PHR Stage 1 guidance notes

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

As part of NIHR response to the Government’s call for further reduction in bureaucracy the Stage 1 application has recently been reduced in scope. The changes include:

• Lead Applicant: the lead applicant’s research background (publications and grants) are no longer required at this stage.
• History of Application: information about the history of application is no longer required at this stage.
• Joint Lead Applicant: Less information is requested at this stage about the joint lead applicant.

Application summary information

Contracting organisation

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

Research title

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 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.

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

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.

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 note: you are not required to complete this section as it is no longer required as part of a stage 1 application submission. However, as it is a mandatory field please enter N/A.

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. 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/programme.

This role should be a budgeted and resourced research team member. Examples of the activities a PPI lead might be accountable for.

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
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 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.

Further guidance on writing in plain English 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

Using all of 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 patient and public involvement plans will be assessed by the funding committees including patient and public members.

Information and resources to assist you can be found on NIHR website, including Briefing notes for researchers on how to involve patients/service users, carers and the public,  (including definition of involvement engagement and participation) and payments guidance for researchers and professionals with information on budgeting for involvement.

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.

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:

• Geographical location 
• Age
• Disability
• Gender reassignment
• Marriage and civil partnership
• Pregnancy and maternity
• Ethnicity - useful links (for example) to:
  The toolkit for increasing participation of BAME groups in health and care research 
  The INCLUDE Ethnicity Framework, which aims to improve trial delivery for under-served groups 
• 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. 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) 

Helpful links:
Promoting equality,diversity and inclusion in research

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 and/or public 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 and social care interventions.

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.

In your response, please refer to the criteria 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? 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.
• Expressed need: Please state how the research or evidence generated will be relevant and important to the need to improve public health. 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?”
• 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.
• 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.
• 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 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).

• 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.
• 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).
• Control/comparator group: please state what appropriate comparator(s) will be used in an evaluation and how it will be selected.
• 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?
• Setting: where will the research be undertaken and the intervention delivered?
• Outcome measures: please state and justify the primary and secondary outcome measures.
• Methods for data collection: for each outcome, process or economic measure proposed, please state the method of data collection, including qualitative methods where appropriate.
• 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.
• 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.
• Health economic evaluation: to inform affordability and return on investment a health economic evaluation should be included in your study. If you do not intend to include a health economic evaluation, justification for why this is not appropriate should be provided.
• 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). 
• Project timescale and milestones: please provide a clear indication of the study timescale and dates by which key milestones should be achieved.
• Study management: please state how and by whom the study will be managed, referring to the roles of specific applicants as appropriate. 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. Examples of the activities a PPI lead might undertake.
• Public involvement: The NIHR expects appropriate 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.
  Further resources to support the design of your PPI.

  For more guidance, please see our manage your project pages. 

• 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. It is important to include details of how you will share with study participants the progress and findings of the study.

• NIHR Dissemination guidance: How to disseminate your research: Getting your message heard - and used.
• 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.
• 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. 
• 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

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. 

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.  

PHR are unable to fund intervention costs, it is important that letters of support from funders are included as uploads. These will be mandatory within the stage 2 application.

Attachment 2: references

Upload a list of references used throughout your proposal, using either the Vancouver or Harvard referencing conventions (maximum 1 side of A4) and include the DOI of the main related publication.

Attachment 3: CTU support letter  (if required / appropriate to the study)

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

Attachment 4: logic model or equivalent

Where appropriate please supply a logic model or equivalent

Attachment 5: letters of support

Please upload any letters of support from study collaborators or partners. Where applicable a letter from the provider of the intervention costs for the purposes of the study should be provided.

Attachment 6: papers in press

Supporting research papers not yet published or publicly available should be provided.

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. 
(Note that terms and conditions statement to include expectation/responsibility for applicant keep the contracting institution/interested parties informed).

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 users, carers and the public
• A clear, appropriate and relevant plan for dissemination
• A flow diagram illustrating the study design / flow of participants (document upload)
• A single A4 page of references (document upload)
• A logic model (document upload)
• Letters of support (document upload)
• Papers in press (document upload)
• CTU letter of support (if appropriate) (document upload)