NIHR Commercial Research Delivery Centre Application Guidance

Introduction

The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. NIHR delivers against this mission through six core workstreams set out in Best Research for Best Health - the next chapter.

The NIHR is launching a new, open competition to designate and fund NIHR Commercial Research Delivery Centres (CRDCs). This scheme replaces the current NIHR Patient Recruitment Centre scheme.

It is anticipated that a total of up to £77.125m is available over seven years from 1 April 2025, subject to DHSC approvals. Eligible NHS organisations may submit one application.

Aim of the Scheme

The NIHR Commercial Research Delivery Centres (CRDCs) will be centres of excellence, offering additional commercial research delivery capacity to existing health and care organisations. The CRDCs will accelerate the delivery of commercial clinical research for the benefit of the health and wealth of the nation. They will work with industry and other research delivery infrastructure to support the UK to remain one of the best places in the world for innovative companies to bring their portfolio of research.

The CRDCs will be dedicated to delivering commercial clinical research and respond to the five pillars of the UK Clinical Research Delivery Vison: clinical research embedded in the NHS; patient-centred research; streamlined, efficient and innovative research; research enabled by data and digital tools; and a sustainable and supported research workforce. They will also align with the future direction for research delivery set out in the Government’s response to the O’Shaughnessy Review.

The aims of the NIHR Commercial Research Delivery Centres are to:

• provide additional capacity to conduct commercial research through centres with dedicated staff and facilities;
• act as a gateway to a network of commercially active sites with gold standard set-up times and performance, standardised costing and contracting, and a dedicated staff and facilities with consistency of practice;
• for more established commercial research sites, develop a hub and spoke model for their CRDC to support the decentralisation of clinical trials to primary, community and social care settings to make taking part in research as easy as possible for participants;
• drive innovation and act as a test bed for pioneering approaches to delivering commercial research;
• increase research inclusion to ensure people from all eligible communities and those living with the greatest burden of disease can participate in clinical trials;
• work collaboratively with all parts of the clinical research infrastructure, including but not limited to contract research organisation (CRO) sites; wider NIHR research delivery infrastructure and aligned organisations within the devolved nations;
• work to provide training to enhance skills and workforce development to build further capacity and expertise for the delivery of commercial contract research; and
• support and contribute to a newly convened Commercial Research Delivery Centre (CRDC) Network, working as a good citizen across the NIHR CRDCs and equivalent centres in the devolved nations, as appropriate.

Selection Criteria

An independent Funding Committee will be established to make recommendations to the Department of Health and Social Care (DHSC) on the designation and funding of the NIHR CRDCs. They will review applications and make recommendations based on the following selection criteria:

• The strength of the strategic plan for the CRDC, including the leadership and governance arrangements, mechanisms for managing competing demands on the CRDC, plans to support skills and workforce development, a clear demonstration of public and patient involvement and engagement and research inclusion practices.
• The strength of strategic partnerships and collaborations with the life sciences industry and other clinical research infrastructure, including but not limited to NIHR CRFs and the RDN and aligned infrastructure across the devolved nations. This should include plans to proactively facilitate and contribute to collaboration across the CRDC Network, when in place.
• A strong track record in delivering commercial research to time and target with full adherence to nationally mandated process such as National Contract Value Review (NCVR), unmodified use of model Clinical Trial Agreements (mCTAs) etc
• The appropriateness of the facilities provided by the CRDC to support the delivery of commercial contract studies, including the expertise of the research delivery staff.
• Appropriate and feasible plans to increase capacity to deliver commercial research in smaller trusts and primary care, community and social care settings using a hub and spoke model (eligible CRDCs only).
• Value for money.

The overarching NIHR principles of transparency and contestability relating to NIHR funding competitions will be applied.

Eligibility Criteria

Applications will be accepted from NHS organisations in England who clearly demonstrate the following:

1. The average volume of NIHR CRN portfolio adopted, commercially funded and sponsored clinical trials open to recruitment since Q1 2022/23 to be greater than 15 or greater.
2. Strict adherence to national mandates and initiatives aimed at streamlining and expediting the delivery of commercial research, including comprehensive compliance with the National Contract Value Review process.
3. An existing dedicated purpose-built facility with appropriate supporting infrastructure (e.g. well established public transport links, car parking).
4. Implementation of sound financial practices, ensuring full cost recovery to the CRDC, and effective fund management across financial years to optimise the utilisation of capacity build elements within commercial research contracts, ensuring capacity build funding within cost recovery is spent as intended.
5. A comprehension of how geography, patient demographics and disease prevalence factor into the feasibility of clinical trials and the selection of appropriate research locations.
6. Demonstrate current collaborations, or willingness and ability to establish collaborations, with various NHS, public health and social care organisations within the Centre’s region in a hub and spoke model to facilitate swift establishment and execution of commercial research while broadening access to a more extensive patient cohort. This should include other NHS trusts, primary care, community, and social care.

