EME Programme supporting information (REALMS)

About this supporting information

This document contains information to assist applicants submitting a Stage 1 or Stage 2 application form to the Efficacy and Mechanism Evaluation (EME) Programme. Applications for funding are made online through the Research Awards Lifecycle Management System (REALMS). You must register or log-in to REALMS to complete and submit your application.
 
Please also ensure that you have read the stage 1 or stage 2 application form guidance notes fully and referred to the EME Programme website before contacting us with any queries. We have endeavoured to cover all necessary information relating to the application form through these resources. Incorrectly completed applications may be rejected.

The EME Programme

The following additional supporting information is available:

• EME Programme page This outlines the programme 'scope' and 'what we fund' and should be considered carefully before any application. 
• Current funding opportunities 
• Proof of concept for applications to the EME Programme
• Mechanistic components
• EME stage 1 guidance notes
• General criteria used by advisory committees when assessing applications 

For support developing applications, applicants are encouraged to contact their local NIHR Research Support Service (RSS) or equivalent in the first instance. Or contact the EME secretariat at eme@nihr.ac.uk.

Application timeline

The EME Committee typically meets in February/March, June/July and October/November. The timelines are detailed below: 

February/March Funding Committee

Stage 1 applications submitted and deemed in remit and competitive will be reviewed at the EME Funding Committee meeting in February/March. If shortlisted, applicants will be invited to submit a Stage 2 application for consideration at the EME Funding Committee meeting in June/July. We anticipate informing applicants of the outcome within a month of the meeting and that contracts will be signed within approximately 9 months after the date of the outcome letter, although this is dependent on the complexity of the project and changes required.

June/July Funding Committee

Stage 1 applications submitted and deemed in remit and competitive will be reviewed at the EME Funding Committee meeting in June/July. If shortlisted, applicants will be invited to submit a Stage 2 application for consideration at the EME Funding Committee meeting in October/November. We anticipate informing applicants of the outcome within a month of the meeting and that contracts will be signed within approximately 9 months after the date of the outcome letter,  although this is dependent on the complexity of the project and changes required.   

October/November Funding Committee

Stage 1 applications submitted and deemed in remit and competitive will be reviewed at the EME Funding Committee meeting in October/November. If shortlisted, applicants will be invited to submit a Stage 2 application for consideration at the EME Funding Committee meeting in February/March of the next year. We anticipate informing applicants of the outcome within a month of the meeting and that contracts will be signed within approximately nine months after the date of the outcome letter,  although this is dependent on the complexity of the project and changes required. 

Eligibility

Researchers in England, Northern Ireland, Scotland and Wales are eligible to apply for funding under this programme. Within the United Kingdom anyone who considers that they can carry out high-quality research is likely to be eligible. If you have any concerns regarding your eligibility to apply we advise that you contact us before completing an application. NIHR programmes welcome applications that are within the programmes' remits from all sectors. Applicants are strongly advised to consider establishing partnerships with other relevant sectors or organisations to demonstrate they have the full breadth of expertise to carry out their proposed research in their applications to NIHR programmes. Applicants should always check individual call specification documents for any additional eligibility requirements. We recommend that lead applicants from Industry contact the EME office prior to submitting an application. If you are planning co-funding with a charity partner, please discuss your plans with the EME office.

Studies funded by the EME Programme are generally UK-based. We will consider funding an international study where the chief investigator and lead institution are based in the UK and the study is relevant to and a priority for the UK population, and where overseas recruitment is funded from other sources. It will be exceptional for NIHR programmes to fund recruitment overseas. The EME Programme is open to bids to support a UK recruitment arm of an international study where the study is relevant to and a priority for the UK population; a UK based principal investigator should be the lead applicant. Each project will be considered on a case by case basis and applicants interested in submitting a proposal for an international study should contact us for advice.

Collaboration and team expertise

Proposals should involve a multi-disciplinary team with appropriate skills and experience, including an appropriately experienced statistician on the study team. The involvement of an accredited Clinical Trials Unit (CTU) is strongly encouraged in the design of clinical trials. Where appropriate, applicants are expected to work with suitably accredited clinical research facilities. All applications should include significant contributions from at least two of the following partners; industry, academia, and the NHS. The EME Programme is particularly keen to encourage collaboration with small and medium enterprises. The involvement of charities is also welcome, and if your research will be co-funded by a charity, you must notify the EME Programme.

