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NIHR Artificial Intelligence for Multiple Long-Term Conditions (Multimorbidity) (AIM): Clusters Call – Research Support Facility - Research Specification

 

Contents

Timetable and Budget

Stage 1 – Outline Application
Deadline for submission: 29 September 2020
Notification of outcomes: November 2020

2nd Stage - Full Application
Deadline for submission: 12 January 2021
Notification of outcomes: March 2021
Expected start of RSF: April 2021

Budget: Up to £3m

Summary

1. The National Institute for Health Research (NIHR) invites proposals for a Research Support Facility (RSF) to work with Research Collaborations funded through the NIHR Artificial Intelligence for Multiple Long-term Conditions (AIM) call. Up to £3m funding is available for up to 40 months.

2. The NIHR AIM call will fund 4-6 Collaborations to undertake programmes of research to spearhead the use artificial intelligence (AI) methods to develop insights for the identification, and subsequent prevention of multiple long-term conditions (multimorbidity) or MLTC-M.

3. The Research Collaborations funded through the AIM initiative will use AI and data science methods, combined with existing methodology and expertise in clinical practice, applied health and care research and social science, to systematically identify or explore clusters of disease. In addition to the identification and mapping of new clusters of disease, the call seeks research to better understand the trajectories of patients with MLTC-M over time and throughout the life course, including the influence of wider determinants such as environmental, behavioural and psychosocial factors.

4. The purpose of the RSF is to provide leadership, technical expertise and capabilities to work with the AIM Research Collaborations to overcome the challenges in conducting AI and MLTC research. The purpose of the RSF is not to perform original research itself.

5. The RSF will have recognised technical competencies and expertise (e.g. technical AI expertise; data curation; resource development to support data access and governance); a proven record in community building and facilitating networks across disciplinary boundaries; and be proficient in communicating evidence for impact and supporting shared learning and synergies across programmes of work. The RSF will play a leadership role to bring the combined voice of the Research Collaborations together, working with wider stakeholders, as necessary, to help breakdown existing barriers on data quality and linkage.

6. The exact roles and functions of the RSF should be defined and developed by the successful applicant. Applicants should set out their view of the key challenges to the successful delivery of the AIM initiative, and how the skills and services they would offer would address them. The RSF should support the Research Collaborations to produce innovative and high-quality AI & MLTC research.

7. The RSF will be commissioned via a two-stage process. At stage 1, the NIHR reserves the right to suggest mergers of complementary tenders ahead of stage 2.

Definitions

8. For the purpose of this document, the following definitions apply:

a. Artificial Intelligence: the use of digital technology to create systems capable of performing tasks commonly thought to require ‘intelligence’ (see ‘A guide to using artificial intelligence in the public sector’). AI is constantly evolving, but generally it:

i. involves machines using statistics to find patterns in large amounts of data
ii. is capable of performing repetitive tasks with data without the need for constant human guidance

b. Machine learning: is a subset of AI and refers to the development of digital systems that improve performance on a given task over time through experience.

c. Multiple Long-Term Conditions (Multimorbidity) : The co-existence of two or more long-term conditions, each one of which is either:

i. A physical non-communicable disease of long duration, such as a cardiovascular disease or cancer.
ii. A mental health condition of long duration, such as a mood disorder or dementia.
iii. An infectious disease of long duration, such as HIV or hepatitis C

Background

9. The background to the AIM initiative is outlined in the AIM research specification. Applicants should familiarise themselves with the requirements of the Research Collaborations funding call.

10. A substantial and growing number of people around the world suffer from two or more long-term conditions, sometimes referred to as multimorbidity (MLTC-M). Having multiple long-term conditions affects quality of life, leads to poorer health outcomes and experiences of care, and accounts for disproportionate healthcare workload and costs. However, current understanding of how conditions co-occur or ‘cluster’, the complex interactions of different conditions and treatments and the underlying pathways throughout the life course is limited.

