research archiving procedures.

    Developed to support Research management teams with their processes for archiving this course is for anyone who has responsibility for archiving research in their organisation. Whether you are a named archivist or part of a team with delegated responsibility we hope that you will find this course useful. As with all Forum activities it is also a valuable opportunity to meet with your colleagues from across the country to discuss challenges and solutions.

    Click herefor further information

    Local Capacity and Capability for Research
    24th June, London 
    £330 No Vat 
     
    Understand the requirements of an NHS organisation when determining whether to take part in a particular research study as a host. This course 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.
     
    The first half of the day concentrates on making delegates familiar with process. The second half is spent putting everything into practice working through an example study.
     
    Clickherefor further for information

    Regulatory Ready 
    25thJune, London
    £330 No Vat 

    This 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.

    Click herefor further for information

    Regulatory & Policy Updates


    AnchorHR Good Practice Pack: GDPR update and move to IRAS Help website
     
    The HR Good Practice Resource Pack has been reviewed and updated in light of the Data Protection Act 2018 (DPA 2018) and the General Data Protection Regulation (GDPR), which came into force in the UK on 25 May 2018.  At the same time the pack has moved from the NIHR website to the Research Passport Section of IRAS Help.
     
    Please ensure that colleagues in HR departments and are made aware of the update and change of location

    Click here for further information: http://www.rdforum.nhs.uk/content/2019/04/09/hr-good-practice-resource-pack-update/

    AnchorDetails of the new UK Local Information Pack: To be launched 5th June
     
    UK Local Information Pack will be introduced on the 5June 2019 to support the set-up of NHS / HSC research in the UKResearchers working with NHS / HSC organisations across England, Northern Ireland, Scotland and Wales will benefit from a consistent package to support study set-up and delivery across the UK.
     
    Read more about the pack including llnks to the new Organisational Information Document here: http://www.rdforum.nhs.uk/content/2019/04/18/details-new-uk-local-information-pack-launched-5th-june/

    AnchorCombined Ways of Working Project: Organisations needed 

    The HRA and MHRA are look for new organisations that would like to take part in the combined ways of working pilot.  A pilot project to make applying for approval for Clinical Trials of Investigational Medicinal Products (CTIMPs) quicker and simpler for researchers continues to encourage new studies to take part.

    Click here for further information: http://www.rdforum.nhs.uk/content/2019/04/18/combined-ways-wo…nisations-needed/ 

    AnchorClinical Research Practitioners and the road to recognition

    The Clinical Research Practitioner Directory is an exciting new venture that aims to promote a strong professional identity for CRPs and provide assurance for patients.

    Clinical Research Practitioners (CRPs) are crucial to delivering the clinical research that is transforming treatment in the NHS and the care we receive.

    The Directory is a collaboration between the NIHR and the Academy for Healthcare Science. It’s a fast growing community and space for CRPs to be consulted and to contribute to an application seeking accredited registration for CRPs.

    Click here for further information: http://www.rdforum.nhs.uk/content/2019/04/18/clinical-researc…road-recognition/ 

    Organisations requested to liaise with IT departments to allow emails from the HRA and partner organisations

    Please liaise with your IT departments to allow emails from the HRA and partner organisations (sender email address is noreply@harp.org.uk) to be delivered to the recipients inbox, rather than be sent to the junk folder or be blocked. If you need any further support please contact hra.approvalprogramme@nhs.net.


    AnchorNew Welcome Trust report: A blueprint for the oversight of emerging science and technologies

    Key principles that should underpin a dynamic approach to the oversight of emerging science and technologies in the UK
                             
    Click here for further information: https://wellcome.ac.uk/reports/blueprint-oversight-emerging-science-and-technologies



    View the Resource Exchange here
     
    Please send in your tools, resources and helpful links. You can submit them directly here or send to info@rdforum.org.uk. Just one resource from every organisation would really make a difference and help to keep us all current.

    Other News, Call & Funding 

    Anchor#whywedoresearch Tweetfest 2019 13th– 24th May 

    The fantastic #whywedoresearch Tweetfest is back bigger and better than ever with 2 weeks worth of brilliant topics all exploring why or how we do research. 
     
    Join in http://whywedoresearch.weebly.com/tweetfest-2019.html
     
    The (virtual) School for Change Agents that starts on Thursday 16th May 2019.

    The School for Change Agents is an online and global community across health and care, run by my team, NHS Horizons. It is free and highly interactive. It provides an opportunity for change agents and leaders in health and care to build their skills, confidence and networks for leading change. It is open to everyone and provides virtual learning sessions over six weeks in May and June (breaking for the half-term week).

    Click here for further information: http://www.rdforum.nhs.uk/content/2019/04/04/school-change-agents/

    AnchorNursing Times & awards are open
     
    The Nursing Times Awards are open for 2019! These awards are all about celebrating the best of the profession. Find out about Clinical Research Nursing award category and how to enter at http://bit.ly/2UiwlqX 

    Title: NIHR Funding Opportunities 
    https://www.nihr.ac.uk/funding-and-support/funding-opportunities/
     
    Health & Care Research Wales Funding Opportunities 
    https://www.healthandcareresearch.gov.wales/funding/our-funding-schemes/
     

    Latest Jobs

    NIHR CRNCC 0.5wte GCP subject matter expert and learning advisor 
     
    The NIHR CRNCC are recruiting to the post of GCP Subject Matter Expert and Learning Advisor 
     
    http://jobs.leeds.ac.uk/MHNCC1166 
     
    There are many other new jobs this month – see here.

    Please submit your latest vacancies and we will also tweet them out. 


  • Clinical Research Practitioners and the road to recognition (4/18/2019)

    The Clinical Research Practitioner Directory is an exciting new venture that aims to promote a strong professional identity for CRPs and provide assurance for patients.

    Clinical Research Practitioners (CRPs) are crucial to delivering the clinical research that is transforming treatment in the NHS and the care we receive.

    The Directory is a collaboration between the NIHR and the Academy for Healthcare Science. It’s a fast growing community and space for CRPs to be consulted and to contribute to an application seeking accredited registration for CRPs.

    Deirdre Brooking, Clinical Research Practitioner at the Royal National Orthopaedic Hospital,said:

    “I think there is a big lack of awareness about our role and the skills required. It’s vitally important we are recognised for what we do and the CRP Directory is an important step on that journey.

    “Accredited registration would not only help our professional identity, it would give us a credibility in clinic and give patients assurances when they enter into a clinical study.”

    Janice Paterson, Workforce Intelligence Manager at the NIHR Clinical Research Network,said:

    “CRPs bring a wealth of research knowledge and expertise to the delivery of safe, ethical and high quality clinical research care.  Around a quarter of the workforce funded by the NIHR Clinical Research Network are working in CRP roles – their enthusiasm and expertise is essential to the future of clinical research.”

    “The CRP Directory offers Clinical Research Practitioners the opportunity to play a big part in shaping their profession and securing accredited registration.”

    More information:

     

     

     

     

  • Combined Ways of Working Project: Organisations needed  (4/18/2019)

    A pilot project to make applying for approval for Clinical Trials of Investigational Medicinal Products (CTIMPs) quicker and simpler for researchers, continues to encourage new studies to take part.

    The Combined Ways of Working pilot (CWoW), a joint project from the Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA), in collaboration with the Devolved Administrations, offers applicants a more streamlined process for the submission and review of applications to run CTIMPs in the UK.

    The pilot process requires a single CTIMP application to be submitted for both the Clinical Trial Authorisation (CTA) and the Research Ethics Committee (REC) opinion. The reviews are undertaken independently, but the outcome of the review is coordinated. Applicants receive a single request if any further information is needed, and just one communication to confirm the final decision. The process also aims to align with the requirements of the EU Clinical Trial Regulation.

    During its first year, the pilot has received more than 40 applications. The mean time from submission to authorisation has been 42 days, well within statutory timelines, and feedback from sponsors has been very good.

    Participation in the pilot is voluntary, and capacity is limited, but the HRA and MHRA are now looking for new organisations who would like to take part. Full guidance is available at www.hra.nhs.uk/cwowand please contact cwow.admin@nhs.netfor more information.

  • Details of the new UK Local Information Pack: To be launched 5th June (4/18/2019)

    AUK Local Information Packwill be introduced on the 5June 2019 to support the set-up of NHS / HSC research in the UK. Researchers working with NHS / HSC organisations across England, Northern Ireland, Scotland and Wales will benefit from a consistent package to support study set-up and delivery across the UK.

     

    The UK Local Information Pack is the set of documents that NHS / HSC organisations use to formally start preparing to deliver the study. More information is given in the Local Information Pack section of IRAS Helpbut there are some key features:

    • One new feature of the UK Local Information Pack is the Organisation Information Document,which will replace the current Statement of Activitiesused in England and Wales for non-commercial studies and the Site Specific Information Form, used in Northern Ireland and Scotland.  After this date the Statement of Activities and NHS / HSC Site Specific Information Form will no longer be in use.

    In outline format the Organisational Information Document will be a component of the IRAS Form submission and in a localised format will be required as part of the UK Local Information Pack for both commercial and non-commercial research. Organisation Information Documenttemplates and associated guidance are available in IRAS Help.

    For non-commercial, studies that are not clinical trials or clinical investigations, the Organisation Information Document should also be used as the agreement between sponsor and participating NHS / HSC organisation.

    • Another feature of the UK Local Information Pack is the inclusion of a delegation log template, which is intended to be used at participating NHS / HSC organisations. This will allow NHS/HSC organisations to locally record who will be working on the study.
    • For non-commercial studies an IRAS Schedule of Events or a SoECATwill be a part of the IRAS Form submission and is used in the UK Local Information Pack as a way of providing clarity to participating NHS / HSC organisations on the cost attributions associated with a study.

    Guidance on the use of the UK Local Information Pack has now been published in the Site Specific page of IRAS Helpto help applicants get ready for the change. If you are making an IRAS Form submission or planning to set up research in an NHS / HSC organisation from 5 June 2019 please read the transition guidanceso that you prepare the correct materials.

    To support researchers and NHS / HSC organisations make the transition to using UK Local Information Packs, change management activities will be scheduled throughout April and May, with continuing support following implementation in June.  Webinarshave been scheduled to support the change (if you have not previously used the new HRA Learning Management System please register for an account via the link).

    Guidance and information is provided in IRAS Helpand some explanatory questions and answers are available on the Four Nations Compatibilityproject web page.

  • HR Good Practice Resource Pack update (4/9/2019)

    HR Good Practice Pack: GDPR update and move to IRAS Help website

    The HR Good Practice Resource Pack has been reviewed and updated in light of the Data Protection Act 2018 (DPA 2018) and the General Data Protection Regulation (GDPR) which came into force in the UK on 25 May 2018.  At the same time the pack has moved from the NIHR website to the Research Passport Section of IRAS Help.

    The changes are:

    –          A Transparency Notice has been drawn up and is included in the HR Good Practice Pack. This informs and clarifies to the applicant the purpose of collecting their personal data , their rights relating to data processing, as well as fulfilling other GDPR transparency requirements.

    –          The data requested in the Research Passport application form has been minimised following discussion with Data Protection and Information Governance Officers and Human Resource experts.

    –          All references to the Data Protection Act 1998 have been updated to DPA 2018.

     

    Please ensure that colleagues in HR departments and are made aware of the update and change of location.

  • School for Change Agents (4/4/2019)

    The (virtual) School for Change Agents that starts on Thursday 16th May 2019.

    The School for Change Agents is an online and global community across health and care, run by my team, NHS Horizons. It is free and highly interactive. It provides an opportunity for change agents and leaders in health and care to build their skills, confidence and networks for leading change. It is open to everyone and provides virtual learning sessions over six weeks in May and June (breaking for the half-term week).

    You can sign up by submitting your email address on the webpage.

    About the School for Change Agents

    The School for Change Agents builds change agency which is the power, individually and collectively, to make a difference. It is about pushing the boundaries of what is possible, mobilising others and making change happen more quickly.

    Often, being a change agent and challenging the status quo of the existing system can be a very lonely life. When you join the School for Change Agents, you become part of a community with like-minded people from across the globe. Many participants have described it as an extraordinarily empowering experience.

    In addition, the School’s curriculum has been externally evaluated by the Chartered Institute for Personnel and Development, and shown to deliver significant impact for both individuals and their organisations in terms of:

    • Knowledge and skills in leading change.
    • Building a sense of purpose and motivation to improve practice.
    • Ability to challenge the status quo and rock the boat without falling out.
    • Connecting with others to build support for change.

    The change skills that we teach in the School complement other methods and approaches such as quality improvement, Lean, programme management and culture change.

    Who takes part in the School for Change Agents?

    The School for Change Agents is relevant to everyone who wants to develop their knowledge and skills for making change happen. Many people from outside the usual definition of “health and care” join, including change agents from the police service, education, housing, local government and community activists. We are anticipating around 10,000 enrolments for the School for Change Agents 2019.

    The School is online, which means that anyone who has an internet connection, a headset or a phone can take part from wherever they are. No previous experience of digital learning is required.

    Key information about the School for Change Agents 2019

    Each Thursday we’ll run a live webinar session from 15.00-16.00 (BST). The sessions will be led by Helen Bevan and Kathryn Perera. These are the topics we will cover:

    • Change starts with me (Thursday 16th May, 15:00 BST)
    • Resilience is an act of defiance (Thursday 23rd May, 15:00 BST)
    • Purpose and power (Thursday 6th June, 15:00 BST)
    • Moving to action (Thursday 13th June, 15:00 BST)
    • Being a change agent in a complex world (Thursday 20th June, 15:00 BST)

    We know that not everyone will be able to attend the live sessions, so each session will be available for catch-up viewing at a time that suits you.

    In 2019, the live webinars will be supported by an e-learning platform, Futurelearn, delivered in partnership with the NHS Leadership Academy. The e-learning platform supports participants to connect with and learn from each other, as well as to deepen their understanding of the subjects covered in the live sessions.

    Continuing Professional Development

    The programme offers CPD points that can be claimed by a range of colleagues from doctors to finance specialists. We are also incorporating opportunities for nurses and other clinical professionals to use the School experience as part of their CPD reflective accounts for revalidation.

    The School is completely free at the point of use. For those participants who want to receive CPD accreditation as certificated change agents, we offer an upgrade option for a fee of £32 (GBP) via Futurelearn.

    Why not enrol as a group?

    Most people report that they get value from the School for Change Agents whether they join individually or as part of a group. However, there are particular benefits for those who join as a team or larger group. It gives you more opportunity to discuss your learning with colleagues, and it’s often easier to put the learning into action as a result. Typically, groups of participants agree a time to watch the live sessions together (whether live or on catch-up).

    We also offer additional benefits for groups of 50+ who want to upgrade their experience to claim CPD points through accreditation. Groups of 50+ participants can claim a discount on accreditation, making it the most cost-effective way to use the School for your continuing professional development needs.

    The lead organiser of groups of 50+ participants can also be granted access to bespoke reports, showing participant activity across the cohort. This can help you to track your group’s progress and arrange your own additional learning opportunities on topics of interest.

    Please join the School for Change Agents

    We hope you will join more than 15,000 people from 44 countries across the world who have become certified Change Agents through the School for Change Agents to date. The curriculum has been co-produced with School alumni, making it truly focused on the needs of health and care staff (in the widest sense), as well as patient and citizen leaders/activists.

    Registering is quick and easy – sign up via the website. If you know other people who might also be interested in the School, please do forward this email to them. Participants are connecting already via Twitter at @sch4change hashtag #s4ca, and through the School Facebook group.

    We look forward to welcoming you to the School for Change Agents 2019. If you have any queries, please contact Rosie Redstone at rosalind.redstone@nhs.net  or telephone 07730 374620.

  • New tool to support making Visible the ImpaCT Of Research – VICTOR (3/25/2019)

    In an attempt to navigate the busy landscape of research impact ideas in way that is a practical and pragmatic in an NHS setting,  a group of Trusts in Yorkshire and the Humber, supported by NIHR CLAHRC YH and NIHR YH CRN, have come together to create VICTOR (making Visible the ImpaCT Of Research). Victor is a tool which has been co-produced with NHS organisations to help identify and capture the impact of taking part in research within their organisation. VICTOR takes into account existing literature and the areas in which impact is important in the NHS. It sets out six domains of potential impact, and this information is collected by a questionnaire method, or by using the questionnaires to guide conversations. VICTOR enables engagement with research participants, professionals, managers and researchers to identify impact that has happened where it matters to them. VICTOR findings can be used to raise awareness of research impact in the NHS or across healthcare systems, and help plan for improved impact in future.

