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NIHR Artificial Intelligence for Multiple Long-Term Conditions (AIM): Research Support Facility- Stage 2 Guidance for Applicants

 

Contents

Section 1: Application Summary Information

Host Organisation

Provide details of the organisation who will be the contractor if the Research Support Facility (RSF) is funded.

If you have any queries, please contact the AIM Team via the online form before submitting your application. Please ensure that you provide a contactable phone number and a member of the team will get back to you.

Title

The title of the RSF. Any abbreviations should be spelled out in full.

Proposed Start Date

Note this should be from 1st of the month regardless of whether this is a working day or not. Please be realistic about your possible start date taking account of the necessary contracting, and staff recruitment prior to starting your facility.

Duration (months)

Ensure you include sufficient time to complete all aspects of the work including applications for regulatory approvals (where required) and the final report. PLEASE NOTE: The duration should not exceed the maximum of 40 months.

End Date

This field will automatically populate once you have entered the start date and duration information.

Total (Stage 2) Costs

This will be automatically pulled through from the budget section in Stage 2 applications.

Total (Stage2) NHS Support & Treatment costs or external (not NHS) intervention costs

Enter the total amount of NHS support and treatment costs associated with this proposal.

Section 2: CV - Lead and Co-applicants

Complete your name, contact details and other requested information.

Co-applicants who are patients, service users or carers are not obliged to complete a standard CV but are required to provide a summary of any knowledge, skills and experience relevant to their role in the application in a separate text box. This appears when a co-applicant selects ‘yes’ to indicate that they are a member of the public.

We recognise and value the varied perspectives that patients / service users and carers bring to a project as applicants. In this section, please provide a summary of any relevant knowledge, skills and experience that you will draw upon to contribute to this project.

This could include information about:

  • Previous or present work (paid or unpaid) with any relevant organisations
  • Links with any relevant groups, committees, networks or organisations
  • Experience of particular health conditions, treatments, use of services - or as a member of a particular community
  • Knowledge and experience of research including previous research undertaken
  • Knowledge and experience of patient and public involvement including previous involvement activities
  • Skills from any other roles that are transferable
  • Relevant qualifications, training and learning.

The bullet point list above is not exhaustive. Please include anything else that is relevant to the application.

Section 3: Research Background - Lead and Co-applicants

Publication record

Provide details of a MAXIMUM of 6 of your most recent / relevant publications (in the last 10 years) relevant to this application (using Vancouver or Harvard citation format). Please use DOI reference numbers if needed.

Grant record

Please select grants held (as a named applicant) CURRENTLY or IN THE LAST 5 YEARS – as well as any additional previous grants, relevant to this application, stating who the grant is with and the amount of each grant. If no grants are held please enter N/A (as this is a mandatory field).

Section 4: The Research Support Facility Team

Specify your (lead applicant) role in this facility (100 words)

Explain in addition to your role as Lead Applicant, the role that you will be undertaking in the facility, e.g. co-ordination and project management, leadership; capacity and community building; provision of technical expertise etc.

%FTE

Commitment: This refers to the percentage of your time that you will commit to this project.

Joint Lead Applicant

Where appropriate and justified it is acceptable for the application to be led by joint Lead Applicants. Where this applies, please complete your name, contact details and other requested information.

Justification for Joint Lead Applicant

Justification should be given to demonstrate why more than one person would be required to lead this facility and how this brings added value to the application.

Relevant expertise and experience of joint Lead Applicant

Please summarise the proposed Joint Lead Applicant’s relevant expertise and track record in terms of skills and experience.

Specify role in RSF

Please provide a brief overview of your role in the proposed facility. You have the opportunity to elaborate upon this further in the ‘Research Support Facility Plan’ section.

%FTE

Commitment: This refers to the percentage of your time that you will commit to this project.

NOTE: For application/contracting purposes, the joint lead applicant will be counted as a co-applicant.

Add all co-applicants supporting your facility

Add details of all co-applicants and their specific role in the RSF. Do not include collaborators, who should be mentioned (if necessary) in the Detailed Research Support Facility Plan section of the form.

We encourage the inclusion of public co-applicants, where appropriate. Please include a clear description of their role and the reasons why a public co-applicant is joining the team. For further information please access the 'Public Co-Applicants in Research' guidance.

