NIHR Policy Research Programme Research Specification Research Call on Epidemiology for Vaccinology Timetable and Budget Deadline for stage 1 applications: 14 November 2017 Notification of outcome of stage 1: Mid December 2017 Deadline for stage 2 application: 16 January 2018 Stage 2 Panel meeting: 6-8 February 2018 Notification of outcome of stage 2: Mid February 2018 Award of contract: March 2018 (subject to pre-contract negotiations) Budget: 5m
Table of content Introduction 3 Background 3 Research Priorities and Objectives 4 Optimal Deployment of Vaccines in Outbreak Situations 4 Development of other tools, technologies and methodologies 5 Out of Scope 5 Budget, Duration and Specific Assessment Criteria 6 Governance Issues 7 Additional Information 7 References and Key Documents 8 Standard Information for Applicants 9 General Comments about Applications 9 Research Management 9 Risk Management 11 Patient and Public Involvement (PPI) 11 Outputs and Reporting Arrangements 12 Finance 13 Dissemination 13 Transparency 14 Application Process 14 Commissioning Process 15 Selection Criteria 16 Contacts 17 2
Introduction 1. This research call will provide Official Development Assistance (ODA) funding through the National Institute for Health Research Policy Research Programme (NIHR PRP). The NIHR PRP invites proposals (Stage 1, see Commissioning Process section ) on the use and development of epidemiological models, tools and technologies to assist with the deployment and clinical trialling of vaccines in outbreak situations in Low and Middle Income Countries (LMICs) on the Development Assistance Committee (DAC) list. Background 2. In line with the UK aid strategy, HM Treasury has allocated Official Development Assistance (ODA) funding to the Department of Health (DH) to commission internationally outstanding applied global health research. 3. The purpose of the initiative is to support world-class global health research undertaken through the National Institute of Health Research (NIHR) that will deliver benefits for patients and the public in LMICs. The Government s wider strategy for improving health in LMICs can be found here. Those wishing to apply for this funding must ensure that the principle and direct aim of the research is to improve the health, welfare or economic development of countries on the Organisation for Economic Co-operation and Development s (OECD) DAC list of 1 ODA recipients. NIHR expects that most or all of the research that arises as a result of the funding is translational or applied and aims to benefit poorer people within ODA-definition countries. Engagement and collaboration with researchers in countries on the DAC list is preferable under this call. 4. The need for this call was highlighted by the UK Vaccine Network, which is chaired by the Department of Health s Chief Scientific Adviser, and was established following the 2014-2016 Ebola outbreak in order to ensure the UK and 1 Please note that it is anticipated that Antigua & Barbuda, Chile, Uruguay, Argentina and Venezuela will graduate from the DAC list in 2017. For proposals which engage partners from these countries, or are specifically focused on challenges in these countries, to ensure ODA compliance you must ensure their involvement will contribute to the wider economic development and welfare of other developing countries (not just the graduating country partner/focus country). 3
broader international community are better prepared to utilise vaccines in the prevention of and response to infectious disease outbreaks. Research Priorities and Objectives 5. This call is split into two parts: a. Optimal Deployment of Vaccines in Outbreak Situations A single 1.5m research contract will be awarded in this area. It is expected that this contract will cover a programme of epidemiological impact assessments, encompassing infectious disease dynamic modelling and trial methodologies, based on a rigorous assessment of the transmission dynamics in humans and animals of the twelve diseases prioritised for investment by the UK Vaccine Network. 2 In practice, this means for the twelve prioritised diseases the successful project will: Develop rigorous models for how each of the twelve diseases could spread in 3 outbreak settings; For each disease, taking into account their known and plausible epidemiology, develop trial designs and methodologies for how an unlicensed vaccine could be deployed in field trials in a manner that has the potential to demonstrate 4 efficacy and is likely to be acceptable to a competent Regulatory Agency; For each disease, taking into account their known and plausible epidemiology, 5 develop feasible and optimal approaches for how a licensed vaccine could be deployed. This may include consideration of whether the vaccine should be deployed in a proactive or reactive manner, its deployment in human at-risk 2 Ebola, Marburg, Lassa Fever, Crimean-Congo Haemorrhagic Fever, Hantavirus, Rift Valley Fever, MERS, Plague, Q Fever, Zika, Chikungunya and Nipah. 3 This should include reasonable worst case scenarios such as seen in the 2014-2016 Ebola outbreak in West Africa. 4 For the purpose of this work, if the WHO have already published a Target Product Profile (TPP) for a candidate vaccine for the disease, the trial should be based on using a vaccine in line with that TPP. If a WHO approved TPP for a vaccine does not exist, the project will be expected to develop an outline TPP for a vaccine, and use that for the purpose of the modelling. 5 Similar to the above footnote, the project should assume that if a WHO TPP exists for a vaccine, a future licensed vaccine for the purpose of the modelling would be similar. If a WHO TPP does not exist, the project should develop an outline TPP for a vaccine, and use that for the purpose of the modelling. 4
