STANDARD APPLICATION FORM

Transcription

1 STANDARD APPLICATION FORM Section: Introduction Please note the following information and guidance is provided to applicants submitting an i4i stage 1 application ONLY. There are a number of resources available to you throughout the online form to help guide you when submitting a research application and it is advised that you take care to read the Guidance for Applicants document as well as the online guidance prompts (marked as a?) carefully whilst completing your application. The deadline for this call is 1pm on Wednesday 14 January 2015 Please ensure that all co-applicants invited to collaborate on this application have confirmed their involvement and approval of the application form content well in advance of this deadline. Applicants are expected, before submission, to have discussed the content of their application with their own and any other body whose co-operation will be required in the conduct of the research. Page 1 of 29

2 Research Details Research Title: Please provide the title for the project. This should be both concise and clearly descriptive and should contain keywords relevant to the project. Host Organisation (which will administer any award): If your organisation does not appear on this list, please contact the Central Commissioning Facility Please indicate which organisation would act as the contracting organisation if the application is successful. NOTE: If your organisation does not appear on this list, please contact the Central Commissioning Facility. Research Duration: Please indicate the expected length of the proposed projects in months. NOTE: i4i projects can be up to a maximum of 36 months in duration. Proposed Start date if awarded funding: (Cannot be before 01/09/2015) Please select... Please indicate the proposed date on which the project would start. A 'cannot be before' date has been suggested on your behalf to ensure that you allow sufficient lead in time to obtain any regulatory approvals necessary and/or so that any documents required by the i4i programme can be submitted, prior to commencement of the actual project, should your application be supported. NOTE: You may not know this date exactly, but a rough estimate must be supplied. Page 2 of 29

3 Section: Lead Applicant Details Some of the responses required in this section of the form will have been pre-populated based on your CV details. Please complete the remainder of this section. Title: Forename: Surname: Position held: Specialty: Institution: Department: Address: City/Town: County: Country: Post Code: Phone number: Please ensure that your role on this research and %FTE commitment information is detailed within the Co-Applicants Details section. Provide an approximate breakdown (%) of how your current appointment is divided between the following owing activities: Service/Clinical Research Teaching Other % If applicable, please specify what your 'other' activity consists of. (20 words max) Administrative Contact Information: If appropriate, please provide details for an administrative contact who you would wish to act as a secondary point of contact for any queries relating to the proposed project, should it be supported. NOTE: This person does not need to be a co-applicant. Administrative contact name: Administrative job title: Administrative telephone number: Administrative address: Page 3 of 29

4 Section: Lead Applicant CV The following CV details are required as part of this research application. They will have autopopulated from the details you entered in the Manage my Details part of this research management system. To update your CV details, please visit the Manage My Details area by selecting 'Save and Close' at the top of this screen and accessing the left hand menu toolbar. Degrees (including details of degree subject/professional qualification(s), awarding body and date) Please ensure that your CV details are up to date. Present and previous positions held or experience of service user (including job title, employing organisation, and start/end dates) Please ensure that your CV details are up to date. Selected recent relevant publication(s) (including list of authors, article title, publication name, volume reference) Please ensure that your CV details are up to date. Research awards(s) held Please ensure that your CV details are up to date. Page 4 of 29

5 Section: Co-applicant Details: Please note there is a maximum limit of 6 co-applicants. Please note all co-applicants are expected to make a substantive contribution to the delivery and management of the project. Please list the key individuals and organisations who will be participating in the project. To reflect this, each co-applicant invited must have confirmed and approved this application before the submission deadline. Please note completed CVs for all co-applicants are a mandatory requirement for submission and will be pulled through into the application. To update these details, a co-applicant should visit the Manage My Details section by selecting 'Save and Close' at the top of this screen and accessing the left hand menu toolbar. 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. A separate text box is provided for this purpose in the 'Add applicant role and %FTE commitment...' section. All key contributors to the project must be represented as co-applicants. Where a project requires specialist services or expertise from an organisation i.e. a sub-contract arrangement is planned, this can be detailed in the Case for Support and their inclusion justified under relevant expertise and experience. NOTE: Please note that 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. A separate text box is provided for this purpose in the Add applicant role and % FTE commitment... section. Add co-applicant: POP UP TEXT Please note if the relevant individual does not immediately appear on this list, ensure that your search criteria are accurate and refined, using both Forename and Surname fields. Forename(s): Surname : Add Applicant role and %FTE commitment Please select the name of the applicant from the drop down list below. Name of applicant: The i4i programme is a collaborative research and development programme, and the co-applicants listed here are expected to reflect this. Where appropriate, please include details of those who will be responsible for research, project management, IP and commercial aspects of the project. NOTE: Please see separate programme guidance document for further information. Page 5 of 29

