Level of Innovation

Must be able to:

• Demonstrate how the proposed device, technology or intervention presents a significant level of innovation
• Show an advance over currently commercially available products
• Show innovation can be integrated into clinical practice and be able to be adopted into the NHS

Healthcare innovation can be defined as “any developments, simple or complex, that lead to improvements in health outcomes and patient experiences”. Wellbeing-type apps do not normally fall into this category when considering translational research.

Translational Research can be defined as “taking new scientific discoveries made in the laboratory, in the clinic or community and transforming them into new treatments and approaches to medical care that improve the health of the population (from laboratory to adoption)”.

Patient Benefit

Product must:

• Improve quality of treatment and clinical care offered
• Improve the patient experience
• Improve efficiency within the NHS and healthcare system
• Save or generate money for the NHS

Public Involvement

Plans must:

• Demonstrate how public involvement has shaped and influenced your ideas
• Show how you will include public involvement throughout the project

Unmet Clinical Need

The proposed research must:

• Be relevant to the needs of the NHS and broader healthcare priorities
• Have an impact on clinical practice
• Have advantages over current gold standard practice
• Deliver a clear benefit to patients and/or practice within the NHS

Proof of Concept

Projects must have already demonstrated:

• Proof of concept refers to there being enough evidence to convince an assessment committee that a technology/intervention has a high potential to be developed into a tangible product
• Proof of concept will differ depending on the type of technology/intervention
• Evidence for proof of concept should come from preclinical or early-stage clinical studies and supportive data
• A need for further development
• A clear pathway towards adoption and commercialisation

Value for Money

Requested project costs:

• Should be justified and essential
• Should cover costs to allow effective development of the idea
• Should include a justification for the NHS support and treatment costs

Adoption

The proposed research must:

• Be adoptable into clinical practice
• Present a strategy to overcome barriers to adoption

Further Points to Consider

• Case for further development
• Quality of the project plan
• Strength of the project team and management arrangements
• Health economic case and impact on the NHS and patients
• Intellectual property (IP) and commercialisation strategy
• Equality, diversity and inclusion issues ie is your device accessible by everyone and if not is there an alternative
• Measures of success

Invention for Innovation Programme

NIHR i4i -guidance for Stage 1 and Stage 2 

NIHR i4i - PDA scope and requirements in supporting information

A clearly defined arrangement for managing the project should be proposed. The appointed lead (Principal Investigator) should, wherever possible, be supported by a dedicated project manager and a team of co-applicants. A maximum of 7 co-applicants is permitted (which includes the joint lead applicant if listed). The project manager should take responsibility for and oversee day-to-day project activities.

The project team should provide the expertise and experience to support the proposed project from the development stage through to adoption and commercialisation. The roles and responsibilities of the individual team members who will undertake the proposed research should be clearly defined.

A public involvement lead should be appointed as a co-applicant. A public involvement lead coordinates public involvement meetings and organises payments, this shouldn't be confused with a Public Co-applicant which is someone who brings the public voice and represents the views of the public involvement advisory group within the project team.

It can be assumed that further external resources to cover specific themes such as small-scale manufacturing, health economics, regulatory development, stakeholder analysis, adoption into NHS etc. (Sub-contractors that provide external specialist services) may be required in addition to the main project team. Additional inclusion of the NIHR supporting infrastructure for research (RSS, CTUs, CRNs and NIHR HealthTech Research Centres (HRCs) is also considered.

Consideration should be given to having a small external advisory team to support the project. The composition of such an advisory team would be project dependent and may consist of public contributors or other stakeholders such as commissioners, NHS involved in the innovation pathway.

Building the Research Team

Key persons are those that oversee important components of your project. The principal investigator will oversee the project, but co-applicants are expected to support critical functions and lead on work packages. The project team should consist of key personnel who will make a project succeed and without whom the project is likely to fail.

Principle Investigator (PI)
PI will act as Lead Applicant and be responsible for e.g. co-ordination and project management, analysis, methodological input etc.

Co-Applicants
Co-applicants are those individuals with responsibility for the day-to-day management and delivery of the project and can also include patients, carers and service users as Public Co-applicants. Co-applicants are considered part of the project team and are expected to share responsibility for its successful delivery.

Collaborators and Sub-Contractors
Do not include collaborators or subcontractors as co-applicants.
Collaborators normally provide specific expertise on particular aspects of the project but do not share the responsibility for the delivery of the project.

Research Team Details

 Lead Applicant (Principal Investigator -PI)

• Name
• Specify your (lead applicant) role in the research
• %FTE commitment

Add Joint Lead Applicant and %FTE commitment

Public Involvement Lead (co-applicant)

• There should be a named person with appropriate skills and experience who is responsible for leading the public involvement element within the project.

Co-Applicants  (up to 7)

• Name
• Specify role in research
• %FTE commitment

CRN - Clinical Research Network

CTU - Clinical Trials Unit

HIEM - The Health Innovation Network

HRC - HealthTech Research Centres

NIHR Research Infrastructure 

RSS - Research Support Service

The plain English summary is read by a range of reviewers from many fields, not only clinicians and academics, but also those who may not have specialist knowledge of your field of research or be members of the public. The plain English summary, therefore, must give a clear, easy to read overview of the research.

It is not the same as the scientific abstract.

It is advisable to involve patients/carers/service users/practitioners and members of the public in developing a plain English summary.

The plain English summary should cover the whole of the project including:

• Aim(s) of the research – what you are aiming to find out
• Background to the research – why the research is important and the scale of the issue
• Design and methods used – how design methods were chosen and who are the participants
• Public involvement – how have the public been involved in the planning of the project and future involvement in the research
• Dissemination – who will communicate research findings and by what means

Simple guidelines for the writing of the plain English summary:

• The use of jargon, abbreviations and technical terms should be avoided (or if unavoidable they should be clearly explained)
• Avoid complicated English or uncommon words
• Keep sentences short
• Use project headings above to break up text to make the summary easier to read

The plain English summary is the first thing and sometimes the only section that the panel members will read of your application. It needs to be well written, easy to understand and capture attention. The following video talks through the most important aspects of the plain English summary.

