NIHR BIOMEDICAL RESEARCH CENTRES

Transcription

1 NIHR BIOMEDICAL RESEARCH CENTRES FULL APPLICATION GUIDANCE INTRODUCTION The vision of the National Institute for Health Research (NIHR) is to improve the health and wealth of the nation through research. This document sets out in detail the process for NHS/University partnerships, shortlisted on the basis of Pre-qualifying Questionnaires, to submit a Full Application for NIHR Biomedical Research Centre (BRC) designation and funding. An International Selection Panel will review applications and make recommendations on NIHR BRC designation and levels of funding. NIHR BRC designation will be awarded only to NHS/University partnerships that can genuinely demonstrate the highest levels of both existing research excellence internationally across a substantial portfolio and existing critical mass for any particular research theme. AIMS OF THE SCHEME The scheme aims to provide NIHR BRC funding for NHS/University partnerships in England that have a substantial portfolio of world-class biomedical research across either a range of clinical or research areas, or in a specific clinical or research area. In all cases NIHR BRCs will contain substantial existing critical mass, a significant number of researcher leaders, and a wide range of underpinning facilities. The aims of the NIHR BRCs will be to: drive innovation in the prevention, diagnosis and treatment of ill-health through early translational (experimental medicine) research; translate advances in biomedical research into benefits for patients, the health system and for broader economic gain; and provide a key component of the NHS contribution to our nation s international competitiveness. To achieve these aims we will: provide substantial levels of sustained funding to create an environment where scientific endeavour can thrive, attract the foremost talent and produce world-class outputs; and support a critical mass of people and infrastructure in NIHR BRCs focused on biomedical innovation and early translational (experimental medicine) research for the benefit of patients, the health system and for broader economic gain. 1

2 The key characteristics of NIHR BRCs will include: existing research excellence with a substantial portfolio across either a range of clinical or research areas or in a specific clinical or research area; existing critical mass; strong clinical informatics platform to underpin the delivery of NIHR BRC objectives; track record of excellence in collaborative research partnerships, including with industry; ability to translate basic/discovery science and to pull through benefits for patients, the health system and for broader economic gain. SCOPE OF THE AWARD The NIHR BRC scheme funds people- and/or patient-focused early translational (experimental medicine) research, the aim of which is to translate discoveries from basic/discovery science 1 into clinical research, and through to benefits for patients, the health system and for broader economic gain. The expectation is that once NIHR BRC-funded translational research and/or research to demonstrate proof of concept or feasibility has been undertaken, then other sources of public, charity and industry funding will be found for the later phase clinical research (for example, later than phase II). It should be noted that, in addition to research to develop new therapeutic interventions, the focus of NIHR BRC research includes early translational (experimental medicine) research supporting the development of devices, preventative measures, diagnostic tests etc. It is recognised that research leaders will often be working across basic, translational and clinical research and that translation is an iterative rather than a linear process. However the focus of activity within a NIHR BRC should be on early translational (experimental medicine) research. By definition, this will not focus on health services research (HSR), although HSR methodologies may be employed on early translational (experimental medicine) activity within the NIHR BRCs, as appropriate. Animal research is not eligible for funding under this scheme. NHS/University partnerships are encouraged to collaborate with and make full use of other NIHRfunded research infrastructure (e.g. Clinical Research Facilities, other NIHR BRCs and the Clinical Research Network) to ensure that, where appropriate, research supported by the NIHR BRC includes people/patient populations in areas where the disease burden and clinical need are greatest, which may include populations not served directly by the NHS partner. A full application for a NIHR BRC will be expected to comprise a substantial portfolio of original high quality research. It is expected that the NIHR BRC s Research Themes will deliver their own structured portfolio of translational research that will build on, or be closely linked to, work supported by other research funders. The relationship between the proposed Research Themes (and any proposed Cross-cutting Themes) and any existing and proposed funded research should therefore be described in the application. It is however essential that the International Selection Panel will be able to identify clearly what the specific and distinctive contribution the funding requested for the NIHR BRC would make to each Research and Cross-cutting Themes. HIGHLIGHT AREAS FOR THE NIHR BIOMEDICAL RESEARCH CENTRES NIHR BRC designation and funding may be made in any clinical area where the applying NHS/University partnership can demonstrate the highest levels of both existing research excellence internationally across a substantial portfolio and existing critical mass in that clinical area. In addition, a number of clinical areas of particular strategic importance to patients are being Highlighted. To identify these areas, the Department of Health has taken into consideration disease burden, unmet clinical need and existing levels of research spend. We welcome applications from NHS/University partnerships which can demonstrate the highest levels of both 1 The discoveries may come from medical or biomedical science as well as from a broad range of disciplines such as engineering, computer science and material science. 2