Co-applicants are those individuals with responsibility for the day to day management and delivery of the project and can include patients, carers and service users. Co-applicants, including public co-applicants, are considered part of the RSF team and are expected to share responsibility for its successful delivery. In contrast, collaborators normally provide specific expertise on particular aspects of the RSF but do not share in the responsibility for the delivery of the RSF.

PPI Lead

There should be a named person with appropriate skills and experience who is responsible for leading the PPI element within the RSF. This role should be an adequately costed and resourced member who is able to manage the PPI plans and related activities. Examples of the activities a PPI lead might undertake can be found here.

Allow sufficient time for your co-applicants to complete their sections of the online form before the application deadline.

NOTE: Members of the team previously invited to participate as co-applicants during Stage 1 will still need to approve their participation in the Stage 2 application before the submission deadline. New team members will need to be invited via email to participate as co-applicants and both confirm and approve their participation before the submission deadline. Once a colleague has approved their participation, their CV details will populate the application; the application cannot be submitted without doing so.

A maximum of 15 co-applicants is permitted.

Section 5: Other supporting roles – signatories (electronic)

Other supporting roles

The following supporting roles from the host organisation must be added to the application:

  1. Director of Finance
  2. Head of Department or Senior Manager

Electronic signatures

On assigning these contacts an email will be sent to each of them by the system. They will be required to tick a check box indicating that they have read and understood the terms on which they have been nominated for this proposal and accept this role. Ticking this box constitutes an electronic signature of the supporting role for the full application.

At the time of adding the necessary supporting roles required to approve your application you are advised to inform the Trust R&D office of the site most likely to be the lead site for your proposed work. The aim is to help speed up the permissions process should your application be successful. Please note this will not apply to all proposals.

The Lead Applicant will also be required to tick a checkbox to indicate that they have read and understood the terms on which he/she has been nominated as Chief Investigator for this proposal along with the associated documentation and accept this role.

Once everyone has approved the application you will be able to proceed to submit.

No original or ‘wet ink’ signatures are required for this application.

Section 6: Scientific Abstract (approx 500 words)

The scientific abstract should be a clear and concise scientific summary of the Detailed Research Support Facility Plan.

It will be for applicants to decide the appropriate elements to be included in the scientific abstract.
Applicants may find the guidance on the EQUATOR Network website (www.equator-network.org) useful.

Section 7: Plain English Summary (approx 450 words)

A plain English summary is a clear explanation of your RSF.

Many reviewers use this summary to inform their review of your funding application. They include people who do not have specialist knowledge of your field as well as members of the public. If your application for funding is successful, the summary will be used on the National Institute for Health Research (NIHR) and other websites.

A good quality plain English summary providing an easy to read overview of your whole study will help:

  1. those carrying out the review (reviewers and board and committee members) to have a better understanding of your RSF proposal
  2. inform others about your RSF such as members of the public, health and social care professionals, policy makers and the media
  3. the research funders to publicise the impact of the facility.

If it is felt that your plain English summary is not clear and of a good quality then you may be required to amend it prior to final funding approval.

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

Content

When writing your summary consider including the following information where appropriate:

  1. Objective(s) of the RSF
  2. Context for the RSF
  3. Proposed structure and delivery model
  4. Patient and public involvement
  5. Impact

Please note this is note an exhaustive list.

The plain English summary is not the same as a scientific abstract - please do not cut and paste this or other sections of your application form to create the plain English summary.

Further guidance on writing in plain English is available online at NIHR Make it clear

For further support and advice on writing a plain English summary, please contact your local Research Design Service (where applicable)

Section 8: Changes from First stage - Responses to Committee Feedback (Max 3,700 words)

Please list the feedback received at first stage and against each comment indicate what has changed as a result.

Please describe and explain any additional changes that have been made to this proposal since the stage 1 application.

Section 9: Detailed research support facility plan (approx 7,000 words)

Using all of the headings (in the order presented) and guidance below, clearly explain your proposed RSF work. Schematics, tables, illustrations, graphs, and other types of graphics can be embedded to clarify the RSF plan but they should not clutter the central narrative. Images do not count towards the overall word count but inclusion of them to overcome word limits is not permitted. Images may only be included within the 'Research Support Facility Plan.' Images included in other sections will be removed from the application and not seen by reviewers.

As this is the main part of your application which will be considered by the reviewing committee you should ensure that the information is accurate, succinct, clearly laid out and provides adequate detail. Please also refer to the detailed assessment criteria outlined in the commissioning brief.