How to Write a Lay Summary Duke, M (2012)

Plain English Campaign

Plain English Lexicon  Cutts, M (2011)

NIHR Plain English Summaries Guide

The Research Question

A research question is "a question that a research project sets out to answer"

It should:

• Be presented in a single statement
• Be clear and focused and state what the researcher needs to do
• Have appropriate scope; not too broad or too narrow
• Not be a simple yes or no
• Be answerable thoroughly within the given timeframe of the project
• Be analytical rather than descriptive

Aims, Objectives/Deliverables

Aims = what you hope to achieve

• Aims are statements of intent
• They are usually written in broad terms
• They set out what you hope to achieve at the end of the project
• Aims support the research question
• Consider having a key aim to support the research question

Objectives/sub-aims = steps that the researcher will take to achieve the research aims

• Should make research aims more practical and actionable
• Need to be far more specific (higher resolution) and actionable than the research aims

Deliverable = the action(s) you will take in order to achieve the aim

• Deliverables should be specific statements
• Define measurable outcomes
• Define what steps will be taken to achieve the desired outcomes

Milestones = review points in the project where go/no-go decisions can be considered alongside alternative approaches

• A milestone is an event on a schedule which marks the completion of a key activity
• This could be a completion of a work package, a technical stage or a management stage
• There should be fewer milestones than deliverables or Work Packages
• There should be enough milestones at major intervals to gauge whether or not the research plan is proceeding as expected

The aims/objectives and deliverables should link to individual work packages within your project and your project milestones.

It is a good idea to craft your research aims/objectives using the “SMART” criteria. In other words, they should be Specific, Measurable, Achievable, Relevant and Time-bound.

You should:

• Clearly state what your key aim is. This should be the key purpose of the project and what the team are working to accomplish (the target)
• Consider what sub-aims/objectives should support the key aim. These should be presented in a logical order and form the basis for your project management
• Project aims/objectives should be doable and measurable
• Consider what deliverables you need to complete the aim. Deliverables are steps for each aim and need to be accomplished (including goals/milestones) to complete the aim
• Ensure that deliverables are in a logical order and are discernible and measurable
• Deliverables in the aims should be linked to work packages and outputs
• Research aims and objectives should be written using “SMART” criteria (Specific, Measurable, Achievable, Relevant and Time-bound)

Example - Aims/Work Package relationship diagram

The research plan should be between 24 and 36 months in length, must involve at least two eligible types of organisation (small-to-medium-sized enterprises (SME), NHS providers or higher education institutions (HEI)) and lead organisation must be registered in England.

Funded activities covered are research and development of:

• Medical devices
• In vitro diagnostic devices
• Digital health technologies that fall under Tier C of the NICE Evidence Framework for Digital Health Technologies
• Artificial Intelligence (AI) technologies including Augmented or Ambient Intelligence (these will be classed as medical devices)

The research plan should cover the following:

• What is the problem being addressed
  • A clear explanation of the problem to be addressed
  • The impact on patients, the public and health and care services
  • The current unmet need both within the NHS and globally
  • How your proposed solution would meet these needs

• Why is this research important in terms of improving the health and/or wellbeing of the public and/or to patients and health care services
• Clearly identify the health and care need your research meets or contributes to
• What will be the anticipated value or contribution the intervention will provide
• Have a clear health economic case
• Have outcomes/impact on patient benefit short and long term (see IMPACT Section)
• Why is the approach superior to existing NHS practice
• Review of existing evidence – How does the existing literature support this proposal
• Why this research is needed now, in terms of time, relevance, and competing solutions
• What is the level of innovation of the proposed technology
• What is the level of innovation including technical and clinical validation (proof of concept)
• What challenges still need to be addressed and overcome
• What is the research question/aims and objectives? (see Research Planning - Research question/aims and objectives Section)
• Project plan (see Project Planning Section)

Before starting your project:

• Consider your research question
• Ensure your application meets NIHR assessment criteria
• Involve patients, carers and the public
• Get methodology advice
• Seek advice on how to run your study
• Develop your research team
• Consider whether your research might generate intellectual property
• Seek regulatory approval
• Plan for impact
• Present your application clearly
• Plan costs

Other information:

Health Technology Pathway Navigation Tool: 
This tool has been specifically designed to cater to innovators, developers, and stakeholders who are interested in exploring and gaining a comprehensive understanding of England's Med-Tech landscape. It serves as a guide, outlining the essential steps and activities involved in the entire process of developing Health Technology in England, starting from research all the way to patient treatment.

Developed by the Accelerated Access Collaborative (AAC), this tool offers a thorough mapping of the crucial stages that innovators should navigate, beginning with concept development and extending to the widespread implementation of their innovations within the NHS. It also provides information about the support services available at each stage of this journey.

Each step in the tool includes a schematic flowchart that highlights important milestones, key organisations, timelines, policies, guidelines, a checklist of tasks, and other pertinent considerations that innovators should keep in mind. While the flowchart primarily focuses on medical devices and diagnostics, it can also be applied to a wide range of digital health technologies.

NHS Innovation Service:
The primary goal of the NHS Innovation Service is to enhance and expedite the adoption of meaningful innovations within the NHS and social care sector. They offer valuable resources and coordinated assistance to innovators, equipping them with the necessary information and guidance to effectively navigate the complex health and care system. By leveraging this support, innovators can accelerate the delivery of their innovations to healthcare professionals and patients.

The NHS Innovation Service operates as a centralised online support service that caters to health and care innovators nationwide. They also facilitate collaboration among various organisations, fostering an environment where stakeholders can come together to address the specific needs of innovators.

If you require further guidance and advice, it is highly recommended to reach out to the NHS Innovation Service. You can log your product even as an early innovation via NHS Improvement’s Innovation Team 

Health Technology Pathway Tool 

NHS Innovation Service

NICE Evidence Framework for Digital Health Technologies

The Health Innovation Network

Involving members of the public in the design and management of your research will improve its quality and relevance.

When using the term ‘public’ we include patients, potential patients, carers and people who use health and social care services as well as people from specific communities and from organisations that represent people who use services. Also included are people with lived experience of one or more health conditions, whether they’re current patients or not.

Involvement

• Significant and active involvement of patients and the public in the project at all stages
• Public involvement has been shown to be research being carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them
• Use of relevant patient/user groups
• Clearly defined input
• Support and input into the writing of the plain English summary
• Consideration has been made on how to make involvement opportunities inclusive for all pubic contributors
• Helping to ensure that the research is focused, patient-centered and relevant to the needs of the public

Here are examples of how members of the public might get involved in research:

• As joint grant holders or co-applicants on a research project
• Identifying research priorities
• As members of a project advisory or steering group
• Commenting on and developing patient information leaflets or other research materials
• Undertaking interviews with research participants
• Carrying out research as user and/or carer researchers

Engagement

Where information and knowledge about research is provided and disseminated.

• Science festivals open to the public with debates and discussions on research
• Awareness of research through media such as television, radio, newspapers and social media
• Dissemination of project outcomes to research participants and members of the public

Participation

Where people actively take part in a research study.

• Recruited into clinical trials or other research studies
• Completing questionnaires
• Participating in research focus groups

Briefing notes for researchers - public involvement in NHS, health and social care research

Public co-Applicants in research – guidance on roles and responsibilities

Public Involvement Planning Tool - NIHR Newcastle IVD Co-operative

Public Involvement - Project Planning

A Gantt Chart indicating a schedule for the completion of work, including the timing of key milestones and deliverables should be included to support the application. 

