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March 2021 Newsletter

Date: 1 March 2021

Welcome to the Forum March 2021 Newsletter

This month is the official start of spring and with much focus on hope and new beginnings we are making tentative steps towards brighter times. In recent days we have seen a new UK -wide vision for clinical research delivery and reports on research culture; last month a white paper for Integrated care systems. All of these initiatives have in common many of the things we hold true as a Forum as we continue work together as an R&D community. These are collaboration and partnership, patient and public focus and an effective and valued workforce.

Thank you for all that you are doing.

Did you know?

Every Thursday our working groups hold a Covid coffee catch up for those working in R&D departments to share initiatives, questions, challenges and solutions. We also use the sessions to feed real time insights to those who are shaping our restart, resilience and growth (link to RRG).

Read a blog on COVID Coffee written by Sally Humphreys

If you would like to join in you are welcome, click here

Wednesday 31st March 2021, 11-12pm

The next virtual round table is being held jointly with UKRD and invites those with strategic oversight of NIHR funding in their organisation to discuss open access policy. Join colleagues and members of the DHSC policy team.

“How can the NIHR sustainably and strategically support research active health and care organisations to fund open access?”

Click below to join colleagues and members of the DHSC policy team.

Do you want to host a discussion or suggest a topic? Please complete the form on our website or get in touch info@rdforum.org.uk

More details and booking

Clinical Investigations of Medical Devices: 13th April 2021

A new virtual course which covers the regulatory framework governing clinical investigations in the EU and the UK including:

The Regulatory Environment for medical devices including the currently applicable Medical Device Directives and the changes coming in with the new Medical Devices Regulations which will apply in the next few years will be covered. The course then turns to Clinical Investigations with Medical Devices and their role in demonstrating Conformance for CE marking and the requirements for the UK process post Brexit.

Click on the button below for full course information and details of how to book your place.

More details and booking

Reflect & Connect: 17–21 May 2021

Hear from key leaders connected to R&D in a week packed full of content.

* Policy & decision making: DHSC, HRA, MHRA and NIHR Clinical Research Network

* Chief Investigators of main Covid 19 Urgent Public Health Studies: Covid-19 vaccine trials delivery programme, PRINCIPLE, RECOVERY, REMAP-CAP and PHOSP-COVID

* Making Research Happen: nursing & midwifery workforce contribution and impact, public involvement in a public health emergency, the cost of covid, the future of research and rebuilding the charity sector

Each session is 45 minutes with three sessions per day during 17-21st May. Registration is £100 (+VAT) per person.  There are 14 sessions and you can attend as many them across the 5 days. If you are unable to attend a specific session you can watch the recording of the session at a later date.

More details and booking

Archiving Masterclass: 7th June 2021

A one day in-depth master class developed to support research management teams with their processes for archiving. Taking participants through all the key requirements for managing, storing and archiving essential documents and research data, this virtual course is for anyone who has responsibility for archiving research in their organisation.Click on the link below for full course information and details of how to book your place.

More details and booking

Essentials of NHS Research: 14th & 15th June 2021

This interactive two day 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.

Click on the link below for full course information and details of how to book your place.

More details and booking

Local Capacity & Capability: 28th June 2021

This one-day course is 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. Designed for staff in R&D offices responsible for assessing and confirming local capacity & capability, for sponsors of health research and researchers designing studies.Click on the link below for full course information and details of how to book your place.

More details and booking

Influence

Forum response to government white paper: Working together to improve health and social care for all

The Government has published a White paper setting out legislative proposals for a Health and Care Bill.

NHS R&D Forum Executive member Shona Haining has written to the Department of Health & Social Care on behalf of the Forum and UKRD, to outline that research might be further considered in Integrated Care Systems. Forum members will continue to discuss in groups meetings.

Read the white paper here

NHS R&D Forum response to the CQC strategy consultation

A written response to the CQC strategy consultation has been submitted  in order to to champion the inclusion of research.

The CQC well-led inspection framework has played an important role in ensuring research is on the radar of Trust boards and senior NHS leadership however we now have an opportunity to ensure research is really core to quality and improvement in health and care.

Read more about our response

Meetings

Alongside weekly COVID Coffee, training events and roundtable discussions Forum representatives have attended the following stakeholder meetings in the past month, on behalf of the community:

* HRA study set up board

* HRA champions

* MHRA stakeholder meeting

* DHSC ETC feedback

* 4 nations contracting group

* HRA Non-commercial Sponsors

* CARE (Coordinated approaches to Research and care Embedded)

* Cross sector policy group

* RRG advisory board

* Industry road map group

Forum group meetings last month

* Research Management working group

* Primary Care and Commissioning working group

* Evidence for Commissioning working group

* Service Users & Carers Working Group

All groups are working with key stakeholders on topics relevant to research management, support and leadership practice. These include: remote monitoring, RCF in primary care 2021, IT in primary care, evidence and evaluation practice, knowledge transfer frameworks and contracts for public contributors. The primary care working group were pleased to have received a very positive letter from DHSC in response to their paper submitted last month in relation to RCF in primary care during COVID.