    Follow our website (http://clahrc-yh.nihr.ac.uk/victorimpact) and twitter (#VICTORImpact) to find out how others have used VICTOR.

    Those who have used the VICTOR tool have found it very helpful in uncovering impact of research in NHS organisations. With some beginning to use it as part of their governance and reporting processes, and to celebrate success.

    VICTOR is an actionable tool. It helps

    • NHS research teams identify and use stories of impact to feedback into their organisations
    • to plan further impact
    • to share impact case studies with partners, for example on CLAHRC projects and CRN impact case studies. It can be used as evidence in CQC ‘well led’ submissions.
    • to engender a research culture and capacity building. Seeing that research makes a difference is a mechanism for increasing capacity in organisations and individuals ( Cooke et al 2018)

    The tool was piloted across 12 Trusts and 24 case studies were created.  So far, Trusts have said that:

    • “Victor has been hugely helpful”
    • “Lots came up that we hadn’t expected”
    • “Seeing it written down was very powerful”
    • “Some of the case study information will go into a follow on funding bid”
    • “Encouraged reflection on challenges”
    • “Uncovering hidden impacts”
    • “We got a huge amount more information than we would have without the VICTOR structure. Without that we wouldn’t have got the detail”
    • “Patients wanted to give their views”
    • “Doing this helped build relationships between the clinical teams and research team”
    • “The Board loved the hexagons – a great visual summary”
    • “It captures people’s attention”
    • “It captured additional information that funders wouldn’t have got otherwise”
    • “I wish I’d had it at the beginning when I was designing the study”
    • “You don’t reflect very often and then you think wow, we did that”
    • “Very rewarding for staff (research and clinical)”
    • “It was an educational experience. That interaction has led to clinical teams being more aware of research and that hasn’t been obvious to me before”

    If you would like to request a pack so that you can use VICTOR in your own organisation, please contact Beth.Stevenson@sth.nhs.uk.

    VICTOR pack contents:

     How to use VICTOR. This section is for Impact Case Study Co-ordinators (ICC) to guide them through the VICTOR process.

     VICTOR Impact Questionnaire: Principal Investigator, Research Team, Research Manager and Industrial Partners. This is the questionnaire to be used with most stakeholders. It can be self-completed or used as a structured interview/ guided conversation to collect information.

     VICTOR Impact Questionnaire: Patient, Family and Carers. This questionnaire is for research participants and their family. We find this is best used as a structured conversation.

     Summary document. This is a document used by the ICC to pull out the most relevant material collected during the VICTOR process, and to summarise this. This section also includes a populated example of a summary document.

     Impact planning template. This can be used by the ICC in partnership with the research team to plan further action where needed, in order to promote more impact. This is used only when a need for further planning is thought to be useful.

  • Short format DSUR for Type A trials (3/22/2019)

    In line with efforts to support UK sponsors of clinical trials, the MHRA has recently made available a short format DSUR form for sponsors of individual clinical trials authorised under the Notification Scheme (Type A trials).

  • Brexit updates (3/22/2019)

    New updates have been added to the HRA website with key information about preparations for Brexit in the event of a no deal. Review the updates (including amendments) here

     

  • Setting up NHS/HSC research in the UK: A UK Local Information Pack will be introduced on 5 June 2019 (3/22/2019)

    Following previous communications in February, it is confirmed that a UK Local Information Pack will be introduced on the Wednesday 5 June 2019. From this date an Organisation Information Document will replace the current Statement of Activities used in England and Wales and the Site Specific Information form, used in Northern Ireland and Scotland.  After this date the Statement of Activities and Site Specific Information form will no longer be in use. The Organisational Information Document will be required as part of the UK Local Information Pack for commercial and non-commercial research. Researchers working with NHS/HSC organisations across England, Northern Ireland, Scotland and Wales will benefit from a consistent package to support study set-up and delivery across the UK.

    The Organisational Information Document template will be made available from end April 2019.  Regular communications and updates will be available on the Four Nations NHS/HSC Compatibility website

  • HRA Research Transparency (3/22/2019)

    The HRA has formed The Research Transparency Strategy Group, and is recruiting for a fixed term position to support the development of its Transparency strategy. Juliet Tizzard, Director of Policy, shall be presenting on this work at our conference in May

  • Results from a retrospective cross‐sectional study show patients admitted to more research‐active hospitals have more confidence in staff and are better informed about their condition and medication (3/22/2019)

    Jonker, Fisher and Dagnan,  Feb 2019, have published a new paper adding to the evidence that research active organisations contribute to better health and care.

  • CQC Inspection and Well-Led Research in NHS Trusts (3/22/2019)

    A briefing about the outputs from the work to establish research markers in CQC inspection has been published for the NHS R&D Forum and members will continue to support this so please do continue to share your experiences via kate.greenwood@rdforum.org.uk

     

     

  • NHS R&D Forum: Top Tips for EudraCT Reporting (3/22/2019)

    All Sponsors of CTIMPS are legally required to report the end of study summary on EudraCT. The Research Management working group has issued its top tips for Sponsors and R&D offices to help you work through these reporting obligations. Tips were collated by the group and expertly pulled together in an infographic by the chair Sally Humphreys

    EudraCT Twitter

  • NHS R&D Forum Response to the Mental Capacity Act Code of Practice Call for Evidence (3/22/2019)

    The Research Management Working Group contributed a response to the following call for evidence consultation: Revising the Mental Capacity Act Code of Practice

    Mental Capacity Act Code of Practice RMWG Response

  • Forum members respond to the Department of Health & Social Care (DHSC): In support of the Life Sciences Sector Deal 2: Plans for establishing 5 commercial centres for late phase commercial research. (2/22/2019)

    The NHS R&D Forum is committed to supporting the Life sciences Industrial strategy and to play our part in the Sector Deal 2, which includes supporting the development of some key initiatives within it. 
One of these initiatives is the introduction of 5 centres for late phase commercial research, which aim to enable the UK to deliver an ambitious increase in contract clinical research opportunities for patients. Our members and the organisations they represent welcome this.

    These 5 centres are expected to provide additional capacity and capability within the NHS/NIHR infrastructure to deliver exceptional service and fast study set up such that the UK is better able to compete for this research. It is hoped once the first 5 are established in England that additional centres will be enabled in the future across the UK.

    This paper, written by members, sets out a basic framework of principles aimed at ensuring that this new initiative derives success for all stakeholders and that patients and healthcare research benefit optimally.

    Final Forum Response to DHSC – In support of the Life Sciences Sector Deal 2. Implementing the 5 commercial centres Finalversion

  • January Newsletter 2019 (2/11/2019)
    Welcome to Forum January Newsletter

    Did you know?

    Our mission as a Forum is
     
    To enable:

    1. The R&D community (you, us and each other)
    2. Excellent research management, support and research leadership practice
    3. High value quality health & care research  
    4. Improved patient care

     As a professional community we work to ensure health & care research in our organisations is supported, well managed, and well led.
     
    Did you read…?

    • The government’s life sciences industrial strategy sector deal 2 with opportunities for research. Our Forum groups are working with partners to support some of the key deliverables around this second deal including contributing to community learning around novel research methods and providing feedback on the implementation of 5 centres for late phase commercial research   
    • Our December Forum newsletter. All news items remain on the Forum website here.

    RDF19: Early Bird Ends Tomorrow


    The programme is live. Early bird rate ends 31st January

    The early bird discount rate ends tomorrow for delegates attending RDF19 in Brighton from the 12-14 May. Demand for places this year has been overwhelming and the Main Conference Hotel is now almost fully booked. We are delighted to announce that we have secured a large number of rooms in the Jury’s Inn Waterfront Hotel. This hotel is located a very short walk from the Conference venue and is located on the seafront near Brighton Pier.

    Full details of the Programme, Posters, Exhibitors and Sponsors can be found on the Conference Website: Click here

    Over the coming weeks we will be providing numerous updates about RDF19 on social media. These will be on Twitter and LinkedIn so please ensure that you follow us on the links below. Please use the hashtag #rdf19 when using social media in relation to the conference. 
     

    Professional Learning & Development


    In response to demand we have added news dates to the calendar of courses. 
     
    AcoRD Master Class
    25th March, London 2019
    £330 No Vat 
     
    This course is for Sponsors and R&D office staff, Universities, non-commercial funders, finance teams, facilitators or grant advisors who are working with researchers on their cost attribution and completion of their SoECAT for funding applications.  
     
    Materials will contain all up to date information received from DHSC and the AcoRD specialist community so that Forum members are accessing consistent training.  As this is intended to be a master class members should have completed the NIHR e learning course and have some practical experience before attending.
     
    Click here for further information.

    Essentials of NHS Research 
    25th & 26th March, Bristol

    This is for all levels of role new to a health care R&D department, as well as colleagues in industry, academia and third sector that would like to better understand managing NHS Research. Content covers, understanding the landscape, policy, regulation, patient & public involvement, roles of R&D, capacity & capability, costing, AcoRD, contracts, safety, data, oversight, impact, strategy and more! 
     
    Click here for further information 
     
    Data Management in a Health Care Setting 
    3rd April, London

    NHS R&D Forum and the Association for Clinical Data Management (ACDM). All staff involved in the operational conduct or oversight of clinical research across NHS, academic and commercial research units including Data Managers, Study Monitors, Research Managers, Study Coordinators, Sponsor representatives and other site staff. It is particularly relevant to Sponsor teams and CTU staff. 
     
    Click here for further information 

    Archiving Masterclass
    13th June, London 

    An excellent course providing expert insight into the practicalities of research archiving procedures. Developed to support Research management teams with their processes for archiving this course is for anyone who has responsibility for archiving research in their organisation.

    Whether you are a named archivist or part of a team with delegated responsibility we hope that you will find this course useful. As with all Forum activities it is also a valuable opportunity to meet with your colleagues from across the country to discuss challenges and solutions.

    Click here for further information 
     
    Local Capacity and Capability for Research
    New date 24th June, London 
     
    Understand the requirements of an NHS organisation when determining whether to take part in a particular research study as a host. This course 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.
     
    The first half of the day concentrates on making delegates familiar with process. The second half is spent putting everything into practice working through an example study.
     
    Click here for further information 

    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

    Regulatory & Policy news:


    NHS England Long term plan is published 
     
    The NHSE Long Term plan is the plan for the NHS over the next 10 years with clear commitment that research will play its part in ensuring this is possible.
     
    There is recognition of our excellent capabilities for research and innovation across the UK and their importance in improving mortality rates in hospitals and driving forward future medical advance. There is a clear commitment to growing more commercial and collaborative R&D, more real world testing and the linking of data (genomic, clinical and patient), as well as ensuring the fast spread of proven innovations via colleagues in the AHSNs.
     
    A strong emphasis on prevention, primary care and mental health services shows the direction of travel and there is much in the plan around clinical priorities, enabling digital technologies and service re-designs.  
     
    How this will be implemented over time is the next step but research has a key part to play, is valued and very much part of the NHS of the future. 
     
    The plan sets out an expectation that:   

    • We increase the number of people registering to participate in health research to one million by 2023/24.
    • People will be able to view opportunities to participate and register their interest on the NHS App by 2020
    • Performance on adopting proven innovations and on research including in mental health services will become part of core NHS performance metrics and assessment systems, as well as benchmarking data

     
    Click here for further information

    Excess Treatment Costs update
     
    Forum members continue to provide feedback and views from both provider and commissioning perspective on the new ETC process as the pilot phase rolls out. It is however really important that queries or challenging impacts are captured so that the scale of the issue can be identified. Therefore please report issues via supportmystudy@nihr.ac.ukwhere they will be collected, coded and collated for review.

    The AcoRD Annex B FAQs have been updated by the Department of Health and Social Care to reflect the new arrangements for excess treatment costs, and are available to download from the NIHR website 

    Some additional updates have been made in connection with wider research delivery work, such as references to public health research.

    New guidance is available from Public Health England for Managing Excess Treatment Costs for Research into Public Health Interventions Commissioned by Non-NHS Organisations in England

    Link https://www.nihr.ac.uk/funding-and-support/documents/study-support-service/etc-public-health-research.pdf 

    To stay up to date with the new arrangements to better manage excess treatment costs, visit the dedicated NIHR webpage.            
     
    As more amendments to the system follow and payments start to be made, the NIHR webpage for ETCS will be updated. 

    Improving commercial clinical research set up

    The second of the new NHSE pilot schemes is to improve commercial clinical research set-up by implementing a standard costing methodology. As this rolls out Forum members are linked into the national oversight of this project. Email info@rdforum.org.uk with any comments or queries.

    Click here for further information 

    HRA latest on the implications of no-deal, guidance updated 11th Jan 

    Clinical research is one of 7 key areas of readiness that organisations must look at in preparation for Brexit.  Sponsors should refer to the latest HRA guidance on a no-deal Brexit. 

    Click here for further information

    Statement from the Association of British Insurers – Participation in clinical trials and travel insurance  

    The Association of British Insurers (ABI) have confirmed that participation in clinical trials does not affect eligibility criteria for travel insurance and have now withdrawn their guidance document “Clinical research trials and insurance”.

    Click here for further information 
     

    MRC Regulatory round up

    The MRC regulatory support centre have published their regulatory round up

    Click here to read

    Around the Forum


    New Forum guides published

    1. Service users as co-applicants, project leads and team members in research: A guide for research managers
     
    This publication is the result of work by members of the Forum service user and carer working group following their own personal experience
     
    This guide has been produced following extensive consultation across the NHS R&D Forum, and in conjunction with National Institute of Health Research (NIHR) INVOLVE and HRA, who have produced accompanying guidelines for researchers and the public.

    Click here for further information 

    2. Public co-applicants in research: guidance on roles and responsibilities.   
     
    New guidance has been published for public co-applicants in research from NIHR INVOLVE with the NHS R&D Forum and HRA. This guidance is intended to help:
     

    • Researchers wanting to include public co-applicants in a study 

    • Public contributors wanting to become a co-applicant 

    • Research staff who coordinate public involvement activities or advise on funding applications 


    Those working in or with research organisations to review or process research applications.

    Click here for further information 
     
     
    CHART: Community Health Care Alliance of Research Trusts in England

    On the 7th November 2018 The Community Healthcare Alliance of Research Trusts known as CHART held its launch. This was an NHS Community Trust initiative hosted by Birmingham Community Healthcare NHS Foundation Trust. The day was an enormous success with interactive discussions to plan the future and immediate next steps for the alliance.

    There was clear support from organisations and agreement in the benefit of connecting through an alliance. Opportunities to discuss the challenges experienced in community trusts, working to increase their research activity were made to speak to NIHR, CRN and AHSN with recognition of similarities across organisations. Next steps are being planned as we write, with an update soon. Exciting time for community trusts.

    Follow CHART on twitter @CommunityHART.

    If you are interested to know more about CHART or you want to become part of the alliance contact: Christine Burt Christine.Burt1@BHAMCommunity.nhs.uk and Lee Tomlinson: lee.tomlinson@nhs.net

    Calls from the community 



    CQC inspection and research. Experience from an NHS organisation.  

    Thank you to Iva Hauptmannova for writing up details of her recent CQC visit. You can down load this from our resources exchange. 
     
    We would like to continue to collate your experiences and so if you have anything to share with colleagues around the process then please send them to kate.greenwood@rdforum.org.uk
     
    Any top tips, preparation or lessons learned that might be useful please send them on. 

    New Resources this month


    New resources this month

    • Cumbria & North East Primary Care Research Strategy. NECS & NIHRCRN
    • Trust experience of CQC inspection
    • Developing a patient registry a practical guide: Medical Research Charities Group Ireland 
    • Updated IDEAL Framework: No surgical innovation without evaluation 
    • Draft ethics guidance for AI 

    View the latest additions to the Resource Exchange here

    Please send in your tools, resources and helpful links. You can submit them directly here or send to info@rdforum.org.uk. Just one resource from every organisation would really make a difference and help to keep us all current.

    Other News, Call & Funding 


    R&D Manager secondment opportunity to support delivery of the NHSE programme for Commercial Contract Research

    The NIHR CRN coordinating centre is looking to second an individual (2-3 days per week) to join the multi-agency team to lead on delivery of this high profile national project.  Remote working arrangements are possible, with occasional travel to London and/or Leeds based CRN or stakeholder offices.

