Guidance notes - Asthma UK

?Guidance notes for applicantsAsthma UK Programme Development GrantCall for applications for a Programme Development Grant on the use of data from smart inhalers for asthma management in adultsMarch 2020Asthma UK’s research programme and the role of Programme Development GrantsStop asthma attacks. Cure asthma.Asthma UK’s mission is to stop asthma attacks and cure asthma. We do this by funding world-leading research, campaigning for improved care and supporting people to reduce their risk of a potentially life- threatening asthma attack. We are entirely funded by voluntary donations. To date, the charity has spent over ?50 million on basic and clinical research to understand more about asthma, its causes and treatments, making us a significant contributor to the asthma research landscape in the UK. Programme Development Grant – the use of smart inhalers for asthma management in adults.The routine asthma review (every 12 months, regardless of disease state or control) is ineffective, with patients expecting new technology to be utilised to enable more convenient care pathways. However, with uncertainty surrounding what the regulation is at present, it is likely that a high bar of evidence would be required in future for the approval of new technology.There has been rapid progress in the development of advanced data analytics techniques and tools to drive discovery and deeper insights. Algorithms are getting increasingly sophisticated and can be “trained” through large volumes of healthcare data to flag risk and assist with disease diagnosis and treatment suggestions. In addition to being able to rapidly analyse big data in real time, the storage of large-scale datasets is now possible and cost effective. Further, using smart inhaler data linked with other data sets will provide new opportunities for deep phenotyping.Connected devices are increasingly being used for the management of asthma and will become cheaper as the costs of sensors and processors fall and as a result of competition and economies of scale. New care programmes enabled by connected technologies that are market-ready e.g. smart inhalers have already been piloted and shown positive results for improving adherence. Yet, there has not been widespread adoption of smart inhaler-enabled clinical pathways in any healthcare system for the management of asthma. Building on two of the top research priorities for asthma (optimising supported self-management and understanding asthma sub-groups), the intent of this award is to fund the development phase of a larger Programme Grant seeking to link real-time data from connected asthma inhalers (smart inhalers) to improve routine asthma care for adults. The ambition is to generate sufficient evidence to achieve guideline body (NICE) and regulatory body endorsement. Please note that Asthma UK is unlikely to be able to fund the larger Programme Grant, but will work with successful development grant holders to support funding applications elsewhere.Type of awardProgramme Development GrantWhatCall for applications for a Programme Development Grant on the use of smart inhalers for asthma management in adultsWhoPrincipal investigators based at UK research institutionsCostUp to ?250,000 per proposal. DurationUp to 18 monthsThe vision for this overall programme of work aims to realise the following:A reduction in the number of asthma attacks, emergency healthcare visits and deaths; enabled by more effective, digitally enabled and data driven care models for asthma management used throughout the UKImproved experiences for people with asthma through the use of connected data and digital technologies; leading to improved self-management of asthma for adult patients in routine asthma careMore effective and efficient use of NHS resources when diagnosing, treating and helping people with asthma manage their conditionCreation of a proven blueprint that will enable a wider roll-out of Smart Inhaler technologiesAsthma management that is continuously improving and keeping pace with changes in user behaviour and technological advances over timeThe ability to combine data collected from digital devices with other data sources; to allow for effective phenotyping with subsequent research enabling the transformation of asthma diagnosis, management and treatmentApplications will not be accepted where the primary intent is the purchase of equipment, the study is currently underway or is from commercial organisations. Key dates for the 2020 Programme Development Grant call12 March 2020Application for call opens1 pm on 10 June 2020Application submission deadlineJune-July 2020All applications will be reviewed by the Review Panel, comprising of scientific experts and people affected by asthmaAugust 2020 The Review Panel will shortlist applications to be considered at the Panel meeting in September 2020. W/C 14 September 2020Review Panel meeting to discuss applications and make recommendations to Asthma UK’s Chief Executive and Director of Research and Innovation for funding.Late September 2020All applicants and reviewers will be notified of the outcome 17145217805The deadline for submission of applications is 1pm on 10 June 202000The deadline for submission of applications is 1pm on 10 June 2020Assessment Criteria for ApplicationsThe Review Panel will consider the following when assessing applications:A plan to generate real-time data from smart inhalers in a form that can be integrated into NHS electronic health record systems across primary, secondary and tertiary care.Considerations: data quality; data linkage; Information Governance; NHS App and future research platforms. A process of linking the generated data within routine asthma care (interoperability through primary, secondary and tertiary care record systems) to enable effective monitoring of inhaler use.A detailed description of the real-world trial to be undertaken with the larger Programme Grant that will measure the efficacy of using linked real-time data from smart inhalers, in comparison to the standard of care for adults with asthma in the UK. The development work is expected to:Conduct any pilot or feasibility work required; a minimum viable technology integration