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PHR Programme stage 1 guidance notes (REALMS)

Contents

These are the Public Health Research Programme (PHR) 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.

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’.

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.

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 (intervention)

Enter the total amount of non-NHS excess treatment costs associated with this proposal. These are similar to NHS excess treatment costs, but they mainly apply to the intervention costs associated with Public Health and Social Care Research. Non-NHS excess treatment costs include costs incurred in delivering the treatment, or intervention, which would continue to be incurred after the study, 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.

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, degrees and professional qualifications, other affiliated organisations and contact details will be automatically populated from your contact profile. Update your contact profile to complete any missing information or make any updates here.

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) which can be used to populate your application. The ORCiD ID number is a mandatory requirement.

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

Research team

The research team 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.

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, linked 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 National Institute for Health Research (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.

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

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

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 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

Guidance for applicants on equality, diversity and inclusion for study participants

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

All NIHR applications are expected to include information about how this data will be collected.

In addition, applicants should demonstrate how these factors have been considered and addressed in their proposal, including steps taken to ensure the research sample is representative of the population the study is targeted at. Applicants need to explain who they are planning to recruit to ensure inclusivity of study participants and justify and explain any exclusions, for example by completing an Equality Impact Assessment. 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:

Other helpful links:

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.

Please explain how your proposed research is within the remit of the PHR Programme and how it will generate evidence to inform the delivery of non-NHS public health interventions.

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.

In your response, please refer to the criteria set out below:

  1. Health need: Please identify the anticipated benefits in terms of improving the health of the population and reducing inequalities in health. This may cover the potential to promote or protect health, or to prevent ill health, reducing avoidable mortality or morbidity, or improving quality of life.? Benefits may also arise from improving the acceptability, effectiveness, and cost effectiveness of interventions, with better targeting and equity of access to services.
  2. Expressed need: Please state how the research or evidence generated will be relevant and important to the need to improve public health.
  3. Sustained interest and intent: Please provide evidence that the issue or area is one in which there will be sustained interest in the future, such that the results of research once commissioned and undertaken will remain relevant and important to public health in the future.
  4. Capacity to generate new knowledge: Please identify the existence of uncertainty or “knowledge gaps” which cannot be addressed by the existing body of research in this area and that require new research.
  5. Generalisability and transferability of findings and prospects for change: The PHR Programme wants to ensure that the findings of the research it funds benefit as many people as possible. PHR will, therefore, be looking for evidence and an explanation as to how findings can be used and translated for implementation in routine policy or practice and will be generalisable beyond the participant group/location for your study.

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.

Proposals that include primary research should reference the existing evidence, including within the PHR portfolio and those of other funders, and explain how this evidence has informed the proposed research. Where a systematic review already exists that summarises the available evidence this should be referenced, as well as including reference to any relevant literature published subsequent to that systematic review. Where no such systematic review exists, it is expected that the applicants will undertake an appropriate review of the currently available and relevant evidence (using as appropriate 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.

All proposals recommended for funding which involve a clinical trial will be double-checked for potential overlaps using WHO trials (http://apps.who.int/trialsearch/) 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 policy and practice.

What is the research question/aims and objectives?

Please summarise the research question / key aims and objectives.

Please provide the precise aims and research questions your project will address. You may like to present this in a PICOST format (Population, Intervention, Comparator, Outcome/s, Setting and Timing).

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 the points made (e.g. in the use of particular outcome measures or methods of analysis).

  1. Research Design: Primary Research: please provide a clear summary of the study design, including all of its components (e.g. primary and secondary outcomes, process and economic evaluations) and relevant time points for baseline and follow-up data collection for each component. Reference should be made to established research techniques and any adaptations of these for the purposes of the research proposed should be fully explained and justified. Where an RCT is being proposed please describe and justify the chosen method of randomisation. Evidence Synthesis: if you are proposing a systematic review and/or an evidence synthesis, details regarding the size of the available literature base should be provided, along with details of the search and review strategy.
  2. Planned intervention: you should include details of the planned intervention(s) and components, and their frequency and intensity, theoretical basis, specific techniques used, modes of delivery, and who will deliver the intervention. You may like to refer to the TiDIER guidance on reporting interventions (Template for Intervention Description and Replication (TIDieR).
  3. Control/comparator group: please state what appropriate comparator(s) will be used in an evaluation and how it will be selected.
  4. Study population: which population(s) will be the target for the intervention and the subject of the research? How will the population(s) be recruited and retained?
  5. Setting: where will the research be undertaken and the intervention delivered?
  6. Outcome measures: please state and justify the primary and secondary outcome measures.
  7. Methods for data collection: for each outcome, process or economic measure proposed, please state the method of data collection, including qualitative methods where appropriate.
  8. Sample size: please justify the proposed sample size for each element of the study. Justifying the values used in the calculation by giving their source or some sensitivity around assumed values.
  9. Data & Statistical analysis: please provide details of how each study data set will be analysed. Clearly state the purpose of any statistical analysis. The proposed type and frequency of analyses must be stated including the selection of participants to be included in the analyses. Describe any planned interim and sub-group analyses, sensitivity analysis and how missing data will be handled.
  10. Health economic evaluation: Understanding the value of public health interventions - whether the outcomes justify their use of resources - is integral to the PHR programme, where resources relating to different economic sectors and budgets are potentially relevant.  The main outcomes for economic evaluation are expected to include health (including health-related quality of life) and the impact on health inequalities as a minimum, with consideration of broader outcomes welcomed. Different approaches to economic evaluation are encouraged as long as they assess the value and distributive impact of interventions.  Applications that do not include an economic component should provide appropriate justification.
  11. Research Governance and Ethical approval: please indicate what research governance issues will need to be addressed in your research and state how ethical approval will be sought and obtained. Applicants must either comply with the research ethics framework formulated by the Economic and Social Research Council (ESRC) or obtain approval via the National Research Ethics Service (NRES).  
  12. Project timescale and milestones: please provide a clear indication of the study timescale and dates by which key milestones should be achieved.
  13. Study management: please state how and by whom the study will be managed, referring to the roles of specific applicants as appropriate.
  14. Public involvement: the NIHR expects the active involvement of patients and the public and other key stakeholders in the research it supports. In this section it is important that you describe how patients and the public, as well as relevant stakeholders (including evidence users), have been involved in the development of the application as well as plans for involvement in the proposed research. More guidance is available on our website. 
  15. Dissemination, knowledge exchange and impact: Explain how the findings from the proposed research will be disseminated to key stakeholders and end users and what other methods will be used to maximise the potential impact of the proposed research. Describe who the likely beneficiaries of the research are, when are they likely to benefit and in what ways. Applicants should clearly state the public health utility of their project outcomes and the mechanisms by which they will inform future public health policy and practice. Details about the potential impact and scalability of interventions, if shown to be effective, should be provided. This includes how health economic evaluation will inform affordability and return on investment where appropriate. 

