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HS&DR Application form guidance notes for submitting Stage 1 applications

 

Contents

Recent changes to the NIHR Stage 1 application guidance notes (as at April 2020)

Please note that these application guidance notes have recently been ‘refreshed’ to include important NIHR changes and updates which applicants need to take note of and reflect in their stage 1 applications. The changes/updates include the following:

  • More explicit guidance for applicants on NIHR’s expectations with regard to patient and public involvement
  • New guidance for applicants on Equality, Diversity and Inclusion for study participants (research following patient need and clusters of morbidity)
  • New guidance information about the provision of applicants equality and diversity monitoring information
  • A broadening of the guidance wording to ensure appropriateness for social care research

Application Summary Information

Host organisation

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

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 of existing data, select ‘Secondary Research’. If you are not sure which category to select, choose the closest match to your project as this can be adjusted later.

Proposed start date

Note this should be from 1st of the month regardless of whether this is a working day or not. Please be realistic about your possible start date taking account of the necessary contracting, and staff recruitment prior to starting your project.

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 & Treatment costs).

Estimated NHS support and treatment costs or external (not NHS) intervention costs

Enter the total amount of NHS support and treatment costs or external (not NHS) intervention costs associated with this proposal.

Estimated non-NHS intervention costs

Non-NHS intervention costs include costs incurred in delivering the 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 intervention 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 intervention costs for the purposes of the study should be supplied.
These are similar to excess treatment costs, but they mainly apply to Public Health and Social Care Research. They are unlikely to be applicable to HS&DR unless the intervention is being delivered outside the NHS (e.g. in school or by a local authority etc).

Administrative contact details

Do you wish us to contact you, the lead applicant, regarding this application? If no, provide administrative contact details (name, post held, department, organisation, contact details and access rights)

Lead applicant details / CV

Complete your name, contact details and other requested information.

Specify your (lead applicant) role in this research (Limit: 200 characters)

Explain in addition to your role as Lead Applicant, the role that you will be undertaking in the research,
e.g. co-ordination and project management, analysis, methodological input etc.

Lead applicant’s % FTE commitment

Commitment: This refers to the percentage of your time that you will commit to this project.

Lead applicant research background

Publication record (Limit: 10000 characters)

Provide details of a MAXIMUM of 6 of your most recent / relevant publications (in the last 10 years) relevant to this application (using Vancouver or Harvard citation format) listed one after another with a blank line between each one. Please use DOI reference numbers if needed.

Research grants held (Limit: 10000 characters)

This should include research grants held (as a named applicant) CURRENTLY or IN THE LAST 5 YEARS – as well as any additional previous grants, relevant to this application. Please include who the grant is with and the amount of each grant. If no grants are held please enter N/A (as this is a mandatory field). For each entry you should state: registration number and name of registry and the DOI of the main related publication. Where the study is still ongoing or final results have not yet been published, please provide an estimated publication date. This is in line with the NIHR policy on clinical trial registration and disclosure of results. 

Has this application been previously submitted to this or any other funding body?

Select ‘Yes’ or ‘No’ from the drop-down box to indicate whether this or a similar application has previously been submitted to this or any other funding body. For more information about resubmission of a research/ trainee funding application, or joint funding please contact the appropriate NIHR research funding programme.

Applications submitted to other NIHR programmes

Where this application or a similar one has been submitted to this or another NIHR programme or elsewhere please click the ‘Add’ button and complete the necessary information.

We are keen to know if the application has been submitted elsewhere and you must be as open about this as possible. This includes, but is not limited to, any facts that, should they come to light at a future date, would embarrass either the programme or the individual who withheld the fact (e.g. if a member of the team holds a patent or has a financial interest within the research area).

Failure to disclose accurately or fully will be considered by the programme as academic misconduct and treated accordingly. You should also include in this section information on whether this or a similar application has been submitted to any programme previously, or to any other funder including other NIHR programmes. You should name and provide dates and outcomes of these. Please indicate whether you hold or have ever held an NIHR programme contract which has been terminated prior to completion, extended in time or in terms of funding.
 

The research team – Joint Lead Applicant / Co-applicants

Joint Lead applicant

Where appropriate and justified it is acceptable for the application to be led by joint Lead Applicants.