1. What challenges for the MLTC-M community should the RSF address?

Provide a clear explanation of the objectives the RSF should address and how this will benefit the AIM call.

2. What are the aims and objectives

Explain how your proposed RSF addresses the requirements outlined in the research brief. Summarise the key aims and objectives of your RSF. Please provide a clear pathway to benefit for the AIM call Research Collaborations.

3. What is the proposed structure and delivery model?

Summarise the proposed structure of your RSF and how it will delivery of its key objectives. How does this align with existing initiatives/organisations/infrastructure in the space? Outline how the RSF will deliver a leadership function for MLTC-M and AI communities and build a cohesive community of expertise, taking into consideration how it should adapt to meet the needs of the funded Research Collaborations. There may be other relevant functions or services that the RSF can deliver beyond the five broad objectives outlined in the commissioning brief. Please describe any additional offering that could be provided to successful AIM applicants, including the rationale for how these will support the delivery of the wider AIM ambitions.

4. Team experience and expertise

Describe the skills, experience and expertise of the proposed team that makes it well placed to deliver the services and functions outlined within the proposal for the RSF.

5. Management arrangement and collaborations

Describe how your RSF will be managed and governed. Indicate how the RSF team will be organised. Please also indicate how the RSF team might draw on further expertise available in the NIHR and the wider research community, and other successful groups.

The RSF will need to be in place as soon as possible to support the Research Collaborations. Therefore, applicants will need to demonstrate they will be able to start delivery by April 2021.

Clearly outline the main risks and challenges to delivery, as well as mitigating actions, drawing analogies with past experience where appropriate.

Note: For only full applications, a concise (one page) risk assessment table can be uploaded in the Supporting Documentation section of the application, where appropriate.

6. Plans for stakeholders engagement and impact

Provide details of the full range of potential stakeholders for your RSF, nationally and internationally, and a reasoned approach to engagement, paying particular attention to the needs of the target audience and how these will be met, and accounting for varying needs over the lifetime of the facility. Describe who you need to communicate with and your plans for engaging relevant audiences and building meaningful collaborative partnerships. Please set out your key areas for impact and how you intend to achieve these.

Upload a Gantt chart

It is mandatory to attach a Gantt chart indicating a schedule for the completion of work, including the timing of key milestones and deliverables.

Section 10: Patient and Public Involvement

Please describe how patients and the public have been involved in developing this proposal. (350 words)

You should describe who has been involved and why this is appropriate, what role(s) they have played and what influence or change has happened as result of their involvement

Please describe the ways in which patients and the public will be actively involved in the proposed research support facility, including any training and support provided. (350 words)

INVOLVE has developed guidance both on how patients and public can be involved http://www.invo.org.uk/posttypepublication/involve-briefing-notes-for-researchers/ and the processes, procedures and values necessary to support this involvement www.invo.org.uk

Patients and public can be involved in every stage of a project, from developing a proposal through to dissemination and evaluation.

In your description, you will need to say who will be involved and why.

Explain why your approach to public and patient involvement is appropriate for this proposal

Describe how you will support and enable patient and public involvement in your work (e.g. payments, training).

In rare cases where proposals do NOT involve patients and the public, clear justification must be provided. (200 words)

Complete/justify as necessary.

Section 11: Detailed Budget

Justification of costs (2,000 words)

Provide a breakdown of costs associated with undertaking the work and provide justification for the resources requested, including the following:

  1. staff costs,
  2. travel, subsistence and conference fees
  3. dissemination costs
  4. equipment (including lease versus purchase costs)
  5. consumables,
  6. patient and public involvement
  7. any other direct costs

For help with estimating PPI costs please see the INVOLVE cost calculator available at http://www.invo.org.uk/resource-centre/payment-and-recognition-for-public-involvement/involvement-cost-calculator/

When justifying staff costs you should also provide the % amount of time input of each member of staff and link this to the specific area/work package of the proposed study where this input will be taking place.

You should indicate here how the research support facility will potentially benefit the successful research collaborations / development awards and, over time, the wider NHS and/ or public health / social care.

You should describe the value for money– the strength of the team and contribution of each member in light of the strategic objectives of this initiative.

Also provide a breakdown of the NHS costs associated with undertaking the work and provide justification for the resources required. If there are no NHS Support or Excess Treatment Costs associated with the work you must explain why you think this is the case.

Provide a breakdown of any non-NHS intervention costs and provide justification for the resources required. Non-NHS intervention costs should include costs incurred in delivering the intervention which would continue to be incurred after the trial, should the intervention become standard care.