    We acknowledge that defining impact can be challenging and pathways to impact are complex with many steps beyond your control. We therefore define impact broadly as the contribution, effect on, or benefit that excellent research makes to knowledge, people, health and care, the NHS, health and care services, society, the economy and policy. We wish to understand the ways in which the proposed research will change activity, attitudes, awareness, behaviour, capacity, opportunity, performance, decision-making, practice or processes. Impact can also result from new understanding that benefits individuals, population, organisations, communities, constituencies or the nation.

    How to disseminate your research: Getting your message heard - and used.

  16. We require that all NIHR funded research will be reported fully and made publicly available when the research has been completed. It is expected that research funded by the NIHR PHR Programme will publish a full and complete account of that research in the NIHR PHR Journal. This will ensure that this research is reported fully, and is publicly available with the abstract and full report freely available via the NIHR Journals Library website and the abstract freely available via Europe PubMed Central. 

    We expect that all researchers who have a contract with the NIHR to undertake research shall ensure that the outcome of the research is prepared as one or more research papers for publication in suitable peer-reviewed journals.

  17. Further guidance. All applications to the PHR programme that propose to carry out feasibility and/or pilot studies should include clear criteria to judge whether progression to the definitive study is justified. If a definitive trial is being proposed details of any prior feasibility and/or pilot work should be included as an upload. How the progression criteria of the feasibility and/or pilot study have been met should also be detailed. There are no set progression criteria to use but they should aim to address whether the uncertainties that were set out to be resolved in the preliminary studies have been determined. Examples of progression criteria could include (but not limited to):

    a. Did you recruit people / centres within a reasonable timespan?
    b. Was the intervention sufficiently acceptable and feasible to implement?
    c. Was the intervention delivered with reasonable fidelity?
    d. Do you have commitment to fund the intervention for the duration of the study?
    e. Could you assess the outcome measures?
    f. Is the underlying question still the same/has the context changed?
    g. Do you have reasonable estimates of effect size and variability to inform a sample size calculation?
    h. Have you established whether there is contamination between the arms of a cluster study and any strategies to mitigate this?
    i. Does the initial evaluation suggest that the intervention could be effective?
    j. Has the study led to refinement of the logic model?

    Please note that the criteria listed above should be used as a guide only and do not represent a comprehensive list of all the progression criteria that should be included within an application.

  18. Collaborators: Collaborators normally provide specific expertise on particular aspects of the project. Please detail who your collaborators are and how they have aided the development of the proposal. Where possible letters of support from collaborators should be added as an upload.  

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). Applicants should also describe complex interventions and controls as accurately and fully as possible within their diagram. 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. 

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

Attachment 3: CTU support letter

If appropriate to the study, please supply and upload a CTU letter of support.

Attachment 4: Logic model

You should also upload a logic model (single-side of A4), as a separate PDF file, to support the application. The logic model should describe the theory of change underpinning the intervention. You may find it useful to refer to the Nesta guidance when developing your logic model.

Attachment 5: Letters of support

Please upload any letters of support from study collaborators or partners. PHR are unable to fund intervention costs. Where applicable a letter from the provider of the intervention costs for the purposes of the study should be provided. These will be mandatory within the Stage 2 application.

Attachment 6: Papers in press

Supporting research papers not yet published or publically available should be provided where necessary.

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)
  • A logic model (document upload)
  • Letters of support (document upload)
  • Papers in press (if appropriate) document upload)
  • CTU letter of support (if appropriate) (document upload)