• The Gantt chart or project management plan is normally a horizontal bar chart that shows the project’s planned schedule
• It should include work packages, deliverables (tasks), and go/no-go milestones
• The chart should include public involvement meetings
• The chart should also, where possible, show task dependencies
• The Gantt chart must make it clear how the research plan will be delivered over the duration of the project, with critical milestones and key deliverables clearly set out and relatable back to those in the detailed research plan

Example 1

General overview -Linking work package content to research pathway

Example 2

Project plan showing deliverables and milestones for a medical device research project

Key risks/barriers to success should be identified and mitigated against. These risks should be considered when defining milestones (the go/no-go points for your project). A risk register should be produced and managed by the Project Manager and/or Principal Investigator (Lead). Individual risks may be assigned to a relevant team member who should take responsibility for monitoring and controlling that risk. Once a risk is identified, contingencies should be put in place to mitigate it.

Mitigating Against Risks/Barriers to Success

Risk Management:

• A risk is an uncertain event(s) that will affect the achievement of the aims and deliverables
• Risk consists of a combination of probability and perceived threat or opportunity occurring that will have an impact on project outcomes
• Management of risk is a continual activity performed throughout the life of the project
• Effective risk management gives confidence that the project will meet its objectives and is worth continuing
• Risk should be identified, assessed and controlled
• It is important to maintain a risk management policy/register reporting on risks regularly

The Risk Register should cover all aspects of the research/project plan

Example - Risk Based on Likelihood and Impact (PRINCE2 Probability Impact Grid)

Risks are scored from very low to very high for likelihood and impact. This can be used to judge if risk is low (green) or high (red)

Example of Risks and Barriers

Project exit points are conditions that must be met at the end of the project before advancing to next stage. Project exit points should minimise project management risk and support next stage project planning and request for further funding.

Examples of exit criteria

• A clinically evaluated, market ready (scalable) product
• Feasibility data to inform a definitive clinical trial
• Health economic assessment of the costs and patient benefit to the NHS
• A business plan – including commercial and adoption strategies and implementation of product into the NHS
• Technical file and documentation for UKCA/CE mark readiness for approval
• A dissemination strategy

AI development stages

Describe the entry point (or the minimum requirement on eligibility), the exit point, as well as the activities, for each phase of the AI development stage:

1. 1. Proof-of-concept
   2. Development and clinical evaluation of the prototype
   3. Real-world testing of the innovation in health or social care settings
   4. Health system adoption

The researcher should consider and give details of the innovation and its AI component(s), including the following.

• The need
  • What is the health problem (unmet clinical need) that the technology is trying to solve?
  • In what way does the technology support the priorities of the health and social care systems?
  • Who are the intended users?
• The innovation
  • Give a clear description of the proposed innovation.
  • What is the rationale for choosing AI to solve the problem?
  • What AI approaches are being used and why?
  • Is there clear proof-of-concept, that is, are you able to demonstrate that the approach is technically feasible and has practical potential?
  • What are the functionality, structure, intended use, and limitations of the technology?
  • What are the benefits and concerns of the technology (safety, risks, ethics, and distortions to decision-making)?
• Feasibility and acceptability of the technology
  • Is the AI product ethically permissible, justifiable, worthy of public trust, fair and non-discriminatory?
  • Has the technology been shown to be trusted/accepted by diverse end-users and clinicians, including different demographics and professional backgrounds (e.g., patient and public involvement and engagement, and clinical acceptability studies)?
  • What will be your data protection procedure to mitigate the risks of patients, care professionals, or service users being identified?

• Model validation
  • What training datasets will be used (source, access, size, security, diversity)?
  • Will independent datasets be used to validate the technology?
  • How representative are the training and validation datasets of “real-world” data?
  • How will the robustness of the model be assessed and improved?

• Regulatory and adoption
  • Has the technology been regulatory assessed/approved?
  • Does the product have or need a CE marking and risk classification?
  • How and by whom will the technology be adopted into the clinical pathway and what is the pathway to adoption?

Examples of NIHR-funded projects involving AI are available at:  https://www.nihr.ac.uk/documents/ai-in-health-and-care-award-funded-projects-2021/27866

• A buyers guide to AI in health and care
• A guide to good practice for digital and data-driven health technologies. Department of Health and Social Care
• AI Code of Conduct
• Artificial Intelligence Funding
• Artificial Intelligence in Health and Care Award – AI definition
• Artificial intelligence: How to get it right. Putting policy into practice for safe data-driven innovation in health and care
• Invention for Innovation - Product Development Award Supporting Information for Applicants
• NHS Digital Standards
• NICE Evidence Standards Framework
• Recommendations for diversity, inclusivity, and generalisability in artificial intelligence health technologies and health datasets
• Regulatory Horizons Council: The regulation of Artificial Intelligence as a Medical Device
• The National AI strategy
• The National Strategy for AI in Health and Social Care
• The NHS Long Term plan
• Understanding artificial intelligence ethics and safety
• Understanding regulations of AI and digital technology in health and social care

The project manager must ensure that the project proceeds and completes within the specified time frame, and within budget, and that all aims, milestones and reporting are accomplished. The project manager maintains relationships between co-applicants and external collaborators.

• Developing a project plan (Work Packages – see below)
• Managing deliverables according to the decided plan
• Managing the team
• Deciding the methodology used in the project
• Establishing and working to a project timeline
• Ensuring tasks are completed by team members
• Providing regular updates and reporting
• Ensure any major issues are reported to NIHR in a timely manner
• A risk register should be maintained (see Research Planning – Risk Register)

Arrangements for managing the project must be clear and ensure that all team members understand their own and other members' roles in the project (including sub-contractors, consultants and external agencies).

Work Packages

The project should be broken down into individual work packages and contain deliverables and milestones.
The work packages should be supported by a Gantt chart.
The work packages should cover the following:

• Implementation research plan – project design should target the clinical pathway and those users affected when delivered
• Health economic assessment – project should include this to aid the case for NHS adoption
• Manufacturing – project must ensure that enough devices can be produced for evaluation
• Clinical study – project involves a clinical evaluation that has ethics approval and supports how the technology fits into the clinical pathway, is safe and acceptable and produces sufficient data for planning for follow-on, larger effectiveness/efficacy trials
• Stakeholders – project undertakes a stakeholder mapping exercise to identify and engage with key stakeholders

Project Planning

Project Meetings
It is expected that there will be monthly (regular) project meetings of the team as a whole or in part to maintain project progress. This also includes ensuring public involvement groups meet as required.
NIHR expect to have quarterly meetings that include the Research Steering Group (RSG) and the Intellectual Property management Group (IPMG):

Research Steering Group (RSG)
The role of this group is to:

• Monitor the performance and technical content of the project against an agreed project plan
• Assess the ongoing results of the project and what has been learned and agree on future research
• Critically assess the results of the project
• Identify and address any weaknesses or delays in the project
• Co-ordinate internal and outsourced components of the project
• Agree to any changes to the submitted project plan

The RSG normally includes the Principal Investigator (Chair), co-applicants and relevant team members, public involvement representative, NIHR representative (Programme Manager) and may include an independent advisor.