*Please note as you are now required to submit a Schedule of Events Cost Attribution Template (SoECAT) with your Stage 2 application you are not required to add costs on this form under the NHS Support Costs or NHS Treatment Costs sections as these are now entered on the SoECAT form. Please do complete all other questions on the budget form*

Detailed Budget Breakdown

The finance section should provide a breakdown of costs associated with undertaking the work as described in the proposal.

Programme specific information

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

General information

The information entered in this section should provide an analysis of the total funds requested to undertake the work proposed and should be based on current prices. These costs will be used to assess value for money.

It is in your best interest to undertake a thorough, realistic and accurate costing. Where an outline/stage 1 application has been produced and this is the full stage (2) application, the committee will pay close attention to any material increase in costs. You must provide a clear and full justification for all costs including NHS costs. You must also ensure that you include all costs including those required to secure good management.

  • Costs must be provided at current prices. An adjustment for inflation will be made annually thereafter at rates set by the Department of Health. Whilst allowances for incremental increases should be included on the form, nationally or locally agreed pay increases should be excluded.
  • Years should be calculated starting from the anticipated start date of the proposed research. For example, if your research is expected to start on 01 June 2020 then its second year starts 01 June 2021.
  • Further itemisation of costs and methods of calculation may be requested to support the application at a later date.
    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 sub-contracts must be put in place for any element of the research which is to be paid to another organisation.
  • NHS support costs are funded via Clinical Research Networks. Researchers should contact their local NHS R&D department initially and, if they are unable to help directly or if there is no local NHS R&D department, contact the Local Comprehensive Research Network (LCRN) senior manager for advice on NHS support costs. Further details about LCRN contacts are available at https://local.nihr.ac.uk/lcrn/
  • All applications are expected to have appropriate NHS, HEI, commercial and other partner organisation input into the finance section of the application form.

Please note that whilst the applicable percentages will be used to calculate the maximum grant payable, the programme reserves the right to award a grant for less than this maximum where it is considered appropriate.

Information on different types of organisations

Higher Education Institutions (HEIs)

Higher Education Institutions (HEIs) should determine the Full Economic Cost (FEC) of their research using the Transparent Approach to Costing (TRAC) methodology. For HEIs, up to 80% of FEC will be paid, provided that TRAC methodology has been used.

NHS bodies and other providers of NHS services in England

For applications where the contractor is an NHS body or provider of NHS services in England, up to 100% of direct costs will be paid.

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.

Direct costs

These are costs that are specific to the facility, which will be charged as the amount actually spent and can be supported by an audit record. They should comprise:

Details of posts and salaries (posts and salaries summary)

This section presents an overview of salary and associated on-costs for the applicant(s) contributing to the work, including normal salary increments broken down individually.

  • Please include all members of staff working on the research by clicking ‘Add Staff Details’ or editing a current one.
  • If there are any applicant(s) whose costs are not being claimed you should still include their details within this section, but don’t include any actual costs.
  • Where applicants are already in receipt of NIHR funding for any part of their salaries (e.g. NIHR Fellowships), these should not be additionally charged to the project.
  • Where applicants are already receiving salaries funded by NIHR, these should be declared in the application.
  • The Apprenticeship Levy can be included in the salary costs from 1 April 2017 where relevant.

Salary costs (apply to years)

This section specifies the annual costs of each applicant contributing to the research. You should now allocate the individual staff member costs to each year of the work, allowing for increments. Use current rates of pay, and build in any known annual increments (again at current rates). You will not be able to claim for pay awards retrospectively, once your research is underway.

  • Please note the ‘Total’ and ‘Overall’ column figures need to be calculated using the current annual costs, %FTE and number of months. If the research lasts for several years and an individual’s involvement varies over the course, it may be necessary to explain fully in the justification of costs section the % FTE and months per year for an individual staff member.
  • It is important to double check that the % FTE, total months and yearly costs information are consistent with the information presented in ‘Details of Posts and Salaries’ (‘Details of Posts and Salaries’ should show the full current staff costs independent of % FTE etc., whereas the yearly costs in ‘Annual Costs of Posts’ depend on % FTE etc.).
  • Please ensure that you check the ‘Type of Cost’ box which describes the employing organisation for a member of staff as this impacts on the level of funding provided. Staff employed by a Higher Education Institution (HEI) are funded at up to 80% of cost and staff employed by NHS, commercial or other partner organisation at up to 100% of cost.

