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Guidance on the impact of COVID-19 on research funded or supported by NIHR

Guidance on the impact of COVID-19 on research funded or supported by NIHR

 

CRN Greater Manchester staff support during COVID-19 outbreak

 

Getting a study nationally supported or funded as high priority COVID-19 Urgent Public Health Research

Government support is available to prioritise, coordinate and deliver these studies, regardless of sponsorship and funding source.

This support includes expedited identification of sites to ensure appropriate geographical distribution of Urgent Public Health Research to maximise recruitment and minimise over-commitment of resource.

To be considered for this support, please follow the Department of Health and Social Care review process.

Local queries

If you wish to contact NIHR CRN Greater Manchester with any queries, please do so via our usual contact address, which is being monitored as usual: researchsupport.crngm@nihr.ac.uk 

We have also created an online COVID-19 notification form if you want to make us aware of any issues which have arisen as a result of the virus. 

Training 

As you will understand, all NIHR CRN Greater Manchester face-to-face training for the remainder of March/April/May has been cancelled or postponed, with June dates likely to be added to that list.

Our Workforce, Learning and Development Lead has provided full details of the interim arrangements and advice

Recording delays

The data recording system, R-Peak, now has a new functionality which allows Trust R&I teams to record/capture research delays caused to NIHR Portfolio studies by COVID-19.

Our Head of Information Management & Technology has provided full details.

 

Latest NIHR statements 

 

A letter to all UK NHS trusts on the importance of COVID-19 Clinical Trials, from UK Chief Medical Officers and NHS England National Medical Director - 2 April 

Dear colleagues,

Novel Coronavirus: Clinical Trials

We are writing to ask that every effort is made to enrol COVID-19 patients in the national priority clinical trials; there are trials in primary care, hospital settings and ICUs.

As yet, there are no proven treatments for Covid-19. We need to gather reliable evidence through clinical trials. Using international evidence and UK expertise the most promising potential treatments, at this stage, have been identified and the UK is running national clinical trials to gather evidence across the whole disease spectrum.

The key three national trials are:

PRINCIPLE (higher risk patients in primary care trial). www.principletrial.org 

RECOVERY (in hospital trial) https://www.recoverytrial.net For further information please email: recoverytrial@ndph.ox.ac.uk 

REMAP-CAP (critically ill patient trial) https://www.remapcap.org For further information please email: ukremap-cap@icnarc.org 

Other priority studies, including observational studies, are listed here - https://www.nihr.ac.uk/covid-19/urgent-public-health-studies-covid-19.htm 

These trials are being run as simply as they can to reduce the burden on the NHS, with adaptive designs so further treatments can be added if new promising candidates are identified. The results are essential to the future treatment of UK and global patients. We will ensure important results are disseminated rapidly to improve practice.

The faster that patients are recruited, the sooner we will get reliable results. While it is for every individual clinician to make prescribing decisions, we strongly discourage the use of off-licence treatments outside of a trial, where participation in a trial is possible.

Use of treatments outside of a trial, where participation was possible, is a wasted opportunity to create information that will benefit others. The evidence will be used to inform treatment and benefit patients in the immediate future.

Any treatment given for coronavirus other than general supportive care, treatment for underlying conditions, and antibiotics for secondary bacterial complications, should currently be as part of a trial, where that is possible.

Best wishes,

Dr Frank Atherton, Chief Medical Officer for Wales / Dr Catherine Calderwood, Chief Medical Officer for Scotland / Dr Michael McBride, Chief Medical Officer for Northern Ireland / Professor Chris Whitty, Chief Medical Officer for England / Professor Stephen Powis, National Medical Director for NHS England and NHS Improvement

 

Prioritising funding and support for COVID-19 research across the UK - statement 26 March 

Working with partners across the health and care system, NIHR is leading, enabling and delivering world-class COVID-19 research, a key element of the Government’s overall response to the pandemic. Given the extraordinary pressures currently being faced by the health and care system, we must also ensure that we are making best use of the limited resources and capacity available to support research.

We will do this by establishing and implementing a single, national process that will allow the Chief Medical Officer (CMO) / Deputy Chief Medical Officer (DCMO) for England to draw on expert advice to prioritise the COVID-19 studies which hold the most potential for tackling the challenges we face.

This process will cover funded studies, irrespective of whether they are funded by the public sector, industry or charities and also, in partnership with UKRI, studies that require funding. It aims to prevent duplication of effort and to ensure that the capacity of the health and care system to support research is not exceeded.

Details of the process and the new single point of entry for prioritising COVID-19 studies are now published.

