Q&A on the impact of COVID-19 on research funded or supported by NIHR
How did the NIHR respond at the beginning of the COVID-19 pandemic?
In March 2020, we supported the NHS by enabling clinical and academic health and care professionals funded by NIHR who were working on topics other than COVID-19 to return to clinical care where requested to do so by their employing organisations. We emphasised the importance of continuing studies if discontinuing them would have significant detrimental effects on the care of individual participants. This staff redeployment, together with the reduction in routine care services in the NHS, reduced the capacity for non-COVID-19 research. Recognising this, the NIHR Clinical Research Network decided to temporarily pause site set-up of all new or ongoing studies other than nationally prioritised urgent public health research into COVID-19.
Can studies that were paused now be restarted?
While our priority continues to be COVID-19 urgent public health research, we believe the time is right to work towards the restoration of a diverse and active portfolio of research funded and/or supported by the NIHR. While our priority continues to be COVID-19 urgent public health research, we believe the time is right to work towards the restoration of a diverse and active portfolio of research funded and/or supported by the NIHR. To help initiate this process, we have developed a ‘Framework for restart’, which is a guidance document to support local decision-making.
Should studies that were not paused due to COVID-19 now be paused in order to be assessed using the restart framework?
No, this is not necessary. Studies should not be newly paused unless specific issues have recently arisen that need to be addressed, such as site capability or concerns that the study is no longer necessary or viable.
Is NIHR monitoring whether studies are being restarted?
As of 1 July, according to Clinical Research Network data received from 207 out of 223 NHS trusts, 174 Trusts (84%) have non-COVID-19 studies open to recruitment, up from 57% at the height of the pandemic.
The Network also has data on 3,906 non-commercial studies (79% of the non-commercial portfolio) that were open or in set-up during the acute phase of the pandemic. As of 1 July, 55% of these studies are paused, down from 70% at the peak; 26% are open for recruitment, up from 12% at the peak. Only 1.3% (51 studies) have had to close due to COVID-19. We are aware of 461 non-commercial studies that have restarted since the height of the pandemic.
The NIHR Central Commissioning Facility (CCF), NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) and NIHR Academy are also gathering information on the impact of COVID-19 on the work they fund and commission. All of this information is being combined and analysed to help the NIHR monitor restart activity and to help communicate changes in studies and activities to all stakeholders.
How can patients and members of the public get involved in the restart of research?
Be Part of Research has been updated to provide ready access to information on how to participate in current COVID-19 and non COVID-19 research.
According to the restart framework, one of the suggested pre-conditions for restart of paused studies is assessment of study viability. Should sponsors wait for sites to confirm viability or should sites wait for sponsors to confirm?
The default position for sponsors of commercial studies is to restart their studies. Sites can therefore proceed to assess the other pre-conditions outlined in the framework (safety and capacity/ site readiness) in order to inform the sponsor of their readiness to restart.
Non-commercial funders also support the prompt restart of studies so long as they are deemed viable at site level. If studies are able to restart without the need for a protocol amendment or study extension, studies may proceed to assessment of other pre-conditions. They urge all studies requiring a protocol amendment to liaise with their funder on requirement to re-open studies.
NIHR also supports the prompt restart of studies funded through NIHR programmes. If the Chief Investigator and sponsor determine that there is no need for a research plan or protocol amendment or study extension of more than six months or additional funding, studies may proceed to assessment of other pre-conditions. In all other cases, studies should liaise with their NIHR Research Programme monitoring contact.
Will NIHR fund extensions for research funded through NIHR Programmes?
NIHR acknowledges its ethical obligation to continue to support research projects funded through its Research Programmes prior to the COVID-19 pandemic, where these are likely to deliver their anticipated results, albeit on a longer timescale. We are sympathetic to extending contracts so that research paused or delayed because of COVID-19 has longer to complete, and will also consider applications for additional funding to cover such extensions.
The following criteria will apply:
- Projects that are following a research plan or protocol previously agreed with NIHR that do not require additional funding and only require an extension of up to six months will automatically be considered viable. There is no need for further confirmation from NIHR before continuing or recommencing such research.
- Projects requiring an extension of more than six months or a material change to the research plan or protocol or additional funding will be reviewed through the usual NIHR monitoring processes, and variation to contract (VTC) requests will be reviewed sympathetically. Where the Research Programme agrees to material changes and/or confirms a VTC, with or without additional funding, the project will be considered viable.
It is the responsibility of a project’s Chief Investigator to communicate the outcome of any decisions by the NIHR Research Programme to local Assessment and Prioritisation panels. Any difficulties encountered at local level should be reported to the project’s monitoring contact in the relevant NIHR Research Programme team.
When it comes to prioritisation, who decides whether a study is Level 2 or Level 3 priority?
Prioritisation levels only need to be considered if, given limited NIHR resources at a site, a decision has to be made on which studies to allocate resources to. Level 2 relates to potentially life-preserving or life-extending treatment not otherwise available to the patient. The decision on whether a study is Level 2 or Level 3 priority is made by the local Assessment and Prioritisation panels. If sites find it helpful, the prioritisation level agreed by the local panel may be recorded in their Local Portfolio Management System.
Why do level 1 studies (urgent COVID-19 research) take priority over Level 2 studies (urgent non-COVID research) in the restart framework?
We are continuing to prioritise urgent public health research into COVID-19 because we need to give the NHS better evidence on diagnosis, management and outcomes in anticipation of further increases in viral transmission (a 'second' wave).
