April 2020 Newsletter
Date: 1 May 2020
Help, Support, Leadership & Connection
While we all focus attention on the brilliant COVID-19 research effort we are keen to ensure there continues to be help, support, leadership and connection for the research management community.
This April newsletter highlights some of the things going on across the Forum at the moment, alongside all the latest regulatory updates and news from policy makers and partner organisations.
We do hope you and your teams are keeping well. A new helpful guide from the British Psychological Association to support leaders & managers who need to consider the well-being needs of all health care staff is now in the resources exchange.
If you need an ear or some support then please get in touch FAO Kate at info@rdforum.org.uk
Did you know?
One of the leading trials responding to the COVID-19 challenge is the RECOVERY Trial which is an adaptive study design.Insights into adaptive studies and other complex and novel methods were shared at our Forum symposium in early March. You can download the slide set from this event here.
The NIHR CRNCC has also just launched a very helpful infographic in NIHR Learn entitled: COVID-19 Research & Platform (Complex Innovative Design) Trials which we have also added to our resources exchange.
Well done and thank you to everyone who has gone above and beyond to make the RECOVERY study and others a success to date.
RDF2020
Publication of posters or oral presentations
We are considering enabling those who have already worked on their poster or oral presentations for RD20 to publish if they wish. This initiative must support the community and not add any burden, therefore we would like to hear from you if you had an abstract accepted for RDF20 and would like to contribute. There will be other opportunities to share work, however we would like to support those who have already spent considerable time developing their outputs. Please get in touch via info@rdforum.org.uk
Training & Learning Plans
The Forum Executive team continue to look at the best way to support a meaningful and accessible learning programme and are developing a strategy to ensure we can continue to offer training over the coming months without creating an extra burden.If you have booked onto a course that has been postponed due to COVID-19 we will be contacting you directly with options.
If you have a particular training need that is either urgent or something for the longer term then it would help us to know more details so that we can be most effective. Email FAO Kate via info@rdforum.org.uk
Short weekly COVID-19 hangouts
Members of our Forum working groups have been “meeting” weekly to share, discuss practice and check in on general well-being. Based on these calls we have been feeding back to the Department of Health & Social Care stakeholder meeting, representing R&D management teams.
Our Forum group members act as representatives of both the R&D community and the Forum itself so please share your challenges with them or email FAO group chairs at info@rdforum.org.uk
The main items discussed and shared to date have been around:
- Visibility of the pipeline & workforce capacity
- Managing a remote team
- Recovery plans & financial risks
- Nightingale Hospitals
- Managing grants
- Use of RCF
- Study delivery & workload requests
On the basis of our hangouts we continue to feed into the DHSC stakeholder meeting, HRA, NIHR CRN and others on a regular basis.
R&D community goes #Red4Research
On the 3rd April the entire R&D management community went red in support of the fantastic research efforts for COVID-19.
The #Red4Research campaign was conceived by Sally Humphreys and, in true pandemic response fashion was launched within 3 days! Sally is a nurse, clinical researcher and chair of the Forum research management working group. Sally wanted to bring some positivity and to raise the profile of the COVID-19 research being mobilised. Supported by the Forum, HRA and others #Red4Research is a great example of how one person in a community can make a difference.
The campaign was exactly the tonic we needed to lift spirits and made a phenomenal 9.9 million impressions, raising the profile of research for COVID-19 across the world and ending on a day when the Chief Medical Officer announced unprecedented support for research across the NHS and the UK in his letter to NHS organisations.Thank you and well done to all
#whywedoresearch
This is another great campaign and the #why team are hosting some fabulous tweet chats at the moment all centred around COVID-19.
MRC Regulatory Advice Service: Special Bulletin.
The COVID-19 pandemic has significantly impacted health research as it has every aspect of our lives. In this bulletin the MRC pull together information about the special research governance arrangements currently in place to help tackle the pandemic. Many of these arrangements will be temporary. Read more here.
HRA
HRA COVID-19 webpages have recently been updated with information on fast-track amendments, patient consent, use of patient data and approved studies. Read more here.
The March 2020 versions of the commercial model Clinical Trial Agreement (mCTA) and Clinical Research Organisation model Clinical Trial Agreement (CRO-mCTA) have been published on IRAS Help.
