Sheffield Healthcar e Gateway Research & Innovation Services. Guidance for MRC Confidence in Concept Scheme Round 4 (January 2016) Application deadline: 6th April 2016. MRC Confidence in Concept Round 4 monies have been obtained by a consortium led by University of Sheffield with Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield Children’s NHS Foundation Trust and Sheffield Hallam University. Please note: The appropriate business/commercial manager from your institution must be contacted at least 3 weeks before the closing deadline to ensure that applications fit the scheme and that concepts are registered with the respective institutions and the University of Sheffield. To help with application development It is required that applications led by our partners also involve a University of Sheffield Business Manager. 1. What is the purpose of the MRC Confidence in Concept Scheme? 1.1 The MRC Confidence in Concept Scheme is part of the MRC’s Translational Research Strategy and is a component of the MRC/Innovate UK Biomedical 1 Catalyst. The Confidence in Concept Scheme is designed to “accelerate the transition from discovery research in any healthcare area into translational development projects by supporting preliminary work or feasibility studies to establish the viability of an approach”. 1.2 The financial support available is intended to ensure that fundamental science is translated into new therapies, diagnostics and medical devices in line with the MRC’s strategy (http://www.mrc.ac.uk/publications/browse/strategicplan-2014-19/). The scheme aims to accelerate the transition from discovery science to the early stages of therapeutic/diagnostic development by supporting preliminary translational work. 1.3 The MRC anticipates that projects submitted to the MRC CiC scheme will have emerged from strong fundamental research. The MRC CiC awards are to address a gap in the funding between discovery research and translational research to develop a product/ therapy/ diagnostic/device for healthcare benefits. The aim of a MRC CiC award is to generate the data package necessary for a project to be competitive for more substantive follow on funding. Hypothesis driven discovery research is not eligible for this funding stream. 1.4 The aim of projects funded under the scheme are to provide sufficient preliminary data to establish the viability of an approach and provide enough confidence in the underlying concept in order that the project team will then seek more substantive funding from larger schemes (e.g. MRC DPFS/DCS, NIHR HTA/i4i, Innovate UK funded initiatives or similar). 2. Project Development & Eligibility 2.1 MRC Confidence in Concept Round 4 monies have been obtained by a consortium led by The University of Sheffield with Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield Children’s NHS Foundation Trust and Sheffield 2 Hallam University. Academics, academic clinicians and clinicians from these institutions, their departments and research centres are eligible to lead an application for this funding. Applications and the work packages detailed must involve the activities of a University of Sheffield collaborator. 2.2 The primary investigator must be a member of staff at one of the Sheffield consortium partners for the MRC CiC Round 4 award. 2.3 Project budgets are expected to be ca. £60K but where exceptional costs are anticipated and can be justified, applicants may request up to £85k. 2.4 Projects that received MRC Confidence in Concept monies in Round 1 (2012) Round 2 (2013), or Round 3 (2014) are not eligible for Round 4 funding. 2.5 Projects may be up to 12months in duration 2.6 Projects should be completed by 31st July 2017 2.7 Projects are eligible only if they are registered both with the partner’s opportunity capture mechanism and additionally with the University of Sheffield Commercial Assessment System (CAS) to help with monitoring and ensuring appropriate support is available. Projects led by a partner institution can be registered via the University of Sheffield collaborator by completing an Initial Commercial Enquiry (ICE) form at the following URL by the University of Sheffield applicant team: https://www.sheffield.ac.uk/ris/post-project/commercialising/cod-form Please note that submission of an ICE does not constitute an application to the scheme and business managers will be required to sign off the application. 