groups, and potentially its use in livestock or other animal populations where that would be epidemiologically appropriate. b. Development of other tools, technologies and methodologies The remaining 3.5m of funding will be allocated flexibly across projects on a broader range of themes, with 250,000-750,000 available per project. It is expected such projects will not significantly overlap with section a., as outlined above, and instead focus on areas such as: The development and/or refinement of novel methodologies and tools that would assist with epidemiological work in outbreak settings, including reference diagnostics. 6 Work on Biostatistics relevant to the response to disease outbreaks. 7 The development of technologies that would assist with the epidemiological assessment and/or vaccine response to infectious disease outbreaks. Anthropological and sociological work on the deployment and administration of vaccines in disease outbreaks, and how to ensure the acceptance and uptake of vaccines in such situations. The development of a manual for establishing a field based GxP compliant blood sampling facility. Other innovative work in the fields of Epidemiology - including molecular epidemiology or Biostatistics - that is relevant to the overarching focus of this call for proposals, i.e.the response to infectious disease outbreaks, including the deployment of vaccines (whether they are licensed or as part of a clinical trial). Out of Scope 6. The following areas are out of scope for the purpose of this call as they are covered by other routes: 6 The term Biostatistics is used to represent the development and application of theory and methods in the collection, analysis and interpretation of data used in response to disease outbreaks 7 For example, but in no way limited to, smart phone applications. 5
Vaccine Development and Clinical Trialling applications focussed on actually developing or trialling vaccines will not be accepted. Development of diagnostic devices Diagnostics are not included within the remit of the technologies referenced in section b. above. Budget, Duration and Specific Assessment Criteria 7. The total call size is will be 5m. As outlined above, 1.5m of the funding will be allocated to a single project on optimal deployment of vaccines in an outbreak, with the remaining funding allocated to projects on a broader range of themes, with awards of 250,000-750,000 to support individual projects. Institutions may submit more than one application. 8. Each application should clearly indicate whether it is addressing part a. or part b. of this call. 9. Proposals should not request more funding than has been made available for either part a. or part b. of this call. 10. Applicants who are successful at stage 2 will be notified between February and March 2018. 11. Proposals should demonstrate capability to initiate the project by 01 April 2018 and finish by 31 March 2021. 12. In addition to the PRP standard assessment criteria outlined below in this document, at Stage 1 the Commissioning Panel will be asked to consider whether applicants have demonstrated the following: That they meet ODA compliance criteria and outline which country/ countries on the DAC list will directly benefit, how the application is directly and primarily relevant to the development challenges of those countries, and how the outcomes will promote the health and welfare of a country on the DAC list, and in particular poorer people in those countries; An awareness of relevant prior and ongoing work in the field and the of the specific needs for LMICs 6
A previous successful track record in delivering similar work The ability to access the required range of methodological expertise needed to deliver the proposed work Previous successful collaborations or liaisons with relevant stakeholders in the UK and LMICs. An awareness or ability to identify and address potential risks and challenges in delivering this type of work. Governance Issues 13. Each project should establish a research advisory group including relevant stakeholder groups, including representatives of the Department of Health (DH). The advisory group will provide guidance for the research, meeting regularly over the lifetime of the research. The successful bidders for this research should be prepared to review research objectives with the advisory group, and to share emerging findings on an ongoing basis. They will be expected to: provide regular feedback on progress produce timely reports to the advisory group produce a final report for sign off 14. Research contractors will be expected to work with nominated officials in DH and the NIHR Central Commissioning Facility. Key documents including, for example, research protocols, research instruments and reports must be provided to DH in draft form allowing sufficient time for review. Additional Information 15. Lead applicants should be based in a UK university or research institute and demonstrate to have an established network and track-record in delivering similar work in resource poor settings. Collaboration with researchers and organisations in ODA eligible countries on the DAC list is preferred, but not essential, under this call. 16. Applicants should let NIHR know if they have or are planning to submit a similar application to any other funding call. 7
