COVID-19 RAPID RESPONSE ROLLING CALL – FUNDING

1. Title: COVID-19 RAPID RESPONSE ROLLING CALL – FUNDING2. Awarding Authority: NIHR, DHSC, UKRI, GB Email: ccf-nCoV@nihr.ac.uk. Web: 3. Contract type: Service contract4. Description: Building on the initial calls of their Initiative, DHSC, through the Awarding Authority, and UKRI are jointly launching a rolling call for proposals for rapid research into COVID-19. As this is a rolling call there is currently no fixed end date to the call, we are open to applications and will aim to review complete proposals within 4 weeks of submission.For UK-led academic, SME and wider industry research that will address a wide range of COVID-19 knowledge gaps/needs, and which will lead to a benefit in UK, potentially international, public health within 12 monthsBackgroundThe 21st Century has already seen a number of epidemics including Ebola, MERS, Zika and Nipah. Epidemics are defined by the complex interactions between microbes, people, animals and ecosystems, and factors such as increased global mobility, population density and climate change are contributing to the rise of epidemics caused by emerging and re-emerging infectious diseases.On December 31, 2019, the WHO Office in China was informed that cases of pneumonia of an unknown cause had been detected in Wuhan City, in the Hubei Province of China. The Chinese authorities identified this to be a previously unknown type of coronavirus (SARS-CoV2, with the disease it causes being COVID-19) with subsequent phylogenetic analysis suggesting that the new virus is similar to the SARS coronavirus when compared to other coronaviruses known to infect humans. Initial cases had some link to a large seafood and animal market, suggesting animal-to-person spread, but there is now clear evidence for person-to-person spread. The outbreak was declared as a Public Health Emergency of International Concern (PHEIC) on January 30, 2020.The research responseResearch to understand the disease, prevent, treat and control it will be critical for mitigating the severity of the COVID-19 outbreak. Rapid progress in addressing this epidemic will depend upon a coherent and integrated response from researchers, industry, the healthcare system and the public. Consequently, in early February 2020 we launched a strategic Initiative encompassing two different calls i) active intervention development including vaccines and therapeutics, and ii) diagnosis and understanding of COVID-19. Over £20m was made available for this Initiative through the primary government funders of UK medical research – the Department of Health and Social Care (DHSC), through the National Institute for Health Research (NIHR), and UK Research and Innovation (UKRI), funding awards in both calls. Details of the first six awards to be funded through this initiative can be found here.We are now launching a subsequent, rolling call for rapid research proposals with potential to deliver public health impacts within 12 months.These calls are contributing to the global response by actively collaborating with and being informed by the WHO’s COVID-19 Global Research Roadmap and Global Coordinating Mechanism (GCM) for R&D in epidemics, the Global Infectious Disease Collaboration for Infectious Disease Preparedness (GloPID-R), the UK Collaborative on Development Research and the Coalition for Epidemic Preparedness Innovations (CEPI).ScopeShort term (up to 12 month) proposals are sought. All proposals will need to be able to show how progress within the period of award could make a significant contribution to the understanding, prevention and/or management of the COVID-19 outbreak. The research scope of this call is as below:Virology, Immunity and Pathophysiology – Research as part of an experimental medicine and/or clinical study focused on defining critical biological/pathological parameters necessary for the prioritisation of preventative, supportive and/or therapeutic interventions.Diagnostics – Rapid point of care diagnostics for use at the community level. Proposals will need to robustly justify their added value, in the context of significant existing activity, and to provide strong evidence in terms of deliverability and route to commercialisation, at scale and speed.EpidemiologyTransmission – Research that will enable better understanding of the nature of transmission of and exposure to the virus, including via surfaces and aerosols.Disease Susceptibility and Severity – Understanding susceptibility of different populations (age, sex, ethnicity, demographics, underlying health conditions, etc), including vulnerable and marginalised groups, such as the homeless and drug users. Characterization of the spectrum of clinical manifestations and disease severity of SARS-CoV2 infections, including potential contribution of viral load, kinetics and genotype, sites of infection and associated immunopathology, variability in immune responses, collateral tissue damage, and associated factors (demographics, etc.).Control and Mitigation – Research to understand social distancing measures that are most effective at preventing or reducing spread of SARS-CoV2, and how such distancing and isolation measures may be most effectively relaxed. With comparative studies particularly welcomed.IPC and PPE – Studies to optimize use of personal protective equipment and other infection prevention and control measures in health care and community settings.Public Health, Media and Communication – research to better understand how to enhance and implement acceptability of and adherence to management, IPC and public health measures, and simultaneously how to minimize stigma and prejudice. This being essential for putting evidence-based measures into practice.Public Health – including what are relevant, feasible, effective approaches to promote acceptance, uptake, and adherence to public health measures for COVID-19 prevention and control, and how secondary impacts, including mental health, social isolation