Previous roundtables

Two roundtable discussions were held last month. Thank you to our partners from ECMC Network and the 4 nations contracts group. Download the slide sets from these sessions here 

Please remember that your feedback makes a difference. Working through the Forum with all our partners across the research ecosystem we have real opportunities for influence.

All comments can be made via our influencing pages or directly to Kate via info@rdforum.org.uk

Hot off the press

New UK Vision for Clinical Research Delivery

Partner organisations from across the health research ecosystem have welcomed the publication of a bold and ambitious vision for the future of clinical research delivery in the UK. NHS R&D Forum representatives will continue to support the implementation of this vision.

This UK-wide vision sets out the ambition to create a patient-centred, pro-innovation and data-enabled clinical research environment, which empowers everyone across the health service to participate in delivering research and enables people across the country to take part in research that is of relevance to them.

The vision has been developed through the cross-sector Recovery, Resilience and Growth programme, with NIHR working alongside the NHS, regulators, medical research charities, life sciences industry, the UK government and devolved administrations.

Five key themes underpin the vision and there are 7 areas for action. Read more here

New eligibility criteria for student research from 1 September 2021

The HRA and the devolved administrations, supported by the Wessex Institute at the University of Southampton, have reviewed their approach to study approval for student research.

The review aimed to ensure students have the best learning experience of health and social care research, and to reduce the time that the HRA, DAs and NHS Research Ethics Committees (RECs) spend advising on and reviewing student applications. Read more here

Key changes to UK amendment process

The devolved administrations, the HRA and the MHRA have agreed to make two key changes to the UK amendment process with effect from 25 March 2021.

Firstly, the addition of a new NHS/HSC site or a change of PI at an NHS/HSC site for a CTIMP study will now be classified as a Non-Substantial Amendment*. This was previously considered a Substantial Amendment. The change is designed to speed up new site set up. This is possible because new sites were categorised as substantial due to EU guidance and therefore, from January 2021, we can take a different interpretation for NHS/HSC sites due to the UK system in place.
Read more here

Mapping the recovery of cancer research: report

Read more here

New NIHR Primary Care Research Strategy Published

Read more here

The ARMA Survey on Research Culture 2020

Read more here

NIHR Update

We would like to share the following updates on behalf of NIHR.

* Over 1 million participants take part in COVID-19 research – Thank You!

* The Future of UK Clinical Research Delivery

* Applications no longer being accepted for studies to be designated as Urgent Public Health

* Supporting the Life Sciences Sector

* NIHR Urgent Public Health Studies Research Workforce Participation Certificate

* Spotlight on ENRICH (ENabling Research In Care Homes and how care home research has become more important during the pandemic.

* Introducing the NIHR CRN INCLUDE Guidance: Improving inclusion of under-served groups in clinical research

* Lessons From COVID-19 Research in the UK

* Increasing Participation of Black, Asian and Minority Ethnic Groups in Health and Social Care Research

* CRP Accredited Register

* NIHR MOOCS (free online courses)

* New Cluster C Specialty Cluster Lead

* New appointments at the NIHR Clinical Research Network

* Join Dementia Research turns 6!

* NIHR Digital Office update

Read the full NIHR update

New resources in REX this month

Template: Vaccination Trials Model Service Level Agreement for NHS Organisations and University Service Providers. Useful for hub and spoke models

* Wellcome Research Culture Festival Resources

* eClinical Forum has released the 2021 version of their “eSource Readiness Assessment” – eSRA including handbook and assessment questionnaire. These updates have been made in response to a growing expectation by regulatory agencies for clinical trial sponsors to verify that clinical research site systems (e.g., EHRs) comply with requirements to protect confidentiality and provide accurate and reliable data for the use in a regulated research environment.

Did you read?

The following excellent articles, blogs and commentary has been published this month:

What does the new clinical research vision mean for NHS patients and health professionals?

Read the blog by Alison Austin, Deputy Director of Research, NHS England and NHS Improvement

Moving forward together – supporting the future of clinical research in the UK.

Read the blog by Dr Janet Messer, Director of Approvals

Recovering clinical research in the UK

Read the blog by Dr Matt Westmore, Chief Executive HRA

Involvement in Research: offer choice and don’t let Zoom become the default

By Penny Vicary (PPI contributor) in conversation with Elspeth Mathie (University of Hertfordshire, ARC East of England). Penny is also a member of the NHS R&D Forum service users and carers working group. Read more here

Covid: The London bus trip that saved maybe a million lives

By James Gallagher BBC Health and science correspondent. Read more here

One year on since the first COVID-19 research studies were approved

Read the blog by Naho Yamazaki, Head of Policy and Engagement HRA

Inspectors grounded – a year of innovation

Read the blog by Paula Walker, MHRA GCP Inspectorate Operations Manager and a Senior GCP inspector.

Please be mindful that some resources will require updating over time.

View the latest additions to the Resource Exchange

 

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