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September 2021 Newsletter

Date: 30 September 2021

Welcome to the Forum September 2021 Newsletter

Welcome to the NHS R&D Forum newsletter for September.  I hope you have all being able to get some rest and relaxation over what passes for Summer in the UK. It is obvious, from study recruitment numbers, that NHS R&D staff are making superhuman efforts to recover clinical research as well as continuing to open new Covid and non-Covid studies and maintain follow-up for Urgent Public Health and vaccine studies.

We’ve all seen, in the general media as well as the medical science press, that the massive research efforts over the past 18 months has resulted in significant progress in therapies and vaccines for Covid. It’s rare for those of us involved in research to see findings implemented so soon and with such immediate impact. Whatever part you have played, and continue to play, we should all be very proud of the combined effort which has saved hundreds of thousands of lives, and probably considerably more, worldwide.

The Forum is looking to recruit a part time coordinator – please take a look at the details and bring to the attention of anyone you think might be interested.

This month there is is updated guidance and information on the use of blood test vials in research studies during the current shortage, the MHRA and UK Ethics Service combined review due to be implemented for CTIMPs from 1St January 2022 and Information on Excess Treatment Costs.

The joint R&D Forum/UKRD Finance Group has produced a Research Finance Manual which is now available for consultation and feedback on the UKRD website (https://www.ukrdleaders.org/). The manual provides a broad overview across many areas with a number of specific case studies. The Forum Learning and Development Group will be looking to include relevant material in existing courses and also aims to develop more specialist Research Finance training in due course.

The Learning and Development Group, Chaired by Allyson Bailey, is working on new CPD offerings and continuing to work on our existing courses making them appropriate for virtual and face-to-face delivery.

In all the chaos you are doing a sterling job with real life impact. Stay safe.

Maria Palmer
Director, NHS R&D Forum

 

Forum Coordinator Role

The NHS R&D Forum is looking for a coordinator to support the activities of the Working Groups and membership.

Part-time / Secondment opportunity – Fixed term for 12 months in the first instance (0.3-0.6 WTE negotiable)

The NHS R&D Forum is seeking a part time, highly motivated, organised and proactive individual with experience of health or social care research management to join us as the Forum Coordinator.

This post is offered for 12 months in the first instance. The Coordinator will support the executive team, Chairs of Forum working groups and wider Forum membership in our activities.

Working for the NHS R&D Forum provides an excellent personal development opportunity to gain experience at a UK level. Mentoring and coaching will be provided by the Executive and Leadership community.

This role is offered as a secondment opportunity or on a consultancy basis. It is essential that if applying on a secondment basis, you have full support from your line manager in writing before applying.

For further information and to read the full job description, please click below.

R&D Forum Coordinator – Full Job Description

Best Patient Care, Clinical Research and You – By Ashley Solleri, Group Head of Research at Mid and South Essex NHS Foundation Trust

I was delighted to be asked to work with the NIHR, NHSE, NHSi, and UKRD on behalf of the NHS R&D Forum to develop a guide to support organisations with embedding research into everyday clinical practice and help fulfil the research components of the CQC Well Led Framework; the result was Best Patent Care, Clinical Research and You.

The guide outlines how each group of staff within an organisation has a role to play in research wherever they work in an organisation; that maybe being able to signpost people to someone in the research team, to clinical staff identifying potential recruits to senior managers enabling and leading the organisation’s research endeavour.

Read the full blog here

RDF20 Conference Credits
As a reminder, RDF20 Conference credits can be used against any NHS R&D Forum training course and symposia events.  If you have a credit account and wish to register for an event, please ensure you are logged into your credit account before you start the booking process. Once on the booking summary page, you can then choose to apply the credit. Within the credit account, you can also view the remaining balance and any invoices/bookings where credits have been applied. You should have been sent login details on how to access the credit system. If you need any assistance please contact the Forum.

Regulatory Inspection Ready. A One Day Training Course: 4th October 2021
This one-day course is aimed at those who deliver research in a healthcare setting either in a Sponsor team or as a Host, and that maybe subject to regulatory inspection. Preparation for Inspection is critical but compliance driven from preparation rather than from quality systems can lead to poor practice and Inspection findings.

(JUST 2 PLACES REMAINING FOR THIS COURSE)
More details and booking

Archiving Masterclass. A One Day Training Course: 18th October 2021
A one day in-depth master class delivered by trainers with advanced clinical records management expertise taking participants through all the key requirements for managing, storing and archiving essential documents and research data.
More details and booking

Essentials of Research Sponsorship: 1st November 2021
This course is designed to provide the essentials to become and/or improve the management of clinical research as a sponsor.  A one day course that will provide an opportunity to develop skills and gain knowledge in the underlying principles of sponsorship. The course covers widely accepted concepts that not only directly apply to sponsorship but are transferable to other areas of the research industry.
More details and booking

AcoRD Practitioner: 15th November 2021
The set up of non-commercial studies in the UK requires cost attribution in accordance with DHSC AcoRD Guidance. The ability to attribute research activities swiftly is critical to ensuring the correct funding streams fund the research appropriately and that projects run well across all sites. A skilled AcoRD specialist plays an important role and this course complements a package of training to support them as well as those in R&D roles and Sponsor teams who advise researchers in their applications for funding.