The EME Programme welcomes applications proposing joint funding arrangements. You must clearly demonstrate how the arrangement would work in practice and be explicit about where responsibility lies contractually in terms of publication, and research governance issues for example. We expect that any other organisations contributing funding would provide an ‘open grant' and not require any terms, conditions or limitations on the research. The Programme would require assurance that the funding contribution would be guaranteed for the duration of the research, and a letter of intent should be included with the application.

If your application is successful, you should note that the EME Programme will require sight of the agreement between you and any other funding partners before any contract is issued. Where your research proposal involves industry collaboration, you should ensure that the arrangements and details are determined early in the study development. The EME Programme will require assurance that any industry collaboration allows transparency in the project design and in the analysis and publication of results (including if these are negative).

If the collaboration involves the supply of reagents, drugs or other technologies, we will require written assurances that the industry collaborator will provide these products for the duration of the study

Timescales and funding

There are no fixed limits on the duration of projects and proposals should be tailored to fully address the questions posed. Applicants should be aware that they are competing for limited funds and proposals should represent good value for money. All funding requested should be clearly justified, but there is no upper limit.

Project management and monitoring of studies

Where appropriate, projects funded through this call may be organised into distinct stages (usually up to three). At the end of each stage there should be clearly delineated go/no-go decision points with measurable criteria which will allow an assessment of whether the stage has completed successfully. The purpose of this delineation is to clearly identify critical points that determine whether the research should proceed to the next stage. It is anticipated that there will be a significant number of projects that will fail to meet criteria in the early stages. The EME Programme retains the right to reassess project progress in light of other new developments in the research area before subsequent stages of funding are released.

For all projects it is expected that there will be a number of milestones which will allow the project team and EME Programme to track progress through routine project reporting. Applicants will need to demonstrate a clear management plan for all stages of the project as well as detailed plans for how they will actively manage individual stages.

Research networks

The EME Programme expects that applicants will work, where appropriate, with the relevant NIHR Clinical Research Network.

Governance and regulation

Applicants should follow the Medical Research Council’s Good Clinical Practice guidelines in planning how studies, particularly RCTs, will be supervised. Note that trials involving medicinal products must comply with ‘The Medicines for Human Use (Clinical Trials) Regulations 2004’. In the case of such trials, the NIHR expects the employing institution of the chief investigator to be nominated as the sponsor. Other institutions may wish to take on this responsibility or agree co-sponsorship with the employing institution. The NIHR is prepared to accept the nomination of multiple sponsors.

Applicants who are asked to submit a Stage 2 application will need to obtain confirmation of a sponsor(s) to complete their application. The NIHR reserves the right to withdraw from funding the project if they are not satisfied with the arrangements put in place to conduct the trial.

The Medicines and Healthcare products Regulatory Agency (MHRA) can provide guidance as to whether your trial would be covered by the regulations. The Department of Health/MRC website also contains the latest information about Clinical Trials regulations and a helpful FAQ page. 

Other programme proposal resubmission policy/submissions to more than one NIHR Programme 

NIHR does not prohibit the submission of research project applications that were previously unsuccessful but applicants will be encouraged not to re-apply until they have re-worked their application and responded to the feedback provided. If they do re-apply their application will be treated as a new application and considered on its merits at the time

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

Data protection

We have an obligation to keep data secure and to use it appropriately. To fulfil our obligations under law and as a result of our contract with the Department of Health, we adopt various procedures to use and protect data. This will impact on how we deal with you and your joint applicants.

The Department of Health and Social Care, (NIHR) is the Data Controller under the Data Protection Act 1998 ('the Act'). Under the Data Protection Act, we have a legal duty to protect any information we collect from you. You should be aware that information given to us might be shared with other DHSC NIHR bodies for the purposes of statistical analysis and other DHSC NIHR research management purposes. NIHR also reserves the right to share, in confidence, details of your application with other approved research funding organisations outside NIHR in order to coordinate research activity in the UK.

Information collected from you will not be passed to any third party outside the NIHR except specifically as detailed above without your consent except where we are under a statutory obligation or entitled to do so by law. Applicants may be assured that DHSC NIHR is committed to protecting privacy and to processing all personal information in a manner that meets the requirements of the Act.

