Published: 12 July 2022
Version: 1.2 March 2023Print this document
These are the Efficacy and Mechanism (EME) Programme guidance notes, for applicants submitting a Stage 2 application via the REsearch Awards Lifecycle Management System (REALMS).
The ‘Add New Ticket’ button towards the top of the screen can be used to raise a support ticket if you have any questions relating to the call or completion of the online application form
This guidance should be used by applicants who have either:
- been shortlisted at Stage 1 and asked to submit a Stage 2 application, or
- by those applying for a specific call where a single stage, straight to Stage 2 application has been requested as part of the call. Typically for an Evidence Synthesis or Systematic Review topic.
Some fields in the online Stage 2 application form will be automatically populated with content input to the Stage 1 form. This content is editable and should be updated in line with any changes made to the application following feedback from the funding committee at Stage 1.
Please regularly press the 'Save Draft' button, found towards the bottom of the screen to save your progress.
We would like to draw your attention to the 'Info still required' button at the bottom of the application page. We encourage you to click this well before submitting - it will bring up a list of all the sections that still need completing and any errors the system has detected (if any). These can then be corrected in good time before the submission date.
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 firstname.lastname@example.org before submitting your application.
Research title (Limit: 300 characters)
The project title should state clearly and concisely the proposed research. Any abbreviations should be spelled out in full.
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.
Note this will 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 project.
Please be realistic about your possible start date taking account of the necessary contracting, and staff recruitment prior to starting your project.
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.
This field will automatically populate once you have saved the research duration information.
Total research costs
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 EME.
Further information is available with the AcoRD guidance on how to allocate the costs of your proposal to each of the above categories.
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
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.
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, along with other associated ORCiD data (e.g. any publications and grants you have allowed ORCiD to make visible to the public or trusted parties). Grants and Publications drawn from ORCiD in this way will be available for you to use in populating the relevant sections of 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.
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.
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.
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.
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.
This section contans the Scientific abstract and plain English summary.
Scientific abstract (Limit: 3,500 characters)
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
- Aims and objectives
- Timelines for delivery
- Anticipated impact and dissemination
Plain English summary of research (Limit: 3,500 characters)
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.
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
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.
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 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.
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.
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.
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 is 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.
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.
- 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 Programmes, NIHR 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. 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.
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.
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 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.
- General office and basic laboratory consumables
- Premises costs
- Library services/learning resources
- 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 Study Support Service webpages.
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.
Please be aware that if your planned project includes the recruitment of participants, your stage 2 application should be accompanied with the ‘Funder Export’ from the online SoECAT, obtainable via NIHR’s Central Portfolio Management System (CPMS)?
Guidance for the use of the SoECAT is embedded within the tool itself but general guidance around locating the application within CPMS is available?in this video.
The research award does NOT include NHS support and/or treatment Costs. These costs, including costs for Social Care research, are funded via?NIHR Local Clinical Research Networks.
More information on the SoECAT is available on the NIHR website, including:
In order to create a SoECAT, you will need to create an account in CPMS. After creating the account, you will need to access CPMS when logged in in order for this account to be activated. If any assistance is required in creating the account, please refer to our user guide which can be found on NIHR Learn:?https://www.nihr.ac.uk/documents/getting-started-and-logging-in-to-cpms/11462?Once your account has been created and is active, you can proceed.
If you have any queries around registering or logging into your account, please email@example.com
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)
- 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.
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
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 20 A4 pages.
Your detailed research plan should include the following:
- Use Arial font size 11
- Not exceed 20 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 20 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
- 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.
For Efficacy studies or Efficacy studies with Mechanism of Action components, please briefly explain:
- 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.
- 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.
- 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.
For stand-alone Mechanisms of Action studies please also include:
- A short overview of the protocol of the main study that this application relates to. It should include details of the funding arrangements, set out the aims and objectives of the study and provide a full description of the population, intervention, comparator and outcomes. Please provide the ISRCTN or Clinical Trials.gov reference number. You should also include and a link to or upload of the project protocol and any relevant published work.
