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Q&A on the impact of COVID-19 on research funded or supported by NIHR

 

Contents

Is NIHR continuing as usual with studies unrelated to COVID-19?

No. Given the scale of the COVID-19 challenge, we are encouraging clinical and academic health and care professionals funded by NIHR who are working on topics other than COVID-19 to prioritise frontline care where requested to do so by their employing organisations. This means 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.

In addition 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.

What does ‘pausing’ the site set up of new or ongoing studies mean?

As of 23 March 2020, the NIHR Clinical Research Network will not be assessing any new commercial or non-commercial studies for CRN Support (with the exception of nationally sponsored COVID-19 studies received through the Department of Health and Social Care’s expedited Urgent Public Health processes). No new commercial feasibility service requests (early feedback, site identification, site intelligence and costing validation) or attribution support for non-commercial studies submitted on or after 23 March will be processed by CRN until further notice. Responses to any services currently in the system may also be impacted. Eligibility and feasibility services from CRN require input from clinical experts or local NHS organisations. In most cases, their priority is now to deliver the nationally sponsored COVID-19 studies, or return to frontline care as requested by their employing organisations. 

We are delaying 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Funding will not be withdrawn as a result of delayed starts due to COVID-19. Once the situation is clearer we will discuss contract variations for studies that have been forced to delay start on a case by case basis.

Will organisations which hold NIHR contracts and who need to pause research be penalised?

No. In the short term, organisations that need 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. 

How will payments be made to trusts which are pausing research and diverting staff?

Organisations that pause research will continue to receive funding from DHSC/NIHR in line with processes which support existing payment schedules. If COVID-19 pressures continue for an extended period, the mechanisms of funding flows to organisations who are re-deploying staff may be revisited after further discussion between DHSC and NHSE/I.

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.  

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 may be needed to support subsequent consideration of requests to extend NIHR contract durations. All non-research related additional costs associated with COVID-19 response should be discussed with NHSE/I regional teams.  

What does ‘pausing’ a study mean?

Ultimately, the aim of pausing a study will be to release staff time for frontline care and/or to protect public health. This is likely to delay the research contract end date with implications for research deliverables and for funding flows to contracted organisations.

Who needs to do what to pause a study?

An arm of a study can be paused by the organisation hosting the research, but this should be done in discussion with the Principal Investigator and study sponsor. An entire study can be paused if all of the organisations hosting the study choose to pause the arms that they are responsible for. Alternatively, a sponsor/funder can choose to pause an entire study, but they should do so in discussion with the Chief Investigator and organisations hosting the research. The Chief Investigator of a study which is wholly or part funded by NIHR should contact their relevant NIHR Coordinating Centre to inform them that a study has been paused. 

Who is monitoring which studies are being paused?

The Clinical Research Network (CRN) Coordinating Centre is coordinating work which is asking funders and sponsors of studies on the CPMS whether they will be pausing entire studies.

Will studies that are paused be restarted?

The aim should be to restart paused studies and fulfil contracts. Where this might prove difficult, the relevant NIHR Coordinating Centre will be able to advise on the process associated with closing a study. Studies that restart are likely to require a contract extension and again, NIHR Coordinating Centres will advise on process.

Can NIHR funded studies on topics other than COVID-19 continue?

NIHR's priority is COVID-19 urgent public health research. However, where host organisations are content for studies into topics other than COVID-19 to continue, they need not be paused - however, frontline care should be prioritised. For non-COVID-19 research, priority should be given to studies where discontinuation would have a significant detrimental effect on the ongoing care of participants. These are clinical decisions which will need to be made on the basis of local risk and capacity assessments.

Will NIHR provide guidance on how to decide which studies to pause, either proactively or upon request?

There are no plans currently for NIHR to provide further guidance on which studies should be paused or continued. Local decision-making is paramount. 

Might different organisations hosting research reach different decisions regarding continuing/pausing multi-centre studies?

Different centres could reach different conclusions about whether to proceed with certain arms of a multi-centre study, due to local public health risk assessments and/or workforce pressures placed on frontline services. In this scenario, Chief Investigators would need to discuss with sponsors whether to pause a study overall. 

What will happen to people who have already been recruited into research/clinical trials which are being paused?

The Principal Investigator will need to discuss with their local line manager and the hosting Trust R&D department how quality of care can be maintained taking account of need across the institution.

What will happen to studies where research costs are met by research charities, commercial organisations and public funders other than NIHR, but where CRN/NIHR infrastructure support needs to be put on hold due to diversion of staff?

The implications of pausing any studies due to redeployment of supporting CRN/NIHR infrastructure staff should be discussed between sponsoring organisations and the organisation/s hosting the research.

I have an NIHR career development award, where can I find advice about the impact of COVID-19 on my award?

Please refer to information on the NIHR Academy page

Does this policy apply to all studies and staff in the areas of public health and social care research?

Yes, this policy also applies to public health and social care research.

Is this a UK-wide policy? 

DHSC, which funds NIHR, is working closely with its counterparts in the Devolved Administrations to have an aligned approach to this issue. The policy applies to research taking place outside of the UK funded through the NIHR Global Health Research programme. 

What will happen to research activity funded through the NIHR Global Health Research programme that is taking place in low and middle income countries? 

As COVID-19 is a global pandemic, we understand 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 NIHR are being sent via the contracted lead institution for onward sharing with low and middle income and other non-UK based partners.

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 which we will ask to be updated when the full annual reporting exercise is completed at a later date. We have written directly to award holders to provide details of what this will entail.

Can I still apply for funding via calls that are currently open and will there be new calls in the coming months?

Research into COVID-19 is the NIHR's top priority. However, we recognise the importance of maintaining a research pipeline and therefore all NIHR funding and training schemes and calls will continue to be open for applications, and there will be new calls in the coming months. Where the commissioning process can be completed without interfering with COVID-19 research or frontline care, we will contract for research using electronic signatures. Start up may however be paused. 

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.