Data security - data about you

Personal information will be held on a database in the NIHR password-protected network that is available only to NIHR staff.  Your details and those of your joint applicants will be retained by NIHR on behalf of the Department of Health to facilitate the running of the EME programme. If your application is successful at any stage of our process your name, and the details of the sponsoring organisation, will appear on the EME page on our website. In addition, once funding has been agreed and the contract signed, your details will appear in other literature as a grant holder and will be passed to the Department of Health and Social Care (DHSC) for inclusion in their publicly available databases of research projects. Your name and those of your joint applicants will be added to our mailing list. This means that you will be sent updates on all the programmes.  We may also send you separate literature about the EME Programme and related events in medical/health research.  If you have any questions, or if you would prefer not to receive routine and/or general communications, please contact us at: eme@nihr.ac.uk.    

Useful resources

Research Support Service

Applicants are recommended to seek advice from suitable methodological support services, at an appropriate stage in the development of their research idea and application.  It is advisable to make contact at an early a stage as possible to allow sufficient time for discussion and a considered response.

The NIHR Research Support Service can advise on appropriate NIHR programme choice, and developing and designing high quality research grant application.

Clinical Trials

The UKCRC CTU Network provides a searchable information resources on all registered units in the UK, and lists key interest areas and contact information.

Researchers designing or undertaking clinical trials are encouraged to consult the Clinical Trials Toolkit. This NIHR resource is an innovative website designed to help researchers navigate through the complex landscape of setting up and managing clinical trials in line with regulatory requirements. Although primarily aimed at those involved in publicly funded Clinical Trials of Investigational Medicinal Products (CTIMPs), the Toolkit will also benefit researchers and R&D staff working on trials in other areas, who will find useful information and guidance of relevance to the wider trials environment.

NHS Medicines Repurposing Programme

NIHR supports the national multi-agency Medicines Repurposing Programme. This initiative identifies and progresses opportunities to use existing medicines in new ways, outside the current marketing authorisation. Researchers planning a study of a medicine used outside its licensed indication, dose, or formulation are encouraged to contact the Medicines Repurposing Programme for support and advice before submitting their NIHR application. 

Public involvement

The NIHR expects the active involvement of patients and the public in the research it supports, including research undertaken as part of an individual training award. NIHR recognise that the nature and extent of active patient and public involvement is likely to vary depending on the context of each study or award. The term involvement refers to an active partnership between patients, members of the public and researchers in the research process. This can include, for example, involvement in the choice of research topics, assisting in the design, advising on the research project or in carrying out the research.

In this section, it is important that you describe in as much detail as possible how patients and the public have been involved in the development of the application as well as plans for involvement in the proposed research. Please note that this section does not refer to the recruitment of patients or members of the public as participants in the research. Information and resources to assist you can be found on the NIHR website, including: Briefing notes for researchers on how to involve patients/service users and the public, including the definition of involvement, engagement and participation; and payments guidance for researchers and professionals with information on budgeting for involvement. 

The NIHR Research Support Service provide advice on developing research applications including involving patients and the public and the James Lind Alliance has a step-by-step guide on involvement in research identification and priority setting.

Advice on non-standard methodologies

The Methodology Advisory Service for Trials (MAST), offered by the Network of Hubs for Trials Methodology Research, is a resource for resolving non-standard methodological issues. Referrals to MAST, should ideally be made through Clinical Trials Units (CTUs).

UK Biobank

UK Biobank is a major national health resource, and a registered charity in its own right, with the aim of improving the prevention, diagnosis and treatment of a wide range of serious and life-threatening illnesses – including cancer, heart diseases, stroke, diabetes, arthritis, osteoporosis, eye disorders, depression and forms of dementia. UK Biobank recruited 500,000 people aged between 40-69 years in 2006-2010 from across the country to take part in this project. They have undergone measures, provided blood, urine and saliva samples for future analysis as well as detailed information about themselves. The health of members of this large cohort will be followed over the coming years and the participants have consented to be approached about health research. 

Applicants are encouraged to consider whether Biobank may be able to provide suitable data for their study. We do not want to discourage establishment of new collections of participants and their data where this is necessary to address the research questions under consideration, our aim is to avoid applications for funding to set up Biobank-like cohorts where the use of Biobank would prevent wasteful duplication of Biobank-like activities. 

Information for estimating costs

In order to accurately attribute the costs between research and NHS support and treatment costs, please refer to the following guidance on ‘Attributing the costs of health & social care Research & Development (AcoRD)’.

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. 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.

In addition, for the EME Programme you should only need to include costs in the Research costs and NHS Support and Treatment costs boxes. The application form is used across NIHR and therefore the Non-NHS Intervention costs box is for use by, for example, the Public Health Research Programme which may need to include local government costs. 