3 existing research excellence internationally and critical mass in these, and indeed any clinical areas. As such funding will not be limited to or ring-fenced for these Highlighted areas. Cardiovascular Disease o Including coronary heart disease and diseases of the vasculature and circulation including the lymphatic system Deafness and Hearing Problems Dementia o Including Alzheimer s disease, Lewy body dementia, vascular dementia Gastrointestinal (including Liver and Pancreatic) Disease o Including inflammatory bowel disease, Crohn s disease, and non-malignant diseases of the digestive system (including colon) Infection and Antimicrobial Resistance Mental Health Musculoskeletal Disease o Including osteoporosis, osteoarthritis, rheumatoid arthritis, muscular and skeletal disorders Nutrition, Diet and Lifestyle (including Obesity) Oral Health and Conditions o Including chronic mouth and facial pain, oral and throat cancer, oral sores, birth defects such as cleft lip and palate, periodontal (gum) disease, tooth decay and tooth loss, and other diseases and disorders that affect the oral cavity Respiratory Disease o Including asthma, chronic obstructive pulmonary disease, and other, non-malignant respiratory diseases ELIGIBILITY Applications will be accepted from NHS/University partnerships whose Pre-Qualifying Questionnaires for NIHR BRC designation and funding were shortlisted based on the review by the International Selection Panel. NHS/University partnerships may only include those Research Themes which were shortlisted within their full applications, plus any Cross-cutting Themes listed in their Pre-Qualifying Questionnaire. NIHR BRC funding will only be awarded to NHS/University partnerships which have substantial portfolios of world-class biomedical research across either a range of clinical and research areas, or in a specific clinical or research area. These may be either whole organisations that are focused on a single clinical or research area, or a specific clinical or research group within an organisation with a wider remit. In order to ensure critical mass, focus, and clarity, the funding for NIHR BRC will be awarded to a single NHS organisation working in partnership with a single University [1]. However, it is permissible to involve other NHS organisations (or organisations from the independent sector providing NHS services) and other universities in the work of the proposed NIHR BRC, and pass funding to them via a subcontract. In these cases, there should be good reasons for doing so, such as bringing strength and depth to the proposed Research Themes, and these should be justified in the full application. Where a NHS/University partnership proposes to subcontract an entire Research Theme or Crosscutting Theme to a third party, there should be good reasons for doing so, and it must provide additional research excellence and bring strength and depth to the work of the proposed NIHR BRC. This should be justified in the full application. In all cases, the level of any proposed subcontracting should be of a relatively low level and not detract from the aims of the NIHR BRC funding scheme; namely to provide substantial level of sustained funding to support critical mass within single NHS/University partnerships in England. The level of subcontracting will be considered by the International Selection Panel. [1] The term University is used here to include all Higher Education Institutions 3

4 FURTHER CONSIDERATIONS Athena SWAN The Department of Health has stated its requirement for the achievement of at least the Silver Award of the Athena SWAN Charter for Women in Science by the academic partner 2 (for example the Medical School/Faculty of Medicine) from the NHS/University partnership. Where a NHS/University partnership proposes to subcontract an entire Research Theme or Crosscutting Theme to a third party it will need to confirm the academic partner with which each subcontracted Theme Lead is associated (i.e. the academic partner where the Theme Lead has a substantive contract of employment) has achieved at least the Silver Award. In addition, successfully designated and funded academic partners of the NIHR BRC will be expected to maintain at least the Silver Award of the Athena SWAN Charter for Women in Science for the duration of the award. Data exclusivity deals The NIHR operates an open and transparent research system and would not expect to award funding to a host NHS organisation that has signed data exclusivity deals which either limit or restrict the use of data held by the NIHR BRC to individuals, organisations or companies. Clinical Research Facilities for Experimental Medicine A competitive process to renew and refresh NIHR funding for Clinical Research Facilities (CRFs) is being held in 2016, in parallel with the new, open competition for NIHR BRC designation and funding. Through the CRF renew and refresh NHS organisations will be eligible to apply for NIHR CRF designation and NIHR funding to support the NHS Support Costs 3 for research activity within dedicated, purpose-build facilities, which support world-class experimental medicine research to translate scientific advances into benefits for patients and the public. NHS/University partnerships shortlisted, and eligible to submit a full application for NIHR BRC designation and funding (which indicated a Cross-cutting CRF Theme in the Pre-Qualifying Questionnaire) will be eligible to apply for a Cross-cutting CRF Theme within the proposed NIHR BRC, provided it directly supports the work programme of early translational (experimental medicine) research in the proposed NIHR BRC. Please note that NHS/University also applying for dedicated NIHR CRF funding through the separate competition for a renewal and refresh of NIHR CRFs, are not permitted to double count their CRF funding applications; as such applications for NIHR CRF funding must not include any costs simultaneously applied for through an NIHR BRC application. In cases where the NHS/University partnerships include a Cross-cutting CRF Theme in their application for NIHR BRC designation and funding, the NHS organisation will be asked to indicate if it would like an appropriate proportion of the CRF Cross-cutting Theme to be considered for funding as part of the separate (non-nihr BRC) renew and refresh of NIHR CRF funding in the event that the NIHR BRC application is unsuccessful. NIHR Translational Research Collaborations The NIHR supports a number of Translational Research Collaborations, including those currently termed: NIHR BioResource, NIHR Dementia and Rare Diseases Translational Research Collaborations (TRCs) and the NIHR Translational Research Partnerships (TRPs) in joint and related inflammatory diseases and inflammatory respiratory diseases. NHS/University partnerships will be expected to describe how they will support the NIHR Translational Research Collaborations relevant to their proposed Research Themes and NIHR BRC if designated and funded, including their track record, ability and ambitions to work 2 An academic partner might be, for example, a Faculty, College, School, Department, Division or Institute. 3 NHS Support costs see 4