should be built and tested to enable effective execution of trial(s) and evaluation(s) in accordance with protocols, and trial and evaluation sites selected.Establish a relationship with NICE and have an ongoing dialogue with regards to evidence requirements for implementing digitally enabled models of asthma care. Evidence requirements are expected to include clinical efficacy; safety; health economics; feasibility; usability and acceptability by both patients and clinicians; and interoperability and transferabilityFully cost the trialIdentify potential risks of delivering the proposed study, and propose mitigating actions for these risksDemonstrate how work will be carried out with regulators and legislative frameworks, such as GDPREvidence of appropriate expertise and resource within the group to undertake the research. Asthma UK expects to receive applications from co-ordinated multidisciplinary teams of investigators spanning both health and non-health specialties/disciplines, bringing together the necessary skills and expertise required to deliver the research proposed. The involvement of patients and the public in the plans to ensure people with asthma are at the centre of the work.The value for money provided by the proposal.Submission of applicationsThe Review Panel will not reconsider unrevised applications that have previously been rejected by the Panel under another Asthma UK funding round.Applicants should not approach the Chair or members of the Review Panel about their research application either before or after the decision on the Awards. Applicants may seek advice on the application process from Asthma UK’s Research Team before applications are submitted. Once the application has been submitted, no additional unsolicited information intended to support the application will be accepted unless related to new legislative or regulatory changes that will have a significant impact on the work undertaken. Applications will not be accepted from investigators (whether applicants, sponsors or collaborators) who have an overdue final report from a previous project funded by Asthma UK at the time of submission (i.e. the deadline date). Applicants should consult with any sponsors and collaborators involved in their application to ensure that they have submitted their final reports; otherwise the application will be rejected.For any applicants who have held an Asthma UK grant that is ongoing or has finished in the last five years, applications will not be funded until the relevant data is entered onto Researchfish - see the Research web-pages for more details: Lay reviewers (non-scientists who are affected by asthma) will be involved in reviewing and scoring your application. These scores along with the scores given by the other reviewers will be used to rank your application, so it is imperative that you give sufficient attention to the ‘lay summary’ section of the online application form. The lay summary must be clear and understandable and must not be just a lay translation of the ‘scientific abstract’ as it has an entirely different focus and should therefore include different information. The lay summary should be an overall summary of the project.Guidance for completing the application formThe application form should be completed in typescript of 11 point Corbel font. Word limits must be adhered to in each section of the form. Once completed, please email the application form as an attachment to ykhan@auk-.uk, cc research@.uk. Please also send an original signed copy to: Dr Yarunnessa KhanResearch Team, Asthma UK18 Mansell Street, London, E18AA. Please ensure that all necessary additional paperwork is attached as an Appendix to the email. Both electronic and signed paper copies must be received by the submission deadline. The deadline for submission of applications is 1pm on 10 June 2020The deadline for submission of applications is 1pm on 10 June 2020Asthma UK Privacy PolicyData you provide here will be used in connection with your application and be shared in accordance with the Asthma UK Privacy Policy.Asthma UK Privacy PolicyData you provide here will be used in connection with your application and be shared in accordance with the Asthma UK Privacy Policy.If you have any questions about any aspect of the application process, please contact: Dr Yarunnessa Khan Email: ykhan@auk-.uk Tel: 020 7786 4943.Applicant InformationAll applicants are required to provide a CV attached within the Appendix at the end of the application form. The CV should include:Work contact informationAcademic/professional qualifications Employment - present and previous position(s) heldKey publications in the standard scientific format (i.e. Harvard or Vancouver style) - list details of references that you feel will aid your application. Include full title and all authors (failure to cite a reference in full may impede processing of your application). References for up to 10 of the most recent and/or relevant papers for each applicant will be adequate.Current research grants held - please list all current Asthma UK and non-Asthma UK grants held, providing details of the grant reference number (if available), title, awarding body, value and funding period.Any other information you feel will demonstrate your track record in, and commitment to, asthma research.Lead ApplicantsThe lead applicant should be able to demonstrate evidence of a strong research record including publications, successful grant applications, in addition to providing evidence of leadership skills.The lead applicant and the proposed grant must be based in the UK. Where applicants are on fixed term contracts, their contract must extend at least one year beyond the lifetime of the grant or the host institution/organisation must demonstrate that it intends to award a permanent position at the end of the fixed term (evidence can be provided by way of a letter of support that can be included in the Appendix at the end of the application).Any lead applicants affiliated with the MRC-Asthma UK Centre in Allergic Mechanisms of Asthma or the Asthma UK Centre for Applied Research must be indicated as such.All lead applicants submitting an application must be willing and able to agree