Please note that this section also includes ‘Shared Staff Costs’ which is located under directly allocated costs in some other funders’ applications. These are costs of an institution’s research resources which can be charged to the research on the basis of estimated use, rather than actual costs. These may include: IT technicians, laboratory staff, and costs of pooled staff efforts.

Travel, subsistence and conference dissemination costs.

This section includes journey costs, subsistence and conference fees. Where applicable, you will need to include the travel and subsistence costs of your project advisory group, steering committee and/or data monitoring & ethics committee. Travel and subsistence costs relating to dissemination should also be included here, as should costs relating to overseas travel.

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 programmes do not usually fund first class travel.

Subsistence

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

Conferences

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.

For research projects of three years or more, the programme will usually fund up to a maximum of two international conference attendances (two people attending one conference or one person attending two conferences). There are no limits on the number of UK conference attendances.

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 normally restricted to a maximum of £650 each excluding VAT and 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 check the box ‘VAT cannot be reclaimed’.
  • You will need to seek expert advice from the organisation purchasing the equipment regarding its VAT status. If you check the ‘VAT cannot be reclaimed’ column, VAT at 20% will automatically be calculated into the overall cost of that item.

Consumables

This section includes non-reusable items specific to the facility. Please itemise and describe the requirements fully (e.g. postage, stationery, photocopying). These items should be research specific, not just general office costs which should be covered by indirect costs.

Patient and public involvement

Please itemise and describe fully the costs associated with patient and public involvement. These are likely to include out of pocket expenses, payment for time and any relevant training and support costs.

INVOLVE have produced a number of useful payment-related resources, including the ‘Budgeting for Involvement’ guide and the INVOLVE cost calculator, which can be found at the following link:

http://www.invo.org.uk/resource-centre/payment-and-recognition-for-public-involvement/

Other direct costs

These are costs, not identified elsewhere, that are specifically attributed to the facility. For example, open access costs, other dissemination costs, costs associated with the use of research facilities, external consultancy costs, computer licensing, recruitment and advertising costs.

Please note that for organisations claiming indirect/overhead costs, costs such as recruitment of staff, and general training (e.g. in common IT packages) are costs that should be covered by the indirect costs element of the award being sought and should not appear in this section.

If external consultancy costs are included in this section they must be fully justified in the ‘Justification of Costs’ section. Please specify the hourly rate and the number of hours and note that consultants must not be people who are already employed by the applicant’s institution. If they are, any costs should be entered as direct costs in the ‘Details of Posts and Salaries’ and ‘Annual Costs of Posts’ sections.

Open access costs

During the course of your project and throughout the review and publishing phase, you may choose to submit an article based on your work to an open access publication. Depending on the publication, you may be subject to an Article Processing Charge (APC). APC rates vary but are usually within the range of £300 and £3000. Open access publications usually list their APC rates on their websites.

Where possible, you should include an estimate for any APC in your funding application, since NIHR expects that APCs will be covered by the funding award. https://www.nihr.ac.uk/documents/nihr-open-access-policy/12251

Other dissemination costs

Any large costs should be further detailed with a breakdown of constituent parts or a timescale profile of the costs. Meetings to share best practice, training events and events to disseminate findings must be run at the lowest possible cost with minimal catering. ‘Conferences’ which are described as such are not eligible for funding.

Indirect costs/overheads

Indirect costs will be charged in proportion to the amount of research staff effort requested on the award.

They comprise:

  • 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 bodies or other providers of NHS services indirect costs

NHS indirect costs cannot be claimed through NIHR/DHSC programme funding. NHS bodies or other providers of NHS services have been allocated NIHR Research Capability Funding (RCF) to contribute to the cost of hosting NIHR/DHSC-supported research. For more information please click on the link below:

https://www.nihr.ac.uk/about-us/our-contribution-to-research/research-capability-funding.htm

HEI indirect costs

Please see the Programme Specific Information above.

Commercial/other partner organisation indirect costs

Commercial/other partner organisations can claim indirect costs which are the costs of resources used by the facility that are shared by other activities. Please seek advice from your finance department about the appropriate cost for this section.

Total Commercial/other partner organisation indirect costs must be fully justified.

NHS support and treatment costs (incl. excess treatment costs/savings)

The finance section includes a section that asks researchers to provide an estimate of the patient care costs associated with the research (if applicable). An explanation of why these costs are being incurred and the basis on which the estimations have been made should be fully detailed under the relevant ‘Justification of Costs’ section.