5 collaboratively with other parts of the NIHR research infrastructure, the NIHR Office for Clinical Research Infrastructure (NOCRI) and with other sectors engaged in health research. The open competitive process for NIHR BRC designation and funding will review and determine which NHS/University Partnerships have the appropriate capacity, expertise and focus to participate in these NIHR Translational Research Collaborations. The NIHR BioResource will provide a national cohort of healthy volunteers, patients and their relatives who wish to participate in clinical research, and are willing to provide clinical information and samples that enable recall to studies by genotype and phenotype. NHS/University partnerships wishing to participate in the NIHR BioResource will need to describe their experience and willingness to integrate existing cohorts into a larger national cohort such as the NIHR BioResource. They will need to have experience of building, maintaining and integrating cohorts and confirm and demonstrate their strong desire and ability to facilitate and support the recall of participants on the basis of genotype and phenotype for collaborative research through the NIHR BioResource, as national infrastructure for research. Additional dedicated funding for activities within the currently termed NIHR BioResource and the NIHR Rare Diseases TRC will be made available following the confirmation of NIHR BRC designation and funding to appropriate and qualifying BRCs. There will be no additional dedicated NIHR funding for the NIHR Translational Research Collaborations for Inflammatory Respiratory Disease or Joint and Related Inflammatory Diseases. As such, NHS/University Partnerships applying for NIHR BRC designation and funding, with relevant Research Themes, will need to outline the resources (drawn from the proposed NIHR BRC award and/or other resources available to the partnership) and expertise that will support their contribution to the collaboration. Biosample storage NHS/University partnerships will only be eligible to use NIHR BRC funding for long-term (greater than 3 months) biosample storage at the NIHR National Biosample Centre. NIHR BRC funding can be used for short-term biosample storage, and/or handling, processing, dispatch and storage where there is a strong case which precludes the use of the NIHR National BioSample Centre, for example, on the basis of cost-effectiveness. SELECTION PROCESS The number of NIHR BRCs has not been determined in advance. The NIHR BRCs will be selected by open competition. The number will be determined by the quality of the applications, in the light of the need not to spread the funding too thinly. The timetable will be: April 2016: International Selection Panel recommended a shortlist of those NHS/University partnerships which appear to have the most substantial portfolios of truly world-class biomedical research in England and are eligible to submit a full application. Recommendations will be made on the basis of the published selection criteria, informed by the Pre-qualifying Questionnaire and supporting information. April 2016: Shortlisted NHS/University Partnerships notified. 27 April 2016: Briefing workshop for shortlisted NHS/University Partnerships to be held in the Academy of Medical Sciences in London between 11:00 13:00 to provide additional guidance to partnerships shortlisted for an NIHR BRC award. 6 June 2016: deadline for receipt of full applications July 2016: International Selection Panel reviews full applications and makes recommendations on NIHR BRCs. September 2016: Department of Health confirms selected NIHR BRCs. Autumn 2016: Contracting process initiated. 1 April 2017: Funding for selected NIHR BRCs commences. 5