(JUST 4 PLACES REMAINING FOR THIS COURSE)
More details and booking

Student Research
New eligibility criteria for student research is now live, designed to ensure that students get a great experience of how modern health and social care research is conducted.
Read more here

Question and Answers: Student Eligibility Criteria
We’ve worked with ⁦‪@arma_uk⁩ to answer some of your questions about the new changes to eligibility criteria for student research, which come in from 1 September.
Read full news item here

Health Research Authority – Make It Public Conference
On the afternoons of 3 – 4 November the Health Research Authority will be hosting their first transparency conference where they will be showcasing best practice in transparency in health and social care research as part of the DHSC ‘Make it Public’ strategy.

#MakeItPublic

Register your Interest and Ask Questions via Email Here

The Health Research Authority moves to make research transparency the norm
From Wednesday 15 September health and social care researchers are expected to submit information at the end of their research study to the HRA online, explaining how they have fulfilled their transparency responsibilities. This is part of a set of changes which make it easy for researchers to be transparent and enable the HRA to know whether they are meeting the requirements.A key responsibility is that researchers plan at the outset of their study how they will communicate the results to participants at the end of the study. The new reporting requirement will help the HRA check that this has been done. Researchers are also expected to submit a lay summary of results, which the HRA will publish on its website, ensuring research participants and the public can easily find and understand the outcome of the studies.
Read more here

CCG Excess Treatment Cost Helpdesk Service
Since October 2018, when the NIHR Clinical Research Network assumed responsibility for managing the payment of Excess Treatment Costs (ETCs) for studies commissioned by CCGs, a helpdesk service has been in place to support study teams, R&D offices and the wider research community with ETC-related questions.The ETC Helpdesk team (etc.helpdesk@nihr.ac.uk) is available to answer any questions or queries about the CCG ETC national payment process and principles, including Provider Thresholds and assigning a payment model to a study. We aim to respond to enquiries within five working days. Please note that queries regarding studies marked as Specialised Commissioning should be directed to england.speccommetcs@nhs.net.
Read more here

Blood Tube Products Guidance and Research
Everyone is aware of the blood tube products shortages and how it may impact on research. The updated blood guidance has been published, see link below.The updated guidance focuses on getting back to best practise. There is a section on acute shortages and also where guidance on research is, this states:7.7 Blood tests as part of clinical research
7.7.1 Blood tests in the context of ongoing clinical research studies should not be disrupted where doing so would lead to deviation from the study protocol or risk invalidating the research. Where tests can safely be modified or omitted, this should be done in consultation with the appropriate research governance bodies.
7.7.2 Please continue to follow the study protocol (without modifications or deviations) except where changes have been agreed in advance with the chief investigatorPlease keep checking this guidance and your own trust to manage any challenges in research.
Read full and updated guidance here

Combined review for clinical trials – get ready for January 2022
From 1 January 2022 all new CTIMPs (Clinical Trials of Investigational Medicinal Products) in the UK will benefit from a combined review from the MHRA and UK Ethics Service – one application, one coordinated review, one decision. Offering a more streamlined and efficient end-to-end service using a new part of IRAS, it’s open now to all CTIMP applicants and sponsors.
Read more here

R&D managers awareness and role in sharing outputs of research
NIHR strives to make its research outputs readily available to a wide range of end users. NIHR Alerts are plain English summaries of important findings; NIHR Collections are overviews of research on wider themes. Both Alerts and Collections highlight the action points that flow from research, to promote its use in practice. We would like all in the research community to be aware of them.Recent Alerts have covered practical changes in cancer care that could reduce fear and confusion among people with dementia,  slip resistant shoes that could prevent injuries in NHS staff, and personal risk assessments for women with kidney disease who are considering pregnancy. Collections have looked at why we need more inclusive research and the brief conversations in primary care that are an opportunity to boost health.

Please use all opportunities in the organisations you work in, and with stakeholders, to raise awareness of the NIHR Evidence website. Sign up for the NIHR Evidence monthly newsletter, which summarises the latest publications, and follow NIHR Evidence on Twitter.

NIHR Updates

 

NIHR Clinical Research Network:  The Next Ten Years.  DHSC Consultations

Over the summer the Forum, together with UKRD, responded to the DHSC request for consultation about the future of the CRN. The DHSC posed 3 main questions:

  1. What do you think the CRN is meant to do? What do you think the CRN actually does in practice? Are these different? If so, why?
  2. Given carte blanche policy-wise, what would you ideally make the core functions of the CRN?
  3. What would you make sure to preserve about the current work of the CRN?

A combined response was submitted this week and will be posted on the UKRD website with a link from the Forum website. Many thanks to all those who sent responses – Forum responses were collated and are included in the joint document.

NIHR Learn – Research & Quality Improvement Learning Community for Primary Care

NIHR Learn Research and Quality Improvement Learning Community for Primary Care is now live! This community offers a rich portal for users to interact with colleagues from across the UK as well as access to a range of high quality resources and related training.

Read more here

Contacting the R&D Forum

As a reminder, should you need to contact the Forum the best way is via email which is info@rdforum.org.uk

The latest job vacancies displayed on our website.

 

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