Agreed by the Association of the British Pharmaceutical Industry (ABPI), Health and Care Research Wales (HCRW), Health and Social Care Northern Ireland (HSC NI), the Health Research Authority (HRA, England) and NHS Research Scotland (NRS), the revised and updated templates reflect significant engagement with commercial research sponsors, CROs and the NHS. They provide GDPR and Data Protection Act 2018 compliant clauses for the processing and sharing of personal data. Commercial sponsors and CROs are advised to make provision for unmodified use of the revised templates at their earliest opportunity. All parties should however note that a period of at least six months will be allowed for the transition to the new templates and that, during this period, the previous versions of the templates will be permitted in IRAS applications. Full detail of the changes instanced in the March 2020 templates, and contacts for feedback, are provided in the guidance document accompanying both templates.
NIHR update
NIHR MOOCs (Massive Open Online Courses)
Based upon requests from research delivery colleagues, we are pleased to confirm that the NIHR MOOC (Massive Open Online Course) ‘Improving Healthcare through Clinical Research’ is now available. Originally this had been scheduled to restart on the 4th May.
The course is particularly useful for clinical colleagues or volunteers with an interest in research. The course covers the history, theory and practice of clinical research. Although it is not specifically focused towards the needs of COVID-19 research, several sections are highly relevant. There will be an extended period of actively moderated discussion (6 weeks rather than 4 weeks). Moreover there will be ongoing access to the course materials will be enabled for the foreseeable future, and a further period of active moderation throughout July.
We have also enabled ongoing access to the content of our other NIHR MOOC ‘What is Health Research?’. This is particularly relevant for members of the public; helping inform their decision on whether to take part in research.
Key contacts at the Coordinating Centre:
sarah.cluderay@nihr.ac.uk and tara-sienna.hartman@nihr.ac.uk
NIHR OpenLearn ( openlearn.nihr.ac.uk )
All NHS and UK academic colleagues can access the NIHR Learn LMS. Last year over 43,000 researchers used this platform to undertake GCP Education.
To ensure relevant NIHR learning is easily accessible to volunteers and those returning to the NHS, we have recently launched NIHR Openlearn. User accounts can be created using any email domain.
A key new learning programme hosted on both NIHR Learn and NIHR OpenLearn is Research Practice in Clinical Settings. This training is appropriate for staff working to support research delivery where typically the work does not involve being delegated tasks that are the responsibility of a Principal Investigator. They will be following the defined processes of each research study without delegated ‘freedom to act’.
This can be used as part of Induction Training (by an NHS Trust R&D department) or by a specific research study sponsor (e.g. for COV-001 and COV-002 vaccine research studies). However, this is NOT an Introduction to Good Clinical Practice (GCP). Research staff who are required to complete GCP training should complete the e-learning ‘An Introduction to Good Clinical Practice (GCP)’ course and any additional learning instructed by study sponsors, and Trust R&D departments.
COVID-19
You can stay up to date with the latest information on NIHR’s response to COVID-19 via the NIHR website, including the Q&A section here.
The NIHR has established a single, national prioritisation process for COVID-19 research to prevent duplication of effort and ensure that the resources and capacity of the health care system are not exceeded.
A live list of COVID-19 studies that have been given urgent public health research status by the Chief Medical Officer/ Deputy Chief Medical Officer for England is maintained on the website. All NHS Trusts, health and care providers and universities will need to prioritise support for studies which have been nationally prioritised.
National and local research delivery teams are working closely to support the rapid set-up and delivery of the nationally prioritised studies, including assisting with site selection, supported by visibility of ongoing activity through CPMS. Please continue to link closely with your LCRN for support and information on the priority studies.
New resources in REX this month
Newcastle JRO: COVID-19: Deviations to Current SOPs
Trial Forge: Evidence packs to provide up-to-date summaries of evidence for trial process interventions, especially in recruitment and retention and recommendations regarding their use.
The British Psychological Association Guidance: The psychological needs of healthcare staff as a result of the Coronavirus pandemic
NIHR CRNCC Infographic: COVID-19 Research & Platform (Complex Innovative Design) Trials
View the latest additions to the Resource Exchange here
Latest Jobs
Please submit your latest vacancies and we will also tweet them out.
Latest News
Virtual Courses