6 Is this a patient/public co-applicant? Yes/No If yes: Co-applicants who are patients, service users or carers are 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. (500 words) We recognise and value the varied perspectives that patients/service users and carers bring to a project as applicants. In this section, please provide a summary of any relevant knowledge, skills and experience that you will draw upon to contribute to this project. This could include information about: Previous or present work (paid or unpaid) with any relevant organisations Links with any relevant groups, committees, networks or organisations Experience of particular health conditions, treatments, use of services - or as a member of a particular community Knowledge and experience of research including previous research undertaken Knowledge and experience of patient and public involvement including previous involvement activities Skills from any other roles that are transferable Relevant qualifications, training and learning. The bullet point list above is not exhaustive. Please include anything else that is relevant to the application. Specify role in research: (300 words max) Each co-applicant should provide a brief overview of their role in the proposed project. Further description of their day-to-day contribution to the project can be made within the 'relevant expertise and experience' section in the Case for Support. %FTE commitment: (% value under 100) Each co-applicant should include the percentage of time that they will devote to the project. NOTE: Full-Time Equivalency (FTE): percentage of full-time hours per week. Page 6 of 29

7 Section: Research & Development office contact: Please note we will notify the R&D office of the outcome of this application including any associated feedback Host organisation ation (which will administer any award): R&D contact name: Please provide the name, contact details and job title of the contact person in the R&D office of the contracting organisation so that we are able to notify this person of the outcome of this application including any associated feedback. In the event of this project being recommended for funding, we would also need to communicate with this person with regards to contract negotiations and general management of the project throughout its duration. NOTE: Please note this person does not need to be included as a co-applicant. R&D contact job title: R&D contact telephone number: R&D contact address: Page 7 of 29

8 Section: History of this application Has this application, or a similar application previously been submitted to this or any other funding body? Yes No Select 'Yes' if this application, or part of this application, has been submitted to another funding organisation or other National Institute for Health Research or Department of Health funding scheme previously. Title of previous application: (100 words max) Provide the full research title for the application. Name of Lead Applicant: Funding body to whom it was submitted: Identify the organisation to which it was submitted previously. Funding scheme under which the application was submitted: Identify the funding scheme to which it was submitted previously. Please indicate whether this was a Stage 1 (outline) or Stage 2 (full) application. Please Select... Reference number of previous application: Provide the reference number for the application. Outcome Please Select... Please state the outcome date, if a decision is still pending. calendar view (dd/mm/yyyy) Page 8 of 29

9 If unsuccessful, please indicate why. (200 words max) Where a previous, related application was made, please indicate how this research proposal differs from the previous application. (150 words max) You should highlight both successful and unsuccessful applications that were submitted to any funding stream. For unsuccessful applications, please summarise any changes made to the research in response to any feedback received. NOTE: Where there has been a previously successful i4i application, please describe how this project follows on from the funding received. Page 9 of 29

