HTA Programme stage 1 guidance notes (REALMS)

These are the Health Technology Assessment (HTA) Programme, guidance notes for applicants submitting a Stage 1 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. 

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. 

Summary information

Contracting organisation

Please give details of the organisation who will be the contractor if the project is funded. 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 a 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.

Applicants must talk to their R&D offices, or equivalent, and follow their host organisation's application review and sign off procedures before submitting an 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.

Research type

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

Start month

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

Start year

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

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.

End date

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

Estimated research costs

Enter the total amount of research costs requested (not including NHS Support and Treatment costs). Please ensure that any costs attributable to higher education institutions (HEIs) are included here at 80% of the full economic cost, which is the rate at which these costs will be awarded.

Open Access costs - Applicants should no longer include open access costs as part of their stage 1 application estimated Research 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.

Estimated NHS support costs

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

Estimated NHS excess treatment costs

Enter the total amount of NHS excess treatment costs associated with this proposal. 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 access excess treatment costs.

Estimated non-NHS excess treatment costs

Enter the total amount of non-NHS excess treatment costs associated with this proposal. 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 figure that should be entered here is the difference between the cost of the intervention and 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 excess 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 HTA unless the intervention is being delivered outside the NHS (e.g. in school or by a local authority etc.).

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

Research team

Lead applicant research background details

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

ORCiD ID

Please note: You (and Joint Lead Applicant – if included) 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. By clicking the link ‘Create or connect your ORCiD ID’ within the ‘ORCID’ section of your user profile you will be taken to the ORCiD website where you will need to register or sign in. Once logged in to ORCiD and following acceptance of T&Cs, you will need to click on the ‘Continue to import your ORCID Data’ button which will update your profile with your ORCiD ID number and other associated data (e.g. publications and grants - however, please note publications and grants are not required for a stage 1 application) which can be used to populate your application. The ORCiD ID number is a mandatory requirement.

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 monitoring information

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

Research team

The research team table will update automatically as joint lead applicants and co-applicants are added. Use the update button to enter the following information:

• Role (Limit 200 characters) – Explain the role that the applicants will be undertaking in the research, e.g co-ordination and project management, analysis, methodological input etc.
• Commitment – percentage of the applicant’s time that will be committed to this project (%FTE).
• Organisation – 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 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. If you are a PPI representative and can’t find or don’t have an appropriate registered organisation, please start typing ‘PPI Representative Based in…’ and select the England/Scotland/Wales/Northern Ireland option as appropriate.

Joint lead applicant

Where appropriate use the envelope button to add and then invite a Joint Lead applicant to your application. Once the Joint Lead Applicant has accepted their invitation they will appear in the Research Team table. Use the Update button to enter the information regarding their role on the project, %FTE, Organisation.

Co-applicants

Use the ‘Add / Edit Co-Applicants' button to add any co-applicants and provide the necessary information, including contact details, organisation, role and commitment (%FTE). You should consult with co-applicants before adding them to the application. Do not include collaborators, who should be mentioned (if necessary) in the 'Research Plan' section of the on-line application form.

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 do not share the responsibility for delivery of the project.

We encourage the inclusion of public co-applicants where appropriate. For further information please access the 'Public Co-Applicants in Research' guidance.

PPI lead

The role of the PPI lead can be undertaken by any of the co-applicants within the research team (or a named member of the team), who has the relevant skills, experience and authority to be accountable, represent, manage and embed patient and public involvement in all aspects of the research study. This role should be a budgeted and resourced research team member. For examples of the activities a PPI lead might be accountable for, more information is available in the 'Public Co-Applicants in Research' guidance, as linked to from the Co-applicants section above.

Add administrative contact

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.

Use the envelope icon below to enter the administrative contact's details and invite them to participate in this application.

Application details

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

The importance of a plain English summary

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

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

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

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

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

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

Content

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

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

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

Guidance on writing a plain English summary is available on the NIHR website.