NOTE: For application / contracting purposes the joint lead applicant will be regarded as a co-applicant.

Please click the ‘Add’ button and select the Joint Lead Applicant Role drop down option and enter their details (if applicable)

Justification for Joint Lead Applicant (Limit: 1500 characters)

Justification should be given to demonstrate why more than one person would be required to lead this research and how this brings added value to the application.

Relevant expertise and experience of Joint Lead Applicant (Limit: 1500 characters)

Please summarise the proposed Joint Lead Applicant’s relevant expertise and track record in applied health or social care research, in terms of skills and experience, previous publications, grant funding and impact on health service provision.

Joint Lead Applicant / Co-applicants / Co-applicants - PPI

Add details of all co-applicants (including Joint Lead Applicant if appropriate) and their specific role in the project. The number of co-applicants is calculated automatically. Do not include collaborators, who should be mentioned (if necessary) in the Research Plan section of the on-line application form.

We encourage the inclusion of public co-applicants, where appropriate. Please include a clear description of their role and the reasons why a public co-applicant is joining the team. For further information please access the 'Public Co-Applicants in Research' guidance

PPI Lead

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. For examples of the activities a PPI lead might undertake please find more information here

Co-applicants are those individuals with responsibility for the day to day management and delivery of the project. Co-applicants are considered part of the project team and are expected to share responsibility for its successful delivery. Collaborators normally provide specific expertise on particular aspects of the project but who do not share in the responsibility for the delivery of the project.

Please note that once you enter a co-applicant’s details they will receive an automated email informing them that this information has been added into our Management Information System (MIS) in conjunction with your application. Therefore, we would expect for you to have consulted with co- applicants before adding their details into the MIS.

Plain English summary of research

The importance of a plain English summary (Limit: 3500 characters)

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

Many reviewers use this summary to inform their review of your funding application. They include clinicians and 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 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 this or other sections of your application form to create the plain English summary.

Further guidance on writing in plain English is available online at NIHR Make it clear www.involve.nihr.ac.uk/makeitclear.

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

Research plan

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 overall amount of information that you can provide at this stage is limited to -4 pages (Limit: 20000 characters). 

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 prioritisation/funding committee including patient/service users, carers and public members.

Information and resources to assist you can be found on the INVOLVE website  (a detailed definition of patient and public involvement in researchbriefing notes for researchers on how to involve patients and the public and an involvement cost calculator and budgeting guide).
In this section it is important that you identify all stakeholders who are relevant to your research proposal. For each stakeholder group you need to 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.

Guidance for applicants on Equality, Diversity and Inclusion for study participants:

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

  • Geographical location
  • Age
  • Disability
  • Gender reassignment
  • Marriage and civil partnership
  • Pregnancy and maternity
  • Ethnicity - link (for example) to the toolkit for increasing participation of BAME groups in health and care research 
  • Religion or belief
  • Sex
  • Sexual orientation
  • Socioeconomic status
  • Access to health or social care 

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

Helpful links:

https://www.invo.org.uk/current-work/diversity-and-inclusion/

https://www.nihr.ac.uk/about-us/our-contribution-to-research/equality-diversity-and-inclusion.htm

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. Explain how your proposed research is within the remit of the HS&DR programme, specifying how it addresses the key aim of the programme to produce rigorous and relevant evidence on the quality, access and organisation of health and care services.

Why is this research important in terms of improving the health and/or wellbeing of the public and/or to patients and health and 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.
The HS&DR classification of need for research is set out below:

