Funding
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Capital investment in human tissue banking and linked data, in partnership with charities

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Summary
Background
Scope
Charity partnership
Who can apply?
How to apply?
Timeline
Ethics and governance
Costs
Contact

Summary

Through this call, MRC will support the establishment of a focussed number of world-class human tissue banks and associated linked-data repositories, which will work in close partnership with research charities to enable new avenues of research into disease mechanism, diagnosis and treatment.

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Background 

Banked human tissue and linked data provide invaluable real-world resource for research into disease mechanism and development of therapies and diagnostics.  Human tissue – from precisely defined clinical conditions and stages, and with good quality linked data – is highly sought-after for research, by both academia and industry. 

Research-funding charities see human tissue banks as highly valuable resources; many charities have invested in tissue banking on some scale, or would wish to do so but find the costs of establishing and maintaining tissue banks beyond what they can afford individually.  There is an opportunity for public-charity partnership to support development of progressive human tissue resources to enable new science.

Consultation with industry highlights access to human tissue as an attractant for industry investment into partnership with UK academia and the NHS; industry’s recognition of the importance of biobanks and human tissue access speaks to its importance in the process of developing new diagnostics and treatments for disease.

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Scope of the Call

£5m of capital is being made available to support between two and five human tissue banks with linked data resources.  Awards will be made to teams of academics working in close partnership with medical research charities.

Opportunities exist to make best use of this £5m capital investment by aligning with current public and charity investment in strategically important areas involving biobanking and data linkage (or with the potential to benefit from these).  Given the high cost of de-novo creation of tissue banks, the current preponderance of small tissue banks lacking in interoperability, and the relatively modest level of funds available, the greatest impact from the funds available is likely to be through consolidation and augmentation of existing but fragmented investment, alignment with strategically important areas, and/or improving research access to underexploited tissue sources.

Human tissue bank proposals funded through this call will clearly demonstrate how the proposed tissue resource will align with and support delivery of strategic priorities for MRC and UK biomedical research, such as in stratified medicine, molecular pathology, regenerative medicine, target validation or informatics.  Successful proposals will involve recognised expertise in such strategic priority areas, and will build on relevant existing critical mass and infrastructural investment.  Applicants should also include individuals with a strong record in tissue banking and associated data linkage. 

Successful proposals will involve:

  1. Consolidation and augmentation of existing biobanking facilities, improving volume, accessibility, utility, data linkage and alignment to strategic priority areas

OR

  1. Augmentation of an existing strategic investment (e.g. a MRC Molecular Pathology Node, MRC Stratified Medicine Consortium, charity-funded centre of excellence) with a new human tissue/linked data resource.
  2. Partnership with a charity, at various levels as appropriate (outlined below).  Upfront commitment of new charity funds is not mandatory.  Value for money and added value from partnership is crucial.
  3. Clear plans for making tissue visible and usefully accessible to the wider relevant research community.
  4. A vision for how the tissue bank will be sustainable beyond the period of this award.  Is further investment from other sources available?  Will a cost-recovery model be developed?  

Successful proposals are also likely to involve (as appropriate for the disease/tissue/clinical context):

  • Facilitation of transformative uses of human tissue collections in research e.g. in repeat sampling over time to explore disease evolution or response to therapy/emergence of resistance, or multiple organ/tissue samples from the same individual, to explore interplay of mechanisms in multi-organ/system disease.
  • Increasing research access to currently underexploited sources of human tissue and improving usefulness for research of collected tissue/linked data. Underexploited tissue sources might include, for example:
    • The huge amount of routinely collected tissue samples taken for diagnostic purposes in the NHS, which can be linked to detailed clinical data.
    • Samples taken during clinical trials having great potential for further research use, e.g. with repeat samples available pre- and post-treatment.
    • Smaller existing tissue collections without longer-term funding may provide a well-characterised source of tissue and linked data which could be consolidated and fed into a central resource.

