Guidance for MRC Confidence in Concept Scheme Round 6 (February

2018)

Application deadline: 8 May 2018

MRC Confidence in Concept (CiC) Round 6 funding has been obtained by a consortium led by University of Sheffield (TUoS) with Sheffield Children’s NHS Foundation Trust (SCH), Sheffield Hallam University (SHU) and Sheffield Teaching Hospitals NHS Foundation Trust (STH).

Key Points To Note:● Due to the volume of applications anticipated, the appropriate

business/commercial/research manager from your institution must be contacted at least 4 weeks before the closing deadline (ie by 10 April 2018) to ensure that applications fit the scheme and that concepts are registered with the respective institutions and TUoS.

● To help with application development it is required that all applications must also involve a TUoS business/commercial manager.

● All projects must have a Primary Investigator or Co-Investigator who holds a substantive (not honorary contract) with TUoS.

● An information session on the scheme will be held. Further details to be announced soon. All interested applicants are welcome to attend.

● Where projects are led by, or in collaboration with, SCH and STH, these institutions must make a 10% contribution (financial or in kind) to the work that they are carrying out. The Universities have contributed at source: SHU is contributing £20k and TUoS £80k to the MRC CiC Round 6 award.

1. What is the purpose of the MRC CiC Scheme?1.1 The MRC CiC scheme is part of the MRC’s Translational Research Strategy and is a component of the MRC/Innovate UK Biomedical Catalyst. The scheme is designed to “accelerate the transition from discovery research in any healthcare area within MRC remit into translational

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development projects by supporting preliminary work or feasibility studies to establish the viability of an approach”. Details regarding MRC remit can be found in Appendix 1 of this document. If you have questions regarding whether your project is within MRC remit, please get in touch with your TUoS business/commercial manager.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/strategic-plan-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 CiC scheme will have emerged from strong fundamental research. The 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 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, NIHR HTA / i4i, Innovate UK funded initiatives or similar). Indeed, further awards of MRC CiC funds to the Sheffield consortium will reflect the success of previously funded MRC CiC projects awarded in earlier MRC CiC rounds, for example, in securing further funding (translational and Innovate UK), supporting patent applications, setup of spin-out companies, licencing of knowhow and results, etc.

2. Project Development & Eligibility

2.1 MRC CiC Round 6 monies have been obtained by a consortium led by TUoS with SCH, SHU and STH. Academics, academic clinicians and clinicians from these institutions, their departments/research centres are eligible to lead an application for this funding. Applications and the work packages detailed within them must involve the activities of a TUoS collaborator with a substantive employment contract with TUoS (not a honorary contract). A TUoS business/commercial manager must also be involved in the preparation of the application to help ensure it is as strong as possible.

2.2 The Primary Investigator must be a member of staff at one of the Sheffield consortium partners for the MRC CiC Round 6 award.

2.3 Project applications should request what is needed to conduct the

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project. Applications are expected to be ca. £60k of directly incurred costs, but where exceptional costs are anticipated and can be justified, applicants may request £60k-£85k for directly incurred costs.

2.4 Projects that received MRC CiC monies in Round 1 (2013) Round 2 (2014), Round 3 (2015), Round 4 (2016) or Round 5 (2017) are not eligible for Round 6 funding to continue the work. However, if a previously CiC funded project generated results that indicated that there may be merit in taking a different approach, this alternative strategy may warrant an application to CiC Round 6. Please discuss with your TUoS business/commercial manager.

2.5 Projects may be up to 12 months in duration.

2.6 Projects should be completed by 30 November 2019 (anticipated).

2.7 Projects are eligible only if they are registered on the system of every Sheffield CiC consortium partner involved in that proposal and additionally with TUoS Commercial Assessment System (CAS) to help with TUoS responsibilities of monitoring and reporting to MRC, and ensuring appropriate support is available. Projects led by a partner institution can be registered on CAS by completing a simple Initial Commercial Enquiry (ICE) form at the following URL (note: where projects are led by our external partners, the associated TUoS business/commercial manager will register the project on TUoS CAS with information provided on the CiC application): https://www.sheffield.ac.uk/rs/commercialisation/ice-form Note: that submission of an ICE does not constitute an application. Please discuss with your TUoS business/commercial manager.

2.8 Once funding is awarded to projects involving more than one Sheffield partner, an individual project agreement will be put in place. The template has been agreed by the Sheffield partners and is available on request to r.m.dwyer@sheffield.ac.uk. Included within the agreement are terms relating to confidentiality and intellectual property (IP) etc. With respect to IP generated by the project, each Party shall own the Arising IP generated by its employees, students and/or agents in the performance of the project and shall ensure that it secures ownership of such Arising IP 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 IP.

2.9 The MRC CiC scheme is designed to build on an idea developed through basic research and to support the initial translational research stages i.e. feasibility or proof of concept studies in any healthcare area to establish the viability of an approach in order to enable applications for further more substantive follow on funding. Proposals to CiC should not represent a continuation of discovery science. Hypothesis driven discovery research is NOT eligible for this funding stream

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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 and ideally the medical need and solution proposed will have been discussed with practicing clinicians.