- The start and end date of the main study, and if it is on-going information about the status of the study including recruitment. Please note that studies not funded by NIHR (or similar schemes from the devolved administrations) can only provide samples or data for this scheme if recruitment in that study has been completed. Please provide a letter of support from the funder and sponsor of the index study if not NIHR, detailing their support and willingness to communicate with NIHR if required. Please refer to the call brief for further information.
- If your project is linked to a host study funded by one of the NETSCC managed programmes you may want to consider whether the protocol for the EME work should be embedded within the protocol of the host study. This would need to be arranged with the approval of the research team of the host study and would need to meet HRA requirements. It would also need to be clear in the combined protocol document that it covers work from two separate NIHR awards. If you think this might be a useful approach, please make a note to that effect in your application.
4. Aims and objectives
Please summarise the aim of the research and research questions / objectives. Please provide:
- The aim(s) – broad and general statement(s) of intent addressing the overall purpose of your proposed research.
- A clear hypothesis being tested both for the clinical study as well as any mechanistic components, including an indication of how the tests / measurements will confirm or refute these hypotheses. All applications must be hypothesis-driven, i.e. funding will not be available for studies where the main aim is hypothesis generation.
- A strong case for how a better understanding of the mechanisms of action of the intervention will potentially contribute to the future use or development of the technology, future wealth creation and for the ultimate benefit of individual patients or the wider NHS.
- 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.
- Mechanistic components to studies are strongly encouraged. These must test a clear hypothesis concerning the mechanism of action of an intervention, 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.
- For clinical trials, include a single sentence describing the study including the primary outcome measure.
- 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:
- Geographical location
- Gender reassignment
- Marriage and civil partnership
- Pregnancy and maternity
- Ethnicity - see the toolkit for increasing participation of ethnic minorities in health and care research, the INCLUDE Ethnicity Framework, which aims to improve trial delivery for under-served groups and the NIHR Race Equality Framework.
- Religion or belief Sex Sexual orientation Socioeconomic status
- Access to health or social care
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: Promoting equality, diversity and inclusion in research.
Proposed sample size: Specify the number of samples/data sets and the expected accrual rates, and how this links to the power of the study to answer the question. A justification for the assumptions underlying the sample size/power 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.
For Mechanisms of Action studies: Please provide full details of the population drawn from the index trial who will provide data/samples for the mechanistic study and describe how adequate numbers of samples or data will be obtained from each group, especially in blinded studies. For stored samples please include evidence of permissions to use the samples, and an indication of the storage life.
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.
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 deliverables: Detail the deliverables from the study.
Value for money: Provide an explanation of how the project offers value for money.
Applicants may apply for up to £30,000 funding to evaluate alternative ways of managing studies and may complete these as part of their main study. Any Methodological Sub -Study (SWAT) proposed should represent a very minor element of a larger study and must not undermine the delivery of the main study.
At Stage 2 Applicants who intend to do a SWAT must provide a brief description of the SWAT, the methodological approach proposed, expected outcomes, justification for the inclusion of the SWAT and the choice of SWAT intervention in the ‘Detailed Research Plan’. Applicants are also encouraged to review the work of Trial Forge and consider the Trial Forge additional guidance for support with how to write about SWATs within a Stage 1 or Stage 2 research proposal.
Before including a SWAT in an application, applicants should firstly check for overlaps on the Northern Ireland Network for Trials Methodology Research website which provides a register of ongoing current SWATs. If the application is funded the applicants must apply for registration of their SWAT on the Northern Ireland MRC Trials Hub for Methodology Research SWAT/SWAR registry.
The findings of the SWAT must be made publicly available as soon as possible after the SWAT is completed (this may be before the end of the main study). This can be in a standalone peer reviewed publication, but a full description of all SWAT undertaken must also be included in the NIHR Journal Library publication.
Given the available sample size will be set by the main study, many SWATs are likely to be underpowered. All SWATs will therefore need to be designed to include potential for meta-analysis and this must be considered within the dissemination strategy.
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.
- 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.
- 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?