NIHR carbon reduction guidelines and sustainability

The NIHR is committed to playing a role in helping to meet the UK Net Zero carbon targets. The NIHR would therefore encourage all applications to consider, where feasible, addressing issues of environmental sustainability including their impact and appropriate outcomes within the remit of the applying programme. Advice can be obtained from the NIHR Carbon Reduction Guidelines.  

Transparency agenda

In line with the government’s transparency agenda, any contract resulting from this tender may be published in its entirety to the general public. Further information on the transparency agenda is at:

• Government efficiency, transparency and accountability
• Contracts Finder

To access the application form for Stage 1 applications only

Select the call to which you wish to apply for on the funding opportunity page on the NIHR website. From within the call details page press the ‘Click here to apply’ button to access the Stage 1 application form. This also provides call specific supplementary information e.g. the commissioning brief or specification document. This will direct you to the REALMS login page. If you already have a username (email address) and password, enter these details or, if you have not yet registered, complete the short registration process. You will then be directed to the confirmation page for the specific call. If this is the correct call, click on the ‘Apply Now’ button and this will start the application process.

Applying for a funding opportunity creates a task called ‘Pending Application’. This task will be available for you to complete until 1pm on the closing date as indicated on the research call and on your task list.

The ‘Pending Application’ task can be accessed at any time until you either submit the application (using the Submit button in the application) or the call closes.
Clicking on the relevant Pending Application link takes you to the online application where you can complete your application information.
Additional guidance will be available on most screens as you progress through your application.

The REALMS can always be access directly, where all your applications and other tasks will be listed.

To submit a Stage 1 application

In order to submit a Stage 1 application to the programme you must:

• Complete all mandatory fields as indicated with a red asterisk *. When you click the ‘Info Still Required’ button at the bottom of the online application page a list of outstanding information (hyperlinked to relevant section/question) will be displayed at the top of the application screen.

Please note: you must not attach any additional information as it will not be included in your application to the EME Committee. 

Giving others access to the form

Co-applicants

Access to your application is through your user login to REALMS. This should not be shared. The Stage 1 application does not require a co-applicants to complete this form however as lead applicant you must ensure they are aware of being involved in the study team.  If you want to share your form with your co-applicants, please create a PDF of the form and send it to them.  Options to create a PDF are available on the Home page and the Review and Submit page. Where appropriate to the study a Joint Lead Applicant can be added to the application (stage 1 and stage 2) and full access can be provided.

To access the electronic online Stage 2 application form for applicants shortlisted from a Stage 1 form

The ‘Pending Application’ task can be accessed at any time until you either submit the application (using the Submit button) or the call closes.

Clicking on the Pending Application link takes you to the application’s main page where you can complete your application information (clicking on this link will not submit an incomplete application).

Additional guidance will be available on most screens as you progress through your application.

To submit a Stage 2 application

In order to submit a Stage 2 application to the programme you must:

• Complete all mandatory fields. When you click the ‘Info Still Required’ button at the bottom of the application a list of outstanding information (hyperlinked to relevant section/question) will be displayed at the top of the application screen.Please note any additional information uploaded with your application may be removed prior to your application being considered by the Committee.

Please note any additional information uploaded with your application may be removed prior to your application being considered by the Committee.

Giving others access to the Stage 2 form

Including Joint Lead applicant / co-applicants in your Stage 2 application

Access to your application is through your REALMS user login. This should not be shared. The Stage 2 application is designed as a collaborative submission. As the lead applicant, you must nominate Joint Lead applicants / co-applicants to provide their personal information via the Applicant Detail Form and collaborate on sections of the application. You select the type of access they have to the application. As a result of the nomination, your Joint Lead applicants / co-applicants will be invited via email to login to the REALMS, accept their role and complete their application tasks.

You will not be able to complete and submit your application until the Joint Lead applicants / co-applicants have provided the information that we require from them.

Once you have completed the details for each co-applicant you should click on the ‘Save’ button before clicking on the ‘invite’ button. This will then prompt an email to be sent to each co-applicant with a task for them to approve involvement with the project and provide the necessary personal information via the Applicant Detail Form.

•  Stage 2 Application, depending on the access permissions granted by the lead applicant, this allows the Joint Lead applicant / co-applicant to read and/or amend any details in the application. It is the responsibility of the lead applicant to ensure that the Joint Lead applicant / co-applicants complete all the tasks generated.
• Enter Joint Lead applicant / co-applicants details accurately as we will use these to contact them (the exact email address used as their REALMS username is essential to ensure they receive the automatic communication as part of the application process).
• Please make sure that you allow sufficient time for your Joint Lead applicant / co-applicants to complete both parts of their task in the online form before the application deadline.

