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EME Supporting Information

 

Contents

About this supporting information

This document contains information to assist applicants submitting a Stage 1 or Stage 2 application form. Applications for funding are made online through the NETSCC Management Information System (NETSCC MIS).  You must register or log-in to the NETSCC MIS 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 on the EME/NIHR funding web pages:

EME Programme page

Current Funding Opportunities 

Proof of Concept

Mechanistic Components

EME stage 1 Guidance Notes

General Assessment Criteria 

Application timeline

The EME Board typically meets in February, June and October. An example of the potential timeline of your application is outlined below for reference. 

 

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. NETS 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 NETS 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 full proposal 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 MHRA (info@mhra.gsi.gov.uk) 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. 

NETSCC proposal resubmission policy

Please note that an unsuccessful proposal cannot normally be resubmitted to this or any other NETS programme within one year of the original decision letter, unless applicants can demonstrate that it has changed significantly and is essentially a new proposal. 

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, National Institute for Health Research (DH 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 DH NIHR bodies for the purposes of statistical analysis and other DH NIHR research management purposes. NETSCC 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 DH 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 NETSCC password-protected network that is available only to NETSCC staff.  Your details and those of your joint applicants will be retained by NETSCC 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 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 (DH) 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 Design 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 Design Service can advise on appropriate NIHR programme choice, and developing and designing high quality research grant application.

Clinical Trials Support

NIHR CTU Support Funding provides information on units receiving funding form the NIHR to collaborate on research applications to NIHR programmes and funded projects.

The UKCRC CTU Network (http://www.ukcrc-ctu.org.uk) provides a searchable information resource 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 (www.ct-toolkit.ac.uk ).  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.

INVOLVE / 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. Further information and resources can be found at the INVOLVE website http://www.invo.org.uk/.

This includes a detailed definition of patient and public involvement in research, briefing notes for researchers on how to involve patients and the public and an involvement cost calculator and budgeting guide. The NIHR Research Design 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
(http://www.methodologyhubs.mrc.ac.uk/methodology_advisory_service.aspx), is a resource for resolving non-standard methodological issues.  Referrals to MAST, should ideally be made through Clinical Trials Units (CTUs) (http://www.ukcrc-ctu.org.uk/)

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. http://www.ukbiobank.ac.uk/

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

Researchers applying for NIHR funding are asked to consider the carbon footprint of their research and take steps to reduce carbon emissions where appropriate. Advice on how to do this 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:

https://www.gov.uk/government/topics/government-efficiency-transparency-and-accountability 
https://www.gov.uk/contracts-finder

To Access the Application form for Stage 1MI applications only

Select the call to which you wish to apply for on the funding opportunity  page on the NETSCC 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 NETSCC MIS 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 button and this will start the application process.  Clicking Cancel will return you to your ‘home page’.

Applying for a funding opportunity creates a task called ‘Stage 1 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 ‘Stage 1 Application’ task can be accessed at any time until you either submit the application (using the Submit button in the application process which will appear once all the validation is complete) or the call closes.

Clicking on the Stage 1 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.

The NETSCC MIS can always be accessed directly at www.netscc-mis.nihr.ac.uk for you to go to your home page 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 *. The final review and submit page of the application provides a final check of the mandatory fields as well as providing reminders about optional entries.

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

Giving others access to the form

Joint Lead applicant / Co-applicants

Access to your application is through your user login to the NETSCC MIS. This should not be shared. The Stage 1 application does not require a Joint Lead applicant / 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 Joint Lead applicant / 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.

Signatories

You are not required to provide signatories for Stage 1 applications. 

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

The ‘Stage 2 Application’ task can be accessed at any time until you either submit the application (using the Submit button in the application process which will appear once all the validation is complete) or the call closes.

Clicking on the Stage 2 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.

The NETSCC MIS can always be accessed directly at https://netscc-mis.nihr.ac.uk for you to go to your home page where all your applications and other tasks will be listed. 

To access the electronic online Stage 2 application form for applicants applying to the Mechanism of Action call only 

If you are applying for the Mechanism of Action call, press the ‘Click here to apply’ button to access the eligibility form which should be sent to eme@nihr.ac.uk.  If you are eligible for this call you will be given details on how access to the call. 

Applying for a funding opportunity creates a task called ‘Stage 2 Application’. The task will then be available for you to complete until 1pm on the closing date as indicated on the research call and on your task list.

To submit a Stage 2 application

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

  • Complete all mandatory fields. The final review and submit page of the application provides a final check of the mandatory fields as well as providing reminders about optional entries.

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

Giving others access to the Stage 2 form

Co-applicants

Guidance for how co-applicants complete their sections can be found at: http://www.nihr.ac.uk/about-us/documents/NETSCC/MIS/MIS-brief-for-Co-Applicants.pdf  

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

Access to your application is through your NETSCC MIS 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 CV information 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 MIS, 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 Joint Lead applicant / co-applicant you have to select the option ‘notify’ on the Research Team Instructions page. This will then prompt an email to be sent to each Joint Lead applicant / co-applicant with a task Accept Stage 2 Application Participation (Joint Lead applicants / Co-Applicant) for them to approve involvement with the project. If the applicant agrees this generates two new tasks which will appear on their homepage.