11. Following the publication of the Academy of Medical Sciences (AMS) report ‘Multimorbidity: a priority for global health research’ , and subsequent workshops, the NIHR, MRC, Wellcome and the AMS have come together to coordinate a cross-funder group to progress the research agenda in this area. The group has published a framework which aims to deliver a step-change for understanding the clusters, mechanisms and causes, prevention, management and treatment of multimorbidity through research. The NIHR has published a response to this in its strategic framework for Multiple Long-Term Conditions (Multimorbidity) which sets out our high level aims for an evidence base; and a cultural change to facilitate high-quality research for patient benefit .

12. Developing a better understanding of disease clusters in MLTC-M, including trajectories over the life course requires novel and powerful research and analytical tools that can operate across complex and distributed sets of data and sources of evidence. Progress in the area has been limited by the poor quality and fragmented nature of the existing data, and the paucity of methodological approaches. For example, pattern recognition to look for de novo clusters, taking an agnostic approach to discovery, paired with a deep clinical understanding to interpret the data and ensure that identified clusters are clinically meaningful.

13. For a long time, and in part because of the data and methodological challenges outlined above, MLTC research has been left in the ‘too difficult’ box . To support the AIM call, and the wider NIHR commitment to MLTC research, we are funding the RSF to start to overcome these challenges to drive forward research in this field.

14. The UK is making additional significant investments in the development and deployment of big data, AI infrastructure, tools and techniques, including but not limited to: investment in the Alan Turing Institute as the national institute for data science and AI; Health Data Research UK’s (HDR-UK) National Multimorbidity Resource ; and the Health Foundation’s Networked Data Lab initiative . Applicants to this call should situate their proposed programme of research in the context of these national initiatives.

15. The RSF will work with a wide range of stakeholders to promote this significant investment, stimulate the AI and machine learning community and mobilise the expertise required to make the funded projects a success. The UK is ideally placed to capitalise on this new technology given the quality and range of data available across the health and care system.

THE AIM CALL

16. The funding available through the AIM call will lead to scientific understanding which will allow researchers to start addressing key challenges in our understanding of MLTC-M and generate insights which will support the health and social care system in the management, treatment and care for people with MLTC-M in the future. This will include:

a. finding solutions for the UK health and social care sector; improving the quality of life and health outcomes for people with MLTC-M;
b. exploring steps for new approaches and future industry collaborations to diagnose disease early, progress drug development and address the burden of polypharmacy; and
c. to reduce progression to a greater number of conditions.

17. Through the AIM call, the NIHR seeks to fund 4-6 Research Collaborations which will use the application of advanced data science and AI tools to systematically identify de-novo clusters of long-term conditions, and to explore the trajectories and development of MLTC-M over the life-course to identify tipping points and potential targets for intervention. To achieve the aims of this call successful Research Collaborations will need to combine technical and methodological skills and expertise in AI and data science, with clinical and health and care research expertise. The clusters identified will need to be validated to ensure real-world relevance. The research specification for the AIM call Research Collaborations can be found here.

18. The RSF call is part of the AIM initiative. Applicants for the RSF funding (this call) should outline how the facility would support the funded Research Collaborations in achieving the objectives set out for the AIM call.

Objectives of the RSF

FUNCTIONS OF THE RSF / WHAT THE RSF WILL DELIVER

19. The purpose of the RSF is to provide leadership for the MLTC and AI community; the technical skills and capabilities to work with the AIM Research Collaborations to overcome the challenges in conducting AI and MLTC-M research; and to build a community of expertise. The RSF will support the Research Collaborations to develop and apply innovative and robust AI techniques to deliver their programmes of work. The purpose of the RSF is not to perform original research.