to the current Terms and Conditions if their application is successful. There will be no flexibility on the clauses contained within them post-award, but Asthma UK reserves the right to amend these terms and conditions in future years.It is a condition of the award that the lead applicant and their Host institution/organisation co-operate with Asthma UK on fundraising and publicity initiatives around the award and the research to be undertaken, always acknowledging the need for caution where wide publicity might confound the study (e.g. by affecting control groups). Wherever appropriate, researchers will be expected to acknowledge and promote the work of Asthma UK (e.g. in scientific meetings, presentations to the media and other similar contexts).A CV for the lead applicant must be attached within the Appendix at the end of the application.Co-applicantsCo-applicants are those individuals with responsibility for the day-to- day management and delivery of the development grant work. They are considered part of the project team and are expected to share responsibility for its successful delivery.CVs must be provided for each co-applicant within the Appendix at the end of the application. However, co-applicants who are patients, service users or carers are not obliged to complete a standard CV, but are required to provide a summary of any knowledge, skills and experience relevant to their role in the application. This could include information about (but not limited to):Previous or present work (paid or unpaid) with any relevant organisationsLinks with any relevant groups, committees, networks or organisationsExperience of health conditions, treatments or use of services Knowledge and experience of research including previous research undertakenKnowledge and experience of patient and public involvement including previous involvement activitiesSkills from any other roles that are transferableRelevant qualifications, training and learningStaff members/EmployeesAny individual whose salary, or proportion of salary, is going to be paid using the grant must be named as a staff member. This may include postdoctoral researchers, research technicians, PhD students etc. Any co-applicants who wish to claim their salary must additionally be listed as staff members in the application form. Although tenured staff members cannot normally claim a salary, Asthma UK would consider this on a case-by-case basis.If the staff member(s) who will be employed on the grant has not yet been recruited or is unknown at this stage, please provide the title of the position to be filled and which will be paid for by the grant (e.g. PhD student). However, information about specific individuals must be provided to Asthma UK as soon as possible after the award letter is issued to indicate that the recruitment for the role has been successful (if applicable).There is no limit to the number of staff members that can be involved in an application, provided their salary costs (or a portion thereof) can be accommodated within the grant. Any staff members affiliated with the MRC-Asthma UK Centre in Allergic Mechanisms of Asthma or the Asthma UK Centre for Applied Research must be indicated as such.Collaborators There is no limit to the number of collaborators that can be involved in an application, but for each collaborator there must be a signed declaration letter on official letter-headed paper which confirms they have consented to co-operate in the programme of research. It should also outline their reasons for collaborating and explain their role in the project (which should correlate with the detailed proposal). Please add the collaborator letter of support in the Appendix at the end of the application.Any collaborators affiliated with the MRC-Asthma UK Centre in Allergic Mechanisms of Asthma or the Asthma UK Centre for Applied Research must be indicated as such.Institutions/OrganisationsThe lead applicant and host institute/organisation must be UK-based. There is no restriction on the location of the collaborators.Academic institutions ‘hosting’ an application must show support for the applicant through commitment to facilitate the research proposed (for example this may be through payment of indirect costs, or research costs such as consumables). The ‘hosting’ institution is expected to take full responsibility for the management, monitoring and control of the research work, the staff working on the project and the dissemination of the results of the research.The ‘hosting’ institution is required to own, manage and appropriately exploit all intellectual property (IP) rights arising from the award. The current Terms and Conditions contain further details regarding Asthma UK’s position on IP.All institutions ‘hosting’ an application must be willing and able to agree to the current Terms and Conditions if their application is successful. There will be no flexibility on the clauses contained within them post-award, but Asthma UK reserves the right to amend these terms and conditions in future years.Lay AbstractIt is important that the lay summary is written in plain English and is understandable to a non-scientific audience. This summary will be used by lay reviewers (people with asthma and parents/carers of children with asthma with no scientific background) when reviewing and scoring your application to assess its relevance to people with asthma, and in the final ranking of applications. It is therefore imperative that the lay summary is accessible and provides enough information for lay reviewers to make informed decisions. You should:state clearly the aims and objectives for a lay audience, including the research problem the project is trying to address and its relevance to asthma and associated allergiesdescribe clearly, without jargon, what you are actually going to do in the projectexplain how achieving the research objectives will benefit people affected by asthma, either as a direct result of your findings, or to inform future research that may result in clinical benefitprovide details of how people with asthma will be involved by providing input into the design and delivery of the research. Provide an indication that you have considered the practical