10 Section: Patient & Public Involvement In this section it is important that you describe, in as much detail as possible, how patients and the public have been involved in the development of the application as well as the plans for involvement in the proposed research. The NIHR expects the active involvement of patients and the public in the research it supports. NIHR recognises that the nature and extent of active patient and public involvement (PPI) is likely to vary depending on the context of each study or award. The Guidance for Applicants document provides more information on PPI in research. In addition: a definition of patient and public involvement in research, further information and resources are available from INVOLVE; the NIHR Research Design Service provides advice on applications and the James Lind Alliance has a step-by-step guidebook on involvement in research identification and priority setting. Were patients and the public actively involved in identifying the research topic, prioritising the research questions and/or preparing this application? Yes No If ' Yes' box is ticked the following text appears: If Yes, please tick the appropriate boxes below. Involved in identifying the research topic/prioritising the research questions Involved in preparing the application Please further describe how patient and public involvement has informed and/or influenced the development of the application and how patients and the public have been actively involved. If you have selected either of the boxes above please further describe the aims of the involvement and the ways in which you have involved patients and the public. Explain how patient and public involvement has informed and/or influenced the development of the research application including any of the following: -Identification and/or prioritisation of the research topic -Identification and/or prioritisation of the research questions -Development of the research design -Preparation of the application. Page 10 of 29

11 If 'No' box is ticked the following text appears: If patients and the public were not actively involved please explain why patient and public involvement was not thought necessary. Please indicate the ways in which the public will be actively involved in the proposed research, by ticking all relevant boxes below: Design of the research Management of the research (e.g. steering/advisory group) Developing participant information resources Undertaking/analysing the research (e.g. member of the research team) Contributing to the reporting of the study report Dissemination of research earch findings No plans for involvement Other If Other box is ticked the following text appears: Please explain how patients and the public have been actively involved in other ways. If any of the above box(es) are ticked the following text appears (N/A if box ticked 'no plans for involvement') : Please give more details, including how patient and public involvement will benefit the research, the reasons for taking this approach and arrangements for training and support. (300 words max) For the boxes ticked above, please outline: - the aims of the patient and public involvement, - the ways in which patients and the public will be involved (where appropriate, provide - names of individuals and/or groups (with consent) and - a description of any plans for training and/or support. Please note that a budget line for the costs of patient and public involvement is included in the finance section which applicants are expected to complete. For further information you can access an involvement cost calculator and budgeting guide via INVOLVE's website. if ticked 'no plans for involvement' box the following text appears : If there are no plans for active involvement, please explain why it is not necessary. (300 words max) Page 11 of 29

12 Section: Case for Support Research Title: This is the full research title of your application as detailed within the initial 'Research Details' section. Please do not amend this unless you wish to amend the title of your application. NOTE: This is largely administrative istrative and has been autopopulated based on your previous entry within the 'Research Details' section. Aims and objectives: This section should be used to indicate the main aims/objectives of the proposed project. (450 words max) This section should be used to indicate the main aims/objectives of the proposed project. Projects in this programme will vary considerably in their design; however, it is expected that applicants will clearly describe: The technology to be developed Key aims for the project Main hurdles to be overcome technically, clinically and commercially Key measures of success How the funding will be utilised to achieve the goals set out. NOTE: The inclusion of a diagram(s), picture(s) or figure(s) to aid description of the technology being developed can be included as part of the Supporting Documentation section. Plain English summary: Please summarise your proposed research in plain English. (500 words max) The importance of a plain English summary A plain English summary is a clear explanation of your research. Many reviewers use this summary to inform their review of your funding application. They include clinicians and researchers who do not have specialist knowledge of your field as well as members of the public. If your application for funding is successful, the summary will be used on National Institute for Health Research (NIHR) and other websites. A good quality plain English summary providing an easy to read overview of your whole study will help: those carrying out the review (reviewers and board and panel members) to have a better understanding of your research proposal inform others about your research such as members of the public, health Page 12 of 29

13 professionals, policy makers and the media the research funders to publicise the research that they fund. If we feel that your plain English summary is not clear and of a good quality then you may be required to amend your summary prior to final funding approval. It is helpful to involve patients / carers / members of the public in developing a plain English summary. Content When writing your summary consider including the following information where appropriate: aim(s) of the research background to the research design and methods used patient and public involvement dissemination. The plain English summary is not the same as a scientific abstract - please do not cut and paste this or other sections of your application form to create the plain English summary. Further guidance on writing in plain English is available online at NIHR Make it clear For further support and advice on writing a plain English summary, please contact your local Research Design Service (where applicable). Page 13 of 29