17. To be eligible to receive ODA funding, applications must demonstrate how they meet ODA compliance criteria and outline: which country or countries on the DAC list of ODA-eligible countries will directly benefit; how the application is directly and primarily relevant to the development challenges of those countries; how the outcomes will promote the health and welfare of a country or countries on the DAC list. 18. Where countries that will benefit from the research are listed as middle-income on the DAC list (for example China, India, Brazil), the application should demonstrate how the research will benefit the health and welfare of the poorest and/or most vulnerable groups of people in those countries and how their findings could have wider applicability to other low income countries. 19. Although any funds distributed overseas will be directed through the lead UK institutions, the proportion of funds directed overseas is at the discretion of the applicants and must be based on the best balance to achieve the research objectives. Details on how collaborations and partnerships with researchers and other partners (NGOs, Governments, businesses) in LMICs will be sustained beyond the duration of this funding cycle would be welcome. References and Key Documents 20. UK aid and international development strategy 21. Development Assistance Committee (DAC) list 8
Standard Information for Applicants 22. The sections below provide standard information on different aspects of NIHR PRP funding and will contain details relevant to your application. General Comments about Applications 23. Applications are invited from UK-based (England, Scotland, Wales and Northern Ireland) Higher Education Institutes and Research Institutes. 24. Applicants are encouraged to submit multidisciplinary applications. 25. Applicants will be expected to provide details of the pathway to impact. These should include plans for engaging relevant stakeholders to ensure beneficial research knowledge is translated into policy and practice. Monitoring and evaluation plans should be developed to determine the extent to how the activities proposed will deliverable measurable benefits to patients and public in LMICs. 26. It will be important to communicate research findings directly to policy makers, practitioners and users, as well as through traditional communication routes. This requirement will need to be reflected in work programmes and dissemination plans. The NIHR expects that research data will be made available for analysis and re-use. 27. Applicants should consider the full range of potential audiences and describe how the research findings could be disseminated most effectively to ensure that the lessons from this research impact on policy and practice. Research Management 28. Day-to-day management of this research will be provided by the principal investigator. They and their employers should ensure that they identify, and are able to discharge effectively, their respective responsibilities under the Department of Health (DH) Research Governance Framework for Health and 9
8 Social Care (Department of Health, 2005), which sets out the broad principles of good research governance. 29. Where appropriate, the successful research team must adhere to the Data Protection Act (1998) and the Freedom of Information Act (2000). Effective security management, and ensuring personal information and assessment data are kept secure, will be essential. In particular: the research team shall, at all times, be responsible for ensuring that data (including data in any electronic format) are stored securely. The research team shall take appropriate measures to ensure the security of such data, and guard against unauthorised access thereto, disclosure thereof, or loss or destruction while in its custody; personal data shall not be made available to anyone other than those employed directly on the project by the research team, to the extent that they need access to such information for the performance of their duties. The research team should show that they have experience of and access to appropriate databases and IT support to maintain data security and integrity and that meets regulatory standards. 30. For any research involving clinical trials, the successful team will be expected to be familiar with the Medical Research Council (MRC) Framework for 9 Evaluating Complex Interventions (MRC, 2000), and to follow the principles of the 10 MRC Guidelines for Good Clinical Practice in Clinical Trials (MRC, 1998) in proposing structures for oversight of such trials and comply with the Medicines for Human Use (Clinical Trials) Regulations 2004. 31. The Institution leading the proposal should confirm that it has the capacity and is prepared to take on sponsorship responsibilities for clinical trials undertaken as part of the programme. Where the proposal includes a proposal for multi-site clinical trial activities the research unit should demonstrate that they 8 Department of Health. (2005). Research governance framework for health and social care [Online]. 2ndEd. London: HMSO; [cited 2008 March 26]; Available from URL: https://www.gov.uk/government/publications/research-governance-framework-for-health-and-social-care-second-edition 9 Medical Research Council. (2000). A framework for development and evaluation of RCTs for complex interventions to improve health [Online]. [cited 2008 March 26]; Available from URL: http://www.mrc.ac.uk/ 10 Medical Research Council. (1998). Guidelines for good clinical practice in clinical trials [Online]. [cited 2008 March 26]; Available from URL: http://www.mrc.ac.uk/documents/pdf/good-clinical-practice-in-clinical-trials/ 10