Funding eligibility for the new CRDCs will be stratified into three categories, based on the average volume of NIHR CRN portfolio adopted, commercially sponsored clinical trials open to recruitment since Q1 2022/23, as specified below:

• (A) between 25-70 commercial trials - organisations can apply for core funding and funding for the hub and spoke model
• (B) over 70 commercial trials - organisations can apply for funding for the hub and spoke model with a lower level of core funding available.
• (C) between 15-24 commercial trials - organisations can apply for core funding (funding over the course of the lifetime of the contract may become available for funding for the hub and spoke model subject to revised eligibility and performance)

All designated CRDCs will be eligible to apply to host the CRDC Network once the competition is launched; further details on this will follow.

The designated NHS organisation may collaborate with other NHS organisations and may pass funding to them via an appropriate mechanism, such as a subcontract. Please note that applicants are not asked to provide a list of organisations the proposed NIHR CRDCs will collaborate with during the contractual period but are expected to explain their proposed approach.

Scope of the Scheme

The NIHR CRDC scheme provides infrastructure funding to undertake the delivery of industry sponsored research and commercial collaborative studies across the whole clinical trials pathway. The NIHR CRFs already support the delivery of early translational and experimental medicine studies across a range of clinical/disease areas. It is therefore anticipated that the CRDCs will focus on later phase trials (Phase IIb and later). However, CRDCs may support a combination of early and late phase trials, if applicants can demonstrate that the centre has the appropriate facilities and expertise in place. Eligible organisations should develop a hub and spoke model to facilitate capacity and capability building in smaller NHS trusts in their region and primary and community settings who have an interest in research delivery.

While facilities may vary, all hub CRDCs should include the following:

• a dedicated physical space for hosting the Centre, equipped with the necessary facilities such as reception spaces and consultation rooms;
  highly trained dedicated research support and management personnel;
• specialist equipment and laboratories to conduct a variety of research studies, including links with key services, including pharmacy, radiology and pathology. Where resources and equipment are shared with care services, a plan for how these shared resources will be managed, should be provided;
• facilities for pharmacy and dispensing, secure storage for Investigational Medicinal Products (IMPs), accommodations for phlebotomy and sample storage, and secure storage for study documents;
• Sponsor, participant and patient accessibility considerations, covering parking, access through public transport, signage, waiting areas and treatment rooms, monitoring space and remote capabilities;
• Standard Operating Procedures to ensure studies adhere to UK Policy Framework for Health and Social Care Research requirements and, where appropriate, are compliant with Good Clinical Practice.

Spoke centres should have:

• a dedicated physical space for hosting the Centre, equipped with the necessary facilities such as reception spaces and consultation rooms;
  highly trained dedicated research support and management personnel;
• secure storage for study documents;
• Sponsor, participant and patient accessibility considerations, covering parking, access through public transport, signage, waiting areas and treatment rooms, monitoring space and remote capabilities;
• Standard Operating Procedures to ensure studies adhere to UK Policy Framework for Health and Social Care Research requirements and, where appropriate, are compliant with Good Clinical Practice.

Priorities within the health and care system change and NIHR CRDCs will need to be responsive to emerging needs and situations that arise (nationally and globally) which require access to research delivery expertise and resources at short notice. NIHR CRDCs will be expected to prioritise resources towards addressing national health and care priorities at the request of the Department for Health and Social Care (DHSC).

Skills and Workforce Development

In this new competition, NIHR CRDCs will have a remit to support the development of a highly skilled research delivery workforce for commercial contract studies. NHS organisations will be expected to demonstrate how they will support skills and workforce development through the provision of both theoretical and practical training. Consideration should be given to providing support across the career development pathway for research delivery staff at all levels from early training into continuous professional development to build capacity and expertise within the Centre.

Host organisations may wish to refer to the principles and best practices outlined within relevant Charters and Concordats such as the Researcher Development Concordat.

CRDC Network

Once CRDCs are designated, a CRDC Network, similar to the UKCRF Network, will be commissioned. This will act as a coordination function with a remit including but not limited to:

• strategic collaboration across the UK health and care research system to increase the leadership and visibility of the CRDCs with industry bodies such as the ABPI and with individual commercial companies that bring a significant portfolio of research to the UK. The Network will provide proactive business development and engagement with initiatives and strategic conversations across the system, working with the NIHR infrastructure including the UK Clinical Research Facilities (UKCRF) Network and the RDN in England and related infrastructure in the devolved nations;
• acting as a focal point to facilitate national links with system partners such as the MHRA, HRA, NHS England and equivalent organisations in the devolved nations;
• collaboration with other parts of the system to deliver the UK Clinical Research Delivery Vision such as the NIHR RDN, Vaccines Innovation Pathway, the Dementia Clinical Trial Delivery Accelerator, the UKCRF Network, the ECMC Network and equivalent organisations in the devolved nations to maximise investment in health and care research delivery, sharing learning to optimise best practice and avoid duplication of effort;
• coordination of CRDC activities working to maximise cross centre impact and wider collaboration with relevant organisations and facilitate the CRDCs being ‘good citizens’ within the Network;
• the CRDC Network will actively engage in facilitating feasibility assessments and strategic study placement in collaboration with the RDN and UKCRF, in England, aiming to ensure the "right study in the right place", to optimise the alignment of studies with the capabilities and strengths of various research environments; and
• championing a collaborative and cooperative approach by actively involving and working alongside other research delivery infrastructure, fostering synergies, leveraging collective expertise to enhance the efficiency and impact of clinical research initiatives.

This would be commissioned from designated CRDCs post award and will include CRDCs in the devolved nations.

Research Inclusion

Embedding inclusion in everything we do is one of the NIHR’s key operating principles and is key to the successful delivery of NIHR’s Research Inclusion Strategy 2022-2027. This requires active involvement of everyone within our NIHR people framework.

Applicants will be required to fully explain how research inclusion will be embedded throughout their research, culture and systems. It is important applicants consider research inclusion in line with the themes outlined in NIHR’s Research Inclusion Strategy 2022-2027:

• Become a more inclusive funder of research
• Widen access and participation for greater diversity and inclusion
• Improve and invest in the NIHR talent pipeline
• Embed evidence-led diversity and inclusion approaches
• Collaborate with partners for impact and sustainability

Patient and public involvement, engagement and participation

NIHR CRDCs will be expected to incorporate patient and public involvement, engagement and participation in the development of their proposals and in both governance and individual research activities.

NIHR CRDCs should consider how their plans will incorporate the UK Standards for Public Involvement in research. The Standards provide a framework for reflecting on and improving the purpose, quality and consistency of public involvement in research. They describe the building blocks for good practice and provide a baseline of expectations.

Please note that patient and public involvement, engagement and participation in research are distinct but often interrelated activities. Please use NIHR definitions of ‘involvement’, ‘engagement’ and ‘participation’ to differentiate between these areas.

NIHR CRDCs should consider how their plans will respond to current challenges and opportunities for involvement, engagement and participation in research delivery including how this will support and promote equality, diversity and inclusion. CRDCs are encouraged to align their plans, as well as work collaboratively with other patient/public and community involvement, engagement and participation efforts in their region (and where appropriate nationally) and ensure that sufficient resource, staff time and senior leadership are provided to support these activities. Successful applicants will be required to submit a fully developed strategy within six months from the contract start date.

NIHR position on the sharing of research data: The NIHR strongly supports the sharing of data in the most appropriate way, to help deliver research that maximises benefits to patients and the wider public, the health and care system and which contributes to economic growth in the UK. To enable research data to be discoverable and effectively re-used by the scientific community, researchers are required to take the actions outlined in the NIHR position on the sharing of research data.

NIHR Performance monitoring

The Centre and its host organisation will demonstrate high performance in the delivery of commercial research, including full adherence to NIHR terms and conditions as to be stated in the NIHR contract. NIHR data in later phase trials is underpinned by the effective use of the NIHR Clinical Research Network (soon to the NIHR Research Delivery Network) Central Portfolio Management System (CPMS), being fed by Local Portfolio Management Systems (LPMS), this data is expected to be well maintained in appropriate timelines.

Data Exclusivity Deals: The NIHR operates an open and transparent research system and would not expect to award funding to a host NHS organisation that has signed data exclusivity deals that either limit or restrict the use of data held by the NIHR CRDCs to individuals, organisations or companies. The NIHR would expect to be notified of any approaches for data exclusivity deals immediately. Host organisations are expected to adhere to the principles outlined in the Creating the right framework to realise the benefits of health data guidance when taking decisions about entering into data agreements.

Funding

It is anticipated that up to £77.125 million is available for this round of NIHR CRDCs, subject to DHSC approvals. Information on eligible costs is provided at Annex 2. Funding will be awarded for a seven-year period (commencing 1 April 2025). This is subject to the Authority’s right to review progress at the end of the fifth year. The Authority will have the right to terminate the funding with effect from the fifth anniversary of the award date if the host organisation fails to achieve the agreed objectives (or earlier if other funding conditions are not met).