2.7 Should funding be awarded to projects involving Sheffield consortium partner(s) an individual project agreement will be put in place. The template has 3 been agreed by Sheffield partners and is available on request to the University of Sheffield. Included within the agreement are terms relating to confidentiality, intellectual property etc. With respect to IP generated by the project, each Party shall own the Arising Intellectual Property generated by its employees, students and/or agents in the performance of the Project and shall ensure that it secures ownership of such Arising Intellectual Property from its employees, students and agents. Each Party shall co-operate, where required, in relation to the preparation and prosecution of patent applications and any other applications relating to Arising Intellectual Property. 2.8 The MRC Confidence in Concept Scheme is designed to support preliminary work or feasibility studies in any healthcare area to establish the viability of an approach in order to enable applications for further more substantive follow on funding. MRC have requested that institutions select projects that provide evidence of good translational pathways and do not represent extended discovery projects. While applications will contain an element of risk, they should also demonstrate a viable translational direction rather than be a continuation of discovery science. The scheme will aim to support and accelerate the earliest stages of research translation within the healthcare remit. Example projects may include but are not limited to: Developments of new therapies Improvements in existing therapies Drug reprofiling Development of imaging methodologies, diagnostics or medical devices. 2.9 Successful applications will demonstrate: 4 assistive technologies, Medical need Good project plan with specific, measurable, achievable, realistic and timely (SMART) milestones and objectives Novelty of the concept That the concept has IP potential and freedom to operate That there is a likely market for the concept and that the concept is distinguished from existing solutions either already available on the market or in development. The level of anticipated or actual industry interest That the CiC project proposed will generate the data needed to allow a strong application to be made to more substantive translational funding scheme(s) to allow the idea to be progressed That the translational funding scheme(s)and the anticipated follow-on work proposed after the C8C project seem appropriate Give confidence that there is a realistic translational route to progress the project and ultimately lead to societal impact. Upcoming funding opportunities (with example deadlines) that may represent possible means to progress the work supported by an MRC Confidence in Concept Scheme award include but are not limited to: o MRC DPFS/DCS: outline deadlines – 27 Jul 2016, 01 Dec 2016, Mar 2017 (anticipated) o BBSRC Follow-on fund: Deadlines TBC o Wellcome Translation awards: Concept note deadlines- April and Oct 2016 (anticipated) o Wellcome/Dept of Health Health Innovation Challenge Fund: Future deadlines TBC o Wellcome Pathfinder awards: 20 Jun 2016 5 o NIHR Research for Patient Benefit: 23 Mar 2016, May 2017 (anticipated), Dec 2017 (anticipated) o NIHR Invention for Innovation (i4i): Jan 13 2016, Apr 06 2016, o Additional charitable funding – anticipated schemes should be specified in the application. (Please check the individual funder’s eligibility criteria to ensure that your project is suitable for any of the above). 2.10 Eligible costs include: Direct costs associated with the project Staff conducting the research, but not staff (including the lead applicant or co-applicants) in a supervisory capacity) Project-related consumables and equipment. Subcontracted consultancy or other development services. Market assessment Other costs, such as travel to collaborators/ contractors and subsistence. 2.11 The MRC stipulate that the Confidence in Concept Scheme cannot pay for: Entire translational projects Staff between posts/funding (i.e. as “bridging” funds) or PhD studentships Continuation of normal research grants Costs relating to protection of intellectual property Capital equipment purchases. 2.12 The University of Sheffield as institutional holder for the overall award of MRC CiC Round 4 monies must adhere at all times to its Financial Directives for the expenditure of funding. and all projects must be costed using the University 6 of Sheffield’s URMS (http://www.sheffield.ac.uk/ris/systems/urms). Non University of Sheffield staff therefore need to provide the costs for their part of the project to University of Sheffield faculty-based support staff or R&IS Pricing Team staff as per existing arrangements for other collaborative grant applications agreed between the partners. 2.13 Salary costs will not be paid as personal salary (as with consultancy). 2.14 Applications with industrial collaborators are eligible for the scheme. Standard MRC guidelines and intellectual property arrangements for industrial collaboration will apply. For further information please see http://www.mrc.ac.uk/innovation/mrc-industry-collaboration-agreement-mica/. 