14 Scientific abstract of research: Please provide an overview of the project plan. (600 words max) Please provide an overview of the project plan. NOTE: It is essential to include well-defined milestones and deliverables. Background and rationale: What is/the problem being addressed? (500 words max) Please provide an indication of the clinical need for the proposed device/technology, both domestically and globally, outlining the size and nature of the problem(s) to be addressed. Evidence for both the clinical and technical rationale should be provided. Reference should be made to any relevant outputs from research undertaken by the research team or members there of and other key outputs from others within the field. Why is this research important in terms of improving the health of the public and/or patients and the NHS: (500 words max) Please indicate the shortcomings of the current state-of-the-art art clinical techniques and/or technologies and explain how the proposed development aims to address these. If your application is related to one of the past NIHR themed calls, please indicate which call here. Options: Obesity Dementia Surgery Very Rare Diseases Primary Care Interventions Antimicrobial Resistance Long-term Conditions in Children and Young People N/A Page 14 of 29

15 Section: Case for Support contd. Relevant expertise and experience: Please outline the individual role of each member of the research team, highlighting the skills and experience of the team that make them well placed to carry out the work. (400 words max) Outline the individual role of each member of the research team. In addition, please explain why the group as a whole is well qualified to undertake this research. If there are any skills missing from the collaboration, please explain how these will be addressed. NOTE: If the salary costs of members of the team are not being sought via this application, there is the opportunity to explain further how their contribution will be supported within the 'Finances' section. Page 15 of 29

16 Section: Management & Governance Research management arrangements Please explain the practical arrangements for managing the research and its constituent components. (200 words max) Please outline the process that will be put in place to ensure that the research is well managed, commenting on: Project management structure that will ensure that milestones are achieved in a timely manner IP management Financial management. Explain also the practical arrangements for managing the project and its constituent components. Please also highlight the role of any Advisory or Reference Groups associated with the research. Has any work relevant to this application already commenced? Yes No If yes, please give details of any relevant work that has already commenced in the preparation of this research. (200 words max) Success criteria and barriers to proposed work Please set out the measurements of success you intend to use and also the key risks to delivering this research and what contingencies you will put in place to deal with them. (300 words max) In addition to success criteria and key risks to the project, please highlight the key go/no go points. Page 16 of 29

17 Does the proposed research raise any ethical issues? Yes No Please outline any ethical issues associated with this research (e.g. any risks associated with the research, any data protection issues), and the arrangements for handling them. Please also describe any research governance arrangements that would apply to the proposed research. NOTE: Research must adhere to the Research Governance Framework. If Yes, discuss how these issues will be addressed. (300 words max) Please detail how and when you intend to get ethical review completed. (300 words max) If no, please justify why you consider an ethical review is/will not be required. (150 words max) Have any appropriate regulatory bodies already granted a favourable opinion? Yes No If yes, please upload the letter from the relevant committee. attach a file option Page 17 of 29

18 Section: Intellectual Property & Innovation The definition of Intellectual Property (IP) includes copyright (such as new software, checklists, scales, protocols, questionnaires, toolkits, guidelines or similar) and research tools (such as data analysis techniques, assays, cell lines, biomarkers, materials or equipment and devices) patents, trademarks and designs. What relevant IP (patents, design right, copyright etc.) is held by the applicants and how does it relate to this application? (300 words max) IP may include: Patents Trademarks Designs Copyright (e.g. software, checklists, protocols, questionnaires, etc) Research tools (e.g. techniques, devices, assays, cell lines, biomarkers, etc) Trade secret NOTE: Please note that we would not expect an application to elaborate on trade secret. Has a freedom to operate search been conducted and by whom? Yes No If yes, please provide details of all relevant IP and how it relates to the application. (150 words max) All related IP not owned by any of the applicants should be listed, including details relating to third party licence requirements. Please indicate briefly the procedure you used to search for existing IP. NOTE: You should indicate here what you have found from your searches, even if you have found nothing. If no search has been conducted please set out the rationale. (150 words max) Page 18 of 29