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

Research plan (limit: 20,000 characters)

Using all the headings (in the order presented) and guidance below, please use this section to clearly explain your proposed research. As this is the main part of your application which will be considered by the reviewing committee you should ensure that the information is accurate, succinct and clearly laid out.

The NIHR expects appropriate and relevant involvement of patients/service users, carers and the public and other key stakeholders in the research it supports. It is essential to set out your plans to involve patients/service users, carers and the public in the Stage 1 application. Your involvement plans will be assessed by the funding committee including patient and public service users, carers and members. Information and resources to assist you in involving patients/service users, carers and the public can be found on the NIHR website. 

In the 'Research Plan' section it is important that you identify all stakeholders who are relevant to your research proposal. For each stakeholder group be clear about how they benefit from your proposed research and, where appropriate, how they have been involved in the development of the application, as well as the plans for their involvement in the proposed research.

If this application is a resubmission for which you previously received feedback, please explain what you learned and how the application has improved. Please provide the date of your last submission. If this application is pending a decision from another funder please give details of the funder and the expected decision date.

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 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

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 any protected characteristics.

All NIHR applications are expected to include information about how data on the protected characteristics 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. 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)

Other helpful links

• Information on Equality, Diversity and Inclusion 
• The toolkit for increasing participation of ethnic minorities in health and care research
• The INCLUDE Ethnicity Framework
• The NIHR Race Equality Framework

What is the problem being addressed?

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

For commissioned calls only

Much of this information will be provided in the Commissioning Brief and you should only provide any relevant additional information not already captured in the commissioning brief.

For researcher-led calls only

Please explain how your chosen research is in the remit of the HTA Programme, and a clear explanation of the impact on patients/service users, carers and the NHS.

Why is this research important in terms of improving the health and/or wellbeing of the public and/or to patients and health care services?

It is essential that you clearly identify the health and care need your research meets or contributes to. Please outline the anticipated value or contribution the study will provide. You must justify that this unmet need is a high priority to the NHS, social care or those who use these services. Your justification should be proportionate to the level of funding you are asking for. In some cases, substantive justification will be needed to prove your research is in an area of major importance. This includes detailing what support there is for this work from relevant clinical and patient communities.

For commissioned calls only

Please treat this section as a single field and use it to describe how your proposal meets the specification set out in the commissioning brief. If you wish to propose a study that does not meet one or more of the requirements set out in the brief, please use this section to explain the reasons for your approach.

For researcher-led calls only

This section is used in the first stage of proposal assessment and is therefore the most important part of your application in terms of demonstrating competitiveness against others received. It allows you to demonstrate why your chosen research area is needed by the NHS.

Please justify the clinical importance of your proposed study and outline the anticipated value or contribution the study will provide to clinical practice and how it could be implemented across the wider NHS or social care. Classification of need for research is set out below:

• Health/Care need: How will the public/patients see this as a need and as a potential improvement to their health and/or lives? These will be expected benefits in terms of substantial health gain with the ultimate aim of improving the health or care of public, patients, service users and/or carers. This covers the potential for preventing avoidable mortality and morbidity, improving quality of life and considerations of disease prevention and should be justified in terms of burden of disease;
• Sustained interest and intent: Evidence that the issue or area is one in which there will be sustained interest in the future, such that the results of research if commissioned and undertaken will remain highly relevant and important to the needs of the NHS or social care in the future;
• Capacity to generate new knowledge: Please explain how the proposed research will contribute to development of the research area;
• Scientific knowledge: Please explain how the study will make a substantial advance in scientific understanding and knowledge and the potential substantial health gain.

Review of existing evidence. How does the existing literature support this proposal?

Explain why this research is needed now, both in terms of time and relevance. We will only fund primary research where the proposed research is informed by a review of the existing evidence.

For commissioned calls only

Where the request for research to address a specific research question is via a commissioning brief advertised through a commissioned call, the review of the existing evidence will have already been undertaken by the NIHR HTA Programme to inform the commissioning brief.

