Internet Explorer is no longer supported by Microsoft. To browse the NIHR site please use a modern, secure browser like Google Chrome, Mozilla Firefox, or Microsoft Edge.

EME Application Acceleration Award Stage 2 Guidance Notes

Published

16 May 2022

Version

1.0

Contents

MRC-NIHR funding collaboration

These are the Efficacy and Mechanism (EME) Programme guidance notes, for applicants submitting a straight to Stage 2 application via the REsearch Awards Lifecycle Management System (REALMS).

For Acceleration Award applications, please make best endeavours to complete all sections as appropriately as possible, noting the text in bold within these Guidance Notes which provides targeted advice for this call. Some of the sections will not be applicable to the Acceleration Award but may be useful information regarding what will be required for applications to the subsequent planned call.

Summary Information

Contracting organisation

Please give details of the organisation who will be the contractor if the project is funded. Please note that we expect the CI’s contracting organisation (substantive employer) to act as the contractor. Your primary organisation will be shown by default. If this is not the contracting organisation, search for the correct contracting organisation by typing the name of the organisation in the search box. If the organisation you require does not appear in the search box, you can request to ‘Add New Contracting Organisation’. New organisations need to be approved by the REALMS team prior to submission of your application. Please contact us if this request is being made within two weeks of the call close date.

Please also bear in mind that:

  • Thought must be given to the most appropriate institution to act as the contractor as part of the application process, as changes are unlikely to be agreed once a funding decision has been made.
  • The contractor is expected to respond to annual financial reconciliation exercises, provide the final financial reconciliation statement for the project and to provide ad hoc requests for financial information during the lifetime of the project. In the unlikely event that a request is made for the contractor to differ from the CI’s contracting (host) institution, the suggested contractor must be able to fulfil these expectations and to do so in the usual timeframes.
  • In the same way, the contractor is expected to respond to any queries relating to Intellectual Property, commercialisation and benefit realisation.

If you have any queries, please contact nets-finance@nihr.ac.uk before submitting your application.

Please note the role that can be undertaken by international collaborators within the Accelerator Award, as noted in the Commissioning Brief. The lead institution and CI must be based in the UK.

Research title (Limit: 300 characters)

The project title should state clearly and concisely the proposed research. Any abbreviations should be spelled out in full.

Research type

Select the appropriate research type. If your proposed project includes any element of primary research, please select ‘Primary Research’. If you are carrying out new analysis/synthesis of existing data, select ‘Secondary Research’ or ‘Evidence Synthesis’ as appropriate. If you are not sure which category to select, choose the closest match to your project as this can be adjusted later.

Start month

Note this will be from first 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 project.

Start year

Please be realistic about your possible start date taking account of the necessary contracting, and staff recruitment prior to starting your project.

Please note, in relation to Start Month and Start Year, successful teams will be expected to start their Application Acceleration Awards by 1st September 2022, as detailed in the call commissioning brief.

Research duration (months)

Ensure you include sufficient time to complete all aspects of the research including applications for regulatory approvals (where required) and the final report.

Award duration will be a maximum of 12 months for Acceleration Award applications.

End date

This field will automatically populate once you have saved the research duration information.

Total research costs

The MRC-NIHR EME Programme is typically not able to provide research costs for international recruitment. Applicants will be required to demonstrate that consideration has been given to the funding of any recruitment outside of the UK.

These figures are automatically populated from the detailed budget section.

Total National Health Service (NHS) support costs

These figures are automatically populated from detailed budget section. NHS support costs are the participant care costs which will not continue after the end of the study, and can usually be claimed in connection with NHS and non-NHS research.

Total NHS excess treatment costs

These figures are automatically populated from detailed budget section. NHS excess treatment costs are the additional costs or savings associated with the treatment of the participants during the research. The costs included are the additional costs compared with the current cost of standard care, which would continue to be incurred after the research, should the treatment become standard care in the future.

Information is available on how to assess excess treatment costs.

Total Non-NHS Excess Treatment costs

These figures are automatically populated from detailed budget section. Non-NHS excess treatment costs include costs incurred in delivering the treatment, or intervention, which would continue to be incurred after the trial, should the intervention become standard care. The costs included are the additional costs compared with the cost of current standard care. Please note that NIHR have no provision to cover non-NHS excess treatment costs, and it is the responsibility of the applicant to secure these costs if they are needed. Where applicable a letter from the provider of the treatment costs for the purposes of the study should be supplied.
These are similar to NHS excess treatment costs, but they mainly apply to Public Health and Social Care Research. They are unlikely to be applicable to HS&DR unless the intervention is being delivered outside the NHS (e.g. in school or by a local authority etc.).

Further information is available with the AcoRD guidance on how to allocate the costs of your proposal to each of the above categories.

Previous submission

Has this application, or a similar application previously been submitted to this or any other funding body within the last 3 years?

We are keen to know if the application has been submitted to this or another NIHR programme or elsewhere and you must be as open about this as possible. This includes, but is not limited to, any facts that, should they come to light at a future date, would embarrass either the programme or the individual who withheld the fact (e.g. if a member of the team holds a patent or has a financial interest within the research area).

Failure to disclose accurately or fully will be considered by the programme as academic misconduct and treated accordingly. You should also include in this section information on whether this or a similar application has been submitted to any programme previously, or to any other funder including other NIHR programmes. You should name and provide dates and outcomes of these. Please indicate whether you hold or have ever held an NIHR programme contract, which has been terminated prior to completion, extended in time or in terms of funding.
Select ‘Yes’ or ‘No’ to indicate whether this or a similar application has previously been submitted to this or any other funding body.