6 NIHR BRC full applications will be considered by an International Selection Panel, who will make recommendations on designation and funding levels. Interviews for shortlisted NHS/University partnerships will be held during the week July 2016, at Cumberland Lodge, near Egham mainline station. FUNDING Funding will be awarded for a five-year period (starting 1 April 2017). A total of 800 million is available for 5-years from April 2017 for this round of NIHR BRC funding. The amount of funding allocated to each centre will be determined by the scale, nature and quality of the research activity to be conducted by that NIHR BRC. The number of NIHR BRCs has not been determined in advance. The number will be determined by the quality of the applications, in the light of the need not to spread the funding too thinly. Funding will be awarded to a single NHS organisation (working in partnership with a University), and is to be used to support the translation of world-class basic biomedical research (already being undertaken including in universities) through excellent early translational (experimental medicine) research (underway or to be undertaken within the NHS), for the benefit of patients, the health system and for broader economic gain. The expectation is therefore that the scheme will fund the recurrent costs of patient- or peoplefocused early translational (experimental medicine) research in the NHS 4. NHS/University Partnerships are eligible to apply for funding up to the maximum amount specified in the letter from the NIHR Central Commissioning Facility notifying them that their Pre-Qualifying Questionnaire had been shortlisted, and of their eligibility to submit a full application for NIHR BRC designation and funding. As part of their application NHS/University Partnerships will also be asked to indicate how research would be supported if the final award were at +10%, -10% or -50% of the amount specified in the letter. The final amount of funding allocated to each NIHR BRC will be determined by the scale, nature and quality of the research activity to be conducted, and assessment against the assessment criteria. Value for money will be an important selection criterion. The purpose of the NIHR BRC funding is to meet the research infrastructure costs incurred by the NHS/University partnership in carrying out an approved programme of early translational (experimental medicine) research. We would expect standard NHS accounting policy and guidance to be followed (as set out in the NHS Finance Manual) in determining the appropriate costs to be charged to this scheme. Further information on eligible costs is provided in Annex 1. NHS/University partnerships wishing to apply for a Cross-cutting CRF Theme should also refer to the information in Annex 2. 4 The NIHR BRC scheme will fund patient- or people-focused early translational (experimental medicine) research, the aim of which is to translate basic biomedical research into clinical research, for the benefit of patients, the health system and for broader economic gain. This differs from the research to be funded via the NIHR Programme Grants for Applied Research scheme, which aims to provide evidence to improve health outcomes, and is largely focused on the later stages of the research process, where research findings are expected to impact on healthcare within a three to five year timescale. 6

7 SELECTION CRITERIA FOR THE FULL APPLICATION STAGE The selection criteria for the full application stage will be: the quality, volume and breadth of internationally-excellent biomedical and early translational (experimental medicine) research and researchers; existing research capacity and capability, and plans for increasing capacity including through the provision of training and development; the strength of the strategic plan; the relevance of the research portfolio to the health of patients and the public; the track record in translating advances in basic biomedical research into clinical research, and pulling through basic/discovery science into benefits for patients and the public, the health system and for broader economic gain; the strength of the strategic partnerships, including those with industry and other NIHR-funded research Infrastructure; value for money. Applications will have to demonstrate that the NHS/University partnership has the necessary crosscutting expertise and facilitates to underpin the wide range of early translational (experimental medicine) research to be undertaken within the proposed NIHR BRC. INFORMATION TO BE PROVIDED AT THE FULL APPLICATION STAGE Shortlisted NHS/University partnerships are asked to complete and submit the following details and supporting evidence: A full application Details of each of the specific Research Themes and Cross-cutting Themes to be conducted with the funding provided through this scheme o Please note that partnerships wanting an appropriate proportion of the CRF Crosscutting Theme to be considered for funding as part of the separate (non-nihr BRC) renew and refresh of NIHR CRF funding in the event that the NIHR BRC application is unsuccessful will also be required to provide additional information for their proposed separate CRF. A financial plan for each specific Research and Cross-cutting Theme and for the Centre as a whole, within the funding range specified Curriculum vitae for the proposed Director, Research Theme Leads and Cross-cutting Theme Leads 5-minute (maximum) DVD/video 1. Full Application The full application will need to set out: 1.1 Details of the NHS/University partnership and authorisations to endorse the application for a NIHR BRC and confirm that appropriate support will be provided should the application be successful. Specified representatives of both the NHS Trust and the University should confirm that both parties fully endorse the application for a NIHR BRC award and that appropriate support will be provided to the Centre should the application for funding be successful; and that they will comply with all NIHR research governance initiatives including uptake of NIHR Research Support Services, use of model research agreements/contracts, and compliance with the Research Governance Framework (and its successor) requirements. 1.2 A short plain English summary presenting NHS/University partnership s research background and specific overarching aims of the proposed NIHR BRC. It should explain to a public audience the nature of the proposed NIHR BRC and its short, medium and long-term aims, 7