    Click here for further information 

    NIHR Academy fellowship schemes 

    Research professorship schemes, Advanced Fellowships and Doctoral Fellowships available. Closing November/December.

    Click here for further information 

    New scheme for bringing consultants back into research

    MRC & NIHR launch the Clinical Academic Research Partnership (CARP) scheme. By supporting NHS consultants to partner with outstanding research groups, CARP will contribute to the people and skills needed for the future: ‪https://mrc.io/2RoJYPP 

    NIHR Funding Opportunities 

    Health & Care Research Wales Funding Opportunities 

    Research Fish submission window opens 4th Feb – 14th March 2019. 

    Organisations that host NIHR research and personal awards (not infrastructure awards) are required to report annually through Research fish whilst the award is active and for 5 years after completion.  
     
    The next submission window will open 4th February and close 4pm 14th March 2019 and so if you host awards there are a number of things you should do next.
     

    Latest Jobs


    There are lots of new jobs this month – see here.
    Please submit your latest vacancies and we will also tweet them out. 

  • 2 new guides published in partnership for service users as co-applicants, project leads and team members in research (1/30/2019)
    1. Service users as co-applicants, project leads and team members in research: A guide for research managers (NHS R&D Forum)

    This publication is the result of work by members of the Forum service user and carer working group following their own personal experience

    This guide has been produced following extensive consultation across the NHS R&D Forum, and in conjunction with National Institute of Health Research (NIHR) INVOLVE and HRA, who have produced accompanying guidelines for researchers and the public.

    Anne-Laure Donskoy,  Penny VIcary and  Virginia Minogue have led this work on behalf of the Forum and the working groups.

    SUC Co-applicancy Project lead and Collaborator Guidelines

    1. Public co-applicants in research: guidance on roles and responsibilities (NIHR INVOLVE)

    This new guidance has been published for public co-applicants in research from NIHR INVOLVE with the NHS R&D Forum and HRA.

    This guidance is intended to help:

    • Researchers wanting to include public co-applicants in a study
    • Public contributors wanting to become a co-applicant
    • Research staff who coordinate public involvement activities or advise on funding applications
    • Those working in or with research organisations to review or process research applications.

    NIHR Involve guidance on Public Co-applicants in Research – Guidance on Roles & Responsibilities

    Any comments or ongoing feedback please email info@rdforum.org.uk

     

  • Statement from the Association of British Insurers -Participation in clinical trials and travel insurance (1/24/2019)

    Statement from the Association of British Insurers -Participation in clinical trials and travel insurance 

    The Association of British Insurers (ABI) have confirmedthat participation in clinical trials does not affect eligibility criteria for travel insurance and have now withdrawn their guidance document “Clinical research trials and insurance”.

    ABI agree that taking part in a clinical trial should not affect insurance cover if the medical condition itself doesn’t. Please share the following message with your teams, organisations etc.

    ‘When individuals apply for travel insurance, insurers will typically ask questions about an individual’s health in order to make an accurate risk assessment. This risk assessment takes into consideration the health of the individual and the insurer will often ask questions about any pre-existing health conditions and medical treatments for those conditions. Travel insurers do not typically ask about clinical research trials. Where an insurer does ask an individual about their participation in clinical research trials, the insurer must ensure the question is clear and the individual should answer it accurately and honestly”.

    https://www.abi.org.uk/

  • HRA latest on the implications of no-deal, guidance updated 11th Jan (1/24/2019)

    Clinical research is one of 7 key areas of readiness that organisations must look at in preparation for Brexit.  Sponsors should refer to the latest HRA guidance on a no-deal Brexit.

    link here for further information

  • Improving commercial clinical research set up (1/24/2019)

    The second of the new NHSE pilot schemes is to improve commercial clinical research set-up by implementing a standard costing methodology. As this rolls out Forum members are linked into the national oversight of this project. Email info2rdforum.org.uk with any comments or queries.

     

    Link here for further information

  • Excess Treatment Costs update (1/24/2019)

    Forum members continue to provide feedback and views from both provider and commissioning perspective on the new ETC process as the pilot phase rolls out. It is however really important that queries or challenging impacts are captured so that the scale of the issue can be identified. Therefore please report issues via supportmystudy@nihr.ac.ukwhere they will be collected, coded and collated for review.

     

    As more amendments to the system follow and payments start to be made, the NIHR webpage for ETCS will be updated. It is a little difficult to find this page easily so we have created an easy link from the main Forum homepage here.

  • NHS England Long term plan is published (1/24/2019)

    The NHSE Long Term plan is the plan for the NHS over the next 10 years with clear commitment that the NHS will play its part in ensuring this is possible.

     

    There is recognition of our excellent capabilities for research and innovation across the UK and their importance in improving mortality rates in hospitals and driving forward future medical advance. There is a clear commitment to growing more commercial and collaborative R&D, more real world testing and the linking of data (genomic, clinical and patient), as well as ensuring the fast spread of proven innovations via colleagues in the AHSNs.

     

    A strong emphasis on prevention, primary care and mental health services shows the direction of travel and there is much in the plan around clinical priorities, enabling digital technologies and service re-designs.

     

    How this will be implemented over time is the next step but research has a key part to play, is valued and very much part of the NHS of the future.

     

    The plan sets out an expectation that:

     

    • We increase the number of people registering to participate in health research to one million by 2023/24.

     

    • People will be able to view opportunities to participate and register their interest on the NHS App by 2020

     

    • Performance on adopting proven innovations and on research including in mental health services will become part of core NHS performance metrics and assessment systems, as well as benchmarking data

     

    Link: https://www.longtermplan.nhs.uk/online-version/

  • December Newsletter 2018 (1/3/2019)

    Did you know?
     
    The Forum is…

    • Made of individuals from the research management, research support and research leadership community who work in, with and for providers and commissioners of health and care across the UK
    • Inclusive of service users and carers, individuals from partner organisations and universities and staff from non-traditional NHS settings. 
    • Free to join. Some members are very active taking part in working groups on behalf of others.
    • A professional network & community of practice

    Our Goals are:

    • To make a difference – enabling high value, quality health research.
    • That Community members engage and value the Forum
    • That Partner organisations value our voice and our contribution 
    • That we are financially sustainable

    Our goals will be met by working together to deliver our strategic aims. These are to collectively:

    • LEAD – Driving solutions to problems & setting standards
    • SHAPE – Influencing policy makers and partners as a professional voice 
    • HELP – Supporting each other in our daily roles
    • CONNECT – Bringing members together from across the UK
    • THRIVE – As both a network and a community 

    Did you read…?

    The Forum Strategy Document 2017-2022

    Link here for further information

    The non-commercial sponsors symposium slide set and mind maps 

    Link here for further information 

    2019 Annual NHS R&D Forum Conference Update 


    Final Call for Posters. Deadline for abstracts by 31st December 
     
    The poster zone is one of the most popular places during the annual conference. We hope next year will be as vibrant as ever so please submit and give yourself the opportunity to win an RDF19 poster award. Previous posters can be viewed on the conference website.
     
    The programme committee is keen to promote submissions from all organisations and roles and from across the whole of the UK. Thank you for all the brilliant abstracts for oral presentation, the programme group are reviewing them now.
     
    Link Here

    Professional Learning & Development


    New Spring AcoRD Master class. 
    25thMarch, London 2019
    £330 No Vat 
     
    Using materials agreed with the members of the DHSC non-commercial costing group this new important 1-day course will take an in-depth look at the AcoRD guidance and attribution in practice. 

    1. Understand and apply AcoRD guidance correctly
    2. Understand the processes used for capturing all types of cost attribution including how these processes relate to external funding and other supported tools (e.g. Schedule of Events Cost Attribution Tool  (SoECAT), the NIHR Annual Allocation, Specialist Commissioning etc) 
    3. Appreciate attribution in the wider context including roles and responsibilities, NHS commissioning and the research management process.

    This course is for Sponsors and R&D office staff, universities, non-commercial funders, finance teams, facilitators or grant advisors who are working with researchers on their cost attribution and completion of their SoECAT for funding applications.  
     
    Materials will contain all up to date information received from DHSC and the AcoRD specialist community so that Forum members are accessing consistent training.  As this is intended to be a master class members should have completed the NIHR e learning course and have some practical experience before attending.
     
    Link here for further information

    New Course:  Local Capacity and Capability for Research
    February 4th, London  
     
    The learning & development group are delighted to launch this new 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.
     
    The first half of the day concentrates on making delegates familiar with process. The second half is spent putting everything into practice working through an example study.
     
    Link here for further information

    Essentials of NHS Research 
    25th& 26th March, Bristol

    This is for all levels of role new to a health care R&D department, as well as colleagues in industry, academia and third sector that would like to better understand managing NHS Research.Content covers, understanding the landscape, policy, regulation, patient & public involvement, roles of R&D, capacity & capability, costing, AcoRD, contracts, safety, data, oversight, impact, strategy and more! 
     
    Link here
     
    Data Management in a Health Care Setting 
    3rd April, London

    NHS R&D Forum and the Association for Clinical Data Management (ACDM). All staff involved in the operational conduct or oversight of clinical research across NHS, academic and commercial research units including Data Managers, Study Monitors, Research Managers, Study Coordinators, sponsor representatives and other site staff. It is particularly relevant to Sponsor teams and CTU staff. 

    link here

    Regulatory & Policy news:

    New December briefing note and communication issued by NHSE for ETCS 

    There are a number of changes in the way CCGs, NHS England Specialised Commissioning and NHS providers are expected to manage excess treatment costs (ETCs) related to non-commercial research.

    Link here for further information 

    Title: Updated AcoRD Annex B: FAQs have now been published on the NIHR website:
     
    Link here for further information 

    The Government publishes 2nd Life Sciences Sector Deal with support for clinical research in the NHS. 
     
    The Forum welcomes publication of this second sector deal and specifically the role of the NHS, clinical trials, research and data valued within it. This deal represents the commitment that the life sciences industry makes in partnership with Government in order to meet the ambitious goals within the life sciences industrial strategy itself.
     
    We look forward to supporting the implementation of this deal. Working with partners the Forum has committed to supporting delivery of the deal as part of the skills package for novel and innovative trials, embedding this within our work and activities in 2019. 

    Professor Chris Whitty and Emma Lowe discuss the deal here in an article for the Pharma Times 

    Link to the article
     
    Link to the Sector Deal
     
    Link to the Life Sciences Industrial Strategy

    Link here for further information 

    Academy of Medical Sciences report published “Our data driven future: People and partnerships at the heart of health related technologies”

    This report published by the academy outlines a set of principles based on dialogues with patients, the public and healthcare professionals, for the development, evaluation and deployment of data-driven technologies in healthcare. 

    Link here for further information
     
    ICO issues new data guidance in preparation for Brexit
     
    The Information Commissioners Office has issued new data guidance to help organisations prepare for ‪Brexit. The HRA news has further information and links to their GDPR webpages
     
    Link here for further information
     
    NICE publish Evidence standards framework for digital health technologies
     
    Nice have developed a set of standards to ensure new technologies are clinically effective and offer economic value.
     
    The aim of these standards is to make it easier for innovators and commissioners to understand what good levels of evidence for digital healthcare technologies look like, while meeting the needs of the health and care system, patients, and users.
     
    Link here for further information
     
    Prof Jonathan Montgomery to become Chair of Oxford University Hospitals NHS Trust
     
    Congratulations to Prof Jonathan Montgomery who has been appointed chair of the Oxford University Hospitals NHS Trust, taking over from Dame Fiona Caldicott when she steps down in March. Arrangements for his current post at the HRA will be made clearer in the New Year. Jonathan will be in conversation with Dame Fiona at our annual conference in Brighton – a plenary session certainly not now to be missed. 
     
    Link 

    Results of the HRA Transparency in Research Survey are Published
     
    As discussed at the Forum non-commercial Sponsors symposium systems for ensuring research transparency must span the life cycle of a project. 
     
    The four pillars of research transparency described are:
     

    • Registering research
    • Publishing and disseminating findings and conclusions
    • Giving access to the data and tissue used in the research
    • Giving information at the end of research to participants

     
    The survey explored current knowledge, progress in delivering transparency and feedback on what helps and what hinders.
     
    Link to further information 

    You can continue to feed into the survey the ongoing work on transparency here
     
    Link here for further information
     
    Research Fish submission window opens 4th Feb to 14th March 2019. Understanding the Impact of NIHR investment in Research 
     
    Organisations that host NIHR research and personal awards (not infrastructure awards) are required to report annually through Researchfish whilst the award is active and for 5 years after completion.  
     
    The next submission window will open 4th February and close 4pm 14th March 2019 and so if you host awards there are a number of things you should do next.

    Link here for further information

    Around the Forum

    Forum R&D Contacts Directory has an important role
     
    Policy makers and research Sponsors use the information in the Forum R&D contacts Directory to send important information to organisations via their R&D departments. This month, for example, the NIHR CRNCC has used the listing to contact some Sponsors about their studies to complete remaining ETC study values in CPMS. 
     
    We are getting some Directory email addresses bouncing back and so please help us to keep this valuable resource up to date by checking your organisations details, junk mail and updating your email address where necessary.
     
    Link here for further information 

    Forum Working Groups 
     
    This month members of the Forum have represented the community on partnership groups including the NHSE ETC feedback group, cCOG, HRA projects board & informal learning group.  Members were also invited to attend the RQA and UKRD summit, which was invaluable for strengthening relationships
     
    Working group meetings saw discussions with policy makers, including DHSC on the following: 
     

    • The Life sciences sector deal, including 5 centers for commercial research 
    • RCF funding 
    • The use of the SoECAT as an attribution tool
    • Quality of information to R&D offices from Sponsors
    • Evidence for commissioners
    • Amendments 
    • Finance & Metrics 

     
    We helped to organise and host an AcoRD specialist-training day with the NIHR CRN, NIHR funders and representatives from across the Devolved Administrations enabling feedback and FAQS to be collated. 
     
    Members continue to keep a Strategic watch on the landscape to help prioritise areas of importance to the R&D community.  
     
    Work on outputs around adding value in research, non-disclosure agreements for commercial contract studies, Sponsorship, guidance for research managers around Service user and carers as co-applicants, training and conference planning continue.

    HRA webinars of interest 
    10th January 2019
     
    The HRA are running a couple of useful webinars on the 10th January including:

    • Applying for HRA approval ‘Getting applications right first time’ 
    • Understanding GDPR in relation to Health Research in the UK 
    • Managing your approval

    Link here 
     


    Calls from the community 


    Share your experiences of CQC inspection and research 
     
    We would like to collate experiences of CQC inspection under the new framework including research. 
     
    If you have anything to share with colleagues around the entire process then please send them to kate.greenwood@rdforum.org.uk
     
    Any top tips, preparation or lessons learned that might be useful please send them on. 
     
    The inspection framework and NIHR links for further information are here: 
     
    Link here for further information
     
    Link here for further information

    Please send in your tools, resources and helpful links. You can submit them directly here or send to info@rdforum.org.uk. Just one resource from every organisation would really make a difference and help to keep us all current.

    New HRA bite sized e learning for students and their supervisors/sponsors
     
    These helpful packages aim to improve the information provided to those students and supervisors who might be new to the processes in order to support them and avoid common errors. 
     
    Share these with student researchers and universities and to help them navigate the requirements to undertake research in NHS. 
     
    Link here for further information

    Other News, Call & Funding 


    NIHR National survey for patients, carers, service users and the public involved in designing NIHR research/work to feedback on what it was like 

    This survey is for patients, service users, carers or members of the public who have been involved in NIHR’s work including: At an NIHR centre or facility. As a member of a local advisory group. Reviewing research applications. Being a co-applicant on a research study. Helping design, deliver and disseminate a research project as a Patient Research Ambassador

    The survey is not about people’s experience of being a participant in a research study.

    Please promote this survey or take part

    NIHR Academy fellowship schemes 
     
    Research professorship schemes, Advanced Fellowships and Doctoral Fellowships available. Closing Nov/Dec 
     
    Link here for further information 
     
    NIHR Funding Opportunities 

    Link here for further information

    New scheme for bringing consultants back into research
    MRC & NIHR launch the Clinical Academic Research Partnership (CARP) scheme. By supporting NHS consultants to partner with outstanding research groups, CARP will contribute to the people and skills needed for the future: ‪https://mrc.io/2RoJYPP 
     
    Health & Care Research Wales Funding Opportunities 
     
    Link here for further information 

    Latest Jobs


    There are lots of new jobs this month – see here.
    Please submit your latest vacancies and we will also tweet them out. 