Applications for continuation of existing tissue banks which are approaching the end of their current funding will not be competitive unless the proposal involves an enhancement of the scope and strategic value of the tissue bank, as addressing the above criteria.

Investment could potentially be made more effective by exploiting existing centralised, high-specification tissue storage facilities, e.g. the National Institute for Health Research (NIHR) National Biosample Centre.

Visibility/discoverability of the samples collected, and standardisation of sample and data acquisition and curation, should follow the leadership of the work from the UK Clinical Research Collaboration (UKCRC) Tissue Directory and Coordination Centre.  All funded tissue banks must fully register their tissue collections with the Centre and make their samples accessible for use by the wider research community.

For the purpose of this call, capital will be defined as any investment which helps to create the asset that is the tissue bank and its linked data (including equipment, relevant estates costs and staff engaged in creation of the asset).  Funding is only available to support collection, characterisation, curation and storage of tissue and linked data, in order to create and maintain the asset over the period of funding, and to make it visible and accessible to investigators. Research projects using banked tissue are not eligible for funding through this call.

Awards will need to spend over the period of financial years 2017/18 to 2020/21.  Therefore (given the timeline described below, with funding decisions taken in July 2017) awards will be for a maximum period of 3.5 years, and will be required to profile spend evenly across these four financial years (i.e. 25% of each award must be spent in the latter half of FY 2017/18, followed by 25% in each of the three following financial years).

All applicants are directed to the UKCRC Funders’ Vision for UK Tissue Resources, which provides helpful direction on maximising the value and usefulness of human tissue collections, covering issues such as consent, data linkage and regulations. 

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Charity partnership

Every application to this call is required to have at least one medical research charity engaged as a partner in the design, delivery and/or utilisation of the proposed human tissue/data bank.  Academic applicants to this call are responsible for identifying and establishing interactions with relevant partners; MRC will not broker relationships.  At the outline stage, a signed letter of support from the charity confirming the nature of the partnership will be required.

The following (non-exclusive) list of medical research charities have confirmed their willingness to partner on proposals to this call:

Alzheimer’s Research UK, Alzheimer’s Society, Arthritis Research UK, Asthma UK, Bloodwise, the Brain Tumour Charity, the British Heart Foundation, the British Lung Foundation, Brain Tumour Research, Breast Cancer Now, Diabetes UK, Kidney Research UK, the Motor Neurone Disease Association, Parkinson’s UK, Prostate Cancer UK, The Stroke Association, the Wellcome Trust.

Proposals may involve partnership with any recognised UK Medical Research Charity which is a member of the Association of Medical Research Charities.

Opportunities for close charity engagement exist at various levels, for example:

  1. Charity/charities closely partner with the applicants, helping to make the strategic case for investment and also contributing to patient/public/scientific community engagement and building of critical mass around the proposed award.
  2. Existing Charity investments could be exploited, consolidated or augmented e.g. charity-funded biobanks, or sample generation through charity-funded experimental medicine centres, trials or cohorts.
  3. Charities could subsequently fund separate research project grants to lever and utilise the tissue and data resource funded by this call. 
  4. Charities could commit new funding to co-fund individual applications, to augment the funds requested through this call.  

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Assessment

Proposals will be assessed against the applicants’ plans for:

  1. Scientific excellence; what new science would the proposed tissue bank/data resource enable?  How would this proposed research benchmark against the state of the art worldwide? How do the proposal and the track record of the individuals involved attest to the likelihood that, once created, the proposed resource will attract users and further investment in projects utilising the tissue bank? 
  2. Added value; Differentiation from the field – what tissue resources currently exist in the disease/research area in question, and how would the proposed resource differ? How does the proposed award consolidate, lever and/or build on existing public or charity investments in the field in question? How would the proposed investment enable extraction of additional value from existing resources?
  3. Close engagement with charity partners; provision of explicit detail on the value to be added through partnership, and/or the value added to existing or planned charity investments. The appropriateness of the particular model of charity engagement and input will be evaluated.
  4. Strategic importance; what relevant areas of strategic importance for MRC and UK biomedical research will the proposed tissue bank support and enable? What is the case for the scientific added value in this context?
  5. Tissue access; how will the applicants build strong links to relevant sources of human tissue, and the relevant infrastructure and protocols to enable access to tissue, e.g. NHS trusts and their pathology services, the NIHR Biomedical Research Centres, pharmaceutical companies collecting human tissue as part of clinical trials etc.?
  6. Tissue and Data standards; how will the applicants ensure that human tissue and linked data are collected, processed, stored, characterised and linked to the highest standards of quality and security (in line with MRC principles), and ensure linkage to the UKCRC Tissue Coordination Centre to improve visibility and accessibility of the banked tissue to the wider research community?
  7. Sustainability; how will the applicants ensure sustainability of the tissue bank beyond the period of this award?

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Who can apply?

The normal MRC eligibility rules apply; please see the MRC guidance for applicants. Please also ensure that you read the terms and conditions governing MRC grants.

Research council units and institutes (including intramural MRC units) can apply to this scheme.

Research proposals that are led by commercial entities are not eligible. Applications may, however, include collaborations with commercial parties under the MRC Industry Collaboration Agreement (MICA) framework.  

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How to apply  

There is a two-stage application process – an outline application followed by a full application (where invited).

The deadline for outline applications is 27th March 2017, 4pm. Your proposal must be submitted through the RCUK Je-S system by 4pm on this date.  The JeS call is open now, and you can begin preparing the online submission.

Outline applications should be submitted using the Capital Tissue Banking Charity Outline Form, which should be uploaded as the Case for Support. The completed outline form must be completed in Arial 11-point font, and must be no more than 5 pages.

In addition, applicants should submit the CV and publication list of each of the applicants (standard MRC format as described in the guidance) and the high-level estimated costings and summaries required by the Je-S system.  At the outline stage, only indicative costs are required; it is recognised that between the outline and full proposal stages, requested costs may change somewhat as plans are developed in greater detail.  Value for money will be a key assessment criterion at the full stage.

A signed letter of support from each Charity partner organisation, detailing the nature of charity support for/involvement in/investment into the proposal, must be submitted.

Full applications will be invited to submit to a deadline in June 2017, with decisions in July 2017.  The full application form will be provided to successful applicants following the outline stage decision.

Please bear in mind that all proposals have to be submitted via your research organisation’s administrative department. Please ensure sufficient time to complete their parts of the proposal before the MRC deadline dates. Standard MRC terms and conditions will apply to this scheme.

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Timeline

27th March 2017: Outline deadline

End of Apr 2017: Panel shortlisting decision

29th June 2017: Full application deadline

End of July 2017: Full Panel decision

Sep/Oct 2017: Spend commences

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Ethics and governance

MRC does not require ethics permissions and regulatory approvals to be in place when you submit an application.

However, given that research involving human tissue and data may raise various ethical and regulatory issues, applicants will be required to demonstrate at the full proposal stage that they have adequately considered these matters.

Early discussions with regulatory bodies are advised to ensure that all requirements can be met in a timely manner. Once an application is successful, it is the responsibility of the host institution to ensure that the appropriate ethics and regulatory approval has been obtained and that no research requiring such approval is initiated before it has been granted.

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Costs

Proposals are funded on the usual MRC basis of 80% of the full economic cost (except for 'exceptional costs', which are funded at 100% - see the guidance for applicants.

NHS* costs: Applicants should refer to the AcoRD guidance to ensure that research costs, NHS treatment costs and NHS support costs are correctly attributed.

*This guidance is applicable to England, Wales, Scotland and Northern Ireland.

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Contact

You are encouraged to discuss your proposal with the MRC Programme Manager before submission:

Email: tissuebanking@headoffice.mrc.ac.uk

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