The committee will take NHS support and treatment costs into account when considering the value for money of the research. It is important that you consider these costs and discuss them with the NHS bodies or providers of NHS services involved in order to avoid any delay in commencing the research.

Please be aware that the research award does NOT include NHS support and/or treatment costs. NHS support costs will be funded via the Comprehensive Research Networks. NHS Excess Treatment costs, can be accessed via the Lead LCRN managing the process on behalf of the local sites.

A representative of the NHS body or provider of NHS services - incurring any NHS support and treatment costs - must sign off the application. The ‘Other supporting roles – signatories (electronic)’ page is intended to ensure that the aforementioned organisation is satisfied that all NHS support and treatment costs in the application are correct and is prepared to meet these costs.

Upload a Schedule of Events Cost Attribution Template (SoECAT) form

It is mandatory to attach a Schedule of Events Cost Attribution Template (SoECAT) form.

Please note that as part of the work to address the issues surrounding the way in which Excess Treatment Costs are funded, new arrangements are now being implemented as part of a pilot. To underpin the new arrangements, a cost attribution tool has been created by the Health Research Authority (HRA) in partnership with charity funders and research sponsors. This tool provides a standardised approach across England, ensuring that the attribution of study activities complies with the Department of Health and Social Care Guidance on Attributing the Costs of Health and Social Care Research and Development (AcoRD). As part of their funding applications, researchers are required to complete this new tool, known as a Schedule of Events Cost Attribution Tool (SoECAT) for clinical research, which has been developed from the current HRA Schedule of Events. This tool is designed to capture the different costs associated with clinical research and attribute them accordingly. The totals for excess treatment costs and NHS support costs are calculated by using the SoECAT. Therefore you are not required to add costs to the online application form under the ‘NHS Support Costs’ or ‘NHS Treatment Costs’ sections. However please still complete the question over whether the costs have been discussed and agreed with the Lead Network’.

Researchers and/ or their study teams and Research Sponsor/ Lead NHS Provider (e.g. R&D office/ Clinical Trial Unit) are supported by AcoRD Specialists in the Local CRN to verify the accuracy of the SoECAT. For more information please see the NIHR CRN Routemap available at

https://www.nihr.ac.uk/explore-nihr/support/study-support-service.htm

Under the new arrangements, sign off via the LCRN AcoRD Specialist is required to confirm the study attribution complies with the Department of Health and Social Care AcoRD guidance. This early attribution support will underpin the excess treatment cost management process by providing formal sign off, supporting the role of the research sponsor and lead R&D office or Clinical Trial Unit. Completion of the Schedule of Events Cost Attribution Template will be required for studies eligible for the NIHR portfolio and the support this provides, which will include access to excess treatment cost payments under the new arrangements. This ETC value, alongside recruitment activity in the NIHR Central Portfolio Management System, will then be utilised to inform the payments to NHS providers.

SoECATs will need to be updated and resubmitted for studies that are dependent on the outcomes of work completed in the first part of the programme

A completed Schedule of Events Cost Attribution Template (SoECAT) is now required to be uploaded and submitted as part of the application submission for all applications. The SoECAT must be signed off by an AcoRD Specialist even where there are no Excess Treatment Costs.

The SoECAT form and more information can be found here

https://www.nihr.ac.uk/researchers/collaborations-services-and-support-for-your-research/run-your-study/excess-treatment-costs.htm

Guidance for completing the Schedule of Events Cost Attribution Template (SoECAT):

https://www.nihr.ac.uk/documents/how-to-complete-a-soecat/23415

https://www.nihr.ac.uk/documents/schedule-of-events-cost-attribution-template-soecat-guidance/23214

NHS support costs

These are the additional patient care costs associated with the research, which would end once the R&D activity in question has stopped, even if the patient care service involved continues to be provided. These might cover items such as extra patient tests, extra in-patient days and extra nursing attention. Researchers should contact their local NHS R&D department initially and, if they are unable to help directly or if there is no local NHS R&D department, contact the Local Comprehensive Research Network (LCRN) senior manager for advice on NHS support costs. Further details about LCRN contacts are available at

https://local.nihr.ac.uk/lcrn/

*Please note: you are not required to add NHS Support Costs on the online form as these are now part of the new SoECAT form. However please still complete the question over whether the costs have been discussed and agreed with the Lead Network’*

NHS treatment costs

Please read the following guidance on the funding of excess treatment costs prior to completing your application https://www.england.nhs.uk/ourwork/research/etc/.