feasibilities of involving them in the study outline likely timescale to impact and reasons whydescribe what steps you would take to disseminate the results of the research.Lay reviewers are not expected to comment on the science – this is the role of the external peer reviewers and scientific members of the Review Panel. Therefore, it is vitally important that your lay summary passes the ‘so what?’ test and demonstrates why the research is important to people with asthma.As someone who is affected by asthma, a lay reviewer’s knowledge and experience provides a unique and valuable perspective for peer reviewing project proposals. They have a particularly important role in answering questions such as:Is the research question important to people affected by asthma?Is the research exploring potential benefits that would be helpful to people affected by asthma?Will participants be willing to take part in the project? Or will it inconvenience them so much that they are unlikely to agree to take part?Did the researchers seek the advice of people affected by asthma when they planned their research? What difference did this make?Have the researchers considered that people affected by asthma come from different genetic, social and ethnic backgrounds and may therefore have different experiences and perspectives of asthma? Is any information for participants clear and easy to understand?We recommend that your summary is shown to people affected by asthma without a scientific background for their comments before submission. For further tips and an example of an effective lay summary, please read our Grant Application Toolkit available on our website.Please ensure that your lay summary does not contain any confidential or sensitive information, as this section will be used to publicise your award should it be funded.FinancesFunding informationAsthma UK will fund Programme Development Grants for the duration of up to 18 months only, capped at a maximum of ?250,000.Once the final award amount has been agreed by Asthma UK’s Chief Executive and Director of Research and Innovation, this cannot and will not be amended at a later date.Asthma UK is reliant upon income from voluntary sources and funding will be subject to the availability of the necessary funds.As a member of the Association of Medical Research Charities (AMRC), Asthma UK adheres to the AMRC statement on supporting research in universities. Charitable funding of research relies on public donation and philanthropy; donors expect their money to be spent on research to develop treatments. Asthma UK will therefore only support the directly incurred costs of research and will not cover indirect or directly allocated costs, which are primarily the responsibility of the host institution.Asthma UK will only fund directly incurred costs. These include the costs directly associated with the delivery of the research, such as:Staff (e.g. salaries for research assistants, post-doctoral researchers)Consumables and other costs directly attributable to the projectEquipment specific to the needs of the projectTravel costs related to members of staff travelling between multi-centre research sites or for scheduled collaborator meetings relating to the projectAsthma UK will not fund:Any directly allocated costs i.e. shared costs, based on estimates, which do not represent actual costs on a project-by-project basis. This would include estate costs and the costs of shared resources, such as clerical and administrative staff, nurses, supervisors and collaborators who are already employed. Equipment not specific to the research is classed as directly allocated costs. If justified, appropriately, Asthma UK may consider contributing towards the cost of shared resources, but this would be considered on a case-by-case basis. Applicants are encouraged to seek advice from the Asthma UK Research Team on this issue before applications are submitted.Any indirect costs necessary for underpinning research, which cannot be allocated to individual projects (i.e. overheads or full cost recovery). These costs cover computing and information support, library costs, living expenses, central services, general maintenance, lighting, heating and other infrastructure costs. Please note that the recently introduced apprentice levy is included as an indirect cost. Indirect costs will be calculated separately by each Higher Education Institution, according to TRAC methodology. Please consult your host institution’s finance team for guidance on allocating these costs.Other costs (including but not limited to conference travel) associated with dissemination of research findings not associated with Asthma UK fundingResearch linked to tobacco industry fundingAsthma UK urges all applicants to work with their finance offices, clinical trials units, local NHS trusts and the Local NIHR Clinical Research Network to ensure that all the costs of research have been identified and appropriately funded.SalariesThe lead applicant is expected to hold a secure or tenured position. Although tenured staff members cannot normally claim a salary, Asthma UK would consider this on a case-by-case basis.Applicants can apply for the salaries of staff members they employ to deliver the project. This may include postdoctoral researchers, research technicians etc. Any co-applicants who wish to claim their salary must additionally be listed as staff members in the application form.Any individual whose salary, or proportion of salary, is going to be paid using this grant must be entered as a staff member in the salaries section. There is no limit to the number of staff members that can be included on an application, provided their salary costs can be accommodated within the award.Staff costs should include any anticipated (and realistic) nationally agreed pay awards.If funded, staff names and CVs will need to be provided to Asthma UK for grant administration purposes.Asthma UK does not build inflation into contractual grant commitments and all costs expected to be claimed for must be quoted in the application. This should include inflation projections not in excess of the current market rate (which is typically a maximum of 3%, but is much reduced at the present