If Yes:

Use the ‘Previous Submissions’ button to select any relevant submissions from the list. If a previous submission was made to another funder or is not listed use the ‘+’ button under the Other Previous Submissions section to record the details of that submission.
For more information about resubmission of a research/trainee funding application, or joint funding please contact the appropriate NIHR research funding programme.

NIHR will not accept the same or substantially similar applications to more than one NIHR programme. If two similar applications are submitted, once the overlap is identified, the application that is most advanced through the funding process will continue and the second will not be taken further.

Similar applications will only be considered by two programmes concurrently if:

  • the aims and research proposals are substantially different
  • if successful, NIHR would be prepared to fund both proposals
  • the successful delivery of one project is not dependent on the other

Research team

For Accelerator Award Applications please see refer to the commissioning brief regarding expectations as to the collaborative nature of the research team. Proposed activities within the Accelerator Award application may involve expansion of the research team.

The EME programme is looking to support the preparation required to develop applications for a subsequent call in 2023 for large, ambitious platform studies which efficiently evaluate multiple interventions, with a particular interest in those taking a precision medicine approach.

Lead applicant

Information on your name, main and other affiliated organisations and contact details will be automatically populated from your contact profile. Degrees and professional qualifications can be added to your contact profile. Update your contact profile to complete any missing mandatory information or make any updates here – you can do this via the ‘My Profile’ icon on your home page whilst in the application form by first clicking the ‘Update’ button alongside your details in the Research Team section and then clicking on the ‘Update Contact Profile’ button. Your contact profile will need to be validated prior to your application submission. 

ORCiD ID

Please note: You and your Joint Lead / co-applicants are required to obtain a free unique ORCiD ID number and update your REALMS user contact profile with this before you can submit your application - the requirement for an ORCiD ID is mandatory for all applicants except PPI co-applicants. However, if a PPI co-applicant has an ORCiD account and wishes to add this to their REALMS contact profile they can. By clicking the link ‘Create or connect your ORCiD ID’ within the ‘ORCiD’ section of your user contact profile you will be taken to the ORCiD website where you will need to register or sign in. Once logged in to ORCiD and following acceptance of T&Cs, you will need to click on the ‘Continue to import your ORCID Data’ button which will update your profile with your ORCiD ID number and other associated data (e.g. publications and grants) which can be used to populate your application. 

If additional publications and grants need to be added to an application, and you would like these available to select for other applications, you will need to update your ORCiD account first and then click ‘Re-Import ORCiD Data’ on your REALMS ‘My Profile’.

Equality and diversity reporting system (EDRS)

NIHR is committed to promoting equality, diversity and inclusion in research and asks applicants to provide Equality and Diversity Monitoring Information (age, sex, ethnicity and race, and disability). By answering these Equality and Diversity Monitoring Information questions, you will help us to better understand the different groups of people that apply to us for funding and their experiences of the funding process – particularly the groups protected by UK equality legislation. Although it is mandatory to answer these questions, it is possible to select “prefer not to say” as a response. However, the more information you provide, the more effective our monitoring will be. This information will not be used to make decisions about funding.

Research team

The Research Team section lists any applicants who have been added to this application. NOTE the Joint Lead Applicant, Co-applicants and Administrative contacts are all required to be invited and accept their participation in a Stage 2 application (if not already invited and accepted at stage 1). The ‘Update’ button can be used to access the Applicant Details Form for each applicant and update the details of each user's involvement in this application. Different types of applicants can be added (e.g. Co-applicant / Co-applicant PPI).

Once ORCiD accounts have been linked up, the Lead, Joint Lead and co-applicants need to select which publications and grants are relevant for this application within the Applicant Details Form. This form can be found in the Action Items on each person’s home page once the Lead applicant has added them. 

The Applicant Details Form for all applicants must be in Submitted status in order to submit your application.

Research team – lead applicant ‘update’

Click the ‘Update’ button to the right of your Lead Applicant information to add the information regarding your role on the application.

Role (limit: 200 characters)

Specify Applicant's role in research. Enter the role that you will be undertaking in the research e.g. co-ordination and project management, analysis, methodological input etc.

% Full-time equivalent (FTE) commitment

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

Organisation

Select your primary organisation for the purpose of this application. Your main organisation and any other affiliated organisations that you have already added will be listed by default. Select your primary organisation for the purpose of this application. If the correct organisation is not listed, this can be added by using the ‘Update contact profile’ button towards the top of the page and adding a new organisation (to do this click on ‘Other Organisation’ in the left hand selection bar). Department – Select the primary department affiliated with.

Department (Limit: 100 characters)

Select your department for the purpose of this application

Application research background

Recent relevant publications

Provide details of a maximum of six of your most recent / relevant publications (in the last ten years) relevant to this application.

To add relevant publications, click on the ‘Open’ button and either select the relevant listed publications pulled in from your ORCiD record, and/or add any other new relevant publications. Once complete click ‘Save selected Publications’.

Research grants held

This should include research grants held (as a named applicant) currently or in the last five years – as well as any additional previous grants, relevant to this application. Please include who the grant is with and the amount of each grant.

To add relevant research grants, click on the ‘Open’ button and either select the relevant listed research grant pulled in from your ORCiD record, and/or add any other relevant research grants. Once complete click ‘Save selected Publications’.

For each manually added research grant entry you should state the registration number, name of registry and the DOI of the main related publication. 

Once all information has been entered and saved, click the ‘Complete’ button.

Joint lead applicant

Select ‘Yes’ or ‘No’ to indicate whether this application involves a joint lead applicant, and where appropriate use the envelope icon to add a Joint Lead applicant to your application and complete the necessary information. Once complete click the ‘Invite’ button. Once the joint lead applicant has accepted their invitation they will appear in the 'Research Team' list, and their information can be edited as necessary. The joint lead applicant will need to complete their publications and grants information.