have the experience of governance and management of clinical trials across multiple clinical trial sites. Risk Management 32. Applicants should submit, as part of their proposal, a summary explaining what they believe will be the key risks to delivering their research, and what contingencies they will put in place to deal with them. 33. A risk is defined as any factor which may delay, disrupt or prevent the full achievement of a project objective. All risks should be identified. The summary should include an assessment of each risk, together with a rating of the risks likelihood and its impact on a project objective (using a high, medium or low classification for both). The risk assessment should also identify appropriate actions that would reduce or eliminate each risk, or its impact. 34. Typical areas of risk for an evaluation study might include ethical approval, site variation in data gathering, staffing, resource constraints, technical constraints, data access and quality, timing, management and operational issues; however, please note this is not an exhaustive list. Patient and Public Involvement (PPI) 35. The NIHR Policy Research Programme expects the active involvement of patients and the public (e.g. service users and carers) in the research that it supports, where appropriate. However, the nature and extent of patient and public involvement (PPI) is likely to vary depending on the context of the study. Applicants should describe how the issue of PPI will be addressed throughout the research process. For example, this could include patient and public involvement in refining research questions, designing research instruments, advising on approaches to recruitment, assisting in the collection and analysis of data, participation or chairing advisory and steering groups, and in the dissemination of research findings. 36. Applicants are required to detail what active involvement is planned, how it will benefit the research and the rationale for their approach. PPI needs to be undertaken in a manner that acknowledges that some people may need additional support, or to acquire new knowledge or skills to enable them to 11
become involved effectively (see INVOLVE publications for guides for researchers). Applicants should therefore provide information on arrangements for training and support. In addition, applicants should note that a budget line for the costs of PPI is included in the finance form. Where no PPI is proposed, a rationale for this decision must be given. 37. For further information and guidance about PPI, please visit the INVOLVE website: http://www.invo.org.uk/. Outputs and Reporting Arrangements 38. The research team will be expected to provide regular progress reports over the lifetime of the research and will be provided with a progress report template to complete at regular intervals. In addition to describing progress, these reports will allow researchers to indicate any significant changes to the agreed protocol, as well as setting down milestones for the next reporting period, giving an update on PPI and any publications or other outputs. Information on emergent findings that can feed more immediately into policy development will be encouraged and should be made available as appropriate. 39. A final report on the research, with an accessible executive summary, will be required within one month following completion of the research. The report will be peer reviewed and may be circulated among relevant stakeholders within the Department of Health and its partners. Once the study is completed, a summary of the final report will be placed in the public domain, on the relevant Policy Research Programme web pages. This is where the outputs resulting from expenditure of public funds are made available for public scrutiny so it is important that the summary of your final report is easily accessible to the lay reader. 40. Research contractors are obliged to give at least 28 days notice before submission of any publication arising from research funded by the NIHR Policy Research Programme. In this instance, publication concerns any presentation, paper, press release, report or other output for public dissemination arising from a research project funded by the PRP. Research contractors remain under an obligation to provide notice even after the contract has ended. Publication of PRP-commissioned research is subject to prior consent of the Secretary of State, 12
which will not be withheld unreasonably and cannot be withheld for more than three months from the time the publication is submitted. Finance 41. In any joint application from one or more institutions, including developing country institutions, funding will be released via a single contract to a named UK lead institution. The proportion of funds directed overseas is at the discretion of the applicants but financial management arrangements need to be fully described in the application 42. The duration of the research and individual projects within the contract will be no longer than is consistent with high quality studies. In assessing proposals, the Department will be seeking value for money as well as scientific excellence and, in particular, the potential for policy impact which is key. 43. Applicants are asked to address the timing and nature of deliverables, maximising staff resources and other options for interim reporting in their proposals. 44. Applicants should always provide an indicative budget for the planned research. 45. Costings can include up to 100% full economic costing (FEC) but should exclude output VAT. Applicants are advised that value for money is one of the key criteria that peer reviewers and commissioning panel members will assess applications against. 46. All applications are expected to start by 01 April 2017, subject to pre-contract negotiations and specific requirements. Dissemination 47. Applicants should describe how the research findings could be disseminated most effectively, ensuring that results of this research impact on policy and practice. 48. Publication of scientifically robust research results is encouraged. This could include plans to submit papers to peer reviewed journals, national and 13