20. The RSF will deliver the following overarching objectives:

a. To bring together the AI and data science, and the health and care research communities and foster a collaborative approach between the funded teams, to support a culture of shared learning and to develop and sustain a wider, resilient network of multi-disciplinary researchers working in the field of AI and MLTC-M.
b. To provide a range of AI and data science technical expertise to support the Research Collaborations to deliver their programmes of work.
c. To support, where feasible, access, quality, and linkage of health data suitable for AI & MLTC research; providing expert critical knowledge on utilising and linking diverse, large scale health and care data resources of varying data modalities.
d. To build capability and capacity in AI and MLTC-M research.
e. To provide a leadership role and bring the combined voice of the Research Collaborations together to begin breaking down additional data challenges and develop synergies across the programmes of work.

21. The overarching objectives provide a broad framework for what the RSF will deliver; the exact roles and functions will need to be defined and developed by the successful applicant, in discussion with the successful Research Collaborations. We expect the different Research Collaborations will require differing levels of support, and the level and type of support required might vary over the lifetime of the AIM funding.

22. We expect all RSF proposals to address each of these objectives in some form; however, applicants should set out their justification for prioritising particular aims or objectives. There may also be other relevant functions or services that the RSF can deliver beyond the five broad objectives listed above, and we welcome additional suggestions, including the rationale for how they will support the delivery of the AIM call.

23. The NIHR has conducted community and stakeholder engagement to inform this call and outline some of the challenges and potential functions that the RSF could deliver, and these are outlined below. An element of flexibility will be needed, the priorities and work plans for the RSF will need to be finalised when the final funded portfolio of Research Collaborations is known. Applicants should demonstrate that their team has the breadth of experience and relevant networks to support this flexibility.

24. For the stage 1 application we are not expecting a full outline of workplans but would like applicants to outline what they perceive to be the key challenges on which their RSF would focus. Applicants should outline their vision for the RSF, including how it will be situated in the national context and how it will work in partnership with key stakeholders and wider networks.

AI TECHNICAL EXPERTISE & INFRASTRUCTURE

25. To support the application of AI and data science to complex, and often messy, health and care data, and to galvanise innovation in the application of AI to health and care questions will require substantial AI and health and care data technical expertise and support.

26. This could include:

? Providing technical AI services to catalyse the research being conducted and support the Research Collaborations to achieve their aims.
? Having the data manipulation expertise necessary to make complex health and care data “ready for research”; supporting the Research Collaborations with access to this expertise and sharing best practice and tools.
? Enabling rapid prototyping of developments; in particular, supporting problem shooting and learning to develop ideas that are not yet working as intended and sharing relevant lessons and outputs across the Collaborations.
? Providing the computing infrastructure and support needed for the AI technology being developed by the Research Collaborations. Operating to national standards and over a range of trusted research platforms (safe havens), including both national and cloud-based facilities, to ensure a productive research environment is accessible to Research Collaborations to optimise return on compute investment.
? Ensuring suitable health and care expertise to ensure that findings from the research are validated to have meaningful ‘real world’ application.

27. Research Collaborations may require different levels of support with technical AI expertise and infrastructure depending on the expertise and resource held within their own institutions. RSF services in this space should consider how they could accommodate this in their proposed operating structure.

MAKING DATA/OUTPUTS ACCESSIBLE

28. We are aware that to date, the scientific progress in MLTC-M research has been hampered by challenges with data quality and linkage. There are significant barriers and challenges in accessing and using relevant data about individuals using health and social care services. This will be a particular challenge for the Research Collaborations funded through the AIM call due to the large datasets required for effective AI research, and the potential for using new types of structured and unstructured data.

29. The RSF should play a role in helping to break down barriers here, recognising that there are other organisations working in this space (e.g HDR-UK) and avoiding duplication of existing work. Applicants will need to outline what they can realistically achieve in terms of overcoming these challenges within the funding envelope and duration of this call.