Co-applicants

For Acceleration Award applications, consideration should be given to compiling a team that can commence work quickly and over the 12 month duration. The award may include work to expand the project team going forward. Collaborators on the Acceleration Award application need not necessarily be included in the subsequent proposal expected in 2023. Further investigators not involved in the Acceleration Award application may be added to that proposal.

Use the ‘Add / Edit Co-Applicants’ button to add a co-applicant(s) to your application and complete the necessary information. Once complete click the ‘Invite’ button. Once a co-applicant has accepted their invitation they will appear in the 'Research Team' list, and their information can be edited as necessary. Where appropriate co-applicants will need to complete their publications and grants information.

Do not include collaborators, who should be mentioned (if necessary) in the 'Detailed Research Plan' (upload document).

Co-applicants are those individuals with responsibility for the day to day management and delivery of the project. Co-applicants are considered part of the project team and are expected to share responsibility for its successful delivery. Collaborators normally provide specific expertise on particular aspects of the project but who do not share in the responsibility for the delivery of the project.

Patient and public involvement (PPI) co-applicants

We recognise and value the varied perspectives that members of the public, patients, service users and carers bring to a project as applicants and encourage their inclusion where appropriate. They are not required to provide a full curriculum vitae (CV) (i.e. N/A may be appropriate for 'Publication Record and Research Grants held'). PPI co-applicants should provide a summary of any relevant knowledge, skills and experience that they 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, being a carer - 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

For further information please access the 'Public Co-Applicants in Research' guidance.

Signatories

Please note that signatories are no longer a requirement of a stage 2 application submission. However, if your research proposal is recommended for funding you will be required to add the relevant signatories and shortly after receiving your funding recommendation outcome letter as part of the project start-up and contracting process (approximately 2-3 weeks after the funding assessment committee date).

Applicants must follow their host organisation's application review and sign off procedures before submitting an application. Failure to do this may result in any agreement to fund being withdrawn. 

Administrative contact details

This facility allows you to provide an alternative contact(s) who will also have access to the application but will not be able to submit it when complete. The lead applicant must submit the completed application and will still receive all emails automatically generated through the system.

If you wish to include an administrative contact, use the envelope icon below to enter the administrative contact's details, and invite them to participate in this application.

Application details

Scientific abstract and plain English summary

Scientific abstract (Limit: 3,500 characters)

For Acceleration Award applications, please complete this section to the best of your ability using headings which are appropriate for the activities you are undertaking. The headings listed below may not be appropriate and may be changed or adapted.

The scientific abstract should be a clear and concise scientific summary of the 'Detailed Research Plan / Methods', with a character limit of 3,500 characters (one side of A4 maximum). The following is a list of potential elements / headings that might be included depending on the design of the proposed research, the setting and programme being applied to, and whether it is for primary research or secondary research. It will be for researchers to decide the appropriate elements to be included in the scientific abstract, and could include elements outside this list. Applicants may find the guidance on the EQUATOR Network website useful.

  • Research question
  • Background
  • Aims and objectives
  • Methods
  • Timelines for delivery
  • Anticipated impact and dissemination

Plain English summary of research (Limit: 3,500 characters)

For Acceleration Award applications, please complete this section to the best of your ability using headings which are appropriate for the activities you are undertaking.

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

Many reviewers use this summary to inform their review of your funding application. They include clinicians, other practitioners and researchers 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 NIHR and other websites.

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

  • Those carrying out the review (reviewers and funding committee members) to have a better understanding of your research proposal
  • Inform others about your research such as members of the public, health and social care professionals, policy makers and the media
  • The research funders to publicise the research that they fund.

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:

  • Aim(s) of the research
  • Background to the research
  • Design and methods used
  • Patient and public involvement
  • Dissemination

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 a plain English summary is available on the NIHR website.

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

Changes from first stage (Limit: 6,000 characters)

Please note this section is not applicable for the Acceleration Award call. Please write ‘NA’ in the box.

Please list the feedback received at first stage and under separate headings 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 e.g. in the light of new research.

Please note, if you are submitting a one step, straight to stage 2 proposal please ignore this question as it is not applicable to you. If this is the case, please enter ‘not applicable’ in the box.

Patient and public involvement (PPI)

Please describe how patients/service users, carers and the public have been involved in developing this proposal (Limit: 3,500 characters)

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

Please describe the ways in which patients/service users, carers and the public will be actively involved throughout the proposed research, including any training and support provided (Limit: 3,500 characters)

PPI approach, management and support

  • Explain why your approach to patient and public involvement is appropriate for this proposal. In your description you will need to say who will be involved and why.
  • Please use this opportunity to describe how you plan to manage and coordinate the patient and public involvement activities in your project.
  • Describe how you will support and enable patients/service users, carers, the public and members of relevant communities to contribute to your research (e.g. access, payments, training).
  • We would also encourage you to outline plans for the capturing, evaluating and reporting the impact of patient and public involvement activities.

Patients, carers, service users and the public can be involved in every stage of a research project, from developing a proposal through to dissemination and evaluation. You can find further resources to support the design of your PPI.

PPI lead

The role of the PPI lead can be undertaken by any of the co-applicants within the research team (or a named member of the team), who has the relevant skills, experience and authority to be accountable, represent, manage and embed patient and public involvement in all aspects of the research study/programme. This role should be a budgeted and resourced research team member. View examples of activities a PPI lead might undertake.

A summary of PPI activities

Please provide a summary of the proposed PPI activities embedded throughout the research project lifecycle. Please clearly signpost to other sections of the 'Detailed Research Plan' where the PPI is described further in relation to the relevant project stage e.g. dissemination, intervention design, data collection, analysis.