19 Will any IP be produced or improved during the proposed research? Yes No If yes, please describe what IP will be produced and/or improved. (300 words max) Indicate where and when new or improved IP will arise. Link this back to any existing IP that you may have previously mentioned above. Indicate why you think the new IP is novel over what is already known in the literature. Please describe how any new IP generated through the proposed research will be recognised, captured, managed and utilised either through dissemination and adoption in the healthcare service or through commercial exploitation. Please give details on who will lead on dissemination and/or exploitation. (300 words max) Please describe the proposed route to market and by whom, or how you plan on developing this. NOTE: The i4i programme supports projects which aim to develop commercially viable products and devices for use in clinical health care environments. What are the key current and future barriers to utilising any new IP/innovation through dissemination and adoption in the healthcare service or through commercial exploitation e.g. potential regulatory hurdles? (300 words max) Please indicate where and when any regulatory hurdles will arise, referring back to the research plan. You should provide an Indication of timing and any delays that may occur and whether this is something you or a commercial partner will have to deal with. NOTE: You should also indicate whether you are aiming for UK/EU or US approval routes and state why. Page 19 of 29

20 Section: Involvement with NIHR Infrastructure Involvement with other partners What, if any, other NIHR organisation(s) will partner this research? Please select... Please specify what other NIHR organisation(s) will partner this research. (100 words max) Please provide details of the other organisations involved (including international collaborations) and, if applicable, explain how any shared funding arrangements would work. Describe the role, if any, these will have in the research: (80 words max) Page 20 of 29

21 Section: Other sources of funding Will this application be supported by any other funding body? Yes No Please provide details of the other organisations involved (including international collaborations) and provide a possible shared funding arrangement. Please specify the supporting organisation. Please detail any proposed arrangementsfor shared funding. (150 words max) Please provide details of the other organisations involved (including international collaborations) and explain how a shared funding arrangement would work. Which funding body? Reference number The funding amount The start and end dates of funding Start date: End date: calendar view (dd/mm/yyyy) calendar view (dd/mm/yyyy) Page 21 of 29

22 Section: Finances Total Research Costs Requested Please enter the FULL numeric value in s only. NOTE: You should avoid the use of shorthand or inclusion of commas. Please explain how the research costs requested have been calculated and justify how they have been allocated. (750 words max) Please provide a breakdown of research costs, in as much detail as possible, associated with undertaking the research and provide justification for the resources requested. In this section you should provide a brief explanation as to why the following costs are necessary for the research and why these are attributable to research in accordance with AcoRD /publications/guidance-on-attributing-the-costs-of-health health-and-social-careresearch - staff costs, - travel, subsistence and conference fees - equipment (including lease versus purchase costs) - consumables, - patient and public involvement - any other direct costs. Please explain how the research provides value for money. (500 words max) You should describe how this research provides value for money taking into account the total cost of the research, including the NHS costs. Page 22 of 29

23 Section: DH Monitoring information Please use the drop-down down menus and tick boxes to provide the information requested. This will be used by the Department of Health and the NIHR for accountability, audit and monitoring purposes. For guidance please see the UKCRC Health Research Analysis which can be found at UKCRC Health Categories NOTE: For guidance please see the UKCRC Health Research Analysis which can be found at Please select all classifications from the below list that are applicable. Click the headings to expand categories. Refresh Selected Classifications Summary UKCRC Health Categories: Blood Cancer Cardiovascular Congenital Disorders Ear Eye Infection Inflammatory and Immune System Injuries and Accidents Mental Health Metabolic and Endocrine Musculoskeletal Neurological Oral and Gastrointestinal Renal and Urogenital Reproductive Health and Childbirth Respiratory Skin Stroke Generic Health Relevance Other Page 23 of 29