 Intellectual Property Management Group (IPMG)
The role of this group is to:

• Approve all public disclosures relating to the project, including presentations and posters 
• Identify new inventions arising out of the project and make recommendations for IP strategy (patent filing, freedom to operate issues)
• Approve the commercialisation and translation strategy in relation to the Foreground Intellectual Property

The IPMG normally comprises the Principle Investigator, IP lead for project team, any relevant team members and an NIHR representative. It is advisable to include the IPMG meeting as part of the quarterly RSG meeting.

WPX - Project Management | Months X-XX | Cost £xK | Lead: xxxx (Project Lead)/Project Manager

The PI together with a project manager will be responsible for day-to-day project management.

They will work collaboratively with the team to co-ordinate and monitor the delivery of all work packages and produce reports for NIHR to agreed timelines.

The Project Manager will create and maintain a risk register, organise regular project team meetings, quarterly Research Steering Group (RSG) and IP Management Group (IPMG) meetings. The RSG will meet to monitor progress and risk mitigation. The IPMG will be responsible for the IP and commercialisation aspects of the project

Deliverables
D1.1 Quarterly RSG and IPMG meetings
D1.2 Quarterly, periodic highlight and progress reports to NIHR
D1.3 Maintenance of risk register
D1.4 Final report

Milestones
M1.1 Contracts and collaboration agreements signed by month 1

It is expected that there will be early engagement with relevant patient/user groups across all aspects of the project. This engagement should continue throughout the project. It is important that application and project details should be understandable not only to the patient/user groups but also to the general public and all stakeholders.

Public Involvement Support for i4i Projects

• Ensure that there is a public involvement representative in the research team (co-applicant)
• Ensure that public involvement is used pre-award to identify research priorities
• Ensure that there is public involvement in all aspects of product and clinical development and dissemination
• Ensure other relevant stakeholders (eg researchers, practitioners, community organisations) are involved in the development of the technology
• Ensure training is available to public contributors when required
• Ensure the public are involved in deciding what the assessment of impact should focus on, the approach to take, what information should be collected to help assess the impact

Public Representative Co-applicants
Members of the public get involved in research for a variety of personal and social reasons. It may be to have a voice or be able to influence the processes that affect lives. They can make sure that their communities are represented in research.

For these reasons, it is advisable to consider having a public involvement representative as a co-applicant in the team. In this role, they can be an interface between the research team, steering groups, and the public involvement advisory group. This ensures that the patient voice and the views of the public involvement advisory group are heard and integrated into the project planning.

The role and the reason for being part of the research team, of the public involvement representative co-applicant, should be clearly described.

Public Involvement Lead/ Facilitator
The role of the Public Involvement Lead is to support the public involvement groups within the project and should be included in the team. This is separate to the public involvement group representative (co-applicant) in the research team. The Public Involvement Lead should have appropriate skills and experience and be involved in all aspects of the research project.

The Public Involvement Lead may be involved in the following activities:

• Working with public involvement groups to develop plans and the strategy throughout the project
• Act as a point of contact for public involvement group members
• Recruiting and training of new public involvement members
• Planning meetings
• Assist with report writing, creation of documents and dissemination of results
• Ensure good communication between public involvement groups and researchers

Public |Involvement Support/Input Through the Project

Pre-award

• Early-stage input
• Defining research question and aims
• Joining research team/public involvement group/stakeholders to discuss
  • Ethical implications/participant burden
  • Research design
  • Dissemination
  • Impact
• Reviewing the application
• Writing the plain English summary
• Helping to highlight research priorities

Development Stage

• Support design
• Packaging
• Interacting with manufacturer
• Identifying needs and removing potential barriers

Clinical Evaluation

• Input into ethics and patient/study documentation  
• Development of protocols
• Clinical trial design and outcomes
• Writing of patient-centered information sheets
• Regulatory support

Adoption and Commercialisation

• Assist in developing a clinical implementation strategy
• Understanding clinical pathway
• End-user/customer/stakeholder input
• Active dissemination of outcomes (social media, presentations, website input)

WPX - Public Involvement | Months X-XX | Cost £xK | Lead: XXX (Public Involvement Lead)

Public involvement is a key horizontal package throughout the lifetime of the grant. Patient representation is provided by XXX, who is also a co-applicant, and will be an integral part of the grant management team.

The Public Involvement lead will support training and organisation of public involvement groups, assist with patient recruitment and dissemination of results through newsletters and social media. Patient representatives will be involved throughout the grant submission and will help to ensure the research remains patient-centred. Public involvement will support product design and evaluation, protocol reviews and writing of patient-friendly documentation, reporting and dissemination of results through networking and publications.

Deliverables
D1 Public involvement input into all aspects, including involvement in Research Steering Group meetings
D2 Public involvement input into product design and evaluation
D3 Public involvement support with the design of the clinical study and patient-facing materials
D4 Public involvement input into the dissemination of results
D5 Public involvement support with the Final Report

Public Involvement Planning Tool - NIHR Newcastle IVD Co-operative

Public Involvement - Research Planning

Researchers should ensure that research inclusion is considered when planning. Participants for studies should be recruited from geographical areas where patient/service user, carer need is greatest. This may include rural areas and represent areas of socioeconomic and ethnic diversity. Consideration should be given to every person eligible to take part in research studies regardless of for example, age, disability, gender reassignment, ethnicity, religion or belief, sex and sexual orientation and socioeconomic status. Researchers need to be clear on how and who they are planning to recruit to their studies to ensure inclusivity and justify any reasons for exclusivity (should complete an Equality Impact Assessment).

Inclusion representation is provided by co-applicant XXX, who is an integral part of the grant management team and will contribute to all work packages. Barriers and underserved groups for this project may include older people, those on low income, physically disabled, visually impaired, etc. To maximise inclusion of these patients within the clinical study we will include patients together who need the support of their carers and patient-facing material, telephone calls and text messages will be translated where required. Barriers to underserved groups will be discussed within the survey and interviews.

Deliverables
D1 Inclusion input into all aspects, including recruitment and involvement in meetings
D2 Inclusion support with the design of the clinical study and patient-facing materials
D3 Inclusion input into the dissemination of results
D4 Inclusion support with the Final Report

Equality Impact Assessment Toolkit

NIHR's Equality, Diversity, and Inclusion Strategy

NIHR INCLUDE Guidance

RSS Equality, Diversity and Inclusion Toolkit

The INCLUDE Ethnicity Framework

There should be clear evidence for 'proof of concept' for the proposed technology and the status of development of that technology should be described.  It is expected that  experimental data to support the case for further development has been generated.

Any key data generated in prior studies should be presented.