8 which will potentially be made publically available. This should be aimed at members of the public and be written clearly and simply, without jargon and with an explanation of any technical terms included. 1.3 An overview of the excellent early translational (experimental medicine) research recently or currently undertaken by the NHS/University partnership and 3 to 5 examples of the effective translation conducted locally. 1.4 The NHS/University partnership s overall strategy for translating basic/discovery science into excellent people- or patient-based early translational (experimental medicine) research for the benefit of patients, the health service and broader economic gain, including: The NHS/University partnership s strategy for translating discoveries from basic/discovery science conducted within the partnership and elsewhere into excellent early translational (experimental medicine) research: A description of the NHS/University partnership s current and proposed strategic partnerships, including with industry, research charities and with other NIHR-funded infrastructure, and plans to develop these further; Three specific detailed examples of impact by demonstrating effective translation and pull-through from basic/discovery science into benefits for patients and/or service delivery in the past; Specific short (1-2 years), medium (3-4 years) and long term (5+ years) objectives for the proposed NIHR BRC. 1.5 An overview of specific Research Themes and any Cross-cutting Themes that will be pursued within the proposed NIHR BRC, including: the broad areas of research that will be pursued; how these relate to each other and the overall strategy of the proposed NIHR BRC. 1.6 The management arrangements for the Centre, including the arrangements for joint working between the NHS and University partner, the proposed Director (CV details must be provided prior to submission of the application by following the Manage My Details link on the Director s RMS home page) and the way in which the proposed Theme Leads fit into these arrangements. Please provide an organogram outlining the proposed Governance arrangements (including responsibility for finance) for the proposed NIHR BRC. Please confirm that the proposed Director of the NIHR BRC will have responsibility for, and authority over, the NIHR funding, if awarded. 1.7 An indication if any Research or Cross-cutting Theme will be subcontracted, in its entirety, to another NHS organisation (or organisations from independent sector providing NHS services) or other University, providing (if applicable): An indication of which Theme(s) will be subcontracted; Confirmation that the academic partner with which each subcontracted Theme Lead is associated (i.e. the academic partner where the Theme Lead has a substantive contract of employment) has achieved at least the Silver Award of Athena SWAN; Justification of how the involvement of another NHS organisation and/or University will provide additional research excellence and bring strength and depth to the work of the proposed NIHR BRC. 1.8 The NHS/University partnership s strategy for patient and public involvement, engagement and participation in the work of the proposed NIHR BRC; this is a key requirement for the NIHR, with successful applicant required to submit a fully developed PPI/E strategy by the end of the first year of the contract. 1.9 A statement on prioritisation of research activity and the relative priority attached to the Research and Cross-cutting Themes, and the work to be undertaken within them. This should 8

9 include a statement on how the proposed research would be adapted in the event of the final award being different by the funding scenarios (+10%, -10%, -50%) of that applied for A description of the resources that will be deployed on each of the above Research and Cross-cutting Themes and the proposed NIHR BRC, including: A detailed breakdown of the cost to this NIHR BRC funding scheme of those resources (using the Theme finance forms within the Research and Cross-cutting Themes section will automatically generate the summary finances); justification for the resources requested; the financial or other contribution from the NHS Trust and the University partner to the proposed NIHR BRC, noting that value for money will be a key aspect in the designation and funding of the new round of NIHR BRCs. Please also indicate the financial and other contributions from other relevant partners (e.g. other research funders); a statement of how funding provided will build on DH/NIHR investment via other funding schemes The partnership s track-record of, and forward plans and strategy for working with the life sciences and other industry. Please provide examples of key strategic relationships/partnerships with industry for early translational (experimental medicine) research directly relevant to the proposed Research Themes The partnership s track-record of, and forward plans and strategy for working with research charities and other (non NIHR) public funders of research. Please provide examples of any strategic relationships/partnerships with research charities or other public funders of research for early translational (experimental medicine) research directly relevant to the proposed Research Themes An overview of the partnership s track record and forward strategy for linking with other NIHR infrastructure (e.g. other NIHR BRCs, NIHR CRFs, Healthcare Technology Cooperatives, Diagnostic Evidence Co-operatives, Collaborations for Leadership in Applied Health Research and Care, Clinical Research Network, Experimental Cancer Medicine Centres, NIHR National Biosample Centre, MRC-NIHR Phenome Centre, Health Informatics Collaborative, Dementia Clinical Record Interactive Search, Clinical Practice Research Datalink and NOCRI. It will be expected that NIHR BRCs with Research Themes focussing on common clinical areas or diseases will demonstrate real collaboration with other designated NIHR BRCs and other NIHR research infrastructure to maximise the value for money of the total NIHR investments and to provide the maximum joint working for undertaking early translational (experimental medicine) industry contract and collaborative research The NHS/University partnership s proposals for involvement in NIHR Translational Research Collaborations. Providing the following information for the relevant initiative where applicable: NIHR BioResource: NHS/University partnerships wishing to participate in the NIHR BioResource should provide an outline of their proposal for participation, in areas relevant to their proposed Research Themes, outlining: o The track record and experience of building and maintaining cohorts for collaborative early translational (experimental medicine) research; o Experience and willingness to integrate existing cohorts into a larger national cohort such as the NIHR BioResource for use as a national infrastructure for research; o Forward plans, strategy, and resources that will support the recall of cohort participants on the basis of genotype and phenotype for collaborative research through the NIHR BioResource; 9