regional conferences aimed at service providers, professional bodies and professional leaders. It might also include distribution of executive summaries and newsletters. Less traditional dissemination routes are also welcomed for consideration. Transparency 49. In line with the government s transparency agenda, any contract resulting from this tender may be published in its entirety to the general public. Further information on the transparency agenda is at: https://www.gov.uk/government/publications/procurement-and-contracting-transpare ncy-requirements-guidance. 50. If you wish to view the standard terms and conditions of the NIHR Policy Research Programme contract, please go to: www.nihr.ac.uk/prp. Application Process 51. To access the research specification, the application form and relevant guidance, please visit the NIHR PRP web pages at http://www.nihr.ac.uk/prp and the NIHR funding opportunities page. 52. The NIHR CCF runs an online application process and all applications must be submitted electronically. No applications will be accepted that are submitted by any means other than the online process. Deadlines for the submission of outline and full research applications occur at 1.00 pm on the day indicated and no applications can be accepted after this deadline. 53. We strongly recommend that you submit your application on the day before. Once the 1.00 pm deadline passes, the system shuts down automatically and CCF Programme Managers are unable to re-open it. If you are experiencing any technical difficulties submitting your application, please contact the CCF on 0208 843 8027 in good time, before 1.00 pm on a closing date. 54. Applicants are expected, before submitting applications, to have discussed their applications with their own and any other body whose cooperation will be required in conducting the research. 14
55. In order for your full application to be validated and submitted you are required to gain electronic approval from the relevant authorities before the application deadline. The Declarations page must be approved: a. by the Lead Applicant to confirm that the content of the application is complete and correct. b. by an administrative or finance officer for the contracting (host) institution to confirm that the financial details of the application are correct and that the host institution agrees to administer the award if made. c. by a Head of Department or Senior Manager to confirm that they have read the application and that, if funded, the work will be accommodated and administered in the named institution and that the applicants may undertake the work. 56. Until this is completed the lead applicant is unable to validate and submit the application. Commissioning Process 57. The standard NIHR PRP commissioning cycle includes the following steps: 58. In the standard 2 Stages Commissioning, outline applications or, in case of Expression of Interest (EOI), short EOI applications will be short-listed by a Commissioning Panel. Incomplete applications, applications too remote from the issues set out in the research specification, or applications that have clearly inadequate presentation or methods may be rejected at this stage. 15
59. Applications that are successfully short-listed by the Commissioning Panel will proceed to Stage 2 of the application process and will be invited to submit a Stage 2 full application for consideration. 60. All full applications submitted to NIHR PRP will be reviewed by both stakeholder and independent academic referees. 61. Full applications and any related documentation will then be considered by the Commissioning Panel, which is comprised of independent experts (possibly with observers from other government departments and executive agencies), who will advise the NIHR on which applications are most suited to receive funding. The Panel may be informed by input from external reviewers. However, it is ultimately the responsibility of the Panel to make any funding recommendations to the Department of Health. 62. At Stage 2, applicants should expect to be invited to present their application and to be questioned by the Commissioning Panel. The final decision on whether a presentation and Q&A session will be included in the commissioning process will be made after Stage 1 short-listing and will be based on a number of factors, including volume of applications. The Lead-Applicant and up to two selected collaborators are strongly advised to be available for the Stage 2 Commissioning Panel dates (indicated at the beginning of this document). Selection Criteria 63. The Commissioning Panel members are directed to consider applications against the criteria stated in this research specification as well as selection criteria detailed below: RELEVANCE of the proposed research to the research specification QUALITY of the research design QUALITY of the work plan and proposed management arrangements STRENGTH of the research team IMPACT of the proposed work VALUE for money (justification of the proposed costs) INVOLVEMENT of patients and the public 16
Contacts 64. General enquiries regarding the application and commissioning process can be directed to the PRP CCF Help Desk by telephone at 0208 843 8027 or by email to prp@nihr.ac.uk 17