These 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. In determining NHS treatment costs you must assume that the patient care service being assessed will continue even though there may be no plans for it to do so. Where patient care is being provided which differs from the normal, standard, treatment for that condition (either an experimental treatment or a service in a different location from where it would normally be given), 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.

*Please note: you are not required to add NHS Treatment Costs on the online form as these are now part of the new SoECAT form. However please still complete the question over whether the costs have been discussed and agreed with the Lead Network’*

Usual treatment costs

Please note if the patient care intervention under investigation is in addition to usual care there is no need to complete the ‘Usual Treatment Costs’ section however this will need to be justified in the relevant ‘Justification of Costs’ section. If the patient care intervention under investigation either wholly or partially replaces usual care, the ‘Usual Treatment Costs’ section must be completed.

For further information, please see:

Attributing the costs of health and social care research and development (AcoRD)

https://www.gov.uk/government/publications/guidance-on-attributing-the-costs-of-health-and-social-care-research.

Section 12: Management and Governance

Is Clinical Trials Authorisation required?
Yes / No

Does your project require ethics approval?
Yes / No

If yes, has ethics approval already been obtained?
Yes / No

Section 13: Uploads

Please note that all supporting documentation uploaded should be given concise and clear file name descriptions. These should be headed by a numbered ‘Appendix’ and a brief filename description that clearly describes the file (e.g. Appendix_References).

The following file is mandatory to submission for all applicants, please attach:

  • A list of references cited in the application.
  • A Gantt chart
  • SoECAT form

If claiming CTU support, the following files are considered mandatory:

  • CTU letter of support.

The following file(s) are considered non-mandatory to submission; please number your files and attach;

  • Any further supporting documentation (flow diagrams, pictures, logic models, trial protocols etc.)

No more than 5 separate files are permitted. The total file size should not exceed 6Mb. Total file sizes larger than this may not be considered as part of this submission. We strongly recommend that only .doc or .pdf files are uploaded as some file types are not supported by the system (such as .xls and .zip file types which will not render out into the final version of the application form). Should you wish to upload documents of other file types, we encourage you check that they appear in the PDF of the application form prior to submission as changes cannot be made after the deadline has passed.

Section 14: Administrative contact details

Please provide the details of an administrative lead as a secondary point of contact for any queries relating to the application, should it be supported.

NOTE: This person does not need to be a co-applicant.

Section 15: Research and Development office contact details

Please provide the contact details and job title of a person in the R&D office so that we are able to notify them of the outcome of this application including any associated feedback.

NOTE: Please note this person does not need to be included as a co-applicant.

Section 16: Acknowledgement, review and submit

Conflict checks

Please declare any conflicts or potential conflicts of interest that you or your co-applicants may have, including any facts that, should they come to light at a future date, could lead to a perception of bias. Include any relevant personal, non-personal & commercial interest that could be perceived as a conflict of interest. Examples include (this list is not all encompassing) secondary employment, consultancy, financial or commercial gain (pensions, shareholdings, directorships, voting rights), honoraria, etc. In a case of commercial sector involvement with the application or the study, please state clearly the relationship to ownership of data, access to data, and membership of project oversight groups.

Agreement to terms and conditions

As lead applicant, please tick the box to confirm that the information given on this form is correct and that you will be actively engaged in this research and responsible for its overall management. In addition, you will accept responsibility for ensuring that the host institution and interested parties are kept informed.

Ticking this box constitutes an electronic signature of the lead applicant with regard to this application

Section 17: Validation summary

Checklist of information to include when submitting a NIHR stage 2 AIM application

Applicants should click the check boxes to indicate that they have included the necessary information prior to submitting their application.

  • Appropriate and relevant involvement of patients and the public http://www.invo.org.uk/
  • A good quality plain English summary www.invo.org.uk/makeitclear/
  • A clear description of team member roles and contribution
  • A clear scientific abstract
  • A clear description of the changes from first stage
  • A flow diagram illustrating the proposed work (document upload), if appropriate
  • A full and accurate detailed budget breakdown
  • A clear justification of costs / value for money
  • References (document upload)
  • A clear Detailed Research Support Facility Plan
  • A CTU letter of support if required (document upload)
  • The support and agreement from the necessary supporting roles / signatories