2.15 Applicants are not required to enter Impact costs on their URMS entry for this scheme. University of Sheffield applicants should tick the box for Year 1 on the corresponding URMS Impact cost page to acknowledge that no costs have been put in and then write "not applicable to this scheme” as the reason in the available free text box. 3. Monitoring 3.1 The University of Sheffield is required to monitor how the scheme funds are used and to follow project progress, providing MRC with a progress report every 6 months (including completion of the ResearchFish assessment) plus a final accounting and brief report on the outcomes of funded projects at the end of the programme. 3.2 By accepting the award, the applicant(s) and, if appropriate, their Sheffield consortium partner host organisation(s) agree to provide a sufficiently detailed Interim Report, dependent on length of project, (1 is expected, at the half-way 7 stage), a Final Report upon completion and the post-award follow-up Reports that will provide information to be captured via ResearchFish. A presentation to the external review panel members may be required regarding progress with either the interim and/ or final report. 3.3 By accepting the award, the applicants agree to engage with their local professional support staff and/or to work with the University of Sheffield Research & Innovation Services and Faculty Commercialisation or Business Managers to monitor the progress of the project to allow the reporting of outcomes back to the funder. This will include assisting with the development of funder and/or case study reports as appropriate. 3.4 We reserve the right to recover funds where there is evidence that a project is failing to adhere to the agreed application. Similarly, funds may be recovered where these have not been spent in accordance with the application, unless a change has been agreed in writing. 3.5 This funding may only be used to support eligible project activities. 4. Application Process 4.1 Step by step guide to application process Register your project with the appropriate team in your institution. All projects should also be registered by the University of Sheffield applicant team on the project using the CAS system http://www.sheffield.ac.uk/ris/post-project/commercialising/process Meet with the appropriate professional services staff for your institution to discuss the application Submit application form Wait for decision Receive an offer/ decline letter 8 Begin project 4.2 Application for MRC Confidence in Concept scheme funding is a single stage process open to the University of Sheffield, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield Children’s NHS Foundation Trust and Sheffield Hallam University for projects with a healthcare remit. Applications can only be made via the MRC Confidence in Concept Application Form. 4.3 Projects must have been submitted by University of Sheffield staff to the Commercial Assessment System (CAS) via an Initial Commercial Enquiry (ICE). See the following URLs: http://www.sheffield.ac.uk/ris/post-project/commercialising/process http://www.sheffield.ac.uk/ris/post-project/commercialising/cod-form 4.4 All applicants (PIs) must discuss their project with the professional support staff associated with their institution and University of Sheffield at least 3 weeks prior to submission to receive advice and guidance. 4.5 Applications should address the points detailed/raised in each section of the application form. 4.6 All applications will be considered by an interdisciplinary panel and scored against the criteria specified in 2.7. 4.7 Both a completed, unsigned Word application as well as either a signed electronic copy of the application should be sent to r.m.dwyer@sheffield.ac.uk or a signed hardcopy posted to: Rachel Dwyer Research & Innovation Services New Spring House 9 231 Glossop Road Sheffield S10 2GW Contacts University of Sheffield Research & Innovation Services: Dr. Neil Harris Rachel Dwyer neil.harris@sheffield.ac.uk r.m.dwyer @sheffield.ac.uk T:0114 2227439 T:0114 2221437 Professional Support staff: University of Sheffield Faculty of Engineering T: 0114 2222899 Stephen Pyke s.h.pyke@sheffield.ac.uk University of T: 0114 222 Sheffield Faculty 0999 of Science Andy Hogben A.J.Hogben@Sheffield.ac.uk Dentistry & Health Sue Smith sue.smith@sheffield.ac.uk T: 0114 2228723 STHFT Lydia Harris Lydia.Harris@sth.nhs.uk T: 0114 2265911 SCH Gillian Gatenby Gillian.Gatenby@sch.nhs.uk T: 0114 3053219 SHU Rob Evans r.evans@shu.ac.uk T: 0114 2254293 University of Sheffield Faculty of Medicine, 10 For University of Sheffield enquiries outside the faculties listed above, please contact the Commercialisation / Business Manager allocated on submission of your Initial Commercial Enquiry (ICE) form. 11