Applications in response to commissioned calls will need to address the commissioning brief requirements specific to the NIHR HTA Programme.

For researcher-led applications only

We require evidence that the intervention is ready for HTA evaluation. See an example of how to describe the relevant evidence.

Where a relevant published systematic review (or reviews) exists they should be presented.

Where no such published systematic review exists it is expected that the applicants will undertake an appropriate review of the currently available evidence (using a predetermined and described methodology that systematically identifies, critically appraises and then synthesises the available evidence) and then present a summary of the findings of this in their proposal.

You should give reference to any relevant systematic reviews and discuss the need for your study in light of these. References should be provided in the Vancouver or Harvard format (Author(s). Title. Journal. Year; Volume: Start page - End page). All applicants must also include reference to relevant on-going studies, e.g. from trial registries.

If the study proposed builds on previous work funded by the NIHR then the results of the previous study must be made available to the funding committee before an application will be considered. Please either provide a link to published results or a draft report with your application.

The proposed standard for what constitutes a satisfactory review of the existing evidence to inform new primary research is as follows:

• Citing a relevant Cochrane Review (or)
• If no Cochrane Review exists then citing another systematic review that is published in a peer reviewed journal (or)
• If no published systematic review is identified then the research applicants should present the findings of a systematic review that they have undertaken for the purposes of the application, where the definition of systematic review for audit purposes is taken from the HTA Monograph series as “when the account of the search, appraisal and synthesis methods (to minimise biases and random errors) would, in theory, permit the replication of the review by others.

Importantly, if the applicants undertake and present the findings of their own review of the existing evidence undertaken systematically then they have to provide sufficient details of the methodologies employed to allow the review to be replicated.

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.

Applicants should then explain how they expect that the research proposed will add to the body of knowledge with reference to current NHS policy and practice.

What is the research question/aims and objectives?

Please summarise the key aims and objectives of your project and provide a concise statement of the proposed research.

You should include a clear explanation of the main (single) research question phrased in PICO terms where applicable to your study type:

• Population: NHS (or social care) target population i.e. real patients
• Intervention: A technology that is or could be used now in the NHS (or social care)
• Comparator: Usually next best treatment, but could be placebo
• Outcome: Patient/service user centered, leading to effectiveness and cost-effectiveness

Give a brief explanation of how or in what ways the design constitutes a clinical trial or evaluation study. You are welcome to highlight any other aspects of the design that you would like to bring particular attention to, in order to explain how it is within remit or meets the commissioning brief. Please remember that HTA research looks at patients or people seeking healthcare; studies using healthy volunteers and animals are not within the remit of the programme.

Project plan

Provide an expert summary of the project plan of investigation plus any additional points required to support statements made in the previous sections, and include any key references required to justify them (e.g. in the use of particular outcome measures or methods of analysis).