NHS organisations can apply for the following funding according to their eligibility set out above:

• Core funding of up to £500k per annum for seven years – max £3.5m per CRDC (A and C)
• Lower-level core funding of up to £175k per annum for seven years – max £1.225m per CRDC (B)
• Hub and spoke model funding of up to £500k per annum for seven years – max £3.5m (A and B)

NHS organisations with an average volume of NIHR CRN portfolio adopted, commercially sponsored clinical trials open to recruitment since Q1 2022/23:

(A) between 25-70 are able to apply for core funding and funding for the hub and spoke model

(B) over 70 are able to apply for funding for the hub and spoke model with a lower level of core funding

(C) between 15-24 are able to apply for core funding only at this stage

• Although the aim is to designate 12-15 CRDCs, depending on the balance of eligibility (A-C), the number of awards will reflect the quality of the applications.
• For those NHS organisations that do not currently hold an NIHR PRC award, we anticipate that funding will be phased to support the CRDC with time to set up the work programme and recruit to new roles.
• Host organisations with an existing NIHR PRC are expected to apply in line with open competition processes.

Note: No capital funding (for tangible fixed assets such as buildings and equipment costing over £5,000) will be available for NIHR CRDCs through this funding competition. Applications should only include commercial research that can be undertaken with the existing or planned facilities which already have confirmed funding. The NIHR has an annual capital equipment and technology competition which applicants can consider for future needs. Additional funding may become available over the timeframe of the contract, but applicants will be assessed on the basis of their current facilities.

Competition Process and Timetable

Date	Process
17 April 2024	Application opens
03 July 2024	Closing date for receipt of full applications
17-19 September 2024	Funding Committee meeting
September/October 2024	DHSC confirm designation and funding for NIHR CRDCs
October 2024	Invitation to designated CRDCs to host a CRDC Network
January 2025	Closing date for receipt of CRDC Network applications
Early March 2025	Funding Committee meeting for CRDC Network including interview
Late March 2025	DHSC confirm designation and funding for host(s) of CRDC Network
01 April 2025	Funding for CRDCs commences
01 July 2025	Funding for CRDC Network commences

Annex 1: Application Form Questions

Applications must be submitted electronically via the RMS. The following information will be requested.

Applicants are asked to use plain English and avoid jargon where possible. Abbreviations should be spelled out and technical terminologies explained in the first instance.

1. Details of Proposed CRDC

• 1.1 Please select the host NHS organisation for the NIHR CRDC award.
• 1.2 Details of the proposed CRDC Director
• 1.3 Details of the proposed CRDC Co-Director (Optional)
• 1.4 Details of the Host NHS Organisation Lead
• 1.5 Total value requested

2. Summary

Plain English Summary

In plain English, briefly outline the specialist areas covered by the proposed NIHR CRDC; and outline the vision and goals of the proposed NIHR CRDC. This summary may be made publicly available. Please avoid using jargon and explain any technical terms included.

(500 words)

3. Leadership & Governance

3.1 Please describe the leadership and expertise demonstrated by the proposed Director(s) and their proposed contribution to the NIHR CRDC, this should include:

(750 words)

• evidence of their track record of leadership within a commercial research environment. This should cover examples from the national and international level where relevant;
• evidence that they are open to driving innovative and patient centred trial design;
• evidence of their ability to facilitate the integration of local NHS and non-NHS organisations to best facilitate research recruitment and participation;
• experience in leading national or international centres/facilities/institutes;
• evidence of driving the agenda around improving research culture, including research inclusion;
• evidence of commitment to developing research delivery capacity and capability in the research delivery workforce with appropriate skills and training;
• evidence of a commitment to support and contribute to a new CRDC Network and to support decentralisation of trials, where appropriate, to research in smaller trusts and primary care, community and social care settings, employing a hub and spoke model.

3.2 Please describe the management and governance arrangements for the proposed NIHR CRDC, including

(750 words)

• an explanation of how the proposed Director(s) fits into existing host infrastructure arrangements, including how responsibilities will be managed where there may be co-directors;
• how the NIHR CRDC proposes to prioritise research to effectively deliver those with the highest potential to benefit patients and the public and/or the health and care system;
• the Centre’s governance arrangements for overseeing training and capacity building; management and exploitation of intellectual property; patient and public involvement, and communication/ dissemination of NIHR CRDC activities;

3.3 Please upload an organogram to illustrate the proposed governance arrangements and structures (including any external governance body(ies)), outlined above. (Max 1 page)

(Upload)

3.4 Please confirm that the proposed Director(s) of the NIHR CRDC will have responsibility for, and authority over, the NIHR funding if awarded.

(YES/NO)

4. Strategic Plan and Overview of Facilities

4.1 The proposed NIHR CRDC’s overall strategy for supporting commercial clinical research, including:

(2000 words)

• the vision and aims of the NIHR CRDC and the relevance of these to industry partners, the health and care systems, and patients and the public;
• evidence that the Director(s) possess the relevant connections with industry, clinical and other NHS services in England to facilitate the recruitment and execution of commercial research. This includes, but is not confined to, services such as pharmacy, radiology, and pathology;
• confirmation of a dedicated physical facility for hosting the centre, equipped with necessary supporting infrastructure (see scope of call paragraph);
• the proposed NIHR CRDC’s operational plan, including mechanisms for tracking the progress of the CRDC in respect to key activities, for example: training, strategic partnership development, progress of the portfolio of research;
• a brief outline of how the expertise of any additional partners will strengthen the delivery of the NIHR CRDC’s overall objectives.