In rare cases where proposals do not involve patients/service users, carers and the public, clear justification must be provided. (limit 3,500 characters)

Complete / justify as necessary

Management and governance

Is Clinical Trials Authorisation required?

Select Yes / No as appropriate

Does your project require ethics approval?

Select Yes / No as appropriate

If yes, has ethics approval already been obtained?

Select Yes / No as appropriate

Detailed budget

Organisations for budget

Use the ‘Add Organisations’ and ‘+’ button to select and add the organisations who will be responsible for budget items and add them to your application.

Application budget

This section should provide a breakdown of costs associated with undertaking the research as described in the proposal.

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

  • It is in the 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/Panel 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 research 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 and Social Care. 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.
  • When costs have been entered for year 1, it is possible to copy these costs to subsequent years, and they can then be edited if needed.
  • 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).
  • Payments are not able to made in advance of need and, if funded, your payments will be made in accordance with your application budget. Please therefore ensure that your planned costs are included in the budget year in which they are most likely to be incurred.
  • 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, including costs for Social Care research 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 Research and Design Service (R&D) Department, contact the Local Clinical Research Network (LCRN) Senior Manager for advice on NHS Support Costs.
    Further details about LCRN contacts are available.
  • All applications are expected to have appropriate NHS, higher education institutions (HEIs), 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.

Costs for un-named co-applicants

If you need to provide costs for more than one unnamed individual it is important to name them as ‘TBA 1’, ‘TBA 2’ etc. not just ‘TBA’, otherwise their costs will not appear in the PDF version of the form.

Contributions and joint funding

Contributions from other organisations and proposals for joint funding with another organisation can be recorded as such in the ‘Contributions’ tab. If you are considering applying for a joint funding arrangement please get in touch to discuss this.

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.

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 an ‘other 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 research, which will be charged as the amount actually spent and can be supported by an audit record. They should comprise:

I) Posts and salaries

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

Please include all members of staff working on the research by clicking ‘add a new staff member’ salaries’ 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 by selecting ‘Yes’ in the ‘Other NIHR Salary’ drop-down list - please note that the NIHR will not fund more than 100% of an applicant’s time across multiple NIHR projects/awards and this fact will be checked prior to contracting. If you are unsure about this requirement or have any questions please contact the appropriate NIHR research funding programme.

The Apprenticeship Levy can be included in the salary costs where relevant.

The annual costs of each applicant contributing to the research needs to be calculated by specifying the %FTE and number of months. 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 ensure that you check that the ‘Cost Type’ box reflects the organisation which correctly describes the employing organisation for a member of staff (e.g. HEI, NHS, Commercial, Other), as this impacts on the level of funding provided. Staff employed by a Higher Education Institution (HEI) are funded at 80% of cost and staff employed by NHS, commercial or other partner organisation at up to 100% of cost.

II) Travel, subsistence and dissemination costs

This section includes journey costs, subsistence and dissemination costs, including 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 and 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.

Dissemination costs

  • 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 of up to five years, the programme will usually fund up to a maximum of two individuals to attend one international conference attendance, or one individual to attend two international conferences. For research beyond five years, the programme will usually fund up to a maximum of two international conference attendances per five year or part of five-year research period.
  • Open Access Costs - Applicants should no longer include open access costs as part of their stage 2 application Detailed Budget Costs. 

From the 1st of June 2022 all eligible awards contracts issued across NIHR ProgrammesNIHR Personal Awards and NIHR Global Health Research Portfolio will have an Open Access Envelope allocated to them on top of the award value, which is ring-fenced for open access costs of peer reviewed research articles that arise directly from the research funded by the award in question.

Link to Open Access Funding Guidance  

  • 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 research findings must be run at the lowest possible cost with minimal catering. ‘Conferences’ which are described as such are not eligible for funding.

III) 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 £1,000 each to include VAT and any associated software. If the purchasing organisation is unable to reclaim/ recover the VAT on any piece of equipment, then it should be included in the stated cost. A statement of justification must be included, in the relevant ‘Justification of Costs’ section for any purchase above this limit.

IV) Consumables

This section includes non-reusable items specific to the research. 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.

V) Patient and public involvement

Please itemise and describe fully the costs associated with Patient and Public Involvement. These are likely to include individual travel, out of pocket expenses, payment for time and any relevant training and support costs. Costs related to study participants should not be itemised here.

If voluntary, charity or community groups are supporting the research via activities such as facilitating contact with potential participants, contracting research activities or providing advice, an adequate budget must be included to compensate for their time and resources.

For more information on budgeting for involvement, please read the NIHR Payments Guidance for researchers and professionals.

VI) Other direct costs

These are costs, not identified elsewhere, that are specifically attributed to the research. For example, 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. 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 ‘Posts and Salaries’ section.

Indirect costs/overheads

Indirect costs will be charged in proportion to the amount of research staff effort requested on the award. Commercial/Other Partner Organisations should calculate them, using their own cost rates.
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. 

HEI indirect costs

Total HEI indirect costs must be fully justified. HEIs are permitted to claim estate and other indirect costs. These costs are calculated on the basis of TRAC methodology. Proposals from other types of institutions/organisations should leave this section blank.

HEI indirect costs are based on the number of full-time equivalent research staff working on the research and the indirect/estates charges set by an institution. Please note HEI indirect costs cannot be claimed on shared staff costs. Where staff from more than one HEI are working on the research there may be different indirect/estates charges for each one. Please list each institution on a separate line.
The applicant(s) should consult their HEI Finance Departments for the appropriate figures to include in the estate charges and other indirect cost sections

Other partner organisation indirect costs

Other Partner Organisations can claim indirect costs which are the costs of resources used by the research that are shared by other activities. Please seek advice from your finance department about the appropriate cost for this section.