If you have not discussed your idea with clinicians, please contact Dr Dipak Patel (STHFT, contact details below) or Dr Gillian Gatenby (SC NHS FT).

As MRC CiC scheme is to provide proof of concept funding of translational ideas, the application form asks many of the questions required in substantive translational funding schemes including technology readiness levels (see Appendix 2), IP, prior art, freedom to operate and commercialisation route to market etc.

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 re-profiling● development of imaging methodologies, assistive technologies,

diagnostics or medical devices.

2.10 Successful applications will demonstrate:

● medical need ● good project plan with specific, measurable, achievable, realistic

and timely (SMART) milestones and objectives● the project team is strong with the required capabilities and

expertise (or has demonstrated how they will access the required expertise) to take the project forward

● novelty of the concept● that the concept has IP potential and freedom to operate OR a that

there is a realistic route to market without proprietary IP● 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

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● 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 CiC project seem appropriate

● give confidence that, even if the proposal does represent the earliest stages of translational research, there is a credible 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 CiC award include, but are not limited to:

● MRC DPFS outline deadlines – 28 March 2019, July 2019 (anticipated), November 2019 (anticipated)

● BBSRC Follow-on fund : October 2019 (anticipated)● Wellcome Innovator Awards : no deadline● NIHR Research for Patient Benefit – March 2019 (anticipated), July

2019 (anticipated), November 2019 (anticipated)● NIHR Invention for Innovation (i4i) and i4i connect – Apr 2019

(anticipated), Nov 2019 (anticipated) ● 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.

2.11 Eligible costs include:

● Directly incurred costs associated with the project. ● Staff conducting the research, but not senior staff (including the

lead applicant or co-applicants) in a supervisory capacity. Standard practice is for post-doctoral research assistant’s time to be costed into applications,

● Senior staff should not be costed unless they are undertaking research activity that cannot be performed by anyone else. Timesheets recording such work will be required, which should be

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supplied with the reports required for funded CiC projects (see section 3).

● Project-related consumables and equipment.● Subcontracted consultancy or other development services.● Market assessment.● Other costs, such as travel to collaborators/ contractors and

subsistence.

2.12 Ineligible costs include:

● 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 IP● capital equipment purchases that equal or exceed £10k● impact costs (i.e. publication and open access costs, conference

attendance for dissemination purposes, dissemination costs for websites or newsletters etc except when used to provide direct feedback to study participants)

● indirect costs (This funding schemes aims to pump prime activity for larger grant applications, hence directly incurred costs are the only eligible costs.)

2.13 Salary costs will not be paid as personal salary (as with consultancy).

2.14 Partner Institution Contributions

Where a CiC project is led by, or includes work conducted in collaboration with SCH and/or STH, these institutions will make a 10% institutional contribution (financial or in kind) to their eligible research costs (see 2.11). In-kind contributions such as, but not limited to, clinical research time and, direct research delivery by Co-Investigators, the cost of market assessment or access to specialised equipment. (TUoS and SHU have already provided this match to the programme financially at source.)

An example involving three partners might be:

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Item Amount

Staff costs

Partner 1 Primary Investigator time spent of project (leading/supervising)

£0

Partner 1 PDRA (data collection/analysis) £30,000Partner 2 NHS Research Nurse time £17,000Partner 3 Co-Investigator time spent of project (supervising) £0

Consumables

Partner 1 £4,000Partner 2 £5,000Partner 3 £3,000

Equipment Partner 1 £2,000Total Funding requested (Directly Incurred Costs only) £61,000Partner ContributionsPartner 1

● Total Budget requested as grant was £36K.● Additional in kind contribution to the project made by Partner 1 was market

analysis work (£1K) and additional consumables (£2.6K) valued at £3.6K (10% of £36K).

Partner 2● Total budget requested as grant was £22K● Additional in kind contribution to the project made by Partner 2 was clinical time to

identify and consent patients, sample preparation and sample storage valued at £2.5K (11% of £22K).

Partner 3● Total budget requested as grant was £3K.● Partner 3 was TUoS and so no further contribution required.

2.15 Information for costings for STHFT, SCFT or SHU workWhere a CiC project is led by, or includes work conducted in collaboration with SCH, SHU and/or STH (i.e. involves their staff, facilities or patients) the application must:

● be registered with each relevant research office● contain costs provided by each relevant research office● be signed by a representative from each relevant research office.

The TUoS as institutional holder for the overall award of MRC CiC Round 6 monies must adhere at all times to its Financial Directives for the expenditure of funding and all projects must be costed using TUoS’ Costing Tool (https://www.sheffield.ac.uk/rs/pricing). Partner costs for each project will need to be entered into the TUoS Costing Tool before the application is submitted. Non-TUoS staff will therefore need to provide costs to their TUoS collaborators (Primary Investigator or professional support staff) as per existing arrangements for collaborative grants between the partners.

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2.16 Applications with industrial collaborators are eligible for the scheme. Standard MRC guidelines and IP arrangements for industrial collaboration will apply. For further information please see http://www.mrc.ac.uk/innovation/mrc-industry-collaboration-agreement-mica/.