Product development should enable the product to be clinically evaluated and allow for future scale-up manufacture for market readiness. Small-scale manufacture should provide sufficient numbers of the product to be produced for evaluation.

The project plan should support all aspects of prototyping and manufacturing, engineering and performance testing, clinical evaluation, intellectual property protection, market analysis, business case development, health economic analyses, etc.

Product development may require external expertise and/or specialist services to be added to the team as consultants or sub-contractors. This is acceptable assuming adequate justification is provided.

WPX: Device Development | Months xxx | Cost £xK | Lead: xxx

Aims: To develop and produce a commercial and clinically applicable model of the XXX device, including device hardware and software.

The proof-of-concept prototype device will be developed into a final design for manufacture at pilot scale. The device has already been designed with insight from end-users, and public involvement sessions. Public involvement input will be central to the human-centered design phase of development. Hardware and software development will be compliant with applicable standards and be appropriate for clinical evaluation and validation.

The clinical trial data will develop the design file further to support CE/UKCA marking. Software and communication links will be developed in parallel to support the device and its use in the NHS.

Deliverables
D1 Prototype improvement and development to produce workable hardware
D2 Develop supporting user-friendly software
D3 Device production for the clinical study
D4 Quality assurance assessments of hardware/software

Milestones:
M1 Device developed and evaluated ready for clinical investigation by month xx

The first clinical study for a medical device should be aimed at supporting requirements for UKCA/CE marking. Prior evidence and any key data generated should be used to support these follow-on studies.

This study should ensure that safety and performance are clearly demonstrated (safety and acceptability/tolerability study; pilot or feasibility studies). A pilot study can be used to assess the feasibility of conducting a larger follow-on clinical trial. The pilot study will allow the determination of likely difficulties in performing a full clinical trial and inform on the calculations on sample sizes required for a full clinical trial to be done.

Thought should be given to how the clinical study supports the development of the device, how it could support economic evaluation and implementation into the clinical pathway.

Clinical Evaluation

For consideration:

• Emphasis should be to undertake clinical investigations to evaluate safety and performance of the device in accordance with the requirements of the regulatory authorities Pre UKCA/CE approval studies may include:
  • Evaluation of safety and performance against standard care
  • Feasibility study to investigate device design and function against device specification
  • To evaluate patient populations and clinical pathways
• Consider small studies with 10s or 100s of patients
• At this stage, large-scale randomised controlled trials (RCTs) are not normally undertaken due to time and cost
• Need a letter of 'no objection' from the regulatory body (MHRA) to use a non UKCA/CE marked device in a clinical investigation

Regulatory/Ethics Approval

Ethical approval must be obtained either before or at the start of the project and should be part of study planning.

Before the clinical study commences an application should be made to the MHRA for non UKCA/CE marked device assessment.

Applicants can discuss ethical approval requirements with their Local Clinical Research Network (LCRN)and the Health Research Authority (HRA).

Applications for approval for a clinical investigation of a medical device should be made via the Integrated Research Application System (IRAS) website and by completing the Medical Devices form (Clinical Investigation application form). Upload the relevant supporting documents on to IRAS and then follow the instructions on how to submit the application.

The IRAS form also contains a checklist of documentation required for MHRA submission.

The Checklist tab on IRAS contains a list of all documents that should be included in the submission to MHRA:

• Covering letter on headed paper
• Clinical investigation plan
• Investigator’s brochure
• Participant information sheet
• Participant consent form
• CVs for UK clinical investigators
• Device details
• Essential requirements checklist/General Safety and Performance Requirements checklist
• Risk analysis
• Instructions for use of a medical device
• Device labels
• Summary of all bench testing and pre-clinical testing conducted
• Summary of all clinical experience with the device to date
• End-of-study reports for any concluded clinical investigations that involved the same
• Medical device under investigation
• List of standards met
• Sterilisation validation report (where relevant)
• Software information (where relevant)
• Biological safety assessments of patient contacting materials (where relevant)
• Information on animal tissues (where relevant)
• Information on any medicine or human blood derivative, or non-viable human tissues and cells incorporated into the device
• Research ethics committee opinion (if available)

Information on documentation required for submission can be found in the ‘Clinical investigations of medical devices – compiling a submission to MHRA’ document.

Some clinical evaluation parameters and design for consideration when putting protocol together:

• Aims and objectives of clinical study
• Type of investigation
• Sample size (with justification)
• Number of centres participating in the study with justification
• Duration of study with start and finish dates and proposed follow-up period (with justification)
• MHRA Guidance on legislation
• Criteria for patient selection including: Inclusion and exclusion criteria (with justification), criteria for withdrawal
• Details of any proposed post-market clinical follow-up
• Data collection/analysis/statistics
• Description of endpoints (primary and secondary) and the data recorded to achieve the endpoints, method of patient follow-up, assessment and monitoring
• The hypotheses which are to be tested and/or the device performance characteristics including statistical methods
• Description of procedures and details of data to record and report serious adverse events and adverse device-related incidents

Further information can be found in the ‘Clinical investigations of medical devices – compiling a submission to MHRA’ document.

Sponsorship for Clinical Studies

NIHR state that “if support for a clinical study is requested, one of the partners in the research project should be an NHS organisation which has agreed to be the sponsor of the trial”.

For clinical research, the sponsor will normally be the NHS Trust but it may also be a commercial company or a university. The sponsor can be the Principal Investigator's employing organisation.

Proof of an approved sponsor for all research taking place within NHS is required.

All research taking place in the NHS (where the research involves NHS patients, data or tissue) must have sponsor. The sponsor is the organisation that takes the lead and has primary responsibility for the design of the study meeting appropriate standards. The sponsor verifies that arrangements are in place to ensure the correct conduct for collecting and analysing of data and reporting.

Clinical Trials Units (CTU)

CTUs are specialist units which have been set up with a specific remit to design, conduct, analyse and publish clinical trials and other well-designed studies. They have the capability to provide specialist expert statistical, epidemiological and other methodological advice and coordination to undertake successful clinical trials. In addition, most CTUs will have expertise in the coordination of trials involving investigational medicinal products.

Having a CTU on board can be advantageous as it would demonstrate that they are committed to supporting the trial.

Governance

The UK Policy Framework for Health and Social Care Research outlines the principles of good practice in the management and conduct of health and social care research in the UK. All NIHR-funded research must be completed in accordance with this framework.

Patient Consent

People who are invited to take part in health and care research must give informed consent before being enrolled. For consent to be considered both legal and ethical it must be:

• Given by a person with capacity
• Voluntarily given, with no undue influence
• Given by someone who has been adequately informed
• A fair choice

Research funded or supported by the NIHR should follow best practice in consent and the preparation of information for participants, as set out by the Health Research Authority.

Protecting Personal Data

Researchers and study coordinators must comply with General Data Protection Regulation (GDPR) with respect to processing personal data, such as from research participants.