With regard to HRA approvals, researchers should make an application through the national prioritisation process first and will be signposted for expedited regulatory approvals so that approval review can progress in parallel to the system of assessment leading to a view from CMO/DCMO on prioritisation.

All NHS Trusts, health and care providers and universities will need to prioritise support for studies which have been nationally prioritised. A live list of these studies is being collated.

Organisations may support COVID-19 research activity only when this does not impact on the system’s ability to recruit participants and/or provide the resources (including staff, samples and data) needed to support nationally prioritised research. Organisations will be expected to pause any local studies that impede their ability to contribute to national research efforts.

 

COVID-19 studies are only priority - Statement 19 March 

Until further notice, the NIHR Clinical Research Network is pausing the site set up of any new or ongoing studies at NHS and social care sites that are not nationally prioritised COVID-19 studies.

This will enable our research workforce to focus on delivering the nationally prioritised COVID-19 studies or enabling redeployment to frontline care where necessary.

These studies are enabling the clinical and epidemiological evidence to be gathered to inform national policy and will enable new treatments, diagnostics and vaccines to be developed and tested. The complete focus of the NIHR Clinical Research Network will be on delivering these highest priority COVID-19 studies. 

During this time, the MHRA and HRA will continue to provide an approvals service for all studies, prioritised in accordance with the national situation, ensuring site set-up can restart promptly in due course.

 

Department of Health and Social Care / NIHR statement - 16 March 

In response to COVID-19, Dr Louise Wood CBE, has issued the following statement. Dr Wood is Director of Science, Research and Evidence at the Department of Health and Social Care and co-lead for NIHR. 

Working with partners across the health and care system, NIHR enables and delivers world-class research that transforms people's lives, promotes economic growth and advances science. This is why the NIHR community must prioritise nationally-sponsored COVID-19 research activity, a key element of the Government’s overall response. We urge all parts of the research system to help progress these studies at pace. 

Many of our community who drive or deliver NIHR research also provide direct care to patients and the public. Given the scale of the national and global challenge of COVID-19, clinical and academic health & care professionals currently funded by NIHR who are working on topics other than COVID-19 should prioritise frontline care, where requested to do so by their employing organisations. Similarly, research staff with other relevant skills, such as pharmacists and laboratory technicians, should also prioritise support to frontline care. In addition, researchers should consult with their employers to make facilities which currently support research studies available for frontline care. 

This will mean that many research studies funded by NIHR, or supported by NIHR (via the Clinical Research Network and other NIHR infrastructure) may need to be paused, to free up NIHR-funded staff to help bolster the frontline response to COVID-19. In addition, we recognise that NIHR award-holding organisations may need to pause research studies for locally determined public health reasons. 

However, clinical trials or other research studies which are funded or supported by NIHR should continue if discontinuing them will have significant detrimental effects on the ongoing care of individual participants involved in those studies. These are clinical decisions which will need to be made on a case-by-case basis by local decision makers on the basis of local risk and capacity assessments.

All organisations holding NIHR awards that are paused will, in the short term, continue to receive payments from DHSC in line with existing NIHR contractual payment schedules. This will be reviewed and if necessary, payment schedules will be updated as usual following the annual statement of expenditure. Where necessary, contract deliverables will be rescheduled allowing staff to concentrate on frontline care and COVID-19 research. 

Any individuals or organisations funded by and/or supported by a particular NIHR funding stream who have further questions should contact their relevant NIHR Coordinating Centre in the first instance. Your usual contacts will apply but, if in any doubt, please get in touch via the contact points outlined below.

Q&A on this topic can be found here. We will update this advice periodically in response to future developments. 

Finally, may I thank you for the efforts you are already making to support COVID-19 research and your response to the needs of the health and care system during these extraordinary times.

Dr Louise Wood CBE

Director of Science, Research and Evidence at the Department of Health and Social Care and co-lead for NIHR.

 

Contact points for further information:

  • If you are in receipt of career development award funding including fellowships: academy@nihr.ac.uk
  • If you are in receipt of programme funding: either ccf@nihr.ac.uk (i4i, PRP, PGfAR, PDG, RfPB and RIGHT) or netsmonitoring@nihr.ac.uk (EME, HS&DR, HTA, PHR, ESP, CTU support funding, HSPR and global health units and groups)
  • If you have questions about the delivery of a clinical study: crn@nihr.ac.uk
  • If you are part of NIHR's broader research infrastructure or a school or unit: ccf@nihr.ac.uk
  • If you are a patient or member of the public and have been recruited into a research study, please direct any questions to your study team