30. This could include a support and leadership role:

? Supporting Collaborations in making available the data generated or curated though this initiative, which could include new code and metadata through the development of AI methodologies or technology. Applications should outline the plans for doing this, in a way that aligns and engages with existing initiatives, for example through participation in current efforts by Health Data Research UK .
? Including expert knowhow of utilising and linking diverse, large scale health and care data resources of varying data modalities, combined with the data wrangling expertise necessary to make complex health and care data analysis “ready for research”.
? Developing templates and guidance on how to access and link datasets.
? Provide a leadership role, working strategically with other partners and stakeholders, to develop policy and good practice around improving data quality and access to support MLTC-M research in the future.

COMMUNITY BUILDING

31. There is currently a limited, albeit developing, MLTC-M research community. Applicants will need to demonstrate how they will play an active role in developing a community between the funded Research Collaborations and how they will link up with the wider MLTC research community and other MLTC/multimorbidity initiatives as relevant (for example, the NIHR-MRC SPF ‘Tackling multimorbidity at scale’ programme and the NIHR-MRC 2018 ‘Understanding multimorbidity in the UK’ call).

32. The AIM call seeks to build on the wealth of expertise that exists within teams and institutions and support the Research Collaborations to achieve more than the sum of their individual parts. The RSF will need to demonstrate clear leadership in developing the collaborative culture that is required to support innovation in this field.

33. We expect sharing and dissemination of learning and research findings between the Research Collaborations to be part of the community building activities. We are also interested in how the RSF could support the Collaborations in disseminating findings to the full range of potential audiences, and most effectively to ensure that the lessons from this research impact on policy and practice.

DEVELOPING CAPABILITY & CAPACITY

34. The call aims to support capacity building in using AI research to address health and care questions and to develop capacity in MLTC-M research.

35. There will be a role for the RSF in developing relationships between the health and care community and the AI and data science community. We are aware that there are language and cultural barriers, and the new collaborations formed as part of this call will benefit from the centralised network and training opportunities that the RSF will offer.

36. Networking and capacity building will be a key function of the RSF. Proposals are required to describe detailed approaches for achieving these objectives, with particular attention towards technical and leadership training and networking opportunities. Applications will be assessed on how they will use their technical expertise and skills to spread and build capability in the field, particularly among the funded Research Collaborations. The RSF will need to complement existing capacity building initiatives delivered through the NIHR Academy.

37. This could include:

? Providing professional development opportunities for early and mid-career researchers and professionals with potential to contribute to improvements in care for patients with MLTC-M or in developing their AI skills.
? Providing training or upskilling or providing forums for sharing knowledge and learning in accessing and using health data for MLTC-M research.
? Supporting dissemination activities to showcase successes and demonstrate the possibilities and appetite for AI and health research/MLTC-M research to attract researchers into the field.
? Promoting the findings of the Research Collaborations and other funded programmes of work nationally and internationally to create synergies to drive the research agenda in MLTC-M and build future capacity and establish the UK as a world leader in AI and/or MLTC-M research.

38. Individual Research Collaborations will have a responsibility for supporting the development of mid- and early career researchers. Any capability or capacity building offered by the RSF should not duplicate this and the RSF should focus their activity on areas where an overarching role or their specific technical expertise could be of most benefit.

RELATIONSHIP WITH THE FUNDED AIM RESEARCH COLLABORATIONS

39. The Research Collaborations will be funded for either 36 or 30 months. They will have an agreed programme of work. The RSF workplan will need to focus on supporting the Research Collaborations to achieve their aims.

40. The exact functions and support provided by the RSF will need to reflect the needs of funded Collaborations and may change over the course of the awards; therefore, the applicants will need to demonstrate that they have the appropriate skills and expertise in place. Strong applications will demonstrate how they will draw from national and international expertise in AI and data science, and how they can build upon existing partnerships as needed and as opportunities arise.

41. While there will be some core functions (e.g. networking and community building) with which all Research Collaborations will engage, there will be other services or functions which are required to a greater or lesser extent by different Research Collaborations.

42. The RSF should also consider how it can draw on and use the expertise held in the Research Collaborations. They should also outline how the RSF will facilitate learning across the Research Collaborations.