The Health Research Authority has published operational guidance on the implications of the GDPR for the delivery of research in the UK.

WPX Clinical Study | Months X-XX | Cost £XX | Lead: XXX

A clinical study will be performed to evaluate the safety and acceptability of the device and the feasibility of conducting a future follow on multicentre RCT.

The study set up and delivery will be managed by XX CTU and together with the project lead will obtain approvals, monitor progress and recruitment and compile study data. The data will be statistically analysed and provide information for economic assessment.

Outline study headings

• Study design
• Participants
• Inclusion criteria
• Exclusion criteria
• Setting
• Sample size
• Intervention (should include flow chart)
• Control group
• Primary outcome
• Secondary outcome(s)

Criteria used to measure safety, acceptability and feasibility outcomes should be included.

The above is dependent on study design, device being clinically evaluated, relevant clinical condition and recruitment of patients from diverse population.

Deliverables
D1 IRAS submission and MHRA/REC/HRA approval
D2 Prepare clinical protocols
D3 Clinical study
D4 Report of clinical study including qualitative data and statistical analysis of results

Milestones
M1 Submission for ethics/HRA and MHRA approval (Month XX)
M2 Sites open to recruitment / First patient recruited (Month XX)
M3 Data collection complete (Month XX)

Clinical investigations of medical devices – compiling a submission to MHRA

Good Clinical Practice (GCP) guidelines

Governance Arrangements for Research Ethics Committees (GAfREC)

Health Research Authority

Informing participants and seeking consent as set out by the Health Research Authority

Integrated Research Application System (IRAS)

Local Clinical Research Network

NIHR ctu-support-funding

Operational guidance on the implications of the GDPR 

UK Policy Framework for Health and Social Care Research 

NIHR look for details within the project plan to support the compilation of information for future CE/UKCA marking and other regulatory requirements, including any work toward Quality Management System (QMS) development and reporting on clinical evaluation.

Definitions

Medical device -  any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings.

In vitro diagnostic medical device - any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body.

Manufacturer - a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.

Regulatory Compliance and Steps Required Towards UKCA/CE Mark Approval

 Classification - Classification is based on risk and evidence needs to be compiled throughout the project to ensure that the medical device will meet requirements for regulatory approval and will meet conformity assessment if required.

To meet conformity assessment requirements:

• Outline of general safety and performance
  • Benefits must outweigh risks
  • Must be supported by clinical evidence and evaluation
  • Performance characteristics for in vitro diagnostic medical devices
• Technical documentation
• Meet harmonised standards and common specifications (An introductory guide to the medical device regulation (MDR ...)

Risk Classification

Technical File

At a minimum, technical documentation should have:

• A device description and specification section
• Labelling and instructions for use
• Detailed information on design and manufacturing
• Detailed risk management information in compliance with ISO 14971
• General Safety and Performance Requirements (GSPR) (formerly known as essential requirements)
• Verification and validation information. Not just design and development but also clinical evaluation (performance) to support device design and safety
• Post-market surveillance (PMS) information, including PMS plan, post-market clinical follow-up (PMCF) plan, and periodic safety update report (PSUR)

Clinical Evaluation

• The emphasis is to undertake clinical investigations to evaluate safety and performance of the device in accordance with the requirements of the regulatory authorities. Pre UKCA/CE approval studies may include:
  • Evaluation of safety and performance against standard care
  • Feasibility study to investigate device design and function against device specification
  • To evaluate patient populations and clinical pathways
• Consider small studies with 10s or 100s of patients
• At this stage large scale randomised controlled trails (RCTs) are not normally undertaken due to time and cost
• Need a letter of no objection from regulatory body (MHRA) to use a non UKCA/CE marked device in a clinical investigation

WPX: Regulatory | Months xxx | Cost £xK | Lead: xxx

The device is an MHRA Class IIa medical device. The collaborating commercial partners will prepare the technical file and documentation for UKCA/CE Mark approval.

The device and associated AI module will be MHRA approved prior to launch and existing information governance and security documentation will be redrafted to address the wider scope of the device.

Included in this work will be the NHS DSP Toolkit, the DTAC assessment, and creation of a new clinical safety case. Additional regulatory approvals will be required for markets outside of the UK.

Deliverable
D1 Produce technical file and documentation for UKCA/CE Mark approval
D2 Registration with MHRA

Milestone
M1 UKCA/CE Mark documentation reviewed and ready for submission (Month xx)

An introductory guide to the medical device regulation (MDR) and the in vitro diagnostic medical device regulation (IVDR)

Digital Technology Assessment Criteria (DTAC)

EU website – Directives, regulations, harmonised standards list, MEDDEVs, MD Coordination groups (MDCG)

General Safety and Performance Requirements

Guidance - MDCG endorsed documents and other guidance

International Medical Device Regulators Forum

ISO 14971:2019 Medical devices — Application of risk management to medical devices

Medicines and healthcare products regulatory agency

NHS DSP Toolkit

Notify MHRA about a clinical investigation for a medical device

Regulating medical devices in the UK

The Role of the Health Economist

The health economist can offer specialist expertise that adds value to the research project and outcomes. There are many approaches to economic evaluation, the most common form being cost-effectiveness analysis. This looks at the financial cost associated with an intervention and the primary outcome measures often associated with clinical studies. These outcomes are often compared to existing clinical practices and products. They can also analyse outcomes in terms of Quality Adjusted Life Years (QALY). They can also look at Quality of Life (QoL) and devise models for varying patient groups. This is an important aspect of supporting equality, diversity and inclusion of patient populations.

The expertise to model economic measures means that techniques can be applied to creating and extrapolating costs and outcomes of the intervention beyond the timeframe of the research project offering additional information to key stakeholders and decision-makers.

Health economic modelling

Health economic modelling is a process for creating and comparing the costs and benefits of new (proposed) devices to be able to make a decision on whether or not the intervention will produce better/best patient outcomes in line with healthcare resource requirements. It is concerned with allocating health care resources to maximise economic impact of new treatments.

Health economists apply the theories of production, efficiency, disparities, competition, and regulation to make decisions on the most efficient, cost-effective course of action.

• What are the patient benefits and requirements
• Is there evidence to back your assessment
• Are there real health benefits
• Will the healthcare system benefit
• How broad will the HE impact be across the NHS
• Is the product safe

Economic Evaluation/Assessment

Economic evaluation is the process of comparing healthcare costs and health impact of alternative treatments. Data is collected from developmental and clinical evaluation of the device. Results are used by healthcare decision-makers such as NICE to determine whether or not to recommend the adoption of new treatments into routine practice.

Economic assessment forms the basis for providing a value proposition for the device and will be an important addition to the business case. It is important to deliver a clear value proposition to the key stakeholders.