1) Collaborate on Stage 2 Application (Joint Lead applicant / Co-Applicant) which requires the Joint Lead applicant /co-applicant to update their CV details.
And the other task:

2) 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 MIS 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.

Signatories

Guidance for how signatories complete their sections can be found at: https://www.nihr.ac.uk/about-us/documents/NETSCC/MIS/MIS-brief-for-Supporting-Role-Signatories.pdf

Instead of requiring wet ink signatures (for roles such as Sponsor, Department Head, Financial Director, NHS facilities Manager etc.) on a paper copy of the application form, you will be asked to provide contact information (including a valid individual’s email address) about the required signatories for the Stage 2 application so that they can complete their approvals electronically. This process replaces the need for ‘wet ink’ signatures with an electronic version.

For signatories this is a two stage process and requires those nominated to first complete an ‘agree to participate’ task prior to application submission, followed by a ‘confirmation’ task immediately after submission of the application.

Firstly, the lead applicant will be able to ‘Notify’ the signatories which will automatically invite them via email to register/login to the MIS and accept their role.

Following submission the lead applicant will notify each signatory using the MIS, they will then acknowledge that they have seen and support your completed submitted application in time for the deadline by submitting the ‘Provide full application signatures’ task. They will be able to see a PDF copy of your completed application via the system.

The EME Programme acknowledges that it may not be possible for you to obtain confirmation from your Signatories immediately after submission, however; it remains your responsibility to obtain these electronic approvals within two weeks of the submission deadline. You can check that your signatories have completed the approval process on your MIS task page.

Please note, if you, the lead applicant, are also signing as Head of Department you should not complete this signatory task until you are ready to submit your application form. Once the task has been completed, and as a named signatory, various fields within the application form will become non-editable.

Completing the form

ORCiD

In line with other health research funders, NIHR have recently started implementing a new researcher identifier scheme – ORCiD. ORCID provides a digital identifier that, through integration in key research workflows such as manuscript and grant submission, supports automated linkages between researchers and professional activities ensuring that work is recognised.

Applicants can now update their MIS profile with their ORCiD ID, a process that will become mandatory for all applicants in the future. This ID will only need to be entered once.
To add your ORCiD ID to your MIS contact record, log in to the MIS and go to your profile. Click the link ‘View ORCiD record’ and follow the on-screen instructions. You will then be returned to the MIS and the profile field for your ORCiD number will automatically be populated. You will only have to do this once.

N.B. For a Stage 2 application this is a mandatory requirement.

Saving your form

As you work through the application, you are asked to save each page. 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 button is always located at the bottom of each page of the application. Large text areas on the form also have their own save button beside them. The application task will remain on your home page until complete and submitted or the deadline for the application has passed.

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

There is a security time out set on the MIS so that after 60 minutes of inactivity, the user will be logged out of the MIS. It is advisable therefore to save your work at regular intervals using the save button on any page.  The NETSCC MIS 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.

There is a left hand navigation menu in the application so you can select specific parts of the form to complete, however you should always ensure that you save any information entered on your page before using this left hand menu.

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 NETSCC MIS system.

Technical Support

If you encounter any problems with the NETSCC MIS system, you should contact the programme funding support team via email. The contact details can be found on the NIHR website

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 ‘Limit’ and ‘Remaining’ at the bottom of the text entry box. Please note that the system does not provide a spell checker. Carriage returns and spaces are counted as characters. The character count will be slightly less than that of a Microsoft word character count.  

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.

Use of non-standard characters

You are advised not to use any non-standard characters in your text; in particular, you may experience a technical difficulty that affects the use of these characters ‘<’ ‘>’ ‘=’ and ‘=’. The system will currently strip these characters out of the content of the text without warning.

If you need to use these symbols, then please replace them with words (i.e. less than or greater than, or less than or equal to or greater than or equal to). You will not be able to submit the form if you have either of these symbols or any other non-alphabetical or non-numerical characters in your text. For these reasons it is advisable that you either type text directly into the form or ensure these characters are not included in any text that you copy and paste from other documents.

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).

Technical support documents including how to spell check, resize text boxes and use Mac/iPads can be found on the NIHR website.

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 on the last page of the web form. Please note that the Submit button will not appear unless all necessary sections have been completed. Warning signs (!) may appear to indicate that you may have omitted some information but this sign indicates the information is not mandatory and you can submit without it. 

 ?  Complete  The section/form has been filled out correctly 
 X  Incomplete  Mandatory information has not been provided and the task cannot be submitted until this has been completed 
 !  Attention  This section has not been completed but is not mandatory

 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.

Once all sections have been completed and show as green ticks (or as a yellow advisory exclamation mark) a submit button will appear in the top left hand corner of the page and the form can be submitted to the EME Programme.

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: 02380 594303.   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.