  1. Health/Care need: How will the public/patients see this as a need and as a potential improvement to their health and/or lives? There will be benefits in terms of improving health for the 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. For example, research in this area is likely to identify new ways of working that enhance opportunities for health promotion or quality and safety of care. Benefits may also arise from improving the acceptability and effectiveness of care, cost effectiveness to the NHS (or social care), better targeting of services or equity of access to care.
  2. Expressed need: The existence of an expressed need for the research in the health and care management community, and evidence that it is, or will be, highly relevant and important to the needs of the NHS (or social care). You should consider and demonstrate “What evidence is there that patients/service users and the service want the answer to this question and why will they will want to act on the outcomes of the research?”
  3. 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 once commissioned and undertaken will remain highly relevant and important to the needs of the NHS and/or care in the future. Researcher-led applications addressing areas of ongoing need, such as NIHR and HS&DR highlight notices and recent NIHR Themed calls should reference this fact in their proposal (under this heading).
  4. Capacity to generate new knowledge: 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. Generalisable findings and prospects for change: Research in this area is likely to produce generalisable or transferable findings of value to the health and care management community, which health and care organisations are likely to be able to use in their decision-making in ways that bring about change and improvement.
  6. Building on existing work: Research contributes to building a coherent body of knowledge in the area, and may build on, but not duplicate, previous research.

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.

  1. Commissioned calls: where the request for research to address a specific research question is via a commissioning brief advertised through a commissioned call, a review of the existing evidence will have already been undertaken by the funding NIHR Programme to inform the commissioning brief. Therefore, applicants intending to undertake a systematic evidence review as part of their research should build on and not duplicate the evidence review that will have already been undertaken. Applications in response to commissioned calls will need to address the commissioning brief requirements specific to the NIHR Programme.
  2. Researcher-led calls: for researcher-led or researcher-initiated proposals that include primary research then they should include reference to the existing evidence and explain how this evidence has informed the proposed research. Where an existing systematic review 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 normally systematically identifies, critically appraises and then synthesises the available evidence) and then present a summary of the findings of this in their proposal. All applicants must also include reference to relevant on-going studies, e.g. from trial registries.

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 health and social care policy and practice.

What is the research question / aims and objectives?

Please summarise the research question / key aims and objectives.

HS&DR funds research projects, not programmes of work or ongoing work. You must have clearly defined research questions, and aims and objectives, and describe how the planned methodology is likely to achieve these objectives.

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. Design: Please provide a clear summary of the type of study design to be used (e.g. Primary research: controlled trial; Evidence synthesis: systematic review), including methods, proposed sample and analysis methods, and explain why you have chosen the proposed methodology. You should also upload a flow diagram (single-side of A4), as a separate PDF file, for submission with your application form as appropriate. This 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. For qualitative work it may be appropriate to set out your theoretical framework.
  2. Team: Please list and explain the role of key collaborators involved in the research, as well as any patient/service user, carer and public leads (not previously listed as co-applicants). 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. For examples of the activities a PPI lead might undertake please find more information here
  3. PPI – Patient and Public Involvement: 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 lifecycle. 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. These activities could include the development of 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. You can find further resources to support the design of your PPI here. 
  4. Describe your plans for disseminating the outputs / findings of this research: Our key concern is to ensure that projects funded by the HS&DR 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 knowledge products or 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 ways, and describe how the knowledge will be translated into the real world. Link to NIHR Dissemination guidance:How to disseminate your research: Getting your message heard - and used.
  5. Expected Impact: Use this section to provide information about the impact you anticipate the study may have. We acknowledge that defining impact can be challenging and paths 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 or the economy. 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.
  6. 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 a research paper for publication in a suitable peer- reviewed journal. We would also encourage all researchers to disseminate their research findings to the broader public as well as to the research participants / health and care management community (as appropriate) when the study has completed.
    Further information / tips can be found at: Tips for applicants.

Uploads

Attachment 1: flow diagram

Finally, please create a flow diagram (single-side of A4), as a separate PDF file, for submission with your application form. This should illustrate the study design and the flow of participants. Applicants should also describe complex interventions and controls as accurately and fully as possible within their diagram. If proposing an RCT, we advise you refer to the CONSORT statement and website for guidance. Alternatively, you may find the EQUATOR Network website useful. The PDF file should be submitted along with your application form.

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.

Acknowledge, review and submit

Conflict checks

Please declare any conflicts or potential conflicts of interest that you or your co-applicants may have in undertaking this research, including any relevant, non-personal & commercial interest that could be perceived as a conflict of interest.

Agreement to terms and conditions

I have read and understood the terms on which I have been nominated as Chief Investigator for this proposal along with the associated documentation and accept this role.
A list of terms and conditions can be found here: Terms and Conditions

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.

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

Applicants should click the check boxes to indicate that 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)