10 o Details of existing cohorts, including details of consent for recall for early translational (experimental medicine) research, cohorts size, disease areas and genome/phenome data available; o Confirmation of the strong desire to support recall of cohort participants on the basis of genotype and phenotype for collaborative research through the NIHR BioResource, as national infrastructure for research. NIHR Translational Research Collaboration Rare Diseases (TRC-RD): NHS/University partnerships wishing to participate in the NIHR TRC-RD should provide an outline of their proposal for participation, in areas relevant to their proposed Research Themes, including: o The partnership s track record, expertise and capacity for undertaking collaborative world-class early translational (experimental medicine) research for rare diseases; o Which Research Theme(s) will contribute to the TRC-RD and how they will do so; o Forward plans, strategy and resources that will support participation in the TRC- RD including a description of how the BRC will work with NOCRI and the TRC leadership in the successful delivery of the TRC, and how TRC membership will complement the NIHR BRC s strategy for working with industry; o The partnership s experience, ability and capacity to work collaboratively with other parts of the NIHR infrastructure and other sectors engaged in health research; o Confirmation of the clinical academic researcher/theme Lead that will represent the BRC and provide scientific leadership on behalf of the BRC on projects supported by the Collaboration; o Confirmation that there will be a single point of contact at the BRC for all operational matters regarding the Collaboration (who will work closely with the Collaboration s Leadership and provide dedicated operational support locally for the Collaboration s activities and studies, including coordination of costing and contracting discussions, study set up, trial management and delivery at the BRC). NIHR Translational Research Collaboration Dementia (TRC-D): NHS/University partnerships with a Dementia-focussed Research Themes are required to participate in the NIHR TRC-D and should provide an outline of their proposal for participation, including: o The partnership s track record, expertise and capacity for undertaking collaborative world-class early translational (experimental medicine) research for dementia; o An outline of which Research Theme(s) will contribute to the TRC and how they will do so; o Forward plans and strategy detailing how the relevant Research Theme(s) will contribute to the TRC-D including a description of how the BRC will work with NOCRI and the TRC leadership in the successful delivery of the TRC, and how TRC membership will complement the BRC s strategy for working with industry; o The partnership s experience, ability and capacity to work collaboratively with other parts of the NIHR infrastructure and other sectors engaged in health research; o Confirmation of the clinical academic researcher/theme Lead that will represent the BRC and provide scientific leadership on behalf of the BRC on projects supported by the Collaboration; o Confirmation that there will be a single point of contact at the BRC for all operational matters regarding the Collaboration (who will work closely with the Collaboration s Leadership and provide dedicated operational support locally for the Collaboration s activities and studies, including coordination of costing and contracting discussions, study set up, trial management and delivery at the BRC); o An outline of the resources, drawn from the proposed NIHR BRC award that will support the contribution to the TRC-D. NIHR Translational Research Collaboration Inflammatory Respiratory Disease: NHS/University partnerships with relevant Research Themes are required to participate in 10

11 the NIHR Translational Research Collaboration Inflammatory Respiratory Disease and should provide an outline of their proposal for participation, including: o The partnership s track record, expertise and capacity for undertaking collaborative world-class early translational (experimental medicine) research relevant for inflammatory respiratory disease; o An outline of which Research Theme(s) will contribute to the TRC and how they will do so; o Forward plans and strategy detailing how the relevant Research Theme(s) will contribute to the Translational Research Collaboration Inflammatory Respiratory Disease including a description of how the BRC will work with NOCRI and the TRC leadership in the successful delivery of the TRC, and how TRC membership will complement the BRC s strategy for working with industry; o The partnership s experience, ability and capacity to work collaboratively with other parts of the NIHR infrastructure and other sectors engaged in health research; o Confirmation of the clinical academic researcher/theme Lead that will represent the BRC and provide scientific leadership on behalf of the BRC on projects supported by the Collaboration; o Confirmation that there will be a single point of contact at the BRC for all operational matters regarding the Collaboration (who will work closely with the Collaboration s Leadership and provide dedicated operational support locally for the Collaboration s activities and studies, including coordination of costing and contracting discussions, study set up, trial management and delivery at the BRC); o An outline of the resources, drawn from the proposed NIHR BRC award that will support the contribution to the Translational Research Collaboration Inflammatory Respiratory Disease. NIHR Translational Research Collaboration Joint and Related Inflammatory Diseases: NHS/University partnerships with relevant Research Themes are required to participate in the NIHR Translational Research Collaboration Joint and Related Inflammatory Diseases and should provide an outline of their proposal for participation, including: o The partnership s track record, expertise and capacity for undertaking collaborative world-class early translational (experimental medicine) research relevant for joint and related inflammatory diseases; o An outline of which Research Theme(s) will contribute to the TRC and how they will do so; o Forward plans and strategy detailing how the relevant Research Theme(s) will contribute to the Translational Research Collaboration Joint and Related Inflammatory Diseases including a description of how the BRC will work with NOCRI and the TRC leadership in the successful delivery of the TRC, and how TRC membership will complement the BRC s strategy for working with industry; o The partnership s experience, ability and capacity to work collaboratively with other parts of the NIHR infrastructure and other sectors engaged in health research; o Confirmation of the clinical academic researcher/theme Lead that will represent the BRC and provide scientific leadership on behalf of the BRC on projects supported by the Collaboration; o Confirmation that there will be a single point of contact at the BRC for all operational matters regarding the Collaboration (who will work closely with the Collaboration s Leadership and provide dedicated operational support locally for the Collaboration s activities and studies, including coordination of costing & contracting discussions, study set up, trial management and delivery at the BRC); o An outline of the resources, drawn from the proposed NIHR BRC award that will support the contribution to the Translational Research Collaboration Joint and Related Inflammatory Diseases The partnership s strategies, objectives and plans for early translational (experimental medicine) research capacity development for research staff, research support staff and trainees, explaining how this builds on the partnership s track record in this regard. The plan should report on the clinical and non-clinical professions to be developed, the attributes of the 11