How is the NIHR supporting clinical academics who paused their career development awards to support frontline services and now want to return to their research roles?
The NIHR is keen to ensure that clinical academics can resume their planned career paths as quickly as possible. In partnership with other funders and stakeholders, we have produced guidance to support those returning to clinical academic roles with the expectation that this will happen by 5 August. More information is available on the NIHR Academy page.
With research beginning to restart, how will the additional cost of Personal Protective Equipment for researchers and research participants be covered?
For NHS employees, PPE costs will be covered as a general overhead to employing organisations that should be charged to the NHS COVID budget. For university employees, they will be covered as a general overhead to the employing organisation that should be charged to overheads on the research award.
For research participants in hospital, PPE costs should be charged to the NHS COVID budget. For those in non-hospital settings, such as public halls used for COVID-19 vaccine studies, they should be treated as a research cost.
For primary care employees, costs should be met from the GP practice general overhead.
How can research funders that loaned and/or redeployed research staff to the NHS during the acute phase of the COVID-19 pandemic recover the cost?
The Department of Health and Social Care and NHS England and Improvement have developed a guidance document that sets out the process by which non-NHS organisations that have loaned/redeployed research staff to the NHS can recover the cost. This guidance applies to research staff funded by research funders including the NIHR, UK Research and Innovation and charities.
Have calls for funding and career development awards remained open or any new calls been made?
Yes. Urgent public health research into COVID-19 is the NIHR's top priority, but we recognise the importance of maintaining a balanced research pipeline. As a consequence, all NIHR funding and training schemes and calls have continued to be open for applications, and new calls have been launching weekly in line with existing scheme timetables. Where the commissioning process can be completed without detracting from urgent public health research into COVID-19 or frontline care, we contract for research using electronic signatures. Start-up may however be paused subject to local prioritisation.
Will organisations which hold NIHR contracts and have had to pause research be penalised?
No. In the short term, organisations that have had to pause NIHR funded research will continue to be paid in line with their existing payment schedules. This will be reviewed and payment schedules will be updated as usual following the annual statement of expenditure exercise, if contractors indicate that profiles need to change to reflect revised spending plans. NIHR will be sympathetic to extending contracts so that research paused or delayed because of COVID-19 has longer to deliver. Applications for funding to cover additional research costs due to contract extensions will be considered.
What records need to be kept of financial flows in relation to paused NIHR contracts?
This has yet to be determined, but for NIHR funded studies, organisations holding NIHR awards should keep a record of the staff normally funded through the research contract who have been redeployed onto non-research activity and the duration of that redeployment (start and end dates) as this information will be needed to support subsequent consideration of requests to extend NIHR contract durations and for future finance reports. All non-research related additional costs associated with COVID-19 response should be discussed with NHSE/I regional teams.
How does the Government's furlough scheme impact on those in receipt of NIHR funding?
NIHR anticipates that all those in receipt of NIHR funding will follow the Government's published guidelines on furloughing. Only organisations which are not primarily funded through public grants or research contracts should consider claiming through the scheme, and only where staff would otherwise be made redundant.
We have delayed the start of our project, will we lose our funding as a result?
Funding will not be withdrawn as a result of delayed starts due to COVID-19. We will discuss contract variations for studies that have been forced to delay start on a case by case basis.
Are any changes being made to annual reporting cycles for NIHR infrastructure?
Yes. We will be postponing the full 2019/20 annual reporting exercise for the NIHR Infrastructure. When appropriate we will set a new deadline in consultation with Infrastructure Directors and Managers. We will, however, be asking the NIHR infrastructure to provide some high-level preliminary data, either directly to the scheme secretariat or through the appropriate network office/ leads, which we will ask to be updated when the full annual reporting exercise is completed. We have written directly to award holders to provide details of what this will entail.
Has any research activity funded through the NIHR Global Health Research programme been paused?
As COVID-19 is a global pandemic, it is likely that NIHR-funded research taking place in low and middle income countries may be impacted or paused. Please contact the NIHR Centre managing your project or award if you need to discuss implications for delivery of your research. Communications from the NIHR have been sent via the contracted lead institution for onward sharing with low and middle income and other non-UK based partners.
I have a progress report or finance report due to be returned to the NIHR for my study or research training award. Are deadlines being extended for return of reports given the current situation?
Where NIHR studies or personal awards are being significantly impacted by COVID-19 we will not require routine monitoring reports until after the award has returned to the original contracted delivery. You should retain records relating to staff redeployment.
I have not submitted to the recent Researchfish submission window. How do I submit now?
The 2020 Researchfish submission window has now closed.
Holders of NIHR awards with a contractual requirement to submit (this includes most awards with response codes 1 & 4) will be given a further opportunity to submit their information later this year, but this is currently on hold because of the expected impact of COVID-19 on our research community. In the meantime, sanctions will not be applied. You may, of course, continue to enter and edit information on the outputs, outcomes and impact of your NIHR-funded research in Researchfish at any time.
Are any changes being made to Performance in Initiating and Delivering (PID) submission and publication deadlines?
Yes. In light of the unprecedented efforts being made across the system to tackle COVID-19 we are postponing submission and publication deadline for the Performance in Initiating and Delivering (PID) Q4 reporting exercise. We will keep future reporting deadlines under review and when appropriate we will set a new deadline for reporting of all outstanding data in consultation with NHS R&D and NHS England and NHS Improvement.