and domestic violence, can be rapidly identified and mitigated, including special attention to vulnerable groups.Media and communication – Studies into and implementation of the most effective ways to address the underlying drivers of fear, anxieties, rumours, stigma regarding COVID-19, and how to improve public knowledge, awareness, and trust during the response, including strategies to combat misinformation. Studies into the potential benefits of increased use of digital technology, for both communication and data capture.Clinical Management – Rapid assessments of available data from studies to learn what standards of care are the most effective for patients at different stages of the disease, including effective triage, and taking advantage of all available technological innovations to improve survival and recovery.Primary, Adjunctive and Supportive Therapies – Evaluation of the effect of primary, adjunctive and supportive therapies, including immune modulators. Proposals will need to be placed in the context of work already underway in this area, including as listed in the WHO directory of clinical trials.Vaccines – Evaluation of investigational vaccines and passive immunological approaches, improved collaboration and comparison across different studies. Proposals will need to robustly justify their case for funding, given significant existing international activity in this area.Health and Care DeliveryResearch which requires the real time pandemic context for delivery of the proposed study design.Evaluation of innovations in health and social care delivery prompted by the pandemic, which can be generalised and actioned in the pandemic context.Evaluation of implementation, acceptability and feasibility of workforce interventions to support physical and mental health wellbeing.Evaluation of different approaches to resource use and deployment of the workforce across the whole health and social care eco-system.Research to support ensuring and optimising access to health and social care services by people from different sociodemographic groups and ethnic groups.UnderpinningAssays and Animal Models – Development of assays and animal models required to support the development of therapeutics and vaccines. Proposals will need to be placed in the context of work already funded in this area.Provision Infrastructure – Platforms supporting sharing of information, reagents, tools, protocols and standards. Proposals will need to be placed in the context of work already funded in this area.Call priorities continue to be informed by the COVID-19 WHO Research Roadmap developed initially out of the international Research and Innovation Forum convened by WHO and GloPID-R on 11-12 February, and which will be updated as priorities are met or evolve as the pandemic develops. More details are available on the WHO website here.EligibilityAcademic Principal Investigators applying for this call must be hosted by a UK institution which is eligible for UKRI funding. Applications from Small and Medium Enterprises[1] (including start-up or ‘spin-out’ companies), government arms length bodies, and NHS organisations (including NHS Trusts and NHS Foundation Trusts), and equivalent UK authorities are also encouraged in alignment with NIHR funding policies, where these organisations are the lead applicant. Awards to UK-based, non-SME commercial entities will be also considered. Specialist services or expertise may be brought into the team through consultancy or sub-contract arrangements, however, appropriate justification must be provided. Sub-contractors and collaborators (who are partners in the bid but not directly funded by it) may be based outside of the UK.Researchers from overseas research organisations in affected countries providing important local engagement and context are welcomed as Co-Investigators on proposals. Other overseas researchers may be Co-Investigators, if they provide necessary expertise/access to resources not available in the UK.Research institutes, including UKRI Units/Institutes, for which the Research Councils have established a long-term involvement as major funder are also eligible for this call.Principal Investigators may only submit and have under review one application at a time to this rolling call as a Principal Investigator, but may be involved in more applications, if listed as a Co-Investigator. Applicants, whether as Principal or Co-Investigator, may not submit the same or similar application(s) as made to the Initiative’s first two calls or previously to this rolling call, or to the UKRI rolling call.ExpectationsStudies should preferably build on existing relationships, including with relevant commercial, practice or policy partners and relevant data/resource holders. Interdisciplinary proposals are welcomed, where appropriate.Proposals must be timely, with rapid activation, to enable early and valuable outcomes to be established and/or to access time-dependent resources.Data produced as a result of this funding will need to be shared in line with the Joint statement on sharing research data and findings relevant to the novel coronavirus (nCoV) outbreak.Funding availableThe size of grants will vary according to the needs of each research project but will need to provide a robust case for value for money.Requested costs for UK based researchers should be 80% of full economic costs (fEC) and, where relevant, for overseas researchers should be 100% of direct costs only. Funded projects in academia will be subject to standard UKRI T&Cs for fEC research grants. In line with NIHR funding policy this call will cover 100% costs for SME[1] and NHS trusts (across the whole of the UK). NIHR funding for NHS Trusts and SMEs, where they are the lead applicant, will be subject to a research contract which sets out a revenue sharing approach. An example contract for NHS trusts can be found here; an example contract for SMEs can be found here. Contractual terms for awards provided to UK-based, non-SME