43. The RSF will need to be in place as soon as possible to support the Research Collaborations. Therefore, applicants will need to confirm that they will be able to start delivery by April 2021, and to outline their timetable for the RSF becoming fully operational.
HOW THE RSF WILL BE DELIVERED

44. The RSF could be offered by a single organisation, where they demonstrate that they have the required skills and capabilities. Alternatively, it could be delivered by a consortium of organisations. Where a consortium is applying they will need to outline how the consortium will be managed and how the organisations will work together to deliver the RSF.

45. Where we identify potential synergies between proposals at the stage 1 application, we reserve the right to suggest collaboration for the stage 2 application.

46. As part of their proposal, applicants should explain what they believe will be the key risks to delivering their RSF, and what contingencies they will put in place to deal with them.

47. We welcome applicants to consider innovative structures for delivering the RSF, for example, applicants could consider a core and service model where core services are delivered to all Research Collaboratives with the funding from this call, and extra services can be delivered on a costed basis.

48. Applicants will need to outline what can be delivered within the £3m budget. However, applicants can outline what more could be done with a little more funding (e.g. up to £5m) and what the expected benefits from any additional funding would be.

49. All research funded by the NIHR should contribute to reducing health inequalities, referred to as the systematic differences in health which exist between different population groups, (including but not limited to social classes, ethnicity and other protected groups). Health inequalities can manifest at multiple levels. The RSF should consider how it can support the Research Collaborations to address inequalities in their research.

RELATIONSHIP WITH OTHER INITIATIVES / INFRASTRUCTURE

50. All applicants will need to outline how their RSF will complement and build on the existing initiatives in the field of AI, data access and/or MLTC (e.g. those offered by HDR-UK, NHSX AI Lab, NHS AI work, NIHR Academy).

51. Applicants should outline the existing networks and partnerships they have and how they will benefit the delivery of the RSF.

LEADERSHIP AND MANAGEMENT

52. The RSF will play a strong leadership role for the AIM initiative and the MTLC-M and AI research field. It will be vital in developing the collaborative community and ethos that is needed for the AIM initiative and the funded Research Collaborations to achieve their objectives. Applicants should outline their vision for how they will bring the Research Collaborations together to deliver on the objectives of the AIM initiative.

53. Applicants should outline the proposed leadership team, and how they will work to bring the community together. The RSF will need to harness the Research Collaborative capabilities to deliver outcomes that could not be achieved by a single organisation.

54. A strong track record of leading large collaborative teams will be required. Applicants will need to demonstrate that they can work beyond institutional and discipline/specialty-based boundaries.

Proposals

55. Outline (Stage 1) applications can be submitted online via a short application form specific to this call. More details on how to apply are provided in the section below, “Standard information for applicants”.

Eligibility

56. The lead organisation must be either: (a) an NHS organisation (including NHS Trusts and NHS Foundation Trusts) or equivalent UK authorities, or (b) a university, research institutes or not-for-profit organisation. In addition to these lead organisations, SMEs (including start-up or ‘spin-out’ companies) are also eligible to receive funding. If an appropriate case is made, then overseas university partners are permissible and may receive funding. We would expect the application to make a strong case that the chosen overseas academic partner was the organisation best placed to provide input to the RSF.

57. Specialist services or expertise may be brought into the team through consultancy or sub-contract arrangements; however, appropriate justification must be provided. Sub-contractors may be based outside of England. The day-to-day running of the RSF should be handled through a project manager. The NIHR will verify on a regular basis that successful applicants have access to adequate, dedicated management support.

58. Large companies may be involved but are ineligible for funding. For all facilities where a partner is providing in-kind contributions, the exact nature of the commitment of each partner must be clearly detailed.