A measure of health outcome is the Quality Adjusted Life Year (QALY) calculated using the EQ-5D or EQ-5D-5L, a measure of Health-Related Quality of Life (HRQL). These are used to help develop future NICE guidelines.

For HE assessments consideration should be given to the following:

• Does the proposed product address an unmet medical need
• Will the proposed technology have an impact on patient outcomes or quality of life
• Is there a demand for the product
• How will the product be used by NHS
• What will be the impact on NHS resources
• Will the product replace existing devices
• How will current staff be affected by the implementation of technology into the pathway
• Is the correct health economics model being used
• Is correct data being collected
• Does model/data support value-based care with real-world evidence
• Does the primary measure of outcome capture all the benefits (and harms) of the proposed intervention compared to usual care
• Will generic health status measures (i.e. EQ-5D-5L) be sufficiently sensitive to capture the outcomes of the treatment compared to usual care

WPX Health Economic (HE) Evaluation and Value Proposition (VP) | Scoping months x-xx and data collection and analysis months X-XX| Cost £xK | Lead: XXX

An outline value proposition will be developed to inform and support the business case development for the device. Drawing from the stakeholder review (WPX) and outputs from other project work packages, the VP will include recommendations on the evidence base needed for NHS adoption and will articulate the potential for cost savings. The scoping report will include the identification of appropriate outcomes to include in the planned clinical study (WPX) to enable a more robust HE assessment to be made. Once the clinical investigation is complete, the data will be incorporated into an updated HE modelling analysis and VP.

Deliverable
D1 Preliminary HE assessment report (MX)
D2 HE model for commercial strategy (MXX)
D3 Cost pathways and scenarios for usual care pathways and implementation of proposed device

Milestone
M1 HE assessment by (MXX)

Introduction to health economics (RDS London)

Nice guidelines

The definition of Intellectual Property (IP) includes patents, trademarks, designs, copyright (new software, protocols, questionnaires etc) and research tools (data analysis, assays, biomarkers etc).

For the commercialisation plan, it is expected that you have an idea of market size and competition and product pricing. During the project it is expected that you will expand on the commercialisation plan, identifying and mitigating risks and barriers to allow for successful adoption into the NHS and beyond.

The commercial strategy should also consider the regulatory pathway, implementation into clinical practice and health economic assessment.

Further considerations:

• Thought should be given to any potential arising IP
• IP not owned by the applicants should be evaluated in terms of any future third-party licensing arrangements
• Freedom to Operate searches should always be carried out. These can be in-house with support of eg organisation support functions (R&I departments, TTO) or through professional bodies (eg Patent agents). Important to state who carried searches out and what was revealed
• An overview of competitive technologies and market changes should be maintained to ensure your technology remains innovative
• There should be a clear route to market for the technology
• Consideration should be given to outputs and impact on patients and NHS or what impacts the research is seeking to achieve
• Consideration should be given to the dissemination of results from the research and how this may influence future licensing deals, sales or own business development

WPX Intellectual Property and Commercialisation  | Months 0-36 | Cost £xK | Lead: XXX

The background Intellectual Property (IP) covering the product and usage is owned by xxx and is in the form of patents, copyright and know how. In house Freedom to Operate (FtO) search conducted indicated no FtO issues.

IP due diligence will be carried out by the IPMG to identify and monitor the status of any related patents, technologies etc to be able to assess any future FtO issues. A formal FtO search will be carried out as part of the commercialisation strategy.

The project will call on the use of the background IP to progress to a commercial product. Any arising IP will be actively managed through the IPMG to ensure that the technology and commercial exploitation are adequately protected. A decision will be made by the IPMG and NIHR on how best to protect any arising IP

The best routes to market, the primary market will be adoption into the NHS, will be identified and a draft commercial plan completed by the end of the first year of the project. The route to market will be finalised in quarter three of the third year.

Worldwide marketing will run in parallel, but behind NHS adoption, with (eg) UK, EU and US markets being targeted.

The roadmap will include a commercial rollout to xxxx stakeholders in the private healthcare sector including yyyyyyyy and partnership exploration to increase commercial success in this sector.

The product has a unique value proposition ……………………….

A full health economic package will be included in the commercial strategy supported by XXX with support for pricing in the NHS and overall cost-effectiveness of the product.

We will seek to license the technology to a commercial partner(s) for scale-up production and distribution.

Deliverables
D1 IP review
D2 Formal Freedom to Operate search
D3 Draft commercial plan
D4 Full commercialisation strategy plan

Milestone
M1 Completion of Freedom to Operate search by month xx
M2 Draft commercial plan by month xx
M3 Full commercialisation plan to include NHS adoption, health economic assessment and FtO search by month xx

It is important that the process by which the research will enter the health and/or social care environment is understood. Also, how the results of the project will be communicated (disseminated) and introduced into the healthcare system. Consideration should be given to how the technology will be able to be adopted and implemented longer term. Further, the challenges (future barriers to uptake) for getting your research implemented in terms of acceptability, accessibility and feasibility should be identified and mitigated against.

WPX Implementation, Adoption and Dissemination | Months xxx | Cost £xK | Lead: XXX

In order to support NHS adoption, XXX will help with identification and intelligence on the relevant patient pathways and their key stakeholders. Early engagement with stakeholders will facilitate the mapping of the innovation to all relevant NHS pathways ensuring barriers to adoption within the NHS are identified early. Support will also include identification of appropriate funding mechanisms and procurement routes to begin engagement with finance managers, budget holders and decision makers.

A device value proposition (VP) will be developed to inform and support the business case development for adoption of the xxxx device and software in the NHS. The VP will include recommendations on the evidence base needed for NHS adoption, review the enablers and barriers for NHS adoption and will articulate the potential for cost savings that might be realised through deployment of the xxxx in the relevant patient pathways. The work will include identification of relevant patient pathways, identification of all necessary data needed for health economic modelling, and a review of clinical trial outcomes needed to support the device claims. The VP and Health Economic evaluation and modelling could incorporate data from the clinical trial when it becomes available.

Special attention will be given to disseminating the study findings to participants involved in the project and clinical study and to relevant user groups. The public involvement lead/group will aid dissemination by attending relevant conferences and meetings to be able to promote the technology to patient audiences as well as more clinically based presentations as appropriate.

Early identification and engagement of stakeholders, end users and opinion leaders will be undertaken as part of our implementation, adoption, and dissemination strategies.

Publications in key journals and open access publication, presenting at national and international conferences and use of social media and blogs will also maximise dissemination of results. Study participants will be informed through reports/publications.