- 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. Project / research timetable
Project timetable - Provide a detailed project timetable with key deliverables and milestone indicated that assess specific interim achievements which are crucial to fulfilling the stated research objectives. A Gantt diagram must be included as a visual summary of the overall project.
Applications to this call may include a series of linked stages (usually 2 to 3) with progression to the next stage dependent on the outcome of the previous stage(s). In addition to the main clinical evaluation, typical stages include:
- Feasibility stage(s)
Used to estimate important parameters required to finalise design of the next stage of the study or main clinical evaluation, to further develop an intervention or key component of the treatment pathway or to help select the intervention used later in the study.
- Pilot stage(s)
Used to test processes used for the main clinical evaluation when there is a high risk of failure to deliver. Trial/Study processes are typically piloted in initial sites with clear targets set to be reviewed at a specific point early in recruitment as part of an ad hoc monitoring milestone.
Researchers who wish to submit a staged programme of work must make the progression criteria clear, outline what the stages are and how success would be assessed. These need to be identified as decision points and clearly shown. These should be based on verifiable achievements, both concise and realistic, as they will be used for project monitoring purposes. These time points should appear on the overall project timeline and Gantt.
The precise type and number of decision points will depend on the size and nature of the project. Recruitment targets will be continuously monitored by EME and should not be listed as decision points except in studies with a feasibility or pilot stage.
Following review of your application the programme may identify one or more of the decision points listed as contractual Stop/Go decision points. These are typically between project stages where there could be good reasons, other than failure to deliver, for a programme of work not to continue to the next stage. (i.e. even if the research progressed according to the agreed schedule, there would still be a requirement to review results of the previous stage to determine whether the next stage should be funded).
In such cases a contractual Stop/Go decision point is inserted into the DH contract, payment schedules are aligned with costs agreed for the preceding stage with payments over and above this figure held until approval from the programme is granted.
NIHR EME Monitoring: Your progress will be regularly monitored, comparing your submitted progress reports against your planned deliverables and milestones checked. These progress reports will be based on the project timetable and milestones and will occur at approximately six month intervals. If you are late producing progress reports and a single draft final report of the expected standard for the EME Programme, we reserve the right to withhold payments as per the contract. Applicants should note that the EME Programme monitors the degree to which requested timetables are met, and that having a proven track record in delivering on time may be a consideration when deciding future awards.
If your project requires ethics/regulatory approval, you should allow time for obtaining these approvals and submitting appropriate documents to the EME Programme. Time for the recruitment of staff, the production of the draft report and a draft paper suitable for publication in a peer-reviewed journal should also be included.
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
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.
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. Examples of the activities a PPI lead might undertake.
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. A SoECAT is required by NIHR and NIHR non-commercial partner research funders for studies involving participants under an NHS or Health and Social Care duty of care.
The exception to this is where no participants are being recruited and there is no Excess Treatment Cost or NHS Support Cost support, for example in the case of some stand-alone mechanistic studies. In this case, a SoECAT will not be required. This should be confirmed by an AcoRD Specialist by completing front sheet of the template. Only the front sheet of the SoECAT needs to be completed in these circumstances.
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
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.
A list of terms and conditions can be found here: terms and conditions.
Checklist of information to include when submitting a NIHR Stage 2 research application
As a guide, applicants should ensure they have included the below 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 full and accurate detailed budget breakdown
- A clear justification of costs / value for money
- A clear Detailed Research Plan outlining the study design, methods, dissemination etc.
- A CTU letter of support (if applicable, or a justification for why this is not required).
- A flow diagram illustrating the study design / flow of participants
- References, maximum 3 pages of A4
- A completed and approved SoECAT (if applicable, or the just first page confirming this not required)
- A list of abbreviations
- A technology transfer office (TTO) or equivalent letter of support
- Letters of support from collaborators/partners (where relevant). For stand-alone Mechanisms of Action studies, please provide a letter of support from the funder and sponsor of the index study if not NIHR, detailing their support and willingness to communicate with NIHR if required
- Any Papers In Press (where relevant)