  • The Government publishes 2ndLife Sciences Sector Deal with support for clinical research in the NHS.  (12/20/2018)

    The Forum welcomes publication of this second sector deal and specifically the role of the NHS, clinical trials, research and data valued within it. This deal represents the commitment that the life sciences industry makes in partnership with Government in order to meet the ambitious goals within the life sciences industrial strategy itself.

    We look forward to supporting the implementation of this deal. Working with partners the Forum has committed to supporting delivery of the deal as part of the skills package for novel and innovative trials, embedding this within our work and activities in 2019.

    Professor Chris Whitty and Emma Lowe discuss the deal here in an article for the Pharma Times 

  • New December briefing note and communication issued by NHSE for ETCS (12/20/2018)

    There are a number of changes in the way CCGs, NHS England Specialised Commissioning and NHS providers are expected to manage excess treatment costs (ETCs) related to non-commercial research.

    The response to the consultation, Supporting research in the NHS, set out how NHS England, the National Institute for Health Research, the Department of Health and Social Care and the Health Research Authority, working together, would implement changes to simplify arrangements for managing ETCs. These can be found here.

    The new system is aimed at making it simpler and less bureaucratic for ETCs to be identified and reimbursed, which should be better for everyone involved, and we are currently in a pilot phase (until March 2019) to test the new model.

    Download the latest briefing on new arrangements for ETCs. Please note on P2, Para 3 that a formal letter was sent to NHS provider trust Directors of Finance on 5 November
.

     

  • November Newsletter 2018 (11/29/2018)
    Welcome to the November Newsletter

    Did you know?

    • Members are supporting the partnership group led by NHSE and the Department of Health and Social Care, providing feedback from the community on the new system for the management of ETCs. 
    • We are collaborating with partners across the 4 UK Nations to host an AcoRD master class in December for existing AcoRD specialists by invitation only. The materials from this course will be DHSC approved to form a new NHS R&D Forum course open to all R&D staff in the spring.  
    • The Forum Directory is now open to University and other non-commercial Sponsors or R&D offices supporting the running of health research.  The Directory hosts R&D office contacts and is used by researchers and policy makers to contact R&D teams and the NIHR NETSCC team will use it to contact members about impact submissions through Researchfish and so please promote this facility to all. 

    Did you read…?

    • The Forum response to the DHSC RCF consultation, submitted in November 2017. Link for further information  The outcome of the review has just been published (see regulation and policy news below)
    • The slides from our Embedding Research Strategy and Culture in an Health Care Setting  Link for further information 

    2019 Annual NHS R&D Forum Conference Update 


    Call for abstracts – only a few days to go! 

    Oral abstracts by 1st December. Poster abstracts by 31st December.


    Abstracts are absolutely critical to the Annual Forum conference. They ensure content is current and help to spread knowledge, innovation and learning. 
     
    The programme committee are looking for oral and poster presentations that relate to the process, the structure, improving efficiency, improving quality, promoting best practice or adding value in R&D studies, teams, departments or organisations. Please rally your colleagues and teams to submit. It is a great experience and keeps our community connected and current. 

    Link for further information 

    Exhibitor Update

    Exhibitor Zones A and B1 are sold out and stands are being booked in both remaining Zones B2 and C. We are pleased to welcome One Research and ThinkWrite as new exhibitors. You can see the list of current exhibitors here and information on sponsorship and exhibition stand booking can be found here.

    Professional Learning & Development


    New Course: Local Capability & Capability for Research
    February 4th London 

    The learning & development group are delighted to launch this new 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.

    The first half of the day concentrates on making delegates familiar with process. The second half is spent putting everything into practice working through an example study.Further details here

    Regulatory Inspection Ready
    Leicester, 29thJanuary 2019


    This 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.
     
    Further details here

    Essentials of NHS Research 
    25th& 26thMarch, Bristol


    This is for all levels of role new to a health care R&D department, as well as colleagues in industry, academia and third sector that would like to better understand managing NHS Research.Content covers, understanding the landscape, policy, regulation, patient & public involvement, roles of R&D, capacity & capability, costing, AcoRD, contracts, safety, data, oversight, impact, strategy and more! 
     
    Further details here

    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

    Regulatory & Policy news:


    Outcome of the DHSC RCF funding review

    A letter has been sent to RCF recipient Finance Directors confirming the outcome of the RCF review. This letter, Q&A’s and scenarios illustrating the financial impact of planned future RCF policy from 2019/20 can be found on the RCF page on the NIHR website. If you have any questions relating to these forthcoming changes, please email them directly to claire.owen@dhsc.gov.uk

    Link For Further Information

    House of Commons Science and Technology Committee Report on Research Integrity plus HRA Statement 

    An important report has been published by the House of Commons Science and Technology Committee and expresses concern that nearly half of clinical trials fail to publish their results. The Committee is calling for increased transparency and for the HRA to put measures in place ensure Sponsors improve reporting rates. Read the report and HRA responses here. 
     
    Link For Further Information HRA launch Phase 2 Radiation Assurance 

    Following the successful roll-out of Phase 1 of Radiation Assurance and a subsequent period of reviewer recruitment, the HRA have opened Phase 2 of Radiation Assurance on Monday 12 November to all studies involving cardiology, neurology or rheumatology taking place in the NHS/HSC. Oncology studies will also still be accepted for review during Phase 2.

    Link Here for Further Information 

    Understanding the Impact of NIHR investment in Research 
    Organisations that host NIHR research and personal awards (not infrastructure awards) are required to report annually through Researchfish whilst the award is active and for 5 years after completion.  The next submission window will open 4thFebruary and close 4pm 14thMarch 2019 and so if you host awards there are a number of things you should do next.

    Link For Further Information 

    MRC regulatory support centre update 
    The MRC regulatory support centre has published its quarterly update, which you can read here. 

    Link For Further Information 

    Research is now included in the CQC inspection framework for Trust-wide, well-led key question 

    The Care Quality Commission have published the Well-Led Inspection Framework for NHS Trusts and Foundation Trusts and Research is now recognised in W8 (p22-24). A dedicated webpage of FAQs and updates is available on the NIHR website.

    Link Here For Further Information 

    The well-led inspection framework can be accessed via the web address below. W8 p22-24:Are there robust systems and processes for learning, continuous improvement and innovation?

    Link Here For Further Information

    Around the Forum


    Slides & blog summary from the Non-Commercial Sponsors Symposium 

    On the 8thNovember 2018 we hosted the first NHS R&D Forum non-commercial Sponsors Symposium. The event brought together 95 Sponsors from across the NHS and HEI sectors and, it turned out, from across the world as we had Sponsor representation from the University of Auckland. Policy makers, CTU and funding partners, regulators, patients and researchers joined for a days exploration and sharing about what a good, non-commercial Sponsor looks like including some of the hot topics coming up for Sponsors right now. 

    The mind maps, collated thoughts from the day and do not reflect any agreed process, however the Non-commercial Sponsors working stream are committed to now working them up into a process for all. 
     
    Link For Slides Sheffield Teaching Hospitals Research & Innovation Conference 2018 – sharing our experience

    The R&I team at Sheffield Teaching Hospitals have written up their experience of running a research conference for the first time, including some top tips for others embarking on a similar journey. 

    Link Here For Further Information

    Have Your Say



    What are your thoughts on Amendments? 

    We are interested to hear from R&D departments on their experiences around the management of amendments, particularly any issues affecting timely implementation.

    Your views are still wanted on the local information submitted to R&D offices in England.

    These items will be discussed with the HRA at our next Research Management working group on December 11thso please feedback your thoughts to kate.greenwood@rdforum.org.uk by December 9th
     
    Please continue to feed your views on anything of interest or challenge to info@rdforum.org.uk or kate.greenwood@rdforum.org.uk

    New Resources this month


    1. SOP for Registering and Reporting Research in a publicly accessible database. (NHS Tayside and Dundee University)
    2. Sponsorship procedures from North Bristol NHS Trust (NBT) on 
      1. Vendor Pre-qualification questionnaire 
      2. Setting up new studies where NBT are the Sponsor
      3. Sponsor Risk Assessment
    3. Vivli: A Global clinical data sharing platform. 
    4. MRCCTU Induction Pack for PPI Contributors on Trial Oversight Committees
    5. UKRIO & Royal Society, Integrity in Practice toolkit
    6. MHRA Sponsor oversight blog 2
    7. MHRA blog. Making GCP training relevant
    8. HQIP: A Guide for Clinical Audit, Research and Service Review — An educational toolkit designed to help staff differentiate between clinical audit, research and service reviewactivities 
    9. Consort statement for reporting step wedged trials 
    10. Teachers of evidence based health care:  Teaching Tips – Teaching randomisation 
    11. Kristina Staley Series of blogs on PPI in research: Time for a new direction 
    12. Bella Starling Blog: Growing pains (or growth and leadership in public engagement with research) 
    13. New BMJ paper: Research Waste is still a scandal 


    View the latest additions to the Resource Exchange here
     
    Please send in your tools, resources and helpful links. You can submit them directly here or send to info@rdforum.org.uk. Just one resource from every organisation would really make a difference and help to keep us all current.

    Other News, Call & Funding 


    NIHR Academy fellowship schemes 

    Research professorship schemes, Advanced Fellowships and Doctoral Fellowships available. Closing Nov/Dec.

    Link For Further Information 
     
    NIHR Funding Opportunities 

    Link Here For Further Information

    Latest Jobs


    There are lots of new jobs this month – see here.
    Please submit your latest vacancies and we will also tweet them out. 

  • Outcome of the DHSC RCF funding review (11/28/2018)

    A letter has been sent to RCF recipient Finance Directors confirming the outcome of the RCF review. This letter, Q&A’s and scenarios illustrating the financial impact of planned future RCF policy from 2019/20 can be found on the RCF page on the NIHR website. If you have any questions relating to these forthcoming changes, please email them directly to claire.owen@dhsc.gov.uk

    Link For Further Information

    Here is the link to our original Forum response:

    http://www.rdforum.nhs.uk/content/wp-content/uploads/2014/07/FORUM-RCF-Response-VERSION-2.0-10th-November-2017.pdf

  • Non-Commercial Sponsors Symposia Output (11/28/2018)

    Slide Set from the Non-Commercial Sponsors Symposium – November 8th 2018.

    Good & compliant Sponsorship – #noncomsponsors

    95 Sponsors gathered from across the NHS and HEI sectors for this inaugural event bringing the non-commercial Sponsorship community together. Policy makers, CTU and funding partners, regulators, patients and researchers joined for exploration and sharing about what a good Sponsor looks like including some of the hot topics coming up right now

    The full slide set and mind maps are shown below:

    Presentation Slides

    Mind Doodle Blog

    https://minddoodle.com/blog/mapping-project-journeys-at-nhs-symposium

    Mind Doodle Output (click on images for full size output)

    Non-Commercial Sponsors Symposium Mind Doodle 2

    Non-Commercial Sponsors Symposium Mind Doodle 3

    Please note the mind maps were created to capture thinking on the day and will be worked on further by work stream members. If you have comments to make feed them into info@rdforum.org.uk

    A diverse community

    The non-commercial Sponsors community is diverse. Experience and expertise varies and can depend on type of organisation, balance of research portfolio and organisational maturity in terms of research development capacity and capability. Some work closely together as Joint offices or with CTU partners and others have developed more capability ‘in house’.

    This diversity makes for energetic exchange at events like this but has perhaps also meant that training and development opportunities to suit all have been harder to come by.  As Professionals working in an ever-changing environment we must therefore build understanding as we go and lead the way ourselves.

    Leading the way as a community of practice

    Learning from peers is powerful and, if open and diverse, arguably better than many other means. The non-commercial Sponsors community has a wealth of expertise and in joining together at least once a year we hope this will continue to build.

    University and other non-commercial Sponsors can now upload their details onto the Forum R&D Contacts Directory, in the hope that we can create visibility of all working in and for health research. This will not only support research teams to make contact directly with Sponsors but also support Sponsor representatives making connections with each other. Please promote this facility provided for all.

    The NHS R&D Forum non-Commercial Sponsors work stream will work in close partnership with the HRA non-commercial Sponsors reference group to continue to take work forward.

    If you have views on what our priorities should be or you want to take part, please let us know via info@rdforum.org.uk.

    In the first instance we shall be working up the initial mind maps we collated on the day, to publish something more streamlined for all.

    Knowledge exchange

    As a community, the sharing of resources can be supported via submitting to our exchange where there are over 500 tools, templates, SOPS and links, with 45 under keyword search “Sponsor” – alone.

    New resources have been uploaded since the symposium on request for tools supporting vendor pre-selection and risk assessment.

    Resource Exchange can be accessed here

     

     

     

  • Sheffield Teaching Hospitals Research & Innovation Conference 2018 (11/26/2018)

    Sharing our experience

    Thursday 20thSeptember 2018 – the day that saw ~170 delegates attend the first Sheffield Teaching Hospitals Research & Innovation Conference! It felt like it had been a long road to get to that stage; the suggestion of holding a research conference was first mooted towards the end of 2017.

    Until then, it had always been an idea for the future, a bit of an “if only”, but really, in the year the NHS was turning 70, there was no better time to bite the bullet and try and make the vision a reality! We thought it would be the ideal arena for showcasing the wide variety of outstanding research being conducted across the Trust by researchers at all career stages. Ultimately we hoped it could provide a platform for networking and forging future collaborations among our researchers that will improve the health and care of patients.

    In the run up to the day, despite months of planning, it did feel a bit reminiscent of finishing your PhD – you think you’re almost done, but you can never anticipate how long those last few bits will actually take to do!  Now, more than a month on we’ve had time to sit down and reflect, review the feedback, and learn from our experience.

    We know there are many Trusts who have held research conferences, but there may be others who have aspirations to, but don’t know where to start; so we’ve documented some of our reflections/top tips on the process of planning and holding a research conference in the hope that our thoughts and experiences may provide some inspiration.

    As with most things in research, see what’s been done before and identify if there is a need

    Be clear on who the conference is aimed at(in our case, it was all about broader staff engagement in research)

    We circulated a survey to gauge the level of interest from staff involved in research in any capacity to determine what type of event and content people wanted to see. (Within several days we had received 100+ responses with 97% wanting a conference! Happily, the format, content, and mix of speakers that the potential audience would be interested in was broadly what we had in mind, so we at least felt like we were on the right track).

    See what resources are available that can aid planning.

    Our first port of call was the resource exchange on the NHS R&D Forum website (naturally!), and other Trust R&D websites; what was clear very quickly was that there is no one size fits all. There were a wide variety of examples of conference size/topics/speakers etc. – You just have to do what’s right for your intended audience.

    When you ask for help, it’s amazing how supportive people are.

    We were inundated with offers to join our conference planning group and in the end, had to restrict it to one individual per staff group; this ensured a wide mix of opinions and what we collectively considered a more balanced agenda suitable for a wide range of health professionals.

    Remember social media and the brilliant R&D community

    We turned to Twitter to see if anyone could offer any pearls of wisdom about organising a research conference. Rachael Dowling, the Communications Lead at Leicester BRC answered our plea and gave us some helpful advice prior to their first conference (Incidentally, we finally had the pleasure of meeting face to face at the recent NHS R&D Forum symposium in Birmingham!).

    At the outset, be clear on who needs to be involved in the planning and/or delivery of the conference, and set clear timelines of what needs to be achieved and when. Early on we drew up a list of the support services and NIHR infrastructures hosted at our Trust who we wanted representation from, and we invited them to be involved with plenty of notice.

    It probably goes without saying but plan and keep a record of meetings/discussions

    Write detailed, informative meeting minutes. This is crucial; we referred back to these a lot over the course of planning the conference to confirm the decisions made. Delegate tasks where necessary and follow up on all actions points from meetings to ensure nothing falls by the wayside.

    Be ambitious, but realistic

    Don’t try to cram too much into the programme – and leave ample time for breaks, whatever you think is ok – make it longer! People want to have time to network, view posters, visit stands and importantly – get some coffee and lunch!

    We had 4 parallel breakout sessions (each run twice) in the afternoon covering a wide variety of topics; however there were so many more topics that could have been covered. In hindsight, 4 was reasonable – the topics were sufficiently varied, and the logistics of finding people/equipment/resources for the delivery of these sessions was manageable.