12 research training environment and the efforts to be made to ensure that research student/support staff receive a high quality development experience. This may include highlighting the approach taken to mentorship, development of non-medical clinical professions, the support for development of academic careers in women, the utilisation of national priority programmes and track record of PhD graduates in subsequent career development including, through success in post-doctoral fellowships training applications The Centre s plans and strategy for managing and exploiting intellectual property, including its track record of patents filed and granted, the establishment of spin-out companies and any income generated from commercialisation of intellectual assets, and the track record and proposals for the management, dissemination and adoption of intellectual property that may be deemed less commercial in nature but may have direct service benefit for the NHS. 2. Details of each of the specific themes of work to be conducted with the funding provided through this scheme For each proposed Research and Cross-cutting Theme that will be pursued within the proposed NIHR BRC with funding from this scheme, including, for each theme: name of the Theme; the Theme Type (Research, Cross-cutting, Clinical Research Facility, Core costs 5 ); its aims and short (1-2 years), medium (3-4 years) and long term (5+ years) objectives; the research strategy for the Theme; its relevance to the health of patients and the public; three examples over the last five-year period from the NHS/University partnership of how previous research findings in this area have translated into improvements in healthcare and public health; the key contributing researchers associated with it, who will add quality and depth to the proposed Research or Cross-cutting Theme, including a proposed Theme Lead; the department in the academic partner with which the Research Theme Lead is associated. If the Theme Lead has a substantive contract of employment with a University then the name of their main academic department in their employing university should be reported here. If the Theme Lead has a substantive contract of employment with an NHS organisation, please indicate their main academic department in the University with which the Lead holds an honorary contract. Applications for Cross-cutting Themes should also include details of how they will add strength and depth to the main Research Themes. 3. Curriculum vitae for the proposed Director and Theme Leads The proposed BRC Director and each of the Theme Lead is required to submit a CV within the NIHR CCF RMS. See Annex 3 for guidance on completing CVs in the RMS system. 4. Theme financial plan form The financial plan for each Theme will need to set out the costs for each Research and Crosscutting Theme to be undertaken within the NIHR BRC. Separate plans should be completed for each Research and Cross-cutting Theme. This will automatically generate the Summary Finances on the in the Finances & Resources section of the RMS. 5 Please note that applicants must select the Core costs Theme Type to enable applicants to present the cost of core functions and facilities for the NIHR BRC (e.g. Director, management, training, technology platform, etc. costs), which underpin the Research and Cross-cutting Themes, by providing access to a separate Core costs Theme finance form. This should be used for core costs, rather than spreading these core costs across the finance forms for different Research and Cross-Cutting Themes. 12

13 Partnerships will need to present the cost of core functions and facilities (e.g. Director, management, technology platforms, etc.) which underpin the Research and Cross-cutting Themes by completing a separate finance form for Core costs (in addition to those for the Research and Cross-cutting Themes), rather than spreading these costs across the Themes. To access this, Partnerships will need to select the Core cost Theme Type. 5. An overall financial plan table The overall financial plan provides a financial summary for the NIHR BRC as a whole; collating the financial information from each of the individual Themes (this will be automatically updated) minute (maximum) DVD/video (or other digital format) Full stage submissions will also need to be accompanied by a 5-minute (maximum) DVD/video (or other digital format) featuring or demonstrating the research facilities that are in place to support research at the proposed NIHR BRC. The DVD/video must be no longer than 5 minutes in duration. The playback to the International Selection Panel will be timed and will be stopped at 5 minutes to ensure equity and fairness. It should provide a brief overview of the facilities and any underpinning infrastructure that would be used to support the proposed work programme directly. The purpose of the DVD/video is to demonstrate to the Panel that the partnership has the necessary facilities and underpinning infrastructure to support the proposed NIHR BRC. The purpose is not to repeat the presentation of the proposal. The quality of the video production itself is not being assessed. SUBMITTING YOUR APPLICATION The application process is managed through the NIHR CCF. Applications should be submitted via the CCF RMS and applications received through other means will not be accepted. To apply, individuals must create an account in the NIHR Central Commissioning Facility Research Management System at Once registered, details will need to be validated by CCF. You will receive a confirmation and temporary password. If you don t receive any s from manager@ccfrms.org.uk, please check they have not been sent to the spam folder. To generate a new NIHR Biomedical Research Centre Competition 2016 Stage 2 application form. The lead individual for the NHS/University partnership (the proposed Director) should, once registered, use the left hand side toolbar and select My Applications and go to New Application, selecting the Biomedical Research Centre Competition from the open funding rounds section. To navigate, use the menu on the left-hand side of the screen and by using the Previous and Next buttons. It is advisable to use the mouse to go through the sub-sections of the form as hitting TAB will not lead to the next field. Please note that if you hit ENTER the system will close down the page you are currently working on and return to the introductory page. Please start your application as early as possible and ensure you have completed all the fields in the application form and uploaded all the necessary information as requested. Please ensure that you read the online help prompts marked (?) for additional guidance. You will need to validate your form prior to submitting your application. Please complete the application form so that there are no outstanding validation issues, as you will be unable to submit until they are resolved. We recommend performing ongoing validation checks to ensure the forms are being completed entirely and that no fields have been missed. Please note that the system will not allow submissions after the deadline and any mandatory validation issues will prevent you from submitting your application. The proposed Director must complete Details of Formal Authorisation section of the application form and then use the online functions to add the following official contacts: 13