• Design: Give a brief statement on the type of study design to be used.
• Setting: (Primary Research only) State the health service setting(s) in which the study will occur (e.g. general practice, hospital outpatients, ambulance service users, social care).
• Strategy for reviewing literature (Secondary research or Modelling): Explain the criteria applied to assess the quality and relevance of studies identified by the search strategy. Provide an explanation of how these will be decided if these are not yet known.
• Target population: Clearly define the population from which the study sample receives the health technology concerned (or the control intervention where appropriate) e.g. women over 60, people with learning disability, people with advanced cancer.
• Inclusion/Exclusion Criteria: Please provide an explanation of the inclusion/exclusion criteria.
• Health technologies being assessed: Give a clear definition of the health technology to be assessed. The purpose of HTA is to assess the value of a health technology compared to best alternatives or where none exists, against no intervention. Where there are established alternative technologies, these should also be defined. Where the technology is subject to rapid change, details of how this will be dealt with in the project should be included.
• Measurement of costs and outcomes: Not all HTA studies require full economic evaluations. When considering inclusion of a cost effectiveness analysis, applicants should carefully describe what this will add to the study. Where an economic component is proposed, applicants should endeavour to use the simplest approach, or fully justify where more complex methodologies are needed. Details should include justification of the use of outcome measures where a legitimate choice exists between alternatives. If the study includes a health economic component, state from what perspective costs and benefits will be considered, and (briefly) how these will be collected. Where established Core Outcomes exist they should be included amongst the list of outcomes unless there is good reason to do otherwise. Please see The COMET Initiative website to identify whether Core Outcomes have been established.
• Longer-term follow up: Researchers should consider obtaining consent from participants to allow future follow up through efficient means (such as routine data) as part of a separately funded study. This is because it may be useful, after the main study is completed, to undertake longer- term follow up, either because of what is currently known about the possible long term effects of the intervention, or because subsequent research suggests long term follow up of this cohort would be useful. Researchers should therefore consider building in provision for a mechanism to facilitate longer term follow up beyond the life of the main study, including obtaining consent for this from participants at study entry.
• Sample size: State the required sample size, giving details of the estimated effect size, power and/or precision employed in the calculation. Information must be provided so the funding committee can replicate the calculation and understand the assumptions made.
• Difference between current and planned care pathways: Please define the current standard patient care pathway and how this differs from the trial arms.
• Project timetables including recruitment rate: Indicate the anticipated duration of the study, paying particular attention to the expected recruitment rate and a justification for your estimate. Outline the main stages of the proposed project including regulatory steps, team recruitment, patient recruitment, and the expected duration of each.
• Expertise in team: The team should be multidisciplinary and include relevant expertise in the clinical area concerned, in performing systematic reviews, and (where appropriate) others e.g. operational research, PPI lead, public voice with lived experience, health economics. Particular care should be used to describe how you have and will involve patients and the public in your research. 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. View examples of the activities a PPI lead might undertake.
• Patient and Public Involvement (PPI): The NIHR expects appropriate and and well- designed involvement of patients/service users, carers and the public and other key stakeholders in the research it supports. In the Stage 1 application, it is essential to show your plans for involving patients/service user, carers and the public at each appropriate stage of the research project life cycle. For example, sitting on oversight committees, being a member of the research team involved in activities such as recruitment, data collection, analysis, producing study materials and sharing findings.Your PPI (patient and public involvement) plans will be assessed by the funding committee which includes patient and public members. In the rare circumstances where PPI is not appropriate, a clear justification must be provided. You should also outline how PPI has informed the development of the project so far. For example, the involvement of patients/service user, carers or the public in shaping the research question and study design. feasible, relevant and acceptable recruitment plans, data collection tools, information materials, outcome measures, follow-up, intervention design and delivery. For a Stage 2 application, you will be asked how the PPI will be managed, reported and evaluated so whilst it is not necessary to provide the detail in Stage 1, early consideration should be given to these aspects. Find further resources to support the design of your PPI.
• CTU involvement: It is advisable that studies involving a clinical trial have engaged with an accredited Clinical Trials Unit noting a letter of CTU support will be required with all stage 2 applications involving a clinical trial.
• Dissemination: Our key concern is to ensure that projects funded by the HTA programme are designed from the outset to produce useful, timely and relevant research findings, which are then used and actually make a difference. Please describe the main outputs from your research and how they will be presented, disseminated and used. It is important to include details of how you will share with study participants the progress and findings of the study. Explain how the findings from the proposed research will be shared with, or disseminated to others and how this will maximise the potential impact of the proposed research. Describe who are the likely beneficiaries of the research, when are they likely to benefit and in what way. Link to NIHR Dissemination guidance: How to disseminate your research: Getting your message heard - and used.
• Embedded Methodological Studies within a trial/project or review: The HTA Programme supports applicants to embed studies that evaluate approaches to support trials, projects or evidence review delivery success within the main study (SWATs/SWARs) in their applications. Many studies take longer than planned, either struggling to recruit, or retain participants, or going over budget. The NIHR are interested in working with researchers to evaluate interventions to make studies more efficient. Applicants may apply for up to £30,000 funding to evaluate alternative ways of managing studies as part of their main study. Any SWATs/SWARs proposed should represent a minor element of a larger study and must not undermine delivery of the main study. Some examples are provided on the?Northern Ireland Hub for Trials Methodology Research Webpages. 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/SWARs within a Stage 1 or Stage 2 research proposal. SWATs/SWARs may not all be powered to provide meaningful outcomes but will be useful for meta-analysis and applicants should consider using protocols published on theNorthern Ireland MRC Trials Hub for Methodology Research SWAT registry. Applicants who wish to include a SWAT/SWAR in their study should indicate that they intend to do so in their first stage application (there is no need to provide a detailed description of the SWAT/SWAR at this stage).
• Multiple long-term conditions - studies within a project: The HTA Programme would like to encourage researchers to consider a multiple long-term conditions (MLTC) - studies within a project perspective in their projects. This is to further understanding on MLTC, and improve knowledge on the best methods and processes for incorporating MLTC research questions into complex projects (including clinical trials) in health, social care and public health. Applicants can propose an embedded study within a project (SWAP) which would support this. The study would be short and efficient, with findings put into the public domain as soon as they are available, as an interim output. A SWAP will be a small part of the overall application and should be costed at no more than £30,000 to include all dissemination and publication associated with the SWAP. At stage 1 applicants should indicate if they intend to include a SWAP in their study. A detailed description of the SWAP is not required at this stage.
• Mechanistic research: The HTA Programme will support the collection of samples and data, where the HTA study provides an opportunity  for valuable, hypothesis-testing research into the ‘mechanism of action’ of the intervention. The cost of sample collection and storage must  be made clear in the application and must be modest in scale. Unless otherwise specified, any mechanistic work must be funded separately. Applicants should note where there are plans to apply for and undertake the associated mechanistic study, for example via application to the MRC-NIHR Efficacy and Mechanism Evaluation (EME) Programme. Any mechanistic work must not have a detrimental effect on the main study.