Completing the form

ORCiD

In line with other UK health research funders, NIHR have implemented a researcher identifier scheme – ORCiD. In order to submit your Stage 1 and Stage 2 application, you (and Joint Lead Applicant / Co-applicants) are required to obtain a free unique ORCiD ID number and enter this onto your REALMS user profile contact information. You will only have to do this once, however if you add any additional information to ORCiD, you will then need to synchronise this with your REALMS account by going to My Profile > ORCiD > Re-import Data. 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.

To add this go to the ‘Profile’ tab on your REALMS Home page and click on the ORCiD link in the left navigation bar to import your profile. On the next screen either add or register for an ORCiD ID by clicking on ‘Create or connect your ORCiD ID’ which will redirect you to the ORCiD website, where you will be able to sign in or register for an ID number. Once you have registered and authorised your ID you will be redirected back to your REALMS Contact Information page where yor ORCiD ID will now be displayed. More information about ORCiD is available.

Saving your form

As you work through the application, you are asked to ‘Save Draft’. This will save all the information you have submitted so far. You can save the form at any point and leave the application prior to submission. The save draft button is always located at the bottom of each page of the application. The pending application task will remain on your home page until complete and submitted or the deadline for the application has passed, at which point it will appear as either a Submitted Application or Past Application task.

It is important to remember to ‘Save Draft’ as you go through the form before navigating away from the page.

There is a security time out set on REALMS so that after 60 minutes of inactivity, the user will be logged out of REALMS. It is advisable therefore to save your work at regular intervals using the save button on any page. REALMS will give you a warning that you are due to be timed out 10 minutes before it times you out. If this message is displayed, you should close the pop-up.

Leaving the application task

You can leave your application task at any time. As long as you have saved any new information you have entered for the application, you can navigate to your home page or log out of the REALMS system.

Technical support

If you encounter any problems with the REALMS system, you should contact the programme funding support team via email or by phone.

Space restrictions when entering text

You should be aware that there are character limits set for each text box within the application form. For larger text areas these are indicated with ‘XXXX characters left’ at the bottom of the text entry box. Please note that the system does provide a spell checker. Carriage returns and spaces are counted as characters.

The form counts all blank space as a part of the content of each box, so if you are short of space it will help if you delete extra carriage returns and place any bulleted lists into paragraph format.

URL links

You may wish to include URL links to your application or refer to URL links in a body of your text. You are advised not to use any URL shortening service such as ‘tiny.cc’ when completing your application. This type of shortening service is associated with hacking and spamming (as it promotes the sending of links that are unclear where they are pointing).

Review and submit application

Please ensure that before you submit your application, you have completed the required fields and saved a version of your form. You must submit your application form and flow diagram / references where required, by the stated deadline before 1pm. We are unable to grant any time extensions and the deadline will be strictly observed. You should therefore plan your application carefully. We will not enter into negotiations for extensions.

Stage 1 and Stage 2 applications must be submitted electronically.

Submit your application using the ‘Submit’ button at the bottom of the form. Clicking on the ‘Info Still Required’ button will take you to a list of outstanding/incomplete required application information. Each item listed is an active link that will take you to the relevant application question/field.

We strongly advise applicants at this point to check that all sections are completed and the correct documents have been uploaded into the system as they cannot be altered once submitted.

You will then receive an automated confirmation email from the EME Programme. If you do not receive an email please contact us immediately as there may be an issue with your submission.

Un-submitted applications

Seven days prior to the closing date you will receive an email reminder that you have an open application (i.e. not submitted). The EME Programme no longer supports ‘rolling over’ of applications to a subsequent call.

Chief Investigator

Where appropriate and justified it is acceptable for the application to be led by joint Lead Applicants. Please note for application/contracting purposes the joint lead applicant will be regarded as a co-applicant.

We expect the Chief Investigator to be actively engaged in, and in day to day control of, the project and they will be the primary contact on the project record. Further information on the strengths of the team can also be included in the relevant expertise section of the application form.

Assistance

If, after carefully reading all the instructions, you still have difficulties completing your application, please send an email to eme@nihr.ac.uk or contact us at: 023 8059 4303. Please be aware that while every effort is made to answer queries, if the query is made very near the closing date, the EME programme may not be able to provide a considered response. When emailing us please include details of the call which you are responding to, and the name of the lead applicant.