14 Finance Officer for the host NHS Organisation Authorised signatory for the host NHS Organisation, who can authorise the application on behalf of the host NHS Organisation. Authorised signatory for the University or Higher Education Institute partner, who can authorise this application on behalf of the University or Higher Education Institute. An will automatically be sent requesting the application be approved. Without this approval the application cannot be submitted. To submit your application, please go to the application home screen and click SUBMIT in the lower half of the application details web page. You will be asked to confirm your submission. If no grey screen with the confirmation appears, please return to editing the application and ensure there are no outstanding items listed in the Validation Summary section to review. Please ensure you receive a confirmation from the RMS and contact CCF if you do not receive your confirmation. Frequently Asked Questions which we receive will be published to all potential applicants as document available from the NIHR website at: Applicants are reminded that during busy periods, such as close to a competition deadline, it could take slightly longer to submit your application. It is likely that during such periods, our helpline will be receiving a very high volume of calls. We therefore advise that you do not leave your submission until the last 24 hours. We wish to ensure that shortlisted NHS/University partnerships fully understand what is needed in their applications before they submit them. We will therefore respond to requests for clarification from the Lead for each application or from a person nominated by him/her. We cannot, of course, provide advice on what a partnership should say or how they should say it. Members of the International Selection Panel are bound by confidentiality and are not able to discuss this scheme with shortlisted partnerships. Any enquires should be sent to: Katie.cook@nihr.ac.uk or phone Further information about the use of the RMS can be found in Annex 3. SUBMISSION DEADLINE The closing date for electronic submission of full applications is Monday 6 June 2016 at 13:00. The DVD/Videos that have not been submitted within the RMS should be sent by 29 June 2016 to: Dr Katie Cook NIHR Central Commissioning Facility Grange House 15 Church Street Twickenham TW1 3NL 14

15 ANNEX 1: APPLICATION FINANCES AND ELIGIBLE COSTS The purpose of the NIHR BRC funding is to meet the research infrastructure costs incurred by the NHS and University partnership in carrying out an approved programme of early translational (experimental medicine) research, including the funding of staff and core research facilities. Our expectation is that each NIHR BRC will underpin a portfolio of work supported by other research funders (e.g. Research Councils, Charities, Industry), but will also support a portfolio of original research, which is distinct from that supported by NIHR or other funding bodies. Funding awards will be made to the NHS partner, but it is permissible for funds to flow to the university partner, or to other NHS organisations (or organisations from independent sector providing NHS services) and other universities, via a subcontract, with appropriate justification. The finance forms should provide a breakdown of all the requested, necessary recurrent NHS Research Infrastructure Direct Costs, eligible NHS Support Costs and reasonable NHS Indirect Costs for which funding is being requested. No new Department of Health capital funding will be available for NIHR BRCs as part of this current funding competition. Therefore, applications should only include research that can be undertaken within existing facilities or planned facilities that the NHS Trust or University partnership is investing in alone, or with other external organisations, with confirmed funding. In all cases, the value for money of the proposal will be an important selection criterion. REQUIRED READING Prior to completing the finance section of the application it is important applicants have a good understanding of the following: Attributing costs of health and social care Research and Development (AcoRD) guidance The AcoRD guidance clarifies the distinction between the three categories of costs associated with non-commercial research studies/programmes: Research Costs NHS Support Costs NHS Treatment Costs Attributing the costs of health and social care research and development (AcoRD): We strongly recommend that applicants familiarise themselves with these definitions, and consult: AcoRD Annex A: List of common research activities attributed to the Research Costs, NHS Treatment Costs and NHS Support Costs: ex_a_- List_of_Common_research_Activities_March_2013_for_publication.pdf AcoRD Annex B: FAQ: cord_faqs Dec_15.pdf 15