4.2 Overview of the Facilities

Please provide an overview of the facilities that are in place in the CRDC and its partners and collaborators that will be involved in providing the CRDC (if applicable). Please refer to the applicants’ guidance for further detail.

(1500 words)

4.3 Financial practices and strategies

Please describe how the proposed CRDC would implement sound financial practices to ensure full cost recovery to the CRDC including:

(500 words)

• how full cost recovery will support continued delivery of the centre and work towards sustained delivery;
• how the proposed team will work to develop work within the local community, regional NHS, primary care, community and social care settings and PPIEP representatives; and
• how the funding provided will build on DHSC/NIHR investment via other funding for research delivery (including other NIHR Infrastructure) to deliver value for money.

4.4 Adherence to nationally mandates

In ticking this, you as the proposed Director(s) confirm that the host organisation and the proposed CRDC will adhere to national mandates and initiatives aimed at streamlining and expediting the delivery of commercial research, including comprehensive compliance with the National Contract Value Review process and the use of Model Clinical Trials Agreement (mCTA) and Clinical Research Organisation Model Clinical Trials Agreement (CRO-mCTA).
Ticking this box constitutes an electronic signature of the directorial role with regard to this application.

4.5 Supporting Evidence

Please provide up to three case studies highlighting previous successes in delivering commercial research in innovative or patient centred ways. (no more than 250 per case study).

(750 words)

4.6 Performance

Evidence the NHS organisations has an average volume of NIHR CRN portfolio adopted, commercially sponsored clinical trials open to recruitment since Q1 2022/23:

A. between 25-70 are able to apply for core funding and funding for the hub and spoke model

B. over 70 are able to apply for funding for the hub and spoke model with a lower level of core funding

C. between 15-24 are able to apply for core funding only at this stage

4.7 Please complete the table to set out specific (SMART) objectives that will be used to track the progress of the proposed NIHR CRDC. Please include details of how the proposed NIHR CRDC will monitor and determine successful completion of each objective.

• short term (1-2 years);
• medium term (2-4 years); and
• long term (5-7 years).

5. Partnership and Collaborations

5.1 Strategic Partnership and Collaborations

Please list any additional NHS organisations, and other organisations, that will be formally associated with the NIHR CRDC.

5.2 Please provide a one page, signed letter of endorsement from each additional partner.

(Upload)

5.3 Please outline the strength of the existing strategic partnerships between industry and the health and care systems highlighted in the application.

Please describe the approach and strategy of the proposed NIHR CRDC for working with industry, providing examples of key strategic partnerships already in place with the host organisation or proposed director(s) that are directly relevant.

(1000 words)

5.4 Please outline the approach and strategy to support the proposed NIHR CRDC’s commitment to collaborative working across NIHR, including other parts of the NIHR infrastructure (e.g. CRFs and RDN) and wider research delivery infrastructure, in the devolved nations for example.?

This should outline how the proposed NIHR CRDC would work with other parts of the research delivery infrastructure to strengthen regional and national partnerships and ensure appropriate join up to maximise opportunities for driving the commercial research delivery into benefits for patients and the public, the health and care system and for broader economic gain.

(500 words)

6. Research Capacity Development

6.1. Please describe how the applicant approach and future plans for the CRDC will enable further development of the host’s commercial research delivery. Please provide:

(750 words)

• The proposed strategy and objectives for delivering a non-competitive structure across the organisation working in a collaborative way between CRDC and host organisation. This should include consideration of career pathways (including any post-doctoral training and future career development), and personal and professional development opportunities, such as access to mentorship and leadership programmes.
• Evidence of strengths that the host organisation brings to delivering successful research capacity building.
• Demonstration of commitment to research inclusion in capacity building and to improving research training culture.
• The proposed organisational oversight and responsibility for the delivery of the career development strategy for the entire workforce, and where this will fit within the strategic and operational governance structures of the proposed NIHR CRDC.
• Demonstration of how your approach to research capacity development is complementary to the national offer provided by the NIHR Academy and the NIHR Research Delivery Network.

6.2 Data and Health Informatics Capability

Please outline the proposed NIHR CRDC’s existing data and health informatics capability, including information governance systems, and how this will support delivery of the commercial portfolio.

Please also outline which LPMS provider is currently in place and how this will be managed.

(300 words)

7. Patient and Public Involvement, Engagement and Participation

Please describe the applicant organisations approach to and future plans for patient and public involvement, engagement and participation in research.