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/panel 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.

Please note that as part of the work to address the issues surrounding the way in which excess treatment costs are funded, new arrangements have now been implemented. 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 calculated by using the SoECAT can be entered directly into the application form.

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.

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 Tool 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.

Please note: Social care studies are eligible for Clinical Research Network (CRN) support, it does not just apply to NHS based research, and researchers should speak to the CRN and include support costs where relevant. For the purposes of social care studies ‘treatment costs’ should be interpreted as ‘intervention costs’ and should be included in the proposal when needed.

If a project is to be registered with the NIHR portfolio, a completed Schedule of Events Cost Attribution Tool (SoECAT) is required to be uploaded and submitted as part of the application submission. Please note most evidence synthesis projects will not be required to submit a SoECAT. 

More information on the Schedule of Events Cost Attribution Tool (SoECAT), guidance and a link to the tool can be found on this page; Excess Treatment Costs.

I) 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 Clinical Research Network Senior Manager for advice on NHS Support Costs. Further details about LCRN contacts is available.

II) Excess treatment costs

Please read the following guidance on the funding of excess treatment costs prior to completing your application

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 excess 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 that if the patient care intervention under investigation incurs either a higher or lower cost compared to usual care, the excess cost needs to be entered as an 'Excess Treatment Cost'. The excess cost (or saving) is the difference between the total cost of treating the participants outside of the trial via usual care and the total cost of treating all participants during the trial. The value to be entered here should be taken from your completed Schedule of Events Costing Attribution Tool (SoECAT) and can be either a cost or a saving. Please enter savings as a negative value. 

For further information, please see:

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

Justification of costs (Limit: 8,000 characters)

For the Acceleration Award application call, it is anticipated that teams may require up to £200,000 over a maximum of 12 months.

  • Please provide a breakdown of research costs associated with undertaking the research and provide justification for the resources requested. This should include the following costs: staff costs, travel and subsistence, dissemination costs, equipment (including lease versus purchase costs), consumables, patient and public involvement (PPI) and any other direct costs. For help with estimating PPI costs please see the NIHR Payments Guidance for researchers and professionals.
  • 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 this research will potentially benefit the NHS and/ or public health. For example, where appropriate, describe the likely cost savings or benefits in terms of numbers of patients treated, treatment times, service users or carers supported etc.
  • You should describe the value for money of the conduct of the proposed research.
  • Please provide a breakdown of the NHS costs associated with undertaking the research and provide justification for the resources required. If there are no NHS Support or Excess Treatment Costs associated with the research, you must explain why you think this is the case.
  • Please provide a breakdown of any non-NHS intervention excess treatment costs and provide justification for the resources required. Non-NHS intervention excess treatment 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 that NIHR have no provision to cover non-NHS intervention excess treatment costs, and it is the responsibility of the applicant to secure these costs if they are needed.

Uploads

Any additional, non-requested, documents will not be considered by the funding committee during its review. However, there may be other requested documents e.g. cover letter, collaborative documents, dictated by the specification of the call.

To upload a document click on the icon next to the relevant upload type. All required uploads must be added for you to be able to submit your application.

Only the following document types can be uploaded: .doc, .docx & .pdf. If you upload a Word document the system will create a PDF version of it and both versions will be displayed below. Any other document types will need to be converted to PDF format before uploading. If you wish to remove or replace any specific documents all versions of that document will need to be deleted

Attachment 1: Detailed Research Plan

For Acceleration Award applications, please complete this section to the best of your ability. Not all sections will be appropriate for this application compilation. However, their consideration may be appropriate regarding how the Acceleration Award proposal would lead to a high quality application to the subsequent planned call.

Use the headings which are appropriate for the activities you are undertaking during the proposed Acceleration Award. Please refer to the Call Scope within the call Commissioning Brief for examples of types of work which may be supported by the award.

It is mandatory to upload and submit a Detailed Research Plan (DRP), which is a full account of the proposed project. The DRP must also include the Gantt chart described below in Section 7 and may contain relevant diagrams and charts within the 6 A4 pages.

Format

For Acceleration Award applications, please note that the Detailed Research Plan should not exceed 6 pages of A4.

Your detailed research plan should:

  • Use Arial font size 11
  • Not exceed 6 A4 pages
  • Have a header containing your allocated project reference number if known
  • Have a footer showing your page numbers
  • Be converted to a .PDF version before uploading it
  • Include a Gantt chart

Each recommended section of the Detailed Research Plan is not specifically word count limited, which provides applicants with the opportunity to use the 6 pages to provide elaboration in specific sections as required. Broadly, the Detailed Research Plan uploaded document for an intervention trial should follow the following format. For studies of diagnostic or prognostic tests, please modify these headings as appropriate.

1. Full title of project


2. Summary of Research (abstract)

The scientific abstract should be a clear and concise scientific summary of the Detailed Research Plan / Methods. Applicants may wish to refer back to/or duplicate Section 6 of this form and have the opportunity to expand the information if needed.

The following is a list of potential headings that might be included depending on the design of the proposed research. It will be for researchers to decide the appropriate elements to be included in this summary and could include elements outside this list.

  • Research question
  • Background
  • Aims and objectives
  • Methods, including justification of study design
  • Timelines for delivery
  • Anticipated impact and dissemination


3. Background and Rationale

Provide a clear explanation of the health problem to be addressed, the impact on patients and / or public as well as health and care services, and how this research would fill a demonstrable evidence gap.