    Spreading the word

    If you are using Twitter, make a conference hashtag early on and make it short, simple and catchy. Like the R&D Forum, we put the year in our hashtag so that we could just change the year in future if we decide to make this an annual/bi-annual event

    Promote as wide as possible through a variety of channels to ensure as many staff groups have the opportunity to attend

    Make a Twitter story of all the tweets after the event, this is a fun way to reflect on the day, and share it with others who couldn’t be there – here is ours from Wakelet – https://wakelet.com/wake/4813bc1c-12ae-4e89-93a1-bdabdcfc1e47

    Timelines

    Identify and invite any reviewers required for abstract submissions with plenty of notice, and ensure sufficient time is left for scoring these so that successful presenters have time to prepare posters/slides.

    Request oral presentations to be submitted with plenty of notice so that these can be loaded onto laptops etc. in advance of the conference…but be prepared you will likely still be chasing the odd one up on the morning of the conference!

    7 months is sufficient to plan a conference for ~170 delegates, however, during the final couple of months, time spent on preparations increased substantially so be prepared for a shift in work priorities. On reflection we would plan at least nine months in advance for any conference with 150+ delegates; even then, it is still highly likely that the conference will completely take over in the final month, so make allowances for that!

    Some final tips

    IT equipment – check you can get the required cables to link up old projectors with modern laptops! Follow up with any suppliers in the weeks/days before the event to confirm venue location and timings

    Last minute panics…

    With the best will in the world, however well you plan, it’s probably inevitable that something unexpected may crop up that will send your stress levels through the roof! But – with a good team around you with people willing to help, a last minute hiccup can be overcome. As for what our last minute panic was, well…that would be telling.

    As for what our last minute panic was, well…that would be telling! I think it’s safe to say, we actually thoroughly enjoyed planning this conference and learnt so much along the way. Even with a few challenges thrown in, it was worth every second of it given the palpable enthusiasm and buzz from a room jam packed with delegates, and the positive feedback from inspired researchers afterwards. Here’s to the next…!

  • MRC regulatory support centre update (11/26/2018)

    The MRC regulatory support centre has published its quarterly update, which you can read here.

    MRC regulatory support centre update

     

     

  • Understanding the impact of NIHR investment in research (11/26/2018)

    Everyone involved in the health research ecosystem needs to demonstrate the difference that the research we undertake, support, fund and enable makes.  The NIHR is no different.  To do this successfully we need to gather good information. The NIHR, and many other funders, uses a tool called Researchfish to collect information on the outputs and impacts of research. Organisations that host NIHR research and personal awards (not infrastructure awards) are required to report annually through Researchfish whilst the award is active and for 5 years after completion.  The next submission window will open 4thFebruary and close 4pm 14thMarch 2019. 

    The information we gather through Researchfish helps the NIHR to make the case for continued investment in applied health research, respond to requests for information, and to build impact case studies.  Researchers and host organisations can also access their information and use this to support their own impact assessment activities.

    You can find out more information about the submission. We have lots of help and support available to organisations that host NIHR contracts and for researchers working on NIHR awards on our website.

    If your organisation hosts NIHR awards then you need to:

    • Alert award holders to the submission window early next year
    • Encourage your researchers to start entering information – starting early will reduce the pressure near the deadline
    • Get help, advice and support – visit our website for more information nihr.ac.uk/researchfish 
  • HRA launch Phase 2 Radiation Assurance (11/26/2018)

    Following the successful roll-out of Phase 1 of Radiation Assurance and a subsequent period of reviewer recruitment, the HRA have opened Phase 2 of Radiation Assurance on Monday 12 November to all studies involving cardiology, neurology or rheumatology taking place in the NHS/HSC. Oncology studies will also still be accepted for review during Phase 2.

    There is general information on the HRA websiteabout Radiation Assurance, including the review process and the standardized review fee. The standardized review fee of £500 per review, per reviewer will continue to be used for all studies submitted through Phase 2. More detailed guidance for applicants about how to submit a study for review is available on the IRAS website, including updated top tips for a successful submission.

    The HRA are continuing to seek feedback via an online surveyon the Payments Framework Guidance, which gives information about securing appropriate funding and paying for the Radiation Assurance review completion. Our online surveyabout the Radiation Assurance service as a whole, including the review process, is also still open. Please do spend some time to complete these surveys if you have any feedback to give as it will help us to continue to develop and improve our guidance and service.

    For NHS R&D offices only

    We are still accepting applications from both CREs and MPEs who meet the requirements in our role descriptions to register with us as reviewers. Further details are available on the HRA website. Please share this with any experts who may not have registered with us yet and who would be eligible to do so.

    If you have any questions about the Radiation Assurance service please contact the Radiation Assurance team at hra.radiationassurance@nhs.net.

  • The House of Commons Science and Technology Committee Research integrity: clinical trials transparency Tenth Report of Session 2017–19 (11/5/2018)

    This important report has implications for all research Sponsors and we shall be discussing the implications at our non-commercial Sponsors Symposium on November 8th in London.

    Download the report here

    https://www.parliament.uk/business/committees/committees-a-z/commons-select/science-and-technology-committee/news-parliament-2017/clinical-trials-transparency-report-publication-17-19/

    Read the HRA formal statement in response. https://www.hra.nhs.uk/about-us/news-updates/statement-response-failing-publish-data-clinical-trials-presents-risk-human-health-science-and-technology-select-committee/

     

  • NIHR launch nurse and midwife leadership programme (11/1/2018)

    A brand new senior nurse and midwife research leadership programme launched today will “strengthen the research voice” and “drive improvements in future care”, says the National Institute for Health Research (NIHR).

    The 70@70 NIHR Senior Nurse and Midwife ResearchLeader Programme is aimed at senior nurse and midwife clinical leaders with experience of building a research-led care environment for patients, and a record of developing existing practice and contributing to a research rich environment.

    Clare Meachin, NIHR Associate Director of Nursing at the NIHR and 70@70 Programme Director, said:

    “I am delighted to announce the launch of 70@70, an exciting programme that offers senior nurses and midwives the opportunity to support innovation and drive improvements in future care. The programme provides the space and time to share learning across teams, organisations and the NHS.

    “Nurses and midwives are by far the largest group of health care professionals and have such an important contribution to make to research delivery. 70@70 will strengthen the research voice and influence of nurses and midwives in NHS provider organisations.”

    The 70 successful applicants will form a new community of senior clinical nurses and midwives who will champion the promotion of an embedded research active culture, encourage and support innovation, and inform research priorities in their organisations.

    Through protected time they will be able to dedicate two days a week (over a period of three years) to fostering a culture of innovation, with the ultimate goal delivering of high quality, evidenced based nursing, midwifery and healthcare practice.

    The programme is now open for applications. Closing date 30 November 2018

    Find out more and apply at: bit.ly/NIHR70at70

  • October Newsletter 2018 (10/29/2018)
    Welcome to Forum October Newsletter 

    Did you know?


    Members of the Forum working groups and the Forum senior leadership team attend meetings with policy makers and key opinion leaders. In doing this they act as a voice for NHS R&D management teams and gather intelligence to support the R&D community further. You can feed into these groups anytime by emailing info@rdforum.org.ukand read current activities in the Forum roundup. 

    There are over 500 resources in the Forum resources exchange, it is open access and free to use.   

    Link For Further Information
     
    Did you read…?

    Writing a successful abstract for the Annual NHS R&D Forum: Blog by Sally Humphries ACET Lead Clinical Researcher, West Suffolk NHS Foundation Trust   

    Link For Further Information 

    The Forum Briefing Note for R&D Managers on ETCs. Published Sept 2018

    Link For Further Information

    2019 Annual NHS R&D Forum Conference Update 

    The NHS R&D Forum are delighted to announce that Dame Fiona Caldicott & Professor Jonathan Montgomery will be taking part in a very special Plenary Session at RDF19, the 2019 Annual NHS R&D Forum.

    Dr Nicola Williams, Chair of the Programme Content Group and National Director of Support & Delivery, Health and Care Research Wales said “We are delighted to welcome Dame Fiona Caldicott to the conference in 2019.

    AnchorShe will be interviewed on stage by Professor Jonathan Montgomery about the origins of the Caldicott guardians, their importance in research and the future challenges of protecting the use of patient information.”

    Topics of social care and research, trials retention, and clinical trials beyond Brexit are also confirmed. Acadmi Wales will explore finding happiness in the workplace through Applied Positive Psychology and there is much more to come.

    You can see all up-to-date speaker and conference news on the website and most importantly you can book a place! 
     
    Link: https://www.annualrdforum.org.uk/

    Call For Abstracts

    Oral abstracts by 1st December

    Poster abstracts by 31st  December

     
    Abstracts are absolutely critical to the Annual Forum conference. They ensure content is current and help to spread knowledge, innovation and learning. 
     
    The programme committee are looking for oral and poster presentations that relate to the process, the structure, improving efficiency, improving quality, promoting best practice or adding value in R&D studies, teams, departments or organisations. Please rally your colleagues and teams to submit. It is a great experience and keeps our community connected and current. 
     
    Link For Further Information 

    Professional Learning & Development

    Non-commercial Sponsors’ Symposia
    How to be a good, compliant Sponsor 
    November 8th2018, London 
     
    This Symposia is now fully booked and we are running a waiting list. Over 90 non-commercial Sponsors are attending, which is fantastic. We shall of course be tweeting and sharing updates for all. You can follow the day on the hashtag #noncomsponsors and in next month’s news.
     
    Link For Further Information
     
    Improved, new look ‘Essentials of NHS Research’
    25th& 26thMarch, Bristol
     
    The first of this new improved course ran earlier in the month and received such fantastic feedback that we’ve hurried to open bookings again. Attendees ranged from Universities, Trusts, CCGs, NIHR CRN and Government R&D departments, which led to wide and varied discussion around the topics.

    A snapshot of the feedback is provided below and the course leaders are updating it already to make sure it continually improves. The new written workbook in particular was really well received so a huge thanks to Dr Allyson Bailey for leading this for the Forum. 
     
    “I would highly recommend this course to others no matter their experience. The way it is structured I thoroughly enjoyed it. The activities and discussions really helped make it real”
     
    “Wonderful course, I learned so much my head is spinning. Thank you’
     
    “Course handbook will be my bible going forwards”
     
    Essentials of NHS Research is for all levels of role new to a health care R&D department, as well as colleagues in industry, academia and third sector that would like to better understand managing NHS Research.

    Content covers, understanding the landscape, policy, regulation, patient & public involvement, roles of R&D, capacity & capability, costing, AcoRD, contracts, safety, data, oversight, impact, strategy and more! 
     
    further information

    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

    Regulatory & Policy news:

    The HRA and MHRA have published a joint statement on seeking and documenting consent using electronic methods (eConsent)
     
    This statement sets out the legal and ethical requirements for seeking and documenting consent using electronic methods and is supported and endorsed by the UK health Departments in Northern Ireland, Scotland and Wales
     
    Link For Further Information

    CQC publish the Well-Led Inspection framework for NHS Trusts and Foundation Trusts. 
     
    The Care Quality Commission have published the Well-Led Inspection Framework for NHS Trusts and Foundation Trusts and Research is now recognised in W8 (p22-24) 
     
    W8 p22-24Are there robust systems and processes for learning, continuous improvement and innovation?
     
    Link For Further Information 

    Excess Treatment Costs and Commercial Study Set Up
     
    The pilot of new systems for the management of ETCs and commercial study set up for studies on the NIHR Portfolio began on the 1stOctober. It is important to keep watch on the main website hereso that you are informed of any developments. 
     
    Updates include revisions and improvements to the SoECAT based upon your feedback and new resources and tools. 
     
    Forum members are part of a feedback group and so if you have anything to contribute or share with the policy teams please do let us know via kate.greenwood@rdforum.org.uk
     
    Link For Further Information

    HRA Technical Pharmacy Assurance: New process opened 15thOctober 2018 

    The new process for technical pharmacy assurance opened on 15 October 2018 in England, Scotland and Wales, with the process opening in Northern Ireland once a phased rollout is complete in England and Wales.

    Sites will still need to assess local capacity and capability to ensure the study is deliverable but will be saved from conducting their own, separate technical pharmacy reviews. 

    Link For Further Information

    Around the Forum

    Slides from Embedding Research Strategy & Culture Symposium
     
    This small Symposium drew together 50 members of the community who are leading strategy and culture in their organisations. The value of the day came from the sharing of case studies, approaches and lessons learned for driving research strategy right across the different types of organisation.

    It was a hugely enjoyable and fruitful day. We will publish a blog summary soon but in the meantime you can download all of the slides here.

    Positioning UK PLC as a Primary Choice for Clinical Trials
     
    Jonathan Sheffield (NIHR CRN) and Jacqueline Johnson North (IAoCR) hosted this day, which was also attended by the HRA, MHRA, NHS Trusts and Industry leaders, including CROs. The Forum was represented and the Research Strategy and Leadership Working group will review the feedback at their November meeting. 

    Thank you for all your interest  
     
    Thank you to all who have submitted interest in various Forum groups, including working groups, training oversight and communications. We are hugely grateful and all chairs are reviewing the interest.

    The Senior Leadership team are assessing where new groups may need to be convened and how we can grow communities of interest across the Forum network. Please continue to feed in all your thoughts to info@rdforum.org.uk 

    Calls from the Community

    Titlee-Archiving facilities
    Members are seeking any experience or reviews of e-archiving facilities. If you use an e-archive or have researched/audited any providers then please get in touch via kate.greenwood@rdforum.org.uk

    Example Memorandum of understanding between University and Trust
    Members are seeking examples of umbrella agreements or MOUS between Universities and Trusts. If you are able to share anything you have already developed please contact kate.greenwood@rdforum.org.uk


    Have your say 

    Please continue to feed your views on anything of interest or challenge to info@rdforum.org.uk or kate.greenwood@rdforum.org.uk 

    Open for Consultation: MHRA EU Exit non-deal contingency legislation for the regulation of medicines and medical devices 

    This consultation seeks your views on how the Medicines and Healthcare products Regulatory Agency’s (MHRA) legislation and regulatory processes would have to be modified in the event of the UK not securing a deal with the EU after the UK’s exit, with no Implementation Period.  This consultation covers no-deal proposals on medicines, clinical trials and medical devices.

    Closes 1stNovember for submission to the MHRA.

    Link For Further Information

    Your views wanted on local information submitted to R&D
     
    The HRA are keen to hear experience on the quality of information submitted and received into R&D departments during study site set up. This information will help shape what they do in future and will also help shape process. 
     
    If you have comments to make or would like to join a telephone conference call to discuss then please get in touch with kate.greenwood@rdforum.org.uk

    New Department of Health & Social Care Vision for Health Tech. The future of healthcare our vision for digital, data and technology in health and care
     
    The document outlines the DHSC vision for what is needed to enable the health and care system to make the best use of technology to support preventative, predictive and personalised care. You can comment or feedback on this vision by online questionnaire.
     
    Link For Further Information

    New Resources this month

    New resources this month

    1. Animation to explain the new ETC process for research 
    2. AMRC new Q&A sheet explaining the ETC process for research 
    3. List of useful references providing some evidence for how research influences care 
    4. How to tackle clinical trials transparency: University of Bristol Case Study via Transpirimed.
    5. Transparimed Checklist: WHO best practices in Clinical Trials Transparency 
    6. BMJ Blog: Unreported trial of the week. Discussion about who is responsible for overdue reporting when a PI leaves a Sponsor institution. 
    7. NIHR I AM RESEARCH 2018 and NHS70 Campaign highlights Infographic 

     
    View the latest additions to the Resource Exchange here
     
    Please send in your tools, resources and helpful links. You can submit them directly here or send to info@rdforum.org.uk. Just one resource from every organisation would really make a difference and help to keep us all current.

    Other News, Call & Funding 

    NIHR Academy fellowship schemes 
     
    Research professorship schemes, Advanced Fellowships and Doctoral Fellowships available. Closing Nov/Dec 
     
    Link For Further Information 
     
    NIHR Funding Opportunities 

    Link or Further Information 
     
    Health & Care Research Wales: Senior Research Leaders Competition. Closing 14thNovember 
     
    Link For Further Information 

    Latest Jobs

    There are lots of new jobs this month – see here.
    Please submit your latest vacancies and we will also tweet them out. 

  • Slides from Embedding Research Strategy & Culture Symposium (10/25/2018)

    This small Symposium drew together 50 members of the community who are leading strategy and culture in their organisations. The value of the day came from the sharing of case studies, approaches and lessons learned for driving research strategy right across the different types of organisation. It was a hugely enjoyable and fruitful day. We will publish a blog summary soon but in the meantime you can download all of the slides.