time).EquipmentEquipment should be itemised in the application and is considered to be hardware costing in excess of ?500. Smaller items should be included under consumables.TravelWhen travel is an integral part of the project supported by Asthma UK it should be included in the budget.Travel specifically related to conducting research associated with the grant or visits to other research institutions relevant to collaborative working are acceptable, but travel and costs associated with conference attendance is limited to one European or international conference for each year of funding.Travel by the most economic means possible is encouraged; Asthma UK does not fund first class travel, except in exceptional cases.AMRC full economic costing information*Submission of this Programme Development Grant application, if awarded, will imply that the institution is prepared to meet the full economic costs from its own sources of funding*Monitoring the full economic costs of charity-funded research in UK HEIsThe Association of Medical Research Charities (AMRC) issued updated guidance to its members and to universities regarding its position on changes to costing research applications and the move to a system of estimating full economic costs (fECs) in 2004. AMRC member charities do not fund the indirect costs on grants awarded to UK universities as a matter of principle. The move to funding on a percentage basis by other types of funders, such as the research councils, is unlikely to be adopted by the charity sector in the foreseeable future; the reasons for this decision are set out in AMRC’s position statement and guidance document. Following the 2004 Spending Review, the Government recognised the importance of charity funding in universities and announced that a separate stream of funding, administered by HEFCE to English universities, would be introduced from 2006/07 to provide additional support for charitable research. The allocation of the Charity Research Support Fund (CRSF) in England will be based on the amount of income from eligible charities; most AMRC member charities will be eligible for the CRSF. AMRC member charities have agreed that it would be helpful to collect information about the full costs of the research they support, in order to develop a better understanding of the charity contribution, inform future discussions about the CRSF and to assess future sustainability.Applicants and host institutions should note that the data sought is for monitoring purposes only and will not form part of the peer review or decision-making process that AMRC members use. For further information regarding AMRC’s positions on funding in universities, please refer to the web pages at: Property and EthicsIntellectual Property (IP)Asthma UK expects that the Host Institution shall ensure that ownership of the IP arising from work funded in whole or in part by Asthma UK, and lead responsibility for its management, vests in the Host Institution (or its associated technology transfer company). Asthma UK is under an obligation to ensure that the useful results of research that it funds are put into the public domain and applied for the public good. To meet these obligations Asthma UK requires Asthma UK funded researchers, their Host Institutions and associated technology transfer companies to ensure the protection and exploitation of IP (including all inventions, technologies, products, data and know how).Asthma UK will receive a share of any commercial return commensurate with its relative contribution to the research and the value of the results arising, in line with AMRC Guidelines. EthicsAsthma UK expects that before work commences on the research, the applicant has ensured, in collaboration with the host institution, that all appropriate regulatory approvals are in place. If your project requires approval from the National Research Ethics Service, a hard copy of the Ethics Committee approval confirmation will be required before the project can commence.Please provide any relevant documents related to IP or ethics in the Appendix at the end of the application.Mandatory signatoriesPlease note that it is mandatory for the Head of Department and the Finance Officer of the Host Institution to confirm participation. Signatures will need to be provided before the submission deadline.Conflict of InterestAny conflict of Interest (COI) that any of the applicants or collaborators may have should be declared clearly, including any personal, professional or commercial interests that could lead to a perception of bias. Examples include (but not limited to) secondary employment, consultancy, financial or commercial gain (pensions, shareholdings, directorships, voting rights), honoraria, etc. In the case of commercial sector involvement with the application, please state clearly the relationship to ownership of data, access to data, and membership of project oversight groups.Submitting your applicationAfter you have completed all sections on the application form, please ensure you attach all other required documents as an Appendix:Mandatory:CVs for all applicants (Lead applicant and each co-applicant)Letter of support from each collaboratorIf relevant:Gantt charts, schematics, tables, illustrations, graphs and other types of graphics relevant to the applicationLetter of support from the Departmental IP manager/Head of Technology Transfer Unit Documents related to ethical approvalPlease ensure all signatures are hand-written. Scan the application form and email (including the Appendix) to: ykhan@auk-.uk, copying in research@.uk. Please also send an original signed copy to: Dr Yarunnessa KhanResearch Manager Asthma UK18 Mansell StreetLondon E1 8AA Both the electronic and signed paper copies, including all necessary documents in the Appendix, must be received by 1pm on 10 June 2020Both the electronic and signed paper copies, including all necessary documents in the Appendix, must be received by 1pm on 10 June 2020If you have any questions about any aspect of the application process, please contact: Dr Yarunnessa Khan Email: ykhan@auk-.uk Tel: 020 7786 4943.Good luck with your application! ................
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