Please briefly explain:

  1. Why is this research needed now?
    i. Describe the unmet health need to be addressed
    ii. Provide the size of the incident or prevalent patient population in the UK
    iii. Provide context of your proposed research in terms of current practice.
    iv. If relevant, describe any time-limited opportunities.
  2. What is the knowledge gap this research will address? This section should include a brief literature review of published evidence as well as a review of ongoing research, outlining what is already known and research that is currently underway.
    i. Explain how you identified and reviewed all the directly relevant literature. You should outline the methods that you have used to do this review and list databases searched and search terms used. All proposals recommended for funding which involve a clinical trial will be double-checked for potential overlaps using WHO trials before the communication of any funding decision. Consequently, a funding recommendation may not be taken forward if a major overlap is identified at this stage. It is therefore important that applicants highlight any potential overlaps prior to consideration by the funding committee.
    ii. Give details of other recent or on-going relevant trials or research, both nationally and internationally, and critique their relevance to this study.
    iii. Explain why your proposed research would lead to an improvement in the care of the patient population.
  3. Describe the evidence that provides proof-of-concept in man for your research. Please ensure you include references on proof of concept in your bibliography. Please see further information regarding proof of concept that is required.

4. Aims and objectives

Please summarise the aim of the research and research questions / objectives.
Please provide:

  1. The aim(s) – broad and general statement(s) of intent addressing the overall purpose of your proposed research.
  2. The hypothesis should be stated for a clinical study. When a mechanistic component is included the hypothesis that is being tested should also be clearly stated.
  3. Research objectives should be listed. They need to provide a focused indication of what you will do to achieve the aim(s). It may be helpful to divide these, where appropriate, into clinical and mechanistic objectives.
  4. Mechanistic components to studies are strongly encouraged. These must test a clear hypothesis and contain an indication of how the tests / measurements will confirm or refute this hypothesis. Please see examples of EME funded studies with mechanistic components.
  5. For clinical trials, include a single sentence describing the study including the primary outcome measure.
  6. The deliverables from the project.


5. Research Plan / Methods

Research design: Reference should be made to established research techniques. Any adaptations of these for the proposed research should be fully explained and justified. If you are proposing a randomised trial, describe explicitly how participants will be allocated to trial groups, and describe any other methods to protect against bias. State if any pilot study has been carried out using this design and if so, findings must be provided. Also describe any "stopping rules" for parts of, or the entire study.

Study population: Please provide a detailed list of the planned inclusion / exclusion and withdrawal criteria.

Summary of patients/service users/carers/public as research participants: The successful recruitment and retention of study participants is strategically important for the NIHR. If your proposed study involves patients/service users/carers/public as research participants, please use the following bullet points to summarise their characteristics and what would be expected of them throughout the research project lifecycle. The potential burden on study participants can then be understood as well as whether or not the proposed strategies are practical, inclusive and feasible. Please also signpost to where further information on these points can be found in the detailed research plan and application.

Points to cover:

  • Inclusion and exclusion criteria to help ensure that certain groups were not being excluded without justification
  • Recruitment method and consent process to ensure it is practical and fair
  • Type and content of participant information materials
  • Overview of research methods to capture data from participants and their frequency e.g. questionnaires/tests/intervention/focus groups/ interviews
  • Study participant support to consider how drop-out and issues of participation would be handled/helplines/ other access arrangements required
  • Methods for sharing study progress and findings with study participants
  • Payments, rewards and recognition for study participants.

Guidance for applicants on Equality, Diversity and Inclusion for study participants: 

Every person eligible to take part in research should be offered the same opportunity of taking part in that research regardless of:


All NIHR applications are expected to include information about how this data will be collected. In addition applicants should demonstrate how these factors have been considered and addressed in their proposal, including steps taken to ensure the research sample is representative of the population the study is targeted at. Applicants need to explain who they are planning to recruit to ensure inclusivity of study participants and justify and explain any exclusions, for example by completing an Equality Impact Assessment. Costs associated with inclusivity, which may include, but are not limited to justified translation of research participant material into other relevant languages, would be expected and where appropriate should be included in the detailed budget section under ‘Other Direct Costs’. Additionally, applicants should demonstrate that all potential recruiting locations have been considered and the research is deliverable to those areas.

Please see the NIHR INCLUDE Guidance for more information about how to include under- served groups effectively: NIHR INCLUDE Guidance (General) and NIHR INCLUDE Guidance (COVID-19 specific)

The NIHR supports the Researcher Development Concordat which recognises the critical role of research and innovation in delivering the UK’s ambitious economic and industrial strategies, and aims to set the gold standard in researcher development and use it as a competitive advantage. NIHR research applicants should understand the concordat and consider this when completing their application.

Helpful links: Diversity and Inclusion and Promoting equality, diversity and inclusion in research.

Planned interventions: Include both experimental and control interventions. If there are likely to be any problems with compliance or follow up please provide an estimation of the likely loss of analysable data. Clearly justify why this drug / intervention has been chosen over alternatives, and provide a referenced justification for the dosing regimen / treatment schedule.

Proposed outcome measures: Detail both the primary and secondary outcome measures. Again it can be helpful to divide into clinical and mechanistic component where relevant. Validated surrogate markers are acceptable only if evidence in support of the surrogate-to-final end point outcome relationship can be provided.

Assessment and follow up: Please provide details of how/when outcomes/safety will be measured and assessed including:

Assessment of efficacy: Describe the methods and timing for assessing, recording, and analysing of efficacy outcomes.

Proposed sample size: Justifications for the assumptions underlying the sample size calculations must be provided. These should be in sufficient detail to allow replication by the reviewers. Where mechanistic components are included, rigorous power calculations are also expected.

Recruitment Strategy: Specify the number of patients and centres and recruitment rates indicating the total patient numbers available from which the trial patient population may be drawn. Detail of the contemporary incidence or prevalence rates for the condition (whichever is relevant) should be given as well as how you have identified these rates, and descriptions of any other trials recruiting the same group of patients. A full clear justification is required for any patient recruitment planned outside of the UK. Explain how you will recruit and the critical factors that will lead to the optimisation of recruitment.