Uploads

Applicants should only include uploads specified in the call details/commissioning brief, e.g. cover letter, collaborative documents. Any additional documents will not be considered by the funding committee during its review.

Attachment 1: flow diagram

In order to submit a Stage 1 application to the programme you must upload a diagram (single-side of A4), as a separate .PDF file, for submission with your application form.

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 clear enough to be read when printed on A4.

If proposing an RCT, we advise you refer to the CONSORT statement 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 find the EQUATOR Network website useful.

Attachment 2: references

One single-side A4 page, listing references used throughout your proposal is also a mandatory PDF upload. Please use either the Vancouver or Harvard referencing conventions and include the DOI of the main related publication.

Acknowledgements and conflicts

Potential conflicts

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

For HTA commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team. There may be unusual circumstances where the same person could be included on more than one application e.g. a lead from a named charity or a unique national expert in a condition.

For such exceptions (i) each application needs to state why the same person is included (ii) the shared co-applicant should not divulge application details between teams and (iii) both teams should acknowledge in their application that they are aware that one of their co- applicants is part of a competing application and that study details have not been shared.

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 are available.

Checklist of information to include when submitting a NIHR stage 1 research application

Applicants should ensure they have included the necessary information prior to submitting their application.

• A good quality plain English summary
• A clear explanation of the problem being addressed
• A clear demonstration of the need and importance of the research
• A review of existing literature (primary research)
• A clear research question / aim(s) and objectives
• A clear project plan summarising the study design and methods
• A clear description of team member roles and contribution
• Appropriate and relevant involvement of patients/service user, carers and the public
• A clear, appropriate and relevant plan for dissemination
• A flow diagram illustrating the study design / flow of participants (document upload)
• One single-side A4 page of references, using either the Vancouver or Harvard referencing conventions (document upload)