(500 words)

This section should consist of a summary of:

• The proposed NIHR CRDC’s strategic objectives for Patient and Public Involvement, Engagement and Participation, including the approach that will be taken to achieve diversity and inclusion of public members including those from underserved communities.
• An outline of the resources that the NIHR CRDC intends to commit to delivering the programme of activities, highlighting the role(s) and FTE that will be committed to enable delivery of the PPIEP plans.
• Processes for measuring and evidencing the impact of the NIHR CRDC PPIEP approach across its programme of work, and plans sharing the wider learning that is generated.

8. Research Inclusion

The proposed NIHR CRDC will be expected to fully explain how research inclusion will be embedded throughout their research, culture and systems as part of their application. It is important applicants consider research inclusion in line with the themes outlined in NIHR’s Research Inclusion Strategy 2022-2027.

(500 words)

This section should consist of a summary of:

• The proposed NIHR CRDC’s strategic approach to research inclusion, including both the workforce and recruitment participants, with attention to equality, diversity and inclusion, and reaching under-served communities. Please refer to the NIHR’s Research Inclusion Strategy 2022-27 for more information.
• Processes for measuring and evidencing the impact of the research inclusion approach, as well as sharing the wider learning that is generated, across their strategy and operational plans.

9. Financial plan and justification of resources

Finance guidance

Please refer to the associated finance guidance document to aid filling in this form. In addition, there are short videos to visually demonstrate how to complete this form.

Please refer to the associated Commercial Research Delivery Centres - Application Guidance Annex 2 to review eligible and ineligible costs.

If applicants have any financial queries, please first refer to the finance section of the Commercial Research Delivery Centres competition - Frequently Asked Questions. If your finance query is not covered in the FAQ then please direct your query to infrastructure@nihr.ac.uk

Please provide a financial plan for the funding being requested for the NIHR CRDC.

Detailed breakdowns of costs for staff posts and salaries and operational costs including subsistence & staff travel, equipment, consumables, PPIEP, Open Access, other direct costs and indirect costs.

Applicants should refer to the specific guidance provided within the form.

Please provide a description of how these resources will be deployed to support the work of the proposed NIHR CRDC, including:

• Justification for the resources requested;
• Clear demonstration of implementation of sound financial practices, ensuring full cost recovery, directing income to the CRDC, and effective fund management across financial years to optimise the utilisation of capacity build elements within commercial research contracts.
• Please state the resources that you anticipate will be allocated to the PPIEP activities of the CRDC;

(500 words)

10. Administrative contact details

Please provide the details of the administrative contact, in the host NHS body or other provider of NHS services as a secondary point of contact for any queries relating to the application, should it be supported.

NOTE: This person will have access to the application form but does not need to be a co-applicant.

11. Declarations and Signatures

COI declaration

Please declare any conflicts or potential conflicts of interest that you or your co-applicants may have in undertaking this research, including any relevant personal, non-personal and commercial interest that could be perceived as a conflict of interest

(300 words)

Annex 2: Application Finances and Eligible Costs

The purpose of the funding is enabling increased commercial research delivery capacity by enabling host trusts to have specific infrastructure to support that delivery. This function will be managed by the NIHR Coordinating Centre (NIHR CC). This enhanced function will provide best practice guidance and develop training and standardisation tools to ensure all CRDCs are delivering to the highest standard.

Research infrastructure costs incurred by the NIHR CRDC in delivering NIHR portfolio commercial studies, including the funding of staff and core research facilities. Our expectation is that each NIHR CRDC will underpin a portfolio of work supported by commercial research funders but can also directly support a portfolio of publicly important non-commercial research.

Funding awards will be made to the designated NHS organisation, but it is permissible for funds to flow to the university partner or other NHS or university collaborator formally part of the NIHR CRDC, via a suitable mechanism such as a subcontract.

In all cases, the value for money of the proposal will be an important selection criterion.

Required Reading

Prior to completing the finance section of the application it is important applicants have a good understanding of the following:

Interactive Costing Template (iCT)

The iCT is one of two UK-wide tools you will need to use to complete the National Contract Value Review (NCVR) process - the UK’s standardised, national approach to costing and contracting for commercial contract research. The iCT is also required as part of your Integrated Research Application System (IRAS) submission for study approvals.

iCT tariff data

To view the iCT tariff data, read our supporting information: How the interactive Costing Tool (iCT) calculates the costs of studies at sites

National contract value review

The national contract value review (NCVR) is a standardised, national approach to costing for commercial contract research.

The NCVR is underpinned by the National standard contract and the National directive on commercial research studies. The NCVR focuses on agreeing the resources and price needed to set up commercial research studies within NHS providers. This work forms part of a broader common goal to ensure clinical research continues to thrive in the UK, for the benefit of patients and the public.