Statistical analysis: Clearly state the purpose of any statistical analysis, and do not simply name a statistical test or software package. The proposed type and frequency of analyses must be stated including the selection of participants to be included in the analyses. Describe any planned interim and sub-group analyses.

Value for money: Provide an explanation of how the project offers value for money.

6. Dissemination, Outputs and anticipated Impact

The purpose of this section is for the applicant to describe the planned outputs of the research, how these will be communicated and to whom, and how the research may lead to short- and longer-term impacts. NIHR understands that the impact of any research may take time to be realised and will likely involve other funders, institutions and sustained efforts in practice. NIHR also recognises it may be difficult to provide definitive answers or guarantees on longer term impacts. However, applicants are invited below to consider various aspects of pathways below and how the likelihood of impact can be maximised. This includes considering what outputs are produced, how these can be best connected to the health and/or social care environment, what efforts and investment are likely to be needed beyond the project, what barriers are likely to be encountered and what impacts the research is seeking to achieve.

  1. What do you intend to produce from your research?
    Please provide brief details of each anticipated output. NB the term ‘outputs’ refers to any tangible product of the research, not just academic publications. Outputs can include but are not limited to: 
    • Conference presentation or other workshop events
    • Publications (academic or otherwise)
    • Guidelines (clinical, service or otherwise)
    • Other copyright (e.g. questionnaires, training aids, toolkits, manuals, software, etc.)
    • New or improved design of medical devices or instrumentation
    • New or improved diagnostic
    • Trial data that could be used to support a CE mark, market authorisation or equivalent
    • Trial data that could be used to shape or influence a healthcare market or government
    • Potential new drug or health or social care intervention.
  2. How will you inform and engage patients/ service user, carers, NHS, social care organisations and the wider population about your work? Describe who you need to communicate with within this research, and your plans for engaging relevant audiences. For impact, it is unlikely that simply making outputs available will be sufficient. Please consider, and outline the active approach you will take to engaging key parties, or identify the process you will use to identify them and formulate an engagement plan. Link to NIHR Dissemination guidance: How to disseminate your research: Getting your message heard - and used.
  3. How will your outputs enter our health and care system or society as a whole? Describe the process by which the research will enter the health and/or social care environment, including how your outputs will be acknowledged, selected and introduced for use in the health and care service or wider society. Where possible consider how the work will be able to be adopted and implemented longer term. Please describe the proposed route to market (commercial or non-commercial) for your outputs. Describe who is needed to take it forward and the relationship you currently (or propose to) have with these parties. If your outputs are likely to be commercially exploitable, please include details on how you plan to develop this.
  4. What further funding or support will be required if this research is successful (e.g. from NIHR, other Government departments, charity or industry)? Consider what investment or support may be needed at the end of this project to maximise impact. Not all projects will require this but if so, plans should be linked to the responses in points 2 and 3 above.
  5. What are the possible barriers for further research, development, adoption and implementation?Describe the difficulties which may be faced in generating impact from your research. These may be difficulties you will face yourself, or challenges faced by those in the implementing context (e.g. clinicians).
    • Will the proposed research use data, technology, materials or other inventions that are subject to any form of intellectual property protection (e.g. copyright, design rights, patents) or rights owned by another organisation(s)? If yes, provide brief details including how such third party IP will be accessed (e.g. collaboration agreement, drug supply agreement).
    • What are the key current and future barriers to uptake of any likely output or innovation directly in the health and care service, through commercial exploitation or other means, e.g. potential regulatory hurdles?
    • What are the challenges for getting your research implemented in terms of acceptability, accessibility and feasibility? How will you address these?
  6. What do you think the impact of your research will be and for whom? Describe the impacts you aim to achieve as a direct result of the project and those which are anticipated longer term. Please 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. Impacts may include, but are not restricted to:
    • patient/service user/carer benefit
    • healthcare/social care staff benefits
    • changes in NHS or care services (including efficiency savings)
    • commercial return (which could contribute to economic growth)
    • public wellbeing.
  7. How will you share with study participants the progress and findings of your research? What strategies will you use to keep your research participants informed of the progress of your project and the findings? Consider the ethical implications of informing study participants and also what the most accessible methods could be, such as newsletters, leaflets, webpages, social media and where relevant different languages and formats. The Health Research Authority provide guidance on the information participants of trials should receive at the end of the study.

7. Project / research timetable

Please give careful consideration to timelines for Acceleration Award applications. These are standalone projects for a maximum of 12 months.

Please provide a concise summary here of the project plan of investigation, preferably in the form of a monthly project timetable showing the scheduling of all key stages in the project, their expected durations, and the timing of key milestones throughout the project including the production of outputs.

Please note the Acceleration Award process timeline requirements, noting anticipated start date and timings of key activities and deliverables during the Acceleration Award period, as provided in the Commissioning Brief.

Please ensure your timings (e.g. time allowed for securing ethics/governance approval, for undertaking data collection and analysis, and for reporting and writing up, as required) are realistic.

Please note, Acceleration Awards will be expected to produce a short report commensurate with the amount and duration of the award. This should include learning generalisable to the planning, setup and conduct of platform studies.

This timetable will be an important aspect of the monitoring framework during the life of the project.

If your application is successful, you will be required to adhere to the EME Monitoring process as governed by the funding award.