    Slides from Embedding Research Strategy & Culture Symposium

     

  • September Newsletter 2018 (10/8/2018)
    Welcome to our September Forum News

    Did you know…? 


    Working group members and the Forum Senior Leadership Team are volunteers from across the community and that the income generated by training and events goes back into running the Forum for all.
     

    Did you read…?


    Our round up of Forum activities and outputs from May 2017- May 2018

    Our Forum response to the ETC and commercial study set up consultation? 

    If you want to feed in, start a virtual group on a topic, or get involved contact info@rdforum.org.uk

    2019 Annual NHS R&D Forum Conference Update 

    Call for abstracts are now open
     
    Call for abstracts for RDF19 oral presentation or poster display are now open. Feedback tells us that this is one of the most important parts of the conference programme, creating a rich resource of shared practice that continues to be accessible long after the event.
     
    We are inviting Abstracts that relate to the process, the structure, improving efficiency, improving quality, promoting best practice or adding value in R&D studies, teams, departments or organisations. We are particularly interested in innovative solutions to challenges and topics should be relevant to the wider R&D community. 
     
    The Annual NHS R&D Forum is about sharing best practice in R&D within Health and Care settings. Download the abstract submission guide for more detailed information, take a look at those accepted last year and get submitting.

    Writing a Successful Abstract for the Annual NHS R&D Forum
    Read past winner and R&D Management Working Group Chair Sally Humphreys blog on how to create a visual and impactful poster.

    Read Sally’s Blog here

    Professional Learning & Development 

    Embedding Research Strategy & Culture Symposia
    10th October, Birmingham

    This event is now sold out. If you are booked and can no longer attend please let us know as we are running a waiting list. 

    Improved, new look ‘Essentials of NHS Research’
    15th& 16th October, London
     
    This course is for all levels and those new to a health care R&D department, as well as colleagues in industry, academia and third sector who would like to better understand managing NHS Research. Content covers, understanding the landscape, policy, regulation, patient & public involvement, roles of R&D, capacity & capability, costing, AcoRD, contracts, safety, data, oversight, impact, strategy and more! 

    Further Information

    Non-commercial Sponsors’ Symposia – How to be a good, compliant Sponsor 
    November 8th, London.  Only £175
     
    This one day symposium is where non-commercial sponsors from across the health care community are joining together to share practice and work through what good and compliance in sponsorship looks like for all study types. 

    The following speakers are now confirmed:

    • Dr Trish Groves (associate editor BMJ, editorial consultant)
    • Kathleen Meely (Senior GCP consultant MHRA)
    • Dr Janet Messer (Director Approvals HRA)
    • Professor Gareth Griffiths (Director Southampton CTU) 
    • Alastair Nicholson (Senior Development Manager HRA)
    • Iva Hauptmannova (Head of Research & Innovation Centre, Royal National Orthopaedic Hospital NHS Trust) 

    The last few places are remaining. Book soon to secure a place. 
     
    Further Information 

    Forum courses ‘in-house’ 
     
    All courses 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

    Regulatory & Policy news:

    New process for the management of Excess Treatment Costs in non-commercial research in England, starting 1stOctober 2018
    We have previously communicated that there is a new process in trial from the 1stOctober for the management of ETCs in England. This trial period will last until April 2019 and so it is important to keep an eye on all the routes of communication. Please note the following point of clarification:

    The new arrangements for completing a SoECAT at application stage will apply to:

    • New calls for single stage applications issued after 1st October 2018
    • Invitations to submit the second and final stage of an application where the invitation is issued after 1st October 2018 (the call for the first stage application may have been issued prior to 1st October)

    Please see:

    1. R&D Forum Excess Treatment Cost webpage for further information and to read the NHS R&D Forum Briefing Note.
    2. NIHR Website Supporting research in the NHS – simplifying research arrangements to improve patient care. 
    3. The website includes a route map of the process for the management of ETCs
    4. AMRC Blog by Andy Clempson

    Non-commercial Sponsors can hear more about the SoECAT from Alastair Nicholson at the November Symposium. 
     
    National Directive on Commercial Contract Research Studies to come into force from 1st October
    Revisions to the NHS Standard Contract as outlined in the NHS England consultation response will come into force on 1 October. Details of the requirements that providers in England, and therefore commercial companies, will subsequently need to adhere to for commercial contract research are set out in the National Directive.

    Please see R&D Forum webpage for further information. 
     
    NHS England Research Needs Assessment 2018 published
    NHS England has published a summary of information and areas for research identified by by NHS England’s six national priority programmes. They are:

    • Urgent & Emergency Care (UEC)
    • Mental Health
    • Primary Care
    • Cancer
    • Diabetes and Specialised Commissioning
    • The medical and nursing directorates 
     
    New GAFREC Arrangements implemented 
     

    Poor research transparency: excuses or genuine barriers? A blog by Juliet Tizzard, Director of Policy at the HRA
    Further Information

    HRA and MHRA publish joint statement on seeking and documenting consent using electronic methods (eConsent)

    The Health Research Authority (HRA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) have published a joint statement setting out the legal and ethical requirements for seeking and documenting consent using electronic methods.

    eConsent is an approach sponsors and researchers are increasingly keen to adopt, and enables potential research participants to be provided with the information they need to make a decision via a tablet, smartphone or digital multimedia

    READ MORE

    Radiation Assurance: new Information

    Following the success of Phase 1 of Radiation Assurance, HRA are now ready to begin recruitment for further Medical Physics Expert (MPE) and Clinical Radiation Expert (CRE) reviewers in preparation for the launch of Phase 2 on Monday 12 November 2018.  During Phase 2 HRA will accept all cardiology, rheumatology and neurology studies, as well as continuing to accept all oncology studies taking place in the NHS.

    Recruitment began on Friday 14 September with a closing date of Friday 12 October at 4pm.

    Further details

    Around the Forum

    NHS R&D North West #NHSWonderWomen
    NHS R&D North West have launched a brilliant new video series to inspire everyone to think about doing health research. Promote, share and listen to these inspiring researchers. View the first video here and follow #nhswonderwomen @NHSNWRD for more. 
     
    New Blog in the BMJ by Derek Stewart
    “What should research active mean when applied to a hospital, for general practice, or in a care home? Does it actually matter and what benefits might there be for patients?”
     
    ‘Research active’ are two words most of us use… a lot! We might for example use them to encourage and motivate others (it is so important to be research active), to communicate our mission and vision for the future (we want to be a really research active organisation), to express what we do (we are research active), or to measure and report on performance (we are becoming more successful at being research active); but do we use them meaningfully or just use them as a sound bite and what are we really saying about what being research active should mean, particularly in relation to treatment and care?
     
    Derek Stewart, Patient advocate and Associate Dir. Patient Involvement & Engagement NIHRhas written a fantastically insightful blog in the BMJ this month around what he feels research active means and it is worth a few minutes of your time to have a read. It is particularly timely as a Forum we explore embedding research, strategy and culture in a health and care setting and what it means to be a well led, research active organisation 
     
    This sentence stands out: 
    “I believe that being research active adds value, but ….I too want the focus to be on good clinical care. I want a good clinical experience based on the rigour of high quality research methods to validate the evidence to improve health and wellbeing. I want a good hospital that is active in research not a “research hospital.” 
     
    Read the full blog here

    You can also catch up on the #whywedoresearch tweet chat on this topic by searching the hashtag for a wealth of opinion and insight.

    New Resources this month


    1. New GDPR learning resources are available from the MRC regulatory support centre 
    2. Research and Evidence Team Annual Review 2017-2018 Bristol, North Somerset and South Gloucester CCG

    View the latest additions to the Resource Exchange here

    Please send in your tools, resources and helpful links. You can submit them directly here or send to info@rdforum.org.uk. Just one resource from every organisation would really make a difference and help to keep us all current.

    Other News, Call & Funding 

    Apply to become an AHP Research Champion 

    Do you have ideas about how we engage and support AHPs to be research-active in NHS and social care settings? Applications are now open for AHP Research Champion roles working with the National Institute for Health Research (NIHR) and the Council for Allied Health Professions Research (CAHPR)

    Further information
     
    Health and Care Research Wales Senior Research Leaders competition
    Health and Care Research Wales is pleased to announce that it will launch the Senior Research Leaders competition for the next round of appointments to this prestigious group in early Autumn. Keep your eyed peeled for more information.
     
    Health & Care Research Wales Conference 2018
    Theme: Future-proofing research in Wales #ResearchWales18 
    Further information

    NIHR Professorship awards
    The NIHR Academy Research Professorship Schemes are officially open.
    Further information

    NIHR funding awards

    Latest Jobs

    There are lots of new jobs this month – see here.
    Please submit your latest vacancies and we will also tweet them out. 

  • RDF19: NHS R&D Forum Conference Update (10/8/2018)
    RDF19: NHS R&D Forum Conference Update

    Call for Abstracts RDF19

    The NHS R&D Forum are requesting abstracts for oral presentation and poster display at RDF19, the Annual NHS R&D Forum in Brighton on the 12th – 14th May 2019.

    We are looking for Abstracts that relate to the process, the structure, improving efficiency, improving quality, promoting best practice or adding value in R&D studies, teams, departments or organisations. We are particularly interested in innovative solutions to challenges. Topics should be relevant to the wider R&D community. The Annual NHS R&D Forum is about sharing best practice in R&D within Health and Care settings.

    1st December 2018: Abstract submission close for Presentations
    31st December 2018: Abstract submission close for Posters

    Delegate Bookings now open – RDF19, the 2019 Annual NHS R&D Forum

    Over 600 people attended RDF18 at Celtic Manor and many commented that it was the best Annual NHS R&D Forum ever. With over 60 speakers, 60 posters and a fantastic Awards evening the 2018 event was special for many people. RDF19 will start at 6pm on Sunday 12th May with an Interactive Professional Development Workshop delivered by Academi Wales followed by a Networking Buffet. The Main Conference Sessions will start at 10.15am on Monday 13th May.

    It is expected that places will book up very quickly and so to ensure your place with hotel accommodation in the conference venue please book as soon as possible. 

    Further details of booking and outline programme can be found here.

    RDF19 Plenary Speakers Announced

    The NHS R&D Forum Programme Content Committee are pleased to announce our first plenary speakers: Tina Coldham, Chair INVOLVE Advisory Group and Teresa Allen, the CEO of the Health Research Authority, will also be speaking during the first Plenary Session of RDF19. 

    Professor Philip Darbyshire will be returning to speak again during one of the final plenary sessions on Tuesday 14th May. Philip gave presentation at Celtic Manor which was the highlight of the Conference for many people and so we are delighted he will be joining us again for RDF19.

    Sunday 12th May: Professional Development Workshop 

    There will be a 2 hour Workshop entitled “Applied Positive Psychology – finding happiness in the workplace.” This Interactive Workshop will be delivered by Academi Wales and include a blend of theory, research, learning and some fun tools. This Workshop will be in two halves with a short break in the middle. Following the Workshop will be a Buffet and the chance to Network with other delegates. 

    This Workshop Session and Buffet as well as Sunday Night B&B are included in the price of the Full Conference Package. 

    Monday 13th May 2019: Day 1

    10:15 – Main Conference Start and First Plenary Session

    For the first time in Annual NHS R&D Forum history the Conference will be 2 full days. The Conference will start at 10.15am with a Welcome Address and Plenary Session. The Conference sessions following will be a mix of Plenary and Breakout which will run until 18:00.

    TriNetX first to sign-up for Demonstration Hour

    The NHS R&D Forum is delighted to announce that TriNetX are the first organisation to sign-up to take a slot in the Demonstration Hour at RDF19.

    The Demonstration Hour is a new feature introduced for the first time at RDF19. The RDF19 Demonstration Hour will run from 17:00-18:00 on Monday 13th May. This will allow Software/IT based companies the opportunity to provide a comprehensive demonstration of their systems and processes in a conference breakout room. They will form part of the main Conference Programme. Each Session will be designed and organised by the demonstrating company and may include a demonstration, Q&As, user experiences etc.  

    There are a limited number of rooms available for Demonstrations. A fee is charged to organisations wishing to Demonstrate. Delegates will be able to book to attend these sessions when session choice booking opens shortly before RDF19.

  • UPDATED: Managing Excess Treatment Costs in Non-Commercial Research Outcome of the National Consultation (9/29/2018)
  • Radiation Assurance: new Information (9/27/2018)

    Following the success of Phase 1 of Radiation Assurance, HRA are now ready to begin recruitment for further Medical Physics Expert (MPE) and Clinical Radiation Expert (CRE) reviewers in preparation for the launch of Phase 2 on Monday 12 November 2018.  During Phase 2 we will accept all cardiology, rheumatology and neurology studies, as well as continuing to accept all oncology studies taking place in the NHS.

    HRA are looking for MPEs and CREs with expertise in one or more of the following areas

    • radiology
    • nuclear medicine
    • radiotherapy
    • oncology
    • cardiology
    • neurology
    • rheumatology
    • paediatrics with particular knowledge of any of the above specialisms

    Recruitment began on Friday 14 September with a closing date of Friday 12 October at 4pm. Please refer to our advert for role descriptions and details on how to apply.

    Information and guidance on Radiation Assurance can be found on the HRA website, including an overview on how to submit a study and information regarding payment. More detailed guidance for applicants about how to submit a study for review is available on the IRAS website.

    A standardised fee of £500 per review, per reviewer (plus VAT) has been introduced in England, Northern Ireland and Wales to simplify funding applications and the payments process. As the standardised charging and payment processes are new this year, the HRA are seeking feedback via an online survey on the Payments Framework Guidance.

    HRA are also seeking feedback through a second online survey about the Radiation Assurance service as a whole, including the review process.

    Please do spend some time to complete these surveys if you have any feedback to give as it will help us to develop and improve our guidance and service.

    If you have any questions about the Radiation Assurance service or the Payments Framework guidance, please contact the Radiation Assurance team at hra.radiationassurance@nhs.net.

  • HRA and MHRA publish joint statement on seeking and documenting consent using electronic methods (eConsent) (9/27/2018)

    The Health Research Authority (HRA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) have published a joint statement setting out the legal and ethical requirements for seeking and documenting consent using electronic methods.

    eConsent is an approach sponsors and researchers are increasingly keen to adopt, and enables potential research participants to be provided with the information they need to make a decision via a tablet, smartphone or digital multimedia

    READ MORE

  • Managing Excess Treatment Costs in Non-Commercial Research Outcome of the National Consultation (9/10/2018)

    After a national consultation exercise there will be a new system  for the management of Excess Treatment Costs for non-commercial research in England.

    This new system will start as a trial period from October 1st 2018 with full roll out by April 2019.

    To help us understand these new plans, members of the Forum have written a briefing note with partners from the HRA & NIHR CRN CC.

    Please be aware that some elements of the new system are still in development and you can therefore keep yourselves up to date by following our Forum News, HRA_Latest and monitoring our Twitter feeds and the dedicated NIHR CRN webpage here 

    If you have any questions about the new processes you can email them into info@rdforum.org.uk and we will collate and forward them on to policy makers.

    Please read and share this note with your colleagues so that we are all aware of the changes coming soon.

    You can read the briefing note here:

    EXCESS TREATMENT COSTS BRIEFING NOTE FINAL VERSION 1.0-7th Sept 2018

  • August Newsletter (9/6/2018)
    Welcome to our August Forum News

    Did you read…?

    2019 Annual NHS R&D Forum Conference Update

    #RDF19
     
    The Programme Content Group has held its first meeting. Dr Nicola Williams has kindly agreed to chair once again and the group would to know the key topics of interest to the community. Please spare a few minutes and complete our quick survey here.
     
    Sponsor and Exhibitor bookings have started off with a bang with several sponsorship packages being snapped up and Zones A and B1 of the Exhibition Hall are already fully booked. Our RDF19 Gold Sponsors are:

    • Health & Care Research Wales
    • ESMS
    • TriNetX
    • edge
    • NIHR

     Our Silver Sponsor is RQA

    The following Sponsorships are still available:

    • Communications Sponsor
    • Breakout Zone Sponsor
    • Plenary Session Sponsor
    • Overall Plenary Sponsor

    Exhibition Stands are available in Zones B2 and C. Full details available here

    Professional Learning & Development

    Non-commercial Sponsors’ Symposia:Draft Programme Now Online

    How to be a good, compliant Sponsor 

    November 8th2018, London.  Only £175
    An outline Programme is now live on the Forum website and places are filling up fast. A key purpose of this event is to ensure Sponsors from across the non-commercial sector meet together and therefore we may need to keep a number of places available. If you are keen to go to this day to connect and learn with others, you should book soon. 
     