59. If the application is successful, a contract will be placed with the lead organisation for delivery of the RSF.
Patients and Public Involvement

60. The NIHR expects the active involvement of patients and the public (e.g. service users and carers) in the research and infrastructure that it supports, where appropriate. However, the nature and extent of patient and public involvement (PPI) is likely to vary depending on the context of the funding. Applicants should describe how the PPI will be suitably included in the RSF.

61. Applicants are required to detail what active involvement is planned, how it will benefit the RSF and the support it will provide and the rationale for their approach. PPI needs to be undertaken in a manner that acknowledges that some people may need additional support, or to acquire new knowledge or skills to enable them to become involved effectively (see INVOLVE publications for guides for researchers). Applicants should therefore provide information on arrangements for training and support. Where no PPI is proposed, a rationale for this decision must be given.

62. For further information and guidance about PPI, please visit the INVOLVE website: http://www.invo.org.uk/.
Assessment criteria

63. Applicants are expected to include in their application relevant information in line with the assessment criteria outlined below:

a. RELEVANCE of the proposed RSF

i. How relevant is the proposal in relation to the research brief? Does it outline a clear and convincing vision for how the RSF will bring the AI and MLTC research community together to foster shared learning and collaboration?
ii. Does the proposal address the call’s strategic objectives? To what extent does the proposed RSF add distinct value to support Research Collaborations funded through the AIM initiative to deliver more than the sum of their parts?
iii. Does the application demonstrate an awareness and understanding of existing activities, infrastructure and developments in this area? Is it clear how the services provided by the RSF are uniquely valuable, meet a currently unmet need and provide additional capability over and above the existing components of the national AI & data landscape?

b. SKILLS AND EXPERTISE

i. Does the team provide the necessary breadth and depth of expertise to deliver the RSF? Do they have a proven track record of delivering the services and functions they outline in the proposal?
ii. To what extent are the proposed deliverables for all elements of the RSF appropriate, valid and feasible within the timeframe and resources requested? Have the applicants shown they can work flexibly across the Research Collaborations to deliver according to their needs?

c. QUALITY of the RSF proposal

i. Are the key challenges the RSF seeks to address clearly articulated? Are the proposed priority functions coherent, fully justified, and aligned with the overall vision of the proposal?
ii. Have the applicants identified key risks to delivery (e.g. ethical, technical, and organisational)? Have these been adequately addressed?
iii. Does the application outline how the technical expertise and resources of the RSF will be used to deliver research services to the Research Collaborations? How appropriate is the model for working with the Research Collaborations? (Stage 2 only)
iv. Have the applicants provided evidence that they will be able to start delivering the RSF from Apr 2021? Have the applicants outlined what they will be able to offer from Apr 2021 and a timetable for they will become fully operational? (Stage 2 only)

d. STRENGTH of the RSF leadership structure, proposed management arrangements and networks and partnership

i. Does the Principal Investigator appear suitably qualified and experienced to lead the RSF? Are the leadership and management arrangements convincing and coherent?
ii. Does the leadership team have a track record of working with and across organisations, sectors and disciplines to deliver common goals and objectives, and of building meaningful collaborative partnerships?
iii. If appropriate, are the roles and strengths of proposed partner institutions clearly described? Does the application outline how the RSF will harness partnership capabilities to deliver outcomes that could not be achieved by a single organisation?

e. IMPACT of the proposed RSF

i. Does the proposal offer a clear vision and demonstrable benefits to the Research Collaborations, to support them to deliver high quality research that addresses the objectives of the AIM call, and will drive developments in AI and MLTC research?
ii. Are the identified audiences and key stakeholders appropriate and their needs considered? Are there specific resources and competencies dedicated to these activities?
iii. Does the proposal outline credible plans to share learning with the wider health research community and support the Research Collaborations with their commitment to open access products?

f. VALUE for money

i. Does the proposal sufficiently justify the resources required to deliver the proposed RSF?
ii. Do the proposed costs demonstrate value for money?
iii. Is the time committed by the applicants realistic to ensure delivery?

g. PATIENTS AND PUBLIC INVOLVEMENT

i. Have the applicants carefully considered ways to embed input from patients and the public in the definition of research priorities and the delivery of the research?
ii. Are adequate, well justified training and support measures for PPI representatives described in the proposal?
iii. Does the budget reflect the proposed research ambitions for PPI?