24 Section: Research Design Service (RDS) Involvement Did you contact the RDS? Yes No The NIHR Research Design Services (RDS) support those developing application submissions. If you have received advice from your local RDS, we would value your feedback on the services you received in order to improve service. Your individual comments will not be attributed to you. NOTE: Responses to these questions will not constitute a part of the assessment of your application by the NIHR. If not, was this because (please tick all that apply) You felt your team already has sufficient methodological expertise? You were unaware of RDS support available? Other N/A Other, please specify (50 words max) Please indicate in which region Please select.. How satisfied overall were you with the input of the RDS Please select.. To what extent do you feel the quality of your application improved as a result of RDS involvement? Please select.. Would you recommend the RDS to other people developing research proposals? Please select.. Please expand on your responses above, explaining the reasons for your choices, and including details about the extent and nature of the support provided by the RDS. Please also add any other comments about your experience of using the RDS. (150 words max) Page 24 of 29

25 Section: Suggested Reviewers Please suggest three potential peer reviewers who have the relevant expertise to provide appropriate peer review for your application. These reviewers should be independent and have no conflict of interest with respect to your application and your suggestions will be used as only one source of peer reviewers and may not be approached to undertake this review. Reviewers Title: Please select.. Forename: Surname: Expertise: Department: Institution: Telephone: Page 25 of 29

26 Section: Reviewers NOT to approach Please list up to three individuals who would not be suitable to review this application due to competing/conflicting interests. Title: Please select.. Forename: Surname: Department: Institution: Page 26 of 29

27 Section: Supporting Documentation The following file(s) are considered non-mandatory annex(es) to submission; if you wish, please attach: Any supporting diagram(s), picture(s) or figure(s) only NOTE: You may only attach 1 file. The total file size should not exceed 10 Pages or 5Mb. Files larger than this may not be considered as part of this submission. attach a file option Please note that documentation uploaded in this section may not be incorporated into the main body of the PDF of the application form; however please be assured that the information will have been captured by our system as part of the appendix list. Any other form of supplementary information submitted will not be considered as part of your application. Page 27 of 29

28 Section: Declaration Please declare any conflicts or potential conflicts of interest that you or your co-applicants may have in undertaking this research, including any relevant personal, non-personal and commercial interest that could be perceived as a conflict of interest. 300 words Please declare any conflicts or potential conflicts of interest that you or your co-applicants may have, including any facts that, should they come to light at a future date, could lead to a perception of bias. Include any relevant personal, non-personal & commercial interest that could be perceived as a conflict of interest, examples include (this list is not all encompassing), secondary employment, consultancy, financial or commercial gain (pensions, shareholdings, directorships, voting rights), honoraria, etc. In a case of commercial sector involvement with the application or the study, please state clearly the relationship to ownership of data, access to data, and membership of project oversight groups. NIHR Carbon Reduction Guidelines I confirm that I have read the NIHR Carbon Reduction Guidelines and, where possible, taken steps to reduce the carbon emissions generated by this research. Please tick this box to confirm that you have read the NIHR Carbon Reduction Guidelines and, where possible, taken steps to reduce the carbon emissions generated by this research. NOTE: Researchers applying for NIHR funding are asked to consider the carbon footprint of their research and take steps to reduce carbon emissions where appropriate. Advice on how to do this can be obtained from the NIHR Carbon Reduction Guidelines. How did you hear about this call? Please select.. If other: Please specify how you heard about this call. (100 Characters) Page 28 of 29

29 Section: Validation Summary Top of (online) page Please follow the next steps in order to complete your application submission process; Validate all mandatory/required fields listed below (that are required to be completed/amended before submitting) Click 'Save and Close' Click the 'Submit' option (this must be completed by 1pm, 14 January, 2015) You will receive an automated containing an acknowledgment that we have received your application. Bottom of (online) page If there are no validation requirements above you may be ready to submit the application. To do so 'Save and Close' the application. Please note that your submission will not be considered complete until all applicants have both confirmed and approved the application and the submit button becomes visible and is used. Page 29 of 29