    The MHRA, HRA and MRC are all confirmed and the Programme focuses on what good sponsorship looks like from a variety of perspectives and study types. 
     
    Link to further details and booking here
     
    Embedding Research Strategy & Culture in a Health & Care Setting 

    How to be a well-led, research-active organisation 

    Birmingham, October 10th. Only £175  
     
    Are you responsible for leading research in your organisation? Must you report to the Board, influence and build partnerships for research? This is an opportunity for Forum members to link in with others and find space to discuss challenges as well as successes alike.
     
    The agenda for this small symposium is online and aims to bring research management teams together with a breadth of speakers to explore strategies for success and to look at what being well led means for health care research active organisations. 
      
    Link to further details and booking here
     
    Applied Monitoring in a Health Care Setting

    1st& 2ndOctober, Manchester
     
    For study monitors, facilitators, research nurses, practitioners, sponsors and QA teams. 
     
    Work through dummy study files, essential documents and pharmacy files and leave with practical understanding of how to undertaken risk-assessment and monitor well. 
     
    Link to further details here
     
    Improved, new look ‘Essentials of NHS Research’
    15th& 16thOctober, London:
     
    For all levels of role new to a health care R&D department, as well as colleagues in industry, academia and third sector that would like to better understand managing NHS Research. Content covers, understanding the landscape, policy, regulation, patient & public involvement, roles of R&D, capacity & capability, costing, AcoRD, contracts, safety, data, oversight, impact and strategy. 
     
    Link to further details here
    Forum courses ‘in-house’ 

    All courses 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

    Roundup

    Calls from the community
     
    TriNetX 
     
    Are you already using or planning to use TriNetX and willing to share your experiences with others? If you so and you are willing to get in touch please contact jane.greenaway@nhs.net
     
    Communications Professional for Research? 
     
    Do you have a dedicated member of your team for promoting research and research communications, or are you a research communications professional? We are looking to see how many there are! 
     
    If you are happy to let us know and be added to a mailing list, get in touch, by contacting: kate.greenwood@rdforum.org.ukor tweet to @NHSRDFORUM 

    The HRA want to know your thoughts on research transparency 
     
    The survey is aimed primarily at researchers, sponsors and funders, but is open to anyone with an interest in the transparency agenda. You are encouraged to be completely honest. 
    The survey is due to close on 28 September. If you have any queries about this please contact hra.comms@nhs.net
     
    PRIORITY II – what are the 10 most important questions to you for retention to clinical trials? 
     
    The PRioRiTy II PSP now has a list of the 27 questions about methods of retention to clinical trials that were important to people, from the original survey. 
     
    They are asking those who design and run trials, as well as those who take part, to choose the 10 questions that are most important to them in a short survey

    The survey will close on 14th September.

    Regulatory & Policy news:

    Government advice on how medicines, medical devices and clinical trials would be regulated in theres no Brexit deal. 
     
    The Dept. of Health & Social Care has published advice on a no-deal Brexit 
     
    MHRA preparation for exiting the EU including an update on the Clinical Trials Regulation during the implementation period
     
    A letter from Ian Hudson CEO of the MHRA has been received, outlining several pieces of information, which aim to provide some clarity on how the MHRA are preparing for exiting the EU.  You can read the letter here.
    This information includes a published update on the Clinical Trial Regulation during the implementation period. 
     
    Teresa Allen is appointed new HRA CEO
     
    Many congratulations to Teresa Allen who has been appointed as the substantive Chief Executive of the HRA. We very much look forward to continuing to work closely with the HRA and Teresa in the future. 
     
    Updated Statement of Activities and Schedule of Events 
     
    An updated HRA & Health Care Research Wales Statement of Activities and Schedule of events are published 
     
    New UK-wide mNCA published 
     
    The new version of the UK-wide model non-commercial Agreement (mNCA) is published and designed for use without modification 
     
    HRA considers the future of social care research – Read More Here 

    New Resources
    Other News, Call & Funding

    Apply to become an AHP Research Champion 

    Do you have ideas about how we engage and support AHPs to be research-active in NHS and social care settings? Applications are now open for AHP Research Champion roles working with the National Institute for Health Research (NIHR) and the Council for Allied Health Professions Research (CAHPR)

    New Health Visitor Research Champions scheme is launched

    NIHR to launch £3million senior nurse and midwife research programme
     
    Health and Care Research Wales is pleased to announce that it will launch the Senior Research Leaders competition for the next round of appointments to this prestigious group in early Autumn.  Keep your eyes peeled for more information!  
     
    Health & Care Research Wales Conference 2018
    Theme: Future-proofing research in Wales #ResearchWales18 

    NIHR funding awards

     

    Latest Jobs

    There are lots of new jobs this month. Please submit your latest vacancies and we will also tweet them out. 

  • New Health Visitor Research Champions scheme launched (8/29/2018)

    The Institute of Health Visiting has launched a new Research Champions scheme for health visitors (HVs) interested in research. Set up in partnership with the National Institute for Health Research (NIHR), the scheme has appointed its first ten Champions.

    The new HV Research Champions met for the first time at NIHR to learn how to develop their role and will be mentored by existing midwifery champions and supported by the local NIHR Clinical Research Networks (CRNs).  Ultimately there will be 15 research champions, one for each CRN region.

    Dr Cheryll Adams CBE, Executive Director at the Institute of Health Visiting, said: “This is a very exciting development for the Institute, we have seen how successful the Midwifery Champions have been in supporting research for mothers and babies and it is fantastic to now be developing a similar capacity in health visiting.

    “For the Champions themselves and their employers, this is an opportunity to much more closely engage with the many national research programmes.”

    The HV Research Champions will:

    • Work collaboratively with the iHV, NIHR, relevant research teams and other Champions to support the development of portfolios of research
    • Work together to increase health visitor contribution to research studies
    • Support the development of a research-rich culture within the health visiting workforce
    • Contribute to a national forum of Champions including attendance at 3 National forum meetings a year
    • Contribute to national activities of the forum and health visiting including sharing of good practice and development of new ways of working
    • Support the creation of opportunities for more research careers in health visiting.

    The HV Research Champions have a masters, a doctorate or are working towards one, and also some existing or prior direct involvement in research, and they are also members of the iHV. Further opportunities to become a HV Research Champion include the following regions: South West Peninsula; North West Coast; Kent, Surrey and Sussex; Thames Valley; and West of England. Closing date for applications is 7 September 2018.

    For more details and how to apply – https://ihv.org.uk/our-work/research/research-champions/

  • New version of UK-wide model Non-Commercial Agreement (mNCA) published (7/28/2018)

    https://www.hra.nhs.uk/about-us/news-updates/new-version-uk-wide-model-non-commercial-agreement-mnca-published/

  • MRC Regulatory support centre update (7/25/2018)
  • NIHR League Tables (7/25/2018)

    The NIHR have published their 2017 league tables to show a phenomenal 725,000 have received access to better treatments and care during 2017/18, the highest number since records began. https://www.nihr.ac.uk/research-and-impact/nhs-research-performance/league-tables/

  • July Newsletter (7/25/2018)

    Welcome to our JULY Forum News

     

     

     

     

     

    Did you know? Our Vision is:

    Excellence in research management, support and leadership for high value research and for improved health and care.

    We aim to lead, shape, help connect & thrive; acting together as a professional network and community of practice.

    If you want to feed in, start a virtual group on a topic, or get involved contact info@rdforum.org.uk.

    Adding Value in Research: A Framework for Organisations

    We have published the summary of the NIHR adding value in research NHS R&D Forum workshop and conference presentations.

    The workshop aimed to influence the NIHR AViR model and the conference presented a revised framework modeled from an organisational perspective. At the conference we discussed developing as a profession to enable high value research. Both workshop and conference slides are available here.

    6 pillars are recommended for enabling high value research in a health and care setting. They are:

    1. Relevant research
    2. Appropriate design
    3. Appropriate and efficient delivery
    4. Accessible & usable
    5. Valued
    6. Enabled workforce culture & development

    Next steps are planned to develop the model further into a practical framework with guidance for teams.

    New processes for the management of ETCS in England and single contract review for commercial research

    NHS England is working with the NIHR and partners in their response to managing Excess Treatment Costs in non-commercial research: Outcome of the National Consultation.

    From October 1st the new process will begin a trial period and will be rolled out in full by April 2018.

    Members of the Forum are developing a briefing note to support understanding around this new and developing process.

    Members are also part of a multi-stakeholder group shaping the development of a single contract review.

    In the meantime further information can be found on the NIHR website

    Whilst the buzz is still alive from the 2018 Annual Conference at Celtic Manor we are in full swing with RDF19. We are thrilled to say Premium Sponsorship is already sold out and Exhibition Zone A is also now sold out. There are some sponsorship options still available and exhibition stands are being sold in Zones B1, B2 and C.

    See the Sponsorship & Exhibitor opportunities here

    The Programme Content Group will be meeting over the summer to discuss the plenary sessions and finalise the Abstract Submission Guidelines. The Group welcomes news members to join them. All meetings are held via teleconference to focus on the speakers, abstract and poster review. If you would like to take part please email: info@rdforum.org.uk

    Professional Learning and Development

    How to be a well-led research active organisation for high value research

    October 10th 2018, Birmingham

    Are you responsible for leading research in your organisation? Do you report to the Board and build partnerships for research? Are you interested in how to create a thriving high value research strategy and culture?

    This small symposium is designed to bring research management teams together with a breadth of speakers to explore what success and being well led looks like from a health research perspective. It is for all types of organisation.

    Keynote speakers will discuss perspectives in leadership, and members will hear case studies and strategies for research with colleagues from across the community.

    This is an opportunity for Forum members to link in with others and find space to discuss challenges as well as successes alike.

    See here for the Agenda and the booking link

    Non-Commercial Research Sponsors Symposium for Health & Care

    How to be a good, competent Sponsor

    November 8th 2018, London

    Being a research Sponsor is a broad and evolving role, bringing responsibility and accountability with very little formal training or opportunity to share practice.

    This meeting, we hope, is the beginning of a Sponsors community that will meet on annual basis to share expertise, challenges and develop learning.

    This first symposium we will focus on relationships and what it looks like to be a good Sponsor from various perspectives. We will bring you together with policy makers, regulators, sites, researchers and patients to work through what good might look like, and to address current hot topics.

    Bookings are open now with limited spaces. Click here for further details and to book

    A Practical Application of Monitoring in a Health Care Setting

    1st & 2nd October, Manchester:

    For study monitors, facilitators, research nurses, practitioners, sponsors and QA teams.

    Oversight is a fundamental Sponsors responsibility and monitoring plays an important role in ensuring quality control.

    Host organisations will also benefit from working through dummy study files, essential documents and pharmacy files. All will leave with practical understanding of how to undertaken risk-assessment and monitor well.

    For further details and to book click here

    Improved, new look ‘Essentials of NHS Research’

    15th – 16th October 2018, London:

    For all levels of role new to a health care R&D department, as well as colleagues in industry, academia and third sector that would like to better understand managing NHS Research.

    This course, previously the basics, always gets fabulous feedback but consistently members would let us know it really wasn’t basic!

    Our Forum course leader has now updated the material to be a whole new look package of essentials for anyone looking for a complete overview.

    Content covers, understanding the landscape, policy, regulation, patient & public involvement, roles of R&D, capacity & capability, costing, AcoRD, contracts, safety, data, oversight, impact and strategy.

    For further details and to book click here

    Forum courses ‘in-house’

    All courses 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

    Congratulations and thank you to all NHS organisations for contributing to improvement in research activity.

    The NIHR have published their 2017 league tables to show a phenomenal 725,000 have received access to better treatments and care during 2017/18, the highest number since records began. https://www.nihr.ac.uk/research-and-impact/nhs-research-performance/league-tables/

    New Blog – The Whitehouse Report; Executive summary, model and reflections 

    By Claire L. Whitehouse (@ClaireW_UK) & Hazel A. Smith (@smithhazelann)

    The Whitehouse report is a review of Research Nursing and Midwifery across the UK and Ireland in 2017.

    In this fantastic new blog, written for the Forum, authors Claire Whitehouse & Hazel Smith report on their work sharing lessons learned and reflections.

    Calls from the community

    Members have requested examples of the following. If you have any good examples to share in the resources exchange please send to info@rdforum.org.uk

    • Please send any SOPS, worksflows, process maps or descriptions of what you do to conduct commercial study set up and contract negotiation
    • Policies and procedures for research finance and VAT
    • Example subcontract or SLA, for subcontracting provider services when hosting studies
    • Any ‘good’ job descriptions at band 7 and band 6 for any R&I office roles.

    Communications Professional for Research?

    Do you have a dedicated member of your team for promoting research and research communications, or are you a research communications professional? We are looking to see how many there are!

    If you are happy to let us know and be added to a mailing list, get in touch, by contacting: kate.greenwood@rdforum.org.uk or tweet to @NHSRDFORUM

    The HRA have published their annual report. Read their progress here 

    In the meantime further information can be found on the NIHR website https://www.nihr.ac.uk/funding-and-support/study-support-service/resources/supporting-research-in-the-nhs.htm

    ‘International Perspectives on Evaluation of PPI in Research’

    Thursday 15th and Friday 16th November, 2018.

    Newcastle upon Tyne, UK

    Closing date for abstract submissions is Tuesday 31st July.

    The conference will provide an international platform to critically explore and reflect on the issue of evaluation of patient and public involvement in research. Abstracts for oral, poster and workshop presentations for this conference are being accepted until the 31st July. Read more here

     

     

     

     

     

     

     

    CRN HLO Survey: opportunity to review & refresh.

    The NIHR CRN High Level Objectives (HLOs) were developed in collaboration with DHSC in April 2010. The HLOs have been fundamental in increasing the opportunities for our population to access research, speed up the approval process for research and deliver studies faster, therefore, improving the outcomes for our patients as well as offering patients access to new novel treatments with our collaborations with Industry.

    The DHSC have indicated they are willing to consider NIHR CRN’s recommendations for a “review and refresh” of the HLOs to ensure they are still meeting the needs of the population. In response to this, the NIHR CRN wishes to undertake a consultation with LCRNs, their local partners and other key stakeholders, via local discussions and completion of an online survey.

    The survey will run from 9 July 2018 to 20 August 2018 and will take approximately 15-20 minutes to complete.

    A link to the survey along with additional information can be found on the HLO Review Hub site

    Nominate your research hero in celebration of NHS70

    The NIHR we have been recognising the valued contribution of NHS staff to health research.

    If there’s an NHS colleague you would like to thank, you can post a photo of yourself on social media with our #MyResearchHero social media board

    If you want to request help from the Forum community or working groups or f you have something to say on a topic, email kate.greenwood@rdforum.org.uk

     

     

    A practical, interactive guide is suitable for those working at all levels in the NHS, from ward to board, and will show you how to make better use of your data.

    Four principles to make evidence synthesis more useful for policy  

    NHS Improvement Making data count,

    Slides from the MHRA Stakeholder Event can be obtained on request from kate.greenwood@rdforum.org.uk

    Please send in your tools, resources and helpful links. You can upload them directly or send to info@rdforum.org.uk. Just one resource from every organisation would really make a difference and help to keep us all current

    A selection of great blogs

    Why study registration is important for the future of research. Dr Matt Westmore

    Research Waste and ensuring transparency Juliet Tizzard

    Evidence and good research: Jonathan Montogmery

    Patient powered research?: Recognising the power of lived experience in health research. Dr. Bella Starling

    What might impact look like for PPI: Derek Stewart

    From Coventry and Warwickshire University Hospitals Research and Development Summit 2018 #rdsummit2018 @UHCW_RandD @nhsuhcw

    NIHR Applied Research Collaborations  (NIHR  ARCS)

    Application dates: 01 June 2018 to 20 August 2018

    2017 league tables

    NIHR is launching a new, single-stage, open competition to designate and fund NIHR Applied Research Collaborations (NIHR ARCs).

    The new ARC funding and support is for applied health and care research and to support implementation of research into practice, making tangible improvements for patients, the public and to health and care services.

    NHS organisations or providers of NHS services in England, acting on behalf of a collaboration of the local providers of NHS services, local providers of care services, NHS commissioners, local authorities, other relevant local health and care organisations, the relevant Academic Health Science Network (AHSN) and the local University(ies) are eligible to apply.