Timeline

64. AIM Research Support Facility (2-stage process):

Stage 1 Launch: 28 July 2020
Stage 1 close: 29 September 2020
Stage 1 Committee Meeting: November 2020
Stage 2 Launch: November 2020
Stage 2 Close: 12 January 2021
Stage 2 Meeting: February 2021
Outcomes: March 2021
Expected start date for RSF: April 2021

Budget and duration

65. The NIHR is expecting to fund one RSF up to £3m over 40 months. The RSF could be delivered by one organisation, or a consortium of organisations.

66. The funding from this call will not support specific research projects.

67. Costing can include up to 80% full economic costing (FEC) but should exclude VAT. Applicants are advised that value for money is one of the key criteria used by peer reviewers and funding committee members to assess applications.

68. Capability to start promptly will be an advantage and for this commissioning round, applicants should be able demonstrate that the RSF can start by Apr 2021. Applicants should consider which activities they need to prioritise for early delivery.

Management arrangements

69. A scientific advisory group including representatives of a range of stakeholder groups, including the NIHR, should be established. The advisory group will provide guidance, meeting regularly over the lifetime of the funding. The successful applicants should be prepared to review objectives and services being delivered with the advisory group. The successful applicant will be expected to:

a. Provide regular feedback on progress
b. Produce timely reports to the advisory group
c. Produce a final report for sign off

70. Applicants must provide details of the pathway to impact. These should include plans for engaging relevant stakeholders to ensure beneficial research knowledge is translated into policy and practice. Monitoring and evaluation plans should be developed. Applicants should consider the full range of audiences and ensure a plan for dissemination.

Standard information for applicants

1. The sections below provide standard information on different aspects of NIHR funding and will contain details relevant to your application.

General comments about applications
2. Applications will be considered from other UK countries (Scotland, Wales and Northern Ireland) provided they address the priority areas in a way that is relevant to the needs of the Department of Health and Social Care (England) and meet all other selection criteria.

Research governance

3. Day-to-day management of the RSF will be provided by the principal investigator. They and their employers should ensure that they identify, and are able to discharge effectively, their respective responsibilities under the Health Research Authority (HRA) UK Policy Framework for Health and Social Care Research (Health Research Authority, 2018) , which sets out the broad principles of good research governance.

4. The successful RSF must adhere to the General Data Protection Regulation and the new Data Protection Act (2018) and the Freedom of Information Act (2000). Effective security management and ensuring personal information and assessment data are kept secure, will be essential. In particular:

? The RSF shall, at all times, be responsible for ensuring that data (including data in any electronic format) are stored securely. The RSF shall take appropriate measures to ensure the security of such data, and guard against unauthorised access thereto, disclosure thereof, or loss or destruction while in its custody.
? Personal data shall not be made available to anyone other than those employed directly on the project by the RSF, to the extent that they need access to such information for the performance of their duties.

Risk management

5. Applicants should submit, as part of their proposal, a summary explaining what they believe will be the key risks to delivering their RSF, and what contingencies they will put in place to deal with them.

6. A risk is defined as any factor which may delay, disrupt or prevent the full achievement of an objective. All risks should be identified. The summary should include an assessment of each risk, together with a rating of the risk’s likelihood and its impact on an RSF objective (using a high, medium or low classification for both). The risk assessment should also identify appropriate actions that would reduce or eliminate each risk, or its impact.

7. Typical areas of risk for an RSF might include staffing, resource constraints, technical constraints, data access and quality, timing, management and operational issues; however, please note this is not an exhaustive list.