8. Project management

Please demonstrate how you have addressed any “deliverability” issues for your project, including:

  • Ensuring sample size is realistic and achievable
  • Appropriate recruitment strategy
  • Consideration of subject attrition
  • Ensuring sufficient resource, expertise and facilities at each site
  • Potentially competing studies for recruitment

Please note that it is important that you are aware of your institution’s procurement policies so that if successful, your research can begin within your projected timeframe.

9. Ethics / Regulatory Approvals

Depending on the activities proposed, Acceleration Award applications may still be required to have approvals in place and consideration should be given to this when establishing timelines.

Outline any ethical and/or other regulatory issues, and arrangements for handling them. Consider when the project requires approval by an ethics committee and/or any other regulatory body. If there is development work that is essential before you intend to apply for ethics and/or other regulatory approvals, state this and make the timescales clear in your plan of investigation and project timetable. The Funding Committee will consider this in detail and consider whether to offer staged funding.

Guidance on the application process for ethical and other approvals can be found on the HRA website. Please note that if your study is led from England and involves the NHS in England you should apply for HRA approval.

If you are using patient information from an existing database, you should check whether the patients have given their consent for their data to be included in that database for research purposes, or if not whether the database is exempt under Section 251 of the NHS Act 2006. Where exemptions are not already in place, approval to use confidential patient information without consent must be requested from the HRA who make decisions with advice from the Confidentiality Advisory Group (CAG).

The programme is interested in taking advantage of the growing utility of routine data (such as HES, GP records etc), and would like investigators, where appropriate, to ask study participants to consent to long term follow up (e.g. beyond the outcomes to be collected in the funded trial) using routinely collected data, and appropriate linkage to allow this data to be best used.

Researchers may find the SPIRIT 2013 statement a useful resource when preparing their protocol for ethics and other approvals.

10. Project / research expertise

Outline the particular contribution each member of the team will make towards the project and the particular contribution that collaborators are intending to make. In addition, give details of supervision arrangements for junior staff involved, and details of arrangements to retain critical staff or co-applicants who do not have a contract of employment that spans the project period. The EME Programme recommends teams proposing randomised controlled trials to include input from an accredited clinical trials unit, or organisations with equivalent experience.

If commercial partners are involved in the study, a detailed description of the contributions and expectations from all parties must be included.

PPI Lead

There should be a named person with appropriate skills and experience who is responsible for leading the PPI element within the project. This role should be an adequately costed and resourced research team member who is able to manage the PPI plans and related activities. See examples of the activities a PPI lead might undertake in this document.

11. Success criteria and barriers to proposed work

Please set out the measurements of success you intend to use, the risks to the proposed research and how you intend to mitigate against them.

Please explain any barriers to completion of the study that are not covered elsewhere in this form, and your plans to overcome/avoid them. Describe the deliverables that would indicate a successful project completion.

Attachment 2: CTU support letter (if required / appropriate to the study) Not a mandatory upload

If appropriate to the study, please supply and upload a Clinical Trials Unit (CTU) letter of support. 

Attachment 3: Flow Diagram

In order to submit a Stage 2 application to the programme you must upload a diagram (single-side of A4), as a separate .PDF file, for submission with your application form. This diagram may be projected at the funding committee meeting to provide funding committee members with a visual summary of the study proposed.

The diagram should illustrate the study design and the flow of participants (if appropriate). If the project consists of more than one work package, consider a diagram that conveys the sequence and timing of research packages as well as how the work packages are linked.

Please ensure diagrams are large and clear enough for them to be projected as a slide at the funding committee meeting.

If proposing an RCT, we advise you refer to the CONSORT statement and website for guidance. If the commissioning brief requests a pilot or feasibility trial please refer to the consort extension for pilot and feasibility trials. Alternatively, you may also find the EQUATOR Network website useful.

Attachment 4: References (maximum 3 pages of A4)

List all references cited in the full project description, using either the Vancouver or Harvard referencing conventions, and include the DOI of the main related publication.

Attachment 5: Schedule of Events Cost Attribution Tool (SoECAT)

A completed Schedule of Events Cost Attribution Tool (SoECAT) is now required to be uploaded and submitted for projects that are to be registered with the NIHR portfolio.

Attachment 6: Additional EME attachments

  • List of Abbreviations: required
  • Supporting Letter (Tech Transfer Office): required
    This is requested to confirm that the TTO or equivalent has reviewed the application and has had input into areas regarding Intellectual Property. It is also requested to confirm their on-going intention to support the proposed research if funded.
  • If your study involves a collaborator, they must supply a letter of support. You may also submit supporting letters from others if relevant.
  • You may include relevant in-press publications. Please provide details of when these were
    submitted and to which journal.

Acknowledgements and conflicts

Potential conflicts

Please declare any conflicts or potential conflicts of interest that you or your co-applicants may have in undertaking this research, including any relevant, non-personal & commercial interest that could be perceived as a conflict of interest. If in doubt, you should err on the side of disclosure.

Agreement to terms and conditions

I have read and understood the terms on which I have been nominated as lead applicant for this proposal along with the associated documentation and accept this role.

See a list of our MIS terms and conditions here.

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

As a guide, applicants should ensure they have included the necessary information prior to submitting their application.

  • Appropriate and relevant involvement of patients/service user, carers and the public
  • A good quality Plain English Summary
  • A clear description of team member roles and contribution
  • A clear scientific abstract
  • A clear description of the changes from first stage (if applicable)
  • A flow diagram illustrating the study design / flow of participants (document upload)
  • A full and accurate detailed budget breakdown
  • A clear justification of costs / value for money
  • References (maximum 3 pages of A4 - document upload)
  • A clear Detailed Research Plan outlining the study design, methods, dissemination etc. (document upload)
  • A CTU letter of support if required (document upload)
  • The support and agreement from the necessary supporting roles / signatories
  • A completed and approved SoECAT (document upload – where relevant)