We strongly recommend that applicants familiarise themselves with these definitions, and consult:

The Government’s response to Lord O’Shaughnessy’s review of commercial research, which sets out the Government’s commitment to enhance commercial research in the UK.

The October 2023 model Clinical Trial Agreement (mCTA) and Clinical Research Organisation model Clinical Trial Agreement (CRO-mCTA) templates should be used without modification for industry-sponsored clinical trials of investigational medicinal products with NHS/HSC participants in hospitals throughout the UK Health Services.

The guidance notes include contact points from where advice and assistance may be obtained.

• Guidance Notes: mCTA and CRO-mCTA Oct 2023
• mCTA Oct 2023
• CRO-mCTA Oct 2023

General Information

• The financial plan should provide a breakdown of the research infrastructure costs that will be incurred in carrying out the proposed work plan.
• It is important to undertake a thorough, realistic and accurate costing. You must provide a clear and full justification for all major resources. You must also ensure that you include all costs, including those required to secure good research management and governance. In all cases, the value for money of the proposal will be an important selection criterion.
• Further itemisation of costs and methods of calculation may be requested to support the application at a later date.
• Applications should be costed at current prices, based on current salary scales and scale increments. Annual salary increments or other equivalent annual increases should be included in future years but not any other anticipated pay increases (e.g. nationally agreed pay awards). Do not include estimated uplift(s) for inflation. Should an award be made, annual uplifts may be provided, depending upon the budget available to NIHR.
• We would expect standard NHS accounting policy and guidance to be followed (as set out in the NHS Finance Manual) in determining the appropriate costs to be charged to this Research Infrastructure Award.
• Applications are expected to have appropriate NHS, HEI, commercial and other partner input into the finance section of the application form.
• Years should be calculated starting from the anticipated start date of the proposed Award. Once an award has been made, the Department of Health and Social Care will require Host organisations to provide regular financial statements regarding the use of funds provided under the NIHR funding scheme. The Department reserves the right to send independent auditors to the NHS organisation to confirm the actual use of funds.
• Payments will be made to the contracted organisation only, and the contracted organisation will be responsible for passing on any money due to their partner organisation(s).
• Appropriate research project agreement and/or sub-contracts must be put in place for any element of the work programme that is to be paid to another organisation.

Information for Different Types of Organisation

NHS organisations

For applications where the contractor is an NHS body or provider of NHS services in England, up to 100% of direct and reasonable indirect costs will be paid. The NIHR reserves the right to set limits on indirect costs charged.

Higher Education Institutions (HEIs)

For applications where the contractor is a Higher Education Institution, up to 100% of direct costs will be paid. Indirect costs for HEIs will not be paid through this funding stream.

Commercial/other partner organisations

If you are a commercial organisation/consultancy, please fill in direct costs and commercial indirect costs. Indirect costs should be charged in proportion to the amount of research staff effort requested on the funding application form. Up to 100% of costs will be paid.

If you are another partner organisation (e.g. charity or NGO), please fill in direct costs and other partner organisations indirect costs. Indirect costs should be charged in proportion to the amount of research staff effort requested on the funding application form. Up to 100% of costs will be paid.

Eligible Costs

Direct Costs

Direct costs are those eligible research infrastructure costs that will be incurred in carrying out the proposed work programme. These costs will be charged as the amount that will be spent and could be supported by an audit record. They should comprise:

Staff Posts and Salary Costs

The NIHR award will reimburse the time of staff engaged within the work programme. Salaries may be sought for research, research support or other staff (from all professional groups), and research trainees (e.g. MPhil, MD, PhD students), required to work full or part-time on the research programme.

This section outlines the staff salaries and relevant on-costs (i.e. pay increment dates, geographic weighting, superannuation, national insurance). Salary costs should feed into the ‘Annual Costs of Staff Posts’ section.

All known staff members must be listed and their annual salaries must be stated. Where staff are still to be recruited as part of the award, please provide the average annual salary. Use current rates of pay and build in any known annual increments. Nationally or locally agreed pay increases should be excluded.

Please note that annual increments should be based on Agenda for Change pay arrangements as applicable as of 1 April 2023.

Once your award has started, you will not be able to claim for pay awards retrospectively.

Annual Costs of Staff Posts Applications should be costed at current prices, based on current salary scales and scale increments.

For the research trainees (e.g. MPhil, MD, PhD students) costs include the value of the stipend in the salary. The costs of the tuition fees should be included in the Other Direct Cost section.

Travel, subsistence and conference fees

This section of the financial form includes journey costs, subsistence and conference fees. Where applicable, you will need to include the travel and subsistence costs of your collaborative working visits, and for steering, data monitoring and ethics committees. Travel and subsistence costs relating to dissemination should also be included here.