3. Monitoring and Training

3.1 TUoS is required to monitor how the scheme funds are used and to follow project progress, providing MRC with a progress report every six 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 (with timesheets where appropriate) Interim Report, dependent on length of project, (one is expected, at the half-way 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 applicant(s) agree to engage with their local professional support staff and/or to work with TUoS Research Services and business/commercialisation 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 By accepting the award, the applicants agree to engage with training provided by their local professional support staff and/or the TUoS Research Services and business/commercialisation managers. Such training will, for example, be offered through TUoS via the MRC Proximity to Discovery fund or other schemes. 3.4 TUoS 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 Application for MRC CiC funding is a single stage process open to SCH, SHU, STH and TUoS for projects with a MRC healthcare remit. Applications can only be made via the MRC CiC application form.

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4.2 Step by Step Guide to Application Process● Register your project with all the research office of each partner

institution (SCH, SHU, STH). ● All projects must have been submitted by TUoS staff to the

Commercial Assessment System (CAS) via an Initial Commercial Enquiry (ICE) https://www.sheffield.ac.uk/rs/commercialisation/ice-form

● Meet with the appropriate professional services staff for your institution to discuss the application. See the Contact section.

● Create a record on TUoS Costing Tool.● Submit application form by 9am 8 May 2018● Applications will be reviewed by an interdisciplinary panel. Those

deemed in scope will be reviewed by a panel of external experts (conflicts of interest will be eliminated prior to full applications being shared externally) and discussed at the panel meeting.

● Wait for decision (anticipated end of June/ early July 2018).● Receive an offer/ decline email from TUoS Research Services.

4.3 All Primary Investigators must discuss their project with the professional support staff associated with their institution and TUoS at least 4 weeks prior to submission to receive advice and guidance.

4.4 Applications should address the points detailed/raised in each section of the application form.

4.5 Application SubmissionEmail a signed PDF and an unsigned Word version of the application form to d.maltby@sheffield.ac.uk.

5. Contacts

The University of Sheffield Research Services Rachel Dwyer r.m.dwyer@sheffield.ac.uk 0114 2221437Faculty of Medicine, Dentistry & Health

Sue Smith (or your SHG Business Manager)

sue.smith@sheffield.ac.uk 0114 2228723

Faculty of Engineering

Stephen Pyke s.h.pyke@sheffield.ac.uk 0114 2222899

Faculty of Science Richard SeniorAndy Hogben

richard.senior@sheffield.ac.uka.j.hogben@sheffield.ac.uk

0114 22276230114 2220999

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For TUoS enquiries outside the faculties listed above, please contact the TUoS business /commercialisation manager allocated on submission of your Initial Commercial Enquiry (ICE) form.

Sheffield Children’s NHS Foundation TrustResearch Office Gillian Gatenby Gillian.Gatenby@sch.nhs.uk 0114 3053219

Sheffield Hallam UniversityResearch & Innovation Office

Georgia Hatzigiannidou

G.Hatzigiannidou @shu.ac.uk

0114 225 2013

Research & Innovation Office

Jim Walsh J.Walsh@shu.ac.uk 0114 225 4293

Sheffield Teaching Hospitals NHS Foundation Trust Clinical Research & Innovation Office

Dipak Patel Dipak.Patel@sth.nhs.uk 0114 226 5941

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Appendix 1: Information relating to MRC remit

MRC supports research across the entire spectrum of medical sciences https://www.mrc.ac.uk The MRC’s mission is to support research and skilled researchers to improve human health, advance the dissemination of knowledge and technology for the benefit of society and the economy and engage with the public to promote medical research. MRC supports research relevant to human health and disease – from fundamental discovery science in non-clinical, clinical, and population settings, through to development and initial testing of new treatments or preventive measures – and focuses on the areas of fundamental science most important for health. MRC develops routes into industrial and public sector translation of human health research. The scope of MRC-funded research is not limited to the development of new therapeutic drugs. These account for just 32 per cent of medical products reported. New surgical techniques, behavioural and physical therapies and approaches for disease prevention are all developed as a result of MRC research. Likewise technological advances for disease monitoring and diagnostics, ways to guide treatment decisions and predict patient outcomes, are also impacting positively on health care.

MRC will fund innovation in medical technologies where it is driven by the biomedical and clinical sciences rather than engineering and physical sciences, for example, the application of standard imaging methodologies in the study of disease states. Where there is overlap with the other research councils, the MRC CiC will NOT fund

important underpinning questions in biology or normal human physiology*, which can advance knowledge and innovation across many sectors, or

seeks to develop new tools, technologies and approaches that have broad application across bioscience research, e.g. data rich and systems biology, or

informs / is informed by research into animal or plant health engineering-led project work to solve technical problems

MRC Translational Research funding routes(https://www.mrc.ac.uk/funding/science-areas/international-global-health-research/remit-science-we-support/)

Appendix 2: Technology Readiness levels

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Available from https://ncai.nhlbi.nih.gov/ncai/resources/techreadylevels for a readable version

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