Deliverables
D1 Stakeholder mapping analysis and report
D2 Implementation plan for future research and clinical practice
D3 Draft adoption plan for inclusion in the business plan
D4 Produce full business case to include NHS implementation and adoption strategy
D5 Active social media, presentations and open access publications submitted by month xx

Milestones
M1 Stakeholders/Champions identified by month xx
M2 Clinical implementation and adoption strategies completed by month xx

Planning for future adoption of technology into the NHS - NHS MedTech Funding Mandate policy

A detailed breakdown of costs for the project should be produced with justification for resources requested. The costings should be based on current prices and be realistic and accurate. The application at stage 1 involves an outline budget whereas at stage 2 a full breakdown of costs is required. It is, however, advisable to produce full costings at stage 1 so that at stage 2 there are no major variations in the budget from stage 1. All applications are expected to have appropriate NHS, higher education institution (HEI), commercial and other partner organisation input into the finance section of the application form.

For HEIs 80% of full economic cost (FEC) will be paid. For NHS up to 100% of direct costs will be paid. HEIs are permitted to claim estate and other indirect costs. Commercial/other partner organisations can claim indirect costs which are the costs of resources used by the research that are shared by other activities (full justification required).

The following categories should be considered when preparing your budget:

Direct Costs

• Staff costs
  • Include the annual costs of each applicant. Staff costs should include any known annual increments
• Travel, subsistence and conference fees
  • Include travel and subsistence costs for the project advisory group, steering committee, ethics committee etc. Also include costs related to dissemination and any overseas travel
  • Travel should be by the most economic means
  • Accommodation and meals can be included (alcohol is excluded)
  • National and international (max of 2) conferences costs can be included but will require full justification for travel and attendance at the conference
• Equipment (including lease versus purchase costs)
  • Costs for essential equipment and maintenance (up to £5000 for each item) will be considered assuming not covered elsewhere (eg estates). Leasing should be considered for equipment costing more than £5000
  • Cost of computers normally restricted to £650 ex VAT
  • Equipment must exclude VAT unless VAT cannot be reclaimed
• Consumables
  • This refers to non-reusable items specific to the project and not general office costs (see indirect costs)
• Public involvement, engagement and participation
  • NIHR example payments which can be used as a guide/benchmark:
    • £12.50 - For involvement in a task or activity such as reading and commenting on an abstract which equates to less than half an hour. For example, reviewing papers for the development of alerts
    • £25 - For involvement in a task or activity requiring little or no preparation and which equates to approximately one hour of activity or less. For example, participating in a focus group to provide feedback on a proposal
    • £50 - For involvement in a task or activity likely to require some preparation and which equates to approximately two hours of activity. For example, an online meeting with related papers to read or review a few short documents
    • £75 - For involvement in a task or activity where preparation is required and which equates to approximately half a day’s activity. For example, participating in a meeting to interview a small number of candidates who have applied to join a committee or panel, participating in a focus group, or delivering training

• Other direct costs
  • These are costs, not identified elsewhere and can include costs associated with the use of research facilities, external consultancy costs, costs associated with inclusivity (which may include but are not limited to justified translation of research participant material into other relevant languages), computer licensing, recruitment and advertising costs

Other Costs

• Dissemination costs
  • Includes open access costs (an open access envelope will be allocated on top of award value)
  • Includes costs for meetings to share best practice, training events and events for dissemination of research findings

Indirect Costs

• General office and basic laboratory consumables
• Premises 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

NHS Support and Treatment Costs

The research award does NOT include NHS support and/or treatment costs. These costs, including costs for social care research, are funded via Clinical Research Networks and should be detailed in the Schedule of Events Cost Attribution Tool (SoECAT). Applicants should contact their NHS R&D department or Local Clinical Research Network (LCRN).

NHS treatment costs are the patient care costs that would continue to be incurred if the patient care service in question continued to be provided after the R&D activity has stopped. Where patient care is being provided which differs from the normal, standard treatment for that condition, the difference between the total treatment costs and the costs of the “usual standard care" (if any) constitutes excess treatment cost/saving, but is nonetheless part of the treatment cost, not an NHS support or research cost. These costs should be determined in conjunction with your NHS body or provider of NHS services and their commissioners.

Detailed guidance on how to complete the finance section of funding applications can be found here - finance guidance 

In addition further information is given in this video

Core finance guidance

General guidance on SoECAT

Guidance on how to complete a SoECAT

How to complete the finance form

Local Clinical Research Network

NIHR Payment Guidance for Researchers and Professionals

NIHR payment guidance for members of the public

Open Access Funding Guidance

Outputs

A research output can be considered as anything that enters the public domain. Outputs can be written, verbally presented, audio/visual or electronic. These can include the following:

• Publications (Journals, reports, books, manuals, guides, reviews etc)
• Presentations (Conference, websites, blogs, social media channels, podcasts, interviews etc)
• End-user engagement (Training of medical staff, healthcare guidelines, policy documents etc)
• Research tools (Databases, data analysis methods, computer modelling, data handling and control, outcome measures, medical assessments and mechanisms, new technology assays, cell lines etc)
• Intellectual property (Patents, copyright, trademarks, product branding etc)
• New technological/medical products (New and improved techniques, software, new diagnostic tools, clinical service design, disease management, clinical trials output etc)

Impact

Impact can be defined as the ultimate output of the project pathway, delivering a clear benefit to patients and/or practice within the NHS.

• Demonstrable contribution that research makes to society and the economy, of benefit to individuals, organisations and nations

Involve public contributors in the co-production of dissemination and impact plans. Describe the impacts you aim to achieve as a direct result of the project and those which are anticipated longer term. Impacts may include but are not restricted to - patient/service user, carer benefit; health and/or social care staff benefits; changes in NHS or care services (including efficiency savings); commercial return (which could contribute to economic growth); public wellbeing.

Short Term

• Research outcomes (see above)
• Dissemination and knowledge transfer
• Building research networks and data sharing

Mid Term

• Policy making
• Changes to clinical healthcare training, practice, or guidelines
• Networking and collaborative research between academia, clinicians and industry
• Evidence-based practice
• Quality of service delivery
• Cost-effectiveness
• Better use of resource/workforce

Long Term

You should consider how any smaller, more immediate effects may mature over time into larger scale or more significant effects, and the steps by which this may be achieved. As far as possible, indicate anticipated timescales for these benefits and a quantitative estimate of their scale.

• Cultural/social impact - Changes in the values, attitudes, beliefs and patterns of behaviour that benefit members of organisations, social groups or society
• Economic impact -  Monetary benefits arising from research, either in terms of money saved, costs avoided or increases in turnover, profit, funding or benefits
• Environmental impact - Benefits from research that the public derive from a healthy environment
• Impact on health and wellbeing - Research that leads to better outcomes for the health of individuals, social groups or public health, including saving lives and improving people’s quality of life. Also social aspects such as emotional, psychological and economic well-being, and measures of life satisfaction
• Policy influence and change - The contribution that research makes to new or amended laws, regulations or other policy mechanisms that enable them to meet a defined need or objective that delivers public benefit
• Technological developments – Research that leads to longer-term technological advancements that benefit the public and health and social care system

NIHR research outputs and publications guidance

RDS Impact Toolkit