    NIHR to launch £3million senior nurse and midwife research programme

    NHS England Improvement Fundamentals: A brand new, free online course for those involved in health and social care has been launched. The course is made up of bite-sized mini courses running from 16th-20th July and take you through the preparation and delivery of an improvement within your workplace step-by-step.

    Save the Date for Health & Care Research Wales Conference 2018

    Theme: Future-proofing research in Wales #ResearchWales18

    NIHR funding awards


    Latest Jobs 

    There are lots of new jobs this month. Please submit your latest vacancies and we will also tweet them out.

    The professional network for research management, support & leadership in health & care


    Please share your events, successes, activities, jobs, resources and and thoughts via the Forum by sending them to info@rdforum.org.uk

     

  • CRN HLO Survey: opportunity to review & refresh. (7/25/2018)

    The NIHR CRN High Level Objectives (HLOs) were developed in collaboration with DHSC in April 2010. The HLOs have been fundamental in increasing the opportunities for our population to access research, speed up the approval process for research and deliver studies faster, therefore, improving the outcomes for our patients as well as offering patients access to new novel treatments with our collaborations with Industry.

    The DHSC have indicated they are willing to consider NIHR CRN’s recommendations for a “review and refresh” of the HLOs to ensure they are still meeting the needs of the population. In response to this, the NIHR CRN wishes to undertake a consultation with LCRNs, their local partners and other key stakeholders, via local discussions and completion of an online survey.

    The survey will run from 9 July 2018 to 20 August 2018 and will take approximately 15-20 minutes to complete.

    A link to the survey along with additional information can be found on the HLO Review Hub site

  • Call for abstracts now open! ‘International Perspectives on Evaluation of PPI in Research’ (6/29/2018)

    Abstract call now open!

    ‘International Perspectives on Evaluation of PPI in Research’

    Thursday 15th and Friday 16th November, 2018.

    Newcastle upon Tyne, UK

    The conference will provide an international platform to critically explore and reflect on the issue of evaluation of patient and public involvement in research. We are now accepting abstracts for oral, poster and workshop presentations for this conference.

    Closing date for submissions is Tuesday 31st July.

    Reviewer decisions will be available mid-August.

    The conference provides an exciting opportunity for shared learning and for showcasing your patient and public involvement (PPI) in research to an international audience. Rather than pre-set themes we will shape the thematic structure of our parallel sessions and poster presentations around the topics covered within submitted abstracts. Submissions are therefore invited that reflect a range of PPI experience, academic and philosophical interests, and diversity in the practice and evaluation of PPI in research.

    Abstracts are invited from both the ‘professional’ and PPI communities.

    Abstracts led by professionals should ideally include PPI co-authors.

    Find out more about our abstract call here

    Submit your abstract by email here evalppi.conf@newcastle.ac.uk

    The conference website is now live with further information about the 2-day programme, our fantastic line up of speakers, the conference venue and registration.

    A small number of bursaries will be available to support attendance of PPI delegates, details will be provided when registration opens in July.

    Follow us on Twitter for live updates

    @intppieval   #intppieval18

    This conference is jointly chaired and delivered by PPI contributors.

    The organising committee look forward to welcoming you to Newcastle in November!

  • June Newsletter (6/25/2018)

    Welcome to our June News

    Please continue to contribute to the NHS R&D Forum and shape our community.

    Read our updated Privacy Policy and information on how we process your personal data in line with GDPR here

    Ask your teams to sign up to Forum membership…it is open, it is free and it helps to ensure our Professional community thrives.


    NEW EVENTS –  Symposia


    Embedding Research Strategy & Culture in a Health & Care Setting

    How to be a well-led research active organisation

    Birmingham, October 10th. Only £175

    Leading research in an organisation requires many skills and strategies. The rewards are great if the tactics succeed, however there can be many challenges along the route. NHS R&D departments play a key role as enablers and leaders of quality research in health as reflected in our publication Research for All: Best Practice in Research Management.

    During this new symposium you will hear perspectives on research culture and leadership from top Board level NHS executives, patients, and peers who are leading R&D; exploring what has worked well (and not so well) in some NHS organisations.

    Confirmed speakers include: Sarah-Jane Marsh CEO (Birmingham Women’s & Children’s NHS Trust), Sarah Williams (Solent NHS Trust), Jo Hartland, (Avon Primary Care Research Collaborative), Christine McGrath (Southampton University Hospitals), Lucy Wasinski & Dan Lawrence (Sheffield Teaching Hospital NHS Foundation Trust) and Kelly Hard (Birmingham Women’s & Children’s)

    To secure a place BOOK HERE

    Non-Commercial Research Sponsors Symposium for Health & Care

    Being a competent Sponsor

    London, November 8th2018. Only £175

    Being a Research Sponsor representative is a broad and evolving role, bringing responsibility and accountability with very little formal training or opportunity to share practice. The NHS R&D Forum groups want to improve this for non-commercial sponsors and their partners; through learning, development, resources, and events.

    This one day Symposium will bring together those acting for and on behalf of Sponsor organisations across the non-commercial sector, including Sponsor representatives, CTUs, regulators and policy makers. The Symposium will provide space for members to hear from key speakers and to share successes and challenges in the Sponsorship of health and care research studies.

    To secure a place BOOK HERE


    7 Core Elements of Research Management, Support & Leadership 

    During 2017-2018 the Forum training and learning oversight group undertook a comprehensive training needs analysis across members within the community. The group has also scoped a full learning and development programme to serve the spectrum of levels and roles, now called the 7 core elements of a research management support and leadership team.

    These core elements can be mapped to the Forum’s R&D functions wheel and help ensure we cover all the high-level learning needs and competencies required in an R&D team.

    Learning around patient and public involvement is embedded within each of the core elements. You can download a PDF of these core-elements for sharing here

    Presenting this work at the Forum conference, group chair Dr Allyson Bailey, asked for help in prioritising the programme further so that work may begin on writing the new course material so watch this space!


    Training


    Forum courses currently open for bookings this quarter are:

    10thJuly, London: Archiving – Book here

    1st& 2ndOctober, Manchester: Applied Monitoring in a Health Care Setting – Book here

    15th& 16thOctober, London: Essentials of NHS Research – Book here

    See all other events advertised here


    Forum Roundup


     

    Forum Review 2017-2018: What did we achieve as a networked community?

    Read this year’s summary of Forum progress and activities between May 2017 and May 2018. Thank you for all your contributions over the year.

    Do you want to get more involved with the Forum?

    If you want to take partin Forum activity or you have an idea to suggest, explore or share contact info@rdforum.org.uk

    Calls from the community

    Members have requested examples of the following. If you have any good examples to share in the resources exchange please send to info@rdforum.org.uk

    • Policies and procedures for research finance and VAT
    • Example subcontract or SLA, for subcontracting provider services when hosting studies
    • Any good job descriptions at band 7 and band 6 for any R&I office roles.

    Have your say


    Forum group members have recently influenced:

    • Overarching principles for
commercial contract recruitment target setting for NIHR CRN supported studies.
    • MRC/HRA GDPR factsheet
    • NHSE operational plans for ETCs. Alison Steele R&I manager Sherwood Forest NHS Trust has agreed to feed into NHSE working group to provide a DGH perspective.
    • CQC indicators for research operational group

    Look out for a Forum survey coming soon to ask for your views on how we are implementing the strategy, what we can improve on and what our leadership team and working groups should prioritise next on your behalf.

    If you want to request help from the Forum community or working groups or if you have something to say on a topic, email kate.greenwood@rdforum.org.uk


    Other News and Calls


    Improving Performance in Initiating and Delivering Clinical Research 70 day benchmark removed

     Statement from the Department of Health & Social Care

    “The Government is committed to creating the best environment for clinical trials and achieving the ambition set out in the Life Sciences Industrial Strategy to make the UK a top tier global hub for biomedical and clinical research and medical innovation. This includes a commitment to increase the number of clinical trials, improve clinical trial capabilities and reduce the time it takes to initiate and deliver studies, ensuring we are supporting the most innovative trials and meeting the needs of the Life Sciences Industry.

    As part of a package of support to improve performance in initiating and delivering clinical research, the National Institute for Health Research will continue to require providers of NHS services in receipt of NIHR funding to measure and publish their performance in initiating and delivering clinical research. This requirement is also being reinforced through the NHS standard contract, as outlined in NHS England’s ‘12 Actions to Support and Apply Research in the NHS’, as a measure of the importance of clinical trial performance to the NHS, patients and the Life Sciences Industry.

    The 70 day benchmark for clinical trials, which was introduced as part of the publication requirements, has played an important role in driving up trial performance in the NHS in England.  However, we have had feedback from the Life Sciences Industry that publication of performance data using the agreed Minimum Data Set, rather than the 70 day benchmark, will now better meet the needs of industry partners in research site selection and allow sponsors to view the most appropriate timelines for each clinical trial. In response to this, we are now removing the 70 day benchmark for performance in initiating clinical research.

    We are also initiating work to streamline the collection of performance data from NHS Trusts, and to improve data quality and usefulness. We will continue to monitor performance data and feedback from the Life Science Industry as this change is embedded.

    The NIHR Central Commissioning Facility Clinical Trial Performance team have updated the PID guidance documents for Q1 18-19 to reflect the changes in reporting and publishing requirements. If you have any questions or concerns, please do not hesitate to contact them at CTP@nihr.ac.uk.”

    Patient Experience in Research Annual Survey Findings 17/18

    The NIHR CRN CC has published its latest report on findings from 2017/2018 patient experience in research survey. Please take the time to read it.

    This report is really important to our understanding of what it is like to experience being part of the research activity we run in the NHS. It is also critical to helping us understand where we can and must improve and so please cascade widely and take the time to read the helpful recommendations. The report also highlights the fantastic work of research staff in health care organisations and this should be celebrated. Read it here. For an insightful blog from Simon Denegri on the report, see here

    New Governance Arrangements for Research Ethics Committees (GAFREC) published

    The Health Research Authority and the UK health departments in Northern Ireland, Scotland and Wales have published revised Governance Arrangements for Research Ethics Committees(GAFREC), which will replace the 2011 version from 17 September 2018.

    Changes take account of legal, policy and operational developments, as well as feedback from applicants, REC members and staff. There is one new addition to the good practice requirements for REC review. Following public consultation by the Human Tissue Authority, research involving human DNA extracted from acellular material, which previously did not require REC review, is now included for the first time. Read more here

    Single electronic submissions of the IRAS Form for studies led from Northern Ireland, Scotland and Wales

    On 28 June 2018 an update to IRAS, the Integrated Research Application System, will introduce a single, e-submission of IRAS Forms and associated documents.  This change applies to studies taking place in NHS organisations in Scotland and Wales and Health and Social Care (HSC) organisations in Northern Ireland where the lead NHS/HSC R&D office is in Northern Ireland, Scotland or Wales.  Please see the Four Nations Compatibility Programme announcement for more details.

    Single IRAS Form and document e‑submission is already available for NHS/HSC studies where the lead NHS R&D office is in England.

    There is no change to how participating organisations are set up.  IRAS Help provides advice on how to submit site specific/ local information to sites.

    NIHR Involve survey on involving children and young people in research

    NIHR INVOLVE are looking into enablers and barriers that researchers face when involving children and young people in research. Please complete their survey 


    New Resources


    New this month:

     

    Please send in your tools, resources and helpful links. You can upload them directly or send to info@rdforum.org.uk. Just one resource from every organisation would really make a difference and help to keep us all current.


    Funding and Other Programmes


    Funding & programmes


    Latest Jobs


    See all the latest job postings

    Please Submit your vacancies and we will tweet them out


    Please share your events, successes, activities, jobs, resources and and thoughts via the Forum by sending them to info@rdforum.org.

  • NIHR CRN social media toolkit launched (6/25/2018)

    The NIHR CRN are pleased to announce the launch of the NIHR CRN Social Media Toolkit.

    The Toolkit contains a selection of commonly used social media tools and resources, alongside simple guidance and examples of how to apply in everyday practice. This is not just for staff involved with communications and marketing but for colleagues across all parts of the Network as we recognise a number of people are now using social media to support their work. The main objectives of the toolkit is to help build confidence around using social media for work, from a CRN context. We encourage you to take some time to explore the toolkit and see what colleagues have to say about using social media to support them in their work and learning. The Toolkit is available via the Accelerating Digital Programme site. We will continue to update and develop the Toolkit over time to ensure that it remains relevant and useful. Thank you to colleagues that contributed to the Toolkit by sharing their learning around Social Media. If you would like to share your Social Media story with us in the form of a case study or if you would like to feedback any comments about the Toolkit please contact ad@nihr.ac.uk

  • NEW report: Patient experience in research annual survey findings (6/18/2018)
    The NIHR CRN CC has published its latest report on findings from 2017/2018 patient experience in research survey. This report is really important to our understanding of what it is like to experience being part of the research activity we run in the NHS. It is also critical to helping us understand where we can and must improve and so please cascade widely and take the time to read the helpful recommendations. The report also highlights the fantastic work of research staff in health care organisations and this should be celebrated. Read it here

    For an insightful blog from Simon Denegri on the report, see here

  • Improving Performance in Initiating and Delivering Clinical Research (6/5/2018)
    Improving Performance in Initiating and Delivering Clinical Research
     
    Statement from the Department of Health & Social Care
     
    “The Government is committed to creating the best environment for clinical trials and achieving the ambition set out in the Life Sciences Industrial Strategy to make the UK a top tier global hub for biomedical and clinical research and medical innovation. This includes a commitment to increase the number of clinical trials, improve clinical trial capabilities and reduce the time it takes to initiate and deliver studies, ensuring we are supporting the most innovative trials and meeting the needs of the Life Sciences Industry.
     
    As part of a package of support to improve performance in initiating and delivering clinical research, the National Institute for Health Research will continue to require providers of NHS services in receipt of NIHR funding to measure and publish their performance in initiating and delivering clinical research. This requirement is also being reinforced through the NHS standard contract, as outlined in NHS England’s ‘12 Actions to Support and Apply Research in the NHS’, as a measure of the importance of clinical trial performance to the NHS, patients and the Life Sciences Industry. 
     
    The 70 day benchmark for clinical trials, which was introduced as part of the publication requirements, has played an important role in driving up trial performance in the NHS in England.  However, we have had feedback from the Life Sciences Industry that publication of performance data using the agreed Minimum Data Set, rather than the 70 day benchmark, will now better meet the needs of industry partners in research site selection and allow sponsors to view the most appropriate timelines for each clinical trial. In response to this, we are now removing the 70 day benchmark for performance in initiating clinical research.
     
    We are also initiating work to streamline the collection of performance data from NHS Trusts, and to improve data quality and usefulness.
     
    We will continue to monitor performance data and feedback from the Life Science Industry as this change is embedded.
     
    The NIHR Central Commissioning Facility Clinical Trial Performance team have updated the PID guidance documents for Q1 18-19 to reflect the changes in reporting and publishing requirements. If you have any questions or concerns, please do not hesitate to contact them at CTP@nihr.ac.uk.”
  • Revised mNCA stakeholder event 26th June 2018 (6/4/2018)

    The revised model Agreement for Non-Commercial Research in the Health Service (mNCA) will be published in mid-June. Non-commercial sponsors and participating NHS organisations will be expected to use the mNCA in line with the guidance and without modifications.

    Following publication there will be a stakeholder workshop in London on Tuesday 26th June 2018 to:

    • Provide delegates with insight into the redrafting process that created the revised mNCA.
    • Guide delegates through the key changes to the mNCA.
    • Receive stakeholder opinion on further developing associated guidance and implementing the revised mNCA
    • Discuss next-steps with regard to maintaining the mNCA template and developing other template agreements
    The workshop is free and open to representatives from non-commercial sponsor organisations (NHS, CTU, HEI, Research Charities, etc.) and participating NHS organisations, who are responsible for drafting and/or reviewing non-commercial site agreements. Places are limited to 50 delegates. If the event is over-subscribed, we will limit the attendance to one attendee per organisation.
    The meeting will take place 11am-4pm. Lunch will be provided.
    ETC Venue
    Avonmouth House
    6 Avonmouth Street
    London
    SE1 6NX
    (Between Elephant and Castle and Borough Tube stations).
    To register please email Traci Pollitt at hra.systems-development@nhs.net. Registration will close 19th June 2018. Please advise if you have any special dietary requirements.