Outputs and reporting arrangements

8. The RSF will be expected to provide regular progress reports over the lifetime of the facility and will be provided with a progress report template to complete at regular intervals. In addition to describing progress, these reports will allow the RSF to indicate any significant changes to the agreed protocol, as well as setting down milestones for the next reporting period, giving an update on PPI and outputs.

9. Where applicable, a final report on the impact of the RSF will be required within one month following completion of the facility. The report may be peer reviewed and may be circulated among relevant stakeholders within the Department of Health and Social Care and its partners. A summary of the final report will be placed in the public domain. Outputs resulting from expenditure of public funds are made available for public scrutiny so it is important that the summary of your final report is easily accessible to the lay reader.
Dissemination

10. Applicants should describe how the impact of the RSF could be disseminated most effectively.

Transparency

11. In line with the government’s transparency agenda, any contract resulting from this tender may be published in its entirety to the general public. Further information on the transparency agenda is at: https://www.gov.uk/government/publications/procurement-and-contracting-transparency-requirements-guidance.

12. If you wish to view the standard terms and conditions of the NIHR contract, please go to: https://www.nihr.ac.uk/funding-and-support/funding-for-research-studies/manage-my-study/contracts-and-intellectual-property.htm.

Application process

13. To access the research specification and application form, please visit the NIHR Central Commissioning Facility website at www.nihr.ac.uk/.

14. The NIHR CCF runs an online application process and all applications must be submitted electronically. No applications will be accepted that are submitted by any means other than the online process. Deadlines for the submission of outline and full applications occur at 1.00 pm on the day indicated and no applications can be accepted after this deadline.

15. We strongly recommend that you submit your application on the day before the application deadline. Once the 1.00 pm deadline passes, the system shuts down automatically and CCF Programme Managers are unable to re-open it. If you are experiencing any technical difficulties submitting your application, please contact the CCF on 0208 843 8027 in good time, before 1.00 pm on a closing date.

16. Applicants are expected, before submitting applications, to have discussed their applications with their own and any other body whose cooperation will be required in conducting the research.

17. In order for your full application to be validated and submitted you are required to gain electronic approval from the relevant authorities before the application deadline. The Declarations page must be approved:

a) by the Lead Applicant to confirm that the content of the application is complete and correct.
b) by an administrative or finance officer for the contracting (host) institution to confirm that the financial details of the application are correct and that the host institution agrees to administer the award if made.
c) by a Head of Department or Senior Manager to confirm that they have read the application and that, if funded, the work will be accommodated and administered in the named institution and that the applicants may undertake the work.

18. Until this is completed the lead applicant is unable to validate and submit the application.

Commissioning process

19. The standard commissioning cycle includes the following steps:


20. In standard 2 stage commissioning, outline applications will be shortlisted by a Funding Committee. The Committee will make recommendations that will be ratified by the Department of Health and Social Care (DHSC). Incomplete applications, applications too remote from the issues set out in the research specification, or applications that have clearly inadequate presentation or methods may be rejected at this stage.

21. Applications that are successfully shortlisted by the Funding Committee will proceed to Stage 2 of the application process and will be invited to submit a Stage 2 full application for consideration. It is likely that stage 2 applicants will be invited to interview by the Committee. The interview format will be shared with shortlisted applicants at Stage 2.

22. All RSF applications will be peer-reviewed by both stakeholder and independent academic referees. Applicants will be given one week to respond to the peer reviewers’ comments.

23. Full applications, peer reviewers’ comments and any responses to those comments will then be considered by the Funding Committee, which is composed of independent experts (possibly with observers from government departments and executive agencies), who will advise the NIHR on which applications are most suited to receive funding. The Committee will be informed by the reviewers’ comments and any responses made to these comments by the applicants. However, it is ultimately the responsibility of the Committee to make any funding recommendations to the NIHR and the DHSC.

Contacts

24. General enquiries regarding the application and commissioning process can be directed to the AIM Team via the online form. Please ensure that you leave a contactable phone number and a member of the team will get back to you.