Journey costs

Enter the total cost of transport for all journeys for destination/purpose. If travel is by car, apply your institution’s mileage rates (however this should not exceed HMRC approved mileage allowance payments, which is 45p per mile for the first 10,000 miles and 25p thereafter). Travel by the most economic means possible is encouraged; NIHR funding schemes do not usually fund first class travel.

Only a reasonable level of international travel will be considered.

Subsistence

Subsistence covers accommodation (if necessary) and meals associated with the travel, excluding any alcoholic beverages.

Conference fees

Where national or international conference costs are included, a statement naming the conference or purpose of travel and the benefit to the research must also be made; failure to adequately justify your attendance at a conference will mean the programme will not fund this cost.

Equipment

Essential items of equipment plus maintenance and related costs not included as part of estates should be input in this section. These can be lease or purchase costs.

• The purchase cost of pieces of equipment, valued up to £5,000 excluding VAT, will be considered.
• Pieces of equipment costing more than £5,000 to purchase will usually need to be leased. Where applicants are leasing equipment with a purchase price of more than £5,000, a comparison of leasing versus purchasing costs must be provided in the ‘Justification of Costs’ section.
• Items of equipment valued at £250 or more must be itemised separately; however grouping same type equipment is permitted.
• Costs of computers are limited to a maximum of £1000 per item. This includes the costs of any associated software and VAT. A statement of justification must be included, in the relevant ‘Justification of Costs’ section, for any purchase above this limit.
• Equipment must exclude VAT, but if your organisation is unable to reclaim/recover the VAT on a piece of equipment, you should enter the gross value of a cost item (including VAT).
• You will need to seek expert advice from the organisation purchasing the equipment regarding its VAT status.

Consumables

This section includes non-reusable items specific to the work plan. Please itemise and describe the requirements fully. These items should be research delivery specific, not just general office costs which should be covered by indirect costs.

Patient and public involvement, engagement and participation

Please itemise and describe fully all costs to support the delivery of the NIHR Commercial Research Delivery Centre patient and public involvement and engagement strategy. This will include:

• Costs to support novel involvement and engagement mechanisms such as community engagement, digital engagement or other models that broaden reach.
• Payments to recognise time, skills and expertise contributed by public members.
• All out of pocket expenses incurred by public members in supporting PPIE activities. Equal opportunities for involvement are facilitated if expenses are covered. Members of the public should not end up financially worse off for providing a public service.

NIHR has produced guidance to help staff supporting reach identify and calculate costs of public involvement in their research facing activities.

Note: Costs of staff posts to support the delivery of the PPIE strategy should be included in the Staff Posts and Salaries and Annual Costs of Staff Posts tabs. Costs for cross cutting PPIE leadership e.g. the PPIE Lead should be included in the Core costs.

Other direct costs

These are costs, not identified elsewhere, that are specifically attributed to the research infrastructure. For example, external consultancy costs, software licensing, PhD tuition fees and advertising costs.

This section should disclose any surplus or reserves that are anticipated under the Commercial Research Delivery Centre and should be supported by justifications elsewhere in the application as to how these will be reinvested back into the objectives of the funding stream.

Please note that external consultants must not be people who are already employed by any NHS organisations, equivalent non-NHS settings, or organisations from the independent sector providing NHS services and other universities, who will be conducting research activities via an appropriately justified subcontract. If they are, any costs should be entered as direct costs in the ‘Staff Posts and Salaries’ and ‘Annual Costs of Staff Posts’ sections.

Indirect Costs

Indirect costs comprise:

• General office and basic laboratory consumables
• Premises/estate costs
• Library services/learning resources
• Typing/secretarial
• Finance, personnel, public relations and departmental services
• Usage costs of major research facilities
• Central and distributed computing
• Charge out rates for shared equipment
• Cost of capital employed

NIHR Commercial Research Delivery Centre awards will fund legitimate and reasonable, indirect costs for the NHS partner and other NHS collaborations. This will include the proportion of the costs of accommodation in the NHS, used for the NIHR Commercial Research Delivery Centre's work, and an appropriate proportion of HR, payroll, and finance costs. Please seek advice from your finance department about the appropriate cost for this section. Total indirect costs must be fully justified outlining the rate charged.

NIHR will not meet indirect costs incurred by HEIs in delivering the work of the NIHR Commercial Research Delivery Centre.
All indirect costs need to demonstrate value for money. The NIHR reserves the right to set limits on indirect costs charged.

Ineligible Costs

Funding will not be provided for university laboratories or infrastructure, or to meet the costs of animal research, or other work which is not human-facing early translational and experimental medicine research.

Capital equipment costing more than £5,000 will not be funded via the NIHR Commercial Research Delivery Centre award.

No new Department of Health and Social Care capital funding will be available as part of this current funding competition. Therefore, applications should only include research activities that can be undertaken within existing facilities or planned facilities that have confirmed funding.