commercial entities will be agreed on a case-by-case basis between NIHR and the applicant. There are no set rules on the split between collaborators, however, as the contracted organisation, the lead applicant will receive funding payments and would be required to distribute to co-applicants/contractors where applicable.Applicants should provide costs of the proposal as set out in the application form. In Section 1.5 please provide the total request against each category, and provide a breakdown for 80% fEC and 100% costs in parentheses in the same field; the overall (top line) total request should be the sum of staff costs, travel, consumables and other directly incurred costs, and indirect, directly allocated and estates costs (the latter only applicable to fEC applications). A brief description of the resources required, including estimated costs, in the different contributing environments and confidence in access to these will need to be provided in Section 3.4. 5. CPV Code(s): 73000000, 73100000, 73110000, 732100006. NUTS code(s): UKI, UKI3, UKI327. Main site or location of works, main place of delivery or main place of performance: London, Inner London – West, Westminster.8. Reference attributed by awarding authority: Not provided.9. Estimated value of requirement: Not provided.10. Closing date: 1.4.2021 (16:00:00).11. Address to which they must be sent: For further information regarding the above contract notice please visit:12. Other information: Status: OpenType: Grants, Researcher-ledCategories: Infections and immunity, Global health, Public healthDurationProposals are anticipated to be short term studies of up to 12 months. All proposals will need to be able to show how progress within the period of award could make a valuable contribution to the understanding, diagnosis, prevention and/or management of the COVID-19 outbreak, with data and tools/reagents generated under this call to be made widely available.How to applyApplicants must apply by first filling out the information contained in the NIHR Clinical Research Network’s COVID-19 enquiry form. Applicants requiring funding will then be invited to complete a full application. Within this document, please use the tab key to move between cells in the form:All proposals must utilise the provided form and be accompanied by:The regulatory requirements annex that forms part of the application form.An optional but recommended document of supporting figures, GANTT chart and/or data tables (no more than 1xA4 page)A CV for the Principal Investigator and any Co-Investigators. Each CV to provide relevant key publications/outputs and grants and other relevant information indicating their suitability to lead/support the research as described in the application (no more than 1xA4 page per CV using Arial 11 point).Applications must be collated into a single pdf in the following order – Form plus Annex, Document of supporting figures, GANTT chart and/or data tables, CVs – and submitted to ccf-nCoV@nihr.ac.uk.The office will not return applications due to missing data and/or components, with applicants bearing the risk of such missing data and/or components negatively impacting their proposal’s review.Please note that successful applicants will be required to return their award acceptance within five working days of receipt, together with an invoice, from their Administering Authority. Failure to comply with these requirements could result in forfeiture of the award.Award Start DateGiven that this opportunity is for timely proposals, grants are expected to start within four weeks of award notification.Evaluation processProposals will be reviewed firstly by members of a college of experts, chosen based on the subject matter of the proposal. These reviews will then be used by an Expert Panel, who will make recommendations on outcome to UKRI and DHSC. Applicants will not have an opportunity to respond to Panel comments in instances where feedback is provided, except where clarifications and/or changes are required as part of the award process.Key assessment criteria for the submissions will include:The potential for the proposal to have an impact the within the period of the award and to provide a unique value-adding contribution relative to existing activity Access to required resourcesApplicant expertise and experiencePartnership: including strength and clarity of collaborations and opportunities providedDesign and feasibility of project planValue for moneyAlignment with WHO-Roadmap prioritiesThe decisions of the Panel will not be open to appeal and the funders reserve the right to amend the application process.Ethics and governanceThe funders do not require ethics permissions and regulatory approvals to be in place when an application is submitted. If an application is successful, it is the responsibility of the host institution/company to ensure that the appropriate ethics approval(s) has been obtained and that no research requiring such approval is initiated before it has been granted.Contacts and guidanceFor general and scientific queries relating to the call, including queries relating to the administrative process of applying, please contact ccf-nCoV@nihr.ac.ukOther informationThe information collected throughout the application and assessment process will be used to support the peer review process and inform our funding decisions, for the management and monitoring of awards, and the evaluation of the funding programme.Proposal information is treated confidentially and in line with our privacy notice, UKRI fEC Grants Terms and Conditions and our guidance on the Use of Grant Proposal and Training Grant Information. Information relating to proposals may be shared, on a confidential basis, across DHSC and UKRI councils, and with other organisations to support the national and international coordination of research to combat COVID-19 and to seek funding contributions from third parties.TKR-202049-EX-1330409# funding opportunity# COVID-19